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Sample records for tubular coronary stents

  1. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

    Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar

    2014-01-01

    to determine the effects of fabrication processes on the topography of the auxetic stent. RESULTS AND CONCLUSIONS: The elastic recoil (3.3%) of the in vitro mechanical analysis showed that the auxetic stent design effectively maintained the luminal patency of the coronary artery. Also, the auxetic coronary...... was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used...

  2. Incidence and predictors of coronary stent thrombosis

    DEFF Research Database (Denmark)

    D'Ascenzo, Fabrizio; Bollati, Mario; Clementi, Fabrizio

    2013-01-01

    Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent...... thrombosis....

  3. Circadian Variation in Coronary Stent Thrombosis

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Ting, Henry H.; Rihal, Charanjit S.; Holmes, David R.

    Objectives We sought to determine the circadian, weekly, and seasonal variation of coronary stent thrombosis. Background Other adverse cardiovascular events such as acute myocardial infarction are known to have higher incidences during the early morning hours, Mondays, and winter months. Methods The

  4. Acute stent thrombosis after primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Clemmensen, Peter; Wiberg, Sebastian; Van't Hof, Arnoud

    2015-01-01

    OBJECTIVES: This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. BACKGROUND: Bivalirudin started during transport for primary percutaneous coronary int...

  5. Mechanical Behavior of Fully Expanded Commercially Available Endovascular Coronary Stents

    OpenAIRE

    Tambaca, Josip; Canic, Suncica; Kosor, Mate; Fish, R. David; Paniagua, David

    2011-01-01

    The mechanical behavior of endovascular coronary stents influences their therapeutic efficacy. Through computational studies, researchers can analyze device performance and improve designs. We developed a 1-dimensional finite element method, net-based algorithm and used it to analyze the effects of radial loading and bending in commercially available stents. Our computational study included designs modeled on the Express, Cypher, Xience, and Palmaz stents.

  6. Coronary stent on coronary CT angiography: Assessment with model-based iterative reconstruction technique

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Chae; Kim, Yeo Koon; Chun, Eun Ju; Choi, Sang IL [Dept. of of Radiology, Seoul National University Bundang Hospital, Seongnam (Korea, Republic of)

    2016-05-15

    To assess the performance of model-based iterative reconstruction (MBIR) technique for evaluation of coronary artery stents on coronary CT angiography (CCTA). Twenty-two patients with coronary stent implantation who underwent CCTA were retrospectively enrolled for comparison of image quality between filtered back projection (FBP), adaptive statistical iterative reconstruction (ASIR) and MBIR. In each data set, image noise was measured as the standard deviation of the measured attenuation units within circular regions of interest in the ascending aorta (AA) and left main coronary artery (LM). To objectively assess the noise and blooming artifacts in coronary stent, we additionally measured the standard deviation of the measured attenuation and intra-luminal stent diameters of total 35 stents with dedicated software. All image noise measured in the AA (all p < 0.001), LM (p < 0.001, p = 0.001) and coronary stent (all p < 0.001) were significantly lower with MBIR in comparison to those with FBP or ASIR. Intraluminal stent diameter was significantly higher with MBIR, as compared with ASIR or FBP (p < 0.001, p = 0.001). MBIR can reduce image noise and blooming artifact from the stent, leading to better in-stent assessment in patients with coronary artery stent.

  7. Enhancement of endothelialisation of coronary stents by laser surface engineering.

    Science.gov (United States)

    Li, Lin; Mirhosseini, Nazanin; Michael, Alun; Liu, Zhu; Wang, Tao

    2013-11-01

    Coronary stents have been widely used in the treatment of coronary heart disease. However, complications have hampered the long-term success of the device. Bare-metal stents (BMS) have a high rate of restenosis and poor endothelialisation. The drug-eluting stents (DES), although dramatically reduce restenosis, significantly prevent endothelialisation leading to late thrombosis and behave the same way as BMS after drug releasing. Rapid adhesion and growth of endothelial cells on the stent surface is a key process for early vascular healing after coronary stenting which contributes to the reduction of major complications. Surface properties manipulate cell growth and directly determine the success and life-span of the implants. However, the ideal surface properties of coronary stents are not yet fully understood. The objective of this research is to understand how surface micro/nano textures and associated material chemistry changes generated by a laser beam affect the behavior of endothelial cells on bare metal 316L stents. A high power laser beam was applied to modifying the surface properties of 316L coronary stent material and the commercial coronary stents, followed by examination of the adhesion and proliferation of human coronary endothelial cells that were growing on the surfaces. Surface properties were examined by scanning electron microscopy, contact angle measurement, and X-ray photoelectron spectroscopy. A novel surface with combined micro/nano features was created on stent material 316L and coronary stent with a specific surface chemistry. This surface gives rise to a threefold increase in the adhesion and eightfold increase in the proliferation of endothelial cells. Interestingly, such effects were only observed when the surface texture was produced in the nitrogen atmosphere suggesting the importance of the surface chemistry, including the dramatic increase of chromium nitride, for the interaction of endothelial cells with the material surface. This

  8. 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

  9. Coronary bifurcation lesions treated with simple or complex stenting

    DEFF Research Database (Denmark)

    Behan, Miles W; Holm, Niels R; de Belder, Adam J

    2016-01-01

    AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data...

  10. 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.

  11. 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.

  12. Drug-eluting stents versus bare-metal stents for acute coronary syndrome

    DEFF Research Database (Denmark)

    Feinberg, Joshua; Nielsen, Emil Eik; Greenhalgh, Janette

    2017-01-01

    BACKGROUND: Approximately 3.7 million people died from acute coronary syndrome worldwide in 2012. Acute coronary syndrome, also known as myocardial infarction or unstable angina pectoris, is caused by a sudden blockage of the blood supplied to the heart muscle. Percutaneous coronary intervention...... CRITERIA: Randomised clinical trials assessing the effects of drug-eluting stents versus bare-metal stents for acute coronary syndrome. We included trials irrespective of publication type, status, date, or language. DATA COLLECTION AND ANALYSIS: We followed our published protocol and the methodological......-eluting stents group compared with 6.63% in the bare-metal stents group based on the RR of 0.96 (95% CI 0.83 to 1.11, 10,939 participants, 19 trials/20 comparisons, very low-quality evidence). The results of Trial Sequential Analysis showed that we did not have sufficient information to confirm or reject our...

  13. Assessment Of Coronary Arterial Stents By Multislice-CT Angiography

    International Nuclear Information System (INIS)

    Maintz, D.; Fallenberg, E. M.; Heindel, W.; Fischbach, R.; Grude, M.

    2003-01-01

    Purpose: To assess patency and lumen visibility of coronary artery stents by multislice-CT angiography (MSCTA) in comparison with conventional coronary angiography as the standard of reference. Material and Methods: 47 stents of 13 different types were evaluated in 29 patients. MSCTA was performed on a 4-slice scanner with a standard coronary protocol (detector collimation 4 x 1 mm; table feed 1.5 mm/rotation, 400 mAs, 120 kV). Image evaluation was performed by two readers who were blinded to the reports from the catheter angiography. MIP reconstructions were evaluated for image quality on a 4-point scale (1 = poor, 4 = excellent) and stent patency (contrast distal to the stent as an indirect patency sign). Axial images and multiplanar reformations through the stents were used for assessment of stent lumen visibility (measurement of the visible stent lumen diameter) and detection of relevant in-stent stenosis (50%). Results: Image quality was fair to good on average (score 2.64 ± 1.0) and depended on the heart rate (heart rate 45-60: average score 3.2, heart rate 61-70: average score 2.8, heart rate >71: average score 1.4). Thirty-seven stents were correctly classified as patent, 1 was correctly classified as occluded and 9 stents were not assessable due to insufficient image quality because of triggering artifacts. Parts of the stent lumen could be visualized in 30 cases. On average, 20-40% of the stent lumen diameter was visible. Twenty-five stents were correctly classified as having no stenosis, 1 was falsely classified as stenosed, 1 was correctly classified as occluded. In 20 stents lumen visibility was not sufficient for stenosis evaluation. Conclusion: Although the stent lumen may be partly visualized in most stents, a reliable evaluation of in-stent stenoses does not seem practical by 4-slice MSCT. Nevertheless, for stent patency evaluation, MS-CTA might provide valuable clinical information. With submillimeter MSCT (e.g. 16-slice scanners) and more

  14. FORMATION OF SIX SIGMA INFRASTRUCTURE FOR THE CORONARY STENTING PROCESS

    Directory of Open Access Journals (Sweden)

    Mehmet Tolga Taner

    2013-10-01

    Full Text Available The purpose of this study is to show how a tertiary care center in Turkey operating mainly in cardiology initiated Six Sigma principles to reduce the number of complications occuring during coronary stent insertion process. A Six Sigma’s Define-Measure-Analyze-Improve-Control (DMAIC model for coronary stent insertion is suggested. Data were collected for 24-months. Twenty-two Critical-to-Quality (CTQ factors were identified for successful coronary stent insertion. The most frequent causes of complications in the process were found to be patients with previous bypass surgery or PCI, inexperience of staff members, highly damaged vessel structure, thin and/or long vessel diameter, inappropriate selection of stent type, inappropriate selection of balloon type and poor image quality.

  15. Spontaneous coronary artery dissection: complete angiographic resolution without stenting

    Directory of Open Access Journals (Sweden)

    Alexandre Abizaid

    2007-09-01

    Full Text Available A case of spontaneous coronary artery dissection in a 49-year-oldwoman is presented. She did not present the classical cardiovascular riskfactors. Etiology and treatment are discussed. She underwent primarypercutaneous coronary intervention of the left anterior descendingartery with no stenting and had complete angiographic resolution.

  16. Edge detection versus densitometry for assessing coronary stenting quantitatively

    NARCIS (Netherlands)

    B.H. Strauss (Bradley); Y. Juilliere; B.J.W.M. Rensing (Benno); J.H.C. Reiber (Johan); P.W.J.C. Serruys (Patrick)

    1991-01-01

    textabstractThe optimal method used to analyze quantitatively the immediate angiographic results of coronary stenting in the coronary arteries has not been studied. Accordingly, minimal luminal cross-sectional area was determined by 2 methods, edge detection and densitometry, in 19 patients who

  17. Flow disturbances in stent-related coronary evaginations

    DEFF Research Database (Denmark)

    Radu, Maria D; Pfenniger, Aloïs; Räber, Lorenz

    2014-01-01

    Aims: Angiographic ectasias and aneurysms in stented segments have been associated with late stent thrombosis. Using optical coherence tomography (OCT), some stented segments show coronary evaginations reminiscent of ectasias. The purpose of this study was to explore, using computational fluid......-dynamic (CFD) simulations, whether OCT-detected coronary evaginations can induce local changes in blood flow. Methods and results: OCT-detected evaginations are defined as outward bulges in the luminal vessel contour between struts, with the depth of the bulge exceeding the actual strut thickness. Evaginations...... can be characterised cross ectionally by depth and along the stented segment by total length. Assuming an ellipsoid shape, we modelled 3-D evaginations with different sizes by varying the depth from 0.2-1.0 mm, and the length from 1-9 mm. For the flow simulation we used average flow velocity data from...

  18. Surface Topographical Modification of Coronary Stent: A Review

    Science.gov (United States)

    Tan, C. H.; Muhamad, N.; Abdullah, M. M. A. B.

    2017-06-01

    Driven by the urge of mediating the inflammatory response from coronary stent implant to improve patency rates of the current coronary stent, concern has been focusing on reducing the risk of in-stent restenosis and thrombosis for long-term safety. Surface modification approach has been found to carry great potential due to the surface is the vital parts that act as a buffer layer between the biomaterial and the organic material like blood and vessel tissues. Nevertheless, manipulating cell response in situ using physical patterning is very complex as the exact mechanism were yet elucidated. Thus, the aim of this review is to summarise the recent efforts on modifying the surface topography of coronary stent at the micro- and nanometer scale with the purpose of inducing rapid in situ endothelialization to regenerate a healthy endothelium layer on biomaterial surface. In particular, a discussion on the surface patterns that have been investigated on cell selective behaviour together with the methods used to generate them are presented. Furthermore, the probable future work involving the surface modification of coronary stent were indicated.

  19. Association of stent-induced changes in coronary geometry with late stent failure: Insights from three-dimensional quantitative coronary angiographic analysis.

    Science.gov (United States)

    Zhang, Bu Chun; Tu, Sheng Xian; Karanasos, Antonios; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; Regar, Evelyn

    2018-02-05

    The relationship between vessel angulation and large changes in vessel geometry after stent implantation and the occurrence of stent failure still remains unclear. We sought to investigate the association of the change in the coronary bending angle after stenting and the risk for late stent failure by three-dimensional quantitative coronary angiography (3D QCA). The bending angle in coronary lesions that presented with late stent failure and those without stent failure was computed during the cardiac cycle, before and after stenting using a recently developed 3D QCA software. A total of 40 lesions with stent failure (cases) were successfully matched to 47 lesions without stent failure (controls).The mean duration to follow-up coronary angiography was 1,011 days in cases and 1,109 days in the control group (P = 0.14). In stent failure, the systolic bending angle after stenting was smaller (14.45° [12.18, 17.68] versus 18.20° [14.00, 20.30], P = 0.01), while the stent-induced change in systolic bending angle was significantly larger (4.15° [1.13, 7.20] versus 1.80° [-1.90, 4.40], P = 0.004). Multivariable logistic regression analysis suggested that systolic bending angle after stenting (odds ratio: 0.88; 95% CI: 0.79-0.99; P = 0.03), and decrease in systolic bending angle after stenting (odds ratio: 1.13; 95% CI: 1.02-1.26; P = 0.03) were predictors of stent failure. Our study suggests that a change in the natural tortuous course of the coronaries by stent implantation with the decrease in coronary bending angle is a potentially major contributor in stent failure. © 2018 Wiley Periodicals, Inc.

  20. 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 or resteno......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...

  1. Safety of spinal anaesthesia in patients with recent coronary stents ...

    African Journals Online (AJOL)

    We report on a patient with a known history of chronic obstructive airway disease with respiratory tract infection who presented for emergency pseudoaneurysm repair. He underwent recent coronary stent implantation and was treated with clopidogrel and aspirin. Despite dual antiplatelet therapy, spinal anaesthesia was ...

  2. Coated stents to prevent restenosis in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2005-11-01

    Full Text Available Background: In-stent-restenosis (ISR is considered to be an essential limiting factor of stenting in coronary heart disease (CHD. The development of coated stents has raised expectations on substantial lowering restenosis after stenting with decreasing the rate of restenosis and a reduction in the rate of clinical events. Objectives: The present analysis addresses the questions on medical effectiveness and cost-effectiveness of the use of various coated stent types in CHD. Methods: The literature was searched in December 2004 in the most relevant medical and economic databases. The medical evaluation was conducted on the basis of published RCT. The data from the studies regarding various angiographic, sonographic and clinical endpoints were checked for methodical quality and summarised in meta-analyses. Within the scope of economic evaluation the primary studies were analysed and modelling was performed, applying clinical effect estimates from the meta-analyses of the medical evaluation and current estimates of German costs. Results: Medical evaluation: Ten different stenttypes were used in the included 26 RCT. The results for heparin, silicon-carbide, carbon and PTFE coated stenttypes could not reveal any significant differences between the medical effectiveness of coated and uncoated stents. The application of sirolimus, paclitaxel, everolimus and 7-hexanoyltaxol eluting stents showed a significant lower restenosis at 6-9 months with decrease in the rate of restenosis for polymer-based sirolimus, paclitaxel and 7-hexanoyltaxol eluting stents. In contrast, the use of gold-coated and actinomycin-D eluting stents was associated with a significantly higher restenosis. The polymer-based sirolimus and paclitaxel eluting stents also showed a significant and considerable reduction in the rate of repeated percutaneous revascularisations at 6-12 months (3.5% vs. 19.7%; p<0.0001, RR=0.19 [95%CI: 0.11; 0.33] and 3.5% vs. 12.2%; p<0.0001, RR=0.30 [95%CI: 0

  3. 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.

  4. In vitro evaluation of 56 coronary artery stents by 256-slice multi-detector coronary CT

    Energy Technology Data Exchange (ETDEWEB)

    Steen, Henning, E-mail: henning.steen@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Andre, Florian, E-mail: Florian.Andre@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Korosoglou, Grigorios, E-mail: Grigorios.Korosoglou@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Mueller, Dirk, E-mail: Dirk.Mueller@philips.com [Philips GmbH Healthcare Division, Luebeckertordamm 5, Hamburg 20099 (Germany); Hosch, Waldemar, E-mail: Waldemar.Hosch@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Kauczor, Hans-Ulrich, E-mail: Hans-Ulrich.Kauczor@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Giannitsis, Evangelos, E-mail: Evangelos.Giannitsis@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Katus, Hugo A., E-mail: Hugo.Katus@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany)

    2011-10-15

    Objective: We sought to investigate stent lumen visibility of 56 coronary stents with the newest 256-multi-slice-CT (256-MDCT) technology for different reconstruction algorithms in an in vitro model. Background: Early identification of in-stent restenosis (ISR) is important to avoid recurrent ischemia and prevent acute myocardial infarction (AMI). Since angiography has the disadvantage of high costs and its invasiveness, MDCT could be a convenient and safe non-invasive alternative for detection of ISR. Material and methods: Percentages of in-stent lumen diameter and in-stent signal attenuation (measured as contrast-to-noise ratio (CNR)) of 56 coronary stents (group A {<=}2.5 mm; group B = 2.75-3.0 mm; group C = 3.5-4.0 mm) were evaluated in a coronary vessel in vitro phantom (iodine-filled plastic tubes) employing four different reconstruction algorithms (XCD, CC, CD, XCB) on a novel 256-MDCT (Philips-iCT, collimation = 128 mm x 0.625 mm; rotation time = 270 ms; tube current = 800 mA s with 120 kV). Analysis was conducted with the semi-automatical full-width-at-half-maximum (FWHM) method. P-values <0.05 were regarded statistically significant. Results: In-stent lumen diameter >60% for group C stents was significantly larger and CNR was significantly lower (both p < 0.05) for sharp kernels (CD; XCD) when compared to groups A/B. The FWHM-method showed significantly smaller in-stent lumen diameter (p < 0.05) when compared to the manual method. Conclusion: 256-MDCT could potentially be employed for clinical assessment of stent patency in stents >3.0 mm when analysed with cardio-dedicated sharp kernels, although clinical studies corroborating this claim should be performed. However, stents {<=}3.0 mm reconstructed by soft kernels revealed insufficient in-stent lumen visualisation and should not be used in clinical practice. Further improvements in spatial and temporal image resolution as well as reductions of radiation exposure and image noise have to be accomplished

  5. Evaluation of metal allergies in patients with coronary stents.

    Science.gov (United States)

    Hillen, U; Haude, M; Erbel, R; Goos, M

    2002-12-01

    In-stent restenosis is a complication which impairs the success of coronary stenting. Recently, it was supposed that a delayed hypersensitivity reaction to nickel and molybdenum might be one of the triggering factors in in-stent restenosis. We have analyzed the data collected in our centre with respect to this hypothesis. Altogether, 34 patients were investigated (24 male, 10 female). Patch tests were performed with the standard series of the German Contact Dermatitis Research Group and a metal series containing the metal components of 316 L stainless steel. A positive patch test reaction to nickel was observed in 4 (11.8%) patients. None of the patients showed sensitization to the other metals. Retrospective analysis was performed in 20 patients: 2 of these patients had a positive patch test reaction to nickel, one of whom had an in-stent restenosis, and the other not. Restenoses were predominantly observed in patients with negative patch test reactions to nickel (6/18 patients). Out of the patients who were investigated prospectively only one showed sensitization to nickel. Restenosis was observed in 2 patients: neither patient had nickel allergy. Although it still cannot be excluded that metal allergy may play a role in the restenosis process in coronary stenting, there is at present little evidence for it.

