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Sample records for everolimus-eluting stent implantation

  1. Stent Fracture after Everolimus-Eluting Stent Implantation

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    Ali S. Almasood

    2011-01-01

    Full Text Available Compared with bare-metal stents, drug-eluting stents (DES have greatly reduced the risk of in-stent restenosis (ISR by inhibiting neointimal growth. Nevertheless, DES are still prone to device failure, which may lead to cardiac events. Recently, stent fracture (SF has emerged as a potential mechanism of DES failure that is associated with ISR. Stent fracture is strongly related to stent type, and prior reports suggest that deployment of sirolimus eluting stents (SES may be associated with a higher risk of SF compared to other DES. Everolimus eluting stents (EESs represent a new generation of DES with promising results. The occurrence of SF with EES has not been well established. The present paper describes two cases of EES fracture associated with ISR.

  2. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation

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    Yamaji, Kyohei; Brugaletta, Salvatore; Sabaté, Manel

    2017-01-01

    OBJECTIVES: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EE...

  3. Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent

    DEFF Research Database (Denmark)

    Ishibashi, Yuki; Muramatsu, Takashi; Nakatani, Shimpei

    2015-01-01

    OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periproce......OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence...

  4. Intravascular Ultrasound Predictors of Major Adverse Cardiovascular Events After Implantation of Everolimus-eluting Stents for Long Coronary Lesions.

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    Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2017-02-01

    There are limited data on the usefulness of intravascular ultrasound (IVUS) for long coronary lesions treated with second-generation drug-eluting stents. We evaluated IVUS predictors of major adverse cardiovascular events (MACE) 12 months after implantation of everolimus-eluting stents for long coronary lesions. A total of 804 patients who underwent both postintervention IVUS examination and long everolimus-eluting stent (≥ 28mm in length) implantation were included from 2 randomized trials. MACE was defined as a composite of cardiac death, myocardial infarction, and target-lesion revascularization. MACE occurred in 24 patients (3.0%) over 12 months. On multivariable Cox regression analysis, independent IVUS predictors of MACE included the postintervention minimum lumen area (MLA) at the target lesion (HR = 0.623; 95%CI, 0.433-0.895; P=.010) and the ratio of MLA/distal reference segment lumen area (HR = 0.744; 95%CI, 0.572-0.969; P=.028). The MLA and MLA-to-distal reference segment lumen area ratio that best predicted patients with MACE from those without these events were 5.0 mm(2) and 1.0, respectively. Patients with MLAMLA of<5.0 mm(2) or a distal reference segment lumen area were at risk for MACE after long everolimus-eluting stent implantation. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  5. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial

    NARCIS (Netherlands)

    Onuma, Yoshinobu; Sotomi, Yohei; Shiomi, Hiroki; Ozaki, Yukio; Namiki, Atsuro; Yasuda, Satoshi; Ueno, Takafumi; Ando, Kenji; Furuya, Jungo; Igarashi, Keiichi; Kozuma, Ken; Tanabe, Kengo; Kusano, Hajime; Rapoza, Richard; Popma, Jeffrey J.; Stone, Gregg W.; Simonton, Charles; Serruys, Patrick W.; Kimura, Takeshi

    2016-01-01

    We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES). In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to

  6. Impact of total stent length after cobalt chromium everolimus-eluting stent implantation on 3-year clinical outcomes.

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    Hiromasa, Takashi; Kuramitsu, Shoichi; Shinozaki, Tomohiro; Jinnouchi, Hiroyuki; Morinaga, Takashi; Kobayashi, Yohei; Domei, Takenori; Soga, Yoshimitsu; Shirai, Shinichi; Ando, Kenji

    2017-02-01

    The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes. The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear. A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed. After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups. TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  7. Impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold implantation: An observation from the ABSORB Japan trial

    NARCIS (Netherlands)

    Ohya, M. (Masanobu); K. Kadota (Kazushige); Y. Sotomi (Yohei); K. Kozuma (Ken); K. Tanabe (Kengo); Uematsu, M. (Masaaki); Kawasaki, T. (Tomohiro); Morino, Y. (Yoshihiro); Tobaru, T. (Tetsuya); Nakao, K. (Koichi); Tachibana, K. (Kouichi); Kishi, K. (Koichi); Shibata, Y. (Yoshisato); S. Ying (Shihwa); Kusano, H. (Hajime); G.W. Stone (Gregg); J.J. Popma (Jeffrey); Y. Onuma (Yoshinobu); P.W.J.C. Serruys (Patrick); T. Kimura (Takeshi)

    2017-01-01

    textabstractAims: We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. Methods and

  8. Impact of cytochrome P450 2C19 loss-of-function polymorphism on intra-stent thrombi and lesion outcome after everolimus-eluting stent implantation compared to that after first-generation drug-eluting stent implantation.

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    Konishi, Akihide; Shinke, Toshiro; Otake, Hiromasa; Nishio, Ryo; Sawada, Takahiro; Takaya, Tomofumi; Nakagawa, Masayuki; Osue, Tsuyoshi; Taniguchi, Yu; Iwasaki, Masamichi; Kinutani, Hiroto; Masaru, Kuroda; Takahashi, Hachidai; Terashita, Daisuke; Shite, Junya; Hirata, Ken-ichi

    2015-01-20

    The contribution of clopidogrel response due to cytochrome P450 (CYP) 2C19 loss-of-function polymorphism after drug-eluting stent (DES) implantation is unclear. A total of 196 patients who had undergone optical coherence tomography (OCT) at 8 months following first-generation DES (120 lesions) and current-generation everolimus-eluting stent (EES) implantation (127 lesions) were enrolled. Patients were divided into 3 groups by CYP2C19 polymorphism: extensive metabolizers (EMs), intermediate metabolizers (IMs), and poor metabolizers (PMs). OCT findings were compared among the 3 groups. Responsiveness to clopidogrel was assessed by VerifyNow platelet reactivity unit (PRU). The incidence of intra-stent thrombi was significantly higher after first-generation DES implantation compared with EES implantation (35% vs 13%, respectively; p=0.0001). In the first-generation DES group, the incidence of intra-stent thrombi significantly increased among EMs, IMs, and PMs (21% vs 36% vs 63%, respectively; p=0.007), while there was no significant difference among the 3 groups after EES implantation (10% vs 13% vs 20%, respectively; p=0.55). The PRU significantly increased among EMs, IMs, and PMs in each stent group. In multivariate analyses, although PMs had a 3-fold higher risk of thrombi formation compared with non-PMs after first-generation DES implantation, there were no significant differences in thrombi formation between the 2 groups after EES implantation. The optimal PRU cutoff values for the prediction of intra-stent thrombi with first-generation DES and EES were 234 and 256, respectively. CYP2C19 loss-of-function polymorphism is associated with a higher incidence of intra-stent thrombi after first-generation DES implantation, while the impact is attenuated following EES implantation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

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    Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

    2011-01-01

    We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

  10. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials

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    Tanimoto, Shuzou; Serruys, Patrick W; Thuesen, Leif

    2007-01-01

    artery lesions, were enrolled: 27 patients treated with the BVS and 27 patients treated with the everolimus-eluting cobalt chromium stent (EES). Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon......OBJECTIVES: This study sought to evaluate and compare in vivo acute stent recoil of a novel bioabsorbable stent and a metallic stent. BACKGROUND: The bioabsorbable everolimus-eluting coronary stent (BVS) is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing...... the antiproliferative drug, everolimus, and expected to be totally metabolized and absorbed in the human body. Because the BVS is made from polymer, it may have more acute recoil than metallic stents in vivo. METHODS: A total of 54 patients, who underwent elective stent implantation for single de novo native coronary...

  11. Early vascular healing after titanium-nitride-oxide-coated stent versus platinum-chromium everolimus-eluting stent implantation in patients with acute coronary syndrome.

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    Varho, Ville; Kiviniemi, Tuomas O; Nammas, Wail; Sia, Jussi; Romppanen, Hannu; Pietilä, Mikko; Airaksinen, Juhani K; Mikkelsson, Jussi; Tuomainen, Petri; Perälä, Anssi; Karjalainen, Pasi P

    2016-07-01

    Data on early vascular healing response of novel stent designs are scarce. In this randomized prospective trial, we sought to compare early neointimal coverage of cobalt-chromium-based titanium-nitride-oxide-coated bioactive stents (CoCr-BAS) versus platinum-chromium everolimus-eluting stents (PtCr-EES) at 2-month follow-up in patients with acute coronary syndrome (ACS). Forty patients with ACS were randomized to receive either CoCr-BAS (n = 19) or PtCr-EES (n = 21). Neointimal strut coverage and strut apposition were examined by optical coherence tomography; and coronary flow reserve (CFR), fractional flow reserve (FFR) and index of microcirculatory resistance (IMR) were assessed using a coronary pressure wire at 2 months. Two patients in the PtCr-EES underwent OCT out of the time frame of the study, and were excluded from analysis. At 63 ± 8 days, 302 cross-sections (3412 struts) were analysed in the CoCr-BAS group, and 324 cross-sections (3460 struts) in the PtCr-EES group. Median [IQR] neointimal thickness was 203 [108] µm and 42.2 [41] µm for CoCr-BAS and PtCr-EES, respectively (p  0.05 for all). CoCr-BAS showed earlier and more adequate neointimal coverage of struts at 2 months, compared with PtCr-EES, but with more neointimal hyperplasia. Functional healing as assessed by CFR, FFR, and IMR was similar between the two stent arms.

  12. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II)

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    Serruys, Patrick W; Chevalier, Bernard; Sotomi, Yohei

    2016-01-01

    BACKGROUND: No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions......-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA......). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co...

  13. The everolimus-eluting Xience stent in small vessel disease: bench, clinical, and pathology view

    Directory of Open Access Journals (Sweden)

    Sanchez OD

    2014-12-01

    Full Text Available Oscar D Sanchez, Kazuyuki Yahagi, Tobias Koppara, Renu Virmani, Michael Joner CVPath Institute, Inc., Gaithersburg, MD, USA Abstract: Coronary artery disease (CAD is the leading cause of morbidity and mortality worldwide. The pathogenesis of CAD relates to the presence of atherosclerotic plaques in the coronary arteries, which are most frequently treated today by percutaneous coronary intervention. Small vessel disease treatment represents one-third of all percutaneous coronary interventions with higher rates of restenosis and major adverse cardiac events. Initially, drug-eluting stents (DES were developed to reduce in-stent restenosis, improving clinical outcomes and reducing the need for target vessel revascularization. However, late and very late stent thrombosis emerged as a new problem compromising DES's long-term results. The cobalt–chromium everolimus-eluting stent (CoCr-EES represents the results of an evolutionary process in DES technology aimed at improving the shortcomings of first-generation DES. Small vessel CAD has historically been an obstacle to long-term patency following implantation of DES. Antirestenotic efficacy has been shown to be of high relevance in small vessels. Therefore, stent selection may play an important role in determining outcomes in this subgroup of patients. This article will review the performance of CoCr-EES in the treatment of small vessel CAD from preclinical, clinical, and pathology perspectives, and it will highlight the most important findings in this regard. Keywords: small vessel, cobalt–chromiun everolimus-eluting stent, Xience V, pathology

  14. Current status of the Xience V® everolimus-eluting coronary stent system

    NARCIS (Netherlands)

    Claessen, Bimmer E.; Caixeta, Adriano; Henriques, José P. S.; Piek, Jan J.

    2010-01-01

    The introduction of drug-eluting stents has led to a marked reduction of restenosis, which is a major limitation of percutaneous coronary intervention for coronary artery disease. The next-generation Xience V® (Abbott Vascular, CA, USA) everolimus-eluting stent was designed to address the

  15. Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population.

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    Costopoulos, Charis; Latib, Azeem; Naganuma, Toru; Miyazaki, Tadashi; Sato, Katsumasa; Figini, Filippo; Sticchi, Alessandro; Carlino, Mauro; Chieffo, Alaide; Montorfano, Matteo; Colombo, Antonio

    2015-01-01

    To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease. BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited. All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months. In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19). ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  16. Comparison of clinical outcomes of coronary artery stent implantation in patients with end-stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer-EES, platinum chromium-EES, and cobalt chrome-EES.

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    Sato, Takao; Hatada, Katsuharu; Kishi, Syohei; Fuse, Koichi; Fujita, Satoshi; Ikeda, Yoshio; Takahashi, Minoru; Matsubara, Taku; Okabe, Masaaki; Aizawa, Yoshifusa

    2017-11-22

    New-generation bioresorbable polymer-everolimus eluting stents (BP-EES) are available. This study aimed to compare the clinical outcomes for BP-EES compared to more established stent designs, namely the platinum chromium-EES (PtCr-EES) and cobalt chrome-EES(CoCr-EES) in patients with the end-stage chronic kidney disease (CKD) including hemodialysis (HD). One-hundred-forty-one consecutive stents (BP-EES [n = 44], PtCr-EES [n = 45], and CoCr-EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow-up coronary angiography at 12 months after implantation. End-stage CKD was defined as an estimated glomerular filtration rate (eGFR) stent groups after implantation and the 12-month follow-up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter-stenosis (%DS) were measured using quantitative coronary angiography. The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12-month follow-up, a tendency towards higher TLR was observed for the BP-EES group (22.7%) compared with the PtCr-EES (8.8%) and CoCr-EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP-EES (0.51 ± 0.64 mm) group than either the PtCr-EES (0.20 ± 0.61 mm) and CoCr-EES (0.25 ± 0.70 mm) groups (P = 0.03). BP-EES might increase the risk of in-stent restenosis in patients with end-stage of CKD or the need for HD. © 2017, Wiley Periodicals, Inc.

  17. One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial.

    Science.gov (United States)

    Natsuaki, Masahiro; Morimoto, Takeshi; Yamamoto, Erika; Shiomi, Hiroki; Furukawa, Yutaka; Abe, Mitsuru; Nakao, Koichi; Ishikawa, Tetsuya; Kawai, Kazuya; Yunoki, Kei; Shimizu, Shogo; Akao, Masaharu; Miki, Shinji; Yamamoto, Masashi; Okada, Hisayuki; Hoshino, Kozo; Kadota, Kazushige; Morino, Yoshihiro; Igarashi, Keiichi; Tanabe, Kengo; Kozuma, Ken; Kimura, Takeshi

    2016-07-01

    There has been no previous prospective study evaluating dual antiplatelet therapy (DAPT) duration shorter than 6 months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration after CoCr-EES implantation. The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding at 1 year. Between September 2012 and October 2013, a total of 1525 patients were enrolled from 58 Japanese centers, with complete 1-year follow-up in 1519 patients (99.6 %). Thienopyridine was discontinued within 4 months in 1444 patients (94.7 %). The event rates beyond 3 months were very low (cardiovascular death: 0.5 %, MI: 0.1 %, ST: 0 %, stroke: 0.7 %, and TIMI major/minor bleeding: 0.8 %). Cumulative 1-year incidence of the primary endpoint was 2.8 % [upper 97.5 % confidence interval (CI) 3.6 %], which was lower than the pre-defined performance goal of 6.6 % (P < 0.0001). Using the CoCr-EES group in the RESET trial as a historical comparison group, where nearly 90 % of patients had continued DAPT at 1 year, cumulative incidence of the primary endpoint tended to be lower in the STOPDAPT than in the RESET (2.8 versus 4.0 %, P = 0.06) and adjusted hazard ratio was 0.64 (95 % CI 0.42-0.95, P = 0.03). The cumulative incidence of definite/probable ST was lower in the STOPDAPT than in the RESET [0 patient (0 %) versus 5 patients (0.3 %), P = 0.03]. In conclusion, stopping DAPT at 3 months in selected patients after CoCr-EES implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.

  18. Safety and efficacy of everolimus-eluting stents for bare-metal in-stent restenosis

    Energy Technology Data Exchange (ETDEWEB)

    Ota, Hideaki [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Mahmoudi, Michael [University of Surrey, Guildford Road, Surrey, GU2-7XH (United Kingdom); Torguson, Rebecca; Satler, Lowell F.; Suddath, William O.; Pichard, Augusto D. [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Waksman, Ron, E-mail: ron.waksman@medstar.net [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States)

    2015-04-15

    Objective: The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. Background: The optimal treatment for bare-metal in-stent restenosis remains controversial. Methods: The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year. Results: The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES = 3.5%, PES = 4.6%, SES = 4.2%; p = 0.94), MI (EES = 3.5%, PES = 6.3%, SES = 2.1%; p = 0.31), TLR (EES = 9.8%, PES = 9.5%, SES = 5.7%; p = 0.42), TVR (EES = 14.3%, PES = 11.1%, SES = 11.3%; p = 0.74), definite ST (EES = 0.9%, PES = 3.1%, SES = 3.5%; p = 0.38) and MACE (EES = 14.0%, PES = 15.4%, SES = 10.5%; p = 0.54). Male gender (hazard ratio = 0.47; 95% confidence interval = 0.25–0.88) and number of treated lesions (hazard ratio = 1.47; 95% confidence interval = 1.06–2.05) were found to be independent predictors of MACE. Conclusion: The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.

  19. Rationale and design of the EXAMINATION trial: A randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction

    NARCIS (Netherlands)

    M. Sabate (Manel); A. Cequier; A. Iñiguez (Andrés); A. Serra; R. Hernandez-Antolin (Rosana); V. Mainar (Vicente); M. Valgimigli (Marco); M. Tespili (Maurizio); P. den Heijer (Pieter); A. Bethencourt (Armando); N. Vazquez (Nicolás); S. Brugaletta (Salvatore); B.A.M.W. Backx (Bianca); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractAims: To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation

  20. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events

    DEFF Research Database (Denmark)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph

    2014-01-01

    eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. PRIMARY OUTCOMES: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite......OBJECTIVES: To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. DESIGN: Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were...... or probable stent thrombosis, target vessel revascularisation, and all cause death. RESULTS: The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had...

  1. Comparison of platinum chromium everolimus-eluting stent with cobalt chromium everolimus-eluting stent in unselected patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Li, R-G; Lee, C-H; Low, A; Chan, M; Chan, K H; Richards, A M; Qu, X-K; Fang, W-Y; Tan, H C

    2015-06-01

    The recent PLATINUM trial has demonstrated that the use of the new generation platinum chromium everolimus-eluting stents (PtCr-EES) yield clinical outcomes similar to those obtained by the use of cobalt chromium everolimus-eluting stents (CoCr-EES) in selected patients with 1 or 2 de novo coronary artery lesions. This study aimed to compare the safety and efficacy of the PtCr-EES and CoCr-EES in unselected patients from a real-life single-center registry.   From July 2009 through November 2010, 788 consecutive patients in our institution with symptomatic coronary artery disease who were treated with the CoCr-EES (n = 410) or PtCr-EES (n = 378) were enrolled into this study. The primary endpoint of the study was target-lesion failure (TLF) at 12-month follow-up and the secondary endpoints were major adverse cardiovascular events and stent thrombosis. The prevalence of TLF in the PtCr-EES group (4.5%) was similar to that in the CoCr-EES group (3.9%). In addition, there were no significant differences in the 12-month rates of cardiac death (2.1% vs. 1.5%), myocardial infarction (2.4% vs. 3.9%), ischemia-driven target lesion revascularization (2.4% vs. 2.2%), and definite or probable stent thrombosis (0.5% vs. 1.5%, all p > 0.05). At 12-month follow-up, the PtCr-EES is comparable in safety and efficacy to the CoCr-EES in unselected patients with coronary artery diseases.

  2. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents.

    Science.gov (United States)

    Kim, Byeong-Keuk; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2015-02-01

    No randomized data exist regarding optical coherence tomography (OCT) evaluation immediately post-procedure and at the 3-month follow-up for platinum-chromium everolimus-eluting stents (PtCr-EES) versus cobalt-chromium everolimus-eluting stents (CoCr-EES). A total of 100 patients were randomly assigned to undergo PtCr-EES (n = 51) or CoCr-EES (n = 49) implantation. OCT was serially evaluated after stent deployment with nominal pressure and immediately post-procedure, and 3-month follow-up. The primary endpoint was the percentage of malapposed strut after nominal pressure and immediately post-procedure. Compared to the CoCr-EES, the PtCr-EES showed a lower tendency of percent malapposed strut at nominal pressure [median value (interquartile range); 4.1 % (0.5-11.7) vs. 7.6 % (2.9-13.7), p = 0.082] and immediately post-procedure [1.2 % (0-3.4) vs. 2.5 % (0.7-5.3), p = 0.051]. The percentage of cross sections with any malapposed struts was significantly lower with PtCr-EES at nominal pressure [15.0 % (5.6-39.0) vs. 23.8 % (18.2-44.4), p = 0.036] and immediately post-procedure [6.5 % (0-15.3) vs. 10.5 % (7.1-20.0), p = 0.026]. At the 3-month follow-up, both PtCr-EES and CoCr-EES showed comparable percentages of malapposed struts (0 vs. 0 %, respectively, p = 0.332) and uncovered struts (5.3 vs. 4.7 %, respectively, p = 0.829). We found a significant correlation between the immediate post-procedural percentage of malapposed struts versus the percentage of uncovered struts (r = 0.430, p < 0.001) at the 3-month follow-up. Compared to the CoCr-EES, the PtCr-EES shows a lower tendency toward a lower percentage of malapposed struts but no significant difference in strut coverage at the 3-month follow-up. The percentage of malapposed struts immediately post-procedure was correlated with strut coverage at the 3-month follow-up.

  3. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study.

    Science.gov (United States)

    Kim, Young-Hak; Park, Duk-Woo; Ahn, Jung-Min; Yun, Sung-Cheol; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Jang, Yangsoo; Jeong, Myung-Ho; Kim, Hyo-Soo; Hur, Seung-Ho; Rha, Seung-Woon; Lim, Do-Sun; Her, Sung-Ho; Seung, Ki Bae; Seong, In-Whan; Park, Seung-Jung

    2012-07-01

    This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis. The clinical benefit of second-generation DES for ULMCA stenosis has not been determined. The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272). EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16). Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Bennett J

    2013-06-01

    Full Text Available Johan Bennett, Christophe DuboisDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, BelgiumAbstract: The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.Keywords: drug-eluting stent, restenosis, Promus Element, Synergy

  5. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

    DEFF Research Database (Denmark)

    Garg, Scot; Serruys, Patrick W; Silber, Sigmund

    2011-01-01

    This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

  6. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

    Science.gov (United States)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

    2014-11-04

    To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; Pstents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis. © Valgimigli et al 2014.

  7. Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction

    DEFF Research Database (Denmark)

    Räber, Lorenz; Onuma, Yoshinobu; Brugaletta, Salvatore

    2015-01-01

    Aims: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with d...

  8. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V®

    Directory of Open Access Journals (Sweden)

    Imad Sheiban

    2008-02-01

    Full Text Available Imad Sheiban1, Gianluca Villata1, Mario Bollati1, Dario Sillano1, Marzia Lotrionte2, Giuseppe Biondi-Zoccai11Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy; 2Institute of Cardiology, Catholic University, Rome, ItalyAbstract: Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES, such as sirolimus-eluting (Cypher® and paclitaxel-eluting stents (Taxus®, have further improved results of percutaneous coronary intervention (PCI by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor® and everolimus-eluting stents (Xience V®, have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.Keywords: coronary artery disease, everolimus, percutaneous

  9. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V).

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.

  10. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V®)

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher®) and paclitaxel-eluting stents (Taxus®), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor®) and everolimus-eluting stents (Xience V®), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent. PMID:18629361

  11. Trial of everolimus-eluting stents or bypass surgery for coronary disease.

    Science.gov (United States)

    Park, Seung-Jung; Ahn, Jung-Min; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Cohen, David J; Yeung, Alan C; Hur, Seung Ho; Seung, Ki Bae; Ahn, Tae Hoon; Kwon, Hyuck Moon; Lim, Do-Sun; Rha, Seung-Woon; Jeong, Myung-Ho; Lee, Bong-Ki; Tresukosol, Damras; Fu, Guo Sheng; Ong, Tiong Kiam

    2015-03-26

    Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

  12. Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial

    NARCIS (Netherlands)

    Sotomi, Yohei; Onuma, Yoshinobu; Dijkstra, Jouke; Miyazaki, Yosuke; Kozuma, Ken; Tanabe, Kengo; Popma, Jeffrey J.; de Winter, Robbert J.; Serruys, Patrick W.; Kimura, Takeshi

    2018-01-01

    The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the

  13. Three-year follow-up of patients with bifurcation lesions treated with sirolimus- or everolimus-eluting stents: SEAside and CORpal cooperative study.

    Science.gov (United States)

    Pan, Manuel; Burzotta, Francesco; Trani, Carlo; Medina, Alfonso; Suárez de Lezo, Jose; Niccoli, Giampaolo; Romero, Miguel; Porto, Italo; Mazuelos, Francisco; Leone, Antonio Maria; Martín, Pedro; Coluccia, Valentina; Suárez de Lezo, Javier; Ojeda, Soledad; Crea, Filippo

    2014-10-01

    To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents. A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization). At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02). Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years' follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  14. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Hansen, Henrik Steen

    2012-01-01

    BACKGROUND: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. METHODS AND RESULTS: The Scandinavian Organi.......9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88). CONCLUSION: The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877....

  15. Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan.

    Science.gov (United States)

    Aoki, Jiro; Kozuma, Ken; Awata, Masaki; Nanasato, Mamoru; Shiode, Nobuo; Tanabe, Kengo; Yamaguchi, Junichi; Kusano, Hajime; Nie, Hong; Kimura, Takeshi

    2016-01-01

    The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years. Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan.

  16. The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry)

    NARCIS (Netherlands)

    Lemmert, M.E.; Mieghem, N.M. van; Geuns, R.J.M. van; Diletti, R.; Bommel, R.J. van; Domburg, R.T. van; Jaegere, P.P. de; Regar, E.; Zijlstra, F.; Boersma, E.; Daemen, J.

    2017-01-01

    BACKGROUND: A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. METHODS: A total

  17. Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention

    Energy Technology Data Exchange (ETDEWEB)

    Escárcega, Ricardo O.; Baker, Nevin C.; Magalhaes, Marco A.; Lipinski, Michael J.; Minha, Sa’ar; Torguson, Rebecca; Satler, Lowell F.; Pichard, Augusto D.; Suddath, William O.; Waksman, Ron, E-mail: ron.waksman@medstar.net

    2014-09-15

    Objective: To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). Background: EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). Methods: A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. Results: EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p = 0.06 and 8.8% vs. 12.6%, respectively, p = 0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p = 0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome. Conclusion: While EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.

  18. Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

    Science.gov (United States)

    Ishihara, Takayuki; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Sunaga, Akihiro; Awata, Masaki; Nanto, Shinsuke; Uematsu, Masaaki

    2017-03-02

    Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P = 0.38) and heterogeneity of NIC (P = 0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P = 0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4 months after implantation.

  19. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

    Science.gov (United States)

    Pilgrim, Thomas; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Heg, Dik; Jüni, Peter; Windecker, Stephan

    2014-09-01

    Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF. Copyright © 2014 Mosby, Inc. All rights reserved.

  20. Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program

    Directory of Open Access Journals (Sweden)

    R Michael Kirchner

    2009-12-01

    Full Text Available R Michael Kirchner, J Dawn AbbottDepartment of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI, USAAbstract: Drug-eluting stents (DES have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimuseluting (Cypher® and paclitaxel-eluting (Taxus® stents and later approved second-generation everolimus-eluting (Xience V® and zotarolimus-eluting (Endeavor® stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision® stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.Keywords: cobalt-chromium, drug-eluting stent, everolimus, percutaneous coronary intervention, Xience V

  1. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients the randomized diabetes and drug-eluting stent (DiabeDES) IV intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Maeng, Michael; Thayssen, Per

    2013-01-01

    in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.......0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3...

  2. Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography

    Energy Technology Data Exchange (ETDEWEB)

    Tada, Tomohisa, E-mail: tomohisa@dhm.mhn.de [Deutsches Herzzentrum, Technische Universität, München (Germany); Byrne, Robert A. [Deutsches Herzzentrum, Technische Universität, München (Germany); Schuster, Tibor [Institut für Medizinische Statistik und Epidemiologie, München (Germany); Cuni, Rezarta [Deutsches Herzzentrum, Technische Universität, München (Germany); Kitabata, Hironori [Wakayama Medical University, Wakayama (Japan); Tiroch, Klaus [Deutsches Herzzentrum, Technische Universität, München (Germany); Dirninger, Alfred; Gratze, Franz; Kaspar, Klaus; Zenker, Gerald [Landeskrankenhaus Bruck/Mur (Austria); Joner, Michael; Schömig, Albert; Kastrati, Adnan [Deutsches Herzzentrum, Technische Universität, München (Germany)

    2013-03-15

    Background: Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤ 8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months. Methods: A total of 20 patients were randomly assigned to stenting with BP-SES (n = 11) or EES (n = 9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach. Results: Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p = 0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p = 0.97). No difference in percent neointimal volume (14.1 ± 8.2% vs. 11.4 ± 6.4%, p = 0.56) was observed. Conclusions: Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.

  3. Outcome of everolimus eluting bioabsorbable vascular scaffold (BVS) compared to non BVS drug eluting stent in the management of ST-segment elevation myocardial infarction (STEMI) — A comparative study

    Energy Technology Data Exchange (ETDEWEB)

    Chakraborty, Rabin; Patra, Soumya, E-mail: dr_soumyapatra@rediffmail.com; Banerjee, Suvro; Pande, Arindam; Khan, Aftab; Mandol, Prakash Chandra; Ghosh, Debashish; De, Swapan Kumar; Das, Sankha Subhro; Nag, Raja

    2016-04-15

    Background: The safety and efficacy of everolimus eluting bioabsorbable vascular scaffold (BVS) in the management of “ST” segment elevation myocardial infarction (STEMI) are yet to be established. Aims: To evaluate immediate and short term safety and efficacy of the everolimus-eluting ABSORB BVS compared with non BVS drug eluting stent (DES) in patients with STEMI. Methods: From December 2013 to December 2014, 220 patients with STEMI were included in this study. Among them, 35 patients treated with BVS were compared with a control group composed of 180 patients who underwent non BVS DES implantation in the same time period. The incidence of major adverse cardiac events (MACE: stent thrombosis: death, non-fatal myocardial infarction, or target vessel/lesion revascularization) before discharge and up to six months was evaluated. Results: 1 vessel disease was more frequent whereas, 2 and 3 vessel disease was less frequent in BVS group. Procedural characteristics were also similar between groups, except for the use of post dilation (p = 0.04). Procedural success, in-hospital, and up to six-month MACE rates were similar between both groups. Definite or probable stent thrombosis did not occur (according to the ARC criteria) in BVS patients, though two patients during the index admission and another two patients in the first month after DES implantation had stent thrombosis. Conclusion: The use of the ABSORB BVS for STEMI is feasible and associated with good procedural safety, and angiographic success rate.

  4. Sex-related Impact on Clinical Outcome of Everolimus-eluting Versus Bare-metal Stents in ST-segment Myocardial Infarction. Insights From the EXAMINATION Trial.

    Science.gov (United States)

    Regueiro, Ander; Fernández-Rodríguez, Diego; Brugaletta, Salvatore; Martín-Yuste, Victoria; Masotti, Monica; Freixa, Xavier; Cequier, Ángel; Íñiguez, Andrés; Serruys, Patrick W; Sabaté, Manel

    2015-05-01

    The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  5. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres

    2015-01-01

    AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to ...

  6. 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial)

    DEFF Research Database (Denmark)

    Maeng, Michael; Baranauskas, Arvydas; Christiansen, Evald H J

    2015-01-01

    OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes. BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients. METHODS: We...... randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss...... at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up. RESULTS: At 10-month...

  7. Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial.

    Science.gov (United States)

    Sotomi, Yohei; Ishibashi, Yuki; Suwannasom, Pannipa; Nakatani, Shimpei; Cho, Yun-Kyeong; Grundeken, Maik J; Zeng, Yaping; Tateishi, Hiroki; Smits, Pieter C; Barragan, Paul; Kornowski, Ran; Gershlick, Anthony H; Windecker, Stephan; van Geuns, Robert-Jan; Bartorelli, Antonio L; de Winter, Robbert J; Tijssen, Jan; Serruys, Patrick W; Onuma, Yoshinobu

    2016-06-27

    The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm(2) vs. 4.27 mm(2), respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American College of Cardiology Foundation. Published

  8. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: An optical coherence tomography substudy from the RESOLUTE All Comers trial

    NARCIS (Netherlands)

    J.L. Gutiérrez-Chico; R.J.M. van Geuns (Robert Jan); E.S. Regar (Eveline); W.J. van der Giessen (Wim); H. Kelbæk (Henning); K. Saunamäki (Kari); J. Escaned (Javier); N. Gonzalo (Nieves); C. di Mario (Carlo); F. Borgia (Francesco); E. Nüesch (Eveline); H.M. Garcia-Garcia (Hector); S. Silber (Sigmund); S.W. Windecker (Stephan); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractAim s To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers population of patients, in order to clarify the

  9. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

    DEFF Research Database (Denmark)

    Gutiérrez-Chico, Juan Luis; van Geuns, Robert Jan; Regar, Evelyn

    2011-01-01

    To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual ...

  10. Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

    Science.gov (United States)

    Sarno, Giovanna; Lagerqvist, Bo; Olivecrona, Göran; Varenhorst, Christoph; Danielewicz, Mikael; Hambraeus, Kristina; Lindholm, Daniel; Råmunddal, Truls; Witt, Nils; James, Stefan

    2017-11-15

    No previous studies have evaluated the performance of the Synergy stent in a large real-life population. To describe the initial real-life experience with a novel everolimus eluting platinum chromium stent with abluminal biodegradable polymer (SYNERGY) in unselected patients from a nationwide registry. All implanted Synergy stents were compared with other new generation drug eluting stents (n-DES) with >1,000 implantations in Sweden between March 2013 and October 2015. Restenosis, definite stent thrombosis (ST), myocardial infarction (MI) and death rates were assessed using propensity score and Cox regression analyses. A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N = 1,953; Orsiro, N = 4,946; Promus Element Plus, N= 2,543; Promus Premier, N= 20,414; Xience Xpedition, N= 7,971, Resolute/Resolute Integrity, N = 19,021; Ultimaster, N = 1,156; Resolute Onyx, N = 6,425) were implanted in 42,357 procedures. Restenosis and stent thrombosis occurred in 642 and 314 cases, respectively, in the overall population at 1 year. The cumulative rate of restenosis (1.1% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; P = 0.21) and ST (0.4% vs. 0.5%, adjusted HR: 0.97; 95% CI: 0.63-1.50; P = 0.17) up to 1 year was low in both the Synergy group and the other n-DES group. Death occurred in 5.2% versus 4.5% (adjusted HR: 1.14; 95% CI: 0.96-1.36; P = 0.11) and MI in 3.2% versus 3.5%, (adjusted HR: 1.11; 95% CI: 0.93-1.33; P = 0.24) up to 1 year. In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  11. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

    Science.gov (United States)

    Orvin, K; Carrie, D; Richardt, G; Desmet, W; Assali, A; Werner, G; Ikari, Y; Fujii, K; Goicolea, J; Dangoisse, V; Manari, A; Saito, S; Wijns, W; Kornowski, R

    2016-05-01

    To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  12. Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30 mm) de novo coronary artery stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Patra, Soumya, E-mail: dr_soumyapatra@rediffmail.com; Chakraborty, Rabindra Nath; Pande, Arindam; Banerjee, Suvro; Jena, Manabhanjan; Mandal, Prakash Chandra; De, Swapan Kumar; Khan, Aftab; Das, Sankha Suvro; Ghosh, Debashish; Nag, Raja

    2017-04-15

    Background: Procedural and clinical outcomes in patients with very long (>30 mm) coronary lesions who underwent stent-based percutaneous coronary interventions are still unfavorable. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and Xpedition everolimus-eluting stents (X-EES) for patients with de novo very long coronary lesions. Methods: This comparative single-centre, retrospective study compared long R-ZES and X-EES in consecutive patients admitted with very long (≥30 mm) native ACC/AHA type C coronary lesions in 2014. All patients were followed up clinically at 1, 3, 6 and 12 months. In this study, only symptom-driven angiogram was advised. The study end point was to evaluate immediate procedural success and one-year rate of target lesion failure (TLF), which is a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization (TLR). Results: Total number of patients enrolled in this study was 185 (R-ZES = 107; X-EES = 78). The baseline characteristics and post procedural success rate were similar between R-ZES and X-EES groups, including the post stenting lesion lengths (36.6 ± 1.92 mm vs 40.71 ± 6.175 mm, P = 0.09). At 12-month follow-up, there were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). Procedural success was achieved in 94% in R-ZES group and 93% in X-EES group (P = 0.24). The incidence of TLF was 5% in R-ZES and 4% in X-EES groups (HR-1.25; 95% CI-0.86-5.6; P = 0.19). Conclusion: Patients with de novo long coronary artery disease, R-ZES implantation showed similar clinical outcome as compared with X-EES implantation. - Highlights: • This is the first study comparing between R-ZES (Resolute Integrity) and X-EES (Xience Xpedition) used in PCI for long coronary artery disease. Here, single stent length of more than 30

  13. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed...

  14. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); S. Silber (Sigmund); S.A. Garg (Scot); R.J.M. van Geuns (Robert Jan); G. Richard (Gert); P. Buszman (Pawel); H. Kelbaek (Henning); A.J. van Boven (Ad); S.H. Hofma (Sjoerd); A. Linke (Axel); V. Klauss (Volker); W. Wijns (William); C.M. Miguel (Carlos); P. Garot (Phillipe); C. DiMario (Carlo); G. Manoharan (Ganesh); R. Kornowski (Ran); T. Ischinger (Thomas); A. Bartorelli (Antonio); J. Ronden (Jacintha)

    2010-01-01

    textabstractBACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end

  15. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the ...

  16. Metal allergy to everolimus-eluting cobalt chromium stents confirmed by positive skin testing as a cause of recurrent multivessel in-stent restenosis.

    Science.gov (United States)

    Nakajima, Yoshifumi; Itoh, Tomonori; Morino, Yoshihiro

    2016-03-01

    A 54-year-old woman treated with cobalt-chromium everolimus eluting stents (CoCr-EES) for her left distal circumflex and diagonal branch lesions suffered from repeated in-stent restenosis in both lesions. Neointimal proliferation occurred rapidly and almost simultaneously in the two lesions. The cause was established to be metal allergy, as determined by patch tests which were strongly positive for bare metal stents and weakly positive for CoCr-EES. Following the third successive angioplasty, we initiated treatment with prednisolone (30 mg daily) and the anti-allergic and anti-proliferative drug tranilast (300 mg daily). An elective angiogram performed 3 months later showed no evidence of in-stent restenosis in any of the stented lesions. Furthermore, the patient has remained angina-free for 15 months. The unique features of this case include: (1) near-simultaneous repeated multivessel in-stent restenosis in a patient with skin test-documented metal allergy to cobalt-chromium stents; (2) adjunctive systemic medical therapy with prednisolone and tranilast appeared to terminate the malignant restenotic cycle. © 2015 Wiley Periodicals, Inc.

  17. Optical coherence tomography findings after chronic total occlusion interventions: Insights from the “AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions” (ACE-CTO) study (NCT01012869)

    Energy Technology Data Exchange (ETDEWEB)

    Sherbet, Daniel P.; Christopoulos, Georgios; Karatasakis, Aris; Danek, Barbara Anna; Kotsia, Anna; Navara, Rachita; Michael, Tesfaldet T.; Roesle, Michele; Rangan, Bavana V.; Haagen, Donald [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Garcia, Santiago [Minneapolis VA Healthcare System and University of Minnesota, Minneapolis, MN (United States); Maniu, Calin [Bon Secours Health System, Suffolk, VA (United States); Pershad, Ashish [Banner Good Samaritan Medical Center, Phoenix, AZ (United States); Abdullah, Shuaib M.; Hastings, Jeffrey L.; Kumbhani, Dharam J.; Luna, Michael; Addo, Tayo; Banerjee, Subhash [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Brilakis, Emmanouil S., E-mail: esbrilakis@gmail.com [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States)

    2016-10-15

    Background: There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. Methods: The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108 mm. Results: A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126 ± 0.140 mm and − 0.491 ± 0.440 mm, respectively. Conclusion: High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs. - Highlights: • Percutaneous coronary intervention with drug-eluting stents for chronic total occlusion is associated with a 40% rate of binary in-stent restenosis at 8 months • Of patients who receive a drug eluting stent for a chronic total occlusion 88.7% will have stent strut malapposition and 80.7% will

  18. Intensive statin therapy stabilizes C-reactive protein, but not chemokine in stable coronary artery disease treated with an everolimus-eluting stent.

    Science.gov (United States)

    Sukegawa, Hiroaki; Maekawa, Yuichiro; Yuasa, Shinsuke; Anzai, Atsushi; Kodaira, Masaki; Takei, Makoto; Sano, Fumiya; Ueda, Ikuko; Kawakami, Takashi; Hayashida, Kentaro; Kohno, Takashi; Kohsaka, Shun; Abe, Takayuki; Fukuda, Keiichi

    2016-08-01

    Besides its potent plasma cholesterol-lowering activity, statin treatment has several other important effects, including lowering high-sensitive C-reactive protein (hs-CRP), levels, and stabilizing risk factors of atherosclerosis, thereby reducing the risk of cardiovascular events. Our aim in this study was to identify how intensive statin therapy can affect plasma levels of inflammatory markers over the long term. We used a prospective, randomized, open blinded-endpoint design. A total of 30 patients with stable coronary artery disease treated with everolimus-eluting stent implantation were randomized to receive rosuvastatin 2.5 (standard therapy group) or 10 mg (intensive therapy group) for 12 months. Plasma levels of hs-CRP, pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 were measured after a percutaneous coronary intervention, at 1, 3, 6, 9, and 12 months. Levels of LDL cholesterol (LDL-C) and HDL cholesterol were also measured. We investigated short-term and long-term clinical outcomes. After 12 months of therapy, the intensive therapy group had lower levels of LDL-C than the standard therapy group. Plasma levels of hs-CRP largely fluctuated in the standard therapy group, whereas they were stable in the intensive therapy group during the follow-up period. There were no significant differences in serum pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 levels, or in the incidence of any clinical adverse events, between the standard and the intensive therapy groups. Intensive rosuvastatin therapy stabilizes hs-CRP levels, but not chemokine levels, besides lowering LDL-C levels. Thus, this therapy may inhibit the progression of atherosclerosis by stably inhibiting the inflammatory cascade.

  19. Impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent: five-year follow-up optical coherence tomography study.

    Science.gov (United States)

    Kuramitsu, Shoichi; Sonoda, Shinjo; Shinozaki, Tomohiro; Jinnouch, Hiroyuki; Muraoka, Yoshitaka; Domei, Takenori; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji; Otsuji, Yutaka

    2017-10-19

    The impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent (CoCrEES) remains unclear. We sought to evaluate them using optical coherence tomography (OCT). A total of 47 patients with 58 lesions treated only with CoCrEES and no target-vessel events within 5 years after implantation were prospectively enrolled and underwent 5-year follow-up OCT. Quantitative parameters and qualitative characteristics of the neointima were evaluated using multilevel logistic or linear regression models with random effects at three levels: lesion, cross-section (CS), and strut. According to the lesion complexity, the lesions were classified into the two groups: the complex lesion (CL) and non-CL group. The CL was defined as having at least 1 high-risk feature such as acute coronary syndrome lesion, lesion length > 20 mm, severe calcification requiring rotational atherectomy, and chronic total occlusion at the index procedure. A total of 11,034 struts (CL, n = 6240; non-CL, n = 4794) and 1202 (CL, n = 683; non-CL, n = 519) CSs were analyzed. The percentage of uncovered and malapposed struts did not differ significantly between the CL and non-CL groups (0.90 vs. 0.54%, P = 0.78; 0.56 vs. 0.10%, P = 0.16, respectively). The incidence of neoatherosclerosis was comparable between both groups in the CS- and lesion-level analysis (3.5 vs. 4.6%, P = 0.91; 32.0 vs. 24.2%, P = 0.52, respectively). At 5 years, CoCrEES shows an excellent vascular healing and similar frequency of neoatheroslerosis in patients without target-vessel events, regardless of the lesion complexity.

  20. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.

    Science.gov (United States)

    Zbinden, Rainer; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Kurz, David J; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Franzone, Anna; Eberli, Franz; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-03-15

    No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026). Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by

  1. A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

    Science.gov (United States)

    López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

    2014-07-01

    Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  2. Two-year results of an open-label randomized comparison of everolimus-eluting stents and sirolimus-eluting stents.

    Directory of Open Access Journals (Sweden)

    Matthijs A Velders

    Full Text Available BACKGROUND: Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES with first generation sirolimus-eluting stents (SES. METHODS: A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis. RESULTS: In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2 ± 11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES. In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68-1.48. Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types. CONCLUSION: In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice. TRIAL REGISTRATION: TrialRegister.nl NTR3170.

  3. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.

    Science.gov (United States)

    Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Fahrni, Therese; Moschovitis, Aris; Noble, Stéphane; Eberli, Franz R; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2014-12-13

    Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one

  4. Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: Prospective validation of the SYNTAX Score II

    NARCIS (Netherlands)

    C.A.M. Campos (Carlos); D. van Klaveren (David); V. Farooq (Vasim); C. Simonton (Charles); A.P. Kappetein (Arie Pieter); J.F. Sabik (Joseph); E.W. Steyerberg (Ewout); G.W. Stone (Gregg); P.W.J.C. Serruys (Patrick)

    2015-01-01

    textabstractAims To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Methods and results Evaluation of the

  5. Angiographic, optical coherence tomography and histology findings from combination of a drug-coated balloon with an everolimus-eluting stent in a porcine model.

    Science.gov (United States)

    Ong, Paul J L; Kubo, Takashi; Watson, Timothy J; Seah, Agnes S P; Wong, Philip E H; Akasaka, Takashi

    2016-11-15

    We designed a porcine model to compare the angiographic, optical coherence tomography (OCT) and histological findings of implanting an everolimus-eluting stent (EES) in the same segment of the coronary artery pre-treated with a drug-coating balloon (DCB; paccocath as carrier) with EES alone and DCB plus a bare metal stent (BMS). Seven female swine averaging 46.0±2.4kg were treated by random assignment as follows: DCB followed by EES; DCB followed by BMS; and EES alone. Quantitative coronary angiography (QCA) and OCT were carried out post-implantation and repeated after 28±1days. All arteries remained patent and demonstrated no sign of thrombus formation. There was no significant difference at 1month between the treatment groups in lumen loss (0.64±0.43, 0.44±0.43 and 0.33±0.28mm for EES, DCB/EES and DCB/BMS respectively, p=0.37) and binary restenosis (6.86 (2.91-9.12), 4.93 (-1.53-10.7) and 4.18 (3.27-10.2)% respectively, p=0.87). OCT found mean neointimal thickness of 0.15±0.09, 0.07±0.03 and 0.08±0.03mm (p=0.05) for EES, DCB/EES and DCB/BMS respectively. Endothelial strut coverage was 92.3±5.5, 85.4±8.6 and 89.1±8.9% (p=0.05) and mean neointimal area was 1.06±0.42, 0.95±0.24 and 1.20±0.28mm(2) (p=0.09) respectively. Inflammation score was similar between the three groups: 0.20 (0.20-0.28), 0.30 (0.22-0.48), 0.30 (0.20-0.38) for EES, DCB/EES and DCB/BMS respectively (p=0.14) and there were no differences in fibrin deposition. The combination of DCB with EES appeared to be safe and effective. Using EES to bail out suboptimal DCB therapy appeared to be safe and effective in this porcine model. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Very Late Pathological Responses to Cobalt-Chromium Everolimus-Eluting, Stainless Steel Sirolimus-Eluting, and Cobalt-Chromium Bare Metal Stents in Humans.

    Science.gov (United States)

    Mori, Hiroyoshi; Atmakuri, Dheeraj R; Torii, Sho; Braumann, Ryan; Smith, Samantha; Jinnouchi, Hiroyuki; Gupta, Anuj; Harari, Emanuel; Shkullaku, Melsi; Kutys, Robert; Fowler, David; Romero, Maria; Virmani, Renu; Finn, Aloke V

    2017-11-17

    The "very late" clinical outcomes for durable polymer drug-eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long-term vascular compatibility of BMSs is still regarded to be superior to drug-eluting stents; however, no pathologic study to date has specifically addressed this issue. We evaluated the very late (≥1 year) pathologic responses to durable polymer drug-eluting stents (cobalt-chromium [CoCr] everolimus-eluting stents [EESs] and stainless steel sirolimus-eluting stents [SS-SESs]) versus BMSs (CoCr-BMSs). From the CVPath stent registry, we studied a total of 119 lesions (40 CoCr-EESs, 44 SS-SESs, 35 CoCr-BMSs) from 92 autopsy cases with a duration ranging from 1 to 5 years. Sections of stented coronary segments were pathologically analyzed. Inflammation score and the percentage of struts with giant cells were lowest in CoCr-EESs (median inflammation score: 0.6; median percentage of struts with giant cells: 3.8%) followed by CoCr-BMSs (median inflammation score: 1.3 [Pstents and may have implications for future stent design. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  7. Approach to coronary bifurcation lesions using the everolimus-eluting stent: comparison between a simple strategy and a complex strategy with T-stenting.

    Science.gov (United States)

    Ruiz-Salmerón, Rafael J; Valenzuela, Luis F; Pérez, Inés; Fuentes, Marco; Rodríguez-Leiras, Sergio; Vizcaíno, Manuel; Carrascosa, César; Marcos, Francisco

    2013-08-01

    Coronary bifurcation lesions can be approached using a simple or a complex strategy. In clinical trials with first-generation drug-eluting stents, the complex strategy was not superior to the simple approach. However, to date, the best strategy when using second-generation drug-eluting stents has not been defined. We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent. Angiographic and clinical follow-up were performed at 9 months. We included 70 lesions in 69 patients, who were randomized to the simple (34 lesions, 33 patients) or complex strategy (36 lesions and patients). In all, 85.6% of the lesions included were true bifurcations. The crossover rate was 17.1%. The binary restenosis rate was 12.1%, with no differences between the groups. Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis (10.7% vs 0%) but not in the per protocol analysis (5.9% vs 4.2%). The incidence of major adverse cardiac events (cardiac death, myocardial infarction, and target vessel revascularization) was 9.2%, with no differences between groups. There were no cases of stent thrombosis. According to the clinical and angiographic findings, the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  8. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Song, Hae-Geun; Ahn, Jung-Min; Kim, Won-Jang; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Her, Sung Ho; Hur, Seung Ho; Park, Jin Sik; Kim, Myeong-Kon; Choi, Yun Seok; Kim, Hyun Sook; Cho, Jang-Hyun; Lee, Sang Gon; Park, Yong Whi; Jeong, Myung-Ho; Lee, Bong Ki; Lee, Nae-Hee; Lim, Do-Sun; Yoon, Junghan; Seung, Ki Bae; Shin, Won-Yong; Rha, Seung-Woon; Kim, Kee-Sik; Tahk, Seung-Jea; Park, Byoung Eun; Ahn, Taehoon; Yang, Joo-Young; Jeong, Yong Seok; Rhew, Jay-Hyun; Park, Seung-Jung

    2012-06-01

    It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75). In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.

  9. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold

    NARCIS (Netherlands)

    S. Brugaletta (Salvatore); J. Gomez-Lara (Josep); H.M. Garcia-Garcia (Hector); J.H. Heo (Jungho); V. Farooq (Vasim); R.J.M. van Geuns (Robert Jan); B. Chevalier (Bernard); S.W. Windecker (Stephan); D. McClean (Dougal); L. Thuesen (Leif); R. Whitbourn (Robert); I. Meredith (Ian); C. Dorange (Cecile); S. Veldhof (Susan); R. Rapoza (Richard); J.A. Ormiston (John); P.W.J.C. Serruys (Patrick)

    2012-01-01

    textabstractSerial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue

  10. A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

    Directory of Open Access Journals (Sweden)

    Teeuwen Koen

    2012-12-01

    Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

  11. Comparison of 2-year outcomes between zotarolimus-eluting and everolimus-eluting new-generation cobalt-chromium alloy stents in real-world diabetic patients.

    Science.gov (United States)

    Miyazaki, Tadashi; Latib, Azeem; Panoulas, Vasileios F; Miyazaki, Sakiko; Costopoulos, Charis; Sato, Katsumasa; Naganuma, Toru; Kawamoto, Hiroyoshi; Daida, Hiroyuki; Colombo, Antonio

    2015-07-01

    To date, it remains unknown whether different types of new-generation drug-eluting stents have a differential impact on long-term outcomes in diabetic patients. In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new-generation CoCr zotarolimus-eluting stents (R-ZES: 136 patients, 196 lesions) or everolimus-eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2-year follow-up period. MACE was defined as all-cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R-ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2-year follow-up, there was no significant difference in occurrence of MACE (R-ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all-cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity-score matching did not alter the aforementioned associations. After 2 years of follow up similar outcomes (MACE, all-cause mortality/MI, TLR) were observed in real-world diabetic patients, including those with complex lesions and patient characteristics, treated with R-ZES and EES. © 2015 Wiley Periodicals, Inc.

  12. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis

    NARCIS (Netherlands)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G.; Hill, Jonathan; de Winter, Robbert J.; Karjalainen, Pasi P.; Verheye, Stefan; Wijns, William; Lüscher, Thomas F.; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-01-01

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial

  13. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Energy Technology Data Exchange (ETDEWEB)

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  14. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.

    Science.gov (United States)

    Sudhir, Krishnankutty; Hermiller, James B; Naidu, Srihari S; Henry, Timothy D; Mao, Vivian W; Zhao, Weiying; Ferguson, Joanne M; Wang, Jin; Jonnavithula, Lalitha; Simonton, Charles A; Rutledge, David R; Krucoff, Mitchell W

    2013-10-01

    The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated. Copyright © 2012 Wiley Periodicals, Inc.

  15. Pharmacokinetic sub-study in the SPIRIT III Randomized and Controlled Trial of XIENCE V everolimus eluting coronary stent system.

    Science.gov (United States)

    Wang, Qing; Pierson, Wesley; Sood, Poornima; Bol, Cornelis; Cannon, Louis; Gordon, Paul; Saucedo, Jorge; Sudhir, Krishnankutty

    2010-02-01

    Drug-eluting stents (DES) are widely used for treatment of coronary artery disease with benefit of reduced restenosis compared to bare metal stents. The XIENCE VEverolimus Eluting Coronary Stent System is a second-generation DES system for better deliverability while maintaining safety and efficacy profiles. The present pharmacokinetic sub-study from the SPIRIT III Randomized and Controlled Trial (RCT) was to evaluate systemic exposure of patients to everolimus and to further demonstrate safety following implantation of XIENCE Vstents with everolimus doses ranging from 53 to 181 microg. Drug concentrations in whole blood were determined at multiple time points using a validated analytical method with a limit of quantification of 0.1 ng/mL. Individual C(max) ranged from 0.17 to 2.40 ng/mL and occurred between 0.07 and 1.88 hours across all dose levels. Both mean and individual C(max) values were below the trough blood concentrations of everolimus (Certican) for inhibition of organ transplant rejection. The last time point at which drug concentrations could be quantified ranged from 12 to 168 hours postimplantation in individual patients. In most cases, the blood levels dropped below the limit of quantification after 72 hours. This study confirms that the XIENCE Vstent causes a limited and systemic exposure to everolimus. The presumed localized and efficient delivery of everolimus to target vessels coupled with limited and transient systemic drug exposure contributes to the safety and effectiveness of the XIENCE VEECSS in patients of SPIRIT III RCT for longer than 2 years.

  16. Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

    Directory of Open Access Journals (Sweden)

    A. A. Prokhorikhin

    2017-11-01

    Full Text Available Aim. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular when used for treatment of ischemic heart disease patients.Methods. The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline (n = 407 or “XiencePrime” coronary stent (AbbottVascular (n = 203. The follow-up period was 12 months. In order to detect restenosis (secondary endpoint, angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.Results. In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017. Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p>0.05. Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%, in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.Conclusion.

  17. Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients.

    Science.gov (United States)

    Nammas, Wail; de Belder, Adam; Niemelä, Matti; Sia, Jussi; Romppanen, Hannu; Laine, Mika; Karjalainen, Pasi P

    2017-01-01

    The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12months and yearly thereafter for up to 7years. Elderly age was defined as ≥65years. Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2±1.9years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p=0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p=0.002 and p=0.003, respectively). The rates of ischemia-driven TLR were comparable (p>0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p=0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  18. Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.

    Science.gov (United States)

    Hermiller, James B; Applegate, Robert J; Baird, Colleen; Butler, Michael M; Rutledge, David; Wang, Jin; Kakarala, Kalyan; Krucoff, Mitchell W; Sudhir, Krishnankutty

    2016-07-01

    The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study. The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC. Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups. This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4

  19. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

    Science.gov (United States)

    Ferko, Nicole; Ferrante, Giuseppe; Hasegawa, James T; Schikorr, Tanya; Soleas, Ireena M; Hernandez, John B; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Valgimigli, Marco

    2017-05-01

    Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

  20. Cost‐effectiveness of percutaneous coronary intervention with cobalt‐chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta‐analysis of randomized trials

    Science.gov (United States)

    Ferrante, Giuseppe; Hasegawa, James T.; Schikorr, Tanya; Soleas, Ireena M.; Hernandez, John B.; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W.; Valgimigli, Marco

    2016-01-01

    Background Second‐generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first‐generation DES with improved cost‐effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) compared with BMS in percutaneous coronary intervention (PCI). Objective To conduct a cost‐effectiveness analysis (CEA) of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) versus BMS in PCI. Methods A Markov state transition model with a 2‐year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co‐Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta‐analysis of 5 RCTs (n = 4,896). The base‐case analysis evaluated stent‐related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta‐analysis. Results The base‐case and secondary analyses reported an additional 0.018 and 0.013 quality‐adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co‐Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co‐Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Conclusions Using data from a recent patient level meta‐analysis and contemporary cost data, this analysis found that PCI with Co‐Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. PMID:27527508

  1. Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model.

    Science.gov (United States)

    Otsuka, Fumiyuki; Pacheco, Erica; Perkins, Laura E L; Lane, Jennifer P; Wang, Qing; Kamberi, Marika; Frie, Michael; Wang, Jin; Sakakura, Kenichi; Yahagi, Kazuyuki; Ladich, Elena; Rapoza, Richard J; Kolodgie, Frank D; Virmani, Renu

    2014-06-01

    The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months. A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months. Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥ 36 months. Resorption is considered complete at 36 months. © 2014 American Heart Association, Inc.

  2. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: Results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial

    NARCIS (Netherlands)

    M. Sabate (Manel); S.W. Windecker (Stephan); A. Iiguez (Andres); Okkels-Jensen, L. (Lisette); A. Cequier; S. Brugaletta (Salvatore); S.H. Hofma (Sjoerd); L. Räber (Lorenz); Christiansen, E.H. (Evald Høi); M.J. Suttorp (Maarten); T. Pilgrim (Thomas); G.A. van Es (Gerrit Anne); Y. Sotomi (Yohei); H.M. Garcia-Garcia (Hector); Y. Onuma (Yoshinobu); P.W.J.C. Serruys (Patrick)

    2016-01-01

    textabstractAims: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the

  3. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial

    NARCIS (Netherlands)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres; Okkels-Jensen, Lisette; Cequier, Angel; Brugaletta, Salvatore; Hofma, Sjoerd H.; Räber, Lorenz; Christiansen, Evald Høi; Suttorp, Maarten; Pilgrim, Thomas; Anne van Es, Gerrit; Sotomi, Yohei; García-García, Hector M.; Onuma, Yoshinobu; Serruys, Patrick W.

    2016-01-01

    Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome

  4. A Randomized Comparison between Everolimus-Eluting Stent and Cobalt Chromium Stent in Patients with Acute ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Using Routine Intravenous Eptifibatide: The X-MAN (Xience vs. Multi-Link Stent in Acute Myocardial Infarction) Trial, A Pilot Study.

    Science.gov (United States)

    Dharma, Surya; Wardeh, Alexander J; Soerianata, Sunarya; Firdaus, Isman; Jukema, J Wouter

    2014-06-01

    The objective of this study is to determine the efficacy and safety of an everolimus-eluting stent (EES/Xience; Abbott Vascular, Santa Clara, CA) compared with a cobalt chromium stent (CoCr/Multi-Link Vision; Abbott Vascular) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with routine administration of eptifibatide infusion. This is a prospective, single center, randomized trial comparing EES (n = 75) and CoCr stent (n = 75) implantation in patients with acute STEMI undergoing primary PCI. Intravenous eptifibatide administration was mandatory by protocol in this pilot study. The primary efficacy endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of death, reinfarction, and target vessel revascularization. Secondary safety endpoints were stent thrombosis at 30 days and in-hospital bleeding event. Acute reperfusion parameters were also assessed. One-month MACE rate did not differ between EES and CoCr group (1.3 vs. 1.3%, p = 1.0). No stent thrombosis cases were observed in the EES group. The groups did not differ with respect to in-hospital bleeding events (5 vs. 9%, p = 0.37), achievement of final thrombolysis in myocardial infarction flow 2 or 3 (p = 0.21), achievement of myocardial blush grade 2 or 3 (p = 0.45), creatine kinase-MB level at 8 to 12 hours after stenting (p = 0.29), and left ventricular ejection fraction (p = 0.21). This pilot study demonstrates that after one-month follow-up, the use of EES is as safe and effective as the use of CoCr stents in patients with acute STEMI undergoing primary PCI with routine administration of intravenous eptifibatide.

  5. Early vascular responses to everolimus-eluting cobalt-chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (MECHANISM-AMI 2-week follow-up study).

    Science.gov (United States)

    Morino, Yoshihiro; Terashita, Daisuke; Otake, Hiromasa; Kikuchi, Tatsuo; Fusazaki, Tetsuya; Kuriyama, Nehiro; Suzuki, Takahide; Ito, Yoshiaki; Hibi, Kiyoshi; Tanaka, Hiroyuki; Ishihara, Shozo; Kataoka, Toru; Morita, Takashi; Otsuka, Yoritaka; Hayashi, Takatoshi; Tanabe, Kengo; Shinke, Toshiro

    2018-01-09

    The use of cobalt-chromium everolimus-eluting stents (CoCr-EES) for ST-segment elevation myocardial infarction (STEMI) reduces the incidence of stent thrombosis compared with bare metal stents, and a substantial difference is apparent in the initial 2 weeks. However, vascular behavior during this early period remains unclear. This was a prospective study (MECHANISM-AMI-2W) to investigate early vascular responses in STEMI patients immediately after CoCr-EES implantation and at 2-week follow-up using frequency domain-optical coherence tomography (FD-OCT). The study enrolled 52 patients (age 63.7 ± 11.7 years, male 85.0%), of whom 44 patients were available for complete serial FD-OCT analyses. Both % uncovered struts and % malapposed struts were improved at 2-week follow-up (63 ± 20 vs. 21 ± 14%, p stent (28.8 ± 27.7 vs. 18.1 ± 20.2%, p = 0.0001) and maximal area (0.93 ± 0.84 vs. 0.65 ± 0.63 mm2, p = 0.034). As a result, the average lumen area was significantly larger at 2 weeks (6.49 ± 1.82 vs. 6.71 ± 1.89 mm2, p = 0.048, respectively). The number of dissection flaps was lower (0.86 ± 1.11 vs. 0.52 ± 0.90%, p = 0.024). In conclusion, this study showed early vascular responses to CoCr-EES for STEMI lesions-including a significant reduction of thrombus-that resulted in lumen enlargement, earlier progression of strut coverage, and improvements in strut apposition and dissection. The combination of these factors may therefore be responsible for the safety of CoCr-EES within the initial 2 weeks.

  6. Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

    Science.gov (United States)

    Hermiller, James B; Rutledge, David R; Mao, Vivian W; Zhao, Weiying; Wang, Jin; Gruberg, Luis; Lombardi, William; Sharma, Samin K; Krucoff, Mitchell W

    2014-07-01

    The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001). Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35). Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease. © 2013 Wiley Periodicals, Inc.

  7. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

    Science.gov (United States)

    Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

    2017-12-26

    The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier

  8. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

    Science.gov (United States)

    Baron, Suzanne J; Lei, Yang; Chinnakondepalli, Khaja; Vilain, Katherine; Magnuson, Elizabeth A; Kereiakes, Dean J; Ellis, Stephen G; Stone, Gregg W; Cohen, David J

    2017-04-24

    The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906). Copyright © 2017

  9. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial.

    Science.gov (United States)

    Franzone, Anna; Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Vuilliomenet, André; Muller, Olivier; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Räber, Lorenz; Stortecky, Stefan; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2015-06-01

    Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year. URL: http://www.clinicaltrials.gov. Unique identifier

  10. Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II.

    Science.gov (United States)

    Campos, Carlos M; van Klaveren, David; Farooq, Vasim; Simonton, Charles A; Kappetein, Arie-Pieter; Sabik, Joseph F; Steyerberg, Ewout W; Stone, Gregg W; Serruys, Patrick W

    2015-05-21

    To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved. © The

  11. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis.

    Science.gov (United States)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G; Hill, Jonathan; De Winter, Robbert J; Karjalainen, Pasi P; Verheye, Stefan; Wijns, William; Lüscher, Thomas F; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-03-13

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell-capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed. In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis. The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level-based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models-adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 μm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days. The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence

  12. Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

    Science.gov (United States)

    Park, Duk-Woo; Park, Seung-Jung

    2017-06-01

    For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

  13. The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry).

    Science.gov (United States)

    Lemmert, Miguel E; van Mieghem, Nicolas M; van Geuns, Robert-Jan; Diletti, Roberto; van Bommel, Rutger J; van Domburg, Ron T; de Jaegere, Peter P; Regar, Evelyn; Zijlstra, Felix; Boersma, Eric; Daemen, Joost

    2017-08-01

    A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. A total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year. Mean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77-1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively. In all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Prospective rAndomized, single-blind, mulTicenter control clinical study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-elutIng cOronary stenT “Xience Prime”: design and rationale for “PATRIOT” trial

    Directory of Open Access Journals (Sweden)

    А. А. Прохорихин

    2016-12-01

    Full Text Available Aim. This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. Methods. This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406 to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204 to receive coronary stent Xience Prime (Abbott. Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %. Conclusion. A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.Received 5 October 2016. Accepted 6 December 2016.Funding: This study was funded by “Angioline Interventional Devices”, 630090, 18 Inzhenernaya Street, Novosibirsk, Russian Federation. Conflict of interest: The authors declare no conflict of interest.

  15. Is quantitative coronary angiography reliable in assessing the late lumen loss of the everolimus-eluting bioresorbable polylactide scaffold in comparison with the cobalt-chromium metallic stent?

    NARCIS (Netherlands)

    Sotomi, Yohei; Onuma, Yoshinobu; Miyazaki, Yosuke; Asano, Taku; Katagiri, Yuki; Tenekecioglu, Erhan; Jonker, Hans; Dijkstra, Jouke; de Winter, Robbert J.; Wykrzykowska, Joanna J.; Stone, Gregg W.; Popma, Jeffrey J.; Kozuma, Ken; Tanabe, Kengo; Serruys, Patrick W.; Kimura, Takeshi

    2017-01-01

    Aims: Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) in comparison to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The

  16. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study.

    Science.gov (United States)

    Hermiller, James B; Rutledge, David R; Gruberg, Luis; Katopodis, John N; Lombardi, William; Mao, Vivian W; Zhao, Weiying; Sharma, Samin K; Tamboli, Hoshedar P; Wang, Jin; Jonnavithula, Lalitha; Sudhir, Krishnankutty; Krucoff, Mitchell W

    2012-12-01

    This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee.  Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence

  17. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).

    Science.gov (United States)

    Kandzari, David E; Amjadi, Nima; Caputo, Christopher; Rowe, Steven K; Williams, Jerome; Tamboli, Hoshedar P; Christen, Thomas; Allocco, Dominic J; Dawkins, Keith D

    2016-02-15

    The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were "PLATINUM-like." Among the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8% (33 of 1,855) with an upper 1-sided 95% confidence interval of 2.3%, which was significantly less than the prespecified performance goal of 3.2% (pnoninferiority <0.001). In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170 of 2,554), cardiac death was 1.4% (37 of 2,554), MI was 1.1% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7% (19 of 2,554). A prespecified secondary end point of 12-month target vessel failure in diabetic patients demonstrated a rate of 4.2% (14 of 332) with an upper 1-sided 95% confidence interval of 6.03%, which was significantly less than the performance goal of 12.6% (pnoninferiority <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial).

    Science.gov (United States)

    Meredith, Ian T; Teirstein, Paul S; Bouchard, Alain; Carrié, Didier; Möllmann, Helge; Oldroyd, Keith G; Hall, Jack; Allocco, Dominic J; Dawkins, Keith D; Stone, Gregg W

    2014-04-01

    In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Everolimus-induced Pneumonitis after Drug-eluting Stent Implantation: A Case Report

    Energy Technology Data Exchange (ETDEWEB)

    Sakamoto, Susumu, E-mail: susumu1029@gmail.com; Kikuchi, Naoshi; Ichikawa, Atsuo; Sano, Go; Satoh, Keita; Sugino, Keishi; Isobe, Kazutoshi; Takai, Yujiro [Toho University School of Medicine, Department of Respiratory Medicine (Japan); Shibuya, Kazutoshi [Toho University School of Medicine, Department of Pathology (Japan); Homma, Sakae [Toho University School of Medicine, Department of Respiratory Medicine (Japan)

    2013-08-01

    Despite the wide use of everolimus as an antineoplastic coating agent for coronary stents to reduce the rate of restenosis, little is known about the health hazards of everolimus-eluting stents (EES). We describe a case of pneumonitis that developed 2 months after EES implantation for angina. Lung pathology demonstrated an organizing pneumonia pattern that responded to corticosteroid therapy. Although the efficacy of EES for ischemic heart disease is well established, EES carries a risk of pneumonitis.

  20. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

    Science.gov (United States)

    Sabaté, Manel; Brugaletta, Salvatore; Cequier, Angel; Iñiguez, Andrés; Serra, Antonio; Jiménez-Quevedo, Pilar; Mainar, Vicente; Campo, Gianluca; Tespili, Maurizio; den Heijer, Peter; Bethencourt, Armando; Vazquez, Nicolás; van Es, Gerrit Anne; Backx, Bianca; Valgimigli, Marco; Serruys, Patrick W

    2016-01-23

    Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

    Science.gov (United States)

    Kappetein, Arie Pieter; Serruys, Patrick W; Sabik, Joseph F; Leon, Martin B; Taggart, David P; Morice, Marie-Claude; Gersh, Bernard J; Pocock, Stuart J; Cohen, David J; Wallentin, Lars; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Simonton, Charles A; Stone, Gregg W

    2016-09-18

    Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

  2. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

    Science.gov (United States)

    Ellis, Stephen G; Kereiakes, Dean J; Metzger, D Christopher; Caputo, Ronald P; Rizik, David G; Teirstein, Paul S; Litt, Marc R; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O; Popma, Jeffrey J; McGreevy, Robert; Zhang, Zhen; Simonton, Charles; Stone, Gregg W

    2015-11-12

    In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III Clinical

  3. The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study.

    Science.gov (United States)

    Shiode, Nobuo; Kozuma, Ken; Aoki, Jiro; Awata, Masaki; Nanasato, Mamoru; Tanabe, Kengo; Yamaguchi, Junichi; Kusano, Hajime; Nie, Hong; Kimura, Takeshi

    2017-07-19

    Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228 .

  4. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial.

    Science.gov (United States)

    Tandjung, Kenneth; Sen, Hanim; Lam, Ming Kai; Basalus, Mounir W Z; Louwerenburg, J Hans W; Stoel, Martin G; van Houwelingen, K Gert; de Man, Frits H A F; Linssen, Gerard C M; Saïd, Salah A M; Nienhuis, Mark B; Löwik, Marije M; Verhorst, Patrick M J; van der Palen, Job; von Birgelen, Clemens

    2013-06-18

    The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650). Copyright © 2013 American College of Cardiology Foundation

  5. Sex-related impact on clinical outcome of everolimus-eluting versus bare-metal stents in ST-segment myocardial infarction. insights from the EXAMINATION trial

    NARCIS (Netherlands)

    A. Regueiro (Ander); J. Fernández-Rodríguez (Juana); S. Brugaletta (Salvatore); V. Martin-Yuste (Victoria); M. Masotti (Monica); X. Freixa (Xavier); A. Cequier; A. Iiguez (Andres); P.W.J.C. Serruys (Patrick); M. Sabate (Manel)

    2015-01-01

    textabstractIntroduction and objectives The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of

  6. Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study.

    Science.gov (United States)

    Toušek, Petr; Kočka, Viktor; Malý, Martin; Lisa, Libor; Buděšínský, Tomáš; Widimský, Petr

    2016-06-01

    Incomplete stent apposition and uncovered struts are associated with a higher risk of stent thrombosis. No data exist on the process of neointimal coverage and late apposition status of the bioresorbable vascular scaffold (BVS) when implanted in the highly thrombogenic setting of ST-segment elevation acute myocardial infarction (STEMI). The aim of this study was to assess the serial changes in strut apposition and early neointimal coverage of the BVS using optical coherence tomography (OCT) in selected patients enrolled in the PRAGUE-19 study. Intracoronary OCT was performed in 50 patients at the end of primary percutaneous coronary intervention for acute STEMI. Repeated OCT of the implanted BVS was performed in 10 patients. Scaffold area, scaffold mean diameter and incomplete strut apposition (ISA) were compared between baseline and control OCT. Furthermore, strut neointimal coverage was assessed during the control OCT. Mean scaffold area and diameter did not change between the baseline and control OCT (8.59 vs. 9.06 mm(2); p = 0.129 and 3.31 vs. 3.37 mm; p = 0.202, respectively). Differences were observed in ISA between the baseline and control OCT (0.63 vs. 1.47 %; p OCT was performed 4-6 weeks after BVS implantation, and 100 % covered struts in two patients 6 months after BVS implantation. Persistent strut apposition and early neointimal coverage were observed after biodegradable vascular scaffold implantation in patients with acute ST-segment elevation myocardial infarction.

  7. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

    Science.gov (United States)

    Colkesen, E B; Eefting, F D; Rensing, B J; Suttorp, M J; Ten Berg, J M; Karjalainen, P P; Van Der Heyden, J A

    2015-02-01

    Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

  8. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial.

    Science.gov (United States)

    Kereiakes, Dean J; Ellis, Stephen G; Metzger, Christopher; Caputo, Ronald P; Rizik, David G; Teirstein, Paul S; Litt, Marc R; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O; Popma, Jeffrey J; McGreevy, Robert; Zhang, Zhen; Simonton, Charles; Stone, Gregg W

    2017-12-12

    The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). This study sought to assess clinical outcomes through 3 years following BVS implantation. Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  9. A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial.

    Science.gov (United States)

    Park, Kyung Woo; Kang, Si-Hyuck; Kang, Hyun-Jae; Koo, Bon-Kwon; Park, Byoung-Eun; Cha, Kwang Soo; Rhew, Jay Young; Jeon, Hui-Kyoung; Shin, Eun-Seok; Oh, Ju Hyeon; Jeong, Myung-Ho; Kim, Sanghyun; Hwang, Kyung-Kuk; Yoon, Jung-Han; Lee, Sung Yun; Park, Tae-Ho; Moon, Keon Woong; Kwon, Hyuck-Moon; Hur, Seung-Ho; Ryu, Jae-Kean; Lee, Bong-Ryul; Park, Yong Whi; Chae, In-Ho; Kim, Hyo-Soo

    2014-07-01

    This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734). Copyright © 2014 American College of Cardiology

  10. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries).

    Science.gov (United States)

    Lee, Joo Myung; Park, Kyung Woo; Han, Jung-Kyu; Yang, Han-Mo; Kang, Hyun-Jae; Koo, Bon-Kwon; Bae, Jang-Whan; Woo, Sung-Il; Park, Jin Sik; Jin, Dong-Kyu; Jeon, Dong Woon; Oh, Seok Kyu; Park, Jong-Seon; Kim, Doo-Il; Hyon, Min Su; Jeon, Hui-Kyung; Lim, Do-Sun; Kim, Myeong-Gon; Rha, Seung-Woon; Her, Sung-Ho; Hwang, Jin-Yong; Kim, Sanghyun; Choi, Young Jin; Kang, Jin Ho; Moon, Keon-Woong; Jang, Yangsoo; Kim, Hyo-Soo

    2014-11-01

    Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p <0.001) and off-label indication (adjusted HR 1.782, 95% CI 1.169 to 2.718, p = 0.007) were the strongest predictors of target

  11. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials

    NARCIS (Netherlands)

    Ferko, N. (Nicole); G. Ferrante (Giuseppe); Hasegawa, J.T. (James T.); Schikorr, T. (Tanya); Soleas, I.M. (Ireena M.); Hernandez, J.B. (John B.); M. Sabate (Manel); C. Kaiser (Christoph); S. Brugaletta (Salvatore); J.M. De La Torre Hernandez (Jose Maria); S. Galatius (Soren); A. Cequier; F.R. Eberli (Franz Robert); A. De Belder (Adam); P.W.J.C. Serruys (Patrick); M. Valgimigli (Marco)

    2016-01-01

    textabstractBackground: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus

  12. COmplex coronary Bifurcation lesions: RAndomized comparison of a strategy using a dedicated self-expanding biolimus-eluting stent versus a culotte strategy using everolimus-eluting stents: primary results of the COBRA trial.

    Science.gov (United States)

    Dubois, Christophe; Bennett, Johan; Dens, Joseph; De Cock, Dries; Desmet, Walter; Belmans, Ann; Ughi, Giovanni J; Sinnaeve, Peter; Vrolix, Mathias; D'hooge, Jan; Adriaenssens, Tom

    2016-04-20

    We aimed to compare healing responses with optical coherence tomography, and clinical and angiographic outcome after treatment of coronary bifurcation lesions with a dedicated stent versus a conventional culotte technique. Forty patients with true and complex coronary bifurcation lesions were randomly assigned to treatment with the Axxess™ bifurcation stent in the proximal main vessel (MV) and additional BioMatrix™ stents in the branches (Biosensors Europe SA, Morges, Switzerland), versus a culotte technique using XIENCE™ stents (Abbott Vascular, Santa Clara, CA, USA). The primary endpoint of percentage of uncovered struts at nine months was similar with the dedicated strategy vs. culotte in the proximal MV (median 17.8 [IQR 3.3-24.7] vs. 6.8 [2.0-20.5]; p=0.19), bifurcation core (9.5 [5.7-19.5] vs. 4.0 [0.7-17.6]; p=0.17), distal MV (2.6 [2.3-18] vs. 2.2 [0.5-6.0]; p=0.09) and side branch (5.7 [1.5-11.5] vs. 1.9 [0-5.8]; p=0.14). As compared with culotte, a strategy using Axxess resulted in a significantly larger lumen in the proximal MV both acutely (minimum lumen diameter 3.03±0.51 vs. 2.71±0.44 mm, p=0.04) and at follow-up (mean lumen area 10.0±2.1 vs. 7.1±1.8 mm2, pstrategies resulted in good clinical outcomes at one year, and no stent thromboses. As compared with a culotte strategy with XIENCE stents, complex bifurcation stenting using a dedicated strategy combining Axxess and BioMatrix stents results in similar stent strut coverage at nine-month follow-up, and a significantly larger lumen and lower angiographic late lumen loss in the proximal MV.

  13. Clinical outcomes and prognosis of patients with stent fracture after successful drug-eluting stent implantation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, In Soo [Cadiovascular center, Chonnam National University Hospital, Gwangju (Korea, Republic of); Han, Jae Bok; Jang, Seong Joo [Dept. of Radiology, Dongshin University, Naju (Korea, Republic of)

    2014-06-15

    Many studies have suggested that in the era of Drug Eluting Stents (DES) are one of the causes of In-Stent Restenosis (ISR) of Stent Fracture (SF). The present study sought to evaluate clinical characteristics of patients with stent fracture after successful DES implantation. The 4,701 patients were selected for analysis who underwent a follow-up coronary angiography irrespective of ischemic symptoms. The overall incidence of SF was 32 patients(male:female=19:13, Av. age 62.44±9.8 year, 0.68%). Fractures of Sirolimus-Eluting Stents (SES), Paclitaxel-Eluting Stents (PES), Biolimus A9-Eluting Stents (BES), Everolimus-Eluting Etents (EES), Endothelial Progenitor Cell Capture Stent (EPC) and Zotarolimus-Eluting Stents (ZES) are accounted for 19 (59.4%), 9 (28.1%), 2 (6.3%), 1 (3.1%), 1 (3.1%) and 0 (0%) respectively. SF developed in the left Anterior Dscending (LAD) artery in 16 patients (50%) and in complex(type B2, C) lesions in 25 patients (69.4%). Ten patients were treated with heterogenous DES, the rest being treated with either homogenous DES (3 patients), plain old balloon angioplasty (3 patients), or conservative medical treatment (17 patients). None of the patients with SF suffered from cardiac death during a follow-up period of 32.9±12.4 months. The overall rate of DES fracture over up to 3.7 years of follow-up was 0.68% with higher incidence in SES than in PES. SF frequently occurred in the LAD artery and in complex lesions. Of the patients with SF, coronary intervention was performed only when the binary restenosis lesion was significant. During the follow-up, patients with SF have continued on combination antiplatelet therapy. There is a very low rate of major adverse cardiac events(post-detection of SF), especially cardiac death associated with SF.

  14. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

    NARCIS (Netherlands)

    von Birgelen, Clemens; Sen, Hanim; Sen, Hanim; Lam, Ming Kai; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; van Houwelingen, Gert K.; Schramm, Alexander R.; Gin, R. Melvyn Tjon Joe; Louwerenburg, Johannes W.; de Man, Frits H.A.F.; Stoel, Martin G.; Löwik, Marije M.; Linssen, Gerard C.M.; Saïd, Salla A.M.; Nienhuis, Mark B.; Verhorst, Patrick M.J.; Basalus, Mounir W.Z.; Doggen, Catharina Jacoba Maria; Tandjung, K.; Tandjung, K.

    2014-01-01

    Background Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer

  15. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold.

    Science.gov (United States)

    Brugaletta, Salvatore; Gomez-Lara, Josep; Garcia-Garcia, Hector M; Heo, Jung Ho; Farooq, Vasim; van Geuns, Robert J; Chevalier, Bernard; Windecker, Stephan; McClean, Dougal; Thuesen, Leif; Whitbourn, Robert; Meredith, Ian; Dorange, Cecile; Veldhof, Susan; Rapoza, Richard; Ormiston, John A; Serruys, Patrick W

    2012-08-01

    Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately post-ABSORB implantation and at 12 month follow-up. Paired IVUS-VH data, recorded with s5i system, were available in 17 patients (18 lesions). The analysis demonstrated an increase in mean PBS area (2.39 ± 1.85 mm(2) vs. 2.76 ± 1.79 mm(2), P = 0.078) and a reduction in the mean lumen area (6.37 ± 0.90 mm(2) vs. 5.98 ± 0.97 mm(2), P = 0.006). Conversely, a significant decrease of 16 and 30% in necrotic core (NC) and dense calcium (DC) content, respectively, were evident (median % NC from 43.24 to 36.06%, P = 0.016; median % DC from 20.28 to 11.36%, P = 0.002). Serial IVUS-VH analyses of plaque located behind the ABSORB struts at 12-month demonstrated an increase in plaque area with a decrease in its NC and DC content. Larger studies are required to investigate the clinical impact of these findings.

  16. Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score.

    Science.gov (United States)

    Ortega-Paz, Luis; Capodanno, Davide; Gori, Tommaso; Nef, Holger; Latib, Azeem; Caramanno, Giuseppe; Di Mario, Carlo; Naber, Christoph; Lesiak, Maciej; Capranzano, Piera; Wiebe, Jens; Mehilli, Julinda; Araszkiewicz, Aleksander; Pyxaras, Stelios; Mattesini, Alessio; Geraci, Salvatore; Naganuma, Toru; Colombo, Antonio; Münzel, Thomas; Sabaté, Manel; Tamburino, Corrado; Brugaletta, Salvatore

    2017-04-20

    The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events. The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary endpoint was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095). At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.

  17. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

    Energy Technology Data Exchange (ETDEWEB)

    Nef, Holger, E-mail: holger.nef@innere.med.uni-giessen.de [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Wiebe, Jens [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Achenbach, Stefan [University of Erlangen, Medizinische Klinik II, Department of Cardiology, Erlangen (Germany); Münzel, Thomas [Department of Medicine II, University Medical Center, Johannes Gutenberg University Mainz, Mainz (Germany); Naber, Christoph [Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen (Germany); Richardt, Gert [Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg (Germany); Mehilli, Julinda [Department of Cardiology, Klinikum Großhadern, Ludwig- Maximilian Universität, Munich (Germany); Wöhrle, Jochen [Department of Internal Medicine II, University of Ulm, Ulm (Germany); Neumann, Till; Biermann, Janine [University of Essen, Department of Cardiology, Essen (Germany); Zahn, Ralf [Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen (Germany); Kastner, Johannes [Department of Cardiology, University of Vienna Medical School, Vienna (Austria); Schmermund, Axel [CCB, Cardioangiologisches Centrum Bethanien, Frankfurt (Germany); Pfannebecker, Thomas [Abbott Vascular Deutschland GmbH, Wetzlar (Germany); Schneider, Steffen; Limbourg, Tobias [Institut für Herzinfarktforschung, Ludwigshafen (Germany); Hamm, Christian W. [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim (Germany)

    2016-01-15

    Background: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. Methods/design: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German–Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5 years). Conclusion: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information. - Highlights: • The GABI-R addresses a lack of data about bioresorbable scaffolds in daily practice. • 5000 patients with minimal in- and exclusion criteria at 100 sites will

  18. Drug-eluting stents and bare metal stents in patients with NSTE-ACS

    DEFF Research Database (Denmark)

    Pedersen, Sune Haahr; Pfisterer, Matthias; Kaiser, Christoph

    2014-01-01

    the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary...

  19. Impact of stent platform on longitudinal stent deformation: an in vivo frequency domain optical coherence tomography study.

    Science.gov (United States)

    Yamada, Ryotaro; Okura, Hiroyuki; Kume, Teruyoshi; Fukuhara, Kenzo; Koyama, Terumasa; Higa, Tomitaka; Neishi, Yoji; Yoshida, Kiyoshi; Uemura, Shiro

    2017-07-01

    Recently, longitudinal coronary stent deformation has been highlighted as a possible cause of drug-eluting stent failure. Although bench tests and in vivo studies have demonstrated difference in longitudinal stent strength among the stents with different platforms, its clinical impact is still unknown. Furthermore, it is unknown if modified stent platform favorably affect the incidence of stent deformation. The aim of this study was to investigate the longitudinal deformation of the everolimus-eluting stents (EES) with different stent platforms by using frequency domain optical coherence tomography (FD-OCT). Seventy-eight lesions treated with EES (Xience Prime: n = 26, Promus element: n = 29, Promus premier: n = 23) were studied. After successful stent implantation, FD-OCT was performed and stent length was measured using three-dimensional reconstruction of the images in vivo. Percent longitudinal stent shortening (%SS) was defined as the in vivo stent length divided by nominal stent length. Longitudinal stent deformation was defined as  %SS > 10 %. Patients' and procedural characteristics were similar among 3 EESs. There was no difference in mean  %SS between Xience Prime, Promus Element and Promus Premier (1.0 ± 5.8, 2.9 ± 6.7 and 0.8 ± 3.7 %, p = 0.322). Incidence of the longitudinal stent deformation was significantly higher in Promus Element than the other stents (0, 13.8 and 0 %, p = 0.028). Incidence of longitudinal stent deformation was different between EESs with different stent platforms. Stent material, stent design and/or stent delivery balloon may affect longitudinal stent deformation.

  20. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.

    Science.gov (United States)

    Bangalore, Sripal; Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

    2013-11-08

    To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Mixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials. PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. From 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1

  1. Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

    Science.gov (United States)

    Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

    2017-01-01

    To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  2. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

    Science.gov (United States)

    Gilard, Martine; Barragan, Paul; Noryani, Arif A L; Noor, Hussam A; Majwal, Talib; Hovasse, Thomas; Castellant, Philippe; Schneeberger, Michel; Maillard, Luc; Bressolette, Erwan; Wojcik, Jaroslaw; Delarche, Nicolas; Blanchard, Didier; Jouve, Bernard; Ormezzano, Olivier; Paganelli, Franck; Levy, Gilles; Sainsous, Joël; Carrie, Didier; Furber, Alain; Berland, Jacques; Darremont, Oliver; Le Breton, Hervé; Lyuycx-Bore, Anne; Gommeaux, Antoine; Cassat, Claude; Kermarrec, Alain; Cazaux, Pierre; Druelles, Philippe; Dauphin, Raphael; Armengaud, Jean; Dupouy, Patrick; Champagnac, Didier; Ohlmann, Patrick; Endresen, Knut; Benamer, Hakim; Kiss, Robert Gabor; Ungi, Imre; Boschat, Jacques; Morice, Marie-Claude

    2015-03-03

    The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Bioresorbable vascular scaffold (BVS) for in-stent chronic total occlusion: Antegrade recanalization and IVUS-guided BVS implantation by radial access

    Energy Technology Data Exchange (ETDEWEB)

    Medda, Massimo [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Casilli, Francesco, E-mail: frcasill@tin.it [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Bande, Marta [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Latini, Maria Giulia [Cardiologia Interventistica, IRCCS Policlinico San Donato, San Donato Milanese, Milano (Italy); Ghommidh, Mehdi [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Del Furia, Francesca [Unità Operativa di Cardiologia, Azienda Ospedaliera di Melegnano, Milano (Italy); Inglese, Luigi [Interventistica Cardiovascolare, Gruppo Sanitario Policlinico di Monza, Milano (Italy)

    2016-01-15

    The completely absorbable stents represent one of the latest innovations in the field of interventional cardiology, prospecting the possibility of “vascular repair”. In the published trials (ABSORB Cohort A and B, ABSORB EXTEND, and ABSORB II, III and IV) chronic total occlusions (CTOs) were considered an exclusion criteria. More recently the CTO-ABSORB pilot study demonstrated the safety and feasibility of bioresorbable vascular scaffold (BVS) use in case of CTO recanalization. We present the first case, to our knowledge, of in-stent occlusion successfully treated with an everolimus-eluting BVS and discuss its potential advantages in such kind of lesions.

  4. Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

    Science.gov (United States)

    Meneguz-Moreno, Rafael Alexandre; Costa, José de Ribamar; Moscoso, Freddy Antônio Britto; Staico, Rodolfo; Tanajura, Luiz Fernando Leite; Centemero, Marinella Patrizia; Chaves, Auréa Jacob; Abizaid, Andrea Claudia Leão de Sousa; Sousa, Amanda Guerra de Moraes Rego E; Abizaid, Alexandre Antonio Cunha

    2017-02-01

    Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos

  5. Evaluation with in vivo optical coherence tomography and histology of the vascular effects of the everolimus-eluting bioresorbable vascular scaffold at two years following implantation in a healthy porcine coronary artery model: implications of pilot results for future pre-clinical studies

    NARCIS (Netherlands)

    B.D. Gogas (Bill); M. Radu (Maria); Y. Onuma (Yoshinobu); L. Perkins (Laura); J.C. Powers (Jennifer C.); J. Gomez-Lara (Josep); V. Farooq (Vasim); H.M. Garcia-Garcia (Hector); R. Diletti (Roberto); R. Rapoza (Richard); R. Virmani (Renu); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractTo quantify with in vivo OCT and histology, the device/vessel interaction after implantation of the bioresorbable vascular scaffold (BVS). We evaluated the area and thickness of the strut voids previously occupied by the polymeric struts, and the neointimal hyperplasia (NIH) area

  6. Association of Coronary Perivascular Adipose Tissue Inflammation and Drug-Eluting Stent-Induced Coronary Hyperconstricting Responses in Pigs:18F-Fluorodeoxyglucose Positron Emission Tomography Imaging Study.

    Science.gov (United States)

    Ohyama, Kazuma; Matsumoto, Yasuharu; Amamizu, Hirokazu; Uzuka, Hironori; Nishimiya, Kensuke; Morosawa, Susumu; Hirano, Michinori; Watabe, Hiroshi; Funaki, Yoshihito; Miyata, Satoshi; Takahashi, Jun; Ito, Kenta; Shimokawa, Hiroaki

    2017-09-01

    Although coronary perivascular adipose tissue (PVAT) may play important roles as a source of inflammation, the association of coronary PVAT inflammation and coronary hyperconstricting responses remains to be examined. We addressed this important issue in a porcine model of coronary hyperconstricting responses after drug-eluting stent implantation with 18 F-fluorodeoxyglucose ( 18 F-FDG) positron emission tomographic imaging. An everolimus-eluting stent (EES) was randomly implanted in pigs into the left anterior descending or the left circumflex coronary artery while nonstented coronary artery was used as a control. After 1 month, coronary vasoconstricting responses to intracoronary serotonin (10 and 100 μg/kg) were examined by coronary angiography in vivo, followed by in vivo and ex vivo 18 F-FDG positron emission tomographic/computed tomographic imaging. Coronary vasoconstricting responses to serotonin were significantly enhanced at the EES edges compared with the control site ( P inflammation. © 2017 American Heart Association, Inc.

  7. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

    2014-01-01

    OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES...

  8. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...

  9. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

    NARCIS (Netherlands)

    R. Diletti (Roberto); A. Karanasos (Antonios); T. Muramatsu (Takashi); T. Nakatani (Tomoya); N.M. van Mieghem (Nicolas); Y. Onuma (Yoshinobu); S.T. Nauta (Sjoerd); Y. Ishibashi (Yuki); M.J. Lenzen (Mattie); J.M.R. Ligthart (Jürgen); C.J. Schultz (Carl); E.S. Regar (Eveline); P.P.T. de Jaegere (Peter); P.W.J.C. Serruys (Patrick); F. Zijlstra (Felix); R.J.M. van Geuns (Robert Jan)

    2014-01-01

    textabstractAimsWe evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI).Methods and resultsThe present investigation is a prospective,

  10. OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up.

    Science.gov (United States)

    Kala, Petr; Cervinka, Pavel; Jakl, Martin; Kanovsky, Jan; Kupec, Andrej; Spacek, Radim; Kvasnak, Martin; Poloczek, Martin; Cervinkova, Michaela; Bezerra, Hiram; Valenta, Zdenek; Attizzani, Guilherme F; Schnell, Audrey; Hong, Lu; Costa, Marco A

    2018-01-01

    To assess the possible merits of optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI). 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. All patients were scheduled for nine months of follow-up angiography and OCT study. OCT guidance led to post-pPCI optimization in 29% of cases (59% malapposition and 41% dissections). No complications were found related to the OCT study. OCT analysis at nine months showed significantly less in-segment area of stenosis (6% [-11, 19] versus 18% [3, 33]; p=0.0002) in favor of the OCT-guided group. The rate major adverse cardiovascular events were comparable at nine months in both groups (3% in the OCT group versus 2% in the angio-guided group; p=0.87). This study demonstrates the safety of OCT guidance during pPCI. The use of OCT optimized stent deployment in 1/3 of patients in this clinical scenario and significantly reduced in-segment area of stenosis at nine months of follow-up. Whether such improvements in OCT endpoints will have a positive impact on late clinical outcomes, they demand both a larger and longer-term follow-up study. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Hansen, Henrik S

    2014-01-01

    Aims: The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES). Methods and results: We performed a post hoc...

  12. Transient coronary aneurysm formation after Nevo™ stent implantation versus persistent coronary aneurysm after Cypher Select™ stent implantation

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Lassen, Jens Flensted; Jensen, Lisette Okkels

    2011-01-01

    We implanted a Cypher Select™ coronary stent and two months later a Nevo™ sirolimus-eluting coronary stent in another vessel. At a prescheduled angiographic follow-up, coronary aneurysms were seen in the two stented segments, 6 and 8 months after stent implantation, respectively. Six months later......, the aneurysm had healed in the Nevo, but was still present in the Cypher stented segment. We hypothesize that aneurysm formation was induced by sirolimus and the polymer of the implanted stents, and that subsequent healing was possible in the Nevo stent after degradation of the polymer....

  13. Peri-stent contrast staining, major evaginations and severe malapposition after biolimus-eluting stent implantation

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Jensen, Lisette Okkels

    2014-01-01

    Peri-stent contrast staining and late acquired malapposition represent pathological vessel wall healing patterns following percutaneous coronary intervention with stent implantation. Earlier studies have described these abnormal vessel wall responses commonly present after implantation of first......-generation drug-eluting stents. These coronary vascular changes can cause flow disturbance and thereby dispose for later thrombotic events. This case report, based on coronary optical frequency domain imaging, describes peri-stent contrast staining, major evaginations and severe malapposition occurring 18months...

  14. Bridging Experience With Eptifibatide After Stent Implantation.

    Science.gov (United States)

    Barra, Megan E; Fanikos, John; Gerhard-Herman, Marie D; Bhatt, Deepak L

    2016-09-01

    Patients who have undergone intracoronary stent implantation often require surgery within the first year after the procedure. Planned or emergent surgical intervention requires interruption of antiplatelet therapy and is associated with an increased risk of stent thrombosis. Eptifibatide, an intravenous glycoprotein IIb/IIIa inhibitor (GPIIb/IIIa), can be considered for antiplatelet bridging of high-risk patients in the periprocedural period. The aim of this report is to describe the management of antiplatelet therapy and outcomes of patients who were bridged with eptifibatide perioperatively within 1 year of intracoronary stent implantation. We performed a retrospective analysis of patients identified through the hospital's computer system consecutively from January 1, 2011 to December 31, 2014. We included 18 patients who were bridged from an oral P2Y12-receptor antagonist with eptifibatide before surgery. Outcome measures were the incidence of thromboembolic events or stent thrombosis within 30 days of surgery and death within 90 days of hospital discharge. Safety measures were the incidence of thrombolysis in myocardial infarction major, minor, or minimal bleeding. Of the 18 patients assessed, no patients experienced thromboembolic events or stent thrombosis. There was one major bleeding event and one minimal bleeding event postoperatively. Antiplatelet therapy management was highly variable in the perioperative period with 72.2% receiving the recommended GPIIb/IIIa loading dose, 50% of patients not continuing aspirin throughout the surgery, 27.8% of patients stopping antiplatelet therapy less than 5 days before surgery, and 50% not receiving a loading dose of an oral P2Y12-receptor antagonist postoperatively. Within a limited sample size, bridging with an intravenous GPIIb/IIIa inhibitor appeared feasible. Further study is needed on the optimal strategy to manage patients with recent stenting who need surgical procedures.

  15. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents

    NARCIS (Netherlands)

    Sen, Hanim; Tandjung, Kenneth; Basalus, Mounir W.Z.; Löwik, Marije M.; van Houwelingen, Gert K.; Stoel, Martin G.; Louwerenburg, Hans W.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Nijhuis, Rogier; Nienhuis, Mark B.; Verhorst, Patrick M.J.; van der Palen, Job; von Birgelen, Clemens

    2012-01-01

    Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial

  16. Longitudinal deformation of a third generation zotarolimus eluting stent: "The concertina returns!"

    Science.gov (United States)

    Panoulas, Vasileios F; Demir, Ozan M; Ruparelia, Neil; Malik, Iqbal

    2017-01-26

    In the current case series we describe two cases of longitudinal stent deformation in ostial lesions treated with a new generation zotarolimus eluting stent and review current literature on longitudinal stent deformation. Historically not a common occurrence, longitudinal deformation occurred mainly in Promus Element everolimus eluting stents, which had only two rather than the commonly used 3 links between stent rings. Longitudinal deformation commonly occurs secondary to compression of the proximal edge of the stent by either the guide catheters, or intravascular balloons and imaging catheters. The degree of deformation however, depends on the longitudinal strength and design of the stent.

  17. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

    Science.gov (United States)

    Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez Romo, Andrés; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, Bela; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William

    2014-01-01

    Aim The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan. Methods and results The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively. Conclusion The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up. Study registration number UMIN000006940. PMID:24847155

  18. Insights from 2D and 3D Quantitative Angiographic Assessment of Bioresorbable Everolimus-Eluting Vascular Scaffolds.

    Science.gov (United States)

    Witberg, Guy; Lavi, Ifat; Vaknin Assa, Hana; Orvin, Katia; Assali, Abid; Kornowski, Ran

    2016-07-01

    Bioresorbable vascular scaffold (BVS) is a promising technology that potentially offers several advantages over contemporary coronary drug-eluting stents (DES). Crucial to BVS implantation is the correct choice of scaffold size (diameter and length) in order to avoid "geographic miss" in length, provide the maximal support to the vessel wall, and avoid leaving "free-floating" foreign material in the coronary vasculature. To assess the optimal method for measuring coronary stenosis prior to BVS implantation. We compared the performance of two quantitative coronary angiography assessment (QCA) techniques: two dimensional real-time QCA (2D-QCA) and offline 3D QCA (3D-QCA) for the evaluation of coronary lesions in patients enrolled in a multicenter randomized controlled trial of BVS vs. metallic stents, by calculating the weighted kappa value for agreement regarding optimal BVS size with the reference method - CoreLab offline 2D-QCA measurements..In addition, we collected 2 year clinical outcomes (death/myocardial infarction/repeat revascularization/scaffold thrombosis) in BVS-implanted patients. In 17 patients with available CoreLab data, the weighted kappa for agreement for 3D-QCA was significantly better than for 2D-QCA (0.90, 95%CI 0.72-1.00 vs. 0.439, 95%CI 0.16-0.77). The rate of clinical events at 2 years was low (9.5%). Initial experience in a small group of carefully selected patients at our institution, suggests that the use of BVS for coronary revascularization is associated with a low rate of adverse events in suitable patients. 3D-QCA may be superior to 2D-QCA analysis in terms of reproducibility, and results in more patients receiving optimal size BVS.

  19. Stent malapposition, as a potential mechanism of very late stent thrombosis after bare-metal stent implantation: A case report

    Energy Technology Data Exchange (ETDEWEB)

    Higuma, Takumi, E-mail: higuma@cc.hirosaki-u.ac.jp; Abe, Naoki; Hanada, Kenji; Yokoyama, Hiroaki; Tomita, Hirofumi; Okumura, Ken

    2014-04-15

    A 90-year-old man was admitted to our hospital with acute ST-segment elevation myocardial infarction. He had a history of post-infarction angina pectoris 79 months ago and had a bare-metal stent (BMS) implanted in the proximal left anterior descending artery at our hospital. Emergent coronary angiography demonstrated thrombotic occlusion in the previously stented segment. After catheter thrombectomy, antegrade flow was restored, but 90% stenosis with haziness persisted in the proximal and distal portions of the previously stented segment. Intravascular ultrasound imaging showed interstrut cavities or stent malapposition at the proximal and distal sites of stented segment. In close proximity to the sites, residual thrombi were also observed. Optical coherence tomography (OCT) demonstrated neither lipid-laden neointimal tissue nor rupture but clearly demonstrated residual thrombus adjacent to the malapposed region in addition to the stent malapposition. PCI with balloon was successfully performed and stent apposition was confirmed by OCT. Stent malapposition is an unusual mechanism of very late stent thrombosis after BMS implantation. OCT can clearly reveal the etiology of stent thrombosis.

  20. Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

    Science.gov (United States)

    Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

    2016-01-01

    The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide (n = 100) or the control (n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

  1. Late thrombotic events after bioresorbable scaffold implantation: a systematic review andmeta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Collet, Carlos; Asano, Taku; Miyazaki, Yosuke; Tenekecioglu, Erhan; Katagiri, Yuki; Sotomi, Yohei; Cavalcante, Rafael; de Winter, Robbert J.; Kimura, Takeshi; Gao, Runlin; Puricel, Serban; Cook, Stéphane; Capodanno, Davide; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients

  2. Immediate outcomes of eptifibatide therapy during intracoronary stent implantation

    Directory of Open Access Journals (Sweden)

    Hooman Shariati

    2016-01-01

    Conclusion: There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

  3. Optimization of stent implantation using a high pressure inflation protocol.

    Science.gov (United States)

    Vallurupalli, Srikanth; Bahia, Amit; Ruiz-Rodriguez, Ernesto; Ahmed, Zubair; Hakeem, Abdul; Uretsky, Barry F

    2016-01-01

    High-pressure inflation is the universal standard for stent deployment but a specific protocol for its use is lacking. We developed a standardized "pressure optimization protocol" (POP) using time to inflation pressure stability as an endpoint for determining the required duration of stent inflation. The primary study purpose was to determine the stent inflation time (IT) in a large patient cohort using the standardized inflation protocol, to correlate various patient and lesion characteristics with IT, and ascertain in an in vitro study the time for pressure accommodation within an inflation system. Six hundred fifteen stent implants in 435 patients were studied. Multivariate analysis was performed to determine predictors of longer ITs. In an in vitro study, various stents and balloons were inflated in air to determine the pressure accommodation time of the inflation system. The mean stent IT was 104 ± 41 sec (range 30-380 sec). Stent length was the only predictor of prolonged stent inflation. The "accommodation time" in vitro of the stent inflation system itself was 33 ± 24 sec. The protocol was safe requiring premature inflation termination in expand the stent and that the use of a pressure stability protocol will allow for safe, predictable, and more complete stent deployment. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  4. Safety and efficacy of limus-eluting stents and balloon angioplasty for sirolimus-eluting in-stent restenosis

    Energy Technology Data Exchange (ETDEWEB)

    Ota, Hideaki [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Mahmoudi, Michael [University of Surrey, Guildford Road, Surrey, GU2-7XH (United Kingdom); Kitabata, Hironori; Torguson, Rebecca; Chen, Fang; Satler, Lowell F.; Suddath, William O.; Pichard, Augusto D. [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Waksman, Ron, E-mail: ron.waksman@medstar.net [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States)

    2015-03-15

    Objectives: The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). Background: The optimal treatment for drug-eluting in-stent restenosis remains controversial. Methods: The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. Results: The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES = 14%, SES = 18%, POBA = 20%; p = 0.65), death (EES = 2.3%, SES = 6.2%, POBA = 6.1%; p = 0.61), MI (EES = 4.8%, SES = 2.1%, POBA = 2.5%; p = 0.69), TLR (EES = 11.9%, SES = 12.1%, POBA = 24%; p = 0.78), and TVR (EES = 11.9%, SES = 24.8%, POBA = 22.2%; p = 0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p = 0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. Conclusions: In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.

  5. Very Late Stent Thrombosis 42 Months after Implantation of Sirolimus-Eluting Stent and Discontinuation of Antiplatelet Therapy

    Directory of Open Access Journals (Sweden)

    Dirk Sibbing

    2009-01-01

    Full Text Available Although safety profiles of sirolimus-eluting stents do not seem to differ in short-to-medium term from those of bare-metal stents, late stent thrombosis after deployment of drug-eluting stents has emerged as a potential safety concern in the era of high-pressure stent implantation. Here, we describe the case of a patient with acute myocardial infarction due to stent thrombosis of a sirolimus-eluting stent 42 months after stent deployment and 5 weeks after discontinuation of aspirin treatment. To the best of our knowledge, this is one of the most delayed cases of sirolimus-eluting stent thrombosis described so far. The case emphasizes the potential risk that late stent thrombosis can unpredictably occur at any time point after drug-eluting stent deployment.