  6. Sensor to detect endothelialization on an active coronary stent

    Directory of Open Access Journals (Sweden)

    Coffey Arthur C

    2010-11-01

    Full Text Available Abstract Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks.

  7. 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.

  8. Is there a link between nickel allergy and coronary stent restenosis?

    Science.gov (United States)

    Norgaz, Tugrul; Hobikoglu, Gultekin; Serdar, Zehra Asiran; Aksu, Huseyin; Alper, Ahmet Taha; Ozer, Orhan; Narin, Ahmet

    2005-07-01

    Although many patients with coronary artery disease are being treated by coronary stents, in-stent restenosis is the major limitation of percutaneous coronary stenting procedures. Most stents are made of stainless steel, and that, allergic reactions to nickel ions released from coronary stainless-steel stents may be one of the triggering mechanisms for in-stent restenosis. We aimed to evaluate the relationship between in-stent restenosis and nickel allergy in a prospective study. For this purpose, we applied epicutaneous patch test for nickel in 43 patients who had undergone elective intracoronary stent placement for stable angina pectoris in the day following stent placement and evaluated the presence of nickel allergy. Control angiography was performed at 6 months to determine in-stent restenosis. Three (6.9%) patients had allergic reaction to nickel and 16 (37%) patients had developed in-stent restenosis. One of the 3 patients with nickel allergy had diffuse in-stent restenosis and the others not. The present study therefore does not support the proposed relationship between nickel allergy and development of in-stent restenosis in patients having stainless steel stents. Large scale studies are needed to reach a final conclusion.

  9. 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

  10. Silicon-carbide coated coronary stents have low platelet and leukocyte adhesion during platelet activation

    NARCIS (Netherlands)

    Monnink, SHJ; van Boven, AJ; Tigchelaar, [No Value; de Kam, PJ; Crijns, HJGM; van Oeveren, W

    Background: Stent thrombosis and restenosis are of great clinical significance. We constructed a closed loop in vitro heparinized whole human blood circulation model for testing hemocompatibility of coronary stents, This model allows evaluation of human blood activation by blood-stent interaction in

  11. Endovascular tubular stent-graft placement for isolated iliac artery aneurysms.

    Science.gov (United States)

    Okada, Takuya; Yamaguchi, Masato; Kitagawa, Atsushi; Kawasaki, Ryota; Nomura, Yoshikatsu; Okita, Yutaka; Sugimura, Kazuro; Sugimoto, Koji

    2012-02-01

    To evaluate the safety, efficacy, and mid-term outcomes of endovascular tubular stent-graft placement for repair of isolated iliac artery aneurysms (IAAs). Between January 2002 and March 2010, 20 patients (7 women and 13 men; mean age 74 years) underwent endovascular repair of 22 isolated IAAs. Two patients underwent endovascular repair for bilateral aneurysms. Ten para-anastomotic aneurysms (45%) developed after open abdominal aortic aneurysm (AAA) repair with an aorto-iliac graft, and 12 were true aneurysms (55%). Eleven straight and 11 tapered stent-grafts were placed. Contrast-enhanced computed tomography (CT) was performed to detect complications and evaluate aneurysmal shrinkage at week 1, 3, 6, and 12 months and once every year thereafter. Non-contrast-enhanced CT was performed in seven patients with chronic kidney disease. All procedures were successful, without serious complications, during the mean (range) follow-up period of 746 days (47-2651). Type II endoleak not requiring treatment was noted in one patient. The mean (SD) diameters of the true and para-anastomotic aneurysms significantly (p IAAs is safe and efficacious. Tapered stent-grafts of various sizes are required for accurate placement.

  12. Trapped Stent in the Left Coronary Sinus in a Myocardial Infarction Patient

    Directory of Open Access Journals (Sweden)

    Sun Han

    2015-10-01

    Full Text Available Stent entrapment is a very rare complication of percutaneous coronary intervention. The interventional approach could be a treatment strategy. However, if it does not work, surgical treatment should be considered. Here, we report a case of surgical treatment of stent entrapment in the left coronary sinus of a 53-year-old male patient.

  13. High frequency of contact allergy to gold in patients with endovascular coronary stents.

    Science.gov (United States)

    Ekqvist, S; Svedman, C; Möller, H; Kehler, M; Pripp, C M; Björk, J; Gruvberger, B; Holmström, E; Gustavsson, C G; Bruze, M

    2007-10-01

    Stent implantation is an effective method for treatment of atherosclerotic disease. Factors predisposing to in-stent restenosis are still largely unknown. Contact allergy to metal ions eluted from the stent has been suggested to be a risk factor. To explore whether there is a possible induction of contact allergy to metals used in stents among patients with a stainless steel stent containing nickel (Ni stent) and patients with a gold-plated stent (Au stent). Adults (n = 484) treated with coronary stent implantation participated in the study with patch testing. The study design was retrospective and cross-sectional with no assessment of contact allergy before stenting. Age- and sex-matched patch-tested patients with dermatitis (n = 447) served as controls. Of Au-stented patients, 54 of 146 (37%) were allergic to gold compared with 85 of 447 (19%) controls (P stented population there were no statistically significant differences in contact allergy to gold or nickel between Ni-stented and Au-stented patients. In multivariate models where other risk factors for contact allergy to gold were considered, the Au stent showed a trend towards statistical significance (odds ratio 1.43, 95% confidence interval 0.95-2.16; P = 0.09). As the frequency of contact allergy to gold is higher in stented patients independent of stent type it suggests a previous sensitization. However, several pieces of circumstantial evidence as well as statistical analysis indicate the possibility of sensitization in the coronary vessel by the Au stent. Ni stents and Au stents should not be ruled out as risk factors for induction of contact allergy to these metals.

  14. Resolute Integrity drug eluting stent safety and efficacy for the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Burgos JD

    2013-02-01

    Full Text Available Jose D Burgos, Safa Farrag, Debabrata Mukherjee Department of Internal Medicine, Paul L Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA Abstract: The need to develop a local antirestenotic mechanism to prevent in-stent thrombosis has driven the development of new generation stents. The Resolute Integrity® stent is a zotarolimus-eluting system with a new BioLinx™ polymer that allows a slower drug elution. Recently available data has shown the clinical efficacy and safety of this stent in randomized and observational studies. The Resolute Integrity stent system has demonstrated noninferiority when compared with other stents and holds the promise to treat more complex coronary lesions. Keywords: zotarolimus, BioLinx, coronary stenosis, stents, restensosis, stent thrombosis

  15. Blood flow in stented coronary artery: numerical fluid dynamics analysis.

    Science.gov (United States)

    Bénard, N; Perrault, R; Coisne, D

    2004-01-01

    Recent generalization of stent implantation in interventional cardiology require full understanding of blood flow cartography. Interdepency between fluid stresses and in vivo cells covering lumen artery are regularly accused to be one of the instigator of neointimal proliferation (thickening of the inner layer of blood vessels) and mid-term restenosis. This study purpose to numericaly investigate the three dimensional flow in vicinity of an endoprothesis. We used a finite element method to simulate a steady flow of non-Newtonian fluid in a coronary artery using a rigid wall approximation. Results on the velocities, wall shear stress and wall shear stress gradients are presented. Theses simulations allow identification of stagnation site and low wall shear stress area that may be prone to clot formation and neointimal hyperplasia. Intra stent flow knowledge can potentially contribute to optimization of prothesis design and decreasing second intervention rate.

  16. Use of a Three-Stent Technique for a Case of Spontaneous Coronary Artery Dissection.

    Science.gov (United States)

    Dashwood, Alexander M; Saw, Jacqueline; Dhillon, Priyanka; Murdoch, Dale

    2017-06-01

    A 78-year-old woman presented with acute inferior ST-segment-elevation myocardial infarction and complete heart block. Angiography revealed spontaneous coronary artery dissection (SCAD) of her right coronary artery. Given her ongoing instability, we proceeded to primary coronary intervention. A strategy of sealing the distal lesion edge followed by the proximal edge containing the intramural hematoma before placing a final stent to the midsegment was decided on (3-stent strategy). Our case represents the second such "sequential stent-sandwiching" report and provides a strategy for percutaneous coronary intervention in hemodynamically unstable patients with SCAD. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  17. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  18. Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

    Science.gov (United States)

    Quizhpe, Arturo R; Feres, Fausto; de Ribamar Costa, José; Abizaid, Alexandre; Maldonado, Galo; Costa, Ricardo; Abizaid, Andrea; Cano, Manuel; Moreira, Adriana C; Staico, Rodolfo; Mattos, Luiz Alberto; Tanajura, Luiz Fernando; Chaves, Aurea; Centemero, Marinella; Sousa, Amanda M R; Sousa, J Eduardo M R

    2007-08-01

    Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

  19. Computational fluid dynamic simulations of image-based stented coronary bifurcation models

    Science.gov (United States)

    Chiastra, Claudio; Morlacchi, Stefano; Gallo, Diego; Morbiducci, Umberto; Cárdenes, Rubén; Larrabide, Ignacio; Migliavacca, Francesco

    2013-01-01

    One of the relevant phenomenon associated with in-stent restenosis in coronary arteries is an altered haemodynamics in the stented region. Computational fluid dynamics (CFD) offers the possibility to investigate the haemodynamics at a level of detail not always accessible within experimental techniques. CFD can quantify and correlate the local haemodynamics structures which might lead to in-stent restenosis. The aim of this work is to study the fluid dynamics of realistic stented coronary artery models which replicate the complete clinical procedure of stent implantation. Two cases of pathologic left anterior descending coronary arteries with their bifurcations are reconstructed from computed tomography angiography and conventional coronary angiography images. Results of wall shear stress and relative residence time show that the wall regions more prone to the risk of restenosis are located next to stent struts, to the bifurcations and to the stent overlapping zone for both investigated cases. Considering a bulk flow analysis, helical flow structures are generated by the curvature of the zone upstream from the stent and by the bifurcation regions. Helical recirculating microstructures are also visible downstream from the stent struts. This study demonstrates the feasibility to virtually investigate the haemodynamics of patient-specific coronary bifurcation geometries. PMID:23676893

  20. Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis.

    Science.gov (United States)

    Martin, David; Boyle, Fergal

    2015-09-01

    Several clinical studies have identified a strong correlation between neointimal hyperplasia following coronary stent deployment and both stent-induced arterial injury and altered vessel hemodynamics. As such, the sequential structural and fluid dynamics analysis of balloon-expandable stent deployment should provide a comprehensive indication of stent performance. Despite this observation, very few numerical studies of balloon-expandable coronary stents have considered both the mechanical and hemodynamic impact of stent deployment. Furthermore, in the few studies that have considered both phenomena, only a small number of stents have been considered. In this study, a sequential structural and fluid dynamics analysis methodology was employed to compare both the mechanical and hemodynamic impact of six balloon-expandable coronary stents. To investigate the relationship between stent design and performance, several common stent design properties were then identified and the dependence between these properties and both the mechanical and hemodynamic variables of interest was evaluated using statistical measures of correlation. Following the completion of the numerical analyses, stent strut thickness was identified as the only common design property that demonstrated a strong dependence with either the mean equivalent stress predicted in the artery wall or the mean relative residence time predicted on the luminal surface of the artery. These results corroborate the findings of the large-scale ISAR-STEREO clinical studies and highlight the crucial role of strut thickness in coronary stent design. The sequential structural and fluid dynamics analysis methodology and the multivariable statistical treatment of the results described in this study should prove useful in the design of future balloon-expandable coronary stents.

  1. Tubularized incised plate urethroplasty with or without stent in Hypospadias repair: a systematic review and meta-analysis

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    Seyed Abdollah Mousavi

    2014-07-01

    Full Text Available Numerous methods for repair of hypospadias have been introduced. The technique of Tubularized Incised Plate urethroplasty has gained widespread acceptance. In the classical method of Tubularized Incised Plate urethroplasty, to divert urine flow and preventing urethral stenosis, a stent was used, but its necessity is questionable for some surgeons. In this paper we systematically compared the results of operations in different studies. Searching the databases such as PubMed, SCOPUS, and Google Scholar was done and articles found from January 1994 to September 2013 were included. Then articles about the impact of use or non-use of urinary catheters on surgical outcomes were analyzed. By reviewing 168 studies related to repair of hypospadias with TIP, we selected 11 studies that met our inclusion criteria which did not use a stent. A total of 708 children had urethroplasty using the TIP method without stent. The overall complication rate such as meatal stenosis and fistula compared with stents was not significant. It could tell us that at least in some cases especially in distal types, use of stent can be avoided, because its least benefit would be reduction of bladder spasm and urinary tract infections.

  2. 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.

  3. Computational fluid dynamics study of commercially available stents inside an idealised curved coronary artery

    Science.gov (United States)

    Chen, Winson Xiao; Ooi, Andrew; Hutchins, Nicholas; Poon, Eric; Thondapu, Vikas; Barlis, Peter

    2015-11-01

    Stent placement restores blood flow in diseased coronary arteries and is the standard treatment for obstructive coronary atherosclerosis. Analysis of the hemodynamic characteristics of stented arteries is essential for better understanding of the relationship between key fluid dynamic variables and stent designs. Previous computational studies have been limited to idealised stents in curved arterial segments or more realistic stents in straight segments. In clinical practice, however, it is often necessary to place stents in geometrically complex arterial curvatures. Thus, numerical simulations of the incompressible Navier-Stokes equations are carried out to investigate the effects of curvature on hemodynamics using detailed, commercially available coronary stents. The computational domain is a 3mm curved coronary artery model and simulations are conducted using a physiologically realistic inlet condition. The averaged flow rate is about 80 mL/min, similar to the normal human resting condition. The examination of hemodynamic parameters will assess the performance of several commercially available stents in curved arteries and identify regions that may be at risk for restenosis. It is anticipated that this information will lead to improvements in future stent design and deployment.

  4. Long-term mortality of coronary artery bypass grafting and bare-metal stenting.

    Science.gov (United States)

    Wu, Chuntao; Zhao, Songyang; Wechsler, Andrew S; Lahey, Stephen; Walford, Gary; Culliford, Alfred T; Gold, Jeffrey P; Smith, Craig R; Holmes, David R; King, Spencer B; Higgins, Robert S D; Jordan, Desmond; Hannan, Edward L

    2011-12-01

    There is little information on relative survival with follow-up longer than 5 years in patients undergoing coronary artery bypass grafting (CABG) and patients undergoing percutaneous coronary intervention (PCI) with stenting. This study tested the hypothesis that CABG is associated with a lower risk of long-term (8-year) mortality than is stenting with bare-metal stents for multivessel coronary disease. We identified 18,359 patients with multivessel disease who underwent isolated CABG and 13,377 patients who received bare-metal stenting in 1999 to 2000 in New York and followed their vital status through 2007 using the National Death Index (NDI). We matched CABG and stent patients on the number of diseased coronary vessels, proximal left anterior descending (LAD) artery disease, and propensity of undergoing CABG based on numerous patient characteristics and compared survival after the 2 procedures. In the 7,235 pairs of matched patients, the overall 8-year survival rates were 78.0% for CABG and 71.2% for stenting (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.64 to 0.74; p grafting is associated with a lower risk of death than is stenting with bare metal stents for multivessel coronary disease. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Development and characterization of a coronary polylactic acid stent prototype generated by selective laser melting.

    Science.gov (United States)

    Flege, Christian; Vogt, Felix; Höges, Simon; Jauer, Lucas; Borinski, Mauricio; Schulte, Vera A; Hoffmann, Rainer; Poprawe, Reinhart; Meiners, Wilhelm; Jobmann, Monika; Wissenbach, Konrad; Blindt, Rüdiger

    2013-01-01

    In-stent restenosis is still an important issue and stent thrombosis is an unresolved risk after coronary intervention. Biodegradable stents would provide initial scaffolding of the stenosed segment and disappear subsequently. The additive manufacturing technology Selective Laser Melting (SLM) enables rapid, parallel, and raw material saving generation of complex 3- dimensional structures with extensive geometric freedom and is currently in use in orthopedic or dental applications. Here, SLM process parameters were adapted for poly-L-lactid acid (PLLA) and PLLA-co-poly-ε-caprolactone (PCL) powders to generate degradable coronary stent prototypes. Biocompatibility of both polymers was evidenced by assessment of cell morphology and of metabolic and adhesive activity at direct and indirect contact with human coronary artery smooth muscle cells, umbilical vein endothelial cells, and endothelial progenitor cells. γ-sterilization was demonstrated to guarantee safety of SLM-processed parts. From PLLA and PCL, stent prototypes were successfully generated and post-processing by spray- and dip-coating proved to thoroughly smoothen stent surfaces. In conclusion, for the first time, biodegradable polymers and the SLM technique were combined for the manufacturing of customized biodegradable coronary artery stent prototypes. SLM is advocated for the development of biodegradable coronary PLLA and PCL stents, potentially optimized for future bifurcation applications.