  6. Intravascular sonotherapy decreases neointimal hyperplasia after stent implantation in swine.

    Science.gov (United States)

    Fitzgerald, P J; Takagi, A; Moore, M P; Hayase, M; Kolodgie, F D; Corl, D; Nassi, M; Virmani, R; Yock, P G

    2001-04-10

    Intimal hyperplasia and subsequent in-stent restenosis remain a major limitation after stent implantation. In vitro cell culture studies show that low-frequency, noncavitational ultrasound energy may impact smooth muscle cell proliferation. Accordingly, we assessed the efficacy of intravascular sonotherapy treatment on intimal hyperplasia in a swine stent model. After balloon injury, biliary stents (Johnson & Johnson) were implanted in the femoral arteries of 14 swine. A total of 48 stented sites were randomized to sonotherapy or sham treatment using a custom-built, 8-French catheter intravascular sonotherapy system (URX, PharmaSonics Inc). After stent deployment, ultrasound energy (700 KHz) was applied to the treatment group for up to 5 minutes. Smooth muscle cell proliferation was assessed using bromodeoxyuridine histology preparation (BrdU) at 7 days in 28 stented sites. At 28 days, the neointimal thickness and the ratio of neointimal/stent area (percent stenosis) was calculated by histomorphometric quantification in 20 stented sites. At 7 days, percent of BrdU staining was significantly reduced in the sonotherapy group compared with the sham group (24.1+/-7.0% versus 31.2+/-3.0%, Psonotherapy group than in the sham group (36+/-24% versus 44+/-27%, Psonotherapy group was less than in the sham group (417+/-461 micrometer versus 643+/-869 micrometer, P=0.06). In this swine peripheral model, intravascular sonotherapy seemed to decelerate cellular proliferation and decrease in-stent hyperplasia. Therefore, intravascular sonotherapy may be an effective form of nonionizing energy to reduce in-stent restenosis.

  7. Sirolimus-eluting versus bare-metal stent implantation in patients with ostial lesions

    DEFF Research Database (Denmark)

    Jørgensen, Erik; Kelbæk, Henning; Kløvgaard, Lene

    2010-01-01

    To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries.......To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries....

  8. Intravascular brachytherapy with radioactive stents produced by ion implantation

    Energy Technology Data Exchange (ETDEWEB)

    Golombeck, M.-A.; Heise, S.; Schloesser, K. E-mail: schloesser@hzy.fzk.de; Schuessler, B.; Schweickert, H

    2003-05-01

    About 1 million patients are treated for stenosis of coronary arteries by percutaneous balloon angioplasty annually worldwide. In many cases a so called stent is inserted into the vessel to keep it mechanically open. Restenosis is observed in about 20-30% of these cases, which can be treated by irradiating the stented vessel segment. In our approach, we utilized the stent itself as radiation source by ion implanting {sup 32}P. Investigations of the surface properties were performed with special emphasis on activity retention. Clinical data of about 400 patients showed radioactive stents can suppress instent restenosis, but a so called edge effect appeared, which can be avoided by the new 'drug eluting stents'.

  9. Intravascular brachytherapy with radioactive stents produced by ion implantation

    Science.gov (United States)

    Golombeck, M.-A.; Heise, S.; Schloesser, K.; Schuessler, B.; Schweickert, H.

    2003-05-01

    About 1 million patients are treated for stenosis of coronary arteries by percutaneous balloon angioplasty annually worldwide. In many cases a so called stent is inserted into the vessel to keep it mechanically open. Restenosis is observed in about 20-30% of these cases, which can be treated by irradiating the stented vessel segment. In our approach, we utilized the stent itself as radiation source by ion implanting 32P. Investigations of the surface properties were performed with special emphasis on activity retention. Clinical data of about 400 patients showed radioactive stents can suppress instent restenosis, but a so called edge effect appeared, which can be avoided by the new "drug eluting stents".

  10. Distribution of nickel after modified nitinol stent implantation in animals

    Science.gov (United States)

    Chepeleva, E.; Sergeevichev, D.; Lotkov, A.; Kashin, O.; Korobeynikov, A.; Kozyr, K.; Baystrukov, V.; Zubarev, D.; Kretov, E.; Pokushalov, E.

    2017-09-01

    Intravascular stenting of arteries in atherosclerotic lesions is one of the most frequently performed procedures in cardiovascular surgery today. Most stents are made of various stainless-steel alloys and other metals (such as nitinol). Nitinol is a biocompatible, superplastic and corrosion resistant material with an important feature of shape memory. However, the composition of this alloy includes nickel, which shows toxicity to the kidneys, liver, lungs, heart and other organs when it accumulates in the organism. In this research we investigated the nickel content in serum, urine and hair of the laboratory animals after implantation of nitinol stents treated with plasma ionic surface modification by silicon.

  11. Complex bifurcation lesions: Randomized comparison of a fully bioresorbable modified t stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds, an OCT study: Rationale and design of the COBRA II trial.

    Science.gov (United States)

    Bennett, J; Adriaenssens, T; Desmet, W; Dubois, C

    2016-11-15

    There is an ongoing controversy regarding the efficacy and safety of different percutaneous stenting techniques for coronary bifurcation lesions needing >1 stent. The promise of safe vessel restoration with bioresorbable scaffolds (BRS) may not be transferable to complex double BRS bifurcation techniques, and permanent metallic scaffolding of the bifurcation core may be needed. We identified modified-T stenting as the most promising fully bioresorbable 2-stent strategy in a preclinical setting. The objective of this study is to assess acute performance and compare long-term vessel healing with this strategy, versus an approach combining BRS with a dedicated metallic drug-eluting bifurcation stent. In a single center, 60 consecutive patients with true and complex coronary bifurcation lesions will be randomly assigned to treatment with the dedicated self-expanding Axxess™ biolimus-eluting bifurcation stent in the proximal main vessel and additional Absorb™ everolimus-eluting BRS in the branches versus a modified T technique using Absorb™ only. Angiography and optical coherence tomography (OCT) will be performed immediately after implantation and at 30 months, and clinical follow-up is foreseen up to 5 years after implantation. The primary endpoint is the change in minimal luminal area assessed with OCT from baseline to 30 months in pre-specified bifurcation segments. To date the use of Absorb™ BRS in complex coronary bifurcations has not been evaluated in a randomized clinical trial setting. The COBRA II study will examine the role and safety of a double BRS strategy in coronary bifurcations, alone or in combination with a metallic dedicated bifurcation device. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  12. [Stent implantation for relief of pulmonary artery branch stenosis].

    Science.gov (United States)

    Guo, Ying; Yu, Zhiqing; Liu, Tingliang; Gao, Wei; Huang, Meirong; Li, Fen; Fu, Lijun; Zhao, Pengjun

    2014-05-01

    Branch pulmonary artery stenosis is one of the common congenital heart disease. Stent implantation to relieve branch pulmonary artery stenosis (BPAS) is an alternative to failed surgical or balloon angioplasty. The aim of this study was to explore the indication, methods and complications of using balloon expandable stent placement to treat branch pulmonary artery stenosis, and evaluate the results of stent implantation in the treatment of branch pulmonary artery stenosis. From August 2005 to December 2012, 19 patients underwent an attempt at stent implantation. The median age of those patients was 9.1 years (range 4.0-15.0 years). The median weight was 31.7 kg (range 17.0-60.5 kg); 14/19 patients underwent post surgical repair of tetralogy of Fallot, one patient received post surgical repair of pulmonary atresia with ventricular septal defect, one patient underwent post surgical repair of pulmonary atresia with intact septum, one with native left BPAS, and one was after surgical repair of aortopulmonary window and the other truncus arteriosus. CP stent and NuMED Balloon-in-Balloon catheter were selected according to digital subtracted angiography measurements. After checking for correct position by angiography, the inner balloon and outer balloon was inflated successively to expand the stent to desired diameter. Statistical analysis was performed with the unpaired Student t test. A total of 26 stents were implanted successfully in 19 patients. The systolic gradient across the stenosis fell from a median of (36.0 ± 18.3) to (3.8 ± 3.4) mmHg (P aortic pressure ratio fell from 0.68 to 0.49 (P children will require further dilation to keep up with normal somatic growth. Intermediate and long-term follow up studies have shown excellent results after further dilation over time.

  13. Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis. From western denmark heart registry

    DEFF Research Database (Denmark)

    Jensen, Jesper; Jensen, Lisette Okkels; Terkelsen, Christian Juhl

    2012-01-01

    There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis...

  14. Vessel wall reactions to endovascular stent implantation

    NARCIS (Netherlands)

    H.M.M. van Beusekom (Heleen)

    1993-01-01

    textabstractIn order to gain insight in the effects of stenting, we studied the process of wound healing and the short- and long-term effect of these permanently present foreign bodies. Both thrombogenic and less thrombogenic metals were evaluated with respect to thrombogenicity and tissue response.

  15. Outcomes after coronary stent implantation in patients with metal allergy.

    Science.gov (United States)

    Romero-Brufau, Santiago; Best, Patricia J M; Holmes, David R; Mathew, Verghese; Davis, Mark D P; Sandhu, Gurpreet S; Lennon, Ryan J; Rihal, Charanjit S; Gulati, Rajiv

    2012-04-01

    Clinical outcomes after stent placement in patients with a history of metal allergy remain incompletely understood. We performed a single-center retrospective study to evaluate such outcomes. Twenty-nine allergic patients who underwent coronary stent implantation were compared with a nonallergic group (n=250) matched for demographics and a propensity score for allergy to metal. Hypersensitivity to nickel was reported in 26 of 29 and chromium in 9 of 29. Patch testing performed in 11 of 29 patients was positive in all. Comparing allergy versus control subjects, there were no differences in number of segments treated (1.4±0.7 versus 1.5±0.7), stents placed (1.7±1.1 versus 1.6±0.9), and frequency of drug-eluting stent usage (52% versus 60%). In-hospital death (0% versus 0%), myocardial infarction (MI, 4% versus 3%, P=0.27), and 30-day death (3% versus 0%, P=0.53) and MI (3% versus 4%, P=0.71) were statistically similar. There were no differences in 4-year death (12% versus 13%), target lesion revascularization (TLR, 13 versus 17%, P=0.54), or death/MI/TLR (24% versus 34%, P=0.20). Clinically driven repeat angiography in 12 of 29 allergy patients revealed binary restenosis rates of 27% in bare metal stents and 0% in drug-eluting stents, with mean diameter in-stent restenosis of 36% and 8%, respectively. There was no change in circulating eosinophil and lymphocyte counts after stenting in the allergy group (0.19-0.20, P=0.67, and 1.90-1.79, P=0.59, respectively). A history of metal allergy was not associated with adverse early or late outcomes in this single-center study.

  16. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Ong, Andrew T. L.; Piek, Jan J.; Neumann, Franz-Josef; van der Giessen, Willem J.; Wiemer, Marcus; Zeiher, Andreas; Grube, Eberhard; Haase, Jürgen; Thuesen, Leif; Hamm, Christian; Otto-Terlouw, Patricia C.

    2005-01-01

    Background: Everolimus is a sirolimus analogue with similar efficacy in animal models, and has been previously successfully tested in humans using an erodable polymer.Methods: This first-in-man single blind multi-centre randomized controlled trial assessed the safety and efficacy of everolimus

  17. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions].

    Science.gov (United States)

    Li, C J; Xu, B; Guan, C D; Gao, R L

    2017-11-24

    Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1

  18. Aspirin desensitization in patients undergoing planned or urgent coronary stent implantation. A single-center experience

    NARCIS (Netherlands)

    Luca, G. De; Verdoia, M.; Binda, G.; Schaffer, A.; Suryapranata, H.; Marino, P.

    2013-01-01

    INTRODUCTION: Dual antiplatelet therapy (aspirin and ADP-antagonists) is mandatory after stent implantation in order to avoid stent thrombosis, especially in the era of DES. In fact, a delayed re-endothelization process may enlarge the window of occurrence of stent thrombosis beyond 1-year after

  19. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

    Science.gov (United States)

    Lammer, Johannes; Bosiers, Marc; Deloose, Koen; Schmidt, Andrej; Zeller, Thomas; Wolf, Florian; Lansink, Wouter; Sauguet, Antoine; Vermassen, Frank; Lauwers, Geert; Scheinert, Dierk; Popma, Jeffrey J; McGreevy, Robert; Rapoza, Richard; Schwartz, Lewis B; Jaff, Michael R

    2016-06-13

    This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). Drug-eluting BVS has shown promise in coronary arteries. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Hemodynamics of Stent Implantation Procedures in Coronary Bifurcations: an in vitro study

    CERN Document Server

    Brindise, Melissa C; Burzotta, Francesco; Migliavacca, Francesco; Vlachos, Pavlos P

    2016-01-01

    Stent implantation in coronary bifurcations presents unique challenges and currently there is no universally accepted stent deployment approach. Despite clinical and computational studies, to date, the effect of each stent implantation method on the coronary artery hemodynamics is not well understood. In this study the hemodynamics of stented coronary bifurcations under pulsatile flow conditions were investigated experimentally. Three implantation methods, provisional side branch (PSB), culotte (CUL), and crush (CRU), were investigated using time-resolved particle image velocimetry (PIV) to measure the velocity fields. Subsequently, hemodynamic parameters including wall shear stress (WSS), oscillatory shear index (OSI), and relative residence time (RRT) were calculated and the pressure field through the vessel was non-invasively quantified. The effects of each stented case were evaluated and compared against an un-stented case. CRU provided the lowest compliance mismatch, but demonstrated detrimental stent in...

  1. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    Directory of Open Access Journals (Sweden)

    Rose Mary Ferreira Lisboa da Silva

    2014-08-01

    Full Text Available Background: The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. Objective: To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. Methods: This study assessed 61 patients (mean age, 64.0 years; 35 men with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform, measuring the low-frequency (LF and high-frequency (HF components, and the LF/HF ratio before and during the procedure. Results: Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively, with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00. The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Conclusions: Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents.

  2. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    Energy Technology Data Exchange (ETDEWEB)

    Silva, Rose Mary Ferreira Lisboa da, E-mail: roselisboa@cardiol.br [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Silva, Carlos Augusto Bueno [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Greco, Otaviano José [Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Moreira, Maria da Consolação Vieira [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil)

    2014-08-15

    The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. This study assessed 61 patients (mean age, 64.0 years; 35 men) with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform), measuring the low-frequency (LF) and high-frequency (HF) components, and the LF/HF ratio before and during the procedure. Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively), with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00). The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents.

  3. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-12-01

    SUS316L stainless steel and cobalt-chromium and platinum-chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform.

  4. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-01-01

    SUS316L stainless steel and cobalt–chromium and platinum–chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform. PMID:27877545

  5. Multiple coronary micro-aneurysm formation after drug-eluting stent implantation

    Directory of Open Access Journals (Sweden)

    Apostolos H. Christou

    2016-05-01

    Full Text Available Although there are limited data regarding the formation of coronary artery aneurysms (CAAs after drug-eluting stent (DES implantation, CAAs appear to be a rare complication of coronary stenting. The exact mechanism of CAA formation is unknown, but several hypotheses have been proposed. As the use of DES increases, the clinical significance of these findings will become clearer. We report on a patient who developed multiple CAAs in 2 different locations after sirolimus-eluting stent implantation.

  6. The risk and prognostic impact of definite stent thrombosis or in-stent restenosis after coronary stent implantation

    DEFF Research Database (Denmark)

    Thayssen, Per; Jensen, Lisette Okkels; Lassen, Jens Flensted

    2012-01-01

    Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI). Methods and result...

  7. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  8. The underdilation of nitinol stents at TIPS implantation: Solution or illusion?

    Science.gov (United States)

    Mollaiyan, Ashkan; Bettinger, Dominik; Rössle, Martin

    2017-04-01

    This study investigates the behaviour of self-expanding nitinol stents at the time of TIPS-implantation and thereafter. Hundred consecutive patients with cirrhosis receiving a TIPS revision were included. The smallest stent diameter was measured radiologically immediately after implantation and before shunt revision. Accuracy of the measurement was assessed by comparing the nominal stent diameter with the largest stent diameter measured at the time of revision. Pearson correlation between largest measured and nominal diameters was excellent (r=0.952, pballoons were used. During a mean follow-up of 12.7±17.8months (median 3 months, range 1-81) stents expanded by 0.5-1.6mm dependent on the nominal stent size (8, 9, 10mm) and the grade of primary underdilation. No significant difference was found between Viatorr and bare stents. At TIPS-implantation, the compliance of the surrounding tissue predominantly determines the stent diameter. The nominal size of the stent or the dilatation balloon has little influence. Accurate adjustment of a desired pressure gradient is, therefore, not possible. During follow-up, stents expand towards their nominal diameter questioning the usefulness of underdilation. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

    Directory of Open Access Journals (Sweden)

    Chao-Lun Lai

    Full Text Available The clinical outcomes of different limus-based drug-eluting stents (DES in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES, Endeavor zotarolimus-eluting stent (E-ZES and everolimus-eluting stent (EES, using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES. After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group. Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

  10. Intracranial Stent Implantation for Drug Resistant Atherosclerotic Stenosis: Results of 52 Cases

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Kuk Seon; Hwang, Dae Hyun; Ko, Young Hwan; Kang, Ik Won; Lee, Eil Seong; Han, You Mie [Dept. of Radiology, Hallym University Hospital Hangang Scared Heart Hospital, Seoul (Korea, Republic of); Kim, In Soo; Hur, Choon Woong [Dept. of Neurosurgery, Myungji St. Mari' s Hospital, Seoul (Korea, Republic of)

    2011-07-15

    We evaluated the usefulness of intracranial stent implantation for treatment of drug resistant atherosclerotic stenoses. Between March 2004 and July 2007, we tried intracranial stent implantation in 49 patients with 52 lesions (anterior circulation 48 cases, posterior circulation 4 cases) who had an ischemic stroke with more than 50% of major cerebral artery stenosis. We classified the lesions by their location and morphology, analyzed the results in terms of the success rate, complication rate, and restenosis rate during the follow-up period. Intracranial stent implantation was performed successfully in 43 cases (82.7%). In eight of the nine cases, the stent implantation failure was due to the tortuosity of the target vessel. There was no major periprocedural complication. One patient showed cerebellar infarction after the procedure. Mean residual stenoses decreased from 70.2% to 13.0%. Four cases (9.3%) demonstrated in-stent restenoses and more than 50% during the mean and 25.3/month after the follow-up period. Success rate of intracranial stent implantation may improve on developing technique and more experience. Low rate of complication and restenosis suggest that we can consider intracranial stent implantation for treatment of drug resistant atherosclerotic stenoses.

  11. Implante de ducto nasolacrimal de poliuretano: relato de caso Nasolacrimal stent implantation: report of a case

    Directory of Open Access Journals (Sweden)

    Patrícia Lunardelli

    2008-02-01

    Full Text Available Obstrução parcial ou completa da via lacrimal provoca um lacrimejamento constante ou intermitente denominado epífora. O tratamento preconizado para os casos de epífora com obstruções localizadas abaixo do canalículo comum é a dacriocistorrinostomia externa ou a dacriocistorrinostomia via endoscópica. Nos últimos anos foram criadas e aperfeiçoadas técnicas alternativas para o tratamento de epífora como a intubação da via lacrimal com tubos de silicone, dilatação do ducto nasolacrimal (dacriocistoplastia e o desenvolvimento de implantes nasolacrimais. O objetivo deste trabalho é relatar a primeira experiência brasileira com o implante de poliuretano, realizado pelos serviços de Radiologia Intervencionista e Oftalmologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - USP - SP. Embora o implante nasolacrimal tenha suas vantagens por ser um procedimento radiológico intervencionista versus uma cirurgia invasiva, não é o procedimento indicado como tratamento primário da obstrução do ducto nasolacrimal. Estudos a longo prazo ainda são necessários para avaliar e resolver as complicações encontradas nos últimos trabalhos. Novos desenhos e métodos de recanalização in situ (mecanicamente ou com auxílio de medicações talvez melhorem a viabilidade deste método terapêutico para a resolução de epífora.Epiphora (watering eye is generally caused by insufficient drainage of tears. The most common cause of epiphora in adults is idiopathic inflammatory obstruction of the nasolacrimal duct. The traditional surgical treatment of nasolacrimal duct obstruction is an external dacryocystorhinostomy, which has an 85% to 95% success rate. To eliminate cutaneus wounds and scarring some techniques were introduced, for example the endonasal laser dacryocystorhinostomy and the nasolacrimal stent. The aim of this report was to evaluate the first case of nasolacrimal stent implantation in Brazil. The

  12. A simple three-dimensional stent for proper placement of mini-implant

    National Research Council Canada - National Science Library

    Felicita, A Sumathi

    2013-01-01

    This paper deals with the fabrication of a three-dimensional stent which is simple in design but provides an accurate placement of a mini-implant in three planes of space, namely, sagittal (root proximity), vertical...

  13. MIGS: therapeutic success of combined Xen Gel Stent implantation with cataract surgery.

    Science.gov (United States)

    Hohberger, Bettina; Welge-Lüßen, Ulrich-Christoph; Lämmer, Robert

    2018-01-15

    Glaucoma, a common disease in the elderly population, is frequently coexistent with cataract. While the combination of filtration surgery and cataract surgery is a challenging topic with limited success, minimal invasive glaucoma surgery (MIGS), such as Xen Gel Stents, seems to provide promising results. The aim of this study was to investigate the complete and qualified therapeutic success of Xen Gel Stent implantation with (XenPhaco) and without cataract surgery. One hundred and eleven open-angle glaucoma eyes underwent implantation of Xen45 Gel Stent (AqueSys, Inc.) with or without cataract operation. Complete therapeutic success was defined as target intraocular pressure (IOP) success was defined as target IOP success was achieved in 46.9% of single Xen Gel Stent implantation, whereas 53.3% was reached with combined XenPhaco. Qualified success was seen in 2.5% in the eyes of the single Xen Gel Stent implantation group and in 3.3% of the combined surgery group. Therapeutic failure rate was 49.4% in the stand-alone group vs 46.7% in the combined group. Data were not significantly different for group and subgroup analyses. Complete and qualified therapeutic success is similar for the combination of Xen Gel Stent implantation with and without cataract surgery in open-angle glaucoma patients. MIGS using Xen Gel Stent can be recommended in situations if glaucoma surgery is indicated besides coexisting cataract.

  14. Association of moderate chronic kidney disease with insufficient improvement of fractional flow reserve after stent implantation.

    Science.gov (United States)

    Sakoda, Kunihiro; Tanaka, Nobuhiro; Hokama, Yohei; Hoshino, Kou; Murata, Naotaka; Yamashita, Jun; Yamashina, Akira

    2016-08-01

    This study aims to investigate the association of moderate chronic kidney disease (CKD) with fractional flow reserve (FFR) after stent implantation. Patients with moderate CKD have a higher prevalence of severe and diffuse coronary artery disease, and have increased risk of cardiovascular events even after stent implantation. On the other hand, in some patients, FFR could not be sufficiently improved even after stent implantation. However, the association between these pathophysiological processes is unclear. A total of 102 patients with stable angina, in whom a stent was implanted for the left anterior descending coronary artery (LAD) lesion, were included. Patients with a severely decreased glomerular filtration rate (GFR; > CKD stage 4) were excluded. Patients were stratified into 3 groups: those with an estimated GFR (eGFR) ≥ 60 mL per min per 1.73 m(2) (stage 0-2), 45 to 59 mL per min per 1.73 m(2) (stage 3a), and 30 to 44 mL per min per 1.73 m(2) (stage 3b). FFR after stent implantation (post-stent FFR) was significantly lower in the stage 3b group than in both the stage 0-2 group and the stage 3a group (P < 0.01). Post-stent FFR had a significant positive correlation with eGFR (r = 0.223, P = 0.024). Multivariate analysis demonstrated that eGFR was an independent predictor of post-stent FFR. Moderate CKD was independently associated with insufficient improvement of FFR after stent implantation. This can partly explain the poor prognosis of patients with CKD. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  15. Differential aspects between cobalt-chromium everolimus drug-eluting stent and Absorb everolimus bioresorbable vascular scaffold: from bench to clinical use.

    Science.gov (United States)

    Sotomi, Yohei; Suwannasom, Pannipa; Tenekecioglu, Erhan; Tateishi, Hiroki; Abdelghani, Mohammad; Serruys, Patrick W; Onuma, Yoshinobu

    2015-10-01

    Drug-eluting stents have significantly improved the outcomes of percutaneous coronary intervention by substantially reducing in-stent restenosis and stent thrombosis. However, a potential limitation of these stents is the permanent presence of a metallic foreign body within the artery, which may cause vascular inflammation, restenosis, thrombosis, neoatherosclerosis, permanent impairment of the physiological vasomotor function and interference with potential future grafting of the stented segment. Bioresorbable scaffolds have the potential to overcome these limitations as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage and restoring pulsatility, cyclical strain, physiological shear stress and mechanotransduction. This article presents a comparison between the most widespread bioresorbable vascular scaffold 'Absorb BVS' and second-generation drug-eluting stent (cobalt chromium everolimus-eluting stent) from bench to clinical use.

  16. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Song, Hae-Geun; Ahn, Jung-Min; Kim, Won-Jang; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Seung, Ki-Bae; Yang, Tae-Hyun; Lee, Sang-Gon; Lee, Jae-Hwan; Seong, In-Whan; Cheong, Sang-Sig; Lee, Bong-Ki; Lee, Nae-Hee; Lee, Se-Whan; Lee, Seung-Wook; Lee, Keun; Kim, Hyun-Sook; Jeon, Doo-Soo; Kim, Min-Kyu; Nah, Deuk-Young; Tahk, Seung-Jea; Park, Seung-Jung

    2011-10-01

    This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  17. Haemodynamic impact of stent implantation for lateral tunnel Fontan stenosis: a patient-specific computational assessment.

    Science.gov (United States)

    Tang, Elaine; McElhinney, Doff B; Restrepo, Maria; Valente, Anne M; Yoganathan, Ajit P

    2016-01-01

    The physiological importance of the lateral tunnel stenosis in the Fontan pathway for children with single ventricle physiology can be difficult to determine. The impact of the stenosis and stent implantation on total cavopulmonary connection resistance has not been characterized, and there are no clear guidelines for intervention. Methods and results A computational framework for haemodynamic assessment of stent implantation in patients with lateral tunnel stenosis was developed. Cardiac magnetic resonances images were reconstructed to obtain total cavopulmonary connection anatomies before stent implantation. Stents with 2-mm diameter increments were virtually implanted in each patient to understand the impact of stent diameter. Numerical simulations were performed in all geometries with patient-specific flow rates. Exercise conditions were simulated by doubling and tripling the lateral tunnel flow rate. The resulting total cavopulmonary connection vascular resistances were computed. A total of six patients (age: 14.4 ± 3.1 years) with lateral tunnel stenosis were included for preliminary analysis. The mean baseline resistance was 1.54 ± 1.08 WU · m(2) and dependent on the stenosis diameter. It was further exacerbated during exercise. It was observed that utilising a stent with a larger diameter lowered the resistance, but the resistance reduction diminished at larger diameters. Using a computational framework to assess the severity of lateral tunnel stenosis and the haemodynamic impact of stent implantation, it was observed that stenosis in the lateral tunnel pathway was associated with higher total cavopulmonary connection resistance than unobstructed pathways, which was exacerbated during exercise. Stent implantation could reduce the resistance, but the improvement was specific to the minimum diameter.

  18. Artery Soft-Tissue Modelling for Stent Implant Training System

    Directory of Open Access Journals (Sweden)

    Giovanni Aloisio

    2004-08-01

    Full Text Available Virtual reality technology can be utilised to provide new systematic training methods for surgical procedures. Our aim is to build a simulator that allows medical students to practice the coronary stent implant procedure and avoids exposing patients to risks. The designed simulation system consists of a virtual environment and a haptic interface, in order to provide both the visualization of the coronary arteries and the tactile and force feedback generated during the interactions of the surgical instruments in the virtual environment. Since the arteries are soft tissues, their shape may change during an operation; for this reason physical modelling of the organs is necessary to render their behaviour under the influence of surgeon's instruments. The idea is to define a model that computes the displacement of the tissue versus time; from the displacement it is possible to calculate the response of the tissue to the surgical tool external stimuli. Information about tools displacements and tissue responses are also used to graphically model the artery wall and virtual surgical instrument deformations generated as a consequence of their coming into contact. In order to obtain a realistic simulation, the Finite Element Method has been used to model the soft tissues of the artery, using linear elasticity to reduce computational time and speed up interaction rates.

  19. Eosinophilic responses to stent implantation and the risk of Kounis hypersensitivity associated coronary syndrome.

    Science.gov (United States)

    Kounis, Nicholas G; Giannopoulos, Sotiris; Tsigkas, Grigorios G; Goudevenos, John

    2012-04-19

    The use of drug eluting stents constitutes a major breakthrough in current interventional cardiology because it is more than halves the need of repeat interventions. It is incontrovertible that coronary stents, in general, have been beneficial for the vast majority of patients. A small increase in thrombosis, following DES implantation, is offset by a diminished risk of complications associated with repeat vascularization. However, late and, especially, very late stent thrombosis is a much feared complication because it is associated with myocardial infarction with increased mortality. Despite that stent thrombosis is thought to be multifactorial, so far clinical reports and reported pathology findings in patients died from coronary stent thrombosis as well as animal studies and experiments, point toward a hypersensitivity inflammation. The stented and thrombotic areas are infiltrated by interacting, via bidirectional stimuli inflammatory cells including eosinophils, macrophages, T-cells and mast cells. Stented regions constitute an ideal surrounding for endothelial damage and dysfunction, together with hemorheologic changes and turbulence as well as platelet dysfunction, coagulation and fibrinolytic disturbances. Drug eluting stent components include the metal strut which contains nickel, chromium, manganese, titanium, molybdenum, the polymer coating and the impregnated drugs which for the first generation stents are: the antimicrotubule antineoplastic agent paclitaxel and the anti-inflammatory, immunosuppressive and antiproliferative agent sirolimus. The newer stents which are called cobalt-chromiun stents and elute the sirolimus analogs everolimus and zotarolimus both contain nickel and other metals. All these components constitute an antigenic complex inside the coronary arteries which apply chronic, continuous, repetitive and persistent inflammatory action capable to induced Kounis syndrome and stent thrombosis. Allergic inflammation goes through three phases

  20. MRI assessment of thoracic stent grafts after emergency implantation in multi trauma patients: a feasibility study

    Energy Technology Data Exchange (ETDEWEB)

    Rasche, Volker [University Hospital Ulm, Department of Internal Medicine II, Ulm (Germany); University Hospital Ulm, University of Ulm, Department of Internal Medicine II, Ulm (Germany); Oberhuber, Alexander; Orend, Karl-Heinz [University Hospital Ulm, Department of Vascular and Thoracic Surgery, Ulm (Germany); Trumpp, Stephan [University Hospital Ulm, Department of Internal Medicine II, Ulm (Germany); University Hospital Ulm, Department of Vascular and Thoracic Surgery, Ulm (Germany); Bornstedt, Axel; Merkle, Nico; Rottbauer, Wolfgang [University Hospital Ulm, Department of Internal Medicine II, Ulm (Germany); Hoffmann, Martin [University Hospital Ulm, Department of Diagnostic and Interventional Radiology, Ulm (Germany)

    2011-07-15

    To evaluate the feasibility of MRI for static and dynamic assessment of the deployment of thoracic aortic stent grafts after emergency implantation in trauma patients. Twenty patients initially presenting with a rupture of the thoracic aorta were enrolled in this study. All patients underwent thoracic endovascular aortic repair (TEVAR). The deployment of the implanted stent graft was assessed by CTA and MRI, comprising the assessment of the aortic arch with and without contrast agent, and the assessment of the motion of the stent graft over the cardiac cycle. The stent graft geometry and motion over the cardiac cycle were assessable by MRI in all patients. Flow-mediated signal variations in areas of flow acceleration could be well visualised. No statistically significant differences in stent-graft diameters were observed between CT and MRI measurements. MRI appears to be a valuable tool for the assessment of thoracic stent grafts. It shows similar performance in the accurate assessment of stent-graft dimensions to the current gold standard CTA. Its capability of providing additional functional information and the lack of ionising radiation and nephrotoxic contrast agents may make MRI a valuable tool for monitoring patients after TEVAR. (orig.)

  1. Fabrication of a radiographic and surgical stent for maxillofacial implants: a case report

    Directory of Open Access Journals (Sweden)

    Ghoveizi R

    2010-06-01

    Full Text Available "nA procedure was explained to fabricate a surgical stent to aid the placement of maxillofacial implants for prosthetic auricular rehabilitation. An impression of the defect was made, and a wax pattern of the missing ear completed and evaluated on the patient. The definitive wax prosthesis was processed in clear acrylic resin. Also an occlusal maxillary splint was fabricated and joined to the acrylic resin ear by using an extraoral acrylic resin bar. Surgical stent provides proper orientation of the acrylic resin ear while remaining attached to the maxillary arch. This surgical stent can also be used for radiographic examination.

  2. Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation: A Five Year Follow-Up of the SORT OUT II Study

    DEFF Research Database (Denmark)

    Kristensen, S. L.; Galloe, A. M.; Thuesen, L.

    2014-01-01

    stent implantation, use of statins, initial PCI urgency (STEMI [primary PCI], NSTEMI/unstable angina [subacute PCI] or stable angina [elective PCI]), and glucose-lowering agents did not seem to influence risk of stent thrombosis. Conclusion: In a contemporary cohort of coronary stented patients, stent...

  3. Anastomotic leak after oesophagectomy and stent implantation: a systematic review

    Directory of Open Access Journals (Sweden)

    A.N. Kanatas

    2011-12-01

    Full Text Available Anastomotic leaks following oesophageal cancer resection have a high mortality. Stents have an established position in the palliation of dysphagia due to malignancy and in treating malignant perforation or fistula. They are increasingly used for benign conditions such as spontaneous oesophageal perforation with encouraging results. In this systematic review we examine the available evidence and attempt to define the role of stents in the management of oesophageal anastomotic leaks after resection for cancer. It is evident from the review that plastic- and metal-covered stents are an effective strategy for the treatment of anastomotic leaks. Vigilance is required as complications such as stent migration and incomplete sealing are not uncommon. Further clinical studies with greater methodological rigor in terms of sample size and study design may confirm that stents have an important contribution to make in the management of oesophageal anastomotic leak.

  4. Risk factors for in-stent restenosis of vertebral artery origin after stent implantation: a Meta-analysis

    Directory of Open Access Journals (Sweden)

    Fang-fang HAO

    2018-01-01

    Full Text Available Objective To systematically review the risk factors for in-stent restenosis (ISR of vertebral artery origin after sent implantation to provide theoretical foundation for clinical prevention and treatment. Methods Taking vertebral artery, vertebrobasilar insufficiency, stents, drug-eluting stents, self expandable metallic stents in English and Chinese as key words, retrospective clinical studies about risk factors for ISR of vertebral artery origin were searched by using PubMed, EMBASE/SCOPUS, Cochrane Library, China Biology Medicine (CBM, China National Knowledge Infrastructure (CNKI, Wanfang Data and VIP database from January 1, 1966 to March 30, 2017. Quality assessment and Meta-analysis were made by using Newcastle-Ottawa Scale (NOS and Stata 12.0 software. Results The research enrolled 3468 articles in all, from which 11 studies were chosen after excluding duplicates and those not meeting the inclusion criteria. A total number of 1352 patients were divided into ISR group (N = 440 and non-ISR group (N = 912. The ISR incidence rate of smokers was significantly higher than non-smokers (OR = 2.179, 95%CI: 1.373-3.458; P = 0.001. The differences of bare metal stents (BMS utilization rate (OR = 2.072, 95% CI: 1.560-2.753; P = 0.000 and drug-eluting stents (DES utilization rate (OR = 0.483, 95% CI: 0.363-0.641; P = 0.000 between ISR group and non-ISR group were statistically significant. Conclusions Smoking and using BMS are risk factors for ISR of vertebral artery origin, and using DES is protective factor. Due to limited study quality, more high-quality studies are needed to verify this conclusion. DOI: 10.3969/j.issn.1672-6731.2017.12.004

  5. Coronary artery aneurysm formation following implantation of a bioresorbable vascular scaffold for in-stent restenosis.

    Science.gov (United States)

    García-Guimaraes, Marcos; Cuesta, Javier; Alvarado, Teresa; Rivero, Fernando; Bastante, Teresa; Benedicto, Amparo; Alfonso, Fernando

    2017-06-01

    Coronary artery aneurysm (CAA) formation is a rare complication of coronary intervention that may develop after implantation of bare-metal or drug-eluting stents. The etiology of this entity appears to be multifactorial and its prognosis is poorly understood, but it has been associated with an increased risk of stent thrombosis. To date few cases of CAAs related to bioresorbable vascular scaffold (BVS) implantation have been reported, and the development of CAA after BVS implantation for the treatment of in-stent restenosis (ISR) has not been previously described. Here we present two cases of CAA formation after BVS, which represent the first demonstration of CAA formation after the use of BVS for ISR. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. Similarities and differences in coatings for magnesium-based stents and orthopaedic implants

    Directory of Open Access Journals (Sweden)

    Jun Ma

    2014-07-01

    Full Text Available Magnesium (Mg-based biodegradable materials are promising candidates for the new generation of implantable medical devices, particularly cardiovascular stents and orthopaedic implants. Mg-based cardiovascular stents represent the most innovative stent technology to date. However, these products still do not fully meet clinical requirements with regards to fast degradation rates, late restenosis, and thrombosis. Thus various surface coatings have been introduced to protect Mg-based stents from rapid corrosion and to improve biocompatibility. Similarly, different coatings have been used for orthopaedic implants, e.g., plates and pins for bone fracture fixation or as an interference screw for tendon-bone or ligament-bone insertion, to improve biocompatibility and corrosion resistance. Metal coatings, nanoporous inorganic coatings and permanent polymers have been proved to enhance corrosion resistance; however, inflammation and foreign body reactions have also been reported. By contrast, biodegradable polymers are more biocompatible in general and are favoured over permanent materials. Drugs are also loaded with biodegradable polymers to improve their performance. The key similarities and differences in coatings for Mg-based stents and orthopaedic implants are summarized.

  7. Shrinking the Supply Chain for Implantable Coronary Stent Devices.

    Science.gov (United States)

    Moore, Sean S; O'Sullivan, Kevin J; Verdecchia, Francesco

    2016-02-01

    Stenting treatments for the management of disease in the heart, arterial and venous systems, biliary ducts, urethras, ureters, oesophageal tract and prostate have made enormous technical advances since their introduction into clinical use. The progression from metallic to polymer based bio-absorbable stents, coupled with the advances in additive manufacturing techniques, present a unique opportunity to completely re-envision the design, manufacture, and supply chain of stents. This paper looks at current stenting trends and proposes a future where the stent supply chain is condensed from ~150 days to ~20 min. The Cardiologist therefore has the opportunity to become a designer, manufacturer and user with patients receiving custom stents specific to their unique pathology that will be generated, delivered and deployed in the Cath-lab. The paper will outline this potentially revolutionary development and consider the technical challenges that will need to be overcome in order to achieve these ambitious goals. A high level overview of the generating eluting stents in situ program-GENESIS-is outlined including some early experimental work.

  8. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation.

    Science.gov (United States)

    Kaya, Mehmet Gungor; Okyay, Kaan; Yazici, Huseyin; Sen, Nihat; Tavil, Yusuf; Turkoglu, Sedat; Timurkaynak, Timur; Ozdemir, Murat; Cemri, Mustafa; Yalcin, Ridvan; Cengel, Atiye

    2009-03-01

    We sought to investigate the early and late effects of magnetic resonance imaging (MRI) on stent thrombosis and major adverse coronary events after coronary artery stent (CAS) implantation at a long-term follow-up period. Forty-three patients (28 men, mean age 63+/-10 years) who underwent CAS implantation before MRI examination were included. MRI was performed on a 1.5-T MR-system with a phased array multicoil. An average of 1.3 stents per patient were implanted (1-4 stents). More than one MRI was performed for two patients. Patients who underwent MRI within 8 weeks after the procedure were included in the early-term group (17 patients), and those who underwent MRI after 8 weeks were included in the late-term group (26 patients). Mean follow-up period was 36+/-15 months. There was no acute or subacute stent thrombosis. Late stent thrombosis that resulted in acute myocardial infarction was observed in a patient from the early group after an operation for prostate hyperplasia 5 months after MRI, and the patient underwent percutaneous coronary artery angioplasty. De-nova lesion was observed in four patients in the early group and two patients in the late group (P=0.14). In-stent restenosis was recorded in two patients in the early group and three patients in the late group (P=0.98). Composite major adverse cardiac events (acute coronary syndrome, myocardial infarction, death, and cerebrovascular event) were observed in seven of the early-group patients (41%), and in six of the late-group patients (23%) (P=0.20). MRI can be safely performed in patients with CAS implantation both in the early and late course, and is not associated with an increased risk of major adverse clinical cardiac events at long-term follow-up.

  9. Biodegradable nanocomposite magnetite stent for implant-assisted magnetic drug targeting

    Energy Technology Data Exchange (ETDEWEB)

    Mangual, Jan O.; Li Shigeng; Ploehn, Harry J.; Ebner, Armin D. [Department of Chemical Engineering, Swearingen Engineering Center, University of South Carolina, Columbia, SC 29208 (United States); Ritter, James A., E-mail: ritter@cec.sc.ed [Department of Chemical Engineering, Swearingen Engineering Center, University of South Carolina, Columbia, SC 29208 (United States)

    2010-10-15

    This study shows, for the first time, the fabrication of a biodegradable polymer nanocomposite magnetic stent and the feasibility of its use in implant-assisted-magnetic drug targeting (IA-MDT). The nanocomposite magnetic stent was made from PLGA, a biodegradable copolymer, and iron oxide nanopowder via melt mixing and extrusion into fibers. Degradation and dynamic mechanical thermal analyses showed that the addition of the iron oxide nanopowder increased the polymer's glass transition temperature (T{sub g}) and its modulus but had no notable effect on its degradation rate in PBS buffer solution. IA-MDT in vitro experiments were carried out with the nanocomposite magnetic fiber molded into a stent coil. These stent prototypes were used in the presence of a homogeneous magnetic field of 0.3 T to capture 100 nm magnetic drug carrier particles (MDCPs) from an aqueous solution. Increasing the amount of magnetite in the stent nanocomposite (0, 10 and 40 w/w%) resulted in an increase in the MDCP capture efficiency (CE). Reducing the MDCP concentrations (0.75 and 1.5 mg/mL) in the flowing fluid and increasing the fluid velocities (20 and 40 mL/min) both resulted in decrease in the MDCP CE. These results show that the particle capture performance of PLGA-based, magnetic nanocomposite stents are similar to those exhibited by a variety of different non-polymeric magnetic stent materials studied previously.

  10. Stent thrombosis after coronary stent implantation: a protective effect of high-dose statin therapy?

    Science.gov (United States)

    Jeger, Raban V; Brunner-La Rocca, Hans Peter; Bertel, Osmund; Kiowski, Wolfgang; Pfisterer, Matthias E; Kaiser, Christoph A

    2013-01-01

    To assess independent predictors of stent thrombosis (ST) in an all-comer trial. This is an observational case-control study based on a retrospective analysis of the Basel Stent Kosten Effektivitäts Trial (BASKET) (n = 826). Patients with ST were compared to controls with regard to baseline parameters. Multivariate models were performed to identify independent predictors of ST. At 36 months, there were 53 (6.4%) patients with ST, 17 (32%) of whom had early ST and 36 (68%) of whom had late/very late ST. Patients with ST were at a higher cardiovascular risk but received lower doses of statins than the controls (n = 212). Stents in ST patients were longer, had more overlap and were not as well expanded, with significantly more remaining stenoses than the stents in the controls. Multivariable analysis revealed interventions in saphenous vein grafts, malapposed stents, an overlap >3 mm, complex coronary anatomy and treatment with low-dose/no statins as risk factors for ST, while interventions in saphenous vein grafts, underexpanded or malapposed stents, a history of myocardial infarction and treatment with low-dose/no statins were risk factors for late ST. The use of statins might have a protective effect against ST. This observation is new, hypothesis-generating and should be evaluated in an adequately powered randomized trial. Copyright © 2013 S. Karger AG, Basel.

  11. Stent-related cardiac events beyond three years after implantation of the sirolimus-eluting stent (from the EVASTENT Patients).

    Science.gov (United States)

    Barone-Rochette, Gilles; Foote, Alison; Motreff, Pascal; Vanzetto, Gerald; Quesada, Jean-Louis; Danchin, Nicolas; Machecourt, Jacques

    2011-11-15

    The frequency of very late stent thrombosis (VLST) up to 3 years after sirolimus-eluting stent implantation is 0.5% to 0.6%/year but incertitude remains about the frequency of VLAST after 3 years. Diabetic (db+) and nondiabetic (db-) patients with or without multiple diseased vessels included in the EVASTENT matched-cohort registry were followed up to 6 years after stent implantation. Long-term follow-up was obtained for 1,564 of the 1,731 included patients. All-cause deaths (including cancer and complications of diabetes) occurred at steady rates of 2.5%/year up to 3 years and 1.2%/year after 3 years (difference not significant). In contrast, VLST (any Academic Research Consortium definition) was only 0.18%/year (95% confidence interval 0.08 to 0.39) after 3 years versus 0.63%/year (confidence interval 0.41 to 0.98) from 1 year to 3 years (p = 0.03). Target lesion revascularization rates were also lower after 3 years than before 3 years (1.9% vs 7%, p ≤ 0.01) with 66% of revascularization procedures after 3 years being for nontarget lesions. Six-year all-cause death and cardiac death cumulative rates were higher in db+ than in db- patients. However, after 3 years compared to before 3 years, no differences between db+ and db- patients were observed for target lesion revascularization and ST rates. It is noteworthy that 51% of patients continued to be on clopidogrel therapy nearly 6 years after receiving ≥ 1 sirolimus-eluting stent. In conclusion, all-cause deaths continued at a steady rate over 6 years. However, cardiac deaths and "very" VLST leveled out beyond 3 years. Copyright © 2011 Elsevier Inc. All rights reserved.

  12. Intravascular ultrasound-guided stenting of left main stem dissection after medtronic corevalve implantation

    NARCIS (Netherlands)

    N.M. van Mieghem (Nicolas); P.P.T. de Jaegere (Peter)

    2013-01-01

    textabstractTranscatheter aortic valve implantation (TAVI) implies the introduction, positioning, and deployment of a stented bioprosthesis in the (calcified) native aortic valve. We report an at first glance uneventful TAVI with the Medtronic Corevalve System, which was followed by transient

  13. Long-term clinical outcome after sirolimus-stent implantation for in sirolimus-eluting stent restenosis

    OpenAIRE

    Guidon, A.

    2009-01-01

    Rapport de synthèse : But: la resténose intra-stent au sirolimus (SAS) reste un problème clinique. Parmi tes diverses approches thérapeutiques disponibles aujourd'hui aucune n'a la primauté car tes résultats à moyen terme restent relativement médiocres. Méthodologie: les patients souffrant d'une resténose intra-SAS chez lesquels un second SAS a été implanté comme traitement de cette resténose ont été inclus dans ce registre. Lors d'ischémie clinique ou électrique après implantation d'un...

  14. Long-term results of young patients with acute coronary syndrome undergoing coronary stent implantation.

    Science.gov (United States)

    Yao, Yuan; Zhang, Yao

    2016-09-01

    Long-term follow-up studies on young patients with acute coronary syndrome (ACS) undergoing coronary stent implantation are relatively scarce. This study was applied to review the long-term results of young ACS patients who had undergone coronary stenting in our hospital. One hundred and two young patients with ACS underwent coronary stent implantation in our hospital. In this study, inpatient records and long-term data of the 102 patients were comprehensively collected for analysis. Major gender of the young patients was men. Most of the patients had smoking, and each patient had at least one risk factor. During hospitalization, no patient died. At last follow-up, all patients were alive and the occurrence rate of major adverse cardio/cerebrovascular accidents was 4.9%. In summary, long-term follow-ups revealed extremely satisfactory outcomes in young ACS patients after coronary stent implantation. Smoking and traditional ACS risk factors are the leading causes of ACS in young population.

  15. Relationship between aspirin/clopidogrel resistance and intra-stent thrombi assessed by follow-up optical coherence tomography after drug-eluting stent implantation.

    Science.gov (United States)

    Park, Junbeom; Shin, Dong-Ho; Kim, Byeong-Keuk; Her, Ae-Young; Kim, Yong Hoon; Choi, Hyun Hee; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2013-12-01

    No data exist regarding the relationship between aspirin/clopidogrel resistance and intra-stent thrombi on follow-up optical coherence tomography (OCT) after drug-eluting stent (DES) implantation. The purpose of this study was to evaluate the relationship between aspirin/clopidogrel resistance and intra-stent thrombi on the follow-up OCT in DES-treated patients. A total of 308 DES-treated patients who underwent follow-up OCT and simultaneous measurement of aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU) using the VerifyNow assay system were selected for the study. Aspirin and clopidogrel resistance were defined as ARU ≥550 and PRU ≥275, respectively. Intra-stent thrombi were detected in 29 patients (9.4%). The mean time interval from DES implantation to OCT was 195 ± 133 days (202.9 ± 103.0 days for patients with intra-stent thrombi vs. 194.7 ± 136.0 days for patients without intra-stent thrombi; P = 0.750). There were no significant differences between patients with and without intra-stent thrombi with regard to the incidence of aspirin resistance (13.8 vs. 11.1%, respectively; P = 0.630) or clopidogrel resistance (72.4 vs. 50.5%, respectively; P = 0.056). The percentage of uncovered struts was 17.9 ± 15.8% in patients with intra-stent thrombi and 12.7 ± 17.3% in patients without intra-stent thrombi (P = 0.098). Stent length was significantly longer in patients with intra-stent thrombi (22.9 ± 6.0 vs. 19.4 ± 5.0 mm, P = 0.006). Multivariate logistic regression analysis showed that stent length (odds ratio = 1.152, 95% confidential interval 1.025-1.295; P = 0.017) was the only independent risk factor for the presence of intra-stent thrombi on OCT. This OCT study suggested that the presence of intra-stent thrombi may not be associated with aspirin/clopidogrel resistance in DES-treated patients.

  16. Long-Term Outcome After Drug-Eluting Versus Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction

    DEFF Research Database (Denmark)

    Holmvang, Lene; Kelbæk, Henning Skov; Kaltoft, Anne

    2013-01-01

    This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.......This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention....

  17. Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: The Svelte Coronary Stent Integrated Delivery System first-in-man trial

    NARCIS (Netherlands)

    R. Diletti (Roberto); H.M. Garcia-Garcia (Hector); C.V. Bourantas (Christos); R.J.M. van Geuns (Robert Jan); N.M. van Mieghem (Nicolas); P. Agostoni (Pierfrancesco); T. Muramatsu (Takashi); V. Farooq (Vasim); R. Spencer (Richard); J. de Schepper; M. Pomeranz (Mark); P.R. Stella (Pieter); P.W.J.C. Serruys (Patrick)

    2013-01-01

    textabstractAims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. Methods and

  18. Preditores independentes de resultados intra-hospitalares pós-implante de stent coronariano Independent predictors of in-hospital outcomes following coronary stent implantation

    Directory of Open Access Journals (Sweden)

    Antônio José Neri-Souza

    2006-10-01

    Full Text Available OBJETIVO: Identificar preditores clínicos e angiográficos independentes, determinantes de resultados imediatos pós-implante de stent coronário. MÉTODOS: Novecentos e quarenta e seis pacientes com idade média de 61,04 ± 10,98 anos (31 a 91 anos, foram submetidos a implante de stents, sendo 580 do sexo masculino (61,3%. Sucesso do procedimento foi definido quando pelo menos um vaso era dilatado com sucesso, com estenose residual OBJECTIVE: To identify the clinical and angiographic predictors of early outcome following coronary stent implantation. METHODS: Nine hundred and forty-six patients (pt [61.04 ± 10.98 years old, range 31 to 91] underwent stent implantation; 580 male (61.3%. Procedural success was defined when a pt had at least one vessel successfully dilated with a residual stenosis < 20%. Clinical success occured when a pt had at least one vessel successfully dilated without a major complication (MC [death, myocardial infarction (MI, coronary artery bypass graft] during the hospital stay. Clinical and angiographic determinants of outcome were studied. All variables related to early outcome evaluated by univariate analysis were included in a multiple logistic regression analysis (MLR. RESULTS: Procedural success was achieved in 98.9%; clinical success in 95.7%; an unsuccessful uncomplicated outcome in 0.1% and major complications in 4.2%. By MLR, procedural success was related to restenotic lesion, calcification, and irregular contour. Clinical success was related to diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, left ventricular dysfunction, calcification, and total occlusion. Major complications was predicted by diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, multivessel disease, left ventricular dysfunction, calcification, long lesions, and total occlusions. Mortality was predicted by cardiogenic shock, acute coronary syndromes, age, arterial hypertension, and left ventricular

  19. Prospective registry evaluating safety and efficacy of cobalt-chromium stent implantation in patients with de novo coronary lesions.

    Science.gov (United States)

    Buszman, Paweł; Trznadel, Stanisław; Zurakowski, Aleksander; Milewski, Krzysztof; Kinasz, Leszek; Król, Marek; Kondys, Marek

    2007-09-01

    Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). A total of 59 patients with coronary artery diseases (76% men, aged 60+/-9 years, diabetes - 16.9%, smoking - 62.7%, 11.8% - acute myocardial infarction) underwent PCI for de novo lesions in native coronary vessels. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months. In total, we implanted 62 stents in 59 coronary arteries. The mean diameter of the stents was 3.18+/-0.18 mm, and length - 14.62+/-2.12 mm. During a one-month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new myocardial infarction were recorded. Control angiography was done in 55 (92%) subjects. Repeated target vessel revascularisation due to recurrent angina or in-stent restenosis was required in 10 (17%) patients; however, off-line core evaluation found significant re-narrowing in implanted stents (>50% diameter stenosis) only in 6 cases (10.9%). The mean late vessel lumen loss was 0.55+/-0.6 mm and stenosis 25.2+/-17.9%. Implantation of the new Co-Cr Kos stent during PCI is safe and effective.

  20. Evaluation Of Cobalt and Chromium Levels Following Implantation of Cobalt Chromium Coronary Stents: A Pilot Study.

    Science.gov (United States)

    Di Santo, Pietro; Motazedian, Pouya; Jung, Richard G; Simard, Trevor; Ramirez, F Daniel; Chong, Aun-Yeong; Glover, Christopher; Hibbert, Benjamin; Dwivedi, Girish

    2017-12-14

    Large increases in myocardial trace elements may adversely affect metabolism and become detrimental to cardiac function. Percutaneous coronary intervention (PCI) allows for the revascularisation of obstructive coronary artery disease using drug-eluting stents. These stents are comprised of a metallic stent backbone covered in an engineered polymer which delivers a drug over a prescribed period to the vessel wall. Given the potential implications of trace metal accumulation within the myocardium, our goal is to determine if metallic coronary stents are able to cause detectable elevations in serum cobalt and/or chromium levels. This study was a single centre, observational, pilot study with 20 patients who underwent planned PCI with implantation of a cobalt chromium drug eluting stent. Serum blood samples were drawn at baseline prior to PCI, 4hours post-stent deployment and at the time of routine follow-up after PCI. All blood samples were analysed for cobalt and chromium concentrations. The primary outcome of this study was the difference in serum cobalt and chromium levels at routine clinical follow-up. The mean follow up was 64.1±17.3 days. There was no difference in serum cobalt levels when comparing baseline and routine clinical follow up (3.32±2.14nmol/L vs. 3.14±1.00nmol/L, p=0.99) nor in chromium levels (4.24±2.31nmol/L vs. 2.82±1.22 nmol/L, p=0.11). There was also no difference between baseline and 4hours post-PCI serum concentrations. Percutaneous coronary intervention with cobalt chromium coronary stents does not appear to cause an elevation in these trace element serum concentrations. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.

  1. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2011-01-01

    Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the ...... of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients....

  2. 2-Year Patient-Related Versus Stent-Related Outcomes

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2012-01-01

    OBJECTIVES: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). BACKGROUND: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial......, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. METHODS: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2.......6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0...

  3. Serial intravascular ultrasound analysis of peri-stent remodeling and proximal and distal edge effects after sirolimus-eluting or paclitaxel-eluting stent implantation in patients with diabetes mellitus

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Mintz, Gary S

    2009-01-01

    Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Sci...

  4. Optimal duration of dual antiplatelet therapy after coronary stent implantation.

    Science.gov (United States)

    Witberg, Guy; Lev, Eli; Kornowski, Ran

    2015-11-15

    Dual antiplatelet pharmacotherapy reduces ischemic events at the cost of excess bleeding in patients who underwent coronary stenting. The currently recommended treatment period is based on trials held some 20 years ago and not relevant to current clinical practice. In recent years, numerous clinical trials have tried to answer the question of what is the optimal duration of therapy to maximize clinical benefit. These trials showed 2 seemingly conflicting answers-on one hand, shorter treatment duration seems to be safer in reducing bleeding while not increasing ischemic events, and on the other hand, longer duration is superior in terms of preventing ischemic events albeit at the cost of increased bleeding rates. In this review, we summarize the evidence favoring each approach, highlight the limitations of the various pivotal clinical trials in this field, review future directions of research and changes in practice that may influence the duration of antiplatelet therapy, and attempt to propose a personalized approach to achieve maximal benefit for the individual patient. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

    NARCIS (Netherlands)

    Camenzind, Edoardo; Boersma, Eric; Wijns, William; Mauri, Laura; Rademaker-Havinga, Tessa; Ordoubadi, Farzin Fath; Suttorp, Maarten J.; Al Kurdi, Mohammad; Steg, Ph Gabriel; Camenzind, E.; Mauri, L.; O'Neill, W.; Serruys, P. W.; Steg, Ph G.; Wijns, W.; Verheugt, F. W. A.; Bertrand, M. E.; Califf, R.; deMets, D.; Wallentin, L.; Bocksch, W.; Bosmans, J.; Garcia, H.; Garg, S.; Hanet, C.; Herrman, J.-P. R.; Kelbaek, H.; Mc Fadden, E.; Radke, P. W.; Rutsch, W.; Tilsted, H. H.; Wykrzykowska, J.; Boersma, E.; Alvarez, C.; Rodriguez, A.; Meredith, I.; Muller, D.; Whitbourn, R.; Worthley, S.; Whelan, A.; Walters, D.; Shetty, S.; New, G.; Cox, S.; Batra, R.; van Gaal, W.; Bellamy, G.; Mayr, H.; Heigert, M.; Huber, K.; Leisch, F.; Desmet, W.; Boland, J.; Schroeder, E.; Chenu, P.; Legrand, V.; Labinaz, M.; Teefy, P.; Bertrand, O.; Gao, R.; Ge, J.; Kala, P.; Cervinka, P.; Ureña, P.; Hartikainen, J.; Steg, G.; Fajadet, J.; Carrie, D.; Gilard, M.; Barragan, P.; Lablanche, J.-M.; Koning, R.; Eltchaninoff, H.; Darremont, O.; Leroy, F.; Bertrand, B.; Robert, G.; Schiele, F.; Chassaing, S.; Bressollette, E.; Brunel, P.; Quilliet, L.; Brunet, J.; Pansieri, M.; Sideris, G.; Stratiev, V.; Teiger, E.; Lebreton, H.; Bonnet, J.-L.; Karsenty, B.; Delarche, N.; Lusson, J.-R.; Cassagnes, J.; Brachmann, J.; Kurowski, V.; Buerke, M.; Schieffer, B.; Scholtz, W.; Wiemer, M.; Fichtlscherer, S.; Schächinger, V.; Kupatt, C.; Boekstegers, P.; Genth-Zotz, S.; Bode, C.; Frey, N.; Neumann, F.-J.; Witzenbichler, B.; Pels, K.; Strasser, R.; Kuck, K.-H.; Hauptmann, K.-E.; Baldus, S.; Heitzer, T.; Haude, M.; Hoffmann, E.; Jung, W.; Hoffmann, S.; Schmitt, C.; Dissmann, M.; Pauschinger, M.; Werner, G.; Braun-Delleus, R.; Burkhardt, D.; Manz, M.; Voudris, V.; Sionis, D.; Kang-Yin, M.-L.; Tse, T.-S.; Merkely, B.; Mehta, A.; Parikh, K.; Kumar, V.; Chandra, P.; Rath, P.; Hiremath, S.; Crean, P.; Daly, K.; Kornowski, R.; Kerner, A.; Mosseri, M.; Jafari, G.; Giudice, P.; Trani, C.; Manari, A.; Prati, F.; Pangrazi, A.; Bolognese, L.; Jeong, M.-H.; Kim, M.-Y.; Kim, H.-S.; Park, S.-J.; Erglis, A.; Kalnins, A.; Wagner, D.; Zambahari, R.; Ong, T.-K.; Sim, K.; den Heijer, P.; Appelman, Y.; Suttorp, M.-J.; de Smet, B.; Koolen, J.; Stella, P.; Harding, S.; Warwick, J.; Maslowski, A.; Abernethy, M.; Devlin, G.; Rotevatn, S.; Myreng, Y.; Ciecwierz, D.; Peruga, J.; Reczuch, K.; Campante Teles, R.; Farto e Abreu, P.; Leitão-Marques, A.; Pereira, H.; Vinereanu, D.; Alkasab, S.; Mhish, H.; Al Kurdi, M.; Al Turki, F.; Wong, P.; teo, S.-G.; Goicolea Ruigomez, F.-J.; Valdés Chávarri, M.; Bethencourt Gonzalez, A.; Iñiguez Romo, A.; López Minguez, J.; Hernández García, J.-M.; Diaz Fernández, J.; Ruiz Salmeron, R.; Martinez Elbal, L.; Zueco, J.; López-Palop, R. F.; Melgares, R.; Diderholm, E.; Kåregren, A.; Herterich, O.; Olivencrona, G.; Fröbert, O.; Roffi, M.; Verin, V.; Girod, G.; Vuilliomenet, A.; Hsieh, I.-C.; Wu, C.-J.; Gershlick, A.; Densem, C.; Doshi, S.; Manoharan, G.; McCarthy, P.; de Belder, M.; Mills, J.; Fath-Ordoubadi, F.; Simpson, I.; Greenwood, J.; Chamberlain-Webber, R.; Khan, Z.; Cotton, J.; Gunning, M.; Smith, D.; Talwar, S.; Holmberg, S.; Purcell, I.; Anderson, R.; Alamgir, F.; Beatt, K.; Kelly, P.; Moussavian, M.; Aji, J.; Prashad, R.; Zankar, A.; Banerjee, S.; Lewis, S.; McLaurin, B.; Douglas, J.; Brener, S.; Gupta, A.; Walters, L.; Driesman, M.; Aycock, R.; Mego, C.; Fisher, D.; Frankel, R.; Satler, L.

    2014-01-01

    Aim To investigate the putative modifying effect of dual antiplatelet therapy (DAPT) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent (E-ZES) or Cypher sirolimus-eluting stent (C-SES). Methods and results Of 8709 patients in PROTECT,

  6. Angioplastia e implante de stent en pacientes con estenosis de la arteria renal Angioplasty and stent implantation in patients with renal artery stenosis

    Directory of Open Access Journals (Sweden)

    Nabil Hamdan

    2005-06-01

    Full Text Available Introducción y objetivos: la enfermedad aterosclerótica de las arterias renales se considera como una causa común de hipertensión arterial sistémica e insuficiencia renal. El tratamiento percutáneo es un procedimiento seguro, de baja morbilidad y mortalidad, y con alta tasa de éxito. Permite controlar o curar la hipertensión arterial sistémica y estabilizar la función renal (10. En este trabajo se evaluará la eficacia de la angioplastia con implante de stent en pacientes con estenosis significativa de la arteria renal. Materiales y métodos: estudio de cohorte histórico, en el cual se incluyeron 28 pacientes con estenosis significativa de la arteria renal, quienes fueron tratados con angioplastia e implante de stent, entre el 1º de enero de 2001 y el 31 de diciembre de 2003. Se realizó seguimiento clínico intrahospitalario a 12 meses en el cual se evaluaron como objetivos primarios la evolución de la hipertensión arterial y la función renal. Resultados: luego de la intervención percutánea durante la hospitalización, se logró reducir de manera significativa la presión arterial, tanto sistólica de 171,5 mm Hg a 144,5 mm Hg como diastólica de 94,9 mm Hg a 80,2 mm Hg. Se controló la presión arterial en 7 (25% pacientes. La función renal de acuerdo con los niveles de creatinina sérica se mantuvo estable y se observó un discreto aumento de 1,7 mg/dL a 1,9 mg/dL. En el seguimiento a 12 meses la presión arterial sistólica se mantuvo en 142,6 mm Hg y la diastólica en 81.4 mm Hg. En 11 (39,3% pacientes se logró controlar la presión arterial. Hubo mejoría de la función renal en 5 pacientes (17,9% y deterioro renal en 5 pacientes (17,9%, de los cuales 4 requirieron hemodiálisis. La media de creatinina sérica fue de 2,01 mg/dL con un incremento de 0,31 mg/dL con respecto a los niveles basales antes de la intervención. Conclusión: el tratamiento con angioplastia e implante de stent debe considerarse como primera elecci

  7. Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial.

    NARCIS (Netherlands)

    K. Tanabe (Kengo); P.W.J.C. Serruys (Patrick); M. Degertekin (Muzaffer); E. Grube (Eberhard); G. Guagliumi (Giulio); W. Urbaszek (Wilhelm); J.J.R.M. Bonnier (Hans); J.M. Lanblanche (Jean-Michel); T. Siminiak (Tomasz); J. Nordrehaug (Jan); H. Figulla (Hans); J. Drzewiecki (Janusz); A. Banning (Adrian); K. Hauptmann (Karl); D. Dudek (Dariusz); N. Bruining (Nico); R. Hamers (Ronald); A. Hoye (Angela); J.M.R. Ligthart (Jürgen); C. Disco (Clemens); J. Koglin (Jörg); M.E. Russell (Mary); A. Colombo (Antonio)

    2005-01-01

    textabstractBACKGROUND: The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal

  8. Implante de stents em conduto cirúrgico cavopulmonar: relato de dois casos

    Directory of Open Access Journals (Sweden)

    Salvador André Bavaresco Cristóvão

    2011-07-01

    Full Text Available Apesar dos avanços na cirurgia de Fontan, obstruções nos condutos extracardíacos podem ocorrer e causar deterioração clínica. Relatamos dois casos em que foram realizados implante de stent para correção de estenose na cirurgia de Fontan. Ascite era o sinal clínico comum; um paciente tinha enteropatia perdedora de proteínas.Todos os procedimentos obtiveram sucesso angiográfico e clínico.

  9. [Therapeutic effect of Cheatham-Platinum stent implantation for vessel stenosis associated with congenital heart disease in children and adolescents].

    Science.gov (United States)

    Li, Fen; Zhou, Ai-Qing; Gao, Wei; Yu, Zhi-Qing; Sun, Kun; Huang, Mei-Rong; Li, Yun; Yang, Jian-Ping; Zhao, Wu

    2009-04-01

    Although NuMED Cheatham-Platinum (CP) stent was specifically designed to treat vascular obstructions associated with congenital heart disease (CHD), its application in pediatric patients is relatively uncommon, especially in the pulmonary artery stenosis. The aim of this study was to evaluate the immediate-, early- and intermediate-term results of CP stent implantation in the treatment of vessel stenosis associated with CHD in children and adolescents. From August 2005 to May 2007, 5 consecutive patients (3 boys and 2 girls) diagnosed as vascular stenosis associated with CHD underwent CP stent implantation in our institution. One patient had native coarctation of the aorta (CoA) and four patients had pulmonary artery stenosis. The median age and weight of patients were 12 years (range 4 - 15 years) and 24 kg (range 20 - 51 kg), respectively. The CP stent and NuMED Balloon-in-Balloon catheter were selected according to digital subtracted angiography measurements. After checking for correct position by angiography, the inner balloon and outer balloon inflated successively to expand the stent to desired diameter. Totally 6 stent placement procedures were performed and 8 CP stents (8-zig, 22 - 39 mm in length) were implanted in these 5 patients. All stents but one in a case of right pulmonary artery stenosis were immediately successfully placed in the target lesions without displacement during the procedures. For this case, a repeat procedure was performed and a second CP stent was reimplanted successfully 11 months later. After the procedure, the systolic pressure gradient across the stenosis decreased from (43.43 +/- 25.61) mm Hg (1 mm Hg = 0.133 kPa) to (3.29 +/- 3.09) mm Hg (t = 4.320, P stenosis, respectively. The ratio of right ventricular to aortic systolic pressure decreased from 62.3% and 72.2% to 27.0% and 33.3% in 2 cases of bilateral branch pulmonary artery stenosis, respectively. Upper limb blood pressure of one case of native CoA dropped greatly from 206

  10. [Application of (125)I seeds combined with biliary stent implantation in the treatment of malignant obstructive jaundice].

    Science.gov (United States)

    Wang, T; Liu, S; Zheng, Y B; Song, X P; Jiang, W J; Sun, B L; Wang, L G

    2016-03-23

    To study the feasibility and therapeutic effect of the application of (125)I seeds combined with biliary stent implantation on the treatment of malignant obstructive jaundice. Fifty patients with malignant obstructive jaundice treated from September 2010 to February 2013 in Yantai Yuhuangding Hospital were included in this study. Among them, 24 patients received biliary stent implantation combined with (125)I seeds intraluminal brachytherapy as experimental group, and 26 were treated by biliary stent implantation as control group.The total bilirubin, direct bilirubin and tumor markers (CA-199, CA-242, CEA) before and after surgery, the biliary stent patency status was assessed, and the survival time was evaluated. The 24 patients in experimental group were implanted with 30 (125)I seeds successfully in a total of 450 seeds. Jaundice was improved greatly in both groups. The CA-199 and CA-242 after treatment in the experimental group were significantly decreased than that before treatment (P=0.003 and P=0.004). CEA was also decreased, but showed no statistical significance (P>0.05). There were no significant improvement comparing the CA-199, CA-242 and CEA before and 2 months after surgery in the control group (P>0.05). The rate of biliary stent patency was 83.3% (20/24) in the experimental group and 57.7% (15/26) in the control group (P=0.048). The mean biliary stent patency time in the experimental group was 9.84 months (range 1-15.5 months). The mean biliary stent patency time in the control group was 5.57 months (range 0.8-9 months). There was a significant difference between the two groups (P=0.018). The median survival time was 10.2 months in the experimental group and 5.4 months in the control group (Pjaundice, therefore, is a safe and effective treatment in this malignancy.

  11. Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2008-01-01

    -eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. METHODS AND RESULTS: One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared...

  12. Clinical Study on Using (125)I Seeds Articles Combined with Biliary Stent Implantation in the Treatment of Malignant Obstructive Jaundice.

    Science.gov (United States)

    Wang, Tao; Liu, Sheng; Zheng, Yan-Bo; Song, Xue-Peng; Sun, Bo-Lin; Jiang, Wen-Jin; Wang, Li-Gang

    2017-08-01

    Aim: To study the feasibility and curative effect of(125)I seeds articles combined with biliary stent implantation in the treatment of malignant obstructive jaundice. Patients and Methods: Fifty patients with malignant obstructive jaundice were included. Twenty-four were treated by biliary stent implantation combined with intraluminal brachytherapy by (125)I seeds articles as the experimental group, while the remaining 26 were treated by biliary stent implantation only as the control group. The goal of this study was to evaluate total bilirubin, direct bilirubin and tumor markers (cancer antigen (CA)-199, CA-242 and carcinoembryonic antigen (CEA)), as well as biliary stent patency status and survival time before and after surgery. Results: Jaundice improved greatly in both groups. The decreases of CA-199 and CA-242 had statistical significance (p=0.003 and p=0.004) in the experimental group. The ratio of biliary stent patency was 83.3% (20/24) in the experimental group and 57.7% (15/26) in the control group (p=0.048). The biliary stent patency time in the experimental group was 1~15.5 (mean=9.84) months. The biliary stent patency time in the control group was 0.8~9 (mean=5.57) months, which was statistically significant (p=0.018). The median survival time was 10.2 months in the experimental group, while 5.4 months in control group (pjaundice possibly by inhibiting the proliferation of vascular endothelial cells and the growth of tumor. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  13. Estudio comparativo en pacientes con implante de stent liberador de droga y stent convencional. Resultados clínicos e indicaciones

    Directory of Open Access Journals (Sweden)

    Mariano Albertal

    2006-01-01

    Full Text Available Antecedentes Estudios aleatorizados demostraron la superioridad del uso de stents liberadores de droga (SL sobre el stent convencional (SC. La información en nuestro medio sobre el implante de SL es escasa. Objetivo Comparar los resultados clínicos obtenidos en pacientes sometidos a implante de SL versus SC en un centro terciario de la Argentina. Material y métodos Se incluyeron todos los pacientes sometidos a angioplastia electiva desde abril de 2003 hasta junio de 2005 y se dividieron en dos grupos: los pacientes sometidos a implante de uno o más SL (grupo SL, n = 373 y los sometidos solamente a implante de SC (grupo SC, n = 857. Resultados Las características basales fueron similares entre los dos grupos. En el grupo SL se observó un porcentaje mayor de lesiones en la arteria descendente anterior (50,6 versus 40,6%; p 0,001, gracias a una reducción de la tasa de cirugía coronaria (1,4% versus 5,8%; p = 0,045. Conclusión El uso de SL en un centro terciario de la Argentina demostró que es seguro y, en comparación con el implante de sólo SC, dio por resultado una tasa menor de reintervención, primariamente por haber reducido la tasa de cirugía de revascularización miocárdica

  14. Type D personality predicts death or myocardial infarction after bare metal stent or sirolimus-eluting stent implantation

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Lemos, Pedro A; van Vooren, Priya R

    2004-01-01

    We investigated the effect of Type D personality on the occurrence of adverse events at nine months in patients with ischemic heart disease (IHD) after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SESs) or bare stents. Type D patients experience increased negative...

  15. Periprocedural (30-day) risk of myocardial infarction after drug-eluting coronary stent implantation: a meta-analysis comparing cobalt-chromium and stainless steel drug-eluting coronary stents.

    Science.gov (United States)

    Moreno, Raul; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Martin-Reyes, Roberto; Sabate, Manuel; Plaza, Ignacio; Macaya, Carlos; Lopez-Sendon, Jose-Luis

    2011-03-01

    Because of the reduction in the rate events related with in-stent restenosis, most events after drug-eluting stent implantation occur shortly after coronary stenting. Cobalt-chromium alloys allow to reduce strut thickness and improve flexibility and deliverability of coronary stent platforms, and thus could be associated with lower short-term events after stenting. The aim of this study was to test the hypothesis that drug-eluting coronary stents with a cobalt-chromium platform reduce the incidence of periprocedural (30-day) myocardial infarction in comparison with stainless steel drug-eluting coronary stents. A meta-analysis from nine randomised trials comparing cobalt-chromium and stainless steel drug-eluting coronary stents that overall included 11,313 patients was performed. The incidence of myocardial infarction, stent thrombosis, and cardiac death at 30 days was compared between both types of stents. At 30 days, the incidence of acute myocardial infarction was significantly lower in patients allocated to cobalt-chromium drug-eluting stents (2.3% vs. 3.9%, respectively; p=0.006; odds ratio 0.72, 95% confidence interval 0.58-0.91), due to a significant reduction in the rate of non-Q-wave myocardial infarction (odds ratio 0.67, 95% confidence interval 0.51-0.88). The incidence of stent thrombosis was similar between both groups of patients, (0.5% vs. 0.5%, p=0.76; odds ratio 1.09, 95% confidence interval 0.63-1.89). Drug-eluting coronary stents that use cobalt-chromium stent platforms have a better safety profile at 30 days in comparison with stainless steel drug-eluting stents, due to a significant reduction in the rate of myocardial infarction.

  16. [In hospital and mid-term outcome of patients with NIR stent implantation: multicenter ESPORT-NIR registry].

    Science.gov (United States)

    Iñiguez, A; García, E; Seabra, R; Bordes, P; Bethencourt, A; Rigla, J

    2001-05-01

    Despite improvements in the results and techniques of catheter-based revascularization, few studies have evaluated the clinical results of the application of new stent designs. We describe the in-hospital and mid-term outcome of patients undergoing a stent NIR implantation. At least 1 Stent NIR was implanted in 1.004 patients (1.136 lesions) recruited from 50 centers in an international, multicenter, prospective, registry (Spain and Portugal NIR stent registry). Inclusion criteria were objective coronary ischemia related to a severe de novo lesion or first restenosis in native vessels with a reference diameter >= 2.75 mm. The primary end-point was the incidence of major adverse cardiac events within the first 7 months of follow-up. The mean age of the patients was 60 years and 82% were male. Angioplasty was indicated due to unstable angina in 61% of the cases. Stent implantation was successfully achieved in 99.6%. Clinical success (angiographic success without in-hospital major events) was achieved in 98.6% of patients. The rate of angiographic restenosis (> 50% stenosis narrowing) was 16% (CI 95%; 11.7-21.2). The accumulated major cardiac adverse event rate at seven months of follow-up was 8.7%: death (0.9%), acute myocardial infarction (1.2%) and target lesion revascularization (6.6%). In the wide setting of the population included in the ESPORT-NIR registry, stent NIR implantation was a highly effective therapy with a good mid-term clinical and angiographic outcome.

  17. Effects of angiotensin II and angiotensin II type 1 receptor blockade on neointimal formation after stent implantation

    NARCIS (Netherlands)

    Groenewegen, Hendrik C.; van der Harst, Pim; Roks, Anton J. M.; Buikema, Hendrik; Zijlstra, Felix; van Gilst, Wiek H.; de Smet, Bart J. G. L.

    2008-01-01

    Background: To evaluate the effect of supraphysiological levels of angiotensin II and selective angiotensin II type 1 receptor ( AT1-receptor) blockade on neointimal formation and systemic endothelial function after stent implantation in the rat abdominal aorta. Methods: Male Wistar rats were

  18. Natural history of optical coherence tomography-detected non-flow-limiting edge dissections following drug-eluting stent implantation

    DEFF Research Database (Denmark)

    Radu, Maria D; Räber, Lorenz; Heo, Jungho

    2014-01-01

    history and clinical implications remain unclear. The objectives of the present study were to assess the morphology, healing response, and clinical outcomes of OCT-detected edge dissections using serial OCT imaging at baseline and at one year following drug-eluting stent (DES) implantation. METHODS...

  19. Reduced duration of dual antiplatelet therapy using an improved drug-eluting stent for percutaneous coronary intervention of the left main artery in a real-world, all-comer population: Rationale and study design of the prospective randomized multicenter IDEAL-LM trial.

    Science.gov (United States)

    Lemmert, Miguel E; Oldroyd, Keith; Barragan, Paul; Lesiak, Maciej; Byrne, Robert A; Merkulov, Evgeny; Daemen, Joost; Onuma, Yoshinobu; Witberg, Karen; van Geuns, Robert-Jan

    2017-05-01

    Continuous improvements in stent technology make percutaneous coronary intervention (PCI) a potential alternative to surgery in selected patients with unprotected left main coronary artery (uLMCA) disease. The optimal duration of dual antiplatelet therapy (DAPT) in these patients remains undetermined, and in addition, new stent designs using a bioabsorbable polymer might allow shorter duration of DAPT. IDEAL-LM is a prospective, randomized, multicenter study that will enroll 818 patients undergoing uLMCA PCI. Patients will be randomized in a 1:1 fashion to intravascular ultrasound-guided PCI with the novel everolimus-eluting platinum-chromium Synergy stent with a biodegradable polymer (Boston Scientific, Natick, MA) followed by 4 months of DAPT or the everolimus-eluting cobalt-chromium Xience stent (Abbott Vascular, Santa Clara, CA) followed by 12 months of DAPT. The total follow-up period will be 5 years. A subset of 100 patients will undergo optical coherence tomography at 3 months. The primary end point will be major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization) at 2 years. Secondary end points will consist of the individual components of the primary end point, procedural success, a device-oriented composite end point, stent thrombosis as per Academic Research Consortium criteria, and bleeding as per Bleeding Academic Research Consortium criteria. IDEAL-LM is designed to assess the safety and efficacy of the novel Synergy stent followed by 4 months of DAPT vs the Xience stent followed by 12 months of DAPT in patients undergoing uLMCA PCI. The study will provide novel insights regarding optimal treatment strategy for patients undergoing PCI of uLMCA disease (www.clinicaltrials.gov, NCT 02303717). Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  20. Covered stent implantation through a single 8-french guide catheter for the management of a distal coronary perforation.

    Science.gov (United States)

    Sandoval, Yader; Lobo, Angie S; Brilakis, Emmanouil S

    2017-10-01

    Distal coronary perforation can cause early or late tamponade and is usually treated with fat or coil embolization. An alternative treatment strategy is occlusion of the ostium of the perforated vessel via implantation of a covered stent in the main vessel, which is typically achieved using the ping-pong guide catheter technique. In this technique, a balloon is inflated over one guide catheter to stop pericardial bleeding and a covered stent is delivered through a second guide catheter due to inability to fit both a balloon and a covered stent through a single guide catheter. With development of lower profile rapid exchange covered stents, a single guide catheter can be used to both occlude the target vessel and deliver the covered stent. We describe a case of distal vessel perforation in which a balloon was inflated to stop pericardial bleeding, followed by delivery of a covered stent (Graftmaster, Abbott Vascular) through a single 8-Fr guide catheter. This "block and deliver" technique represents a novel paradigm for treating coronary perforations through a single guide catheter, obviating the need for the ping-pong guide catheter technique. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  1. A higher volume of fibrotic tissue on virtual histology prior to coronary stent implantation predisposes to more pronounced neointima proliferation.

    Science.gov (United States)

    Haine, Steven; Wouters, Kristien; Miljoen, Hielko; Vandendriessche, Tom; Claeys, Marc; Bosmans, Johan; Vrints, Christiaan

    2017-08-11

    Since neointima smooth muscle cells (SMC) mainly originate from the vessel wall, we investigated whether atherosclerotic plaque composition influences subsequent in-stent neointima proliferation and restenosis. We performed intravascular ultrasound (IVUS) with virtual histology in 98 patients prior to elective bare-metal stent (BMS) implantation in de novo coronary artery lesions. Virtual histology variables pre-percutaneous coronary intervention (PCI) were related to in-stent neointima proliferation six months after implantation assessed as late luminal loss of 0.88 mm (interquartile range (IQR) 0.37-1.23 mm) on angiography and as maximal percentage area stenosis of 42% (IQR 33-59%) and percentage volume intima hyperplasia of 27% (IQR 20-36%) on IVUS. A ridge-trace based multiple linear regression model was constructed to account for multicollinearity of the virtual histology variables and was corrected for implanted stent length (18 mm, IQR 15-23 mm), stent diameter (3.0 mm, IQR 2.75-3.5 mm) and lesion volume (146 mm³, IQR 80-201 mm³) prior to PCI. Fibrous tissue volume prior to PCI (49 mm³, IQR 30-77 mm³) was significantly and independently related to late luminal loss (p = .038), maximal percentage area stenosis (p = .041) and percentage volume intima hyperplasia (p = .004). Neither absolute nor relative amounts of fibrofatty, calcified or necrotic core tissue appeared related to any of the restenosis parameters. Subgroup analysis after exclusion of acute coronary syndrome (ACS) patients yielded similar results. Lesions with more voluminous fibrotic tissue pre-PCI show more pronounced in-stent neointima proliferation, even after correction for lesion plaque volume.

  2. [Endoscopic covered self-expandable metal stents implantation in the management of anastomotic leakage after colorectal cancer surgery].

    Science.gov (United States)

    Chi, Pan; Wang, Xiaojie; Lin, Huiming; Lu, Xingrong; Huang, Ying

    2015-07-01

    To evaluate the efficacy and safety of covered self-expanding metallic stents (CSEMS) implantation as a treatment option in patients with anastomotic leakages after colorectal cancer surgery. Short-term outcomes of 12 patients with anastomotic leakage after colorectal cancer surgery undergoing CSEMS implantation between May 2013 and November 2014 were analyzed retrospectively. The mean time to diagnosis of anastomotic leakage was 6.3 days (range 2-13). The median time of CSEMS implantation after anastomotic leakage was 8 days (range 2-55). Clinical success without reoperation was achieved in 10 of 12 cases (83.3%) and there was no mortality. The median time to healing of the anastomotic leakage after CSEMS implantation was 13 days (range 10-33). The complications were stent migration (66.7%, 8/12), anorectal pain (58.3%, 7/12), fecal incontinence (25.0%, 3/12) and enterocolic fistula (8.3%, 1/12). Stent implantation one week after relief of peritonitis of postoperative colorectal anastomotic leakages, combined with other conservative therapy (early indwelling of transanal double catheterization cannula and pelvic double catheterization cannula with persistent bathe and negative pressure aspiration) in the management of patients with early diagnosed anastomotic leakages is safe and effective.

  3. Accidental Coverage of Both Renal Arteries during Infrarenal Aortic Stent-Graft Implantation: Cause and Treatment

    Directory of Open Access Journals (Sweden)

    Umberto Marcello Bracale

    2014-01-01

    Full Text Available The purpose of this paper is to report a salvage maneuver for accidental coverage of both renal arteries during endovascular aneurysm repair (EVAR of an infrarenal abdominal aortic aneurysm (AAA. A 72-year-old female with a 6 cm infrarenal abdominal aortic aneurysm was treated by endovascular means with a standard bifurcated graft. Upon completing an angiogram, both renal arteries were found to be accidentally occluded. Through a left percutaneous brachial approach, the right renal artery was catheterized and a chimney stent was deployed; however this was not possible for the left renal artery. A retroperitoneal surgical approach was therefore carried out with a retrograde chimney stent implanted to restore blood flow. After three months, both renal arteries were patent and renal function was not different from the baseline. Both endovascular with percutaneous access via the brachial artery and open retroperitoneal approaches with retrograde catheterization are feasible rescue techniques to recanalize the accidentally occluded renal arteries during EVAR.

  4. [Pulmonary reperfusion syndrome after pulmonary stent implants in a patient with vascular tortuosity syndrome].

    Science.gov (United States)

    Berenguer Potenciano, M; Piris Borregas, S; Mendoza Soto, A; Velasco Bayon, J M; Caro Barri, A

    2015-01-01

    Vascular tortuosity syndrome is a rare genetic disorder that causes tortuosity and stenosis of the pulmonary, systemic and / or coronary circulations. As a result of treatment of pulmonary stenosis, symptoms of pulmonary edema, known as lung reperfusion syndrome, may occur. The case is presented of an adolescent patient with vascular tortuosity syndrome who presented with a pulmonary reperfusion syndrome after multiple stent implants in the left pulmonary artery. After the procedure, the patient immediately developed an acute pulmonary edema with severe clinical deterioration, which required assistance with extracorporeal membrane oxygenation for recovery. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  5. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Kim, Ahsung; Suzuki, Yuki; Furuki, Yuho; Ouchi, Taisuke; Ishii, Yasuhiro; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-10-15

    Stent expansion remains one of the most important predictors of restenosis and subacute thrombosis, even with the use of drug-eluting stents. This study was designed to clarify the impact of lesion preparation on final stent expansion. Sixty-six consecutive patients were included in this trial, and ultimately 52 enrolled non-calcified de novo lesions were randomly assigned to undergo single predilation with either a semi-compliant scoring balloon or a semi-compliant conventional balloon. Lesions were treated with a single 2.5- to 3.0-mm cobalt-chromium everolimus-eluting stent under optical coherence tomography (OCT) guidance without post-stenting dilation. Stent expansion was defined as the ratio of OCT-measured minimum stent area to the predicted stent area. Stent expansion was significantly higher after predilation by a scoring balloon (68.0% vs. 62.1%, p=0.017) with similar stent lumen eccentricity (0.84 vs. 0.80, p=0.18). Intimal disruption was induced significantly more frequently (68.0% vs. 38.4%, p=0.035) and was more extensive in the scoring group (122° vs. 65°, p=0.038). Lesions with intimal disruption after predilation achieved significantly higher stent expansion than that without it (67.7% vs. 61.6%, p=0.023). One case in the conventional group required target lesion revascularization; however, any other adverse clinical events including death, myocardial infarction, and stent thrombosis were not observed up to 9months after PCI in both groups. In this randomized study, pretreatment with a scoring balloon enhanced stent expansion partly through induction of intimal disruption. URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014176. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy.

    Science.gov (United States)

    Kawamoto, Hiroyoshi; Latib, Azeem; Ruparelia, Neil; Miyazaki, Tadashi; Sticchi, Alessandro; Naganuma, Toru; Sato, Katsumasa; Figini, Filippo; Chieffo, Alaide; Carlino, Mauro; Montorfano, Matteo; Colombo, Antonio

    2015-10-01

    The aim of this study was to investigate clinical outcomes of patients treated with a provisional stenting (PS) versus a double stenting (DS) strategy for coronary bifurcation lesions with bioresorbable scaffolds (BRS). There are limited data available with regards to outcomes following BRS implantation for bifurcation lesions. A total of 132 bifurcation lesions treated with BRS between 2012 and 2014 were analyzed. Of the total of 132 bifurcation lesions, 10 lesions were treated without crossover stenting. 99 lesions (81%) were treated with a PS strategy and 23 lesions (19%) with a DS strategy. The DS group consisted of patients with a greater number of true bifurcation lesions (PS 52.0% vs. DS 91.3%: P strategy was employed. Larger studies are eagerly awaited to determine longer-term follow-up of this treatment strategy. © 2015 Wiley Periodicals, Inc.

  7. [Perioperative intensive statin therapy improves outcomes in patients with ischemic stroke undergoing middle cerebral artery stent implantation].

    Science.gov (United States)

    Gao, Ju-Hua; Gao, Xiao-Ping; Pan, Su-Yue

    2016-03-01

    To investigate whether intensive statin therapy during the perioperative period improves outcomes in patients undergoing middle cerebral artery (MCA) stent implantation for ischemic stroke. Forty patients with ischemic stroke undergoing delayed stent implantation in our department from January, 2010 to November, 2014 were randomized to intensive statin group (atorvastatin, 80 mg/day, 3 days before till 3 days after intervention; n=20) and standard therapy group (atorvastatin, 20 mg/day, n=20). All the patients received long-term atorvastatin treatment thereafter (20 mg/day). Serum levels of C-reactive protein (CRP), vascular cell adhesion molecule-1 (VCAM-1), and soluble extracellular matrix metalloproteinase inducer (EMMPRIN/CD147) were measured at 24 h before and 24 h after the intervention. The primary end point was procedure-related intra-stent thrombosis, 1-month incidence of major adverse cerebrovascular events (stroke, transient ischemic attack, in-stent restenosis, death or unplanned revascularization). The basic clinical data were similar between the two groups before the intervention (P>0.05). In the intensive therapy group, the levels of CRP, VCAM-1, and sCD147 were significantly lower at 24 h after the intervention than the levels before intervention (Ptherapy group (Ptherapy group (P>0.05). The incidence of primary end point was lower in intensive therapy group than in standard therapy group (Pintensive statin therapy improves the patients' outcomes, reduces the levels of CRP, VCAM-1 and sCD147 molecules, and lowers the incidences of cerebrovascular events.

  8. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, Morten; Johansen, Martin B; Mæng, Michael

    2012-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The CYP3A4 inhibition by lipophilic statins may attenuate the effectiveness of clopidogrel. • No studies have measured drug exposure in a time-varying manner that detects discontinuation and restart of clopidogrel and statin therapy, allowing clinical...... quantification of the interaction effect. WHAT THIS STUDY ADDS • Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of major adverse cardiovascular events within 12 months after coronary stent implantation. • Although we observed an interaction between use...... of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of major adverse cardiovascular events in patients using clopidogrel after coronary stent implantation. AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major...

  9. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  10. Incidence of periprocedural myocardial infarction following stent implantation: Comparison between first- and second-generation drug-eluting stents

    NARCIS (Netherlands)

    Tandjung, Kenneth; Basalus, Mounir W.Z.; Muurman, Esther; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Jansen, Hanneke; Huisman, Jennifer; Linssen, Gerard C.M.; Droste, Herman T.; Nienhuis, Mark B.; von Birgelen, Clemens

    2012-01-01

    Background: First- and second-generation drug-eluting stents (DES) differ in coating materials, which may influence the incidence of periprocedural myocardial infarction (PMI). Objective: To compare the incidence of PMI between first- and second-generation DES, using the current Academic Research

  11. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    Science.gov (United States)

    Schmidt, Morten; Johansen, Martin B; Maeng, Michael; Kaltoft, Anne; Jensen, Lisette O; Tilsted, Hans-Henrik; Bøtker, Hans E; Baron, John A; Sørensen, Henrik Toft

    2012-01-01

    AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major adverse cardiovascular events (MACE) after coronary stent implantation, using time-varying drug exposure ascertainment. METHODS We conducted this population-based cohort study in Western Denmark (population: 3 million) using medical databases. We identified all 13 001 patients with coronary stent implantation between 2002 and 2005 and their comorbidities. During 12 months of follow-up, we tracked the use of clopidogrel and CYP3A4-metabolizing statins and the rate of MACE. We used Cox regression to compute hazard ratios (HRs) controlling for potential confounders. RESULTS The rate of MACE per 1000 person years was 104 for concomitant clopidogrel and statin use, 130 for clopidogrel without statin use, 108 for statin without clopidogrel use and 446 for no use of either drug. The adjusted HR comparing clopidogrel use with non-use was 0.68 (95% confidence interval (CI) 0.58, 0.79) among statin users and 0.34 (95% CI 0.29, 0.40) among statin non-users, yielding an interaction effect (i.e. relative rate increase) of 1.97 (95% CI 1.59, 2.44). The adjusted HR for MACE comparing statin use with non-use was 0.97 (95% CI 0.83, 1.13) among clopidogrel users and 0.49 (95% CI 0.42, 0.57) among clopidogrel non-users. CONCLUSIONS Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of MACE within 12 months after coronary stent implantation. Although we observed an interaction between use of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of MACE in patients using clopidogrel after coronary stent implantation. PMID:22243420

  12. The Characteristics of In-Stent Restenosis After Drug-Eluting Stent Implantation in Femoropopliteal Lesions and 1-Year Prognosis After Repeat Endovascular Therapy for These Lesions.

    Science.gov (United States)

    Iida, Osamu; Takahara, Mitsuyoshi; Soga, Yoshimitsu; Hirano, Keisuke; Yamauchi, Yasutaka; Zen, Kan; Kawasaki, Daizo; Nanto, Shinsuke; Yokoi, Hiroyoshi; Uematsu, Masaaki

    2016-04-25

    This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR. The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined. This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study. The current study included 210 cases with loss of patency confirmed 1 year after DES implantation. Morphology of DES-ISR was classified into the following subgroups: class I, focal lesions (≤50 mm in length), class II, diffuse lesions (>50 mm in length), and class III, totally occluded ISR. One-year prognosis after re-EVT for DES-ISR was assessed by restenosis and major adverse limb events (MALE). Classes I, II, and III accounted for 50%, 25%, and 25% of DES-ISR, respectively. Factors associated with the morphology of DES-ISR were the presence of chronic total occlusion and the size of the external elastic membrane area before DES implantation (p = 0.009 and 0.017). Compared with the class I restenotic lesion, the class II and III lesions had a significantly higher risk of restenosis (74% and 78% vs. 53%: p = 0.048 and 0.019, respectively) and MALE (56% and 56% versus 32%: p = 0.025 and 0.022, respectively) 1 year after re-EVT. We evaluated the characteristics of ISR after DES implantation for FP lesions and 1-year prognosis of re-EVT for DES-ISR. The morphology of DES-ISR had a significant association with 1-year prognosis after re-EVT. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  13. Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: six-year clinical follow-up of the GISSOC trial.

    Science.gov (United States)

    Rubartelli, Paolo; Verna, Edoardo; Niccoli, Luigi; Giachero, Corinna; Zimarino, Marco; Bernardi, Guglielmo; Vassanelli, Corrado; Campolo, Luigi; Martuscelli, Eugenio

    2003-05-07

    We investigated whether the benefits of stent implantation over balloon percutaneous transluminal coronary angioplasty (PTCA) for treatment of chronic total coronary occlusions (CTO) are maintained in the long term. Several randomized trials have shown that in CTO, stent implantation confers clinical and angiographic mid-term outcomes superior to those observed after PTCA. However, limited information on the long-term results of either technique is available. Six-year clinical follow-up of patients enrolled in the Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche (GISSOC) trial was performed by direct visit or telephone interview. Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, target lesion revascularization (TLR), and anginal status, were recorded. Freedom from MACE at six years was 76.1% in the stent group, compared with 60.4% in the PTCA group (p = 0.0555). This difference was due mainly to TLR-free survival rates (85.1% vs. 65.5% for the stent and PTCA groups, respectively; p = 0.0165). Eleven patients underwent TLR after the nine-month follow-up visit (stent group: n = 5; PTCA group: n = 6); however, in most cases, restenosis of the study occlusion was evident at nine-month angiography. This study represents the longest reported clinical follow-up of patients after percutaneous recanalization of CTO and demonstrates that the superiority of stent implantation over balloon PTCA is maintained in the long term. Stent and PTCA results appear to remain stable after nine-month angiographic follow-up. Stent implantation in CTO that can be recanalized percutaneously is therefore a valuable long-term therapeutic option.

  14. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

    Science.gov (United States)

    Geraghty, Patrick J; Mewissen, Mark W; Jaff, Michael R; Ansel, Gary M

    2013-08-01

    The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The long-term outcomes of

  15. A 2D panoramic surgical stent imaging: Complete arch mandibular implant fixed prosthesis along with bar supported maxillary over denture

    Directory of Open Access Journals (Sweden)

    Mukesh Kumar Singhal

    2017-01-01

    Full Text Available Successful rehabilitation of a patient should restore function, esthetic, and speech by prosthesis. Treatment modalities vary from patient to patient. Semi-precision attachments and implants offer several advantages over the traditional approach. The aim and objective of this report was to assess a case of a 55-year-old female patient who had lost all her teeth, except maxillary canines #13 and #23 and with severe bone loss in the mandible. Tooth-supported bar attachment was planned for maxilla, and a total of five dental implants were placed in the mandible using a flapless approach aided by radiographic gutta-percha surgical stents over panoramic two-dimensional imaging. Customized, radiographic stents help for the placement of implant in the view of paralleling and flapless surgery, completely. An immediate loading protocol is adopted as from day of the surgery to 6 weeks along with implant supported full arch fixed dentures after 4 months. The outcome of the treatment was impressive, and the patient gave a positive response with superb esthetics and functions.

  16. A 2D Panoramic Surgical Stent Imaging: Complete Arch Mandibular Implant Fixed Prosthesis along with Bar Supported Maxillary over Denture.

    Science.gov (United States)

    Singhal, Mukesh Kumar; Billing, Rumneet Kaur; Srivastava, Nitin; Khan, Zainab

    2017-01-01

    Successful rehabilitation of a patient should restore function, esthetic, and speech by prosthesis. Treatment modalities vary from patient to patient. Semi-precision attachments and implants offer several advantages over the traditional approach. The aim and objective of this report was to assess a case of a 55-year-old female patient who had lost all her teeth, except maxillary canines #13 and #23 and with severe bone loss in the mandible. Tooth-supported bar attachment was planned for maxilla, and a total of five dental implants were placed in the mandible using a flapless approach aided by radiographic gutta-percha surgical stents over panoramic two-dimensional imaging. Customized, radiographic stents help for the placement of implant in the view of paralleling and flapless surgery, completely. An immediate loading protocol is adopted as from day of the surgery to 6 weeks along with implant supported full arch fixed dentures after 4 months. The outcome of the treatment was impressive, and the patient gave a positive response with superb esthetics and functions.

  17. Relationship between the Level of Circulating CD45+ Platelets and Development of Restenosis after Implantation of Drug-Eluting Stents to Patients with Coronary Heart Disease.

    Science.gov (United States)

    Gabbasov, Z A; Kozlov, S G; Byazrova, S V; Mel'nikov, I S; Saburova, O S

    2017-02-01

    The study was carried out in 126 patients with stable angina pectoris, who underwent elective coronary artery stenting with drug-eluting stents and follow-up angiography within 6-12 months thereafter. Five significant risk factors of restenosis were identified by binary comparisons of different variables. The logistic regression equation that included the level of CD45-positive platelets, diabetes, small vessel stenting, number of simultaneously implanted stents in one patient, and lesion length demonstrates the highest level of prediction of in-stent restenosis (OR=22.8; plogit model (area under ROC curve 0.87, p<0.001). The data suggest that a close relationship exists between the development of restenosis and the level of circulating CD45+ platelets.

  18. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    Directory of Open Access Journals (Sweden)

    Antenor Portela

    2002-05-01

    Full Text Available An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  19. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    OpenAIRE

    Portela, Antenor; Bastos, Raldir; Costa, Itamar; Paiva, Jayro

    2002-01-01

    An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE) placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  20. Study of the relationship between the indication rod of stent on implant CT and the real path of implant fixture insertion considering residual ridge

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Do Hoon; Heo, Min Suk; Lee, Sam Sun; Oh, Sung Ook; Choi, Soon Chul [Seoul National University College of Medicine, Seoul (Korea, Republic of); Choi, Hang Moon [Kangnung National University College of Medicine, Kangnung (Korea, Republic of); Jeon, In Seong [Inje University Sanggyepaik Hospital, Seoul (Korea, Republic of)

    2003-06-15

    To assess the relationship between the direction of the indicating rod of the radiographic stent for ideal prosthetic design and the actual possible path of implant fixture placement when residual ridge resorption is considered. The study materials considered of 326 implant sites (male 214 cases and female 112 cases) from a total of 106 patients (male 65 patients and female 41 patients) who desired implant prostheses. Computed tomography of patients were taken and reformatted using ToothPix software. Bony defects, bony sclerosis, the change of the direction of indicating rod, and root proximity of the adjacent teeth were examined on the CT-derived images. The rate of the irregular crestal cortex was relatively high on premolar and molar area of maxilla. Mandibular molar area showed relatively high rate of focal sclerosis on the area of implant fixture insertion. The position of the including rods were relatively acceptable on the molar areas of both jaws. However, the position of the indicating rods should be shifted to buccal side with lingual rotation of the apical end on maxillary anterior teeth and premolar area. Clinically determined rod direction and position of the indicating rod for implant placement was not always acceptable for insertion according to the reformatted CT images. The pre-operative treatment plan for implant should be determined carefully, considering the state of the alveolar bone using the reformatted CT images.

  1. Stent pour implantation percutanée d'une valve cardiaque

    OpenAIRE

    Marchand, Coralie

    2009-01-01

    The goal of this work is to develop an atraumatic stent concept for percutaneous aortic valve replacement. Shape setted braided nitinol wires, thanks to their specific geometry and elasticity, allows stent's compressibility, self deployment and aortic root preservation. Prototypes manufacturing technique and relatives constraints are presented. Performance of the obtained prototypes are evaluated in vitro, in terms of sealing, static and dynamic regurgitation. More specifically, the pulsatile...

  2. Placement of an implantable port catheter in the biliary stent: an experimental study in dogs

    Energy Technology Data Exchange (ETDEWEB)

    Ko, Gi Young; Lee, Im Sick; Choi, Won Chan [Asan Medical Center, Seoul (Korea, Republic of)

    2004-04-01

    To investigate the feasibility of port catheter placement following a biliary stent placement. We employed 14 mongrel dogs as test subject and after the puncture of their gaIl bladders using sonographic guidance, a 10-mm in diameter metallic stent was placed at the common duct. In 12 dogs, a 6.3 F port catheter was placed into the duodenum through the common duct and a port was secured at the subcutaneous space following stent placement. As a control group, an 8.5 F drain tube was placed into the gallbladder without port catheter placement in the remaining two dogs. Irrigation of the bile duct was performed every week by injection of saline into the port, and the port catheter was replaced three weeks later in two dogs. Information relating to the success of the procedure, complications and the five-week follow-up cholangiographic findings were obtained. Placement of a biliary stent and a port catheter was technically successful in 13 (93%) dogs, while stent migration (n=3), gallbladder rupture (n=1) and death (n=5) due to subcutaneous abscess and peritonitis also occurred. The follow-up was achieved in eight dogs (seven dogs with a port catheter placement and one dog with a drain tube placement). Irrigation of the bile duct and port catheter replacement were successfully achieved without any complications. Cholangiograms obtained five weeks after stent placement showed diffuse biliary dilation with granulation tissue formation. However, focal biliary stricture was seen in one dog with stent placement alone. Placement of a port catheter following biliary stent placement seems to be feasible. However, further investigation is necessary to reduce the current complications.

  3. Final five-year outcomes after implantation of biodegradable polymer-coated biolimus-eluting stents versus durable polymer-coated sirolimus-eluting stents

    DEFF Research Database (Denmark)

    Jakobsen, Lars; Christiansen, Evald H; Maeng, Michael

    2017-01-01

    AIMS: To report long-term safety and efficacy of the biodegradable polymer-coated biolimus-eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting Cypher stent. METHODS AND RESULTS: SORT OUT V randomized 2,468 patients 1:1 to the Nobori (n=1,229) versus the Cypher stent (n=1...

  4. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries.

    Science.gov (United States)

    Popma, Jeffrey J; Leon, Martin B; Moses, Jeffrey W; Holmes, David R; Cox, Nicholas; Fitzpatrick, Michelle; Douglas, John; Lambert, Charles; Mooney, Michael; Yakubov, Steven; Kuntz, Richard E

    2004-12-21

    Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

  5. Prognostic Value of Plasma Pentraxin-3 Levels in Patients with Stable Coronary Artery Disease after Drug-Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Liu Haibo

    2014-01-01

    Full Text Available Pentraxin-3 (PTX3 is an inflammatory marker thought to be more specific to cardiovascular inflammation than C-reactive protein (CRP. Our aim was to assess the prognostic value of PTX3 in patients with stable coronary artery disease (CAD after drug eluting stent (DES implantation. Plasma PTX3 levels were measured before percutaneous coronary intervention (PCI and at 24 h post-PCI in 596 consecutive patients with stable CAD. Patients were followed up for a median of 3 years (range 1–5 for major adverse cardiovascular events (MACEs. We found that the post-PCI plasma PTX3 levels were significantly higher at 24 h after PCI than pre-PCI, patients with MACEs had higher post-PCI PTX3 levels compared with MACEs-free patients, patients with higher post-PCI PTX3 levels (median > 4.384 ng/mL had a higher risk for MACEs than those with PTX3 < 4.384 ng/mL, and post-PCI PTX3, cTnI, multiple stents, and age but not high-sensitivity CRP (hsCRP were independently associated with the prevalence of MACEs after DES implantation. The present study shows that post-PCI PTX3 may be a more reliable inflammatory predictor of long-term MACEs in patients with stable CAD undergoing DES implantation than CRP. Measurement of post-PCI PTX3 levels could provide a rationale for risk stratification of patients with stable CAD after DES implantation.

  6. Myocardial blush grade: a predictor for major adverse cardiac events after primary PTCA with stent implantation for acute myocardial infarction.

    Science.gov (United States)

    Kaya, Mehmet G; Arslan, Fatih; Abaci, Adnan; van der Heijden, Geert; Timurkaynak, Timur; Cengel, Atiye

    2007-10-01

    Optimal myocardial reperfusion is of great importance for survival of patients with AMI undergoing PTCA. According to the Thrombolysis In Myocardial Infarction (TIMI) 3 score, restoration of epicardial flow is achieved in the majority of patients. However, the myocardial blush grade (MBG) may offer additional information for survival. Therefore, we sought to determine whether myocardial blush grades were associated with MACE during follow-up in a high-risk AMI population undergoing primary PTCA with stent implantation. Hundred-and-thirty patients with AMI underwent PTCA with stent implantation from 1999 to 2004. The clinical, angiographic and follow-up data were extracted from the hospital records. Apart from the availability and technical adequacy of the angiograms for angiographic analysis, there were no exclusion criteria. Post-procedural TIMI 3 flow was achieved in 103 (79%) patients, while MBG-3 was observed in only 44 (34%) patients. Less post-intervention AMI, cardiac deaths or any MACE occurred in patients with MBG 3 (4/44) compared with MBG 1 or 2 (36/86) (P 0.5) in our population. Our data show that (1) MBG 3 is an important marker for survival and (2) the predictive value of MBG is superior to the TIMI flow grades. Given the predictive validity of MBG shown for MACE-free survival and low rate of MBG 3 despite achievement of TIMI 3 flow, a prospective study with adjunctive therapies to enhance myocardial perfusion is warranted.