  6. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.

    Science.gov (United States)

    Tamai, H; Igaki, K; Kyo, E; Kosuga, K; Kawashima, A; Matsui, S; Komori, H; Tsuji, T; Motohara, S; Uehata, H

    2000-07-25

    Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent. Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months. Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.

  7. Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

    Science.gov (United States)

    Abizaid, Alexandre; Lansky, Alexandra J; Fitzgerald, Peter J; Tanajura, Luis Fernando; Feres, Fausto; Staico, Rodolfo; Mattos, Luiz; Abizaid, Andrea; Chaves, Aurea; Centemero, Marinella; Sousa, Amanda G M R; Sousa, J Eduardo; Zaugg, Margo J; Schwartz, Lewis B

    2007-05-15

    The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

  8. 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

  9. Safety and efficacy of angioplasty with intracoronary stenting in patients with unstable coronary syndromes. Comparison with stable coronary syndromes

    Directory of Open Access Journals (Sweden)

    Luís C. L. Correia

    2000-06-01

    Full Text Available OBJECTIVE: To assess safety and efficacy of coronary angioplasty with stent implantation in unstable coronary syndromes. METHODS: Retrospective analysis of in-hospital and late evolution of 74 patients with unstable coronary syndromes (unstable angina or infarction without elevation of the ST segment undergoing coronary angioplasty with stent placement. These 74 patients were compared with 31 patients with stable coronary syndromes (stable angina or stable silent ischemia undergoing the same procedure. RESULTS: No death and no need for revascularization of the culprit artery occurred in the in-hospital phase. The incidences of acute non-Q-wave myocardial infarction were 1.4% and 3.2% (p=0.6 in the unstable and stable coronary syndrome groups, respectively. In the late follow-up (11.2±7.5 months, the incidences of these events combined were 5.7% in the unstable coronary syndrome group and 6.9% (p=0.8 in the stable coronary syndrome group. In the multivariate analysis, the only variable with a tendency to significance as an event predictor was diabetes mellitus (p=0.07; OR=5.2; 95% CI=0.9-29.9. CONCLUSION: The in-hospital and late evolutions of patients with unstable coronary syndrome undergoing angioplasty with intracoronary stent implantation are similar to those of the stable coronary syndrome group, suggesting that this procedure is safe and efficacious when performed in unstable coronary syndrome patients.

  10. The benefits of drug-eluting stents in the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Kiramijyan S

    2016-03-01

    Full Text Available Sarkis Kiramijyan,1 Ming W Liu2 1Division of Cardiology, Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA; 2Heart and Vascular Care Center, White Memorial Medical Center, Los Angeles, CA, USA Abstract: The advent of coronary stents has been a landmark development in the treatment of coronary artery disease with percutaneous coronary intervention. Initial percutaneous treatment using balloon angioplasty alone had limited clinical efficacy due to immediate vascular elastic recoil and dissection, in addition to late negative vascular remodeling and neointimal hyperplasia. With the introduction of coronary stents, initially bare-metal stents (BMS, the problems of dissection and negative remodeling due to injury in addition to vascular elastic recoil were eliminated; however, neointimal hyperplasia remained an ongoing obstacle in the long-term efficacy of stents. Neointimal hyperplasia resulted in in-stent restenosis in 20%–30% of cases after intervention with BMS, which led to high rates of target lesion revascularization. Subsequently, drug-eluting stents (DES were introduced, which had the added advantage of releasing an anti-proliferative drug from the stent to reduce the neointimal proliferation, thus resulting in the reduction of the rates of in-stent restenosis. Although the first-generation DES had significantly improved outcomes over its predecessor, the BMS, several challenges including stent thrombosis and delayed endothelialization of the stent remained. The second-generation DES have been significantly improved over their first-generation predecessors in regard to efficacy and safety, ie, improved long-term outcomes and significant reductions in stent thrombosis. The duration of dual antiplatelet therapy after DES has also been studied extensively in multiple large trials. A newer generation of stents, including those with bioresorbable polymers, polymer-free, and fully bioresorbable scaffolds is still in the early

  11. Five year clinical effect of coronary stenting and coronary artery bypass grafting in renal insufficient patients with multivessel coronary artery disease: insights from ARTS trial.

    Science.gov (United States)

    Aoki, Jiro; Ong, Andrew T L; Hoye, Angela; van Herwerden, Lex A; Sousa, J Eduardo; Jatene, Adib; Bonnier, Johannes J R M; Schönberger, Jacques P M A; Buller, Nigel; Bonser, Robert; Lindeboom, Wietze; Unger, Felix; Serruys, Patrick W

    2005-08-01

    To compare coronary stent implantation and bypass surgery for multivessel coronary disease in patients with renal insufficiency. In the ARTS trial, 142 moderate renal insufficient patients (Ccr<60 mL/min) with multivessel coronary disease were randomly assigned to stent implantation (n=69) or CABG (n=73). At 5 years, there was no significant difference between the two groups in terms of mortality (14.5% in the stent group vs. 12.3% in the CABG group, P=0.81), or combined endpoint of death, cerebrovascular accident (CVA), or myocardial infarction (MI) (30.4% in the stent group vs. 23.3% in the CABG group, P=0.35). Among patients who survived without CVA or MI, 18.8% in the stent group underwent a second revascularization procedure when compared with 8.2% in the surgery group (P=0.08). The event-free survival at 5 years was 50.7% in the stent group and 68.5% in the surgery group (P=0.04). At 5 years, the differences in mortality and combined incidence of death, CVA, and MI between coronary stenting and surgery did not reach statistically significant level. However, the occurrence of MACCE in the stent group was higher than in the CABG group, mainly driven by the higher incidence of repeat revascularization in the stent group.

  12. Usefulness of Drug Eluting Stent in Percutaneous Coronary Intervention—A Single Center Experience in Taiwan

    Directory of Open Access Journals (Sweden)

    Juey-Jen Hwang

    2007-08-01

    Conclusion: The use of DES in the Taiwanese population yielded comparable results as those in large clinical trials. Subacute stent thrombosis rate was higher in acute coronary syndrome. The safety of DES in these situations should be further clarified.

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

    DEFF Research Database (Denmark)

    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)....

  14. 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...

  15. Drug-eluting versus bare-metal stents in large coronary arteries

    DEFF Research Database (Denmark)

    Kaiser, Christoph; Galatius, Soeren; Erne, Paul

    2010-01-01

    Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether...

  16. Safety and efficacy of drug eluting stents in patients with spontaneous coronary artery dissection

    NARCIS (Netherlands)

    Conrotto, Federico; D'Ascenzo, Fabrizio; Cerrato, Enrico; Fernández-Ortiz, Antonio; Gonzalo, Nieves; Macaya, Fernando; Tamburino, Corrado; Barbanti, Marco; van Lavieren, Martijn; Piek, Jan J.; Applegate, Robert J.; Latib, Azeem; Spinnler, Maria Teresa; Marzullo, Raffaella; Iannaccone, Mario; Pavani, Marco; Crimi, Gabriele; Fattori, Rossella; Chinaglia, Alessandra; Presbitero, Patrizia; Varbella, Ferdinando; Gaita, Fiorenzo; Escaned, Javier

    2017-01-01

    Aims: Given the different pathogenesis, use of drug eluting stent (DES) in patients with Spontaneous Coronary Artery Dissection SCAD may delay the healing of the dissected vessel. Aim of our studywas to compare the safety and the efficacy of DES vs. bare metal stent (BMS) in a cohort of patients who

  17. 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 ...

  18. Comparison of zotarolimus-eluting and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette O; Kaltoft, Anne Kjer

    2012-01-01

    ABSTRACT: BACKGROUND: We evaluated the effectiveness and safety of a zotarolimus-eluting (ZES) versus a sirolimus-eluting (SES) coronary stent in a large cohort of patients treated with one of these stents in Western Denmark. METHODS: A total of 6,122 patients treated with ZES (n = 2,282) or SES ...

  19. Stable Titania Nanostructures on Stainless Steel Coronary Stent Surface for Enhanced Corrosion Resistance and Endothelialization.

    Science.gov (United States)

    Mohan, Chandini C; Cherian, Aleena Mary; Kurup, Sujish; Joseph, John; Nair, Manitha B; Vijayakumar, Maniyal; Nair, Shantikumar V; Menon, Deepthy

    2017-06-01

    Stainless steel (SS) coronary stents continue to present risk of in-stent restenosis that impact its long term safety and efficacy. The present work focuses on developing a drug-free and polymer-less surface on coronary stents by utilizing a titania (TiO 2 ) nanotexturing approach through hydrothermal processing, that will offer improved stent performance in vivo. Mechanically stable and durable nanotextured coatings are obtained on SS stents that also offer good corrosion resistance. In vitro vascular cell (endothelial and smooth muscle cells) studies on surface modified SS show preferential rapid endothelialization with enhanced nitric oxide production and reduce smooth muscle cell proliferation, in comparison to unmodified SS. In vivo evaluation of the nanotextured stents after subcutaneous implantation in rabbits show reduced irritability and minimal localized inflammatory response. These beneficial effects suggest that the stable, easily scalable titania nanosurface modification strategy on coronary stent surfaces can be a much cheaper alternative to drug eluting stents in addressing in-stent restenosis. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. 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

    DEFF Research Database (Denmark)

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

    2007-01-01

    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...

  1. Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    DEFF Research Database (Denmark)

    Giustino, Gennaro; Mastoris, Ioannis; Baber, Usman

    2016-01-01

    OBJECTIVES: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). BACKGROUND: The clinical correlates and the prognostic significance of CAC...... through coronary angiography. Co-primary endpoints of interest were the composite of death, myocardial infarction (MI), or target lesion revascularization and death, MI, or stent thrombosis at 3-year follow-up. RESULTS: Among 11,557 women included in the pooled dataset, CAC status was available in 6...

  2. THE RESULTS OF URGENT CORONARY ANGIOGRAPHY AND STENTING IN THE ACUTE CORONARY SYNDROME

    Directory of Open Access Journals (Sweden)

    Vasiliy Davydkin

    2016-07-01

    Full Text Available The acute coronary syndrome is a major cause of hospitalization and high mortality rates. For many there have been ongoing debates years over the treatment method choice and various diagnostic methods. The purpose of the research is to investigate the diagnostic capabilities of emergency coronary angiography and efficacy of transluminal balloon angioplasty with stenting for acute coronary syndrome with lifting and without ST elevation. Results In patients with ACS with ST-segment elevation myocardial contractility was better after thrombolytic therapy, which is appropriate over the first 2 hours of the onset of anginal pain. However, in the group of the patients with ACS with ST-segment elevation violations of local contractility was more common than in the group of patients with ACS without ST-segment elevation. In both groups of patients with ACS the risk of unfavorable outcome did not depend on the number of affected vessels, but on a variant of the syndrome (elevation or without ST elevation. In patients with ACS with ST-segment elevation was significantly more frequently identified hemodynamically significant stenosis of the arteries. In ACS without ST-segment elevation no statistically significant difference in myocardial contractility and risk of unfavorable outcome on the scale of GRACE in groups with single and biarterial coronary disease not obtained. In the case of significant stenoses diagnosed through emergency coronary angiography, emergency balloon angioplasty with stenting is indicated. When there is technical impossibility of angioplasty (excessive tortuosity, occlusion, stenosis of the left main coronary artery, etc., it is advisable to perform emergency bypass surgery. Discussion and Conclusions The analysis of the treatment results it revealed that timely percutaneous transluminal coronary angioplasty with stenting in combination with thrombolytic therapy has contributed significantly to improving not only contractility, but

  3. Effects of tongxinluo on C-reactive protein and clinical prognosis in patients after coronary stenting

    International Nuclear Information System (INIS)

    Xiao Hongbing; Zhang Dadong; Gu Jun

    2007-01-01

    Objective: To investigate the effects of Tongxinluo on C reactive protein(CRP)and clinical prognosis in patients after coronary stenting. Methods: From January 2003 to December 2004, 132 patients in our department diagnosed as coronary artery disease (including acute myocardial infarction, unstable angina pectoris and stable angina pectoris)were divided into two groups: Tongxinluo group and control group. The control group received routine treatment, while Tongxinluo group based on routine treatment was administrated with Tongxinluo capsule in combination for 6 months. Results: CRP level was much lower in Tongxinluo group together with apparent decrease of the major adverse cardiac event (MACE)rate in 6 months' follow-up than those of the control group, but showing no difference in coronary arterial restenosis between the two groups at 6 months after coronary stenting. Conclusion: Tongxinluo has favorable effects to decrease the CRP level and improve clinical efficiency together with prognosis for patients after coronary stenting. (authors)

  4. Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

    Science.gov (United States)

    Karjalainen, Pasi P; Nammas, Wail

    2017-06-01

    Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

  5. Coronary artery bypass surgery or coronary stenting in diabetic patients: too soon to make a statement?

    Energy Technology Data Exchange (ETDEWEB)

    Rodriguez, Alfredo E., E-mail: arodriguez@centroceci.com.ar

    2014-11-15

    Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. However, almost simultaneously with this data, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in adverse cardiac events compared to 1st generation DES in patients with diabetes. In this editorial we review the old and new randomized data in diabetic patients and conclude that there are many unresolved issues to make a definitive statement regarding which is the best revascularization preference in diabetic patients and the measured final efficacy of PCI and CABG will not be reached until the arrival of RCT using next generation DES, including complete absorbable scaffolds. - Highlights: • Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. • In recent years, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in

  6. Advantages of novel BioMimeTM Sirolimus Eluting Coronary Stent system. Moving towards biomimicry.

    Science.gov (United States)

    Upendra, K; Sanjeev, B

    2012-02-01

    Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advancements in interventional cardiology arena have been fast paced. Within the last ten years, these developments have been exponential. Developers & clinicians are fast adapting from the learning curve awarded by the time course of DES evolution. In that light BioMimeTM Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65 µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative - Sirolimus that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and low coating thickness of 2 µm. The resultant stent demonstrates almost 100% endothelialization at 30 days in preclinical model and zero percent MACE >18 months in the primary efficacy and safety clinical study.

  7. Time-dependent 3D simulations of the hemodynamics in a stented coronary artery

    International Nuclear Information System (INIS)

    Faik, Isam; Mongrain, Rosaire; Leask, Richard L; Rodes-Cabau, Josep; Larose, Eric; Bertrand, Olivier

    2007-01-01

    Stenting is becoming the major interventional cardiology procedure worldwide. However restenosis remains a major limitation to the effectiveness of stents. Alterations to the local hemodynamics in the stented segment of the artery could be a potential factor in the development of in-stent restenosis. The characterization of wall shear stress and of blood flow patterns in a stented artery is therefore necessary for a good understanding of the role of hemodynamics in the development of in-stent restenosis. We have used a time-dependent 3D numerical model of a stented coronary artery to study the characteristics of the blood flow and the shear stress distribution. Our results show that the presence of the stent produces significant secondary flow that is limited to an annulus in the near wall region. Low shear stress zones were localized in the vicinity of the struts while the tips of the struts exhibited high values of shear stress. These results support the hypothesis that local hemodynamics may affect the development of in-stent restenosis and could influence the choice of stent geometries for future stent designs

  8. 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

    as time-dependent variables. A total of 12,277 patients were treated with stent implantation. Stent thrombosis was observed in 111 (0.9%) patients and in-stent restenosis in 503 (4.1%) patients within 12 months after the index PCI. Occurrence of stent thrombosis was associated with an increased risk...

  9. 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

  10. Percutaneous coronary intervention in diabetic patients: should choice of stents be influenced?

    NARCIS (Netherlands)

    Harskamp, Ralf E.; Park, Duk-Woo

    2013-01-01

    Patients with diabetes mellitus are prone to a diffuse and rapidly progressive form of coronary artery disease. As a result, diabetic patients undergoing coronary revascularization are at higher risk of cardiovascular events compared with nondiabetic patients. Due to marked advances of stent device

  11. High-Definition Computed Tomography for Coronary Artery Stent Imaging: a Phantom Study

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Wen Jie; Chen, Ke Min; Pang, Li Fang; Zhang, Huang; Pan, Zi Lai [Rui Jin Hospital, Medical School, Shanghai Jiao Tong University, Shangha (China); Guo, Ying; Li, Jian Ying [Beijing Economic and Technology Development Area, Beijing (China)

    2012-01-15

    To assess the performance of a high-definition CT (HDCT) for imaging small caliber coronary stents ({<=} 3 mm) by comparing different scan modes of a conventional 64-row standard-definition CT (SDCT). A cardiac phantom with twelve stents (2.5 mm and 3.0 mm in diameter) was scanned by HDCT and SDCT. The scan modes were retrospective electrocardiography (ECG)-gated helical and prospective ECG-triggered axial with tube voltages of 120 kVp and 100 kVp, respectively. The inner stent diameters (ISD) and the in-stent attenuation value (AVin-stent) and the in-vessel extra-stent attenuation value (AVin-vessel) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISDmeasured]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AVin-stent - AVin-vessel) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. The correlation coefficient of ISD, AVin-vessel and AVin-stent between the two observers was good. The ALNs of HDCT were statistically lower than that of SDCT (30 {+-} 5.7% versus 35 {+-} 5.4%, p < 0.05). HDCT had statistically lower AAI values than SDCT (15.7 {+-} 81.4 HU versus 71.4 {+-} 90.5 HU, p < 0.05). The prospective axial dataset demonstrated smaller ALN than the retrospective helical dataset on both HDCT and SDCT (p < 0.05). Additionally, there were no differences in ALN between the 120 kVp and 100 kVp tube voltages on HDCT (p = 0.05). High-definition CT helps improve measurement accuracy for imaging coronary stents compared to SDCT. HDCT with 100 kVp and the prospective ECG-triggered axial technique, with a lower radiation dose than 120 kVp application, may be advantageous in evaluating coronary stents with smaller calibers ({<=} 3 mm).

  12. Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis.