  7. Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997

    Directory of Open Access Journals (Sweden)

    Luiz Alberto Mattos

    1999-07-01

    Full Text Available PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (>12 atm and antiplatelet drug regimen (aspirin plus ticlopidine. RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64 % vs 48%, p=0.0001. The 30-day results were similar in both years; the success and stent thrombosis rates were equal (97% and 0.8%, respectively. The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p=NS, emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p=NS and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p=NS were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p= NS; the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS. CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.

  8. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial.

    Science.gov (United States)

    2000-12-16

    The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention, are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 microg/kg boluses 10 min apart and a continuous infusion of 2.0 microg/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment

  9. Relationship of serum S1P and HC-II levels with vasoactive substances and cytokines in patients with cerebral vascular restenosis after stent implantation

    Directory of Open Access Journals (Sweden)

    Yong Liu

    2017-04-01

    Full Text Available Objective: To study the relationship of serum sphingosine 1-phosphate (S1P and heparin cofactor II (HCII levels with vasoactive substances and cytokines in patients with cerebral vascular restenosis after stent implantation. Methods: 52 patients who received cerebrovascular stent implantation and developed restenosis in our hospital between May 2012 and December 2015 were collected as observation group, and 40 healthy patients with cerebrovascular stent implantation who had re-examination in our hospital during the same period were selected as control group. ELISA method was used to detect serum S1P and HC-II levels as well as vasoactive substance and inflammatory factor contents. Spearman correlation analysis was used to evaluate the relationship of serum S1P and HC-II levels with vasoactive substances and inflammatory factors. Results: Serum S1P and HC-II levels of observation group were lower than those of control group (P<0.05; serum vasoactive substances endothelin (ET, angiotensin II (AngII and thromboxane B2 (TXB2 contents of observation group were higher than those of control group while nitric oxide (NO content was lower than that of control group (P<0.05; serum inflammatory factors hypersensitive C-reactive protein (hs-CRP, interleukin-1 (IL-1, IL-6, IL-8 and IL-11 contents of observation group were higher than those of control group (P<0.05. Serum S1P and HC-II levels in patients with cerebral vascular restenosis after stent implantation were directly correlated with vasoactive substance and inflammatory factor contents. Conclusion: Serum S1P and HC-II levels decrease in patients with cerebral vascular restenosis after stent implantation, and it is an important cause of cerebral vascular dysfunction and systemic inflammatory response.

  10. Intraluminal Palmaz stent implantation. First clinical case report on a balloon-expandable vessel prosthesis

    Energy Technology Data Exchange (ETDEWEB)

    Palmaz, J.C.; Richter, G.M.; Noeldge, G.; Kauffmann, G.W.; Wenz, W.

    1987-12-01

    A 74-year-old patient suffering from severe iliac artery stenosis and claudication was chosen to be the first candidate in the world to receive the Palmaz stent, a balloon-expandable intraluminal stent. This procedure was done in the Department of Radiology, University of Freiburg, FRG. The intervention and postprocedural course were uneventful. His walking distance improved from less than 100 m to unlimited walking capacity. The intra-arterial pressure gradient and ankle-arm pressure ratio also returned to normal.

  11. Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation

    DEFF Research Database (Denmark)

    Thim, Troels; Johansen, Martin Berg; Chisholm, Gro Egholm

    2014-01-01

    -eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. RESULTS: Discontinuation of clopidogrel within the first 3 months after...... associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation. CONCLUSIONS: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients...

  12. Cilostazol protects vessels against hyperglycemic injury and accelerates healing after implantation of drug-eluting stent in a type 1 diabetes mellitus rat aorta stent model.

    Science.gov (United States)

    Kwon, Jin Sook; Kim, Yong Sook; Cho, Hyang Hee; Kee, Hae Jin; Hong, Moon Hwa; Kang, Wan Seok; Jeong, Hye-Yun; Jeong, Myung Ho; Ahn, Youngkeun

    2013-06-01

    Cilostazol, a selective phosphodiesterase-3 (PDE-3) inhibitor, can effectively suppress platelet activation and attenuate the increase in carotid intima-media thickness in diabetes mellitus (DM) patients. Therefore, we investigated whether cilostazol had effects on the healing process after implantation of a drug-eluting stent (DES) in a rat model of type 1 DM. Streptozotocin-induced DM rats were divided into 2 groups in which cilostazol (30 mg/kg/day; DM-Cilostazol) or vehicle (DM-Vehicle) was orally administered. Age-matched rats treated with the vehicle were used as a control group (NDM-Vehicle). After 4 weeks, cilostazol changed the expression of vascular cell adhesion molecule and intercellular adhesion molecule and the apoptotic cell ratio of the media (DM-Vehicle: 53.5 ± 9.8%, DM-Cilostazol: 26.4 ± 8.3%, p 236.8 μm, p 2013 Elsevier Ireland Ltd. All rights reserved.

  13. Flapless surgery and immediately loaded implants: a retrospective comparison between implantation with and without computer-assisted planned surgical stent.

    Science.gov (United States)

    Danza, Matteo; Carinci, Francesco

    2010-01-01

    Computer planned flapless surgery and immediate loading are the most recent topics in implantology. One new computer-planned implant system uses a three-dimensional parallelometer able to transfer the implant position from the virtual project to the master model. The aim of this study was to verify if the new medical device gives an advantage in term of implant failures and/or crestal bone remodeling. A retrospective study was planned to analyze a series of 193 immediately loaded fixtures inserted by means of flapless surgery. From those sixty six implants were inserted with computer planning whereas 127 were inserted "free-hand". Several variables related to patient, anatomy, implant, surgery and prosthesis were investigated. To detect the clinical outcome implant' failure and peri-implant bone resorption were considered. Kaplan-Meier algorithm and Cox regression were then performed to detect those variables statistically associated with the clinical outcome. Implant length and diameter ranged from 10 to 16 mm and from 3.75 to 6.0 mm, respectively. Implants were inserted to replace 46 incisors, 30 cuspids, 75 premolars and 42 molars. The mean follow-up period was 15 months. Seven implants were lost (survival rate 96.4%) but no studied variable has a statistical impact on failures. On the contrary, implants inserted in sites with completed bone healing, wide diameter fixtures and implants inserted in totally edentulous jaw had a significantly lower crestal bone resorption. The other variables (age, gender, upper/lower jaws, tooth site, implant' type and length, number of prosthetic units antagonist condition) did not have impact on crestal remodeling. Computer-planned and cast model transferred implantology is a reliable technology that provides a slightly higher clinical outcome than "free hand" technique at least in healed sites, wider implants and totally edentulous jaws.

  14. Computational Fluid Dynamics Simulation of Hemodynamic Alterations in Sigmoid Sinus Diverticulum and Ipsilateral Upstream Sinus Stenosis After Stent Implantation in Patients with Pulsatile Tinnitus.

    Science.gov (United States)

    Han, Yanjing; Yang, Qingqing; Yang, Zeran; Xia, Jun; Su, Tianhao; Yu, Jianan; Jin, Long; Qiao, Aike

    2017-10-01

    To investigate the relationships between upstream venous sinus stenosis and pulsatile tinnitus (PT), and to assess the correlation with diverticulum growth and the effectiveness of stent implantation. Patient-specific geometric models were constructed using computed tomography venography images from a patient with PT, with sigmoid sinus diverticulum, and with upstream transverse sinus stenosis, in whom stenting of the upstream sinus stenosis alone achieved complete remission of PT. Computational fluid dynamics simulation based on this patient-specific geometry was performed using commercially available finite element software (ANSYS-14) to qualitatively and quantitatively compare the flow velocity, flow rate, velocity vector, pressure, vorticity, and wall shear stress on the affected side transverse and sigmoid sinuses, before and after stent implantation. Stenting improved the flow direction and magnitude. After stenting, the flow pattern became smoother and more regular. High-speed blood flow at the level of the diverticulum neck was confined to a smaller area, and its direction changed from approximately perpendicular to the diverticular dome to the distal side of the diverticular neck. The diverticulum showed obvious flow reduction, with decreases of 80.7%, 68.7%, 96.1%, and 91.3% in peak velocity, inflow rate, pressure gradient, and peak vorticity, respectively. The abnormally low wall shear stress at the dome of diverticulum was eliminated. Our findings strongly support a major role of diverticulum stenosis before in PT development and suggest that such stenosis is a causative factor of diverticulum growth. They also confirm the effectiveness of stent implantation for the treatment of PT. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Characterization and mechanical investigation of Ti-O{sub 2-x} film prepared by plasma immersion ion implantation and deposition for cardiovascular stents surface modification

    Energy Technology Data Exchange (ETDEWEB)

    Xie Dong [Key Laboratory of Advanced Technologies of Materials, Ministry of Education, College of Materials Science and Engineering, Southwest Jiaotong University, Chengdu, 610031 (China); School of Physical Science and Technology, Southwest Jiaotong University, 610031 Chengdu (China); Wan Guojiang, E-mail: guojiang.wan@home.swjtu.edu.cn [Key Laboratory of Advanced Technologies of Materials, Ministry of Education, College of Materials Science and Engineering, Southwest Jiaotong University, Chengdu, 610031 (China); Maitz, Manfred F. [Key Laboratory of Advanced Technologies of Materials, Ministry of Education, College of Materials Science and Engineering, Southwest Jiaotong University, Chengdu, 610031 (China); Max Bergmann Center of Biomaterials Dresden, Leibniz Institute of Polymer Research Dresden, Dresden (Germany); Lei Yifeng; Huang Nan; Sun Hong [Key Laboratory of Advanced Technologies of Materials, Ministry of Education, College of Materials Science and Engineering, Southwest Jiaotong University, Chengdu, 610031 (China)

    2012-10-15

    Highlights: Black-Right-Pointing-Pointer We prepared Ti-O{sub 2-x} films of good quality by PIII and D successfully on stents product. Black-Right-Pointing-Pointer The Ti-O{sub 2-x} film shows good homogeneity and intergradient film/substrate interface. Black-Right-Pointing-Pointer The Ti-O{sub 2-x} films on stent sustain clinically-required expansion without failure. Black-Right-Pointing-Pointer The films show good mechanical durability for cardiovascular stents application. - Abstract: Up to date, materials for cardiovascular stents are still far from satisfactory because of high risk of biomaterials-associated restenosis and thrombosis. Extensive efforts have been made to improve the biocompatibility of the materials by various surface modification techniques. Ti-O{sub 2-x} films prepared by plasma immersion ion implantation and deposition (PIII and D) have shown good blood compatibility. For clinical application, surface quality and mechanical durability of the Ti-O{sub 2-x} film on stents are also of critical importance for the long-term serving. In this paper we present our research results on surface quality, mechanical investigation and characterization of Ti-O{sub 2-x} films prepared using PIII and D on stent products provided by Boston Scientific SCIMED. Ti-O{sub 2-x} films with mostly Rutile and little non-stoichiometric phases were obtained with smoothness of <3 nm RMS, largely homogeneity as well as good intergradient film/substrate interface. The Ti-O{sub 2-x} films on stents products were sustained balloon-expansion of clinically-required extent without mechanical failure, showing highly potential feasibility for cardiovascular stents application.

  16. Impact of stent diameter and length on in-stent restenosis after DES vs BMS implantation in patients needing large coronary stents-A clinical and health-economic evaluation

    DEFF Research Database (Denmark)

    Zbinden, Rainer; von Felten, Stefanie; Wein, Bastian

    2017-01-01

    AIMS: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels

  17. Cost-Effectiveness Analysis of Infrapopliteal Drug-Eluting Stents

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Karnabatidis, Dimitris; Diamantopoulos, Athanasios; Spiliopoulos, Stavros; Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-02-15

    IntroductionThere are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 Euro-Sign (range 1,685-10,112 Euro-Sign ). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 Euro-Sign (range, 4,945-21,428 Euro-Sign ) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 Euro-Sign were associated with the least economically favorable scenario in both strategies. Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

  18. [Very late drug-eluting stent thrombosis by stent fracture].

    Science.gov (United States)

    Cheaito, R; Tritar, A; Scemama, A; Ferrag, W; Goy, P; Haziza, F; Benamer, H

    2015-12-01

    The superiority of drug-eluting stents in reducing the risk of in-stent restenosis compared to bare-metal stents is no longer challenged. Nevertheless, the drug-eluting stents may carry long-term risk of late and very late stent thrombosis. The promoting factors of this complication are usually divided into three chapters depending on the patient, the procedure and the stent. Indeed, the literature has reported several parameters related to the stent itself, such as its length, the malapposition, its diameter, but also more rarely the occurrence of stent fracture. We present the case of a patient admitted for myocardial infarction after a very late thrombosis of Cypher drug-eluting stent four years after its implantation and related to stent fracture. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  19. Blood level of CD45+ platelets and development of restenosis after drug-eluting stent implantation in patients with stable coronary artery disease.

    Science.gov (United States)

    Gabbasov, Zufar; Kozlov, Sergey; Byazrova, Svetlana; Saburova, Olga; Melnikov, Ivan; Caprnda, Martin; Curilla, Eduard; Gaspar, Ludovit; Kruzliak, Peter; Smirnov, Vladimir

    2016-12-01

    The aim of this study was to assess CD45-positive platelets (CD45+ platelets) involvement in restenosis development after drug-eluting stent (DES) implantation in patients with stable coronary artery disease (CAD). The study comprised 126 male and female patients with stable angina pectoris, who underwent elective coronary stenting with DES and follow-up angiography within 6-12 months. The patients were assigned to the group with restenosis (n = 53) or group without restenosis (n = 73) according to the follow-up angiograms. In both groups we compared the level in blood of CD45+ platelets, the clinical, laboratory and angiographic variables, which may affect the development of restenosis. We have also constructed a logit regression model for prognosis of restenosis occurrence after DES implantation. The blood count of CD45+ platelets was higher in patients with restenosis than in patients without: 0.82 % (0.58; 1.12) vs. 0.34 % (0.20; 0.68), p binary comparisons of more than 35 different clinical, laboratory and angiographic variables we identified 8 significant risk factors for the development of stent restenosis after DES. In order to define the risk of the development of restenosis, we have built a logit regression model. The resulting logit regression equation included the level of CD45+ platelets, the neutrophil to lymphocyte ratio (NLR), small diameter arteries stenting and the number of simultaneously implanted stents in one patient. Receiver operating characteristic (ROC) curve analysis has demonstrated the high prognostic value of the resulting logit regression equation with an area under the curve (AUC) of 0.91 % (p < 0.001). The acquired data indicate the presence of a close relationship between circulating CD45+ platelets and restenosis development after DES implantation in patients with stable CAD.

  20. Prospective and systematic analysis of unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stent implantation.

    Science.gov (United States)

    Kim, Byeong-Keuk; Yoon, Jung-Han; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Lee, Seung-Hwan; Mintz, Gary S; Jang, Yangsoo; Hong, Myeong-Ki

    2014-03-01

    Unexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy (DAPT) frequently occur in daily clinical practice. The objectives of this study were to evaluate prevalence, timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents (DESs) implantation. We prospectively investigated the prevalence, timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients. The prevalence of requested non-cardiac surgery or invasive procedures was 14.6% in 310 requests and 12.3% in 261 patients. Among 310 requests, those were proposed in 11.3%requests) and 53.2% (165 of 310 requests), respectively. On multivariate regression analysis, the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT (OR=5.54, 95% CI 2.95-10.44, prequest (OR=2.84, 95% CI 1.97-4.11, prequests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation. No death, myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT.

  1. Characterization and mechanical investigation of Ti-O2-x film prepared by plasma immersion ion implantation and deposition for cardiovascular stents surface modification

    Science.gov (United States)

    Xie, Dong; Wan, Guojiang; Maitz, Manfred F.; Lei, Yifeng; Huang, Nan; Sun, Hong

    2012-10-01

    Up to date, materials for cardiovascular stents are still far from satisfactory because of high risk of biomaterials-associated restenosis and thrombosis. Extensive efforts have been made to improve the biocompatibility of the materials by various surface modification techniques. Ti-O2-x films prepared by plasma immersion ion implantation and deposition (PIII&D) have shown good blood compatibility. For clinical application, surface quality and mechanical durability of the Ti-O2-x film on stents are also of critical importance for the long-term serving. In this paper we present our research results on surface quality, mechanical investigation and characterization of Ti-O2-x films prepared using PIII&D on stent products provided by Boston Scientific SCIMED. Ti-O2-x films with mostly Rutile and little non-stoichiometric phases were obtained with smoothness of <3 nm RMS, largely homogeneity as well as good intergradient film/substrate interface. The Ti-O2-x films on stents products were sustained balloon-expansion of clinically-required extent without mechanical failure, showing highly potential feasibility for cardiovascular stents application.

  2. Comparison of long-term clinical outcomes after the second-generation cobalt-chromium sirolimus-eluting stents implantation in diabetic versus non-diabetic patients: a subgroup analysis from the prospective FOCUS registry.

    Science.gov (United States)

    Zhang, Feng; Yang, Ji'e; Qian, Juying; Ge, Lei; Zhou, Jun; Ge, Junbo

    2016-01-01

    Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt-chromium sirolimus-eluting stents (CoCr-SES) was less known. A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching. The rates of major adverse cardiovascular event was low (stents.

  3. Association Between Helicobacter Pylori Infection and Long-term Outcome in Patients with Drug-eluting Stent Implantation

    Science.gov (United States)

    Wang, Rui; Chen, Lei-Lei; Wang, De-Zhao; Chen, Bu-Xing

    2017-07-01

    To investigate the relationship between Helicobacter pylori (Hp) infection and the long-term outcome in acute coronary syndrome (ACS) patients with drug-eluting stent (DES) implantation and so as to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB). 539 ACS patients with DES implantation from January 1, 2010 to December 31, 2012 were analyzed. All the patients were divided into two groups according to the result of 13C urea breath test. 253 patients with Hp infection were put into group A (Hp+), and 286 cases without Hp infection were put into group B (Hp-). Demographic data was collected and all patients went through biochemical indicators and other routine blood examinations. We explored the correlations of Hp infection with MACE and UGIB after 3 to 5 years of follow-up using survival analysis. Survival analysis showed that Hp infection was a predictor of MACE and UGI. Sub-group analysis showed that patients with Hp eradication therapy had no relationship with MACE but had a lower rate of UGIB than those without Hp eradication therapy.

  4. Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial.

    Science.gov (United States)

    Franzone, Anna; Taniwaki, Masanori; Rigamonti, Fabio; Heg, Dik; Piccolo, Raffaele; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, Andre; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-08-05

    We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS). Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low 15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS. Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity.

  5. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Donnenfeld ED

    2015-11-01

    .7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg, or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001. Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. Conclusion: In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months. Keywords: iStent, MIGS, OAG, intraocular pressure, IOP reduction

  6. Duration of dual antiplatelet therapy after implantation of drug-eluting stents.

    Science.gov (United States)

    Park, Seung-Jung; Park, Duk-Woo; Kim, Young-Hak; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Han, Ki-Hoon; Park, Seong-Wook; Yun, Sung-Cheol; Lee, Sang-Gon; Rha, Seung-Woon; Seong, In-Whan; Jeong, Myung-Ho; Hur, Seung-Ho; Lee, Nae-Hee; Yoon, Junghan; Yang, Joo-Young; Lee, Bong-Ki; Choi, Young-Jin; Chung, Wook-Sung; Lim, Do-Sun; Cheong, Sang-Sig; Kim, Kee-Sik; Chae, Jei Keon; Nah, Deuk-Young; Jeon, Doo-Soo; Seung, Ki Bae; Jang, Jae-Sik; Park, Hun Sik; Lee, Keun

    2010-04-15

    The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established. In two trials, we randomly assigned a total of 2701 patients who had received drug-eluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis. The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P=0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P=0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to 3.45; P=0.06). The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.) 2010 Massachusetts Medical Society

  7. Three-year-old child with middle aortic syndrome treated by endovascular stent implantation.

    Science.gov (United States)

    Moszura, Tomasz; Goreczny, Sebastian; Dryzek, Pawel; Niwald, Marek

    2013-04-01

    Middle aortic syndrome (MAS) is an extremely rare anomaly and represents both a diagnostic and therapeutic challenge, particularly in young children. A case of a 3.5 year-old child with MAS and arterial hypertension is reported, where owing to the patient's young age and the length of the hypoplastic aortic segment, surgical correction with end-to-end anastomosis was not feasible. Instead of palliative bypass grafting between the thoracic and abdominal aorta, successful percutaneous balloon angioplasty and stenting of the lesion was performed with the assistance of three-dimensional rotational angiography.

  8. Percutaneous pulmonary valve implantation preceded by routine prestenting with a bare metal stent

    DEFF Research Database (Denmark)

    Demkow, Marcin; Biernacka, Elzbieta Katarzyna; Spiewak, Mateusz

    2011-01-01

    with routine prestenting have never been reported. Methods: Consecutive patients who underwent PPVI for homograft dysfunction with prestenting with BMS were studied. The schedule of follow-up assessment comprised clinical evaluation, cardiovascular magnetic resonance, transthoracic echocardiography, and chest.......001) as well as improvement in RV ejection fraction (48.8% ± 13.1% to 57.6% ± 14.4%; P = 0.003) and New York Heart Association class (P = 0.003). All patients completed 6-month follow-up. No stent fractures were observed. Conclusions: PPVI with routine prestenting with BMS is a safe and effective method...

  9. Influence of a pressure gradient distal to implanted bare-metal stent on in-stent restenosis after percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Thuesen, Leif

    2007-01-01

    performed in the target vessel: (1) P(d)/P(a) as distal to the artery as possible (fractional flow reserve per definition); (2) P(d)/P(a) just distal to the stent; (3) P(d)/P(a) just proximal to the stent; and (4) P(d)/P(a) at the ostium. Residual abnormal P(d)/P(a) was defined as a pressure drop between P...

  10. Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT.

    Science.gov (United States)

    Kubo, Takashi; Akasaka, Takashi; Tanimoto, Takashi; Takano, Masamichi; Seino, Yoshitane; Nasu, Kenya; Itoh, Tomonori; Mizuno, Kyoichi; Okura, Hiroyuki; Shinke, Toshiro; Kotani, Jun-Ichi; Ito, Shigenori; Yokoi, Hiroyoshi; Muramatsu, Toshiya; Nakamura, Masato; Nanto, Shinsuke

    2016-04-01

    Even in the drug-eluting stent era, diabetes mellitus (DM) patients have high incidences of restenosis and repeat revascularization after percutaneous coronary intervention. The aim of this study was to compare vascular response after stent implantation between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) by using optical coherence tomography (OCT) in DM patients as well as in non-DM patients. In the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT), the OCT sub-study enrolled 75 patients who underwent 8 months follow-up imaging after SES or PES implantation. Mean neointimal hyperplasia (NIH) thickness was significantly thinner in SES than PES in the DM group (77 ± 47 vs. 201 ± 114 μm, p < 0.001) and in the non-DM group (84 ± 37 vs. 212 ± 128 μm, p < 0.001). Unevenness of NIH thickness in longitudinal axis was significantly smaller in SES than PES in the DM group (348 ± 191 vs. 726 ± 385 μm, p < 0.001) and in the non-DM group (344 ± 174 vs. 679 ± 314 μm, p < 0.001). The percentage of uncovered struts was significantly greater in SES than PES in the DM group (24 ± 4 vs. 9 ± 14 %, p < 0.001) and in the non-DM group (16 ± 16 vs. 3 ± 4 %, p = 0.002). Compared with PES, SES showed more potent NIH inhibition in DM patients as well as in non-DM patients.

  11. Successful Implantation of a Coronary Stent Graft in a Peripheral Vessel

    Directory of Open Access Journals (Sweden)

    Alexander Hess

    2015-01-01

    Full Text Available Peripheral artery disease (PAD is a complex, often underdiagnosed illness with rising prevalence in western world countries. During the past decade there has been a rapid advance especially in the field of endovascular treatment of PAD. Here we present for the first time a case reporting on the placement of coronary stent graft in a peripheral vessel for the management of a peripheral side branch perforation. Interventional angiologists or radiologists may consider such an option for complication management after injury of smaller vessels during peripheral percutaneous interventions. Further specialization and novel options of complication management as described in our case may shift the treatment from surgical to even more endovascular treatment procedures in the future.

  12. A different approach to treatment of failing Fontan: Transcatheter covered stent implantation.

    Science.gov (United States)

    Yücel, İlker Kemal; Ballı, Şevket; Hekim Yılmaz, Emine; Çelebi, Ahmet

    2016-04-01

    A 5-year-old male with a double outlet right ventricle with noncommitted ventricular septal defect and pulmonary stenosis underwent a bidirectional Glenn operation at 2 years and a Fontan operation with ligation of the pulmonary trunk at 5 years. He presented with pleural effusion 3 months after the Fontan operation. Physical examination revealed a grade 3/6 systolic murmur in the pulmonary area. Echocardiographic evaluation revealed an antegrade pulmonary flow (APF) of gradient 80 mmHg across the ventriculopulmonary communication. Cardiac catheterization and angiography demonstrated the presence of residual antegrade pulmonary flow and stenosis at the pulmonary artery bifurcation. Both pathologies were treated using a single covered stent. Relief of the pulmonary artery stenosis and total occlusion of the residual APF was demonstrated on a control angiogram.

  13. Short versus prolonged dual antiplatelet therapy duration after bare-metal stent implantation: 2-month landmark analysis from the CREDO-Kyoto registry cohort-2.

    Science.gov (United States)

    Natsuaki, Masahiro; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Ando, Kenji; Shiomi, Hiroki; Toyota, Toshiaki; Watanabe, Hirotoshi; Ono, Koh; Shizuta, Satoshi; Tamura, Takashi; Inoko, Moriaki; Inada, Tsukasa; Shirotani, Manabu; Matsuda, Mitsuo; Aoyama, Takeshi; Onodera, Tomoya; Suwa, Satoru; Takeda, Teruki; Inoue, Katsumi; Kimura, Takeshi

    2016-09-19

    One-month duration of dual antiplatelet therapy (DAPT) has widely been adopted after bare-metal stent (BMS) implantation in the real clinical practice. However, it has not been adequately addressed yet whether DAPT for only 1-month could provide sufficient protection from ischemic events beyond 1-month after BMS implantation. We assessed the effects of short DAPT relative to prolonged DAPT on clinical outcomes with the landmark analysis at 2 month after BMS implantation. Among 13,058 consecutive patients enrolled in the CREDO-Kyoto registry cohort-2, this study population consisted of 4905 patients treated with BMS only in whom the information on the status of antiplatelet therapy was available at 2 month after stent implantation [single-antiplatelet therapy (SAPT) group: N = 2575 (acute myocardial infarction (AMI): N = 1257, and non-AMI: N = 1318), and DAPT group: N = 2330 (AMI: N = 1304, and non-AMI: N = 1026)]. Cumulative 3-year incidence of the primary outcome measure (a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and GUSTO moderate/severe bleeding) was not significantly different between the SAPT and DAPT groups (9.8 versus 10.6 %, P = 0.34). After adjusting confounders, the risk of SAPT relative to DAPT for the primary outcome measure remained insignificant in the entire cohort (HR 0.97, 95 % CI 0.79-1.19, P = 0.77), and in both AMI and non-AMI strata without any significant interaction between clinical presentation (AMI versus non-AMI) and the effect of SAPT relative to DAPT (P interaction = 0.56). In conclusion, short DAPT <2 month after BMS implantation was as safe as prolonged DAPT ≥2-month in both AMI and non-AMI patients.

  14. Circumferential stent fracture repaired using a covered stent in a 42-year-old man with coarctation of the aorta.

    Science.gov (United States)

    Ayoub, Fares; AlShelleh, Sameeha; A L-Ammouri, Iyad

    2016-02-01

    We present a case of circumferential fracture of aortic coarctation stent with severe re-stentosis presenting 16 years after initial stent implantation with end-stage renal disease. The patient was treated with a covered stent using the stent-in-stent technique. The use of an ultra-high-pressure balloon was proved necessary to overcome the tight, non-compliant stenosis.

  15. Failing left ventricle to ascending aorta conduit-Hybrid implantation of a melody valve and NuMed covered stent.

    Science.gov (United States)

    Gössl, Mario; Johnson, Jonathan N; Hagler, Donald J

    2014-04-01

    We present the case of a 36-year-old woman with increasing shortness of breath, a new 3/4 diastolic murmur, and a complex history of LV outflow tract obstruction. She has undergone multiple surgeries including the replacement of her old LV apex to ascending aorta conduit with a 20-mm Gore-Tex tube graft, addition of a 24-mm homograft sutured between the conduit and the LV apex, and insertion of a 21-mm Freestyle porcine valve conduit between the Gore-Tex tube graft and allograft at age 23. The current assessment showed a failing Freestyle conduit prosthesis leading to left heart decompensation. Due to substantial surgical risk, the patient underwent successful implantation of a Melody valve into the Gore-Tex tube and exclusion of the failing Freestyle bioprosthesis with a NuMed CP stent in a hybrid procedure. The case nicely illustrates the collaborative potential of cardiovascular surgeons and interventional cardiologists in the new arena of a hybrid operating room. Complex hybrid procedures like the current one, especially those including percutaneous placements of valves, offer therapeutic options for patients that are otherwise too high risk for conventional open heart surgery. Copyright © 2013 Wiley Periodicals, Inc.

  16. Periprocedural quantitative coronary angiography after Palmaz-Schatz stent implantation predicts the restenosis rate at six months: results of a meta-analysis of the BElgian NEtherlands Stent study (BENESTENT) I, BENESTENT II Pilot, BENESTENT II and MUSIC trials. Multicenter Ultrasound Stent In Coronaries.

    Science.gov (United States)

    Serruys, P W; Kay, I P; Disco, C; Deshpande, N V; de Feyter, P J

    1999-10-01

    We aimed to identify periprocedural quantitative coronary angiographic (QCA) variables that have predictive value on long-term angiographic results and to construct multivariate models using these variables for postprocedural prognosis. Coronary stent implantation has reduced the restenosis rate significantly as compared with balloon angioplasty in short de novo lesions in coronary arteries >3 mm in size. Although the postprocedural minimal luminal diameter (MLD) is known to have significant bearing on long-term angiographic results, no practically useful model exists for prediction of angiographic outcome based on the periprocedural QCA variables. The QCA data from patients who underwent Palmaz-Schatz stent implantation for short (3 mm and completed six months of angiographic follow-up in the four prospective clinical trials (BENESTENT I, BENESTENT II pilot, BENESTENT II and MUSIC) were pooled. Multiple models were constructed using multivariate analysis. The Hosmer-Lemeshow goodness-of-fit test was used to identify the model of best fit, and this model was used to construct a reference chart for prediction of angiographic outcome on the basis of periprocedural QCA variables. Univariate analysis performed using QCA variables revealed that vessel size, MLD before and after the procedure, reference area before and after the procedure, minimal luminal cross-sectional area before and after the procedure, diameter stenosis after the procedure, area of plaque after the procedure and area stenosis after the procedure were significant predictors of angiographic outcome. Using multivariate analysis, the Hosmer-Lemeshow goodness-of-fit test showed that the model containing percent diameter stenosis after the procedure and vessel size best fit the data. A reference chart was then developed to calculate the expected restenosis rate. Restenosis rate after stent implantation for short lesions can be predicted using the variables percent diameter stenosis after the procedure and

  17. A Case of Pseudoaneurysm of the Internal Carotid Artery Following Endoscopic Endonasal Pituitary Surgery: Endovascular Treatment with Flow-Diverting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Ali Karadag

    2017-10-01

    Full Text Available Internal carotid artery (ICA pseudoaneurysm is a rare complication of endoscopic endonasal surgery occurring in 0.4–1.1% of cases. Pseudoaneurysms can subsequently result in other complications, such as subarachnoid hemorrhage, epistaxis, and caroticocavernous fistula with resultant death or permanent neurologic deficit. In this case, we illustrate endovascular treatment with a flow-diverting stent for an ICA pseudoaneurysm after endoscopic endonasal surgery for a pituitary adenoma in a 56-year-old male. Surgery was complicated by excessive intraoperative bleeding and emergent CT angiography confirmed an iatrogenic pseudoaneurysm on the anteromedial surface of the ICA. The pseudoaneurysm was treated endovascularly with flow-diverting stent implantation only. Follow-up CT angiography after three months demonstrated occlusion of the pseudoaneurysm.

  18. 2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry)

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Jensen, Lisette Okkels; Maeng, Michael

    2009-01-01

    OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST...

  19. Avaliação angiográfica do volume de placa e eventos cardiovasculares após implante de stents coronarianos Evaluación angiográfica del volumen de placa y eventos cardiovasculares tras implantación de stents coronarios Angiographic evaluation of plaque volume and cardiovascular events after coronary Stent Implantation

    Directory of Open Access Journals (Sweden)

    Erlon Oliveira de Abreu-Silva

    2010-12-01

    Full Text Available FUNDAMENTO: O volume de placa (VP está relacionado a eventos cardiovasculares maiores (ECVM após o implante de stents coronarianos. OBJETIVO: Avaliar a associação entre o VP antes do procedimento avaliado por angiografia e desfechos clínicos. MÉTODOS: Trata-se de estudo de coorte prospectivo incluindo pacientes submetidos a implante de stents coronarianos em um centro de referência. O VP antes do implante do stent foi avaliado pela fórmula descrita por Giugliano (Am J Cardiol 2005; 95:173: VP = À X (comprimento da lesão X [(diâmetro do vaso/2² - (diâmetro luminal mínimo/2²]. Os ECVM foram registrados no seguimento clínico de um ano e análise de regressão linear múltipla foi realizada para identificar os preditores de eventos. RESULTADOS: A amostra estudada consistiu em 824 pacientes, com idade média de 60 ± 11 anos, sendo 70,0% do gênero masculino. O diabete melito estava presente em 21,0% e o comprometimento triarterial em 12,0%. O diâmetro médio de referência foi de 3,3 ± 3,2 mm, a média do comprimento da lesão foi de 10,2 ± 4,7 mm e a média da estenose residual foi de 1,0% ± 12,0%. Os pacientes com ECVM apresentaram VP maior do que aqueles sem eventos (92,84 ± 42,85 vs 85 ± 46,85; p = 0,03. Outras variáveis associadas com ECVM na análise univariada foram comprometimento triarterial, IAM, diâmetro do vaso e comprimento da lesão tratada. O VP manteve a associação significativa com ECVM após ajuste para as variáveis descritas e diabete melito. CONCLUSÃO: O volume da placa do ateroma antes do implante do stent foi maior nos pacientes que apresentaram ECVM no seguimento clínico em um ano, independentemente de outros preditores de eventos.FUNDAMENTO: El volumen de placa (VP está relacionado a eventos cardiovasculares mayores (ECVM tras implantación de stentscoronarios. OBJETIVOS: Evaluar la asociación entre el VP antes del procedimiento evaluado por angiografía y desenlaces clínicos. MÉTODOS: Se

  20. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  1. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

  2. Análise morfométrica da carótida de suínos submetidos a angioplastia com ou sem implante de stent de cromo-cobalto Morphometric analysis of swine carotid artery angioplasty with or without cobalt-chromium stent implantation

    Directory of Open Access Journals (Sweden)

    João Luiz de Lara Elesbão

    2010-06-01

    Full Text Available Contexto: A hiperplasia intimal é a reação tardia mais comum decorrente da angioplastia. O uso de stents de cromo-cobalto é bem estudado na circulação coronariana, porém não há muitos estudos que abordem o uso desses stents nas circulações carotídea e periférica. Objetivo: Analisar mediante morfometria a reação intimal presente na artéria carótida de suínos submetidos a angioplastia isoladamente e a angioplastia seguida de implante de stent de cromo-cobalto. Materiais e métodos: Em oito suínos, foi realizada angioplastia da artéria carótida comum direita e angioplastia seguida de implante de um stent de cromo-cobalto na artéria carótida comum esquerda. Após 4 semanas, os animais foram submetidos a eutanásia para a retirada de amostras de tecido arterial e preparo de lâminas histológicas. As imagens das lâminas foram digitalizadas e analisadas por programa de morfometria digital. A análise estatística foi realizada através da média e desvio padrão das áreas em cada grupo, utilizando-se o Teste t de Student. O valor de p Background: Intimal hyperplasia is the most common delayed response to angioplasty. The use of cobalt-chromium stents is well studied in the coronary circulation; however, there are few studies on their use in the carotid and peripheral circulation. Objective: To analyze the intimal reaction in a swine carotid artery undergoing simple angioplasty and angioplasty followed by implantation of cobalt-chromium stent. Materials and methods: We carried out angioplasty in the right common carotid artery and angioplasty with cobalt-chromium stent in the left common carotid artery in eight swine. Four weeks later, all animals were sacrificed for arterial tissue sampling and preparation of histological slides. Slide images were scanned and analyzed using a digital morphometry program. Statistical analysis was performed by mean values and standard deviations of the areas in each group, using the Student's t

  3. Angiographic and histological results following implantation of a novel stent-on-a-wire in the animal model

    NARCIS (Netherlands)

    R. Diletti (Roberto); H.M. Garcia-Garcia (Hector); R.J.M. van Geuns (Robert Jan); V. Farooq (Vasim); L. Bailey (Leonard); S. Rousselle (Serge); G. Kopia (Gregory); W. Easterbrook (William); M. Pomeranz (Mark); P.W.J.C. Serruys (Patrick)

    2012-01-01

    textabstractAims: The Svelte Stent-On-A-Wire (SOAW) is a thin strut novel device consisting of a balloon-expandable cobalt-chromium stent premounted onto a single lumen fixed-wire delivery catheter platform. We evaluated the performance of the novel Svelte SOAW in comparison with the MultiLink

  4. Gender difference on five-year outcomes of EXCEL biodegradable polymer-coated sirolimus-eluting stents implantation: results from the CREATE study.

    Science.gov (United States)

    Zhang, Lei; Qiao, Bing; Han, Ya-Ling; Li, Yi; Xu, Kai; Zhang, Quan-Yu; Yang, Li-Xia; Liu, Hui-Liang; Xu, Bo; Gao, Run-Lin

    2013-03-01

    biodegradable polymer-coated sirolimus-eluting stenting in long term follow-up. Effects of prolonged dual antiplatelet therapy (DAPT) in preventing stent thrombosis was similar with six-month DAPT after EXCEL stent implantation in both men and women groups.

  5. Reduced antiplatelet therapy after drug-eluting stenting: multicenter Janus Flex carbostent implantation with short dual antiplatelet treatment for 2 or 6 months-MATRIX study.

    Science.gov (United States)

    Cassese, Salvatore; De Luca, Giuseppe; Villari, Bruno; Berti, Sergio; Bellone, Pietro; Alfieri, Alfonso; Montinaro, Antonio; Quaranta, Gaetano; Marraccini, Paolo; Piscione, Federico

    2012-09-01

    The Multicentre registry with Antiplatelet TReatment two-sIX months (MATRIX) evaluated safety and efficacy at 12-month follow-up of Janus Flex stenting with 2- or 6-month dual antiplatelet therapy (DAT) period. There are no data of Janus Flex stent (Carbostent and Implantable Devices-CID, Saluggia, Italy), a polymer-free, tacrolimus-eluting coronary stent, followed by short-term DAT, in daily practice. Patients were prospectively enrolled at 12 high-volume procedures centres. After stenting, four sites prescribed 2-month DAT, eight sites 6-month DAT. Major adverse cardiac events (MACE) and stent thrombosis (ST) rate was evaluated at 12-month follow-up, for entire population, as well as for 2- and 6-month DAT groups, distinctly. MACE included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). From March 2007 to June 2008, 572 patients (mean age 64.91 ± 11 years, 77.45% males) were enrolled. After successful stenting, 12-month follow-up showed a 12.74% MACE occurrence (cardiac death 0.98%; MI 3.13%; TLR 8.62%), with good Janus Flex safety profile confirmed by only two (0.39%) ST. After adjustment for potential confounding, no significant differences were noted at 12-month follow-up among 2- or 6-month DAT groups (MACE-8.99% versus 12.47%, P = 0.16; cardiac death-0.54% versus 1.14%, P = 0.52; MI-2.38% versus 2.71%, P = 0.83; TLR-5.66% versus 10.60%, P = 0.20; ST-0% versus 0.55%, P = 0.99). At multivariable analysis, DAT time duration was not an independent risk factor for adverse events (adjusted HR 0.47, 95% confidence interval 0.16-1.35, P = 0.16). Janus Flex coronary stenting, followed by short DAT, is safe and feasible, without differences between 2- and 6-month DAT groups. A randomized trial confirming these encouraging data is needed. Copyright © 2011 Wiley Periodicals, Inc.

  6. Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry.

    Science.gov (United States)

    Kimura, Takeshi; Morimoto, Takeshi; Nakagawa, Yoshihisa; Kadota, Kazushige; Nozaki, Yoichi; Tada, Tomohisa; Take, Shunsuke; Shirota, Kinya; Ito, Akira; Nakashima, Hitoshi; Fujita, Hiroshi; Kawasaki, Tomohiro; Inada, Tsukasa; Nakao, Koichi; Miyazaki, Shunichi; Doi, Osamu; Isshiki, Takaaki; Nobuyoshi, Masakiyo; Mitsudo, Kazuaki; Mitudo, Kazuaki

    2012-09-01

    Due to serious concerns on very late stent thrombosis (VLST), extended use of dual antiplatelet therapy (DAPT) beyond 1 year after DES implantation has become a common clinical practice despite apparent lack of evidence suggesting its efficacy in reducing VLST. The study population consisted of 12812 patients in the j-Cypher registry who were treated with at least one sirolimus-eluting stent (SES). We assessed the relation between duration of thienopyridine therapy and clinical outcomes with a landmark analysis at 1 year after SES implantation. Among 11713 patients without myocardial infarction (MI), stent thrombosis and stroke at 1 year who were eligible for the landmark analysis, 7414 patients (63 %) were maintained on thienopyridine at 1-year landmark point, while 4299 patients (37 %) had discontinued thienopyridine before 1-year landmark point. Patients in the on-thienopyridine group had more complex characteristics than patients in the off-thienopyridine group. Cumulative incidence of and the risk for definite VLST in the on-thienopyridine group relative to the off-thienopyridine group favored prolonged DAPT, but were not significant [0.9 and 1.2 %, P = 0.1, and adjusted HR (95 % CI): 0.71 (0.47-1.06), P = 0.11]. Cumulative incidence of and the risk for a composite of death, MI, or stroke in the on-thienopyridine group relative to the off-thienopyridine group were also not significant [15.3 and 14.3 %, P = 0.15, and adjusted HR (95 % CI): 0.99 (0.89-1.11), P = 0.89]. Prolonged use of thienopyridine beyond 1 year after SES implantation was not associated with significant decrease in the risks for VLST or for serious cardiovascular events including death, MI or stroke.

  7. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial.

    Science.gov (United States)

    Fea, Antonio M

    2010-03-01

    To compare phacoemulsification alone and phacoemulsification with micro-bypass stent implantation in eyes with primary open-angle glaucoma. Instituto di Fisiopatologia Clinica, Clinica Oculistica, Universita' di Torino, Torino, Italy. In this prospective double-masked randomized clinical trial, patients had phacoemulsification alone (control group) or phacoemulsification with iStent implantation (combined group). Primary outcomes were intraocular pressure (IOP) and reduction in medication use over 15 months and IOP after a 1-month washout of ocular hypotensive agents (ie, 16 months postoperatively). The baseline IOP was similar between groups (combined group: 17.9 mm Hg +/- 2.6 [SD]; control group: 17.3 +/- 3.0 mm Hg) (P = .512). Three patients in the control group were lost to follow-up. The mean IOP was 14.8 +/- 1.2 mm Hg in the combined group and 15.7 +/- 1.1 mm Hg in the control group at 15 months and 16.6 +/- 3.1 mm Hg and 19.2 +/- 3.5 mm Hg, respectively, after washout; the IOP was statistically significantly lower in the combined group than in the control group at both time points (P = .031 and P = .042, respectively). At 15 months, the mean number of medications was lower in the combined group than in the control group (0.4 +/- 0.7 and 1.3 +/- 1.0, respectively; P = .007), as was the proportion of patients on ocular hypotensive medication (33% and 76%, respectively). Phacoemulsification with stent implantation was more effective in controlling IOP than phacoemulsification alone; the safety profiles were similar. Copyright 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  8. Treatment effects of eptifibatide in planned coronary stent implantation in patients with chronic kidney disease (ESPRIT Trial).

    Science.gov (United States)

    Reddan, Donal N; O'Shea, John Conor; Sarembock, Ian J; Williams, Kathryn A; Pieper, Karen S; Santoian, Edward; Owen, William F; Kitt, Michael M; Tcheng, James E

    2003-01-01

    The role of platelet glycoprotein IIb/IIIa inhibitor therapy in patients with mild renal impairment is not well characterized. Our objective was to explore the associations of creatinine clearance (CrCl) with outcomes in a trial of eptifibatide therapy in patients who underwent percutaneous coronary intervention (PCI). We analyzed 48-hour and 30-day outcomes of patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. Patients were randomly assigned to placebo or eptifibatide as an adjunct to stent implantation (1,755 with CrCl > or =60 ml/min and 289 with CrCl <60 ml/min). CrCl was calculated using the Cockcroft and Gault formula, and the associations of CrCl with outcomes were evaluated using logistic regression models. Patients with CrCl <60 ml/min were more likely to be older, women, hypertensive, and have a history of coronary artery bypass surgery, stroke, or peripheral vascular disease. The interaction of eptifibatide with CrCl had borderline significance for the 30-day outcome (p = 0.109). Treatment effect trended toward a greater magnitude in patients with lower CrCl (60 ml/min) (odds ratio 0.53, confidence interval 0.34 to 0.83) compared with those with higher CrCl (90 ml/min) (odds ratio 0.68, confidence interval 0.49 to 0.94). An accompanying increase in bleeding risk also was not apparent with lower CrCl. The treatment effect of eptifibatide is realized regardless of renal function and trends toward being greater in patients with mild renal impairment.

  9. Avaliação angiográfica do volume de placa e eventos cardiovasculares após implante de stents coronarianos

    Directory of Open Access Journals (Sweden)

    Erlon Oliveira de Abreu-Silva

    2010-12-01

    Full Text Available FUNDAMENTO: O volume de placa (VP está relacionado a eventos cardiovasculares maiores (ECVM após o implante de stents coronarianos. OBJETIVO: Avaliar a associação entre o VP antes do procedimento avaliado por angiografia e desfechos clínicos. MÉTODOS: Trata-se de estudo de coorte prospectivo incluindo pacientes submetidos a implante de stents coronarianos em um centro de referência. O VP antes do implante do stent foi avaliado pela fórmula descrita por Giugliano (Am J Cardiol 2005; 95:173: VP = À X (comprimento da lesão X [(diâmetro do vaso/2² - (diâmetro luminal mínimo/2²]. Os ECVM foram registrados no seguimento clínico de um ano e análise de regressão linear múltipla foi realizada para identificar os preditores de eventos. RESULTADOS: A amostra estudada consistiu em 824 pacientes, com idade média de 60 ± 11 anos, sendo 70,0% do gênero masculino. O diabete melito estava presente em 21,0% e o comprometimento triarterial em 12,0%. O diâmetro médio de referência foi de 3,3 ± 3,2 mm, a média do comprimento da lesão foi de 10,2 ± 4,7 mm e a média da estenose residual foi de 1,0% ± 12,0%. Os pacientes com ECVM apresentaram VP maior do que aqueles sem eventos (92,84 ± 42,85 vs 85 ± 46,85; p = 0,03. Outras variáveis associadas com ECVM na análise univariada foram comprometimento triarterial, IAM, diâmetro do vaso e comprimento da lesão tratada. O VP manteve a associação significativa com ECVM após ajuste para as variáveis descritas e diabete melito. CONCLUSÃO: O volume da placa do ateroma antes do implante do stent foi maior nos pacientes que apresentaram ECVM no seguimento clínico em um ano, independentemente de outros preditores de eventos.

  10. Restoration of myocardial blood flow following percutaneous coronary balloon dilatation and stent implantation: Assessment with qualitative and quantitative contrast-enhanced magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Sensky, P.R.; Samani, N.J.; Horsfield, M.A.; Cherryman, G.R

    2002-07-01

    AIM: To examine the serial use of magnetic resonance imaging (MRI) to evaluate regional myocardial perfusion changes following percutaneous coronary angioplasty and stent implantation (PTCA). MATERIALS AND METHODS: Six patients with single vessel coronary artery disease (CAD) underwent contrast-enhanced first pass MRI immediately prior to (visit A) and within 7 days after (visit B) PTCA. Three sequential short axis slices were obtained after gadodiamide (Gd) bolus (0.025 mmol/kg{sup -1}) at rest and during adenosine. Each short axis was divided radially into eight regions of interest (ROIs). ROIs were anatomically assigned to a coronary artery territory (CAT). Stress and rest qualitative and quantitative (unidirectional extraction fraction constant (K{sub i}); index of myocardial perfusion reserve (MPRI) = stressK{sub i} / restK{sub i}) perfusion parameters were determined for ROI supplied by remote and stenosed/stented vessels for each visit. RESULTS: In stented ROIs the number of ROIs demonstrating normal perfusion, as opposed to reversible perfusion deficits, increased. Qualitative perfusion assessment in remote CATs was unchanged. MPRI in stenotic CATs was lower than in remote CATs at visit A (P < 0.001). Following PTCA, MPRI increased in stented CATs (P < 0.001) but was unchanged in remote CATs. CONCLUSION: Restoration of myocardial perfusion following PTCA can be delineated with qualitative and quantitative perfusion MRI. Although at present the investigation is technically complex and not perfectly sensitive or specific, MRI has the potential to be a valuable tool for patient follow-up and evaluation of revascularization strategy efficacy. Sensky, P.R. et al. (2002)

  11. Biocompatibility of Coronary Stents

    Directory of Open Access Journals (Sweden)

    Thamarasee M. Jeewandara

    2014-01-01

    Full Text Available Cardiovascular disease is the dominant cause of mortality in developed countries, with coronary artery disease (CAD a predominant contributor. The development of stents to treat CAD was a significant innovation, facilitating effective percutaneous coronary revascularization. Coronary stents have evolved from bare metal compositions, to incorporate advances in pharmacological therapy in what are now known as drug eluting stents (DES. Deployment of a stent overcomes some limitations of balloon angioplasty alone, but provides an acute stimulus for thrombus formation and promotes neointimal hyperplasia. First generation DES effectively reduced in-stent restenosis, but profoundly delay healing and are susceptible to late stent thrombosis, leading to significant clinical complications in the long term. This review characterizes the development of coronary stents, detailing the incremental improvements, which aim to attenuate the major clinical complications of thrombosis and restenosis. Despite these enhancements, coronary stents remain fundamentally incompatible with the vasculature, an issue which has largely gone unaddressed. We highlight the latest modifications and research directions that promise to more holistically design coronary implants that are truly biocompatible.

  12. Optical coherence tomography study of chronic-phase vessel healing after implantation of bare metal and paclitaxel-eluting self-expanding nitinol stents in the superficial femoral artery.

    Science.gov (United States)

    Kozuki, Amane; Shinke, Toshiro; Otake, Hiromasa; Kijima, Yoichi; Masano, Tomoya; Nagoshi, Ryoji; Imamura, Kimitake; Fujiwara, Ryudo; Shibata, Hiroyuki; Takeshige, Ryo; Tsukiyama, Yoshiro; Yanaka, Kenichi; Nakano, Shinsuke; Fukuyama, Yusuke; Kawashima, Seinosuke; Hirata, Ken-ichi; Shite, Junya

    2016-05-01

    This study aimed to assess chronic-phase suppression of neointimal proliferation and arterial healing following paclitaxel-coated (PTX) and bare metal stent (BMS) implantation in the superficial femoral artery using optical coherence tomography (OCT). Twenty-five patients with 68 stents underwent an 8-month OCT follow-up. Besides standard OCT variables, neointimal characterization and frequencies of peri-strut low-intensity area (PLIA), macrophage accumulation, and in-stent thrombi were evaluated. The mean neointimal thickness was significantly less with PTX stents (544.9±202.2 μm vs. 865.0±230.6 μm, phealing was observed compared with BMS. Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  13. Cheatham platinum stent implantation in children with coarctation of the aorta: single-centre short-term, intermediate-term, and long-term results from Turkey.

    Science.gov (United States)

    Baykan, Ali; Narin, Nazmi; Ozyurt, Abdullah; Argun, Mustafa; Pamukcu, Ozge; Mavili, Ertugrul; Sezer, Saadettin; Onan, Sertac H; Uzum, Kazım

    2014-08-01

    Our aim was to evaluate patients who were treated by percutaneous stent implantation. Patients with aortic coarctation (n = 35) who had been treated with 38 stents - 12 bare and 26 covered - were evaluated. The demographics and procedural and follow-up data were recorded from hospital registers and compared according to patient specifications, for example, weight and coarctation nature. The procedure was successful in all patients. There was a statistically significant difference between the patients with native coarctation (n = 17) and those with recurrent coarctation (n = 18) in terms of pre-procedural blood pressures, systolic gradients, coarctation diameters, and the ratio of the coarctation site diameter to the descending aorta diameter. Although all patients received antihypertensive drugs before the procedure, the drug was discontinued in 26 patients during follow-up (p migration was observed in four patients with recurrent coarctation (11.4%), and peripheral arterial injury was seen in three patients (8.5%). The mean follow-up time was 34 ± 16 months. On average, 21 (6-42) months after the procedure, six patients underwent cardiac catheterisation. At least 2 years after the procedure, tomography was performed in 20 patients (57.2%). Patients who were evaluated by multi-slice computerised tomography revealed no pathologies. There was no statistically significant difference between the five patients weighing less than 20 kg and the other 30 patients in terms of demographic and procedural characteristics, procedure success and complication rates, and follow-up data. Stent implantation for aortic coarctation is a method yielding satisfactory results in reducing coarctation gradients, efficient enlargement of the lesion area, and resolution of hypertension for children, including those weighing less than 20 kg.

  14. Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model

    Directory of Open Access Journals (Sweden)

    Ting Wang

    2016-01-01

    Conclusions: The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

  15. Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

    Science.gov (United States)

    Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

    2017-11-01

    Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the

  16. Negative vascular remodelling after implantation of bioabsorbable magnesium alloy stents in porcine coronary arteries: a randomised comparison with bare-metal and sirolimus-eluting stents

    DEFF Research Database (Denmark)

    Maeng, M; Jensen, Lisette Okkels; Falk, E

    2009-01-01

    randomly implanted in 31 porcine coronary arteries (n = 11 pigs). MAIN OUTCOME MEASURES: Neointima formation was measured by histomorphometry at 90 days. Vascular remodelling defined as change in external elastic membrane area from index intervention to follow-up was assessed by serial intravascular...

  17. Impact of statin therapy on late target lesion revascularization after sirolimus-eluting stent implantation (from the CREDO-Kyoto Registry Cohort-2).

    Science.gov (United States)

    Natsuaki, Masahiro; Nakagawa, Yoshihisa; Morimoto, Takeshi; Ono, Koh; Shizuta, Satoshi; Furukawa, Yutaka; Kadota, Kazushige; Iwabuchi, Masashi; Kato, Yoshihiro; Suwa, Satoru; Inada, Tsukasa; Doi, Osamu; Takizawa, Akinori; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2012-05-15

    Therapeutic strategies preventing late target lesion revascularization (TLR) after drug-eluting stent implantation have not been yet adequately investigated. In 13,087 consecutive patients undergoing first percutaneous coronary intervention in the CREDO-Kyoto Registry Cohort-2, we identified 10,221 patients who were discharged alive after implantation of sirolimus-eluting stents (SESs) only (SES stratum 5,029) or bare-metal stents (BMSs) only (BMS stratum 5,192). Impact of statin therapy at time of discharge from the index hospitalization on early (within the first year) and late (1 year to 4 years) TLR, was assessed in the SES stratum (statin group 2,735; nonstatin group 2,294) and in the BMS stratum (statin group 2,576; nonstatin group 2,616). Despite a significantly lower incidence of early TLR (7.8% vs 22.2%, p <0.0001), SES use compared to BMS use was associated with a significantly higher incidence of late TLR (7.7% vs 3.0%, p <0.0001). In the SES and BMS strata, the incidence of early TLR was similar regardless of statin use. In the SES stratum, the incidence of late TLR was significantly lower in the statin group than in the nonstatin group (6.1% vs 9.6%, p = 0.002), whereas no significant difference was found in the BMS stratum (2.6% vs 3.3%, p = 0.38). After adjusting confounders, risk for late TLR significantly favored statin use in the SES stratum (hazard ratio 0.73, 95% confidence interval 0.54 to 0.98, p = 0.04), whereas the risk decrease was not significant in the BMS stratum (hazard ratio 0.74, 95% confidence interval 0.46 to 1.20, p = 0.23). In conclusion, statin therapy at hospital discharge was associated with a significantly lower risk for late TLR after SES implantation. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

    Science.gov (United States)

    Ariotti, Sara; Adamo, Marianna; Costa, Francesco; Patialiakas, Athanasios; Briguori, Carlo; Thury, Attila; Colangelo, Salvatore; Campo, Gianluca; Tebaldi, Matteo; Ungi, Imre; Tondi, Stefano; Roffi, Marco; Menozzi, Alberto; de Cesare, Nicoletta; Garbo, Roberto; Meliga, Emanuele; Testa, Luca; Gabriel, Henrique Mesquita; Ferlini, Marco; Vranckx, Pascal; Valgimigli, Marco

    2016-03-14

    This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p ZEUS]; NCT01385319). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. The conical stent in coronary artery improves hemodynamics compared with the traditional cylindrical stent.

    Science.gov (United States)

    Yu, Yi; Zhou, Yujie; Ma, Qian; Jia, Shuo; Wu, Sijing; Sun, Yan; Liu, Xiaoli; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei

    2017-01-15

    This study sought to explore the efficacy of the conical stent implantation in the coronary artery by comparing the effects of cylindrical and conical stents on wall shear stress (WSS) and velocity of flow and fractional flow reserve (FFR). The traditional cylindrical stent currently used in the percutaneous coronary intervention (PCI) has a consistent diameter, which does not match the physiological change of the coronary artery. On the contrary, as a new patent, the conical stent with tapering lumen is consistent with the physiological change of vascular diameter. However, the effect of the conical stent implantation on the coronary hemodynamics remains unclear. The coronary artery, artery stenosis and two stent models were established by Solidworks software. All models were imported into the computational fluid dynamics (CFD) software ANSYS ICEM-CFD to establish the fluid model. After the boundary conditions were set, CFD analysis was proceeded to compare the effects of two stent implantation on the change of WSS, velocity of flow and FFR. Hemodynamic indexes including FFR, blood flow velocity distribution (BVD) and WSS were improved by either the cylindrical or the conical stent implantation. However, after the conical stent implantation, the change of FFR seemed to be slower and more homogenous; the blood flow velocity was more appropriate without any obvious blood stagnation and direction changes; the WSS after the conical stent implantation was uniform from the proximal to distal side of the stent. Compared with the cylindrical stent, the conical stent implantation in the coronary artery can make the changes of vascular hemodynamic more closer to the physiological condition, which can reduce the incidence of intra-stent restenosis and thrombosis, thus making it more suitable for PCI therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  20. Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

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    Łukasz Rzeszutko

    2016-11-01

    Full Text Available Introduction: There are limited data on the comparison of bioresorbable vascular scaffold (BVS and drug-eluting stent (DES/bare-metal stent (BMS implantation in an unselected population of patients with coronary artery disease. Aim : To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry. Material and methods: A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA, DES or BMS (all available types implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA or acute coronary syndrome were collected. Results : Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001 and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both. The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02, but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01, and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001. Conclusions : Patients treated with BVS implantation presented an acceptable safety and efficacy profile in

  1. Clinical Outcomes of Patients Undergoing Rotational Atherectomy Followed by Drug-eluting Stent Implantation: A Single-center Real-world Experience.

    Science.gov (United States)

    Cuenza, Lucky R; Jayme, Ada Cherryl; Khe Sui, James Ho

    2017-01-01

    Rotational atherectomy (RA) is used to improve procedural success of percutaneous catheter interventions (PCIs) of complex and heavily calcified coronary lesions. We report the clinical experience and outcomes in our institution with the use of RA, followed by drug-eluting stent implantation. Data of 81 patients treated with PCI and adjunctive RA were analyzed. Clinical follow-up for the occurrence of major adverse events (MAEs) was obtained in all patients and correlated with significant variables using multivariate Cox proportional hazards analysis. Mean age was 67.9 ± 9.2 years, 61.7% had diabetes, 20.9% had chronic kidney disease, and 48.1% had previous acute coronary syndrome (ACS). Mean SYNTAX score was 29.8 ± 12.2, with a 92.5% angiographic success rate achieved. In-hospital MAEs rate was 7.4% while mortality rate was 8.6%. On median follow-up of 12.2 months, incidence of MAEs of 13.5% with a 75% free incidence from MAEs at 34 months. Multivariate analysis revealed that a history of previous ACS, ejection fraction, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, SYNTAX score, burr to artery ratio, and attainment of angiographic success were significant predictors of MAEs. RA followed by drug-eluting stent implantation is a safe and effective method in improving procedural success as well as short- and long-term outcomes of PCI in our center. A combination of clinical and procedural factors is predictive for the occurrence of MAEs and should be taken into account in the application of this technique.

  2. Association of morphologic characteristics on optical coherence tomography and angiographic progression patterns of late restenosis after drug-eluting stent implantation

    Energy Technology Data Exchange (ETDEWEB)

    Yamaguchi, Hiroshi, E-mail: yhclinic@po5.synapse.ne.jp [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima city, Kagoshima (Japan); Arikawa, Ryo; Takaoka, Junichiro; Miyamura, Akihiro; Atsuchi, Nobuhiko; Ninomiya, Toshiko; Atsuchi, Yoshihiko [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima city, Kagoshima (Japan); Ohishi, Mitsuru [Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Science, Kagoshima University, Kagoshima (Japan); Terashima, Mitsuyasu [Department of Cardiology, Toyohashi Heart Center, Toyohashi (Japan); Kaneda, Hideaki [Okinaka Memorial Institute for Medical Research, Tokyo (Japan); Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe (Japan)

    2015-01-15

    Objectives: To gain insight into the pathophysiology of late drug-eluting stent (DES) restenosis. Background: Restenosis of DES has a different time course from that of bare metal stents. Methods: Patients who underwent follow-up coronary angiography (CAG) twice (six to nine months and 18 to 24 months) after DES implantation were examined using optical coherence tomography (OCT). All lesions with target lesion revascularization at first follow-up were excluded. Late catch-up was defined as lesions that progressed from less than 50% diameter stenosis (DS) at the first CAG to more than 50% DS at the second CAG. Lesions with the late catch-up were further divided into two groups; lesions with jump-up (less than 25% DS at the first CAG) and lesions with gradual progression (25–50% DS at the first CAG). Results: Of the 25 patients who had late ISR, 23 patients (10 jump-up/13 gradual progression) were examined with OCT at late follow-up and enrolled in this study. In the qualitative OCT assessment, each ratio of homogeneous, layered, heterogeneous with or without attenuation tissue morphologies were in jump-up group, and gradual progression group were 0% and 15%, 0% and 23%, and 60% and 8%, and 40% and 54%, respectively. All of jump-up group showed heterogeneous restenotic tissue, while 62% of gradual progression group showed heterogeneous restenotic tissue (P = .04). Conclusions: These findings suggest different pathophysiology of the late catch-up after DES implantation between the jump-up and gradual progression groups.

  3. Intravascular ultrasound assessment of minimum lumen area and intimal hyperplasia in in-stent restenosis after drug-eluting or bare-metal stent implantation. The Nordic Intravascular Ultrasound Study (NIVUS)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Vikman, Saila; Antonsen, Lisbeth

    2017-01-01

    INTRODUCTION: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients...... presenting with a DES or bare-metal stent (BMS) in-stent restenosis. METHODS: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled...

  4. Long-term outcome of sirolimus-eluting and zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a Danish Organization for Randomized Trials on Clinical Outcome III substudy)

    DEFF Research Database (Denmark)

    Olesen, Kevin K W; Tilsted, Hans-Henrik; Jensen, Lisette O

    2015-01-01

    We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We...... randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target...... vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18...

  5. Estenosis de la arteria mesentérica superior como causa de isquemia intestinal crónica: Tratamiento con angioplastia e implante de stent Superior mesenteric artery stenosis as a cause of chronic intestinal ischemia: Treatment with angioplastia and stent implantation

    Directory of Open Access Journals (Sweden)

    Nabil Hamdan

    2005-02-01

    Full Text Available La isquemia intestinal crónica es un cuadro poco frecuente que se asocia con alta morbilidad y mortalidad, cuya causa más frecuente es la arterioesclerosis. Los pacientes sufren de dolor abdominal localizado en epigastrio o periumbilical, que aparece de 10 a 30 minutos luego de la ingestión de alimentos. Se presenta un caso de isquemia intestinal crónica por estenosis de la arteria mesentérica superior disgnosticado por angiografía, el cual se trató con angioplastia percutánea e implante de stent. Se comentan los hallazgos clínicos y radiológicos y el procedimiento terapéutico.Chronic intestinal ischemia is an infrequent clinical presentation associated with high morbidity and mortality; its main cause is arteriosclerosis. Patients suffer abdominal pain localized in the epigastrium or periumbilical region that appears 10 to 30 minutes after food ingestion. A case of chronic intestinal ischemia due to stenosis of the superior mesenteric artery diagnosed through angiography is presented. The treatment consisted of percutaneous angioplastia and Stent implantation. Clinical and radiological findings and therapeutic procedure are discussed.

  6. Tratamiento con angioplastia e implante de stent versus tratamiento quirúrgico en pacientes con estenosis de la arteria carótida cervical Angioplasty treatment and stent implant vs. surgical treatment in patients with stenosis of the cervical carotid artery

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    Nabil Hamdan

    Full Text Available Introducción y objetivos: en el tratamiento de la estenosis significativa de la arteria carótida cervical (común e interna, la angioplastia con implante de stent es un procedimiento menos invasivo que la intervención quirúrgica (5. En la actualidad, en los grandes estudios publicados en los cuales se comparan la angioplastia con el tratamiento quirúrgico, se observan resultados similares en los eventos mayores como accidente cerebrovascular y mortalidad, pero mayor diferencia significativa en la aparición de infarto agudo del miocardio durante la intervención quirúrgica (5, 11. El objetivo de este estudio es comparar en ambos métodos de tratamiento eventos clínicos mayores y menores, como accidente cerebrovascular, infarto agudo del miocardio, muerte, bradicardia, hipotensión y encefalopatía durante la intervención, la hospitalización y al año de seguimiento, además de la reintervención, el tiempo de hospitalización y las complicaciones de la incisión quirúrgica. Materiales y métodos: en este estudio de cohorte histórica, se incluyeron 46 pacientes con estenosis significativa de las arterias carótidas cervicales, quienes se sometieron a intervención desde el 1 de enero de 2001 al 31 de diciembre de 2003. Se trataron 21 pacientes con angioplastia e implante de stent y 25 con cirugía (endarterectomía. Resultados: durante la angioplastia se presentó 1 (4,8% accidente cerebrovascular mayor y ninguno en los pacientes tratados con cirugía. Ocurrió 1 (4% infarto agudo del miocardio durante la intervención en el grupo de pacientes tratados con cirugía y ninguno en los pacientes tratados con angioplastia. No se presentaron muertes en los grupos durante la intervención, la hospitalización y al año de seguimiento. Luego de 8 meses 1 (4,8% paciente tratado con cirugía se reintervino con angioplastia e implante de stent. No hubo diferencias estadísticamente significativas entre ambos grupos durante la hospitalización y

  7. Primary angioplasty: Effect of deferred stenting on stent size.

    Science.gov (United States)

    Harbaoui, Brahim; Emsellem, Philippe; Cassar, Emmanuel; Besnard, Cyril; Dauphin, Raphael; Motreff, Pascal; Courand, Pierre-Yves; Lantelme, Pierre

    2017-04-01

    Primary angioplasty with immediate stenting (IS) is the gold standard for ST-segment elevation myocardial infarction (STEMI). Deferred stenting (DS) has been proposed to limit periprocedural complications, and may influence stent size because of thrombus and spasm alleviation. We sought to study the effect of DS on stent size. Over the study period, 258 patients underwent primary angioplasty for STEMI (DS, n=84; IS, n=174). An informative coronary angiogram run - i.e. allowing for proper lesion analysis - was selected and anonymized by an independent operator. Two experienced operators randomly analysed these runs, and proposed stent dimensions after having measured vessel diameter and lesion length by quantitative coronary analysis. The primary objective was the variation in stent size between the two coronary angiograms. The median delay between the two coronary angiograms was 2 days. Overall, the stent length was shorter (-1.64mm; P=0.030) and its diameter was larger (+0.13mm; P<0.001) during the second coronary angiogram, especially in the right coronary arteries. DS led to the implantation of a larger and shorter stent; this is probably because DS allows for more accurate assessment of the residual lesion after relief of spasm and thrombus, and may have clinical consequences in terms of stent thrombosis and restenosis. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  8. Long-term effect of persistent smoking on the prognosis of Chinese male patients after percutaneous coronary intervention with drug-eluting stent implantation.

    Science.gov (United States)

    Liu, Jun; Zhu, Zhong-yu; Gao, Chuan-yu; Wang, Xian-pei; Zhang, You; Jin, Wei-dong; Qi, Da-tun; Li, Mu-wei

    2013-11-01

    This study aimed to survey the adherence to smoking cessation and assess the influence of persistent smoking on the prognosis in male patients after drug-eluting stent (DES) implantation. The smoking status at the time of the index procedure and at follow-up was surveyed in 656 male patients undergoing successful percutaneous coronary intervention (PCI) with DES in our center. These patients were divided into three groups, based on their smoking status: nonsmokers (n=226), quitters (n=283), and persistent smokers (n=147). Major adverse cardiac and cerebrovascular events (MACCE) during the follow-up period were carefully recorded and their relationship with smoking status was investigated for 24-41 months. Among 656 patients who were followed up for 27.24±6.33 (7-40) months, 430 of them were smokers (65.5%) at the index procedure. A total of 147 patients (22.4%) who continued to smoke, accounted for 34.2% of smokers at the time of PCI. Persistent smokers and quitters were more likely to be young (psmoking was a significantly determinant factor for all-cause death [hazard ratio (HR)=2.432, 95% confidence interval (CI) 1.170-5.054; psmoking in Chinese male patients after DES implantation. Our findings strongly indicate that poor adherence to smoking cessation is a predictive factor for all-cause death and MACCE. Copyright © 2013 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  9. Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2).

    Science.gov (United States)

    de la Torre Hernández, José M; Alfonso, Fernando; Gimeno, Federico; Diarte, Jose A; Lopez-Palop, Ramón; Pérez de Prado, Armando; Rivero, Fernando; Sanchis, Juan; Larman, Mariano; Diaz, Jose F; Elizaga, Jaime; Moreiras, Javier Martín; Gomez Jaume, Alfredo; Hernández, José M; Mauri, Josepa; Recalde, Angel Sánchez; Bullones, Juan A; Rumoroso, Jose R; Del Blanco, Bruno García; Baz, Jose A; Bosa, Francisco; Botas, Javier; Hernández, Felipe

    2010-09-01

    This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Improved two-year outcomes after drug-eluting versus bare-metal stent implantation in women and men with large coronary arteries

    DEFF Research Database (Denmark)

    Hansen, K W; Kaiser, C; Hvelplund, A

    2013-01-01

    To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels.......To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels....

  11. Quantificação volumétrica da hiperplasia neointimal em artérias ilíacas após implante de suporte intravascular metálico Volumetric assessment of neointimal hyperplasia in iliac arteries after metal stent implantation

    Directory of Open Access Journals (Sweden)

    Samuel Martins Moreira

    2009-08-01

    Full Text Available OBJETIVO: Quantificar a hiperplasia neointimal em artérias ilíacas após stent, correlacionando fatores clínicos, arteriais e materiais dos stents. MATERIAIS E MÉTODOS: De junho de 2003 a agosto de 2005, 60 pacientes realizaram angioplastia transluminal percutânea e stent. Desses, 30 foram reestudados com ultrassonografia intravascular. Os dados foram analisados no laboratório de análise quantitativa. RESULTA-DOS: Dezesseis pacientes eram do sexo masculino (53,3% e 14 (46,7%, do sexo feminino. A média de idade foi de 60,3 anos. Apresentaram hipertensão arterial 22 pacientes (73,3%, tabagismo, 18 (62,1%, hiperlipidemia, 20 (66,7%, e diabetes, 9 (30%. Foram implantados 20 stents de nitinol (66,7% e 10 de aço inoxidável (33,3%. Quatro pacientes eram TASC A (13,3%, 15 eram TASC B (50% e 11, TASC C (36,7%. O volume da hiperplasia variou de 49,02 mm³ a 112,87 mm³ (média de 80,33 mm³. O percentual de obstrução intra-stent variou de 18% a 47% (média de 27,4%. Os resultados clínicos obtidos com stent se mantiveram até o reestudo. CONCLUSÃO: A hiperplasia neointimal sempre ocorre após a angioplastia transluminal percutânea e stent, porém os percentuais de obstrução não foram superiores a 50% em nenhum caso. Não houve diferença estatisticamente significante dos percentuais de obstrução intra-stent quanto aos materiais dos stents, aos fatores clínicos e aos fatores arteriais.OBJECTIVE: To quantify neointimal hyperplasia in iliac arteries after stent implantation, correlating clinical, arterial factors and stent material. MATERIALS AND METHODS: In the period from June/2003 to August/ 2005, 60 patients were submitted to percutaneous transluminal angioplasty and stenting. Among these patients, 30 were followed-up with intravascular ultrasonography. Data were analyzed in a laboratory of quantitative analysis by means of a specific software. RESULTS: Sixteen (53.3% patients were men, and 14 (46.7%, women, and the mean age was 60

  12. Short-term follow-up of tirofiban as alternative therapy for urgent surgery patients with an implanted coronary drug-eluting stent after ST-elevation myocardial infarction.

    Science.gov (United States)

    Xia, Jing-Gang; Qu, Yang; Shen, Hong; Liu, Xiu-Hua

    2013-09-01

    Patients with a recently diagnosed ST-elevation myocardial infarction (STEMI) and implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless aspirin and clopidogrel are discontinued beforehand. However, discontinuation of aspirin and clopidogrel is associated with a high rate of recurrent myocardial infarction, heart failure, and malignant arrhythmias because of stent thrombosis. The main point of debate is how to treat these patients. We hypothesized that perioperative intravenous administration of tirofiban, a GPIIb/IIIa inhibitor, would allow the safe withdrawal of aspirin and clopidogrel without increasing the risk of surgical bleeding. Twenty-one patients implanted with a coronary DES after STEMI who underwent urgent surgery were selected for this clinical trial. Tirofiban was used to replace aspirin and clopidogrel (dual antiplatelet drugs) before and after urgent surgery. Major adverse cardiovascular and bleeding events were observed during hospitalization and within 3 months of discharge. Twenty-one patients with recently diagnosed STEMI and implanted DES [median (range) 6 (3-8) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery. Tirofiban was used to replace aspirin and clopidogrel 5 days before surgery, stopped 4 h before surgery, and resumed until oral aspirin and clopidogrel was resumed after surgery. There were no deaths, myocardial infarction, stent thrombosis, or surgical re-exploration because of bleeding during hospitalization and within 3 months of discharge. There was one case of acute left ventricular failure during hospitalization. In patients who need urgent surgery after recently diagnosed STEMI and implanted DES, a strategy using tirofiban may allow temporary withdrawal of dual antiplatelet drugs without increasing the risk of bleeding. This conclusion needs to be further confirmed by large-scale randomized clinical trials.

  13. Very late stent thrombosis of bare-metal coronary stent nine years after primary percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Đurić Predrag

    2016-01-01

    Full Text Available Introduction. Stent thrombosis (ST in clinical practice can be classified according to time of onset as early (0–30 days after stent implantation, which is further divided into acute ( 30 days and very late (> 12 months. Myocardial reinfaction due to very late ST in a patient receiving antithrombotic therapy is very rare, and potentially fatal. The procedure alone and related mechanical factors seem to be associated with acute/subacute ST. On the other hand, in-stent neoathero-sclerosis, inflammation, premature cessation of antiplatelet therapy, as well as stent fracture, stent malapposition, un-covered stent struts may play role in late/very late ST. Some findings implicate that the etiology of very late ST of bare-metal stent (BMS is quite different from those following drug-eluting stent (DES implantation. Case report. We presented a 56-year old male with acute inferoposterior ST segment elevation myocardial infarction (STEMI related to very late stent thrombosis, 9 years after BMS implantation, despite antithrombotic therapy. Thrombus aspiration was successfully performed followed by percutaneous coronary intervention (PCI with implantation of DES into the pre-viously implanted two stents to solve the in-stent restenosis. Conclusion. Very late stent thrombosis, although fortu-nately very rare, not completely understood, might cause myocardial reinfaction, but could be successfully treated with thrombus aspiration followed by primary PCI. Very late ST in the presented patient might be connected with neointimal plaque rupture, followed by thrombotic events.

  14. Antithrombotic management and 1-year outcome of patients on oral anticoagulation undergoing coronary stent implantation (from the Registro Regionale Angioplastiche Emilia-Romagna Registry).

    Science.gov (United States)

    Rubboli, Andrea; Magnavacchi, Paolo; Guastaroba, Paolo; Saia, Francesco; Vignali, Luigi; Giacometti, Paola; Franco, Nicoletta; Benassi, Alberto; Varani, Elisabetta; Campo, Gianluca; Manari, Antonio; De Palma, Rossana; Marzocchi, Antonio

    2012-05-15

    Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Bronchial stents

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    Ibrahim Emad

    2006-01-01

    Full Text Available Bronchial stents are mostly used as a Palliative relief of symptoms often caused by airway obstruction, It is also used for sealing of stump fistulas after pneumonectomy and dehiscence after bronchoplastic operations. Advances in airway prosthetics have provided a variety of silicone stents, expandable metal stents, and pneumatic dilators, enabling the correction of increasingly complex anatomical problems. Several series have been published describing the application and results of these techniques. This manuscript reviews the historical development of stents, types, indication, outcome, and complications. Alternative therapies for tracheobronchial stenting were also reviewed

  16. Influence of Sex on Long-Term Outcomes After Implantation of Bare-Metal Stent: A Multicenter Report From the Coronary Revascularization Demonstrating Outcome Study-Kyoto (CREDO-Kyoto) Registry Cohort-1.

    Science.gov (United States)

    Yamaji, Kyohei; Shiomi, Hiroki; Morimoto, Takeshi; Toyota, Toshiaki; Ono, Koh; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Ando, Kenji; Shirai, Shinichi; Kato, Masayuki; Takatsu, Yoshiki; Doi, Osamu; Kambara, Hirofumi; Suwa, Satoru; Onodera, Tomoya; Watanabe, Hirotoshi; Natsuaki, Masahiro; Kimura, Takeshi

    2015-12-15

    Female sex was reported to be associated with lower risk for midterm restenosis and repeat revascularization after bare-metal stent implantation. However, the influence of sex on very long-term outcomes after bare-metal stent implantation has not been yet reported. Among the 9877 patients in the multicenter Coronary Revascularization Demonstrating Outcome study in Kyoto (CREDO-Kyoto) registry cohort-1, bare-metal stent implantation was performed in 5313 patients (men, n=3742 and women, n=1571). Follow-up was completed in 4515 patients (85.0%) at 10 years (duration, 10.3 ± 3.1 [0.0-14.1] years). The cumulative incidence of target-lesion revascularization (TLR) was 27% at 1 year and 34% at 10 years (0.8%/y beyond 1 year). Non-target-lesion revascularization (non-TLR) was the dominant coronary revascularization beyond 1 year (13% at 1 year and 31% at 10 years [2.0%/y beyond 1 year]). Cumulative incidence of stent thrombosis was low (1.2% at 1 year and 1.9% at 10 years). Women were older and had greater prevalence of cardiovascular risk factors than men. The cumulative 10-year incidences of and adjusted risk for TLR were significantly higher in men than in women (36% versus 30%, P<0.001; adjusted hazard ratio, 1.29; 95% confidence interval, 1.15-1.46; P<0.001). The higher risk of men relative to women for TLR was consistent regardless of age (<75 years and ≥ 75 years). Men in comparison with women were also associated with significantly higher adjusted risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR. TLR and stent thrombosis continued to occur without attenuation up to 10 years after bare-metal stent implantation. Men in comparison with women were associated with higher adjusted 10-year risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR. © 2015 American Heart Association, Inc.

  17. Desfechos clínicos por região geográfica em pacientes com implante de stent eluidor de Zotarolimus Desenlaces clínicos por región geográfica en pacientes con implante de Stent liberador de Zotarolimus Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent

    Directory of Open Access Journals (Sweden)

    Chaim Lotan

    2011-05-01

    Full Text Available FUNDAMENTO: Diferenças entre regiões geográficas em relação à características de pacientes e desfechos, particularmente em síndromes coronarianas agudas, tem sido demonstradas em testes clínicos. Os desfechos clínicos após intervenções coronarianas percutâneas com o stent eluidor de Zotarolimus em uma população real foram analisados com o tempo. OBJETIVO: A influência da localização geográfica sobre os desfechos clínicos com o stent eluidor de Zotarolimus foi avaliada em três regiões: Pacífico Asiático, Europa e América Latina. MÉTODOS: Um total de 8.314 pacientes (6.572 da Europa, 1.522 do Pacífico Asiático e 220 da América Latina foram acompanhados por 1 ano; 2.116 desses (1.613, 316, e 187, respectivamente foram acompanhados por 2 anos. Características dos pacientes e lesões, terapia antiplaquetária dupla e desfechos clínicos foram comparados entre a América Latina e as outras duas regiões. RESULTADOS: Os pacientes da América Latina apresentavam a maior proporção de fatores de risco e infarto do miocárdio prévio. O uso da terapia antiplaquetária dupla declinou rapidamente na América Latina, de 44,9% em 6 meses para 22,5% em 1 ano e 7,8% em 2 anos (Europa: 87,4%, 61,5%, 19,7%; Pacífico Asiático: 82,4%, 67,0%, 45,7%, respectivamente. Não houve diferenças significantes entre a América Latina e a Europa ou Pacífico Asiático para qualquer desfecho em qualquer ponto do tempo. A incidência de trombose de stent provável e definitiva pelo Academic Research Consortium foi baixa (FUNDAMENTO: Las diferencias entre las regiones geográficas en relación con las características de pacientes y desenlaces, sobre todo en los síndromes coronarios agudos se ha demostrado en ensayos clínicos. Los desenlaces clínicos después de las intervenciones coronarias percutáneas con stent liberador de zotarolimus en una población real se analizaron a través del tiempo. Objetivos: La influencia de la ubicaci

  18. First-Generation Versus Second-Generation Drug-Eluting Stents in Coronary Chronic Total Occlusions: Two-Year Results of a Multicenter Registry.

    Directory of Open Access Journals (Sweden)

    Jong-Hwa Ahn

    Full Text Available Limited data are available regarding the long-term clinical outcomes of second-generation drug-eluting stents (DES versus first-generation DES in patients with coronary chronic total occlusion (CTO who undergo percutaneous coronary intervention (PCI. The aim of this study was to compare the clinical outcomes of second-generation DES with those of first-generation DES for the treatment of CTO.Between March 2003 and February 2012, 1,006 consecutive patients with CTO who underwent successful PCI using either first-generation DES (n = 557 or second-generation DES (n = 449 were enrolled in a multicenter, observational registry. Propensity-score matching was also performed. The primary outcome was cardiac death over a 2-year follow-up period. No significant differences were observed between the two groups regarding the incidence of cardiac death (first-generation DES versus second-generation DES; 2.5% vs 2.0%; hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.37 to 1.98; p = 0.72 or major adverse cardiac events (MACE, 11.8% vs 11.4%; HR: 1.00; 95% CI: 0.67 to 1.50; p = 0.99. After propensity score matching, the incidences of cardiac death (HR: 0.86; 95% CI: 0.35 to 2.06; p = 0.86 and MACE (HR: 0.93; 95% CI: 0.63 to 1.37; p = 0.71 were still similar in both groups. Furthermore, no significant differences were observed between sirolimus-eluting, paclitaxel-eluting, zotarolimus-eluting, and everolimus-eluting stents regarding the incidence of cardiac death or MACE.This study shows that the efficacy of second-generation DES is comparable to that of first-generation DES for treatment of CTO over 2 years of follow-up.

  19. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents.

    Science.gov (United States)

    Sen, Hanim; Tandjung, Kenneth; Basalus, Mounir W Z; Löwik, Marije M; van Houwelingen, Gert K; Stoel, Martin G; Louwerenburg, Hans W; de Man, Frits H A F; Linssen, Gerard C M; Nijhuis, Rogier; Nienhuis, Mark B; Verhorst, Patrick M J; van der Palen, Job; von Birgelen, Clemens

    2012-10-01

    The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome. Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99). Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

  20. Evaluation of safety and efficacy of NexGen – an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population – the Polish NexGen Registry

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    Krzysztof Milewski

    2016-08-01

    Full Text Available Introduction : Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents. Aim: The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population. Material and methods : A prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population. The primary endpoint was occurrence of target vessel revascularization (TVR at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8% and ST elevation myocardial infarction (34.99%. Results : At 6-month follow-up 47 (12.7% patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23, 18.5% (n = 69 and 25.21% (n = 92 respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%. Conclusions : Our study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss.

  1. Evaluation of safety and efficacy of NexGen – an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population – the Polish NexGen Registry

    Science.gov (United States)

    Milewski, Krzysztof; Gąsior, Paweł; Samborski, Stefan; Buszman, Piotr P.; Błachut, Aleksandra; Młodziankowski, Adam; Mendyk, Artur; Król, Marek; Wojakowski, Wojciech; Buszman, Paweł E.

    2016-01-01

    Introduction Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents. Aim The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population. Material and methods A prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI) with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population). The primary endpoint was occurrence of target vessel revascularization (TVR) at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8%) and ST elevation myocardial infarction (34.99%). Results At 6-month follow-up 47 (12.7%) patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23), 18.5% (n = 69) and 25.21% (n = 92) respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%. Conclusions Our study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss. PMID:27625684

  2. Evaluation of safety and efficacy of NexGen - an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population - the Polish NexGen Registry.

    Science.gov (United States)

    Milewski, Krzysztof; Gąsior, Paweł; Samborski, Stefan; Buszman, Piotr P; Błachut, Aleksandra; Wojtaszczyk, Adam; Młodziankowski, Adam; Mendyk, Artur; Król, Marek; Wojakowski, Wojciech; Buszman, Paweł E

    2016-01-01

    Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents. The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population. A prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI) with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population). The primary endpoint was occurrence of target vessel revascularization (TVR) at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8%) and ST elevation myocardial infarction (34.99%). At 6-month follow-up 47 (12.7%) patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23), 18.5% (n = 69) and 25.21% (n = 92) respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%. Our study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss.

  3. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

    Science.gov (United States)

    Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

    2015-01-06

    Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

  4. Mesenchymal stem cell seeding promotes reendothelialization of the endovascular stent.

    Science.gov (United States)

    Wu, Xue; Wang, Guixue; Tang, Chaojun; Zhang, Dechuan; Li, Zhenggong; Du, Dingyuan; Zhang, Zhengcai

    2011-09-01

    This study is designed to make a novel cell seeding stent and to evaluate reendothelialization and anti-restenosis after the stent implantation. In comparison with cell seeding stents utilized in previous studies, Mesenchymal stem cells (MSCs) have advantages on promoting of issue repair. Thus it was employed to improve the reendothelialization effects of endovascular stent in present work. MSCs were isolated by density gradient centrifugation and determined as CD29(+) CD44(+) CD34(-) cells by immunofluorescence and immunocytochemistry; gluten and polylysine coated stents were prepared by ultrasonic atomization spray, and MSCs seeded stents were made through rotation culture according to the optimized conditions that were determined in previous studies. The results from animal experiments, in which male New Zealand white rabbits were used, show that the reendothelialization of MSCs coated stents can be completed within one month; in comparison with 316L stainless steel stents (316L SS stents) and gluten and polylysine coated stents, the intimal hyperplasia and in-stent restenosis are significantly inhibited by MSCs coated stents. Endovascular stent seeded with MSCs promotes reendothelialization and inhibits the intimal hyperplasia and in-stent restenosis compared with the 316L SS stents and the gluten and polylysine coated stents. Copyright © 2011 Wiley Periodicals, Inc.

  5. A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial".

    Science.gov (United States)

    Kedhi, Elvin; Fabris, Enrico; van der Ent, Martin; Kennedy, Mark W; Buszman, Pawel; von Birgelen, Clemens; Cook, Stéphane; Wedel, Hans; Zijlstra, Felix

    2017-06-01

    The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Kaltoft, Anne

    2007-01-01

    OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002...

  7. Analysis of 12 Months Clinical Outcomes Associated with Implantation of Ultrathin (60 μm) Bare Metal Stent in an Unselected Real-world Population with Coronary Artery Disease

    Science.gov (United States)

    Hosad, Uday Kumar; Reddy, Y V Subba; Eruvaram, Srikanth; Srinivas, Ravi; Garg, Rajeev; Lobo, Limmy Loret

    2017-01-01

    Introduction In the era of drug-eluting stents, Bare Metal Stent (BMS) has worked its way up to be recognized in several indications. Moreover, literature suggests that strut thickness has been directly related to the restenosis rate. Aim We intended to evaluate the clinical performance of the ultrathin (60 μm) Flexinnium stent (Sahajanand Medical Technologies Pvt. Ltd. Surat, India) for treatment of a wide range of patients with coronary artery disease in routine clinical practice. Materials and Methods This was an observational, non-randomized, retrospective, single-arm study carried out in real-world patients at three clinical centres of India. A total of 419 consecutive patients’ data was collected for the study, who underwent treatment for coronary lesions by implantation of Flexinnium stent, between April 2013 and December 2014. The primary endpoint of the study was Major Adverse Cardiac Events (MACE), a conglomerate of cardiac death, Myocardial Infarction (MI) (Q-wave and non-Q-wave), Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR). Any incidence of Stent Thrombosis (ST) was also observed as safety endpoint. These endpoints were observed during in-hospital stay, at 30 days, six months and at 12 months follow up. All data were analysed using the Statistical Package for Social Sciences (SPSS; Chicago, IL, USA) program, version 15. Results A total of 491 lesions were treated in 419 patients having mean age of 54.1 years. A total of 525 Flexinnium stents were implanted. There were 243 (58.0%) patients with hypertension. At 12 months the total incidences of MACE were 14 (3.5%). These included 9 (2.3%) cardiac deaths, 1 (0.3%) MI, 3 (0.8%) TLRs and 1 (0.3%) TVR. There was one incidence of definite ST at 12 months follow up. Conclusion Our results demonstrate that the Flexinnium stent is associated with a low 12 months incidence of MACE in a wide range of real-world population. Long-term follow up would further confirm its

  8. Stent development and local drug delivery

    NARCIS (Netherlands)

    E.S. Regar (Eveline); G. Sianos (Georgios); P.W.J.C. Serruys (Patrick)

    2001-01-01

    textabstractStent implantation has become the new standard angioplasty procedure. Instent re-stenosis remains the major limitation of coronary stenting. Re-stenosis is related to patient-, lesion- and procedure-specific factors. Patient-specific factors can not be influenced to any extent.

  9. Implante de stents en ramas de arterias pulmonares en cardiopatías congénitas: experiencia multicéntrica de 10 años

    Directory of Open Access Journals (Sweden)

    Alejandro Peirone

    2016-01-01

    Full Text Available Introducción: La angioplastia con implante de stent se considera el tratamiento de elección para la mayoría de los casos de estenosis congénita o adquirida posquirúrgica de ramas de arterias pulmonares en pacientes portadores de cardiopatías congénitas. Sin embargo, aún persisten dudas sobre la efectividad clínica y la incidencia de complicaciones de esta técnica que necesitan ser esclarecidas. Material y métodos: Estudio multicéntrico descriptivo, retrospectivo, observacional. Los procedimientos se realizaron desde enero de 2005 hasta abril de 2015. Un total 25 pacientes fueron sometidos a angioplastia con implante de stent en ramas de arterias pulmonares, los cuales fueron seguidos evolutivamente en su estado clínico y por diferentes métodos de imágenes. Se definió buena efectividad clínica al mejoramiento clínico sintomático y/o anatómico persistente del paciente intervenido. Resultados: La cohorte de 25 pacientes tenía una edad promedio de 9,48 años (2 meses-34 años, un peso promedio de 27,54 kg (3-104 y el 44% era de sexo femenino. Las cardiopatías congénitas de base intervenidas fueron en su mayoría tetralogía de Fallot y sus variantes, seguida por corazones con fisiología univentricular poscirugías de Glenn bidireccional y/o de FontanKreutzer. La presión sistólica del ventrículo derecho y de la arteria pulmonar disminuyeron significativamente posintervención (de 68,35 mm Hg a 45,8 mm Hg y de 47,4 mm Hg a 32,08 mm Hg, respectivamente (p < 0,0001. El diámetro mínimo de la lesión a tratar se incrementó significativamente posprocedimiento (de 3,98 mm a 9,82 mm; p < 0,0001. La incidencia de complicaciones fue del 8% (2 pacientes y se registró buena efectividad clínica en 22 pacientes (88%. Conclusiones: La angioplastia con colocación de stent en las ramas de arterias pulmonares resultó una técnica segura y eficaz, aunque desafiante, con una marcada mejoría clínica y anatómica de las lesiones

  10. Clinical observation of 6-month versus 12-month oral dual-antiplatelet therapy on patients after implantation of biodegradable polymer-coated and drug-eluted long coronary stents -- insight from the I-LOVE-IT 2 trial

    Directory of Open Access Journals (Sweden)

    Jing QI

    2017-06-01

    Full Text Available Objective To investigate the efficacy and safety of 6-month and 12-month oral dual-antiplatelet therapy (DAPT on patients implanted with biodegradable polymer-coated and drug-eluted long stents (BP-DES. Methods In the I-LOVE-IT 2 trial, 574 patients implanted with biodegradable polymer-coated and sirolimus-eluted long stent (BP-SES (total stent length ≥50mm were randomized to accepting either 6-month (n=270 or 12-month (n=304 DAPT. The primary endpoint of present study was 12-month target lesion failure (TLF, including cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization (CI-TLR. The major secondary endpoint was 12-month net adverse clinical events (NACE, including all-causes of death, myocardial infarction, stroke, all revascularization (CI-TLR plus clinically indicated non-target lesion revascularization and bleeding. Results For the patients implanted with BP-SES of total stent length≥50mm, the total stent length was 73.0±22.5mm and 69.8±19.4mm in the 6-month DAPT group and 12-month group, respectively (P=0.07. No significant difference existed in the incidence of 12-month TLF between 6-month DAPT group and 12-month DAPT group (11.1% vs. 9.2%, P=0.47. The incidence of NACE was similar between the 2 groups (21.9% vs. 19.7%, P=0.57. The incidence of revascularization was lower in 12-month DAPT group (5.6% than in 6-month DAPT group (11.1%, P=0.01. Furthermore, 6-month landmark analysis showed that 12-month DAPT was associated with significantly lower risk of TLF (2.6% vs. 6.3%, P=0.03 at a cost of slightly increased risk of all bleeding events (1.6% vs. 0.7%, Log-rank P=0.32 between 6 and 12-months compared to 6-month DAPT. Conclusions In patients treated with BP-SES of total stent length ≥50mm, 12-month DAPT have similar impacts on 12-month clinical outcomes except for all revascularization. However, 12 months DAPT decreased the incidence of TLF and total revascularization between

  11. An assessment on modified AZ80 alloys for prospect biodegradable CV stent applications

    NARCIS (Netherlands)

    Erinc, M.; Sillekens, W.H.

    2009-01-01

    In medicine, stents are inserted into an artery to prevent local constrictions to blood flow. Commonly used stents are permanent metal stents, yet developments in this area are more and more heading towards biodegradable stents. Implants made of materials that can dissolve in the patient's body by

  12. Determining the Cross-Talk between Smooth Muscle Cells and Macrophages on a Cobalt-Chromium Stent Material Surface using an In Vitro Post-Implantation Co-Culture Model.

    Science.gov (United States)

    Anderson, Jordan A; Lamichhane, Sujan; Vierhout, Thomas; Engebretson, Daniel

    2017-10-19

    Smooth muscle cells (SMCs) and macrophages are important cellular components involved in the development of complications following the implantation of cardiovascular devices. This leads to various disorders such as restenosis, chronic inflammation, and may ultimately result in device failure. In this study, we developed a post-implant stent co-culture model using different ratios of SMCs and macrophages seeded on to cobalt-chromium alloy. The macrophages had an increased affinity to the co-culture surfaces, which resulted in decreased SMC attachment to the alloy surfaces at the initial time point. Once adhered, the macrophages spread freely and displayed advanced stages of inflammation at 48 h when co-cultured with SMCs. This resulted in an increased secretion of pro-inflammatory cytokines (TNF-α, MCP-1, IL-6, and IL-8) by 48 h in the co-culture samples with the greatest increase observed with the high number of macrophages. Therefore, the increased levels of pro-inflammatory cytokines promoted the growth of SMCs in co-culture to a greater extent than when the SMCs were culture alone. Thus, this study demonstrated the constant cross-talk between SMCs and macrophages occurring on the post-implant stent surface. Similar co-culture models can be used to test the biocompatibility of drugs and biomaterials at possible post-implantation scenarios. This article is protected by copyright. All rights reserved. © 2017 Wiley Periodicals, Inc.

  13. Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation

    Science.gov (United States)

    Villablanca, Pedro A.; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schüpke, Stefanie; Briceno, David F.; Bortnick, Anna E.; Garcia, Mario J.; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish

    2016-01-01

    Abstract Background: The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement. Methods: We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel–Haenszel method. Fixed-effect models were used; if heterogeneity (I2) > 40 was identified, effects were obtained with random models. Results: Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69–1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66–1.21), non-CV mortality (OR 0.85; 95% 0.58–1.24), myocardial infarction (OR 1.10; 95% CI: 0.89–1.37), stroke (OR 0.97; 95% CI: 0.67–1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89–2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77–1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49–1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59–0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT. Conclusion: DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES. PMID:28033306

  14. Expressão gênica de adiponectina no tecido adiposo epicárdico após intervenção coronária percutânea com implante de stent metálico Adiponectin expression in epicardial adipose tissue after percutaneous coronary intervention with bare-metal stent

    Directory of Open Access Journals (Sweden)

    Roberta França Spener

    2011-09-01

    Full Text Available INTRODUÇÃO: A visão clássica de tecido adiposo como um reservatório passivo para o armazenamento de energia não é mais válido. Na última década, o tecido adiposo tem demonstrado funções endócrinas, sendo o peptídeo mais abundante secretado pelos adipócitos a adiponectina. O tecido adiposo epicárdico (TAE é distribuído em torno das artérias coronárias e, a lesão endovascular causada pela presença de stent metálico intracoronário, poderia promover alterações inflamatórias na gordura periadventicial, contribuindo para reestenose. OBJETIVO: Determinar a expressão gênica de mediadores inflamatórios no tecido adiposo epicárdico após implante de stent metálico com reestenose que haviam sido encaminhados para tratamento cirúrgico. MÉTODOS: Amostras pareadas de TAE foram colhidas no momento da cirurgia de revascularização miocárdica (CRM em 11 pacientes (n = 22, uma amostra foi obtida do tecido em torno da area com stent e outra amostra em torno da artéria coronária sem stent. Expressão local de adiponectina foi determinada por reação em cadeia de polymerase em tempo real utilizando Taq DNA polimerase. RESULTADOS: Em duas amostras, não houve expressão do gene da adiponectina. Fomos capazes de identificar adiponectina em 20 amostras, no entanto, o padrão de expressão gênica foi heterogêneo. Não percebemos especificidade quando comparamos TAE obtido próximo à área de stent ou distante da área de stent. CONCLUSÃO: Não houve correlação entre a expressão do gene de adiponectina e a presença de stent intracoronárioBACKGROUND: The classical view of adipose tissue as a passive reservoir for energy storage is no longer valid. In the past decade, adipose tissue has been shown to have endocrine functions and the most abundant peptide secreted by adipocytes is adiponectin. Pericardial adipose tissue (PAT is distributed around coronary arteries and endovascular injury, caused by the presence of

  15. A 2D Panoramic Surgical Stent Imaging: Complete Arch Mandibular Implant Fixed Prosthesis along with Bar Supported Maxillary over Denture

    OpenAIRE

    Mukesh Kumar Singhal; Rumneet Kaur Billing; Nitin Srivastava; Zainab Khan

    2017-01-01

    Successful rehabilitation of a patient should restore function, esthetic, and speech by prosthesis. Treatment modalities vary from patient to patient. Semi-precision attachments and implants offer several advantages over the traditional approach. The aim and objective of this report was to assess a case of a 55-year-old female patient who had lost all her teeth, except maxillary canines #13 and #23 and with severe bone loss in the mandible. Tooth-supported bar attachment was planned for maxil...

  16. Influence of initial acute myocardial infarction presentation on the outcome of surgical procedures after coronary stent implantation: a report from the CREDO-Kyoto PCI/CABG Registry Cohort-2.

    Science.gov (United States)

    Tokushige, Akihiro; Shiomi, Hiroki; Morimoto, Takeshi; Ono, Koh; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Iwabuchi, Masashi; Shizuta, Satoshi; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Hamasaki, Shuichi; Tei, Chuwa; Nakashima, Hitoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2013-01-01

    Several previous publications have consistently reported that surgical procedures performed early after coronary stenting were associated with significantly higher risk for ischemic events than those performed late. In the current post hoc analysis of the Coronary REvascularization Demonstrating Outcome Study in Kyoto PCI/coronary artery bypass grafting Registry Cohort-2, we compared the outcomes of early (within 42 days) versus late surgery (beyond 42 days) after coronary stenting stratified by the initial clinical presentations [acute myocardial infarction (AMI) [early N = 153, and late N = 586] and non-AMI (early N = 202, and late N = 1457)]. Cumulative incidence of death/myocardial infarction/stent thrombosis at 30 days after surgery was significantly higher in the early group than in the late group in the AMI stratum [18.4 vs. 2.6 %, P presentation and the timing of surgery (P interaction = 0.03). Deaths in patients with early surgery in the AMI stratum were mostly related to preoperative complications of AMI (76 %), but not related to perioperative stent-related complications (4.0 %). In conclusion, significantly higher risk of early versus late surgery for perioperative ischemic events was seen only in patients with initial AMI presentation, but not in patients with non-AMI presentation. Previous observations suggesting higher risk in early surgery might not be related to the timing after stent implantation per se, but related to more morbid preoperative conditions in patients who underwent early surgery.

  17. Intravascular ultrasound assessment of expansion of the sirolimus-eluting (cypher select) and Paclitaxel-eluting (taxus express-2) stent in patients with diabetes mellitus

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Mintz, Gary S

    2008-01-01

    Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of...

  18. Intravascular ultrasound assessment of expansion of the sirolimus-eluting (Cypher Select) and paclitaxel-eluting (Taxus Express-2) stent in patients with diabetes mellitus

    DEFF Research Database (Denmark)

    Jensen, L.O.; Maeng, M.; Mintz, G.S.

    2008-01-01

    Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of...

  19. Real-world safety and effectiveness outcomes of a zotarolimus-eluting stent: final 3-year report of the RESOLUTE International study.

    Science.gov (United States)

    Belardi, Jorge A; Widimský, Petr; Neumann, Franz-Josef; Mauri, Laura; Albertal, Mariano

    2013-10-01

    We evaluated the safety and effectiveness of the Resolute™ zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years. A randomized comparison of the R-ZES and the XIENCE V™ everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice. RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end-point was the composite of cardiac death and target vessel myocardial infarction (TV-MI) at 1 year. Secondary end-points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST). At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV-MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively. The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials. © 2013 The Authors. Journal of Interventional Cardiology Published by Wiley Periodicals, Inc.

  20. Incidence and outcome of surgical procedures after coronary bare-metal and drug-eluting stent implantation: a report from the CREDO-Kyoto PCI/CABG registry cohort-2.

    Science.gov (United States)

    Tokushige, Akihiro; Shiomi, Hiroki; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Iwabuchi, Masashi; Shizuta, Satoshi; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Ehara, Natsuhiko; Inada, Tsukasa; Kaburagi, Satoshi; Hamasaki, Shuichi; Tei, Chuwa; Nakashima, Hitoshi; Ogawa, Hisao; Tatami, Ryozo; Suwa, Satoru; Takizawa, Akinori; Nohara, Ryuji; Fujiwara, Hisayoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2012-04-01

    There still remain safety concerns on surgical procedures after coronary drug-eluting stents (DES) implantation, and optimal management of perioperative antiplatelet therapy (APT) has not been yet established. During 3-year follow-up of 12 207 patients (DES=6802 patients and bare-metal stent [BMS] only=5405 patients) who underwent coronary stent implantation in the CREDO-Kyoto registry cohort-2, surgical procedures were performed in 2398 patients (DES=1295 patients and BMS=1103 patients). Surgical procedures (early surgery in particular) were more frequently performed in the BMS group than in the DES group (4.4% versus 1.9% at 42-day and 23% versus 21% at 3-year, log-rank P=0.0007). Cumulative incidences of death/myocardial infarction (MI)/stent thrombosis (ST) and bleeding at 30 days after surgery were low, without differences between BMS and DES (3.5% versus 2.9%, P=0.4 and 3.2% versus 2.1%, P=0.2, respectively). The adjusted risks of DES use relative to BMS use for death/MI/ST and bleeding were not significant (hazard ratio: 1.63, 95% confidence interval: 0.93 to 2.87, P=0.09 and hazard ratio: 0.6, 95% confidence interval: 0.34 to 1.06, P=0.08, respectively). The risks of perioperative single- and no-APT relative to dual-APT for both death/MI/ST and bleeding were not significant; single-APT as compared with dual-APT tended to be associated with lower risk for death/MI/ST (hazard ratio: 0.4, 95% confidence interval: 0.13 to 1.01, P=0.053). Surgical procedures were commonly performed after coronary stent implantation, and the risk of ischemic and bleeding complications in surgical procedures was low. In patients selected to receive DES or BMS, there were no differences in outcomes. Perioperative administration of dual-APT was not associated with lower risk for ischemic events.

  1. Imaging of pediatric great vessel stents: Computed tomography or magnetic resonance imaging?

    NARCIS (Netherlands)

    A.M. den Harder (Annemarie); D. Suchá (Dominika); R.W. van Hamersvelt (Robbert W.); R.P.J. Budde (Ricardo); P.A. de Jong (Pim); A. Schilham (Arnold); C. Bos (Clemens); J.M.P.J. Breur (Johannes M.P.J.); I. Leiner (Tim)

    2017-01-01

    markdownabstract__Background:__ Complications might occur after great vessel stent implantation in children. Therefore follow- up using imaging is warranted. __Purpose:__ To determine the optimal imaging modality for the assessment of stents used to treat great vessel obstructions in children.

  2. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography

    DEFF Research Database (Denmark)

    Taniwaki, Masanori; Radu, Maria D; Zaugg, Serge

    2016-01-01

    BACKGROUND: The pathomechanisms underlying very late stent thrombosis (VLST) after implantation of drug-eluting stents (DES) are incompletely understood. Using optical coherence tomography, we investigated potential causes of this adverse event. METHODS AND RESULTS: Between August 2010 and Decemb...