    Science.gov (United States)

    Köster, R; Vieluf, D; Kiehn, M; Sommerauer, M; Kähler, J; Baldus, S; Meinertz, T; Hamm, C W

    2000-12-02

    Coronary in-stent restenosis might be triggered by contact allergy to nickel, chromate, or molybdenum ions released from stainless-steel stents. We investigated the association between allergic reactions to stent components and the occurrence of in-stent restenosis. Patients with coronary stainless-steel stents who underwent angiography for suspected restenosis were consecutively included in this study. Quantitative coronary angiography for analysis of percentage diameter stenosis was done on 131 patients (mean age 62 years [SD 9]) with 171 stents 6.1 months (2.7) after stent implantation. All patients underwent epicutaneous patch tests (Finn chamber method) for nickel, chromate, molybdenum, manganese, and small 316L stainless-steel plates. Patch tests were assessed by independent dermatologists after 48 h, 72 h, and when necessary 96 h of contact with the potential allergen. In-stent restenosis (> or =550% diameter stenosis) occurred in 89 patients. All ten patients with positive patch-test results had restenoses (p=0.03). Four male patients had positive reactions to molybdenum, and seven patients (four male, three female) had reactions to nickel. No patient with an allergic reaction to the standard test substances had a positive reaction to the stainless-steel plates. All patients with positive results had recurrent angina pectoris and needed target-vessel revascularisation. Patients with allergic patch-test reactions to nickel and molybdenum had a higher frequency of in-stent restenoses than patients without hypersensitivity. Allergic reactions to nickel and molybdenum released from stents may be one of the triggering mechanisms for in-stent restenosis.

  13. 64-slice multidetector coronary CT angiography: in vitro evaluation of 68 different stents

    International Nuclear Information System (INIS)

    Maintz, David; Seifarth, Harald; Rink, Michael; Oezguen, Murat; Heindel, Walter; Fischbach, Roman; Raupach, Rainer; Flohr, Thomas; Sommer, Torsten

    2006-01-01

    The purpose of this study was to test a large sample of different coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in 64-slice multidetector-row computed tomography (MDCT) in vitro and to provide a catalogue of currently used coronary artery stents when imaged with state-of the-art MDCT. We examined 68 different coronary artery stents (57 stainless steel, four cobalt-chromium, one cobalt-alloy, two nitinol, four tantalum) in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70). Stents were imaged in axial orientation with standard parameters: 32x0.6 collimation, pitch 0.24, 680 mAs, 120 kV, rotation time 0.37 s. Four different image reconstructions were obtained with varying convolution kernels and section thicknesses: (1) soft, 0.6 mm, (2) soft, 0.75, (3) medium soft, 0.6, and (4) stent-optimized sharp, 0.6. To evaluate visualization characteristics of of the stent, the lumen diameter, intraluminal density and noise were measured. The high-resolution kernel offered significantly better average lumen visualization (57% ±10%) and more realistic lumen attenuation (222 HU ±66 HU) at the expense of increased noise (15.3 HU ±3.7 HU) compared with the soft and medium-soft CT angiography (CTA) protocol (p<0.001 for all). Stents with a lumen visibility of more than 66% were: Arthos pico, Driver, Flex, Nexus2, S7, Tenax complete, Vision (all 67%), Symbiot, Teneo (70%), and Radius (73%). Only ten stents showed a lumen visibility of less than 50%. Stent lumen visibility largely varies depending on the stent type. Even with the improved spatial resolution of 64-slice CT, a stent-optimized kernel remains beneficial for stent visualization when compared with the standard medium-soft CTA protocol. Using 64-slice CT and high-resolution kernel, the majority of stent products show a lumen visibility of more than 50% of the stent

  14. Diagnostic accuracy of coronary in-stent restenosis using 320-row multidetector computed tomography

    International Nuclear Information System (INIS)

    Koeda, Tatsuhiko; Fusazaki, Tetsuya; Niinuma, Hiroyuki; Itoh, Tomonori; Tanaka, Ryoichi; Yoshioka, Kunihiro; Nakamura, Motoyuki

    2010-01-01

    Although a multidetector computed tomography (MDCT) was useful in assessing coronary artery disease, there were several limitations in detecting coronary in-stent restenosis (ISR). The aim of this study was to evaluate the diagnostic accuracy of coronary ISR using a 320-row MDCT (area detector computed tomography: ADCT) in patients after stent implantation. We performed ADCT in consecutive 102 patients (133 lesions) before coronary arteriography (CAG). In 133 lesions, 74 were treated with bare metal stents and 59 with drug eluting stents. The diagnostic accuracy of ADCT for coronary ISR was compared to the results of CAG. ISR was found in 18 cases with CAG analysis. To compare with CAG, sensitivity, specificity, positive predictive value, and negative predictive value to evaluate ISR by ADCT were 100%, 87.8%, 56.3% and 100% respectively. The ISR in a wide range of coronary artery disease was detected by ADCT with good diagnostic accuracy. ADCT may be a promising noninvasive diagnostic imaging modality to evaluate coronary ISR. (author)

  15. Elevated blood viscosity and micro-recirculation linked to coronary stent malapposition.

    Science.gov (United States)

    Poon, Eric; Thondapu, Vikas; Hayat, Umair; Barlis, Peter; Yap, Chooi; Kuo, Po; Wang, Qisen; Ma, Jiawei; Zhu, Shuang; Moore, Stephen; Ooi, Andrew

    2018-02-14

    One particular complexity of coronary artery is the natural tapering of the vessel with proximal segments having larger caliber and distal tapering as the vessel get smaller. The natural tapering of a coronary artery often leads to proximal incomplete stent apposition (ISA). ISA alters coronary hemodynamics and creates pathological path to develop complications such as in-stent restenosis, and more worryingly, stent thrombosis. By employing state-of-the-art computer-aided design software, generic stent hoops were virtually deployed in an idealized tapered coronary artery with decreasing malapposition distance. Pulsatile blood flow simulations were carried out using computational fluid dynamics (CFD) on these computer-aided design models. CFD results reveal unprecedented details in both spatial and temporal development of micro-recirculation environments throughout the cardiac cycle. Arterial tapering also introduces secondary micro-recirculation. These primary and secondary micro-recirculations provoke significant fluctuations in arterial wall shear stress (WSS). There has been a direct correlation with changes in WSS and the development of atherosclerosis. Further, the presence of these micro-recirculations influence strongly on the local levels of blood viscosity in the vicinity of the malapposed stent struts. The observation of secondary micro-recirculations and changes in blood rheology is believed to complement the wall (-based) shear stress, perhaps providing additional physical explanations for tissue accumulation near ISA detected from high resolution optical coherence tomography. This work may aid in helping to optimize future stent properties and designs that will translate to innovations that directly impact clinical outcomes.

  16. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial

    DEFF Research Database (Denmark)

    Kelbaek, H.; Klovgaard, L.; Helqvist, S.

    2008-01-01

    OBJECTIVES: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. BACKGROUND: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited...

  17. 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.

  18. Stent implantation of left main coronary artery stenosis in an infant: Effective long-term treatment?

    Directory of Open Access Journals (Sweden)

    Christian Paech

    2015-01-01

    Full Text Available Coronary artery stenosis is a rare phenomenon in children. Coronary stent implantation is generally not considered a standard treatment option due to technical difficulties and potential complications in this group of patients. Nevertheless, several pediatric cases reporting successful implantation with acceptable short-term experiences have been described. The following case presents a successful stent implantation for left main coronary artery (LMCA stenosis early after surgery for anomalous left coronary artery from pulmonary artery (ALCAPA at the age of 6 months. The excellent mid-term results and notably the procedure′s potential as a long-term treatment in small children are highlighted. A 6-month-old infant underwent surgery for ALCAPA. Due to sudden postoperative deterioration, cardiac catheterization was performed. Coronary angiography revealed severe (90% ostial LMCA stenosis. A PROMUS drug-eluting stent (Promus Element AL3.0 Χ 8 mm, Boston Scientific, Natick, Massachusetts, USA was implanted. The procedure was performed without complications. Antiplatelet therapy with acetylsalicylic acid and clopidogrel was initiated. Subsequently, cardiac function improved slowly. Cardiac catheterization 3 years 8 months after stent implantation showed no restenosis with a proximal LMCA diameter still at the 50 th percentile for age. Neither were signs of heart failure reported at the last follow-up at 7 years of age. Presupposing normal growth, the implanted stent would thus provide sufficient myocardial perfusion with a LMCA lumen at the 40 th percentile at the age of 16 years. In selected cases, coronary stent implantation may be an effective mid- to long-term treatment of coronary artery stenosis even in very young children.

  19. Coronary artery rupture during high-pressure post-dilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery

    Directory of Open Access Journals (Sweden)

    Sina Ali

    2016-06-01

    Full Text Available Coronary artery perforation (CAP is a rare but feared complication of percutaneous coronary intervention. With the use of novel instruments, including hydrophilic and ultrarigid guidewires, rotablator devices, and cutting balloons, the success rate of intervention for coronary artery chronic total occlusion (CTOs and calcified lesions has increased. Along with these changes, the risk of CAP has also increased. In this case report, we present a tip III CAP due to high-pressure postdilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery.

  20. Clinical usefulness of red cell distribution width to angiographic severity and coronary stent thrombosis

    Directory of Open Access Journals (Sweden)

    Erdem A

    2016-09-01

    Full Text Available Aysun Erdem,1 Ufuk Sadik Ceylan,1 Aycan Esen,1 Ertugrul Zencirci,2 Birol Topcu,3 Kivilcim Ozden,1 Selcuk Yazici,1 Sait Terzi,1 Ayse Emre,1 Kemal Yesilcimen1 1Department of Cardiology, Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey; 2Department of Cardiology, Acibadem Hospital Maslak, Istanbul, Turkey; 3Department of Biostatistics, Faculty of Medicine, Namik Kemal University, Tekirdag, Turkey Background: Red cell distribution width (RDW is a quantitative measurement and shows heterogeneity of red blood cell size in peripheral blood. RDW has recently been associated with cardiovascular events and cardiovascular diseases, and it is a novel predictor of mortality. In this study, we aimed to evaluate the clinical usefulness of measuring RDW in patients with coronary stent thrombosis.Patients and methods: We retrospectively reviewed 3,925 consecutive patients who presented with acute coronary syndrome and who underwent coronary angiography at the Siyami Ersek Hospital between May 2011 and December 2013. Of the 3,925 patients, 73 patients (55 males, mean age 59±11 years, 55 with ST elevated myocardial infarction with stent thrombosis formed group 1. Another 54 consecutive patients who presented with acute coronary syndrome (without coronary stent thrombosis, 22 patients with ST elevated myocardial infarction, 44 males, mean age 54±2 years and underwent percutaneous coronary intervention in May 2011 formed group 2. Data were collected from all groups for 2 years. The RDW values were calculated from patients 1 month later at follow-up. Syntax scores were calculated for all the patients. The patients were also divided as low syntax score group and moderate–high syntax score group.Results: The patients in group 1 with stent thrombosis had significantly higher RDW level (13.85 than the patients in group 2 without stent thrombosis (12 (P<0.001. In addition, in all study patients, the moderate

  1. [Percutaneous approach for the treatment of unprotected left main coronary stenosis. New perspectives with the use of coronary stents].

    Science.gov (United States)

    Pessanha, A V; Rodrigues, C; Fuks, V; Murad, H; Murad, M

    1997-03-01

    We describe a case of coronary stenosis located in an unprotected left main coronary artery, treated primarily and electively with the placement of a coronary stent. As a function of the large mass of myocardium involved, this patient would be considered a classical candidate for direct surgery, because the inherent risk involved with conventional balloon angioplasty, mainly due to the eventual occurrence of acute closure during the procedure. Since the previsibility of the immediate results with the use of coronary stents was significantly improved, we propose this new therapeutic approach for this traditionally surgical case, that has been performed with success and without any complication. This strategy for the treatment of unprotected left main lesions with the elective placement of Palmaz-Schatz stents, has not yet been proposed or applied in our country, and may represent a new universe of indication of percutaneous treatment of coronary artery disease, no longer approaching the left main stem only in special or emergency situations, usually a result of complications of left main manipulation during angioplasty of the coronary system. The patient involved in this case did not show any contraindication for the treatment with conventional open heart surgery.

  2. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

    DEFF Research Database (Denmark)

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre

    2015-01-01

    BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9......), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual...... antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days...

  3. Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes

    DEFF Research Database (Denmark)

    Thim, Troels; Maeng, Michael; Kaltoft, Anne Kjer

    2012-01-01

    Eur J Clin Invest 2012 ABSTRACT: Objectives:  To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial. Background:  Currently, only limited data allow direct comparison of clinical outcomes...

  4. Factors Associated with In-stent Restenosis in Patients Following Percutaneous Coronary Intervention

    Directory of Open Access Journals (Sweden)

    Dedi Wihanda

    2015-07-01

    Full Text Available Aim: to determine factors associated with In-Stent Restenosis (ISR in patients following Percutaneous Coronary Intervention (PCI. Methods: a retrospective cross-sectional study was conducted using secondary information from medical records of post-PCI patients who underwent follow-up of angiography PCI between January 2009 and March 2014 at The Integrated Cardiovascular Service Unit, Cipto Mangunkusumo Hospital, Jakarta. Angiographic ISR was defined when the diameter of stenosis ≥50% at follow-up angiography including the diameter inside the stent and diameter with five-mm protrusion out of the proximal and distal ends of the stent. Results: there were 289 subjects including 133 subjects with and 156 subjects without ISR. The incidence of ISR in patients using of bare-metal stent (BMS and drug-eluting stent (DES were 61.3% and 40.7%, respectively. Factors associated with ISR are stent-type (OR=4.83, 95% CI 2.51-9.30, stent length (OR=3.71, 95% CI 1.99-6.90, bifurcation lesions (OR=2.43, 95% CI 1.16-5.10, smoking (OR=2.30, 95% CI 1.33-3.99, vascular diameter (OR=2.18, 95% CI 1.2-3.73, hypertension (OR=2.16, 95% CI 1.16-4.04 and diabetes mellitus (OR=2.14, 95% CI 1.23-3.70. Conclusion: stent type, stent length, bifurcation lesions, smoking, vascular diameter, hypertension and DM are factors associated with ISR in patients following PCI. Key words: bare-metal stent; drug-eluting stent; in-stent restenosis.

  5. 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 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...... 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...

  6. In-Vitro Evaluation of Coronary Stents and 64-Detector-Row Computed Tomography Using a Newly Developed Model of Coronary Artery Stenosis

    International Nuclear Information System (INIS)

    Schlosser, T.; Scheuermann, T.; Ulzheimer, S.; Mohrs, O.K.; Kuehling, M.; Al brecht, P.E.; Voigtlaender, T.; Barkhausen, J.; Schmermund, A.

    2008-01-01

    Background: Stent implantation is the predominant therapy for non-surgical myocardial revascularization in patients with coronary artery disease. However, despite substantial advances in multidetector computed tomography (MDCT) coronary imaging, a reliable detection of coronary in-stent restenosis is currently not possible. Purpose: To examine the ability of 64-detector-row CT to detect and to grade in-stent stenosis in coronary stents using a newly developed ex-vivo vessel phantom with a realistic CT density pattern, artificial stenosis, and a thorax phantom. Material and Methods: Four different stents (Liberte and Lunar ROX, Boston Scientific; Driver, Medtronic; Multi-Link Vision, Guidant) were examined. The stents were placed on a polymer tube with a diameter of 2.5, 3.0, 3.5, or 4.0 mm. Different degrees of stenosis (0%, 30%, 50%, 70-80%) were created inside the tube. For quantitative analysis, attenuation values were measured in the non-stenotic vessel outside the stent, in the non-stenotic vessel inside the stent, and in the stenotic area inside the stent. The grade of stenosis was visually assessed by two observers. Results: All stents led to artificial reduction of attenuation, the least degree of which was found in the Liberte stent (11.3±10.2 HU) and the Multi-Link Vision stent (17.6±17.9 HU; P 0.25). Overall, the non-stenotic vessel was correctly diagnosed in 55.5%, the low-grade stenosis in 58.3%, the intermediate stenosis in 63.8%, and the high-grade stenosis in 80.5%. In the 3.0-, 3.5-, and 4.0-mm vessels, in none of the cases was a non-stenotic or low-grade stenotic vessel misdiagnosed as intermediate or high-grade stenosis. The average deviation from the real grade of stenosis was 0.40 for the Liberte stent, 0.46 for the Lunar ROX stent, 0.45 for the Driver stent, and 0.58 for the Multi-Link Vision stent. Conclusion: Our ex-vivo data show that non-stenotic stents and low-grade in-stent stenosis can be reliably differentiated from intermediate and

  7. Detailing Radio Frequency Heating Induced by Coronary Stents: A 7.0 Tesla Magnetic Resonance Study

    Science.gov (United States)

    Santoro, Davide; Winter, Lukas; Müller, Alexander; Vogt, Julia; Renz, Wolfgang; Özerdem, Celal; Grässl, Andreas; Tkachenko, Valeriy; Schulz-Menger, Jeanette; Niendorf, Thoralf

    2012-01-01

    The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR) holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF) power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR) limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study. PMID:23185498

  8. Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study.

    Science.gov (United States)

    Santoro, Davide; Winter, Lukas; Müller, Alexander; Vogt, Julia; Renz, Wolfgang; Ozerdem, Celal; Grässl, Andreas; Tkachenko, Valeriy; Schulz-Menger, Jeanette; Niendorf, Thoralf

    2012-01-01

    The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR) holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF) power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR) limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study.

  9. Enhanced platelet activation following coronary stent implantation in patients on hemodialysis.

    Science.gov (United States)

    Fu, Qiang; Ishikawa, Shuichi; Yokoyama, Naoyuki; Kozuma, Ken; Takada, Kaoru; Muraki, Aki; Isshiki, Takaaki

    2010-07-01

    Hemodialysis ("HD") has been suggested as a risk factor for stent thrombosis. However, platelet function in HD patients after coronary stent implantation remains unclear. The aim of this study was to evaluate platelet function following coronary stent implantation in HD patients. A total of 10 HD and 31 non-HD patients who underwent a first coronary stent implantation were studied. All patients received 100 or 200 mg of asprin and thienopiridine (either ticlopidine 200 mg or clopidogel 75 mg) daily. Platelet function was assessed 2-6 weeks (21 ± 8 days) after stent implantation by: (1) platelet maximal aggregation, using light transmittance aggregometry; (2) platelet aggregation threshold index, which was defined as putative concentration of agonist giving 50% maximum aggregation using whole-blood aggregometry; and (3) platelet activation markers (PAC-1 and CD62p), using whole blood flow cytometry. There were no differences between the two groups in baseline and procedure characteristics, except for a greater prevalence of hypertension and calcification in the HD group. Early stent thrombosis and bleeding did not occur in either group. Although no differences in platelet maximal aggregation or whole-blood aggregation were observed, expression of PAC-1 (39.6 ± 9.1 vs 24.2 ± 13.2%) and CD62p (10.4 ± 5.5 vs 5.4 ± 2.3%) were significantly increased in the HD group compared with the non-HD group. HD patients exhibited enhanced platelet activation after coronary stent implantation, but suppression of platelet aggregation was achieved by the current dual antiplatelet therapy.