  3. Development and Assessment of a 3D-Printed Scaffold with rhBMP-2 for an Implant Surgical Guide Stent and Bone Graft Material: A Pilot Animal Study

    Directory of Open Access Journals (Sweden)

    Ji Cheol Bae

    2017-12-01

    Full Text Available In this study, a new concept of a 3D-printed scaffold was introduced for the accurate placement of an implant and the application of a recombinant human bone morphogenetic protein-2 (rhBMP-2-loaded bone graft. This preliminary study was conducted using two adult beagles to evaluate the 3D-printed polycaprolactone (PCL/β-tricalcium phosphate (β-TCP/bone decellularized extracellular matrix (bdECM scaffold conjugated with rhBMP-2 for the simultaneous use as an implant surgical guide stent and bone graft material that promotes new bone growth. Teeth were extracted from the mandible of the beagle model and scanned by computed tomography (CT to fabricate a customized scaffold that would fit the bone defect. After positioning the implant guide scaffold, the implant was placed and rhBMP-2 was injected into the scaffold of the experimental group. The two beagles were sacrificed after three months. The specimen block was obtained and scanned by micro-CT. Histological analysis showed that the control and experimental groups had similar new bone volume (NBV, % but the experimental group with BMP exhibited a significantly higher bone-to-implant contact ratio (BIC, %. Within the limitations of this preliminary study, a 3D-printed scaffold conjugated with rhBMP-2 can be used simultaneously as an implant surgical guide and a bone graft in a large bone defect site. Further large-scale studies will be needed to confirm these results.

  4. Polymeric Biodegradable Stent Insertion in the Esophagus

    Directory of Open Access Journals (Sweden)

    Kai Yang

    2016-04-01

    Full Text Available Esophageal stent insertion has been used as a well-accepted and effective alternative to manage and improve the quality of life for patients diagnosed with esophageal diseases and disorders. Current stents are either permanent or temporary and are fabricated from either metal or plastic. The partially covered self-expanding metal stent (SEMS has a firm anchoring effect and prevent stent migration, however, the hyperplastic tissue reaction cause stent restenosis and make it difficult to remove. A fully covered SEMS and self-expanding plastic stent (SEPS reduced reactive hyperplasia but has a high migration rate. The main advantage that polymeric biodegradable stents (BDSs have over metal or plastic stents is that removal is not require and reduce the need for repeated stent insertion. But the slightly lower radial force of BDS may be its main shortcoming and a post-implant problem. Thus, strengthening support of BDS is a content of the research in the future. BDSs are often temporarily effective in esophageal stricture to relieve dysphagia. In the future, it can be expect that biodegradable drug-eluting stents (DES will be available to treat benign esophageal stricture, perforations or leaks with additional use as palliative modalities for treating malignant esophageal stricture, as the bridge to surgery or to maintain luminal patency during neoadjuvant chemoradiation.

  5. Antiplatelet Efficacy of Fixed-Dose Aspirin-Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation.

    Science.gov (United States)

    Lim, Sungmin; Kim, Pum Joon; Baek, Chunyeong; Kim, Tae-Hoon; Koh, Yoon Seok; Park, Hun-Jun; Kim, Hee-Yeol; Chang, Kiyuk; Chung, Wook Sung; Seung, Ki-Bae

    2015-12-01

    A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC. This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks. Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference -1.7; 95 % confidence interval (CI) -6.9 to 4.5, p aspirin reaction units (ARU) (mean difference -2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68). In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment.

  6. Wall shear stress distributions on stented patent ductus arteriosus

    Science.gov (United States)

    Kori, Mohamad Ikhwan; Jamalruhanordin, Fara Lyana; Taib, Ishkrizat; Mohammed, Akmal Nizam; Abdullah, Mohammad Kamil; Ariffin, Ahmad Mubarak Tajul; Osman, Kahar

    2017-04-01

    A formation of thrombosis due to hemodynamic conditions after the implantation of stent in patent ductus arteriosus (PDA) will derived the development of re-stenosis. The phenomenon of thrombosis formation is significantly related to the distribution of wall shear stress (WSS) on the arterial wall. Thus, the aims of this study is to investigate the distribution of WSS on the arterial wall after the insertion of stent. Three dimensional model of patent ductus arteriosus inserted with different types of commercial stent are modelled. Computational modelling is used to calculate the distributions of WSS on the arterial stented PDA. The hemodynamic parameters such as high WSS and WSSlow are considered in this study. The result shows that the stented PDA with Type III stent has better hemodynamic performance as compared to others stent. This model has the lowest distributions of WSSlow and also the WSS value more than 20 dyne/cm2. From the observed, the stented PDA with stent Type II showed the highest distributions area of WSS more than 20 dyne/cm2. This situation revealed that the high possibility of atherosclerosis to be developed. However, the highest distribution of WSSlow for stented PDA with stent Type II indicated that high possibility of thrombosis to be formed. In conclusion, the stented PDA model calculated with the lowest distributions of WSSlow and WSS value more than 20dyne/cm2 are considered to be performed well in stent hemodynamic performance as compared to other stents.

  7. Coronary artery stent (image)

    Science.gov (United States)

    ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ...

  8. Concomitant use of clopidogrel and proton pump inhibitors is not associated with major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, M; Johansen, M B; Robertson, D J

    2012-01-01

    Aliment Pharmacol Ther 2012; 35: 165-174 SUMMARY: Background  Cytochrome P450 inhibition by proton pump inhibitors (PPIs) may attenuate the effectiveness of clopidogrel. Aim  To examine whether PPI use modifies the association between clopidogrel use and major adverse cardiovascular events (MACE.......97-1.58) for clopidogrel users and 1.26 (95% CI: 0.97-1.63) for clopidogrel non-users]. Conclusions  The use of PPIs as a class did not modify the protective effect of clopidogrel, but its use was associated with major adverse cardiovascular events itself, particularly among patients having used PPIs before percutaneous...... implantation between 2002 and 2005 and ascertained their reported comorbidities. During the recommended 12-month postintervention treatment period, we tracked use of clopidogrel and PPI and the rate of MACE. We used Cox regression to compute hazard ratios (HRs), controlling for potential confounders. Results...

  9. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    OpenAIRE

    Usha Kiran; Neeti Makhija

    2009-01-01

    Summary Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implantation and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should ...

  10. Magnetizable stent-grafts enable endothelial cell capture

    Energy Technology Data Exchange (ETDEWEB)

    Tefft, Brandon J. [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States); Uthamaraj, Susheil [Division of Engineering, Mayo Clinic, Rochester, MN (United States); Harburn, J. Jonathan [School of Medicine, Pharmacy and Health, Durham University, Stockton-on-Tees (United Kingdom); Hlinomaz, Ota [Department of Cardioangiology, St. Anne' s University Hospital, Brno (Czech Republic); Lerman, Amir [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States); Dragomir-Daescu, Dan [Department of Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN (United States); Sandhu, Gurpreet S., E-mail: sandhu.gurpreet@mayo.edu [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States)

    2017-04-01

    Emerging nanotechnologies have enabled the use of magnetic forces to guide the movement of magnetically-labeled cells, drugs, and other therapeutic agents. Endothelial cells labeled with superparamagnetic iron oxide nanoparticles (SPION) have previously been captured on the surface of magnetizable 2205 duplex stainless steel stents in a porcine coronary implantation model. Recently, we have coated these stents with electrospun polyurethane nanofibers to fabricate prototype stent-grafts. Facilitated endothelialization may help improve the healing of arteries treated with stent-grafts, reduce the risk of thrombosis and restenosis, and enable small-caliber applications. When placed in a SPION-labeled endothelial cell suspension in the presence of an external magnetic field, magnetized stent-grafts successfully captured cells to the surface regions adjacent to the stent struts. Implantation within the coronary circulation of pigs (n=13) followed immediately by SPION-labeled autologous endothelial cell delivery resulted in widely patent devices with a thin, uniform neointima and no signs of thrombosis or inflammation at 7 days. Furthermore, the magnetized stent-grafts successfully captured and retained SPION-labeled endothelial cells to select regions adjacent to stent struts and between stent struts, whereas the non-magnetized control stent-grafts did not. Early results with these prototype devices are encouraging and further refinements will be necessary in order to achieve more uniform cell capture and complete endothelialization. Once optimized, this approach may lead to more rapid and complete healing of vascular stent-grafts with a concomitant improvement in long-term device performance. - Highlights: • Magnetic stent-grafts were made from 2205 steel stents and polyurethane nanofibers. • Stent-grafts remained patent and formed a thin and uniform neointima when implanted. • Stent-grafts captured endothelial cells labeled with magnetic nanoparticles.

  11. Estudo da resposta tissular à endoprótese recoberta de jugular bovina em veia cava inferior de suínos Bovine jugular covered stent-graft implanted in swine inferior vena cava - a study of tissue response

    Directory of Open Access Journals (Sweden)

    Cristina Ribeiro Riguetti Pinto

    2006-06-01

    Full Text Available OBJETIVO: Avaliar a resposta tissular a uma endoprótese, com cobertura biológica heteróloga, implantada em veia cava inferior de suínos. MÉTODO: Desenvolvemos uma endoprótese auto-expansível, revestida com um segmento de jugular bovina, conservada por processo L-hydro e suturada em um stent de aço inoxidável 316L. O dispositivo introdutor utilizado foi a bainha de liberação da endoprótese aórtica Taheri-Leonhardt (Flórida, EUA. Foram implantadas endopróteses em 10 suínos, todas na veia cava infra-renal. Os animais foram submetidos à flebografia peroperatória. À necropsia, após 2 meses, cada endoprótese foi retirada em bloco e analisada macroscopicamente, visando a avaliação da perviedade, aderência aos tecidos vizinhos e incorporação à parede venosa; e, histopatologicamente, visando a resposta histológica ao enxerto. RESULTADOS: Na análise macroscópica, todas as endopróteses encontravam-se pérvias e totalmente incorporadas à parede venosa, porém seis apresentavam trabeculações grosseiras no seu interior e quatro algum grau de fibrose perivascular. Três animais desenvolveram linfocele, uma retroperitoneal e as outras na parede abdominal. No estudo histopatológico, observamos reação inflamatória granulomatosa tipo corpo estranho em todos os casos, sendo predominante na camada média (80%. CONCLUSÃO: O modelo estudado apresentou baixa trombogenicidade, corroborando com a eficácia do meio de conservação e material escolhidos; porém, baixa biocompatibilidade, provavelmente pelo obstáculo imunológico dos xenoenxertos e resposta tissular exagerada do território venoso.OBJECTIVE: To evaluate tissue response to a bovine jugular vein covered stent when implanted in the swine inferior vena cava. METHOD: We developed a self-expanding stent, using a segment of L-hydro conserved bovine jugular vein, which was trimmed and sutured to a 316L stainless steel stent. We used the Taheri-Leonhardt delivery system for

  12. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt-chromium sirolimus-eluting coronary stent system.

    Science.gov (United States)

    Abhyankar, Atul D; Thakkar, Ashok S

    2012-01-01

    Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt-chromium coronary stent system (Supralimus-Core(®)). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. In vivo acute stent recoil of the Supralimus-Core(®) has higher radial strength compared to other available standard drug-eluting stents. Copyright © 2012 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  13. Finite element analyses for design evaluation of biodegradable magnesium alloy stents in arterial vessels

    Energy Technology Data Exchange (ETDEWEB)

    Wu Wei [Laboratory of Biological Structure Mechanics, Structural Engineering Department, Politecnico di Milano, Piazza Leonardo da Vinci, 32, 20133 Milan (Italy); Gastaldi, Dario, E-mail: dario.gastaldi@polimi.it [Laboratory of Biological Structure Mechanics, Structural Engineering Department, Politecnico di Milano, Piazza Leonardo da Vinci, 32, 20133 Milan (Italy); Yang Ke; Tan Lili [Division of Specialized Materials and Devices, Institute of Metal Research, Chinese Academy of Sciences, Shenyang (China); Petrini, Lorenza; Migliavacca, Francesco [Laboratory of Biological Structure Mechanics, Structural Engineering Department, Politecnico di Milano, Piazza Leonardo da Vinci, 32, 20133 Milan (Italy)

    2011-12-15

    Biodegradable magnesium alloy stents (MAS) can provide a great benefit for diseased vessels and avoid the long-term incompatible interactions between vessels and permanent stent platforms. However, the existing MAS showed insufficient scaffolding to the target vessels due to short degradation time. In this study, a three dimensional finite element model combined with a degradable material model of AZ31 (Al 0.03, Zn 0.01, Mn 0.002 and Mg balance, mass percentage) was applied to three different MAS designs including an already implanted stent (Stent A), an optimized design (Stent B) and a patented stent design (Stent C). One ring of each design was implanted through a simulation in a vessel model then degraded with the changing interaction between outer stent surface and the vessel. Results showed that a proper stent design (Stent B) can lead to an increase of nearly 120% in half normalized recoil time of the vessel compared to the Stent A; moreover, the expectation that the MAS design, with more mass and optimized mechanical properties, can increase scaffolding time was verified numerically. The Stent C has more materials than Stent B; however, it only increased the half normalized recoil time of the vessel by nearly 50% compared to the Stent A because of much higher stress concentration than that of Stent B. The 3D model can provide a convenient design and testing tool for novel magnesium alloy stents.

  14. The clinical outcomes of triple antiplatelet therapy versus dual antiplatelet therapy for high-risk patients after coronary stent implantation: a meta-analysis of 11 clinical trials and 9,553 patients

    Directory of Open Access Journals (Sweden)

    Fan ZG

    2016-10-01

    Full Text Available Zhong-Guo Fan,1,* Guo-Bin Ding,2,* Xiao-Bo Li,1,3 Xiao-Fei Gao,1,3 Ya-Li Gao,1 Nai-Liang Tian1,3 1Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, 2Department of Cardiology, Taixing People’s Hospital, Yangzhou University, Taizhou, 3Department of Cardiology, Nanjing Heart Center, Nanjing, People’s Republic of China *These authors contributed equally to this work Background: The optimal antiplatelet regimen after in-coronary intervention among patients presenting with complex coronary artery lesions or acute coronary syndrome (ACS has remained unclear. This study sought to evaluate the clinical outcomes of triple antiplatelet treatment (TAPT (cilostazol added to aspirin plus clopidogrel in these patients.Methods: The PubMed, EMBASE, MEDLINE, and other Internet sources were searched for relevant articles. The primary end point was major adverse cardiac events (MACE, including all-cause mortality, myocardial infarction, and target vessel revascularization. The incidence of definite/probable stent thrombosis and bleeding were analyzed as the safety end points.Results: Eleven clinical trials involving 9,553 patients were analyzed. The risk of MACE was significantly decreased following TAPT after stent implantation in the ACS subgroup (odds ratio [OR]: 0.72; 95% confidence interval [CI]: 0.61–0.85; P<0.001, which might mainly result from the lower risk of all-cause mortality in this subset (OR: 0.62; 95% CI: 0.48–0.80; P<0.001. The risk of bleeding was not increased with respect to TAPT.Conclusion: TAPT after stent implantation was associated with feasible benefits on reducing the risk of MACE, especially on reducing the incidence of all-cause mortality among patients suffering from ACS, without higher incidence of bleeding. Larger and more powerful randomized trials are still warranted to prove the superiority of TAPT for such patients. Keywords: triple antiplatelet treatment, dual antiplatelet treatment

  15. Duration of dual antiplatelet therapy and long-term clinical outcome after coronary drug-eluting stent implantation: landmark analyses from the CREDO-Kyoto PCI/CABG Registry Cohort-2.

    Science.gov (United States)

    Tada, Tomohisa; Natsuaki, Masahiro; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Byrne, Robert A; Kastrati, Adnan; Kadota, Kazushige; Iwabuchi, Masashi; Shizuta, Satoshi; Tazaki, Junichi; Shiomi, Hiroki; Abe, Mitsuru; Ehara, Natsuhiko; Mizoguchi, Tetsu; Mitsuoka, Hirokazu; Inada, Tsukasa; Araki, Makoto; Kaburagi, Satoshi; Taniguchi, Ryoji; Eizawa, Hiroshi; Nakano, Akira; Suwa, Satoru; Takizawa, Akinori; Nohara, Ryuji; Fujiwara, Hisayoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2012-06-01

    Optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has not been yet fully elucidated. We assessed the influence of prolonged thienopyridine therapy on clinical outcomes with landmark analysis at 4 and 13 months after DES implantation. Among 6802 patients with at least 1 DES implantation in the CREDO-Kyoto Registry Cohort-2, 6309 patients (on thienopyridine, 5438 patients; off thienopyridine, 871 patients) and 5901 patients (on thienopyridine, 4098 patients; off thienopyridine, 1803 patients) were eligible for the 4- and 13-month landmark analyses, respectively. The majority of patients had stable coronary artery disease (73%) and received sirolimus-eluting stents (93%), and approximately 90% of thienopyridine was ticlopidine. Patients taking thienopyridine had more complex comorbidities and more complex lesion and procedural characteristics as compared with patients not taking thienopyridine. After adjusting for confounders, thienopyridine use was not associated with decreased risk for death/myocardial infarction/stroke (hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.89-1.43, P=0.32 in the 4-month landmark analysis; HR, 1.14; 95% CI, 0.90-1.45, P=0.29 in the 13-month landmark analysis, respectively), whereas the risk for GUSTO moderate/severe bleeding tended to be higher in patients taking thienopyridine (HR, 1.51; 95% CI, 1.00-2.23, P=0.049 in the 4-month landmark analysis; HR, 1.44; 95% CI, 0.99-2.09, P=0.057 in the 13-month landmark analysis, respectively). Prolonged thienopyridine therapy beyond 4 and 13 months appeared not to be associated with reduction in ischemic events but to be associated with a trend toward increased bleeding. Optimal duration of DAPT after DES implantation might be shorter than the currently recommended 1-year interval.

  16. MR stress perfusion for the detection of flow-limiting stenoses in symptomatic patients with known coronary artery disease and history of stent implantation; MR-Stressperfusion zur Vorhersage flusslimitierender Stenosen bei symptomatischen Patienten mit bekannter KHK nach Stentimplantation

    Energy Technology Data Exchange (ETDEWEB)

    Seeger, A.; Klumpp, B.; Kramer, U.; Fenchel, M.; Claussen, C.D.; Miller, S. [Universitaetsklinikum Tuebingen (Germany). Radiologische Diagnostik; Doesch, C.; Hoevelborn, T.; Gawaz, M.; May, A.E. [Universitaetsklinikum Tuebingen (Germany). Innere Medizin III

    2007-10-15

    Purpose: The aim of the present study was to determine the correlation of myocardial perfusion MR imaging (MPMRI) and coronary angiography for the detection of flow-limiting stenosis in symptomatic patients with known coronary artery disease and a history of intervention. Materials and Methods: MPMRI was performed in 51 symptomatic patients (44 male, 64.7 {+-} 9.5 years) with known coronary artery disease and a history of stent implantation (between 5 years and 2 weeks prior to MRI). Malperfused myocardial regions were correlated with findings of coronary angiography. A stenosis of > 70 % was regarded as hemodynamically significant. Results: In MPMRI 37 patients (73 %) showed a stress induced perfusion deficit. In 35 of these patients coronary angiography revealed a stenosis of > 70 %. A total of 38 patients (75 %) showed stenoses of > 70 %. MPMRI yielded a sensitivity of 92 % with a specificity of 85 %. The positive predictive value was 95 % and negative predictive value was 79 %. The assignment of malperfused segments to coronary artery territories was carried out according to the standardized myocardial model of the American Heart Association (sensitivity/specificity was 59/85 % for RCA, 79/81 % for LAD and 54/68 % for LCX). Conclusion: MPMRI is a suitable non-invasive method for detecting flow-limiting coronary artery stenoses in patients with a history of stent implantation. (orig.)

  17. Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time

    DEFF Research Database (Denmark)

    Brugaletta, Salvatore; Gomez-Lara, Josep; Bruining, Nico

    2012-01-01

    To analyse and to compare the changes in the various optical coherence tomography (OCT), echogenicity and intravascular ultrasound virtual histology (VH) of the everolimus-eluting bioresorbable scaffold (ABSORB) degradation parameters during the first 12 months after ABSORB implantation. In the A......To analyse and to compare the changes in the various optical coherence tomography (OCT), echogenicity and intravascular ultrasound virtual histology (VH) of the everolimus-eluting bioresorbable scaffold (ABSORB) degradation parameters during the first 12 months after ABSORB implantation...

  18. Surgical Templates for Dental Implant Positioning; Current ...

    African Journals Online (AJOL)

    Surgical templates for dental implant. 5. Nigerian Journal of Surgery. Jan‑Jun 2015 | Volume 21 | Issue 1. 18. Tarlow JL. Fabrication of an implant surgical stent for the edentulous mandible. J Prosthet Dent 1992;67:217‑8. 19. Stellino G, Morgano SM, Imbelloni A. A dual‑purpose, implant stent made from a provisional fixed ...

  19. Coronary artery stent mimicking intracardiac thrombus on cardiac magnetic resonance imaging due to signal loss

    DEFF Research Database (Denmark)

    Qayyum, Abbas Ali; Vejlstrup, Niels Grove; Ahtarovski, Kiril Aleksov

    2012-01-01

    Since the introduction of percutaneous coronary intervention for coronary artery disease, thousands of patients have been treated with the implantation of coronary stents. Moreover, several of the patients with coronary stent undergo cardiac magnetic resonance (CMR) imaging every year. This case ...... the signal loss on MRI associated with implanted metallic devices is known, we report a case where an implanted coronary stent in the left circumflex artery led to an intracardiac signal loss mimicking intracardiac thrombus/tumor....

  20. Early and Long-Term Results of Stent Implantation for Aortic Coarctation in Pediatric Patients Compared to Adolescents: A Single Center Experience

    Directory of Open Access Journals (Sweden)

    Sara Bondanza

    2016-01-01

    Full Text Available Background. Stents have become the treatment of choice for native aortic coarctation in adults and adolescents, but in pediatric patients insufficient data are currently available to identify the best therapeutic option. Methods. To compare the outcomes of pediatric and adolescent patients, we retrospectively evaluated early and long-term results of stenting for aortic coarctation in 34 patients divided into 2 groups (A and B composed, respectively, of 17 children (mean age 8.2±2.3, weight ≤30 kg and 17 adolescents (mean age 14.3±1.7, weight >30 kg. Results. No significant differences in outcome were found between groups immediately after the procedure. In all of our patients, peak systolic gradient pressure significantly decreased after stenting from 43.7±12 to 1.7±3.1 mmHg in group A and from 39.4±16.8 to 1.6±3 in group B (p<0.0001. We observed early and late adverse events in both groups: early femoral vessel injury or thrombosis was more frequent in younger patients, as well as restenosis due to vessel growth requiring stent redilatations, often complicated by stent fractures. Data from long-term follow-up showed that, in younger patients, stress-related hypertension was more frequent. Conclusions. The procedure was immediately safe and effective in both groups. Pediatric patients must be accurately selected before stenting because they could probably need reinterventions and stents could impact on their future therapeutic perspectives.

  1. Stenting for curved lesions using a novel curved balloon: Preliminary experimental study.

    Science.gov (United States)

    Tomita, Hideshi; Higaki, Takashi; Kobayashi, Toshiki; Fujii, Takanari; Fujimoto, Kazuto

    2015-08-01

    Stenting may be a compelling approach to dilating curved lesions in congenital heart diseases. However, balloon-expandable stents, which are commonly used for congenital heart diseases, are usually deployed in a straight orientation. In this study, we evaluated the effect of stenting with a novel curved balloon considered to provide better conformability to the curved-angled lesion. In vitro experiments: A Palmaz Genesis(®) stent (Johnson & Johnson, Cordis Co, Bridgewater, NJ, USA) mounted on the Goku(®) curve (Tokai Medical Co. Nagoya, Japan) was dilated in vitro to observe directly the behavior of the stent and balloon assembly during expansion. Animal experiment: A short Express(®) Vascular SD (Boston Scientific Co, Marlborough, MA, USA) stent and a long Express(®) Vascular LD stent (Boston Scientific) mounted on the curved balloon were deployed in the curved vessel of a pig to observe the effect of stenting in vivo. In vitro experiments: Although the stent was dilated in a curved fashion, stent and balloon assembly also rotated conjointly during expansion of its curved portion. In the primary stenting of the short stent, the stent was dilated with rotation of the curved portion. The excised stent conformed to the curved vessel. As the long stent could not be negotiated across the mid-portion with the balloon in expansion when it started curving, the mid-portion of the stent failed to expand fully. Furthermore, the balloon, which became entangled with the stent strut, could not be retrieved even after complete deflation. This novel curved balloon catheter might be used for implantation of the short stent in a curved lesion; however, it should not be used for primary stenting of the long stent. Post-dilation to conform the stent to the angled vessel would be safer than primary stenting irrespective of stent length. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  2. A new stent design with multiple radio-opaque markers for protection of side-branch vessels in bifurcation lesions: HJ stents.

    Science.gov (United States)

    Hong, Myeong-Ki; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2011-01-01

    Loss of side-branch vessels is a serious complication following stent implantation in parent vessels of bifurcation lesions. The purpose of this study was to introduce and test a new stent design for the protection of side-branch vessels in the management of bifurcation lesions. This stent has multiple radio-opaque markers in its central portion, whose presence is useful in avoiding stent-strut placement across the side-branch orifice and in correctly directing the insertion of a second guide wire through the struts into the side branch to minimize jailing of side branches during stent deployment in the parent vessel. In vitro tests of the acrylic resin bifurcation phantom model were performed under fluoroscopic guidance in the catheterization laboratory with 10 stents with multiple radio-opaque markers and 10 stents without. Kissing balloon angioplasty was performed across the side branch after stent implantation in the parent vessel in both groups. Side-branch jailing by the stent (presence of any stent struts crossing the side-branch orifice) was determined visually and compared between the two groups. The jailed side branch with the stent struts was observed in one of 10 new stents and in five of 10 conventional stents without them. The in vitro tests demonstrated the superiority of a new stent design for the reduction of side-branch jailing in bifurcation lesions. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Thin strut chrome-cobalt stent implantation for treatment of de-novo lesions in small coronary vessels: results of the RISICO Italian Registry (Registro Italiano Mini VISION nei piccolo Vasi) utilizing the Mini VISION coronary stent platform.

    Science.gov (United States)

    Brambilla, Nedy; Morici, Nuccia; Bedogni, Francesco; De Benedictis, Mauro; Scrocca, Innocente; Naldi, Monica; Fiscella, Antonio; Prosperi, Franco; Dominici, Mauro; Rebuzzi, Antonio; Colombo, Antonio; Sangiorgi, Giuseppe M

    2009-11-01

    The Registro Italiano Mini VISION nei piccoli Vasi registry is a prospective, multicenter, observational study, aimed at assessing immediate and long-term angiographic and clinical outcomes of a small-vessel cobalt-chrome super alloy-dedicated stent (Multi-Link RX VISION) in de-novo and long lesions. Small artery size is an important determinant of poor outcomes in percutaneous coronary interventions. Patients with ischemic heart disease were included. The primary end point was procedural success. Secondary end points included clinical restenosis (need for target lesion revascularization ), incidence of major adverse cardiac events at 6 months, and cost-effectiveness analysis. Between September 2004 and October 2005, 143 patients (mean age 67 +/- 11 years; 22% diabetes) were enrolled; 6-month follow-up was completed in May 2006. Average lesion length, mean stent length and diameter were 16.8 +/- 7.1, 17.01 +/- 3.9 and 2.41 +/- 0.14 mm, respectively. Procedural success was 96%. At 6-month follow-up, the hierarchical major adverse cardiac event rate was 11.6%, 2.9% deaths, 2.9% myocardial infarction and 5.8% target lesion revascularization. Cost-effectiveness analysis will be reported in a further publication. Small-vessel disease treatment with Mini VISION stents permits an elevated procedural success rate with low incidence of clinical restenosis and major adverse cardiac events at mid-term follow-up. Such results require confirmation by means of a randomized controlled study against drug-eluting stents.

  4. Comparison of thin-strut cobalt-chromium stents and stainless steel stents in a porcine model of neointimal hyperplasia.

    Science.gov (United States)

    Milewski, Krzysztof; Zurakowski, Aleksander; Pajak, Jacek; Pajak-Zielinska, Ewa; Liszka, Lukasz; Buszman, Piotr P; Bis, Jaroslaw; Debinski, Marcin; Buszman, Pawel E

    2010-01-01

    The high radial force and durability of cobalt-chromium alloy enable the construction of low-profile stents with thin struts, which improves their elasticity and may play a key role in reducing the incidence of neointimal hyperplasia as well as allow faster endothelialization. The aim of this study was to compare cobalt-chromium (CoCr) and stainless steel (SS) coronary stents in a pig model of neointimal hyperplasia. Eighteen stents were implanted into the coronary arteries of nine pigs. Control coronarography was performed 28 days after stent implantation. The animals were then sacrificed, their hearts explanted, and the coronary arteries isolated for further histopathological analysis. Quantitative coronary angiography and histomorphometric analysis revealed no statistically significant difference between the two groups of stents. However, there was a trend toward greater late lumen loss (p=0.09) and neointimal area in the CoCr stents (p=0.08). The qualitative histopathology of the CoCr stents revealed findings typical of bare metal stents reviewed in the literature and approved for use in clinical practice. No signs of stent thrombosis, necrosis, or fibrin deposits were observed nor signs of excessive inflammatory reaction. Endothelialization was complete within 28 days. Despite thinner struts, CoCr stents have no advantage over stainless steel stents in terms of neointimal hyperplasia inhibition. However, their positive safety results together with their high radial strength, low profile, and excellent elasticity can ensure their usage, especially in lesions of complex morphology.

  5. Biomimicry, vascular restenosis and coronary stents.

    Science.gov (United States)

    Schwartz, R S; van der Giessen, W J; Holmes, D R

    1998-01-01

    Biomimicry is in its earliest stages and is being considered in the realm of tissue engineering. If arterial implants are to limit neointimal thickening, purely passive structures cannot succeed. Bioactivity must be present, either by pharmacologic intervention or by fabricating a 'living stent' that contains active cellular material. As tissue engineering evolves, useful solutions will emerge from applying this knowledge directly to vascular biologic problems resulting from angioplasty, stenting, and vascular prosthesis research.

  6. Morphological and pharmacological determinants of peri-procedural myocardial infarction following elective stent implantation: Optical coherence tomography sub-analysis of the PRASFIT-Elective study.

    Science.gov (United States)

    Uzu, Kenzo; Shinke, Toshiro; Otake, Hiromasa; Takaya, Tomofumi; Osue, Tsuyoshi; Iwasaki, Masamichi; Kinutani, Hiroto; Konishi, Akihide; Kuroda, Masaru; Takahashi, Hachidai; Terashita, Daisuke; Hirata, Ken-Ichi; Saito, Shigeru; Nakamura, Masato; Shite, Junya; Akasaka, Takashi

    2017-12-01

    Previous studies have suggested that peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) is associated with adverse short- and long-term outcomes, and several morphological predictors of PMI have been studied. However, the determinants of PMI under novel anti-platelet therapy are not fully elucidated. PRASFIT-Elective is a multicenter, parallel-group study of PCI patients in non-acute settings receiving either prasugrel or clopidogrel in addition to aspirin. Among 742 study patients, 94 (116 lesions) underwent optical coherence tomography (OCT) to evaluate the area of intra-stent tissue (IST, which comprises tissue protrusion and thrombus) after stenting in addition to standard parameters. We investigated the relationship between the peak creatine kinase (CK)-MB fraction levels after PCI and post-stent OCT findings, as well as on-treatment platelet reactivity determined by the P2Y12 reaction units (PRU) at PCI, in a post hoc manner. The multivariate linear analysis revealed that a larger total IST area (standardized coefficient: 0.370, p<0.001) and smaller minimal stent diameter (standardized coefficient: -0.242, p<0.014), but not the PRU value (p=0.988), were independently associated with CK-MB leakage. The IST area after stenting was mainly determined by the target lesion lipid index (averaged lipid arc×lipid length) (r=0.583, p<0.001). Following elective PCI, a large IST area originating from a lipid-rich plaque and a smaller minimal stent diameter were associated with PMI. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  7. iStent trabecular micro-bypass stent for open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Le K

    2014-09-01

    Full Text Available Kim Le, Hady Saheb Department of Ophthalmology, McGill University, Montreal, QC, Canada Abstract: Trabecular micro-bypass stents, commonly known as iStents, are micro-invasive glaucoma surgery (MIGS devices used to treat open-angle glaucoma. Like other MIGS procedures that enhance trabecular outflow, the iStent lowers intraocular pressure (IOP by creating a direct channel between the anterior chamber and Schlemm’s canal. iStents are typically implanted at the time of phacoemulsification for patients with open-angle glaucoma and visually significant cataracts. This review summarizes the published data regarding the efficacy, safety, and cost considerations of trabecular micro-bypass stents. Most studies found statistically significant reductions in mean IOP and ocular medication use after combined phacoemulsification with single or double iStent implantation. The devices were found to be very safe, with a safety profile similar to that of cataract surgery. Complications were infrequent, with the most common complications being temporary stent obstruction or malposition, which resolved with observation or secondary procedures. Future studies are needed to evaluate long-term outcomes, patient satisfaction, cost effectiveness, and expanded indications. Keywords: iStent, trabecular micro-bypass, glaucoma, MIGS, ab interno, surgery

  8. Clinical outcomes after heterogeneous overlap stenting with drug-eluting stents and bare-metal stents for de novo coronary artery narrowings.

    Science.gov (United States)

    Aoki, Jiro; Kirtane, Ajay J; Dangas, George D; Lansky, Alexandra J; Morales, Andy; Kimura, Masashi; Kim, Young-Hak; Moussa, Issam; Weisz, Giora; Kreps, Edward M; Collins, Michael; Frankin-Bond, Theresa; Stone, Gregg W; Moses, Jeffrey W; Leon, Martin B; Mehran, Roxana

    2008-01-01

    When it is difficult to deliver multiple drug-eluting stents (DES) or when size constraints limit DES implantation, bare-metal stents (BMS) may be implanted contiguous to DES. However, the clinical outcomes after overlapping DES and BMS implantation are not known. From September 2004 to June 2006, 4,872 consecutive patients who underwent percutaneous coronary intervention consented to be enrolled in a prospective registry. Of these patients, 44 (0.9%) with de novo lesions were treated with DES and BMS overlap stenting. All patients were followed to 12 months for the assessment of clinical outcomes. The average implanted stent diameter was 2.68 +/- 0.30 mm for DES and 2.35 +/- 0.38 mm for BMS. Overlapping BMS were implanted distal to DES in all but 1 case. One patient (2.3%) experienced acute stent thrombosis and died 2 days after the procedure. No other patient died or had a myocardial infarction during 12 months. The target vessel revascularization rate at 12 months, however, was 31.8%, mainly driven by diffuse in-stent restenosis in the BMS segments. In conclusion, the incidence of DES and BMS overlap stenting is rare in daily practice, but this procedure is associated with a high rate of target vessel revascularization.

  9. Drug-eluting stents in renal artery stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Zaehringer, M. [Marienhospital Stuttgart, Department of Radiology, Stuttgart (Germany); Pattynama, P.M.T. [Erasmus MC-University Medical Center Rotterdam, Rotterdam (Netherlands); Talen, A. [genae associates nv, Antwerp (Belgium); Sapoval, M. [Hopital Europeen Georges Pompidou, Service de Radiologie Cardio-Vasculaire, Paris (France); Inserm U 780 epidemiologie Cardio Vasculaire, Paris (France)

    2008-04-15

    Because of higher acute and long-term success rates compared with balloon angioplasty alone, percutaneous stent implantation has become an accepted therapy for the treatment of atherosclerotic renal artery stenosis. Restenosis rates after successful renal stent placement vary from 6 up to 40%, depending on the definition of restenosis, the diameter of the treated vessel segment and comorbidities. The safety and efficacy of drug-eluting stents for the treatment of renal-artery stenosis is poorly defined. The recently published GREAT study is the only prospective study, comparing bare-metal and sirolimus-coated low profile stent systems in renal artery stenosis, showing a relative risk reduction of angiographic binary in-stent restenosis by 50%. This is an opinion paper on indications, current treatment options and restenosis rates following renal artery stenting and the potential use of drug-eluting stents for this indication. (orig.)

  10. Multiple stent delivery system Multi-LOC, a new technology for spot-stenting of the femoropopliteal artery - proof of concept study in a preclinical large animal model.

    Science.gov (United States)

    Sigl, Martin; Dudeck, Oliver; Jung, Johannes; Koelble, Heinz; Amendt, Klaus

    2017-10-01

    A new stent system was studied in a porcine model to evaluate its feasibility for spot-stenting of the femoropopliteal artery. In a preliminary study in a single pig, handling and mechanical features of the novel multiple stent delivery system were tested. The Multi-LOC system demonstrated great feasibility regarding its pushability, trackability, and crossability. Excellent visibility of the individual stents allowed exact anatomically controlled implantation. In our main study, four to five short Multi-LOC stents (13 mm long) were implanted into the femoropopliteal arteries of six domestic pigs and long (60 to 100 mm) self-expandable nitinol stents were implanted into the same target vessel contralaterally to allow for intraindividual comparison. After four weeks survival under dual antiplatelet treatment, control angiography was performed. The animals were euthanized, stented vessels were explanted, and histologic sections were examined for the presence of neointimal formation. Multi-LOC stents demonstrated no occlusion of the femoropopliteal axis (0 vs. 1 occlusion distal to a control stent), no stent fractures (0 out of 26 vs. 2 out of 6 control stents), and lower percentage diameter stenosis (0.564 ± 0.056 vs. 0.712 ± 0.089; p = 0.008) and length of stenosis (19.715 ± 5.225 vs. 39.397 ± 11.182; p = 0.007) compared to a standard control stent, which was similar in total length to the multiple stented artery segment. Histological examination confirmed myointimal hyperplasia underlying in-stent stenosis. The multiple stent delivery system was studied in a porcine model, which demonstrated its feasibility. Preclinical experience revealed favourable results concerning stent fracture, restenosis, and patency of spot-stented femoropopliteal arteries.

  11. From histology and imaging data to models for in-stent restenosis

    NARCIS (Netherlands)

    Amatruda, C.M.; Bona Casas, C.; Keller, B.K.; Tahir, H.; Dubini, G.; Hoekstra, A.; Hose, D.R.; Lawford, P.; Migliavacca, F.; Narracott, A.J.; Gunn, J.

    2014-01-01

    The implantation of stents has been used to treat coronary artery stenosis for several decades. Although stenting is successful in restoring the vessel lumen and is a minimally invasive approach, the long-term outcomes are often compromised by in-stent restenosis (ISR). Animal models have provided

  12. Portal vein stent placement for the treatment of postoperative portal vein stenosis: long-term success and factor associated with stent failure.

    Science.gov (United States)

    Kato, Atsushi; Shimizu, Hiroaki; Ohtsuka, Masayuki; Yoshitomi, Hideyuki; Furukawa, Katsunori; Miyazaki, Masaru

    2017-02-01

    Portal vein stenosis develops due to different causes including postoperative inflammation and oncological processes. However, limited effective therapy is available for portal vein stenosis. The objectives of this study were to evaluate the efficacy of a portal vein stent for portal vein stenosis after hepatobiliary pancreatic surgery and to determine the factors associated with stent patency. From December 2003 to December 2015, portal vein stents were implanted in 29 patients who had portal vein stenosis after hepatobiliary pancreatic surgery. We conducted a retrospective analysis to evaluate the efficacy and safety of portal vein stent placement. Twelve clinical variables were analyzed for their role in stent patency. The symptoms before portal vein stent placements included nine patients with hepatic encephalopathy, six patients with gastrointestinal bleeding, four patients with ascites, and four patients with hyperbilirubinemia. Portal vein thrombosis due to postoperative portal stenosis was found in four patients. Portal vein stent were successfully implanted without any major complications. Of the 21 patients with symptoms, 17 showed improvement, and stent patency was maintained in 22 (76%) patients. The presence of a collateral vein is the only variable related to the development of an occlusion after portal stenting. Portal vein stent were implanted safely and had good long-term patency. This procedure is useful to relieve portal hypertension-related symptoms and to improve the quality of life. Our data strongly suggest that embolization to block blood flow in a collateral vein during portal vein stent placement will improve the patency of the stent.

  13. Glaukos iStent inject® Trabecular Micro-Bypass Implantation Associated with Cataract Surgery in Patients with Coexisting Cataract and Open-Angle Glaucoma or Ocular Hypertension: A Long-Term Study

    Directory of Open Access Journals (Sweden)

    Pedro Arriola-Villalobos

    2016-01-01

    Full Text Available Purpose. To evaluate the long-term efficacy and safety of the iStent inject device (Glaukos Corporation, Laguna Hills, CA combined with phacoemulsification in patients with coexistent cataract and open-angle glaucoma or ocular hypertension (OHT. Methods. A prospective, uncontrolled, nonrandomized, interventional case series study was conducted in patients with both mild or moderate open-angle glaucoma or OHT and cataract. Patients underwent cataract surgery along with the implant of two iStent inject devices. Outcome measures were intraocular pressure (IOP, topical hypotensive medications required, and best-corrected visual acuity (BCVA. Results. 20 patients were enrolled. Mean follow-up was 47.4±18.46 months. Mean baseline IOP was 19.95±3.71 mmHg with medication and 26±3.11 mmHg after washout. Mean end-follow-up IOP was 16.25±1.99 mmHg, representing an IOP decrease of 36.92%, 9.74±3.14 mmHg (P<0.001, from baseline washout IOP. The mean number of medications was significantly reduced from 1.3±0.66 to 0.75±0.79 (P=0.017. 45% of patients were medication-free by the end of follow-up. Mean log⁡MAR BCVA improved significantly from 0.42±0.16 to 0.18±0.16 (P<0.001. No complications of surgery were observed. Conclusion. The iStent inject device combined with cataract surgery served to significantly reduce both IOP and medication use in the long term in patients with coexistent open-angle glaucoma or ocular hypertension (OHT and cataract.

  14. Intravascular ultrasound assessment of cobalt chromium versus stainless steel drug-eluting stent expansion.

    Science.gov (United States)

    He, Yong; Maehara, Akiko; Mintz, Gary S; Bharaj, Harpreet; Castellanos, Celia; Kesanakurthy, Srinivas; Wu, Xiaofan; Guo, Ning; Choi, So-Yeon; Leon, Martin B; Stone, Gregg W; Mehran, Roxana; Rabbani, Leroy E; Moses, Jeffrey W

    2010-05-01

    It is not clear whether the thin struts and different alloy of a cobalt chromium stent will cause greater acute stent recoil compared to conventional stainless steel stents. We used postintervention intravascular ultrasound (IVUS) examinations to study 99 patients with 116 stented lesions: 61 Xience/Promus stents (cobalt chromium stent group) and 27 Taxus Liberté and 28 Cypher stents (stainless steel stent group). The IVUS images were obtained before and immediately after stent implantation with only the stent-delivery balloon. The ratio of the IVUS-measured to manufacturer-predicted stent diameter and area was the measure of acute stent recoil and expansion. The baseline patient characteristics, lesion morphology, and procedural details were comparable between the 2 groups. The ratio of the IVUS-measured to manufacturer-predicted stent diameter and area was 0.74 versus 0.73 (p = 0.57) and 0.63 versus 0.63 (p = 0.69), respectively, for the cobalt chromium and stainless steel stents. In conclusion, the acute performance of Xience/Promus was similar to that of previous stainless steel stents, and the thinner cobalt chromium metallic platform did not compromise the radial strength of the stent. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease A Meta-Analysis of Individual Patient Data

    NARCIS (Netherlands)

    Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2016-01-01

    OBJECTIVES The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD).

  16. Predictors of long-term outcomes after bypass grafting versus drug-eluting stent implantation for left main or multivessel coronary artery disease

    NARCIS (Netherlands)

    Chang, Mineok; Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Han, Minkyu; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2017-01-01

    Background: We assessed predictors of long-term outcomes after coronary artery bypass grafting (CABG) versus those after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,230 patients with left main or multivessel coronary artery disease (CAD). Methods and Results: Data

  17. Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Nobori Stent Implantation in Patients With Non-ST-Segment-Elevation Myocardial Infarction (OCTACS) Trial

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Maehara, Akiko

    2015-01-01

    BACKGROUND: Incomplete strut coverage has been documented an important histopathologic morphometric predictor for later thrombotic events. This study sought to investigate whether optical coherence tomography (OCT)-guided percutaneous coronary intervention with Nobori biolimus-eluting stent impla...... at 6-month follow-up in comparison with angiographic guidance alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02272283....

  18. Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III Substudy)

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette O; Hansen, Hans-Henrik Tilsted

    2011-01-01

    -generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse...

  19. Mechanical features and in vivo imaging of a polymer stent

    NARCIS (Netherlands)

    W.J. van der Giessen (Wim); C.J. Slager (Cornelis); E.J. Gussenhoven (Elma); H.M.M. van Beusekom (Heleen); R.A. Huijts; J.C.H. Schuurbiers (Johan); R. Wilson (Richard); P.W.J.C. Serruys (Patrick); P.D. Verdouw (Pieter)

    1993-01-01

    textabstractA polyethylene-terephthalate (PETP, polyester), self-expanding, braided mesh stent has been developed for percutaneous (coronary) arterial implantation. In vitro measurements showed that the radial pressure delivered by this device was similar to a self-expanding, stainless steel stent.

  20. Upper Gastrointestinal Stent

    OpenAIRE

    Kim, Sang Gyun; Yang, Chang-Hun

    2012-01-01

    Gastrointestinal (GI) stent has been developed for palliation of obstructive symptoms in various diseases causing obstruction of GI tract. Self-expanding metal stent (SEMS) has replaced old type of plastic stent, and endoscopic insertion of stent has replaced fluoroscopy-guided insertion. Nowadays, newly-designed SEMSs have been developed for prevention of complications such as stent migration and re-obstruction, and indications of stent recently have been widened into benign conditions as we...

  1. Symptomatic stent cast.

    LENUS (Irish Health Repository)

    Keohane, John

    2012-02-03

    Biliary stent occlusion is a major complication of endoscopic stent insertion and results in repeat procedures. Various theories as to the etiology have been proposed, the most frequently studied is the attachment of gram negative bacteria within the stent. Several studies have shown prolongation of stent patency with antibiotic prophylaxis. We report the case of stent occlusion from a cast of a previously inserted straight biliary stent; a "stent cast" in an 86-year-old woman with obstructive jaundice. This was retrieved with the lithotrypter and she made an uneventful recovery. This is the first reported case of a biliary stent cast.

  2. Comparison of bare metal stenting and percutaneous pulmonary valve implantation for treatment of right ventricular outflow tract obstruction: use of an x-ray/magnetic resonance hybrid laboratory for acute physiological assessment.

    Science.gov (United States)

    Lurz, Philipp; Nordmeyer, Johannes; Muthurangu, Vivek; Khambadkone, Sachin; Derrick, Graham; Yates, Robert; Sury, Michael; Bonhoeffer, Philipp; Taylor, Andrew M

    2009-06-16

    Treatment of right ventricular outflow tract obstruction is possible with a bare metal stent (BMS), although this treatment causes pulmonary regurgitation. In this study, we assessed the acute physiological effects of BMS versus percutaneous pulmonary valve implantation (PPVI) using an x-ray/magnetic resonance hybrid laboratory. Fourteen consecutive children (median age, 12.9 years) with significant right ventricular outflow tract obstruction underwent BMS followed by PPVI. Magnetic resonance imaging (ventricular volumes and function and great vessel blood flow) and hemodynamic assessment (invasive pressure measurements) were performed before BMS, after BMS, and after PPVI; all were performed under general anesthesia in an x-ray/magnetic resonance hybrid laboratory. BMS significantly reduced the ratio of right ventricular to systemic pressure (0.75+/-0.17% versus 0.41+/-0.14%; Phybrid laboratory, we have demonstrated the superior acute hemodynamic effects of PPVI over BMS in patients with right ventricular outflow tract obstruction.

  3. Stenting of bifurcation lesions: a rational approach.

    Science.gov (United States)

    Lefèvre, T; Louvard, Y; Morice, M C; Loubeyre, C; Piéchaud, J F; Dumas, P

    2001-12-01

    The occurrence of stenosis in or next to coronary bifurcations is relatively frequent and generally underestimated. In our experience, such lesions account for 15%-18% of all percutaneous coronary intervention > (PCI). The main reasons for this are (1) the coronary arteries are like the branches of a tree with many ramifications and (2) because of axial plaque redistribution, especially after stent implantation, PCI of lesions located next to a coronary bifurcation almost inevitably cause plaque shifting in the side branches. PCI treatment of coronary bifurcation lesions remains challenging. Balloon dilatation treatment used to be associated with less than satisfactory immediate results, a high complication rate, and an unacceptable restenosis rate. The kissing balloon technique resulted in improved, though suboptimal, outcomes. Several approaches were then suggested, like rotative or directional atherectomy, but these techniques did not translate into significantly enhanced results. With the advent of second generation stents, in 1996, the authors decided to set up an observational study on coronary bifurcation stenting combined with a bench test of the various stents available. Over the last 5 years, techniques, strategies, and stent design have improved. As a result, the authors have been able to define a rational approach to coronary bifurcation stenting. This bench study analyzed the behavior of stents and allowed stents to be discarded that are not compatible with the treatment of coronary bifurcations. Most importantly, this study revealed that stent deformation due to the opening of a strut is a constant phenomenon that must be corrected by kissing balloon inflation. Moreover, it was observed that the opening of a stent strut into a side branch could permit the stenting, at least partly, of the side branch ostium. This resulted in the provocative concept of "stenting both branches with a single stent." Therefore, a simple approach is currently implemented

  4. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent

    Energy Technology Data Exchange (ETDEWEB)

    Wang, John C., E-mail: john.wang@medstar.net [MedStar Union Memorial Hospital, Baltimore MD (United States); Carrié, Didier, E-mail: carrie.didier@chu-toulouse.fr [Centre Hôpital Universitaire Rangueil, Toulouse (France); Masotti, Monica, E-mail: MASOTTI@clinic.ub.es [Hospital Clinic, University of Barcelona (Spain); Erglis, Andrejs, E-mail: a.a.erglis@stradini.lv [Pauls Stradins Clinical University Hospital, University of Latvia, Riga (Latvia); Mego, David, E-mail: David.Mego@arheart.com [Arkansas Heart Hospital, Little Rock, AR (United States); Watkins, Matthew W., E-mail: Matthew.Watkins@vtmednet.org [University of Vermont Medical Center, Burlington VT (United States); Underwood, Paul, E-mail: Paul.underwood@bsci.com [Boston Scientific, Marlborough MA USA (United States); Allocco, Dominic J., E-mail: Dominic.allocco@bsci.com [Boston Scientific, Marlborough MA USA (United States); Hamm, Christian W., E-mail: C.Hamm@kerckhoff-klinik.de [Kerckhoff Heart and Thoraxcenter, Bad Nauheim (Germany)

    2015-03-15

    Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤ 28 mm long; diameter ≥ 2.25 mm to ≤ 4.50 mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p < 0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease. - Highlights: • The OMEGA study evaluated a novel platinum chromium bare metal stent. • OMEGA enrolled 328 patients at 37 sites (US and Europe). • The primary endpoint of 9 month target lesion failure was 11.5%. • One-year event rates were low including an ST rate of 0.6% at 12 months.

  5. Protein losing enteropathy secondary to a pulmonary artery stent

    Directory of Open Access Journals (Sweden)

    Narayanswami Sreeram

    2012-01-01

    Full Text Available A 2-year-old patient with hypoplastic left heart syndrome presented 6 months following Fontan completion with protein-losing enteropathy (PLE. He had undergone stent implantation in the left pulmonary artery after the Norwood procedure, followed by redilation of the stent prior to Fontan completion. Combined bronchoscopic and catheterization studies during spontaneous breathing confirmed left bronchial stenosis behind the stent, and diastolic systemic ventricular pressure during expiration of 25 mm Hg. We postulate that the stent acts as a valve, against which the patient generates high expiratory pressures, which are reflected in the ventricular diastolic pressure. This may be the cause of PLE.

  6. [Finite Element Analysis of Intravascular Stent Based on ANSYS Software].

    Science.gov (United States)

    Shi, Gengqiang; Song, Xiaobing

    2015-10-01

    This paper adopted UG8.0 to bulid the stent and blood vessel models. The models were then imported into the finite element analysis software ANSYS. The simulation results of ANSYS software showed that after endothelial stent implantation, the velocity of the blood was slow and the fluctuation of velocity was small, which meant the flow was relatively stable. When blood flowed through the endothelial stent, the pressure gradually became smaller, and the range of the pressure was not wide. The endothelial shear stress basically unchanged. In general, it can be concluded that the endothelial stents have little impact on the flow of blood and can fully realize its function.

  7. Impact of stent strut design in metallic stents and biodegradable scaffolds.

    Science.gov (United States)

    Foin, Nicolas; Lee, Renick D; Torii, Ryo; Guitierrez-Chico, Juan Luis; Mattesini, Alessio; Nijjer, Sukhjinder; Sen, Sayan; Petraco, Ricardo; Davies, Justin E; Di Mario, Carlo; Joner, Michael; Virmani, Renu; Wong, Philip

    2014-12-20

    Advances in the understanding of healing mechanisms after stent implantation have led to the recognition of stent strut thickness as an essential factor affecting re-endothelialization and overall long term vessel healing response after Percutaneous Coronary Interventions (PCI). Emergence of Drug-eluting stents (DESs) with anti-proliferative coating has contributed to reducing the incidence of restenosis and Target Lesion Revascularization (TVR), while progress and innovations in stent materials have in the meantime facilitated the design of newer platforms with more conformability and thinner struts, producing lesser injury and improving integration into the vessel wall. Recent advances in biodegradable metal and polymer materials now also allow for the design of fully biodegradable platforms, which are aimed at scaffolding the vessel only temporarily to prevent recoil and constrictive remodeling of the vessel during the initial period required, and are then progressively resorbed thereby avoiding the drawback of leaving an unnecessary implant permanently in the vessel. The aim of this article is to review recent evolution in stent material and stent strut design while understanding their impact on PCI outcomes. The article describes the different metallic alloys and biodegradable material properties and how these have impacted the evolution of stent strut thickness and ultimately outcomes in patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  8. Two-year Clinical Outcomes Post Implantation of Epic(TM) Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease.

    Science.gov (United States)

    Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

    2017-10-05

    We investigated 2-year clinical outcomes after implantaton of Epic(TM) self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic(TM) self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan-Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. The Epic(TM) self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD.