  10. Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study.

    Directory of Open Access Journals (Sweden)

    Davide Santoro

    Full Text Available The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study.

  11. Coronary stent restenosis and the association with allergy to metal content of 316L stainless steel.

    Science.gov (United States)

    Slodownik, D; Danenberg, C; Merkin, D; Swaid, F; Moshe, S; Ingber, A; Lotan, H; Durst, R

    Most intra-coronary stents in use are made of 316 L stainless steel, which contains nickel, chromate and molybdenum. Whether inflammatory and allergic reactions to metals contribute to in-stent restenosis is still a matter of debate. The aim of this study was to ascertain the relationship between metal allergy and the occurrence of in-stent restenosis. Ninety-nine adult patients who underwent two cardiac catheterisations, up to two years apart, were included in the study. Seventy patients had patent stents at the second angiogram (patent stent group) and 29 were found to have in-stent restenosis (restenosis group). All patients underwent patch testing with the relevant metals and the 316L stainless steel plate. Twenty-eight (28.3%) patients were found to have an allergy to at least one metal. There was no significant difference in the prevalence of metal allergy between the patent stent group and the restenosis group (28.6 and 27.6%, respectively; p = 0.921). Our data do not support the theory that contact allergy plays a role in the pathogenesis of in-stent restenosis.

  12. Determinants of slow flow following stent implantation in intravascular ultrasound-guided primary percutaneous coronary intervention.

    Science.gov (United States)

    Watanabe, Yusuke; Sakakura, Kenichi; Taniguchi, Yousuke; Yamamoto, Kei; Wada, Hiroshi; Fujita, Hideo; Momomura, Shin-Ichi

    2018-03-01

    Slow flow is a serious complication in primary percutaneous coronary intervention (PCI) and is associated with poor clinical outcomes. Intravascular ultrasound (IVUS)-guided PCI may improve clinical outcomes after drug-eluting stent implantation. The purpose of this study was to seek the factors of slow flow following stent implantation, including factors related to IVUS-guided primary PCI. The study population consisted of 339 ST-elevation myocardial infarction patients, who underwent stent deployment with IVUS. During PCI, 56 patients (16.5%) had transient or permanent slow flow. Multivariate logistic regression analysis showed age (OR 1.04, 95% CI 1.01-1.07, P = 0.01), low attenuation plaque on IVUS (OR 3.38, 95% CI 1.70-6.72, P = 0.001), initial Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 (vs. TIMI 0: OR 0.44, 95% CI 0.20-0.99, P = 0.046), and the ratio of stent diameter to vessel diameter (per 0.1 increase: OR 2.63, 95% CI 1.84-3.77, P flow. A ratio of stent diameter to vessel diameter of 0.71 had an 80.4% sensitivity and 56.9% specificity to predict slow flow. There was no significant difference in ischemic-driven target vessel revascularization between the modest stent expansion (ratio of stent diameter to vessel diameter flow following stent implantation in IVUS-guided primary PCI.

  13. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

    Science.gov (United States)

    Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

    2017-10-03

    The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http

  14. Diagnostic efficacy for coronary in-stent patency with parameters defined on Hounsfield CT value-spatial profile curves

    International Nuclear Information System (INIS)

    Yamazaki, Tadashi; Suzuki, Jun-ichi; Shimamoto, Ryoichi; Tsuji, Taeko; Ohmoto-Sekine, Yuki; Morita, Toshihiro; Yamashita, Hiroshi; Honye, Junko; Nagai, Ryozo; Komatsu, Shuhei; Akahane, Masaaki; Ohtomo, Kuni

    2008-01-01

    Purpose: Hounsfield CT values across coronary CT angiograms constitute CT value-spatial profile curves. These CT profile curves are independent of window settings, and therefore, parameters derived from the curves can be used for objective anatomic analyses. Applicability of parameters derived from the curves to quantification of coronary in-stent patency has not yet been evaluated. Methods: Twenty-five CT value-spatial profile curves were delineated from 10 consecutive coronary stents to test correlation between the curve derived parameter (i.e., the minimum extreme value normalized by dividing by the maximum value of the curves obtained at neighboring outside of stents) and three intravascular ultrasound (IVUS) parameters. Results: Correlation coefficients between normalized minimum extreme value of CT value-spatial profile curves and three IVUS parameters (such as patent cross-sectional in-stent area, the percentage of patent cross-sectional in-stent area, and coronary artery intra-stent diameter) were 0.65 (p < 0.01), 0.44 (p < 0.05) and 0.51 (p < 0.05), respectively. Conclusions: CT parameters defined on Hounsfield CT value-spatial profile curves correlated significantly with IVUS parameters for quantitative coronary in-stent patency. A new approach with CT coronary angiography is therefore indicated for the noninvasive assessment of in-stent re-stenosis

  15. Chemico-physical characterisation and in vivo biocompatibility assessment of DLC-coated coronary stents.

    Science.gov (United States)

    Castellino, Micaela; Stolojan, Vlad; Virga, Alessandro; Rovere, Massimo; Cabiale, Karine; Galloni, Marco R; Tagliaferro, Alberto

    2013-01-01

    The vast majority of stent thrombosis occurs in the acute and sub-acute phases and is more common in patients with acute coronary syndromes, due to the thrombotic milieu where stent struts are positioned. Stent thrombosis is likely due to incomplete tissue coverage of metallic stents as the contact between metallic stents and blood elements may lead to platelet adhesion and trigger vessel thrombosis. If a stent is covered after 7 days, the risk that it will be found uncovered at later stages is very low (DLC) coatings, deposited by physical vapour deposition, promote rapid endothelisation of coronary stent devices, with very low platelets activation, reducing thrombotic clots. We relate these behaviours to the surface and bulk material properties of the DLC films, subjected to a comprehensive chemico-physical characterisation using several techniques (X-ray photoelectron spectroscopy, atomic force microscopy, field-emission scanning electron microscope, transmission electron microscopy combined with electron energy loss spectroscopy, Raman and dispersive X-ray spectroscopy). In vivo studies, conducted on 24 pigs, have shown complete endothelisation after 7 days, with no fibrin mesh and with only rare monocytes scattered on the endothelial layer while 30 and 180 days tests have shown reduced inflammatory activation and a complete stabilisation of the vessel healing, with a minimal neointimal proliferation. The integral and permanent DLC film coating improves haemo- and bio-compatibility and leads to an excellent early vessel healing of the stent whilst the extremely thin strut thickness reduces the amount of late neointima and consequently the risk of late restenosis. These data should translate into a reduced acute and sub-acute stent thrombosis.

  16. 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

    BACKGROUND: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. METHODS: We followed 4,154 patients treated with coronary drug-eluting ......BACKGROUND: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. METHODS: We followed 4,154 patients treated with coronary drug......-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...... stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were...

  17. 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.

  18. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography

    DEFF Research Database (Denmark)

    Fuchs, Andreas; Kühl, J Tobias; Chen, Marcus Y

    2015-01-01

    . We defined target segments on CCTAconv as motion-free coronary segments with calcification or stent and low reader confidence. The effect of CCTAsub was assessed. No approval from the ethics committee was required according to Danish law. RESULTS: A total of 76 target segments were identified...

  19. Risk Associated With Surgery Within 12 Months After Coronary Drug-Eluting Stent Implantation

    DEFF Research Database (Denmark)

    Egholm, Gro; Dalby Kristensen, Steen; Thim, Troels

    2016-01-01

    BACKGROUND Guidelines recommend postponing surgery for at least 6 months after treatment with a drug-eluting stent by percutaneous coronary intervention (DES-PCI). OBJECTIVES The goal of this study was to evaluate the surgical risk associated with DES-PCI compared with that in nonstented patients...

  20. High-Definition Computed Tomography for Coronary Artery Stent Imaging: a Phantom Study

    International Nuclear Information System (INIS)

    Yang, Wen Jie; Chen, Ke Min; Pang, Li Fang; Zhang, Huang; Pan, Zi Lai; Guo, Ying; Li, Jian Ying

    2012-01-01

    To assess the performance of a high-definition CT (HDCT) for imaging small caliber coronary stents (≤ 3 mm) by comparing different scan modes of a conventional 64-row standard-definition CT (SDCT). A cardiac phantom with twelve stents (2.5 mm and 3.0 mm in diameter) was scanned by HDCT and SDCT. The scan modes were retrospective electrocardiography (ECG)-gated helical and prospective ECG-triggered axial with tube voltages of 120 kVp and 100 kVp, respectively. The inner stent diameters (ISD) and the in-stent attenuation value (AVin-stent) and the in-vessel extra-stent attenuation value (AVin-vessel) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISDmeasured]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AVin-stent - AVin-vessel) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. The correlation coefficient of ISD, AVin-vessel and AVin-stent between the two observers was good. The ALNs of HDCT were statistically lower than that of SDCT (30 ± 5.7% versus 35 ± 5.4%, p < 0.05). HDCT had statistically lower AAI values than SDCT (15.7 ± 81.4 HU versus 71.4 ± 90.5 HU, p < 0.05). The prospective axial dataset demonstrated smaller ALN than the retrospective helical dataset on both HDCT and SDCT (p < 0.05). Additionally, there were no differences in ALN between the 120 kVp and 100 kVp tube voltages on HDCT (p = 0.05). High-definition CT helps improve measurement accuracy for imaging coronary stents compared to SDCT. HDCT with 100 kVp and the prospective ECG-triggered axial technique, with a lower radiation dose than 120 kVp application, may be advantageous in evaluating coronary stents with smaller calibers (≤ 3 mm).

  1. Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

    Science.gov (United States)

    Ferenc, Miroslaw; Gick, Michael; Comberg, Thomas; Rothe, Jürgen; Valina, Christian; Toma, Aurel; Löffelhardt, Nikolaus; Hochholzer, Willibald; Riede, Florian; Kienzle, Rolf-Peter; Achtari, Amar; Neumann, Franz-Josef

    2016-12-01

    In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For Permissions, please email: journals.permissions@oup.com.

  2. Reversed single string technique for coronary bifurcation stenting-First report of case demonstrations in vitro.

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    Adjedj, Julien; Toth, Gabor G; Pellicano, Mariano; Wijns, William

    2018-02-15

    This work reports the concept and the practical feasibility of Reversed Single String bifurcation stenting technique by demonstrating three in vitro cases. Provisional T stenting is the most used interventional technique to treat coronary bifurcation lesions. However, after main branch (MB) stenting, treatment of the side branch (SB) may become indicated to provide a good final result. Currently applied methods all have their structural limitations with respect to wall coverage, multiple strut layers, poor apposition rate. We reasoned that reversing the Single String technique principle could be used as a bail out after inadequate provisional T stenting. We simulated in three silicone bifurcation phantoms a scenario whereby stenting the SB becomes indicated after provisional T stenting. Thereafter, as first step of Reversed Single String, a stent was deployed into the SB ostium with one single protruding stent-cell into the MB. After wiring that stent-cell and positioning MB balloon across it, final kissing balloon dilation was performed. Results of the in vitro Reversed Single String cases were evaluated by X-ray angiography, optical frequency domain imaging, and 3-Dimensional (3D) reconstruction (OFDI). Each case was successfully performed and completed. In the bifurcation area, perfect apposition was documented in over 81% of the struts. Malapposition remained below 4% of struts in each case. 3D OFDI reconstruction did not reveal any strut fracture. This report suggests that Reversed Single String technique might offer a potential bail out solution for provisional T-stenting cases, when treatment of the SB becomes indicated. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  3. Bioresorbable vascular scaffold for coronary in-stent restenosis: A novel concept

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    Surender Deora

    2014-07-01

    Full Text Available The management of patients with significant in-stent restenosis (ISR with drug-eluting stent is still not well defined. Various treatment modalities include plain old balloon angioplasty (POBA, metallic stent, cutting or scoring balloon and drug-eluting balloon (DEB. Bioresorbable vascular scaffold (BVS is the latest technology for the treatment of de novo coronary artery lesions. The use of BVS in ISR is based on the rationale of local drug delivery as achieved by DEB without the permanent bi-layer of metal and also stabilizes dissection flaps and prevents acute recoil as provided by metallic stent. To the best of our knowledge this is the first case report of the use of BVS in patient with ISR.

  4. In situ coronary stent paving by Pluronic F127-alginate gel blends: Formulation and erosion tests.

    Science.gov (United States)

    Dalmoro, Annalisa; Barba, Anna Angela; Grassi, Mario; Grassi, Gabriele; Lamberti, Gaetano

    2016-07-01

    In this work the development of an experimental protocol to perform the in situ gel-paving of coronary stent is presented. Biocompatible aqueous blends of Pluronic F127 and sodium alginates are used as potential drug dosage system for pharmacological in situ treatment of coronary in-stent restenosis. Pluronic F127/alginate aqueous blend has the unique characteristic to be liquid at room condition and to form gel at physiological temperature. The proposed protocol is based on the blend injection on stent wall previously implanted in a flexible silicon pipe mimicking the coronary artery. Injected blend is warmed up until human body temperature achieving a soft gel, then it is reticulated by copper bivalent ions to obtain an hard gel. To test the gel paving resistance to erosion phenomena when it is exposed to fluid flux (i.e. blood flux) a dedicated device, (the Simulated Artery Device, SAD), was built to simulate the human circulatory apparatus. The SAD is an hydraulic circuit in which a buffer solution (at pH 7.4) was fluxed by a peristaltic pump through the pipe hosting the covered stent. Erosion tests were performed monitoring, by gravimetric and spectrophotometric methods, the residual mass anchored to stent mesh after given times. The obtained results showed that the in situ gel-paving developed protocol was efficacious and reliable. The gel-paving was completely eroded in a time of the same order of magnitude of the physiological period required to restore the coronary lesion (subsequent to the atheroma removal) and of a pharmacological therapy to inhibit the in-stent-restenosis pathology. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1013-1022, 2016. © 2015 Wiley Periodicals, Inc.

  5. Quantification of thrombus formation in malapposed coronary stents deployed in vitro through imaging analysis.

    Science.gov (United States)

    Brown, Jonathan; O'Brien, Caroline C; Lopes, Augusto C; Kolandaivelu, Kumaran; Edelman, Elazer R

    2018-04-11

    Stent thrombosis is a major complication of coronary stent and scaffold intervention. While often unanticipated and lethal, its incidence is low making mechanistic examination difficult through clinical investigation alone. Thus, throughout the technological advancement of these devices, experimental models have been indispensable in furthering our understanding of device safety and efficacy. As we refine model systems to gain deeper insight into adverse events, it is equally important that we continue to refine our measurement methods. We used digital signal processing in an established flow loop model to investigate local flow effects due to geometric stent features and ultimately its relationship to thrombus formation. A new metric of clot distribution on each microCT slice termed normalized clot ratio was defined to quantify this distribution. Three under expanded coronary bare-metal stents were run in a flow loop model to induce clotting. Samples were then scanned in a MicroCT machine and digital signal processing methods applied to analyze geometric stent conformation and spatial clot formation. Results indicated that geometric stent features play a significant role in clotting patterns, specifically at a frequency of 0.6225 Hz corresponding to a geometric distance of 1.606 mm. The magnitude-squared coherence between geometric features and clot distribution was greater than 0.4 in all samples. In stents with poor wall apposition, ranging from 0.27 mm to 0.64 mm maximum malapposition (model of real-world heterogeneity), clots were found to have formed in between stent struts rather than directly adjacent to struts. This early work shows how the combination of tools in the areas of image processing and signal analysis can advance the resolution at which we are able to define thrombotic mechanisms in in vitro models, and ultimately, gain further insight into clinical performance. Copyright © 2018 Elsevier Ltd. All rights reserved.

  6. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were...

  7. Microvascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty treated with a mesh covered stent (MGUARD Stent) versus Bare Metal Stent

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    Lindefjeld, Dante S., E-mail: dslindef@puc.cl [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Guarda, Eduardo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Méndez, Manuel [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Martínez, Alejandro [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Pérez, Osvaldo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Fajuri, Alejandro; Marchant, Eugenio [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Aninat, Mauricio; Torres, Humberto [Hospital Dr. Gustavo Fricke, Viña del Mar-Chile (Chile); Dussaillant, Gastón [Hospital Clínico Universidad de Chile, Santiago-Chile (Chile)

    2013-01-15

    Background: Distal embolization of thrombus/platelet aggregates decreases myocardial reperfusion during primary percutaneous coronary intervention (PCI), and is associated with worse immediate and long-term prognosis of patients with ST-elevation myocardial infarction (STEMI). Objective: Assess the efficacy of a mesh covered stent (MGuard™ stent, MGS) in preventing distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS). Methods: Forty patients with STEMI referred for primary PCI were randomized for stenting the culprit lesion with the MGS (n = 20) or a BMS (n = 20). Blinded experts performed off-line measurements of angiographic epicardial and microvascular reperfusion criteria: TIMI flow grade, myocardial blush, corrected TIMI frame count (cTFC). Results: At baseline clinical, angiographic and procedural variables were not different between groups. Post PCI TIMI flow grade was similar in both groups. We observed better myocardial Blush grade in group MGS compared to BMS (median value 3.0 vs 2.5, 2p = 0.006) and cTFC (mean cTFC: MGS 19.65 ± 4.07 vs BMS 27.35 ± 7.15, 2p < 0.001, cTFC mean difference MGS-BMS: 7.7, CI 95%: 3.94 to 11.46). MGS stent group had a higher percentage of successful angioplasty (cTFC ≤ 23: MGS 85% vs BMS 30%, 2p < 0.001). We had two cases of acute stent thrombosis (one for each group) at 30 days follow up, but no clinical events at 6 months follow up. Conclusions: In this exploratory study, MGS significantly improved microvascular reperfusion criteria compared with a BMS in primary PCI. However its safety and impact on clinical outcomes should be verified in larger randomized clinical trials.