  9. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt–chromium sirolimus-eluting coronary stent system☆

    Science.gov (United States)

    Abhyankar, Atul D.; Thakkar, Ashok S.

    2012-01-01

    Introduction Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. Methods A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt–chromium coronary stent system (Supralimus-Core®). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. Results The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. Conclusions In vivo acute stent recoil of the Supralimus-Core® has higher radial strength compared to other available standard drug-eluting stents. PMID:23253404

  10. Impact of the Everolimus-eluting Bioresorbable Scaffold in Coronary Atherosclerosis.

    Science.gov (United States)

    Campos, Carlos M; Garcia-Garcia, Hector M; Muramatsu, Takashi; de Araujo Gonçalves, Pedro; Onuma, Yoshinobu; Dudek, Dariusz; Thuesen, Leif; Webster, Mark W I; Kitslaar, Pieter; Veldhof, Susan; Reiber, Johan H C; Nieman, Koen; Ormiston, John A; Serruys, Patrick W

    2016-02-01

    The Absorb bioresorbable vascular scaffold has been shown to decrease total plaque areas in the treated segment. However, it is unknown whether plaque size is modified in scaffolded segments only or whether the modification extends to other coronary segments. Absorb Cohort A is a single-arm, prospective study, with safety and imaging endpoints, in which 30 patients underwent percutaneous coronary intervention with the first generation Absorb bioresorbable vascular scaffold. Noninvasive multislice computed tomography imaging was performed in 18 patients at 18 months and 5 years of follow-up. The present study was an intrapatient comparison of matched segments (normalized by the segment length) of the scaffolded region with nonintervened segments for lumen volume, vessel volume, plaque volume, plaque burden, and percent change in plaque atheroma volume. All 18 scaffolded segments could be analyzed. In the nonintervened segments, 1 of 72 segments had a motion artifact and was excluded. Serial comparison showed that the scaffolded segments showed no significant change in the mean plaque burden, total atheroma volume, total lumen volume, or vessel volume between 18 months and 5 years. Conversely, the untreated segments showed a significant increase in plaque burden (2.7 ± 6.5%; P < .01) and normalized plaque volumes (8.0 ± 22.8mm(3); P < .01). This resulted in a significant difference in plaque burden between scaffolded and nonintervened segments (P = .03). In this small series, the Absorb bioresorbable vascular scaffold showed the potential to provide an additional benefit to pharmacological therapy in locally reducing progression of percent plaque burden. These findings need to be confirmed in larger studies. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. Late thrombosis of coronary bare-metal stent: Case report

    Directory of Open Access Journals (Sweden)

    Apostolović Svetlana

    2006-01-01

    Full Text Available Stent thrombosis remains the primary cause of death after percutaneous coronary interventions (PCI. Despite modern concepts of PCI, stent thrombosis occurs in 0.5% -2% of elective procedures and even 6% of patients with the acute coronary syndrome (ACS. Stent thrombosis most often develops within the first 48 hours after the PCI, and rarely after a week of stent implantation. Angiographically documented late (>6 months thrombosis of coronary bare-metal stent (BMS is rare, because the stent endothelialization is considered to be completed after four weeks of the intervention. Our patient is a 41 year old male and he had BMS thrombosis 345 days after the implantation, which was clinically manifested as an acute myocardial infarction in the inferoposterolateral localization. Stent Clinical Centre of Serbia, Belgrade thrombosis occurred despite a long term dual antiplatelet therapy and control of known risk factors. Thrombolytic therapy (Streptokinase in a dose of 1 500 000 IU was not successful in reopening the occluded vessel, so the flow through the coronary artery was achieved by rescue balloon angioplasty, followed by implantation of drug eluting stent in order to prevent restenosis.

  12. Bioabsorbable and biocompatible stents. Is a new revolution coming?

    Science.gov (United States)

    Rogacka, R; Chieffo, A; Latib, A; Colombo, A

    2008-10-01

    With the introduction of drug-eluting stents (DES) the problem of restenosis after percutaneous stent implantation was partially resolved. In the first generation of DES a stainless steel platform was coated with a durable polymer eluting and controlling the release of an active restenotic drug. The impairment of re-endothelization after DES implantation, one of the causes of late stent thrombosis, was to some extent attributed to the properties of the durable polymer and/or drug that it eluted. The introduction of biodegradable platforms and biocompatible polymers may potentially address this issue. Modern technologies are being applied to improve the characteristics of biodegradable stents and find new active pharmacological agents or combinations of standard antirestenotic and antithrombotic drugs that can be eluted from the stents, in order to improve their safety profile and clinical utility.

  13. Resolution of Metallic Biliary Stent Allergic Reaction After Partial Stent Removal in a Patient with Nickel Sensitivity.

    Science.gov (United States)

    Esparaz, Anthony M; Ahmed, Muneeb

    2017-07-01

    Local and systemic reactions to implanted metallic devices, particularly to those containing nickel, are well documented. Metal ions are released due to exposure of the metal to blood, proteins, other body fluids, and sheer mechanical stress. Metal ions then complex with native proteins and become antigens, which can elicit hypersensitivity reactions. Another case report depicts a specific allergic complication (early stent occlusion) related to metallic biliary stent implantation. We present a case of allergic symptoms, associated with eating, in a patient who developed nickel sensitivity after biliary metal stent placement confirmed by allergic skin testing to the same metallic biliary stent placed one year earlier. Symptoms resolved following partial removal of the non-epithelialized portion of the biliary stent.

  14. Unusual balloon rupture during direct stenting with a TaxusExpress stent in a venous graft complicated by vessel rupture: a device-related fatal event

    DEFF Research Database (Denmark)

    Christiansen, Evald H

    2007-01-01

    distal anastomoses, had two significant stenoses. Percutaneous coronary intervention with distal protection, and direct stenting with a drug-eluting stent, was planned. A 3.00 x 16 mm TaxusExpress (Boston Scientific) was used. At an inflation pressure of 10 atm the stent balloon seemed to extend 20 mm...... proximally with a diameter of 4.5 mm, and the balloon ruptured. Angiography showed rupture of the vessel proximal to the implanted stent, and the patient developed severe hypotension. The rupture was treated with a covered stent and pericardiocentesis was performed with evacuation of 600 mL blood. However...

  15. Biocompatibility of coronary stent materials: effect of electrochemical polishing

    Energy Technology Data Exchange (ETDEWEB)

    Scheerder, I. de [University Hospital Leuven (Belgium). Dept. of Cardiology; Sohier, J.; Froyen, L.; Humbeeck, J. van [Louvain Univ. (Belgium). Dept. of Metallurgy and Materials Engineering; Verbeken, E. [University Hospital Leuven (Belgium). Dept. of Pathology

    2001-02-01

    Percutaneous Transluminal Coronary Revascularization (PTCR) is now a widely accepted treatment modality for atherosclerotic coronary artery disease. Current multicenter randomized trials comparing PTCR with the more invasive Coronary Artery Bypass Grafting could not show long-term significant survival differences. During the last two decades progress has been made to further optimize PTCR. The most logic approach to treat atherosclerotic coronary narrowings is to remove the atherosclerotic material using especially developed devices. Several trials, however, could not show a significant beneficial outcome after use of these devices compared to plain old balloon angioplasty. Another approach was to implant a coronary prothesis (stent), scaffolding the diseased coronary artery after PTCA. This approach resulted in a decreased restenosis rate at follow-up. The beneficial effects of stenting, however, was not found to be related to the inhibition of the neointimal cellular proliferation after vascular injury, but simply to be the mechanical result of overstretching of the treated vessel segment. The most important remaining clinical problem after stenting remains the neointimal hyperplasia within the stent, resulting in a significant stent narrowing in 13 to 30% of patients. Further efforts to improve the clinical results of coronary stenting should focus on the reduction of this neointimal hyperplasia. Neointimal hyperplasia after stent implantation results from (1) a healting response to the injury caused by the stent implantation and (2) a foreign body response to the stent itself. Factors that seem to influence the neointimal hyperplastic response are genetic, local disease related, stent delivery related and stent related factors. Biocompatibilisation of coronary stents by looking for more biocompatible metal alloys, optimized surface characteristics and optimized stent designs should result in a better late patency. Furthermore drug eluting and radioactive stents

  16. Percutaneous Stent Implantation for Treating Multivessel Coronary Disease in Patients with and without Involvement of the Proximal Segment of the Anterior Descending Coronary Artery

    Directory of Open Access Journals (Sweden)

    Salgueiro Sandro

    2002-01-01

    Full Text Available OBJECTIVE: To assess coronary stent placement in patients with multivessel coronary disease and involvement of the proximal portion of the anterior descending coronary artery. METHODS: We retrospectively analyzed the in-hospital and late evolution of 189 patients with multivessel coronary disease, who underwent percutaneous coronary stent placement. These patients were divided into 2 groups as follows: group I (GI - 59 patients with involvement of the proximal segment of the anterior descending coronary artery; and group II (GII - 130 patients without involvement of the proximal segment of the anterior descending coronary artery. RESULTS: No significant difference was observed in the success rate of the procedure (91.5% versus 97.6%, p=0.86, nor in the occurrence of major adverse cardiac events (5.1% versus 1.5%, p=0.38, nor in the occurrence of major vascular complications (1.7% versus 0%, p=0.69 in the in-hospital phase. In the late follow-up, the incidence of major adverse cardiac events (15.4% versus 13.7%, p=0.73 and the need for new revascularization (13.5% versus 10.3%, p=0.71 were similar for both groups. CONCLUSION: The in-hospital and late evolution of patients with multivessel coronary disease with and without involvement of the proximal segment of the anterior descending coronary artery treated with coronary stent placement did not differ. This suggests that this revascularization method is an effective procedure and a valuable option for treating these types of patients.

  17. Stent thrombosis: incidence and related factors in the R.I.S.E. Registry(Registro Impianto Stent Endocoronarico)

    Science.gov (United States)

    De Servi, S; Repetto, S; Klugmann, S; Bossi, I; Colombo, A; Piva, R; Giommi, L; Bartorelli, A; Fontanelli, A; Mariani, G; Klersy, C

    1999-01-01

    Although stent thrombosis has been greatly reduced by adequate stent expansion with high-pressure balloon inflations and by the use of antiplatelet drugs, this event is still frightening, as it may lead to acute myocardial ischemia resulting in acute myocardial infarction or sudden death. Therefore, the definition of factors associated with stent thrombosis may provide a better understanding of the mechanisms underlying this phenomenon and may permit us to define therapeutic strategies to further reduce its occurrence. The purpose of this study was to assess factors responsible for the occurrence of stent thrombosis after coronary stent implantation in 939 consecutive patients enrolled in the Registro Impianto Stent Endocoronarico (R.I.S.E. Study Group). Consecutive patients undergoing coronary stent implantation at 16 medical centers in Italy were prospectively enrolled in the registry. Clinical data, and qualitative and quantitative angiographic findings were obtained from data collected in case report forms at each investigator site. The study group consisted of 781 men and 158 women with a mean age of 59 yr: 1,392 stents were implanted in 1,006 lesions and expanded at a maximal inflation pressure of 14.7 +/- 3 atm. The great majority of patients (92%) received only antiplatelet drugs after coronary stenting. During hospitalization there were 45 major ischemic complications in 39 patients (4.2%): 13 events were related to acute or subacute thrombosis (1.4%). Another stent thrombotic event occurred in the first month of follow-up. On multivariate logistic regression analysis, stent thrombosis was related to the following factors: unplanned stenting (OR 3.46, 95% CI 1.65-7.23), unstable angina (OR 3.37, 95% CI 1.11-10.14) and maximal inflation pressure (OR 0.83, 95% CI 0.75-0.93). In conclusion, this registry shows that in an unselected population of patients undergoing coronary stenting, stent thrombosis occurs in less than 2% of patients and is significantly

  18. Impact of six versus 12 months of dual antiplatelet therapy in patients with drug-eluting stent implantation after risk stratification with the residual SYNTAX score: Results from a secondary analysis of the I-LOVE-IT 2 trial.

    Science.gov (United States)

    Qiu, Miaohan; Li, Yi; Li, Jing; Xu, Kai; Jing, Quanmin; Dong, Shaohong; Jin, Zhe; Zhao, Pitian; Xu, Bo; Han, Yaling

    2017-03-01

    The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains undetermined, especially for those at high risk of cardiac events postprocedure. This study was aimed to investigate the impact of 6 versus 12 months of DAPT after DES implantation based on risk stratification with the residual SYNTAX score (rSS). A total of 2737 patients in the I-LOVE-IT 2 trial were grouped according to rSS status (low rSS [rSS = 0, n = 1474] versus high rSS [rSS > 0, n = 1263]) and DAPT duration (6 months vs. 12 months). The primary endpoint was 12-month target lesion failure (TLF), and the major secondary endpoints were 12-month net adverse clinical events (NACE) and major bleeding. Incidences of TLF (5.2 vs. 7.4%, P = 0.01) and NACE (9.2 vs. 13.4%, P rSS, 12-month DAPT was associated with slightly lower risks of TLF (3.0% vs. 1.6%, P = 0.08) and NACE (7.0 vs. 4.4%, P = 0.054) compared with 6-month DAPT within 6 to 12 months after PCI. Patients with different DAPT durations had similar risks of bleeding both in the low and high rSS groups. Patients with high rSSs have an increased risk of TLF and NACE at 12 months after DES implantation. Twelve-month DAPT might be superior to 6-month DAPT in patients with high rSS for reducing adverse events within 6 to 12 months after PCI without excessive risk of bleeding. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  19. Caracterización de la restenosis de stents coronarios convencionales y liberadores de medicamentos en pacientes incluidos en el registro DRug Eluting STent (DREST Characterization of conventional coronary stents restenosis and drug eluting stents in patients included in the Drug Eluting Stent Registry (DREST

    Directory of Open Access Journals (Sweden)

    Jorge A Arroyave C

    2012-06-01

    risk factor associated with stent restenosis of drug-eluting stents (p <0.002. We found smaller diameter of the vessel involved as well as smaller diameter of the implanted stent mainly in the drug-eluting stents associated with stent restenosis (p = 0.000. The focal pattern of stent restenosis was higher with drug eluting stents, while the diffuse pattern with standard stents (p = 0.000. The one-year survival was higher in patients with drug-eluting stent. Conclusions: The rates of stent restenosis and the related characteristics found are similar to those currently published. Dyslipidemia appears as a significant associated factor. The stent restenosis manifested as acute coronary syndrome in 60% of cases; it can not be regarded as a benign condition in this population.

  20. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

    DEFF Research Database (Denmark)

    Pfisterer, M.; Bertel, O.; Bonetti, P.O.

    2008-01-01

    Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove or r...... to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12-versus 6-month dual antiplatelet therapy on these outcomes Udgivelsesdato: 2008/4......Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove...... or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...

  1. Stent-induced tracheal stenosis can be predicted by IL-8 expression in rabbits.

    Science.gov (United States)

    Arellano-Orden, Elena; Serrano, Carolina; Montes-Worboys, Ana; Sánchez-López, Verónica; Laborda, Alicia; Lostalé, Fernando; Lahuerta, Celia; Rodríguez-Panadero, Francisco; de Gregorio, Miguel Ángel

    2017-01-01

    Bare metal stents may cause complications like fibrous encapsulation, granulation and tracheal stenosis. We investigated the behaviour of three commercially available stents in vivo (rabbits) and in vitro (coculture of those stents with epithelial and fibroblast cell lines). Also, we investigated whether development of tracheal stenosis could be predicted by any biological marker. The tracheae of 30 rabbits were implanted with either nitinol stents, with or without paclitaxel elution, or a cobalt-based stent. An additional ten rabbits underwent mock implantation (controls). Serial peripheral venous blood samples were taken throughout the study, and several cytokines measured. Animals were euthanized on day 90, with immediate tracheal endoscopy and lavage performed, then necropsy. Rabbits with cobalt-based stent exhibited more inflammation and the highest stenosis incidence, with reduced survival. Both in vivo and in vitro, this stent induced higher IL-8 levels than nitinol stents. Most important, the presence of stent-induced tracheal stenosis was closely associated to increase in IL-8 expression in blood just 1 day after tracheal stent implantation: a 1·19-fold increase vs. baseline had 83% sensitivity, 83% specificity, 77% positive predictive value, 88% negative predictive value and 83% accuracy to predict development of stenosis. The cobalt-based stent had the highest incidence of tracheal inflammation and stenosis. On the other hand, the paclitaxel-eluting nitinol stent did not prevent those complications and provoked a marked reaction compared with the bare nitinol stent. Early increase in IL-8 expression in blood after stent implantation could predict development of tracheal stenosis in rabbits. © 2016 Stichting European Society for Clinical Investigation Journal Foundation.

  2. Biodegradable Metals for Cardiovascular Stent Application: Interests and New Opportunities

    Directory of Open Access Journals (Sweden)

    Maryam Moravej

    2011-06-01

    Full Text Available During the last decade, biodegradable metallic stents have been developed and investigated as alternatives for the currently-used permanent cardiovascular stents. Degradable metallic materials could potentially replace corrosion-resistant metals currently used for stent application as it has been shown that the role of stenting is temporary and limited to a period of 6–12 months after implantation during which arterial remodeling and healing occur. Although corrosion is generally considered as a failure in metallurgy, the corrodibility of certain metals can be an advantage for their application as degradable implants. The candidate materials for such application should have mechanical properties ideally close to those of 316L stainless steel which is the gold standard material for stent application in order to provide mechanical support to diseased arteries. Non-toxicity of the metal itself and its degradation products is another requirement as the material is absorbed by blood and cells. Based on the mentioned requirements, iron-based and magnesium-based alloys have been the investigated candidates for biodegradable stents. This article reviews the recent developments in the design and evaluation of metallic materials for biodegradable stents. It also introduces the new metallurgical processes which could be applied for the production of metallic biodegradable stents and their effect on the properties of the produced metals.

  3. Advantages and disadvantages of biodegradable platforms in drug eluting stents.

    Science.gov (United States)

    Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

    2011-03-26

    Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

  4. Relation of Nickel Allergy with in-Stent Restenosis in Patients Treated with Cobalt Chromium Stents.

    Science.gov (United States)

    Aliağaoğlu, Cihangir; Turan, Hakan; Erden, Ismail; Albayrak, Hülya; Ozhan, Hakan; Başar, Cengiz; Gürlevik, Zehra; Alçelik, Ayşegül

    2012-11-01

    In-stent restenosis (ISR) is the major limitation of percutaneous coronary stenting procedure. The elements like nickel, chromate and molybdenum are known to cause contact allergy. Hypersensitivity reaction, against these metal ions, may be one of the reasons of ISR. Cobalt chromium coronary stents, which are increasingly being used in percutaneous coronary interventions, have more nickel amount than the stainless steel stents. We aimed to investigate the association between nickel hypersensitivity reaction and ISR in patients treated with cobalt chromium coronary stents. Epicutaneous patch tests for nickel were applied to 31 patients who had undergone elective cobalt chromium coronary stent implantation and had ISR in control angiogram. Thirty patients, without ISR, were included as the control group. Patch test results and other clinical variables were compared. There was no statistically significant difference of the mean age, sex, body mass index, rate of hypercholesterolemia, diabetes, hypertension and smoking between the patients with and without ISR. All other lesion characteristics were similar in the 2 groups. According to the patch test results, 7 patients had nickel contact allergy. All of these patients were in the ISR group, which was statistically significant (pcobalt chromium coronary stents and had ISR were found to have significantly more nickel allergy than the control group. Nickel allergy may play role in restenosis pathophysiology.

  5. Magnetizable stent-grafts enable endothelial cell capture

    Science.gov (United States)

    Tefft, Brandon J.; Uthamaraj, Susheil; Harburn, J. Jonathan; Hlinomaz, Ota; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S.

    2017-04-01

    Emerging nanotechnologies have enabled the use of magnetic forces to guide the movement of magnetically-labeled cells, drugs, and other therapeutic agents. Endothelial cells labeled with superparamagnetic iron oxide nanoparticles (SPION) have previously been captured on the surface of magnetizable 2205 duplex stainless steel stents in a porcine coronary implantation model. Recently, we have coated these stents with electrospun polyurethane nanofibers to fabricate prototype stent-grafts. Facilitated endothelialization may help improve the healing of arteries treated with stent-grafts, reduce the risk of thrombosis and restenosis, and enable small-caliber applications. When placed in a SPION-labeled endothelial cell suspension in the presence of an external magnetic field, magnetized stent-grafts successfully captured cells to the surface regions adjacent to the stent struts. Implantation within the coronary circulation of pigs (n=13) followed immediately by SPION-labeled autologous endothelial cell delivery resulted in widely patent devices with a thin, uniform neointima and no signs of thrombosis or inflammation at 7 days. Furthermore, the magnetized stent-grafts successfully captured and retained SPION-labeled endothelial cells to select regions adjacent to stent struts and between stent struts, whereas the non-magnetized control stent-grafts did not. Early results with these prototype devices are encouraging and further refinements will be necessary in order to achieve more uniform cell capture and complete endothelialization. Once optimized, this approach may lead to more rapid and complete healing of vascular stent-grafts with a concomitant improvement in long-term device performance.

  6. Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial.

    Science.gov (United States)

    Sakamoto, Tomohiro; Ogawa, Hisao; Nakao, Koichi; Hokimoto, Seiji; Tsujita, Kenichi; Koide, Shunichi; Yamamoto, Nobuyasu; Shimomura, Hideki; Matsumura, Toshiyuki; Oshima, Shuichi; Kikuta, Koichi; Oka, Hideki; Kimura, Kazuo; Matsui, Kunihiko

    2016-04-01

    The purpose of this study was to examine the cardiovascular protective effects of candesartan in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). Candesartan has been reported to reduce cardiovascular events when therapy was started 6 months after PCI with bare-metal stents in patients who survived restenosis. Candesartan started immediately after PCI with DESs was also effective in preventing cardiovascular events. The 4C trial was a multicenter, prospective, randomized, open-label study. A total of 1145 patients at 39 centers in Japan were randomly assigned to receive candesartan plus standard medical treatment or standard medical treatment alone. The primary endpoints were all-cause death, and a composite of non-fatal myocardial infarction (MI), unstable angina pectoris (uAP), congestive heart failure (CHF), and non-fatal cerebrovascular events. The follow-up period was up to 3 years after the index PCI (ClinicalTrials.gov NCT00139386). The incidence of total death, one of the primary endpoints, was comparable between the two treatment groups (3.8% each, p=0.9702). Another primary endpoint, non-fatal major cardiovascular events, tended to occur more often in the control group than in the candesartan group (9.2% vs. 12.5%, p=0.0985). In contrast, candesartan significantly reduced one of the pre-specified secondary endpoints: cardiovascular events that included non-fatal MI, uAP, and CHF (4.4% vs. 6.7%, p=0.0136). Furthermore, candesartan significantly reduced another secondary endpoint that included cardiovascular events and cardiovascular death (5.0% vs. 7.7%, p=0.0493). The 4C trial showed that candesartan administered immediately after PCI with DESs did not improve the prognosis after the index procedure, but did reduce some cardiac-related events for 3 years. Copyright © 2015. Published by Elsevier Ltd.

  7. Coronary stent occlusion: reverse attenuation gradient sign observed at computed tomography angiography improves diagnostic performance

    Energy Technology Data Exchange (ETDEWEB)

    Li, Minghua; Zhang, Jiayin [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Radiology, Shanghai (China); Zhang, Qingyong; Pan, Jingwei; Lu, Zhigang; Wei, Meng [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Cardiology, Shanghai (China)

    2014-09-26

    To evaluate the incidence and diagnostic performance of reverse attenuation gradient (RAG) sign in patients with coronary stent occlusion. We retrospectively included patients with suspected restenosis who underwent both coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) within 2 weeks. Stent occlusion at CCTA was defined as (1) complete contrast filling defect of large calibre stents (at least 3 mm), or (2) presence of RAG sign in patients with small calibre stents (less than 3 mm) or (3) presence of RAG sign in patients with non-diagnostic image quality of stents. The diagnostic performance of RAG sign was further assessed by comparison to ICA results. A total of 162 patients with 231 implanted stents were included. ICA confirmed stent occlusion in 59 patients (99 stents). RAG sign was present in 59.3 % (35/59) of all stent occlusions. As shown by patient-based analysis, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of our diagnostic criteria for detection of stent occlusion were 79.7 % (47/59), 100 % (103/103), 100 % (47/47) and 89.6 % (103/115) respectively. Superior diagnostic performance was confirmed by receiver operating characteristic (ROC) analysis with an area under the curve of 0.898. RAG sign observed at CCTA in patients with coronary stenting represents reverse collateral flow distal to stents and is highly specific to indicate stent occlusion. (orig.)

  8. Reduction of late in-stent stenosis in a porcine coronary artery model by cobalt chromium stents with a nanocoat of polyphosphazene (Polyzene-F).

    Science.gov (United States)

    Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi; Stampfl, Sibylle; Lopez-Benitez, Ruben; Radeleff, Boris; Berger, Irina; Richter, Goetz M

    2008-01-01

    The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alpha (TNFalpha), and TGFbeta. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% +/- 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% +/- 4.93% for bare cobalt chromium stents and 9.71% +/- 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 +/- 16 lm in PZF-nanocoated cobalt chromium stents, 74.7 +/- 57.6 lm in bare cobalt chromium stents, and 141.5 +/- 109 lm in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.

  9. Differences of platelet adhesion and thrombus activation on amorphous silicon carbide, magnesium alloy, stainless steel, and cobalt chromium stent surfaces.

    Science.gov (United States)

    Hansi, Christopher; Arab, Amina; Rzany, Alexander; Ahrens, Ingo; Bode, Christoph; Hehrlein, Christoph

    2009-03-01

    Coronary stenting is considered to be the gold standard of percutaneous coronary interventions, because stents are able to reduce early and late elastic recoil (negative remodeling) and restenosis in comparison with balloon angioplasty alone. It is known that stent thrombogenicity and neointimal formation are determined by the surface characteristics of the stent platform, electrochemical features of the stent surface, and the degree of degradation after implantation. Metallic stents coated with amorphous silicon carbide and biodegradable stents made of magnesium alloy have been introduced clinically, but there are no data available comparing the biocompatibility of these novel stent materials with conventional stents. We demonstrate simple and reproducible in vitro methods assessing the rate of platelet adhesion and thrombus activation for biocompatibility tests of different stent surfaces. We show that amorphous silicon carbide and magnesium alloy stent surfaces markedly lower the rate of platelet adhesion and platelet/fibrin activation when compared with uncoated stainless steel or cobalt chromium alloy surfaces. Semiconductor materials on the stent surface reduce platelet and fibrin activation by increasing the critical electron gap to greater than 0.9 eV resulting in a lower electron transfer out of the stent material. Passive stent coatings with specific semiconducting properties such as amorphous silicon carbide or magnesium alloy reduce thrombogenicity and may improve biocompatibility of a stent platform.

  10. Acute and mid-term outcomes of stent implantation for recurrent coarctation of the aorta between the Norwood operation and fontan completion: A multi-center Pediatric Interventional Cardiology Early Career Society Investigation.

    Science.gov (United States)

    Aldoss, Osamah; Goldstein, Bryan H; Danon, Saar; Goreczny, Sebastian; Gray, Robert G; Sathanandam, Shyam; Whiteside, Wendy; Williams, Derek A; Zampi, Jeffrey D

    2017-08-11

    We sought to evaluate outcomes of stent implantation (SI) for recurrent coarctation of the aorta (RC) following the Norwood operation. RC is common following the Norwood operation. Balloon angioplasty (BA) is standard treatment but may result in unsatisfactory relief of RC. SI may improve RC, but outcome data are limited. We performed a multi-center retrospective study of patients who underwent SI for RC between the Norwood operation and Fontan completion. Outcomes were examined, including procedural success, serious adverse events (SAE), and freedom from re-intervention. A core laboratory was utilized to review angiograms. Coarctation Index (CI) was calculated before and after SI. Paired t-test and Wilcoxon signed-rank test were used to compare pre- and post-SI variables. Thirty-three patients at 8 centers underwent SI for RC at a median age of 5 months (IQR 4.1, 13.3) and weight of 5.9 kg (5.2, 8.6). Aortic arch gradient improved from 20 (15, 24) to 0 (0, 2) mmHg following SI (P common and re-intervention is frequent at mid-term follow-up. © 2017 Wiley Periodicals, Inc.

  11. Desfechos clínicos por região geográfica em pacientes com implante de stent eluidor de Zotarolimus

    Directory of Open Access Journals (Sweden)

    Chaim Lotan

    2011-05-01

    Full Text Available FUNDAMENTO: Diferenças entre regiões geográficas em relação à características de pacientes e desfechos, particularmente em síndromes coronarianas agudas, tem sido demonstradas em testes clínicos. Os desfechos clínicos após intervenções coronarianas percutâneas com o stent eluidor de Zotarolimus em uma população real foram analisados com o tempo. OBJETIVO: A influência da localização geográfica sobre os desfechos clínicos com o stent eluidor de Zotarolimus foi avaliada em três regiões: Pacífico Asiático, Europa e América Latina. MÉTODOS: Um total de 8.314 pacientes (6.572 da Europa, 1.522 do Pacífico Asiático e 220 da América Latina foram acompanhados por 1 ano; 2.116 desses (1.613, 316, e 187, respectivamente foram acompanhados por 2 anos. Características dos pacientes e lesões, terapia antiplaquetária dupla e desfechos clínicos foram comparados entre a América Latina e as outras duas regiões. RESULTADOS: Os pacientes da América Latina apresentavam a maior proporção de fatores de risco e infarto do miocárdio prévio. O uso da terapia antiplaquetária dupla declinou rapidamente na América Latina, de 44,9% em 6 meses para 22,5% em 1 ano e 7,8% em 2 anos (Europa: 87,4%, 61,5%, 19,7%; Pacífico Asiático: 82,4%, 67,0%, 45,7%, respectivamente. Não houve diferenças significantes entre a América Latina e a Europa ou Pacífico Asiático para qualquer desfecho em qualquer ponto do tempo. A incidência de trombose de stent provável e definitiva pelo Academic Research Consortium foi baixa (<1,2% entre todos os pacientes em 1 ano e 2 anos. CONCLUSÃO: Os desfechos clínicos foram comparáveis entre os pacientes da América Latina e Europa, e América Latina e Pacífico Asiático, a despeito dos subgrupos clínicos menos favoráveis na América Latina, perfil de risco mais elevado e menor uso acentuado de terapia antiplaquetária dupla com o tempo.

  12. Late Thrombosis of Sirolimus-Eluting Stent: A Multifactorial Problem

    Directory of Open Access Journals (Sweden)

    Igor Kranjec

    2009-01-01

    Full Text Available We report a case of a young patient in whom a sirolimus-eluting stent was implanted on the culprit left anterior descending coronary artery at primary percutaneous coronary intervention (PCI for acute myocardial infarction. Nine months later she suffered from a reinfarction due to the late stent thrombosis despite a continuous antiplatelet therapy with aspirin and clopidogrel. A cluster of factors that might have contributed to the development of the stent thrombosis were identified: suboptimal PCI technique, complete stent fracture, and clopidogrel resistance. The obstructed stent was successfully reopened by repeat PCI, while the clopidogrel maintenance dosage was doubled to 150 mg daily for the following year. The further long-term clinical course was uneventful.

  13. The MGuard coronary stent: safety, efficacy, and clinical utility

    Directory of Open Access Journals (Sweden)

    Gracida M

    2015-09-01

    Full Text Available Montserrat Gracida, Rafael Romaguera, Francisco Jacobi, Joan A Gómez-Hospital, Angel Cequier Heart Diseases Institute, Hospital Universitari de Bellvitge – IDIBELL, University of Barcelona, Barcelona, Spain Abstract: Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions. Keywords: Coronary artery disease, myocardial infarction, coronary stent, complication, thrombus, no-reflow phenomenon

  14. Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation: A meta-analysis and meta-regression.

    Science.gov (United States)

    Villablanca, Pedro A; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schüpke, Stefanie; Briceno, David F; Bortnick, Anna E; Garcia, Mario J; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish

    2016-12-01

    The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement. We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I) > 40 was identified, effects were obtained with random models. Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69-1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66-1.21), non-CV mortality (OR 0.85; 95% 0.58-1.24), myocardial infarction (OR 1.10; 95% CI: 0.89-1.37), stroke (OR 0.97; 95% CI: 0.67-1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89-2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77-1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49-1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59-0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT. DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.

  15. A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial.

    Science.gov (United States)

    Lee, Heesun; Koo, Bon-Kwon; Park, Kyung Woo; Shin, Eun-Seok; Lim, Sang Wook; Rha, Seung-Woon; Bae, Jang-Whan; Jeon, Dong Woon; Oh, Seok-Kyu; Hur, Seung-Ho; Kim, Bum-Su; Lee, Jung-Hee; Park, Tae-Ho; Lee, Nam Ho; Kim, Hyo-Soo

    2017-03-01

    Percutaneous coronary intervention (PCI) has been developed by drug-eluting stent (DES), but stent implantation has brought the issue of stent thrombosis and optimal antiplatelet therapy. Guidelines recommend at least 6- to 12 months of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor such as clopidogrel. Beyond DAPT after PCI with DES, however, there has been still a debate for antiplatelet regimen. Therefore, we report on the upcoming HOST-EXAM trial (NCT02044250), which will evaluate the efficacy and safety of aspirin and clopidogrel monotherapies beyond DAPT after DES implantation. The HOST-EXAM is a prospective, randomized, open-label, multicenter, comparative effectiveness trial, to compare between clopidogrel (75 mg once daily) and aspirin (100 mg once daily) as long-term antiplatelet agents. A total of 5,530 patients with no clinical events during combined antiplatelet therapy for 12±6 months after index PCI will be screened, enrolled, and randomized to either group (1:1 ratio) receiving antiplatelet monotherapy for 2 years. The primary endpoint will be the rate of clinical events defined as a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, or major bleeding at 24 months after randomization. The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. The trabecular bypass stent in a pseudophakic glaucoma patient: A 1-year follow-up.

    Science.gov (United States)

    Fea, Antonio M; Dogliani, Monica; Machetta, Federica; Lale-Lacroix, Gabriella; Brogliatti, Beatrice; Grignolo, Federico M

    2008-12-01

    To describe the 1-year success of a trabecular stent implant in a pseudophakic glaucoma patient. The stent is implanted through a small corneal incision under gonioscopic control. Intraocular pressure control was reported in cultured human anterior segment. Observational case report. We report the case of a patient who was implanted and followed-up for 1 year at the Dipartimento di Fisiopatologia Clinica. The main outcome measures were intraocular pressure and visual field. The patient's intraocular pressure was controlled with topical beta-blockers for 6 months and without therapy for 6 months. Two diurnal curves demonstrated achievement of target pressure during the day. The 1-year visual field was unchanged. We are not aware of previous reports of trabecular stent implantation in pseudophakic patients. The trabecular stent had minimal peri-operative morbidity. Identification of the implantation site is challenging and reduction of efficacy over time may occur.

  17. Stent Polymers: Do They Make a Difference?

    Science.gov (United States)

    Rizas, Konstantinos D; Mehilli, Julinda

    2016-06-01

    The necessity of polymers on drug-eluting stent (DES) platforms is dictated by the need of an adequate amount and optimal release kinetic of the antiproliferative drugs for achieving ideal DES performance. However, the chronic vessel wall inflammation related to permanent polymer persistence after the drug has been eluted might trigger late restenosis and stent thrombosis. Biodegradable polymers have the potential to avoid these adverse events. A variety of biodegradable polymer DES platforms have been clinically tested, showing equal outcomes with the standard-bearer permanent polymer DES within the first year of implantation. At longer-term follow-up, promising lower rates of stent thrombosis have been observed with the early generation biodegradable polymer DES platforms compared to first-generation DES. Whether this safety benefit still persists with newer biodegradable polymer DES generations against second-generation permanent polymer DES needs to be explored. © 2016 American Heart Association, Inc.

  18. Bioabsorbable Stent Quo Vadis: A Case for Nano-Theranostics

    Science.gov (United States)

    Gundogan, Buket; Tan, Aaron; Farhatnia, Yasmin; Alavijeh, Mohammad S.; Cui, Zhanfeng; Seifalian, Alexander M.

    2014-01-01

    Percutaneous coronary intervention (PCI) is one of the most commonly performed invasive medical procedures in medicine today. Since the first coronary balloon angioplasty in 1977, interventional cardiology has seen a wide array of developments in PCI. Bare metal stents (BMS) were soon superseded by the revolutionary drug-eluting stents (DES), which aimed to address the issue of restenosis found with BMS. However, evidence began to mount against DES, with late-stent thrombosis (ST) rates being higher than that of BMS. The bioabsorbable stent may be a promising alternative, providing vessel patency and support for the necessary time required and thereafter degrade into safe non-toxic compounds which are reabsorbed by the body. This temporary presence provides no triggers for ST, which is brought about by non-endothelialized stent struts and drug polymers remaining in vivo for extended periods of time. Likewise, nano-theranostics incorporated into a bioabsorbable stent of the future may provide an incredibly valuable single platform offering both therapeutic and diagnostic capabilities. Such a stent may allow delivery of therapeutic particles to specific sites thus keeping potential toxicity to a minimum, improved ease of tracking delivery in vivo by embedding imaging agents, controlled rate of therapy release and protection of the implanted therapy. Indeed, nanocarriers may allow an increased therapeutic index as well as offer novel post-stent implantation imaging and diagnostic methods for atherosclerosis, restenosis and thrombosis. It is envisioned that a nano-theranostic stent may well form the cornerstone of future stent designs in clinical practice. PMID:24672583

  19. ANALYSIS OF OUTPATIENT PHYSICIANS, PRESCRIPTION OF DISAGGREGANT THERAPY FOR PATIENTS AFTER ACUTE MYOCARDIAL INFARCTION AND/OR CORONARY ANGIOPLASTY WITH STENT IMPLANTATION WITHIN THE RECVAD REGISTRY

    Directory of Open Access Journals (Sweden)

    A. V. Zagrebelnyi

    2015-01-01

    Full Text Available Objective: to estimate the quality of antiaggregants therapy in patients with coronary heart disease in outpatient settings. Materials and methods. The data of the retrospective outpatient RECVAD registry (3690 patients who lived in Ryazan and its Region and had evidence in their outpatient medical records for one of the diagnoses, such as coronary heart disease, hypertension, chronic heart failure, atrial fibrillation, or their concurrence, were used. Forty­nine patients after acute myocardial infarction (AMI and/or percutaneous coro­ nary interventions (PCI with stenting ≤ 1 year before their inclusion in the registry, who were to undergo dual antiaggregant therapy (DAT according to current clinical guidelines (CG, were identified among 427 patients after AMI and/or PCI with coronary angioplasty. Contra­ indications to DAT were simultaneously revealed and a relationship of the use of therapy to their presence was compared. Results. Among the 49 patients who had indications for DAT that was used in 15 (30.6 % cases and that was not in 3 (6.1 % patients in the presence of contraindications, 25 (51.0 % did not receive DAT in the absence of contraindications and 6 (12.3 % patients received the therapy in the presence of contraindications. Conclusion. DAT prescribed by outpatient physicians does not always meet the current CG. There are cases of not using DAT in the presence of obvious indications for DAT and, on the contrary, those of its use in the presence of contraindications. 

  20. [Coronary stent evaluation with cardiac CT: Literature review].

    Science.gov (United States)

    Pesenti-Rossi, D; Allouch, P; Gibault-Genty, G; Baron, N; Augusto, S; Convers-Domart, R; Almeida, S; Aubert, S; Squara, P; Livarek, B

    2015-11-01

    Since the introduction of the 64-generation scanners, the accuracy and robustness of the diagnosis of coronary artery disease has progressed. The main advantage of cardiac CT is the exclusion of coronary artery disease by its excellent negative predictive value. Currently, cardiac CT applications extend thanks to innovations both in terms of technological development systems scanner or stents implanted. This is a literature review of stent evaluation with cardiac CT. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  1. Intravascular and intracardiac stents used in congenital heart disease.

    Science.gov (United States)

    Okubo, M; Benson, L N

    2001-03-01

    Intravascular or intracardiac stenoses occur in many forms of congenital heart disease or after attempted surgical repair. Although balloon dilation is one option for management, restenosis can occur due to elastic recoil immediately after the procedure. To address to such stenotic lesions, many reports support implanting endovascular stents to provide a framework for vessel expansion. Both balloon-expandable fixed tubular mesh stainless steel devices, and self-expandable stents have had an extensive clinical application. In pediatric patients, stents are used for a variety of stenoses, such as systemic venous obstruction pathways (eg, Mustard, Fontan baffle, or bidirectional cavopulmonary connections), pulmonary artery, right ventricular to pulmonary conduits, aortic coarctation, the arterial duct, aorticopulmonary collaterals, or postoperative systemic to pulmonary shunts. Because of improvements in device profile, implantation rates have increased. Complications such as stent fracture, migration, aneurysm formation, and in-stent restenosis occur but only rarely. This latter event may be because of intimal hyperplasia and/or continued vessel (and patient) growth related to the stent diameter. As such, some instances require redilation to manage the acquired lesion. Stent application has importantly altered management algorithms in congenital heart disease.

  2. Tracheal stent prediction using statistical deformable models of tubular shapes

    Science.gov (United States)

    Pinho, R.; Huysmans, T.; Vos, W.; Sijbers, J.

    2008-03-01

    Tracheal stenosis is a narrowing of the trachea that impedes normal breathing. Tracheotomy is one solution, but subjects patients to intubation. An alternative technique employs tracheal stents, which are tubular structures that push the walls of the stenotic areas to their original location. They are implanted with endoscopes, therefore reducing the surgical risk to the patient. Stents can also be used in tracheal reconstruction to aid the recovery of reconstructed areas. Correct preoperative stent length and diameter specification is crucial to successful treatment, otherwise stents might not cover the stenotic area nor push the walls as required. The level of stenosis is usually measured from inside the trachea, either with endoscopes or with image processing techniques that, eg compute the distance from the centre line to the walls of the trachea. These methods are not suited for the prediction of stent sizes because they can not trivially estimate the healthy calibre of the trachea at the stenotic region. We propose an automatic method that enables the estimation of stent dimensions with statistical shape models of the trachea. An average trachea obtained from a training set of CT scans of healthy tracheas is placed in a CT image of a diseased person. The shape deforms according to the statistical model to match the walls of the trachea, except at stenotic areas. Since the deformed shape gives an estimation of the healthy trachea, it is possible to predict the size and diameter of the stent to be implanted in that specific subject.

  3. Histological analysis of cobalt-chromium stents with and without Camouflage® polymer coating: experimental porcine carotid artery model.

    Science.gov (United States)

    Grudtner, Marco Aurélio; de Lara Elesbão, Joao Luiz; Gutierrez, Paulo Sérgio; Meyer, Fabíola Schons; Pereira, Adamastor Humberto

    2011-04-01

    This study evaluated the arterial response to cobalt-chromium stents with and without polymer coating (Camouflage®, Hemoteq AG, Wuerselen, Germany) implanted in pigs. Cobalt-chromium balloon-expandable stents (4 × 16 mm) were implanted in the common carotid arteries of nine pigs. Histological analysis of endothelialization, inflammation and injury was performed one month later. All stents were successfully deployed, and all but one animal survived the 30 study days. All arteries were patent. Endothelialization was nearly complete in most sections of all carotid stents in both groups. There were mild inflammatory infiltrate and mild-to-moderate injury, which were associated with the stent shafts and not significantly different between groups. Our findings suggest that, in porcine carotid arteries, the histological response to balloon-expandable cobalt-chromium stents coated with polymer (Camouflage®, Hemoteq AG) is similar to the response to non-coated cobalt-chromium stents.

  4. Improved predictive value of GRACE risk score combined with platelet reactivity for 1-year cardiovascular risk in patients with acute coronary syndrome who underwent coronary stent implantation.

    Science.gov (United States)

    Li, Shan; Liu, Hongbin; Liu, Jianfeng; Wang, Haijun

    2016-11-01

    Both high platelet reactivity (HPR) and Global Registry of Acute Coronary Events (GRACE) risk score have moderate predictive value for major adverse cardiovascular disease (CVD) events in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI), whereas the prognostic significance of GRACE risk score combined with platelet function testing remains unclear. A total of 596 patients with non-ST elevation ACS who underwent PCI were enrolled. The P2Y 12 reaction unit (PRU) value was measured by VerifyNow P2Y 12 assay and GRACE score was calculated by GRACE risk 2.0 calculator. Patients were stratified by a pre-specified cutoff value of PRU 230 and GRACE score 140 to assess 1-year risk of cardiovascular death, non-fatal myocardial infarction (MI), and stent thrombosis. Seventy-two (12.1%) patients developed CVD events during 1-year follow-up. Patients with CVD events had a higher PRU value (244.6 ± 50.9 vs. 203.7 ± 52.0, p risk independently. Compared to patients with normal platelet reactivity (NPR) and GRACE score risk (HR: 5.048; 95% CI: 2.268-11.237; p risk score yielded superior risk predictive capacity beyond GRACE score alone, which is shown by improved c-statistic value (0.871, p = 0.002) as well as net reclassification improvement (NRI 0.263, p risk of adverse CVD events. The combination of platelet function testing and GRACE score predicted 1-year CVD risk better.

  5. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans Henrik; Jensen, Lisette Okkels

    2014-01-01

    -eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...

  6. The Use and Outcomes of Small, Medium and Large Premounted Stents in Pediatric and Congenital Heart Disease.

    Science.gov (United States)

    Boe, Brian A; Zampi, Jeffrey D; Schumacher, Kurt R; Yu, Sunkyung; Armstrong, Aimee K

    2016-12-01

    We sought to describe the use and outcomes of small, medium and large premounted stents in patients with congenital heart disease, including incidence of and risk factors for re-intervention and development of in-stent stenosis. Premounted stents offer several advantages over traditional manually crimped bare-metal stents, especially in small patients. There are no data describing the medium-term effectiveness and outcomes of premounted stents in congenital heart disease. We performed a single-center retrospective review of all small, medium and large premounted stents implanted over an 8-year period. Premounted stents were implanted in 71 vessels within 59 patients with a 97 % success rate. Regardless of implantation site, premounted stent implantation resulted in significant improvements in vessel size and pressure gradient (p congenital heart disease. Frequent follow-up is required, especially in smaller patients with expected somatic growth, and to evaluate for in-stent stenosis which occurs in nearly half of premounted stents.

  7. Mechanical properties and in vivo performance of a novel sliding-lock bioabsorbable poly-p-dioxanone stent.

    Science.gov (United States)

    Feng, Qimao; Jiang, Wenbo; Sun, Kun; Sun, Kang; Chen, Sun; Zhao, Lijiao; Dai, Ke; Ma, Ning

    2011-10-01

    A bioabsorbable poly-p-dioxanone (PPDO) stent with a novel sliding-lock structure was fabricated to treat stenotic peripheral vessels. The sliding-lock PPDO stents have greater radial strength (107 kPa) than PPDO stents with conventional net-tube structure (32 kPa). The sliding-lock PPDO stents were implanted into the iliac arteries of pigs, and implantation success rate was 90% indicating the feasibility of this design. Additionally, we found that sliding-lock PPDO stents kept vessels patent, although by 3 and 6 months post implantation, luminal diameter decreased slightly due to intimal hyperplasia. At 1 month post implantation, the stents were sparsely covered with endothelial cells, and by 6 months, the stents were mostly absorbed and inflammatory reaction gradually decreased as the stents were absorbed. This study shows favorable mechanical strength, degradability and efficacy for the sliding-lock PPDO stents, and supports further research and development of this unique design of polymer stents for applications in vascular devices.

  8. Comparison of one-year clinical outcomes between intravascular ultrasound-guided versus angiography-guided implantation of drug-eluting stents for left main lesions: A single-center analysis of a 1,016-patient cohort

    NARCIS (Netherlands)

    X.-F. Gao (Xiao-Fei); J. Kan (Jing); Y. Zhang (Yaojun); J.-J. Zhang (Jun-Jie); N.-L. Tian (Nai-Liang); F. Ye (Fei); Z. Ge (Zhen); P.-X. Xiao (Ping-Xi); F. Chen (Feng); G.S. Mintz (Gary); S.-L. Chen (Shao-Liang)

    2014-01-01

    textabstractBackground: The importance of intravascular ultrasound (IVUS)-guided stenting of the unprotected left main coronary artery (ULMCA) remains controversial and has not been fully studied in the subset of patients with ULMCA. This study evaluated the clinical outcome of IVUS-guided stenting

  9. Biodegradable and bioabsorbable stents.

    Science.gov (United States)

    Waksman, Ron; Pakala, Rajbabu

    2010-01-01

    Angioplasty of the coronary arteries has made significant headway in the past 20 years as a treatment for atherosclerotic vascular disease. Though drug-eluting stents are effective, they appear to invoke a thrombogenic response. Biodegradable stents are a promising alternative to permanent stents and may eventually be used to solve the lingering problem of in-stent restenosis. Additionally, fully degradable stents have the ability to deliver more drugs to the target site than a thin coating of drug on metallic stents. A variety of degradable materials have been studied for stent design, including polyesters, polycarbonates, bacterial-derived polymers, and corrodible metals. The ideal biodegradable stent would be reliably deployable under fluoroscopic guidance and situate into the target lesion with minimal endovascular trauma. The stent should degrade into nontoxic byproducts and invoke a minimal degree of inflammation at the target site. Finally, the stent itself should disappear within months (to years) without significant displacement from the deployment site. Although initial data from clinical trials have been sufficient to bring biodegradable materials into the realm of feasibility, future research is undoubtedly necessary to resolve the critical issues of inflammation and mechanical stability.

  10. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    Directory of Open Access Journals (Sweden)

    Usha Kiran

    2009-01-01

    Full Text Available Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implanta-tion and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should be adopted with following precautions. i In a surgical patient with a history of percu-taneous coronary intervention (PCI and coronary stent, determine the date of the procedure, the kind of the stent inserted and the possibility of complications during the procedure. ii Consider all patents with a recent stent implan-tation (e.g. less than three months for bare metal stents and less than one year for brachytherapy or drug eluting stents as high risk and consult an interventional cardiologist. iii Any decision to postpone surgery, continue, modify or discontinue antiplatelet regimes must involve the cardiologist, anaesthesiologist, surgeon, haematologist and the intensivist to balance the risk and benefit of each decision.

  11. Neoatherosclerosis: Coronary stents seal atherosclerotic lesions but result in making a new problem of atherosclerosis.

    Science.gov (United States)

    Komiyama, Hidenori; Takano, Masamichi; Hata, Noritake; Seino, Yoshihiko; Shimizu, Wataru; Mizuno, Kyoichi

    2015-11-26

    Chronic inflammation of the native vessel wall with infiltration of lipid-laden foamy macrophages through impaired endothelium results in atherosclerosis. Percutaneous coronary intervention, including metallic stent implantation, is now widely utilized for the treatment of atherosclerotic lesions of the coronary artery. Bare-metal stents and the subsequently developed drug-eluting stents seal the atherosclerosis and resolve lumen stenosis or obstruction of the epicardial coronary artery and myocardial ischemia. After stent implantation, neointima proliferates within the stented segment. Chronic inflammation caused by a foreign body reaction to the implanted stent and subsequent neovascularization, which is characterized by the continuous recruitment of macrophages into the vessel, result in the transformation of the usual neointima into an atheromatous neointima. Neointima with an atherosclerotic appearance, such as that caused by thin-cap fibroatheromas, is now recognized as neoatherosclerosis, which can sometimes cause in-stent restenosis and acute thrombotic occlusion originating from the stent segment following disruption of the atheroma. Neoatherosclerosis is emerging as a new coronary stent-associated problem that has not yet been resolved. In this review article, we will discuss possible mechanisms, clinical challenges, and the future outlook of neoatherosclerosis.

  12. Clinical and angiographic outcomes of axial stent deformations in unrestricted real world patient population.

    Science.gov (United States)

    Sabbah, Mahmoud; Kadota, Kazushige; Kubo, Shunsuke; Hyodo, Yusuke; Otsuru, Suguru; Hasegawa, Daiji; Tada, Takeshi; Habara, Seiji; Tanaka, Hiroyuki; Fuku, Yasushi; Goto, Tsuyoshi

    2017-12-01

    Prior reports have suggested that the design of the Promus Element stent is prone to longitudinal stent deformation (LSD). However, little is known about the clinical and angiographic outcomes of Promus Element stent axial deformations when implanted in unrestricted coronary lesions. Two independent reviewers retrospectively evaluated the procedure steps of 961 Promus Element stent (833 de novo lesions in 494 consecutive patients) implanted in unrestricted coronary lesions, between February 2012 and March 2013, and compared the prevalence, predictors, and the mid-term clinical and angiographic outcomes between lesions with and without stent deformation. Fifteen stents (1.56%) with LSD were observed (95% confidence interval [CI]: 0.78-2.34%). The proximal edge of the stent was deformed in 13 stents (86.6%). Ostial stenting (Adjusted Odds ratio [OR]: 9; 95%CI: 2.27-33.3; P = 0.002), and bifurcation lesions (Adjusted OR: 3; 95%CI: 1.03-8.8; P = 0.04) were independently associated with the occurrence of stent deformation. LSD led to unplanned stenting in (53%, 8 of 15) of the deformed stents, which consumed larger contrast volume and longer fluoroscopy time. At 8-month follow-up, there was no significant difference in binary restenosis rate and target lesions revascularization between both groups (P = 0.98, and P = 0.56, respectively), while death occurred in six patients of the non-LSD group (1.36%, 6 of 440) and none in the LSD group. All patients of the LSD group had no major adverse clinical events at 8-month follow-up. Axial stent deformation in Promus Element platform is an infrequent event, occurs following manipulation of the interventional tools. Other than unplanned stenting, the LSD was not associated with any adverse clinical events at 8-month follow-up. © 2017, Wiley Periodicals, Inc.

  13. Development and Validation of a Stent Thrombosis Risk Score in Patients With Acute Coronary Syndromes

    NARCIS (Netherlands)

    Dangas, George D.; Claessen, Bimmer E.; Mehran, Roxana; Xu, Ke; Fahy, Martin; Parise, Helen; Henri