  8. Efectos biológicos de los stents medicados en la circulación coronaria Biological effects of drug-eluting stents in the coronary circulation

    Directory of Open Access Journals (Sweden)

    Darío Echeverri

    2010-04-01

    Full Text Available Los stents medicados ofrecen la mejor alternativa disponible no quirúrgica para el tratamiento de la enfermedad coronaria gracias a su demostrada eficacia. Sin embargo, estos excelentes resultados han sido opacados en términos de seguridad, principalmente por la presencia de trombosis de stents de manera tardía o muy tardía. La comprensión de los efectos biológicos que ejercen a nivel de la arteria coronaria luego de su implante, se debe al efecto de la plataforma utilizada, el polímero y la droga que liberan. Los trastornos de reparación vascular inducidos favorecen la trombosis de stents y sus consecuencias clínicas. Se hace una revisión de los diferentes efectos biológicos de los stents medicados en las arterias coronarias, que permite comprender como han surgido rápidamente nuevas versiones en materiales, diseños, polímeros y medicamentos que reducen los efectos adversos a nivel coronario, mejorando su eficacia y seguridad.Drug-eluting stents offer the best available non-surgical alternative for the treatment of coronary disease, thanks to its demonstrated efficacy. However, in terms of security, these excellent results have been overshadowed by the late or very late appearance of stent thromboses.The biological effects they have in the coronary artery after its implantation are due to the effect of the platform used, the polymer and the medication released. The vascular healing disorders induced by drug-eluting stents favor stent thrombosis and its clinical consequences. This is a review of the different biological effects of drug-eluting stents in coronary arteries that allows to understand how the rapid onset of new versions of materials, designs, polymers and medications diminish adverse coronary effects and improve its efficacy and safety.

  9. The SYNERGY biodegradable polymer everolimus eluting coronary stent: Porcine vascular compatibility and polymer safety study.

    Science.gov (United States)

    Wilson, Gregory J; Marks, Angela; Berg, Kimberly J; Eppihimer, Michael; Sushkova, Natalia; Hawley, Steve P; Robertson, Kimberly A; Knapp, David; Pennington, Douglas E; Chen, Yen-Lane; Foss, Aaron; Huibregtse, Barbara; Dawkins, Keith D

    2015-11-15

    SYNERGY is a novel platinum chromium alloy stent that delivers abluminal everolimus from an ultrathin poly-lactide-co-glycide (PLGA) biodegradable polymer. This study evaluated the in vivo degradation of the polymer coating, everolimus release time course, and vascular compatibility of the SYNERGY stent. SYNERGY stents were implanted in arteries of domestic swine. Devices were explanted at predetermined time points (up to 120 days) and the extent of PLGA coating or everolimus remaining on the stents was quantified. Everolimus levels in the arterial tissue were also evaluated. A pathological analysis on coronary arteries of single and overlapping stents was performed at time points between 5 and 270 days. PLGA bioabsorption began immediately after implantation, and drug release was essentially complete by 90 days; PLGA absorption was substantially complete by 120 days (>90% of polymer was absorbed) leaving a bare metal SYNERGY stent. Vascular response was similar among SYNERGY and control stents (bare metal, polymer-only, and 3× polymer-only). Mild increases in para-strut fibrin were seen for SYNERGY at an early time point with no significant differences in all other morphological and morphometric parameters through 270 days or endothelial function (eNOS immunostaining) at 90 or 180 days. Inflammation was predominantly minimal to mild for all device types. In a swine model, everolimus was released by 90 days and PLGA bioabsorption was complete shortly thereafter. The SYNERGY stent and its biodegradable polymer, even at a 3× safety margin, demonstrated vascular compatibility similar to bare metal stent controls. © 2015 Wiley Periodicals, Inc.

  10. A Novel Stent Coated with Antibodies to Endoglin Inhibits Neointimal Formation of Porcine Coronary Arteries

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    Song Cui

    2014-01-01

    Full Text Available Endoglin/CD105 is an accessory protein of the transforming growth factor-β receptor system that plays a critical role in proliferation of endothelial cells and neovasculature. Here, we aimed to assess the effect of novel stents coated with antibodies to endoglin (ENDs on coronary neointima formation. Thirty ENDs, thirty sirolimus-eluting stents (SESs, and thirty bare metal stents (BMSs were randomly assigned and placed in the coronary arteries in 30 juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed that after 7 days, there was no difference in the neointimal area and percent area stenosis in ENDs compared with SMSs or BMSs. After 14 days, the neointima area and percent area stenosis in ENDs were markedly decreased than those in BMSs or SESs (P<0.05. Moreover, the percentage of reendothelialization was significantly higher in ENDs than that in SESs or BMSs (P<0.01 at 7 and 14 days. The artery injury and the inflammation scores were similar in all groups at 7 and 14 days. In conclusion, our results demonstrated for the first time to our knowledge that endoglin antibody-coated stents can markedly reduce restenosis by enhancing reendothelialization in the porcine model and potentially offer a new approach to prevent restenosis.

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

    DEFF Research Database (Denmark)

    Schmidt, Morten Hvid; Johansen, Martin B; Maeng, Michael

    2012-01-01

    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...... 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...

  12. Risk of Adverse Cardiac and Bleeding Events Following Cardiac and Noncardiac Surgery in Patients With Coronary Stent: How Important Is the Interplay Between Stent Type and Time From Stenting to Surgery?

    Science.gov (United States)

    Saia, Francesco; Belotti, Laura Maria Beatrice; Guastaroba, Paolo; Berardini, Alessandra; Rossini, Roberta; Musumeci, Giuseppe; Tarantini, Giuseppe; Campo, Gianluca; Guiducci, Vincenzo; Tarantino, Fabio; Menozzi, Alberto; Varani, Elisabetta; Santarelli, Andrea; Tondi, Stefano; De Palma, Rossana; Rapezzi, Claudio; Marzocchi, Antonio

    2016-01-01

    Epidemiology and consequences of surgery in patients with coronary stents are not clearly defined, as well as the impact of different stent types in relationship with timing of surgery. Among 39 362 patients with previous coronary stenting enrolled in a multicenter prospective registry and followed for 5 years, 13 128 patients underwent 17 226 surgical procedures. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively, and of cardiac and noncardiac surgery was 0.8%, 2.1%, 2.6%, and 4.0% and 1.3%, 5.1%, 9.1%, and 31.7%, respectively. We assessed the incidence and the predictors of cardiac death, myocardial infarction, and serious bleeding event within 30 days from surgery. Cardiac death occurred in 438 patients (2.5%), myocardial infarction in 256 (1.5%), and serious bleeding event in 1099 (6.4%). Surgery increased 1.58× the risk of cardiac death during follow-up. Along with other risk factors, the interplay between stent type and time from percutaneous coronary intervention to surgery was independently associated with cardiac death/myocardial infarction. In comparison with bare-metal stent implanted >12 months before surgery, old-generation drug-eluting stent was associated with higher risk of events at any time point. Conversely, new-generation drug-eluting stent showed similar safety as bare-metal stent >12 months and between 6 and 12 months and appeared trendly safer between 0 and 6 months. Surgery is frequent in patients with coronary stents and carries a considerable risk of ischemic and bleeding events. Ischemic risk is inversely related with time from percutaneous coronary intervention to surgery and is influenced by stent type. © 2015 American Heart Association, Inc.

  13. An in silico study on the role of smooth muscle cell migration in neointimal formation after coronary stenting

    NARCIS (Netherlands)

    Tahir, H.; Niculescu, I.; Bona-Casas, C.; Merks, R.M.H.; Hoekstra, A.G.

    2015-01-01

    Excessive migration and proliferation of smooth muscle cells (SMCs) has been observed as a major factor contributing to the development of in-stent restenosis after coronary stenting. Building upon the results from in vivo experiments, we formulated a hypothesis that the speed of the initial tissue

  14. Computational fluid dynamics study of common stent models inside idealised curved coronary arteries.

    Science.gov (United States)

    Chen, Winson X; Poon, Eric K W; Hutchins, Nicholas; Thondapu, Vikas; Barlis, Peter; Ooi, Andrew

    2017-05-01

    The haemodynamic behaviour of blood inside a coronary artery after stenting is greatly affected by individual stent features as well as complex geometrical properties of the artery including tortuosity and curvature. Regions at higher risk of restenosis, as measured by low wall shear stress (WSS computational modelling and computational fluid dynamics methodologies were used to analyse the haemodynamic characteristics in curved stented arteries using several common stent models. Results in this study showed that stent strut thickness was one major factor influencing the distribution of WSS in curved arteries. Regions of low WSS were found behind struts, particularly those oriented at a large angle relative to the streamwise flow direction. These findings were similar to those obtained in studies of straight arteries. An uneven distribution of WSS at the inner and outer bends of curved arteries was observed where the WSS was lower at the inner bend. In this study, it was also shown that stents with a helical configuration generated an extra swirling component of the flow based on the helical direction; however, this extra swirl in the flow field did not cause significant changes on the distribution of WSS under the current setup.

  15. Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

    Science.gov (United States)

    Philip, Femi; Stewart, Susan; Southard, Jeffrey A

    2016-07-01

    The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  16. 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

  17. Optimal scanning protocols of 64-slice CT angiography in coronary artery stents: An in vitro phantom study

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    Almutairi, Abdulrahman Marzouq [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia); Sun Zhonghua [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia)], E-mail: z.sun@curtin.edu.au; Ng, Curtise [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, Western Australia (Australia); Al-Safran, Zakariya A.; Al-Mulla, Abeer A.; Al-Jamaan, Abdulaziz I. [Department of Medical Imaging, King Fahad Specialist Hospital, Dammam (Saudi Arabia)

    2010-04-15

    Purpose: The purpose of the study was to investigate the optimal scanning protocol of 64-slice CT angiography for assessment of coronary artery stents based on a phantom study. Materials and methods: Coronary stents with a diameter of 2.5 mm was implanted in thin plastic tubes with an inner diameter of 3.0 mm to simulate a coronary artery. The tubes were filled with iodinated contrast medium diluted to 178 HU, closed at both ends and positioned in a plastic container filled with vegetable oil (-70 to -100 HU). A series of scans were performed with a 64-slice CT scanner with the following protocols: section thickness: 0.67 mm, 1.0 mm, 1.5 mm, 2.0 mm, pitch value: 0.2, 0.3, 0.5 and reconstruction interval of 50% overlap of the section thickness. 2D axial and multiplanar reformatted images were generated to assess the visibility of stent lumen, while virtual intravascular endoscopy (VIE) was reconstructed to evaluate the artery wall and stent surface. Results: Our results showed that a scanning protocol of 1.0 mm slice thickness with a pitch of 0.3 produced acceptable images with best demonstration of the intrastent lumen and stent surface with minimal image noise or artifacts. In contrast, submillimeter scans with 0.67 mm resulted in moderate artifacts which affected visualization of the coronary lumen, in addition to the increased noise. When the section thickness increased to 1.5 mm and 2.0 mm, visualization of the artery wall and stent surface was compromised, although the intrastent lumen was still visible. Conclusion: Our in vitro study suggested that a scanning protocol of 1.0 mm section thickness with pitch of 0.3 is the optimal protocol for evaluation of coronary artery stents as it allows generation of acceptable images with better visualization of stent lumen, stent surface and coronary artery wall.

  18. Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

    Science.gov (United States)

    Verheye, Stefan; Khattab, Ahmed A; Carrie, Didier; Stella, Pieter; Slagboom, Ton; Bartunek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W

    2016-08-05

    Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

  19. Drug eluting stent induced coronary artery aneurysm repair by exclusion. Where are we headed?

    Science.gov (United States)

    Subramaniam, Krishnan Ganapathy; Akhunji, Zakir

    2009-07-01

    We present a case of left anterior descending (LAD) coronary artery aneurysm at the site of previous stent placement 3 years previously. The patient presented with recent worsening of angina. Angiography and 64 slice CT angiography confirmed the presence of 6mm aneurysm of LAD at the site of previous stent involving the origin of diagonal, with thrombus proximal and distal to the stent. This patient was successfully managed by taking the posterior wall of the anterior descending artery while suturing the heel of the left internal mammary artery (LIMA)-LAD anastomosis. The idea was to create severe stenosis upstream to prevent distal embolisation from the site of aneurysm. The diagonal was grafted with a saphenous venous graft. Follow-up angiogram at 3 months demonstrated successful exclusion of the aneurysm and unobstructed flow through the grafts.

  20. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries

    DEFF Research Database (Denmark)

    Kurz, David J; Bernheim, Alain M; Tüller, David

    2015-01-01

    BACKGROUND: Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. METHODS: Planned secondary analysis of patients ≥75 years....... The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. RESULTS: Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates...

  1. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

    Science.gov (United States)

    Kandzari, David E; Mauri, Laura; Koolen, Jacques J; Massaro, Joseph M; Doros, Gheorghe; Garcia-Garcia, Hector M; Bennett, Johan; Roguin, Ariel; Gharib, Elie G; Cutlip, Donald E; Waksman, Ron

    2017-10-21

    The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of

  2. Impact of double filtration plasmapheresis on adhesion molecules levels in patients with stable coronary heart disease after coronary stenting.

    Science.gov (United States)

    Tishko, Valerii V; Sokolov, Alexey A; Belskih, Andrei N; Ivanov, Andrei M; Meshkova, Marina E; Skorinova, Tatyana S

    2017-11-01

    Endothelial dysfunction and inflammatory reaction at the site of damage plays a key role in the formation of neointimal hyperplasia, and in the progression of atherosclerosis. The initiating role in these processes is assigned to adhesion molecules. We studied the dynamics of the level of adhesion molecules soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular adhesion molecule-1 (sVCAM-1), soluble form of the molecule platelet adhesion and endothelial type-1 (sPECAM-1), sL-, sP-, sE-selectins during double filtration plasmapheresis (DFPP) with use of plasma fractionators (PF) Cascadeflo EC-50W and EC-40W (Asahi Kasei Medical Co., Japan) in patients with stable coronary heart disease and hyperlipidemia-(a) in the early post-implantation period after coronary stenting. DFPP reduces the level of plasma adhesion molecules. When using PF Cascadeflo EC-40W, a more pronounced decrease occurs. The rejection coefficient (RC) of adhesion molecules has been identified for these PF. These RCs reflect the immediate removal efficiency of adhesion molecules in the perfusion of plasma through PF. The removal effectiveness of adhesion molecules when using PF Cascadeflo EC-40W is higher than when using the PF Cascadeflo EC-50W (sICAM-1 - 2.5 times, sVCAM-1 - 2.2 times, sPECAM-1.6 times, sL-selectin - 5 times, sP-selectin - 2.8 times, sE - selectin - 3 times). Reducing adhesion molecule levels when using DFPP may play an important role in correcting of endothelial dysfunction in response to damage to the arterial wall in percutaneous coronary intervention (PCI) during the early post-implantation period after coronary stenting. DFPP is a promising approach to prevent in-stent restenosis (ISR). Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Prevalence and prognosis of coronary stent gap detected by multi-detector CT: a follow-up study

    International Nuclear Information System (INIS)

    Zhang, Xinghua; Yang, Li; Ju, Haiyue; Zhang, Fan; Wu, Jian; He, Bin; Chen, Yundai

    2012-01-01

    To evaluate the features of stent gap (SG) and the long-term impact of SG on in-stent restenosis (ISR) in patent stents. A total of 347 consecutive patients with 781 stents who underwent MDCT were assessed for SG and ISR. Clinical and stent features were compared between the SG and non-SG groups. In the follow-up study, among 82 patients with 175 patent stents [26 assessed by conventional coronary angiography (CCA) including 6 contacted in a telephone survey, 46 assessed by computed tomography angiography (CTA) and 10 by both], the incidence of ISR was compared between stents with and without SG. Three patients and 13 stents were excluded. SG was observed in 12.5% of patients and 8.6% of stents. ISR detected by CTA was noted in 21.2% of SG, and SG accounted for 23.7% of ISR. Stent number, length, location, overlapping pattern, tortuosity and in-out angle were predisposing factors for SG. During a mean follow-up period of 15 months after detection of SG, the incidence of ISR was significantly higher in the SG group than in the non-SG group (43.8/14.9% by CCA, 33.3/10.1% by CTA and CCA). Patent stents with SG detected by CTA had a higher incidence of late restenosis, indicating that long-term follow-up or further intervention is necessary. (orig.)

  4. Novel nanostructured biomaterials: implications for coronary stent thrombosis

    Science.gov (United States)

    Karagkiozaki, Varvara; Karagiannidis, Panagiotis G; Kalfagiannis, Nikolaos; Kavatzikidou, Paraskevi; Patsalas, Panagiotis; Georgiou, Despoina; Logothetidis, Stergios

    2012-01-01

    Background Nanomedicine has the potential to revolutionize medicine and help clinicians to treat cardiovascular disease through the improvement of stents. Advanced nanomaterials and tools for monitoring cell–material interactions will aid in inhibiting stent thrombosis. Although titanium boron nitride (TiBN), titanium diboride, and carbon nanotube (CNT) thin films are emerging materials in the biomaterial field, the effect of their surface properties on platelet adhesion is relatively unexplored. Objective and methods In this study, novel nanomaterials made of amorphous carbon, CNTs, titanium diboride, and TiBN were grown by vacuum deposition techniques to assess their role as potential stent coatings. Platelet response towards the nanostructured surfaces of the samples was analyzed in line with their physicochemical properties. As the stent skeleton is formed mainly of stainless steel, this material was used as reference material. Platelet adhesion studies were carried out by atomic force microscopy and scanning electron microscopy observations. A cell viability study was performed to assess the cytocompatibility of all thin film groups for 24 hours with a standard immortalized cell line. Results The nanotopographic features of material surface, stoichiometry, and wetting properties were found to be significant factors in dictating platelet behavior and cell viability. The TiBN films with higher nitrogen contents were less thrombogenic compared with the biased carbon films and control. The carbon hybridization in carbon films and hydrophilicity, which were strongly dependent on the deposition process and its parameters, affected the thrombogenicity potential. The hydrophobic CNT materials with high nanoroughness exhibited less hemocompatibility in comparison with the other classes of materials. All the thin film groups exhibited good cytocompatibility, with the surface roughness and surface free energy influencing the viability of cells. PMID:23269867

  5. Clinical benefits of drug-eluting stent implantation in septuagenarians with coronary artery disease

    International Nuclear Information System (INIS)

    Fang Yuehua; Shen Weifeng; Zhang Ruiyan; Zhang Jiansheng; Hu Jian; Zhang Xian; Zheng Aifang

    2005-01-01

    Objective: This study evaluated the safety and long-term outcomes of drug-eluting stents in septuagenarians with coronary artery disease. Methods: Two hundred and thirty-nine consecutive patients with coronary artery disease underwent drug-eluting stenting, including 88 patients aged ≥70 years (group A) and 151 aged <70 years (group B). Baseline clinical characteristics, procedural success rate, occurrence of cardiac events during follow-up were recorded and compared between the two groups. Results: Procedural success rate and complications were similar for the two groups. During follow-up, group A had higher recurrence rate of chest pain than group B (23.9% vs. 7.3%, P<0.001), and occurrence of cardiac events was higher in group A than in group B (5.7% vs. 2.7%, P<0.296). There was no significant difference in the frequency of restenosis between the two groups. Conclusions: Drug-eluting stent implantation for septuagenarians with coronary artery disease is safe but may have more recurrence of angina than younger ones during long-term follow-up. (authors)

  6. Adiponectin expression in epicardial adipose tissue after percutaneous coronary intervention with bare-metal stent.

    Science.gov (United States)

    Spener, Roberta França; Breda, João Roberto; Pires, Adilson Casemiro; Pinhal, Maria Aparecida da Silva; Souto, Ricardo Peres do

    2011-01-01

    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 intracoronary bare-metal stent (BMS), could promote inflammatory changes in the periadvential fat, contributing to vascular restenosis. We sought to determine gene expression of inflammatory mediator in pericardial adipose tissue after bare-metal stent implantation and vascular restenosis that had been referred to operative treatment. Paired samples of PAT were harvested at the time of elective coronary artery bypass surgery (CABG) in 11 patients (n = 22), one sample was obtained of the tissue around BMS area and another sample around coronary artery without stent. Local expression of adiponectin was determined by real-time polymerase chain reaction (RT-PCR) using Taq DNA polymerase. In two samples, there was no gene expression of adiponectin. We are able to identify adiponectin in 20 samples, however, the pattern of gene expression were heterogeneous.We did not notice specificity when we compared PAT obtained near BMS area or far from BMS area. There were no correlation between adiponectin gene expression and presence of BMS.

  7. Morphology characterization and biocompatibility study of PLLA (Poly-L-Llactid-Acid) coating chitosan as stent for coronary heart disease

    Science.gov (United States)

    Widiyanti, Prihartini; Paramadini, Adanti W.; Jabbar, Hajria; Fatimah, Inas; Nisak, Fadila N. K.; Puspitasari, Rahma A.

    2016-03-01

    Cardiovascular disease is a global disease with high urgency. In the severe case of coronary heart disease while a blockage in the coronary arteries reach 75% or more, the patient required stent implantation. Stents are made of metal which has many limitations that can lead to blood clots and stent incompatibility toward the size of the blood vessels. There is a metal stent replacement solution that made from polymer material which is biocompatible. PLLA also has biocompatibility and good mechanical strength. PLLA stent will be coated with chitosan as a candidate for drug-coated stents which is able to work as a drug carrier. The aim of this study is to know the morphology information and biocompability status of PLLA coating chitosan as candidate of heart stent. Morphological results using SEM showed a smooth surface structure which reinforced clinical standard of stent material. Results of cytotoxicity test by MTT Assay method showed that the result of four samples in this experiment living cells is reached 90% which is non toxic and safe to use in the human body. %). The conclusion of this study is PLLA is polymer has potency to be used as stent material.

  8. Stent

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Stent URL of this page: //medlineplus.gov/ency/article/002303.htm Stent To use the sharing features on this page, please enable JavaScript. A stent is a tiny tube placed into a hollow structure in your ...

  9. Safety in simple versus complex stenting of coronary artery bifurcation lesions. The nordic bifurcation study 14-month follow-up results

    DEFF Research Database (Denmark)

    Jensen, Jan Skov; Galløe, Anders Michael; Lassen, Jens Flensted

    2008-01-01

    AIMS: The risk of stent thrombosis has been reported to increase with percutaneous coronary intervention (PCI) complexity. The present study reports the pre-specified secondary endpoint of a 14-month stent thrombosis and major adverse cardiac events in patients stented with a simple versus...... a complex bifurcation technique using sirolimus eluting stents (SES). METHODS AND RESULTS: A total of 413 patients with a coronary bifurcation lesion were randomised to a simple treatment strategy; stenting of main vessel and optional stenting of side branch (MV group), or to a complex stenting strategy......; stenting of both main vessel and side branch (MV+SB group). Mortality data were available in all patients and 14-month clinical follow-up data in 395 (96%) of the patients. After 14 months, the rates of definite, probable and possible stent thrombosis (ARC criteria) were 1.0% vs. 0.5%, 1.0% vs. 0% and 0...

  10. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

    DEFF Research Database (Denmark)

    Raungaard, Bent; Christiansen, Evald H; Bøtker, Hans Erik

    2017-01-01

    OBJECTIVES: The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BACKGROUND: Biodegradable-polymer biolimus-eluting stents are superior to first......:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0...... to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33). CONCLUSIONS: At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome...

  11. 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

  12. 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.

  13. Microstructural changes within similar coronary stents produced from two different austenitic steels.

    Science.gov (United States)

    Weiss, Sabine; Meissner, Andreas; Fischer, Alfons

    2009-04-01

    Coronary heart disease has become the most common source for death in western industrial countries. Since 1986, a metal vessel scaffold (stent) is inserted to prevent the vessel wall from collapsing [Puel, J., Joffre, F., Rousseau, H., Guermonprez, B., Lancelin, B., Valeix, B., Imbert, G., Bounhoure, J.P, 1987. Endo-prothéses coronariennes autoexpansives dans la Préevention des resténoses apés angioplastie transluminale. Archives des Maladies du Coeur et des Vaisseaux, 1311--1312]. Most of these coronary stents are made from CrNiMo-steel (AISI 316L). Due to its austenitic structure, the material shows strength and ductility combined with corrosion resistance and a satisfactory biocompatibility. However, recent studies indicate that Nickel is under discussion as to its allergenic potential. Other typically used materials like Co-Base L605 or Tantalum alloys are relatively expensive and are not used so often. Newly developed austenitic high-nitrogen CrMnMoN-steels (AHNS) may offer an alternative. Traditional material tests revealed that strength and ductility, as well as corrosion resistance and biocompatibility, are as good as or even better than those of 316L [Vogt, J.B., Degallaix, S., Foct J., 1984. Low cycle fatigue life enhancement of 316L stainless steel by nitrogen alloying. International Journal of Fatigue 6 (4), 211-215, Menzel, J., Stein, G., 1996. High nitrogen containing Ni-free austenitic steels for medical applications. ISIJ Intern 36 (7), 893-900, Gavriljuk, V.G., Berns, H., 1999. High nitrogen steels, Springer Verlag, Berlin, Heidelberg]. However, because of a strut diameter of about 100 microm, the cross section consists of about five to ten crystal grains (oligo-crystalline). Thus very few, or even just one, grain can be responsible for the success or failure of the whole stent. During implantation, the structure of coronary artery stents is subjected to distinct inhomogeneous plastic deformation due to crimping and dilation.

  14. Angiographic patterns of in-stent restenosis classified by computed tomography in patients with drug-eluting stents: correlation with invasive coronary angiography

    International Nuclear Information System (INIS)

    Pan, Jingwei; Lu, Zhigang; Wei, Meng; Zhang, Jiayin; Li, Minghua

    2013-01-01

    To evaluate the diagnostic accuracy of Mehran's in-stent restenosis (ISR) classification by coronary computed angiography (CCTA), with reference to invasive coronary angiography (ICA). Consecutive symptomatic patients, who had clinically suspected ISR and implanted stent diameter ≥ 3 mm, were prospectively enrolled in our study. Mehran's classification was employed by CCTA and ICA to classify ISR lesions into four subtypes: focal, diffuse intrastent, diffuse proliferative and total occlusion. CCTA and ICA measurement of lesion length was further compared. Sixty-one patients with 101 implanted stents were included in our study. The overall sensitivity, specificity, PPV and NPV of CCTA diagnosis of binary ISR, as shown by patient-based analysis (n = 61), were 100 % (49/49), 75 % (8/12), 92.45 % (49/53) and 100 % (8/8) respectively. Mehran's classification of CCTA correlated well with ICA findings. The diagnostic accuracy of CCTA for class I, class II, class III and class IV lesions was 92.5 %, 91.67 %, 100 % and 100 % respectively. Lesion length was assessed to be significantly longer with CCTA than with ICA (11.03 ± 5.89 mm versus 8.56 ± 4.99 mm, P < 0.001). Angiographic patterns of in-stent restenosis can be accurately classified by coronary computed angiography. The lesion length measured by CCTA is longer than that assessed by invasive coronary angiography. (orig.)

  15. In-hospital and mid-term clinical outcomes after percutaneous coronary intervention with the use of sirolimus- or paclitaxel-eluting stents

    NARCIS (Netherlands)

    Alidoosti, Mohammad; Salarifar, Mojtaba; Kassaian, Seyed E.; Zeinali, Ali M. Haji; Nematipoor, Ebrahim; Sheikhfathollahi, Mahmood; Poorhosseini, Hamidreza; Dehkordi, Maria Raissi; Abbasi, Ali

    2009-01-01

    Background: Drug-eluting stents improved the outcome after percutaneous coronary intervention (PCI), however, there may be significant differences in their safety and efficacy. Aim: To compare the in-hospital and mid-term clinical outcomes of stenting with sirolimus-eluting stents (SES) versus

  16. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings.

    Science.gov (United States)

    Eric Jones, John; Chen, Meng; Yu, Qingsong

    2014-10-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20-25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH₃/O₂ plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O- and N-contents on the surfaces were substantially increased after NH₃/O₂ plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH₃/O₂ plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. © 2014 Wiley Periodicals, Inc.

  17. Effect of oral sirolimus therapy on inflammatory biomarkers following coronary stenting

    Directory of Open Access Journals (Sweden)

    W.C.M. Rosa

    2010-08-01

    Full Text Available We studied the effect of oral sirolimus, administered to prevent and treat in-stent restenosis (ISR, on the variation of serum levels of inflammatory markers following coronary stenting with bare metal stents. The mean age of the patients was 56 ± 13 years, 65% were males and all had clinically manifested ischemia. Serum levels of high sensitivity C-reactive protein (hs-CRP concentration were determined by chemiluminescence and serum levels of all other biomarkers by ELISA. One group of patients at high risk for ISR received a loading oral dose of 15 mg sirolimus and 5 mg daily thereafter for 28 days after stenting (SIR-G. A control group (CONT-G was submitted to stenting without sirolimus therapy. The increase in hs-CRP concentration was highest at 24 h after stenting in both groups. A significant difference between SIR-G and CONT-G was observed at 4 weeks (-1.50 ± 5.0 vs -0.19 ± 0.4, P = 0.008 and lost significance 1 month after sirolimus discontinuation (-1.73 ± 4.3 vs -0.01 ± 0.7, P = 0.0975. A continuous fall in MMP-9 concentration was observed in SIR-G, with the greatest reduction at 4 weeks (-352.9 ± 455 vs +395.2 ± 377, P = 0.0004, while a positive variation was noted 4 weeks after sirolimus discontinuation (227 ± 708 vs 406.2 ± 472.1, P = 0.0958. SIR-G exhibited a higher increase in P-selectin after sirolimus discontinuation at week 8 (46.1 ± 67.9 vs 5.8 ± 23.7, P = 0.0025. These findings suggest that the anti-restenotic actions of systemic sirolimus include anti-proliferative effects and modulation of the inflammatory response with inhibition of adhesion molecule expression.

  18. 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 <0.01; n=40). Notably, in vivo and ex vivo 18 F-FDG positron emission tomographic/computed tomographic imaging and autoradiography showed enhanced 18 F-FDG uptake and its accumulation in PVAT at the EES edges compared with the control site, respectively (both P <0.05). Furthermore, histological and reverse transcription polymerase chain reaction analysis showed that inflammatory changes of coronary PVAT were significantly enhanced at the EES edges compared with the control site (all P <0.01). Importantly, Rho-kinase expressions (ROCK1/ROCK2) and Rho-kinase activity (phosphorylated myosin phosphatase target subunit-1) at the EES edges were significantly enhanced compared with the control site. These results indicate for the first time that inflammatory changes of coronary PVAT are associated with drug-eluting stent-induced coronary hyperconstricting responses in pigs in vivo and that 18 F-FDG positron emission tomographic imaging is useful for assessment of coronary PVAT inflammation.

  19. 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.

  20. In-stent thrombosis when switching ticagrelor to clopidogrel after percutaneous coronary intervention.

    Science.gov (United States)

    Brice, Aaron E; Hernandez, Gabriel A; Sanchez, Mariluz; Haynick, Marshall; Mendoza, Cesar E

    2017-05-01

    Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker has been proven to reduce subsequent cardiovascular events and in-stent thrombosis in patients undergoing percutaneous coronary intervention. Newer P2Y12 antagonists with faster onset and greater inhibition of platelet activity have improved cardiovascular outcomes but have created uncertainty with the appropriate dosing when switching between agents. Currently, there are no evidence-based guidelines to aid clinicians when switching between P2Y12 receptor blockers. Here we describe two patients that developed in-stent thrombosis when switching from ticagrelor to clopidogrel using a 300 mg clopidogrel loading dose. Both patients presented with ST elevation myocardial infarction and underwent stent placement but then developed in-stent thrombosis 48 hours after switching from ticagrelor to clopidogrel. These cases illustrate the severe consequences of suboptimal platelet inhibition and the need for prospective trials thoroughly powered to assess clinical outcomes in order to determine the most appropriate strategy when switching from ticagrelor to clopidogrel.

  1. Surface modification of coronary artery stent by Ti-O/Ti-N complex film coating prepared with plasma immersion ion implantation and deposition

    International Nuclear Information System (INIS)

    Huang, N.; Leng, Y.X.; Yang, P.

    2006-01-01

    This paper reported the work of surface coating of Ti-O/Ti-N complex films on coronary stents by means of the plasma immersion ion implantation/deposition process. The deformation behavior of the Ti-O/Ti-N coated stainless steel stents was investigated. In vivo investigation of the anticoagulation behavior of Ti-O coated coronary stents was also performed. The results of mechanical characterization of the Ti-O/Ti-N coated stents show that the film has strong binding strength, and to some extent the ability to withstand plastic deformation. The biological response behavior of the coated stent surface was significantly different from the uncoated. The results of implantation of stents into rabbit ventral aorta show no thrombus formation on the surfaces of the Ti-O coated stents, although serious coagulation had occurred on the surfaces of unmodified stents over a period of 4 weeks under conditions with no anticoagulant

  2. Restenosis in coronary bare metal stents. Importance of time to follow-up: a comparison of coronary angiograms 6 months and 4 years after implantation

    DEFF Research Database (Denmark)

    Jørgensen, Erik; Helqvist, Steffen; Kløvgaard, Lene

    2008-01-01

    Objectives. Angiographic late lumen loss measured 6 to 9 month after bare metal stent implantation in the coronary arteries is a validated restenosis parameter. Design. We performed a second angiographic follow-up after 4 years in event free survivors from the DANSTENT trial cohort. Results......-sectional vessel area and a 39% reduction of the binary restenosis rate over time. Conclusions. Instent late lumen loss in bare metal stents decreases spontaneously over time. Maturation of early hyperplastic tissue reaction after stent implantation with subsequent thinning of fibrotic tissue might explain...

  3. Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

    Directory of Open Access Journals (Sweden)

    В. Л. Воробьев

    2017-04-01

    Full Text Available Aim. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA.Methods. The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated, major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated. Results. In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. Conclusion. The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.Received 31 January 2017. Accepted 17 March 2017.Financing: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interest.

  4. Natural history of intravascular ultrasound-detected edge dissections from coronary stent deployment.

    Science.gov (United States)

    Sheris, S J; Canos, M R; Weissman, N J

    2000-01-01

    High-resolution intravascular ultrasound (IVUS) performed immediately after stent deployment often reveals dissection at the stent margin that may not be appreciated by angiography. However, the natural history of these edge dissections is unknown. These intimal disruptions at the stent margins have been previously reported to occur in 5% to 23% of stent implantations. The short-term prognosis of these lesions appears to be good; however, the longer-term effect on restenosis and/or vessel remodeling is not known. We therefore studied a cohort of patients with the use of IVUS immediately after stent implantation and at 6 months to assess the incidence and prognosis of coronary edge dissections. One hundred fifty patients undergoing Palmaz-Shatz stent implantation were imaged with IVUS with the use of a motorized pullback, and the incidence of edge dissections was determined and graded according to depth and circumferential extent. Arterial and lesional morphometric parameters were assessed by digital planimetry. Six-month IVUS images were aligned with the poststent IVUS to determine the natural history of these lesions. Sixteen (10.7%) of 150 had edge tears. All were angiographically silent. Most lesions (n = 9) were superficial intimal tears. Vessel, lumen, and plaque area were similar in the nondissection and dissection groups in both the proximal and distal reference segments. Plaque eccentricity was likewise similar in both groups. At 6 months, lesions (n = 12) healed without a change in plaque burden, undergoing a "tacking down" process. Vessel area (19. 1 +/- 6.4 vs 18.4 +/- 7.1 mm(2), P = not significant), lumen area (8. 2 +/- 4.1 vs 9.2 +/- 4.0 mm(2), P = not significant), and plaque area (10.0 +/- 3.3 vs 9.8 +/- 3.3 mm(2), P = not significant) were unchanged when compared with the lesion site taken at stent deployment. Edge dissections as detected by IVUS do not necessarily proscribe an adverse prognosis at 6 months. This finding may provide reassurance to

  5. Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with second-generation drug-eluting stents for patients with multivessel and unprotected left main coronary artery disease

    Directory of Open Access Journals (Sweden)

    Kyriacos Papadopoulos

    2017-01-01

    Full Text Available Objectives: To compare the efficacy and safety of percutaneous coronary intervention using second-generation drug-eluting stents with those of coronary artery bypass grafting among patients with multivessel disease and/or unprotected left main coronary artery disease in terms of mortality, myocardial infarction, repeat revascularization, and angina. Background: Although coronary artery disease is a leading cause of death in the Western world and in many developing countries, its optimal treatment is still a matter of controversy. Several studies have examined the clinical safety and efficacy of percutaneous coronary intervention using first-generation drug-eluting stents over coronary artery bypass grafting in patients with multivessel disease and/or unprotected left main coronary artery disease. However, this study compared the efficacy of percutaneous coronary intervention using second-generation drug-eluting stents to that of coronary artery bypass grafting for multivessel disease and/or unprotected left main coronary artery disease. Methods: This was a prospective single-center cohort study conducted from September 2012 to November 2014 at the Nicosia General Hospital. In total, 140 patients (94% men and 6% women with chronic coronary artery disease undergoing revascularization with either percutaneous coronary intervention using second-generation drug-eluting stents or coronary artery bypass grafting were evaluated. We examined the differences in clinical outcomes between coronary artery bypass grafting and percutaneous coronary intervention at 1-year follow-up. Results: Percutaneous coronary intervention with second-generation drug-eluting stents as opposed to coronary artery bypass grafting resulted in similar rates of mortality (5.7% vs 11.4%, respectively; p = 0.135, myocardial infarction (0% vs 4.3%, respectively, repeat revascularization (4.3% vs 8.6%, respectively; p = 0.115 and angina (10% vs 18.6%, respectively; p = 0

  6. 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.

  7. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Barbara Campos Abreu Marino

    2015-05-01

    Full Text Available Background: Clinical in-stent restenosis (CISR is the main limitation of coronary angioplasty with stent implantation. Objective: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI] and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization during a minimal follow-up of one year. Results: Mean age was 61 ± 11 years (68.2% males. Clinical presentations included acute coronary syndrome (ACS in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES in 36.4%, Bare Metal Stent (BMS in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5% deaths and 13 (11.8% AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009 and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001. Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001 and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019 emerged as predictors of a secondary outcome. Conclusion: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.

  8. Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

    Directory of Open Access Journals (Sweden)

    Menozzi Mila

    2012-10-01

    Full Text Available Abstract Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

  9. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  10. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries

    DEFF Research Database (Denmark)

    Chevalier, Bernard; Dimario, Carlo; Neumann, Franz-Josef

    2013-01-01

    The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the pr......The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis...... at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years....

  11. Association of Adventitial Vasa Vasorum and Inflammation With Coronary Hyperconstriction After Drug-Eluting Stent Implantation in Pigs In Vivo.

    Science.gov (United States)

    Nishimiya, Kensuke; Matsumoto, Yasuharu; Shindo, Tomohiko; Hanawa, Kenichiro; Hasebe, Yuhi; Tsuburaya, Ryuji; Shiroto, Takashi; Takahashi, Jun; Ito, Kenta; Ishibashi-Ueda, Hatsue; Yasuda, Satoshi; Shimokawa, Hiroaki

    2015-01-01

    The importance of adventitial inflammation has been implicated for the pathogenesis of coronary artery disease. However, the roles of adventitial changes in drug-eluting stent (DES)-induced coronary hyperconstriction remain largely unknown. In the present study, this issue in pigs in vivo with a special reference to adventitial vasa vasorum (VV) formation and Rho-kinase activation, a central mechanism of coronary vasospasm, was examined. Each animal received a sirolimus-eluting stent (SES) and a biolimus A9-eluting stent (BES), one in the left anterior descending and another in the left circumflex coronary arteries in a randomized manner (n=18). After 1, 3 and 6 months, coronary vasomotion was examined. At 1 month, coronary vasoconstriction to serotonin was significantly enhanced at the SES edges as compared with the BES edges (SES, 52±7% vs. BES, 22±3%, Pmicro-CT showed VV augmentation at the SES site, extending to the proximal and distal edges. Immunostainings demonstrated that VV formation, macrophage infiltration in the adventitia and Rho-kinase expressions/activation were significantly enhanced at the SES edges as compared with the BES edges. The DES with durable polymers enhances VV formation and inflammation in the adventitia, associating with the pathogenesis of DES-induced coronary hyperconstriction through Rho-kinase activation in pigs in vivo.

  12. Clopidogrel discontinuation and platelet reactivity following coronary stenting

    LENUS (Irish Health Repository)

    2011-01-01

    Summary. Aims: Antiplatelet therapy with aspirin and clopidogrel is recommended for 1 year after drug-eluting stent (DES) implantation or myocardial infarction. However, the discontinuation of antiplatelet therapy has become an important issue as recent studies have suggested a clustering of ischemic events within 90 days of clopidogrel withdrawal. The objective of this investigation was to explore the hypothesis that there is a transient ‘rebound’ increase in platelet reactivity within 3 months of clopidogrel discontinuation. Methods and Results: In this prospective study, platelet function was assessed in patients taking aspirin and clopidogrel for at least 1 year following DES implantation. Platelet aggregation was measured using a modification of light transmission aggregometry in response to multiple concentrations of adenosine diphosphate (ADP), epinephrine, arachidonic acid, thrombin receptor activating peptide and collagen. Clopidogrel was stopped and platelet function was reassessed 1 week, 1 month and 3 months later. Thirty-two patients on dual antiplatelet therapy were recruited. Discontinuation of clopidogrel increased platelet aggregation to all agonists, except arachidonic acid. Platelet aggregation in response to ADP (2.5, 5, 10, and 20 μm) and epinephrine (5 and 20 μm) was significantly increased at 1 month compared with 3 months following clopidogrel withdrawal. Thus, a transient period of increased platelet reactivity to both ADP and epinephrine was observed 1 month after clopidogrel discontinuation. Conclusions: This study demonstrates a transient increase in platelet reactivity 1 month after clopidogrel withdrawal. This phenomenon may, in part, explain the known clustering of thrombotic events observed after clopidogrel discontinuation. This observation requires confirmation in larger populations.

  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. Third generation dual-source CT enables accurate diagnosis of coronary restenosis in all size stents with low radiation dose and preserved image quality.

    Science.gov (United States)

    Li, Yuehua; Yu, Mengmeng; Li, Wenbin; Lu, Zhigang; Wei, Meng; Zhang, Jiayin

    2018-01-18

    To investigate the diagnostic performance of low dose stent imaging in patients with large (≥ 3 mm) and small (source CT. Symptomatic patients suspected of having in-stent restenosis (ISR) were prospectively enrolled. Coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) were performed within 1 month for correlation. Binary ISR was defined as an in-stent neointimal proliferation with diameter stenosis ≥ 50%. The radiation dose and image quality of CCTA were also assessed. Sixty-nine patients with 140 stents were ultimately included for analysis. The mean total radiation dose of CCTA was 1.3 ± 0.72 mSv in all patients and 0.95 ± 0.17 mSv in patients with high pitch acquisition. The overall diagnostic accuracy of CCTA stent imaging of patient-based, lesion-based and stent-based analysis was 95.7%, 94.1% and 94.3%, respectively. Further, the diagnostic accuracy of CCTA in the small calibre stent group (diameter source CT enables accurate diagnosis of coronary ISR of both large and small calibre stents. Low radiation dose could be achieved with preserved image quality. • Third-generation DSCT enables accurate diagnosis of coronary ISR of all size stents. • Low radiation dose could be achieved with preserved image quality. • The diagnostic accuracy of CCTA of small calibre stents was 88.5%.

  15. Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease.

    Science.gov (United States)

    Javaid, Aamir; Steinberg, Daniel H; Buch, Ashesh N; Corso, Paul J; Boyce, Steven W; Pinto Slottow, Tina L; Roy, Probal K; Hill, Peter; Okabe, Teruo; Torguson, Rebecca; Smith, Kimberly A; Xue, Zhenyi; Gevorkian, Natalie; Suddath, William O; Kent, Kenneth M; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2007-09-11

    Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a "real-world" evaluation of current technology in the treatment of multivessel coronary artery disease. A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes

  16. Aspirin challenge/desensitisation before coronary stenting in subjects with history of hypersensitivity. A pragmatic approach.

    Science.gov (United States)

    Cortellini, G; Testi, S; Severino, M; Chechi, T; Iorno, M L; Santucci, A; Corvetta, A; Piovaccari, G; Santarelli, A; Franco, N; Canonica, G W; Passalacqua, G

    2012-08-01

    Aspirin hypersensitivity may represent a major problem in patients with ischemic coronary disease who need a stenting procedure. In those patients, clinically unsettled reasonably quick desensitisation procedures are needed. In our study we attempted to select the most suitable procedure on the basis of characteristics and severity of ASA hypersensitivity. Thirty patients with a history of mild reactions to anti-inflammatory doses of aspirin (> 325 mg) were considered at low risk and underwent a tolerance test in 5 steps. Thirty-one patients, with a history of severe reactions to anti-platelet doses of aspirin 0 mg) underwent a slow desensitisation in 12 steps, reaching a cumulative dose of 150 mg ASA in 220 minutes. In the first group, 29 patients tolerated the challenge. One developed urticaria, thus underwent challenge/desensitisation and achieved tolerance. In the second group, 3 patients did not tolerate the procedure and had to discontinue. CONCLUSION. Our approach to aspirin hypersensitivity in patients needing coronary stenting, based on a severity stratification, allowed to achieve an effective tolerance to aspirin in the majority of subject in a reasonable short time.

  17. ANGIOPLASTIA PERCUTÁNEA CON STENT EN EL TRONCO PRINCIPAL DE LA ARTERIA CORONARIA IZQUIERDA / Percutaneous angioplasty with stent in the left main coronary artery

    Directory of Open Access Journals (Sweden)

    Javier Almeida Gómez

    2012-10-01

    Full Text Available ResumenIntroducción y objetivos: La afectación significativa del tronco común izquierdo, es la más letal de las presentaciones de la enfermedad arterial coronaria. El tratamiento de elección, es la cirugía de derivación aorto-coronaria. En varios estudios multicéntricos, se sugiere la posibilidad de tratar la enfermedad de tronco mediante el intervencionismo coronario percutáneo con implantación de prótesis endoluminal o stent. El objetivo de esta investigación fue caracterizar la angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda. Método: Se realizó un estudio observacional, descriptivo y transversal en 21 pacientes con angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda, realizadas en el laboratorio de Hemodinámica y Cardiología Intervencionista del Hospital "Hermanos Ameijeiras", entre enero 2010 y julio 2011. Resultados: No existió diferencia significativa en el sexo. Predominó el grupo de edad entre 50-64 años (47,6 % y el color de la piel blanca (76,19 %. El factor de riesgo cardiovascular más encontrado fue la HTA (85,71 %, seguido de dislipidemia (47,61 %. El diagnóstico más observado fue la angina de esfuerzo estable, 14 casos (66,66 %. La lesión en el cuerpo del tronco (12 pacientes, 57,1 %, fue la más encontrada, seguida de la ostial (8 casos. El tipo de stent más utilizado fue el liberador de fármacos (61,9 %, y solamente 4 pacientes presentaban troncos protegidos quirúrgicamente. Conclusiones: La mayor cantidad de casos fueron electivos, con predominio de los troncos no protegidos. El factor de riesgo coronario más encontrado fue la HTA. Se encontró asociación significativa entre la diabetes mellitus y la localización ostial de la lesión tratada. / AbstractIntroduction and Objectives: Significant impairment of the left main coronary artery is the most lethal presentation of coronary artery disease. The treatment of choice

  18. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

    Science.gov (United States)

    de Jaegere, P; Mudra, H; Figulla, H; Almagor, Y; Doucet, S; Penn, I; Colombo, A; Hamm, C; Bartorelli, A; Rothman, M; Nobuyoshi, M; Yamaguchi, T; Voudris, V; DiMario, C; Makovski, S; Hausmann, D; Rowe, S; Rabinovich, S; Sunamura, M; van Es, G A

    1998-08-01

    A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate. The study was designed to be multicentred, prospective, and observational. One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8

  19. Safety and efficacy of drug eluting stents in patients with spontaneous coronary artery dissection.

    Science.gov (United States)

    Conrotto, Federico; D'Ascenzo, Fabrizio; Cerrato, Enrico; Fernández-Ortiz, Antonio; Gonzalo, Nieves; Macaya, Fernando; Tamburino, Corrado; Barbanti, Marco; van Lavieren, Martijn; Piek, Jan J; Applegate, Robert J; Latib, Azeem; Spinnler, Maria Teresa; Marzullo, Raffaella; Iannaccone, Mario; Pavani, Marco; Crimi, Gabriele; Fattori, Rossella; Chinaglia, Alessandra; Presbitero, Patrizia; Varbella, Ferdinando; Gaita, Fiorenzo; Escaned, Javier

    2017-07-01

    Given the different pathogenesis, use of drug eluting stent (DES) in patients with Spontaneous Coronary Artery Dissection SCAD may delay the healing of the dissected vessel. Aim of our study was to compare the safety and the efficacy of DES vs. bare metal stent (BMS) in a cohort of patients who underwent stenting for SCAD. Consecutive patients with SCAD between January 1995 and August 2014 were retrospectively identified in 12 centers and included. Major Adverse Cardiac Events (MACE) was the primary end point. A total of 238 SCAD patients were identified: of them 108 patients underwent PCI with DES or BMS. Overall 24 patients (22.2%) suffered an intra-procedural complication without any differences between the 2 groups. At median follow-up of 1201days (Inter Quartile Range 541-2760), incidence of the primary endpoint showed a trend towards less events in the DES-treated patients (38.7% vs. 25.9% p=0.14) mainly driven by the benefit of DES in terms of TVR (17.6% vs. 4%, p=0.08), mortality (16.8% vs. 9.3%, p=0.4), and MI rate (16% vs. 8.4%, p=0.33). STEMI at presentation (HR 6.4, CI 95% 1.29-31.9, p=0.02) but not kind of stent (HR 0.97, CI 95% 0.2-4.7, p=0.9) emerged as independently related to prognosis at multivariable analysis. In SCAD patients use of DES seems to be as safe as BMS with trend of better efficacy in the long term. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Type D personality predicts chronic anxiety following percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Spindler, Helle; Pedersen, Susanne S.; Serruys, Patrick W.

    2007-01-01

      Background: Anxiety is an often overlooked risk factor in coronary artery disease (CAD). Hence, little is known about predictors of unremitting chronic anxiety in CAD patients. This study examined whether the distressed personality (Type D) predicts chronic anxiety post percutaneous coronary...... intervention (PCI). Methods: Unselected patients treated with PCI using sirolimus-eluting or bare metal stents as part of the RESEARCH registry, who were anxious 6 months post-PCI, qualified for inclusion. Patients completed the Hospital Anxiety and Depression Scale at 6 and 12 months and the Type D Scale 6...... months post-PCI. Results: Of 167 patients anxious at 6 months, 108 (65%) were still anxious 12 months post-PCI. Significant univariable predictors of chronic anxiety were Type D personality (OR:3.17: 95% CI:1.64-6.14) and sirolimus-eluting stents (OR:0.51; 95% CI:0.27-0.98), with sirolimus-eluting stents...

  1. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions).

    Science.gov (United States)

    Eisenstein, Eric L; Wijns, William; Fajadet, Jean; Mauri, Laura; Edwards, Rex; Cowper, Patricia A; Kong, David F; Anstrom, Kevin J

    2009-12-01

    This study was designed to evaluate long-term clinical and economic outcomes for subjects receiving Endeavor drug-eluting versus Driver bare-metal stents (both Medtronic CardioVascular, Santa Rosa, California). Early studies found that the drug-eluting stent (DES) was a clinically and economically attractive alternative to the bare-metal stent; however, associations between DES and very late stent thrombosis suggest that longer follow-up is required. We used clinical, resource use and follow-up data from 1,197 subjects randomized to receive Endeavor (n = 598) versus Driver (n = 599) stents in ENDEAVOR II (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions) study with Medicare cost weights and quality of life adjustments applied from secondary sources. We compared differences through 4-year follow-up (1,440 days). Patients in both treatment groups had similar baseline characteristics. The use of Endeavor versus Driver reduced 4-year target vessel revascularization rates per 100 subjects (10.4 vs. 21.5; difference: -11.1; 95% confidence interval [CI]: -16.0 to -6.1; p AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848).

  2. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    NARCIS (Netherlands)

    Dewilde, W.; Verheugt, F.W.A.; Breet, N.; Koolen, J.J.; Berg, J.M. ten

    2010-01-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment

  3. Multicenter assessment of the reproducibility of volumetric radiofrequency-based intravascular ultrasound measurements in coronary lesions that were consecutively stented

    DEFF Research Database (Denmark)

    Huisman, Jennifer; Egede, Rasmus; Rdzanek, Adam

    2012-01-01

    To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented. To evaluate the reproducibility...

  4. Successful treatment of cardiogenic shock by stenting of the left main coronary artery in acute myocardial infarction

    Directory of Open Access Journals (Sweden)

    Knežević Božidarka

    2008-01-01

    Full Text Available Introduction. Patients with non-ST elevation acute coronary syndromes (NSTE-ACS are sometimes severely hemodynamicly compromised. Urgent coronary angiography should be performed in these patients in percutaneous coronary intervention (PCI centers according to the ESC NSTE-ACS guidelines to determine suitabilty for percutaneous or surgical revascularization. Case report. We reported a 62-year-old male with chest pain admitted to the Coronary Care Unit. ST segment depression of 2 mm in leads I, L and V4-6 was revealed at electrocardiogram. After following 6 hours the patient had chest pain and signs of cardiogenic shock despite of the therapy. Chest x-ray showed pulmonary edema. Echocardiographic examination showed dyskinetic medium and apical segments of septum. The patient underwent coronary angiography immediately which revealed 75% stenosis of the left main coronary artery with thrombus. The use of a GPIIb/III inhibitor-tirofiban and stent implantation resulted in TIMI III flow. After that the patient had no chest pain and acute heart failure subsided in the following days Echocardiography done at the fourth day from PCI showed only hypokinesis medium and apical segment of septum. The patient was discharged at day 11 from admission in a stable condition. Conclusion. Stenting of left main coronary artery stenosis in patients with cardiogenic shock and non- ST segment elevation acute coronary syndromes may be a life saving procedure.

  5. 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

  6. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

    NARCIS (Netherlands)

    B.A. van Hout (Ben); P.A. Lemos Neto (Pedro); G.A. van Es (Gerrit Anne); W.K. Lindeboom (Wietze); M-C. Morice (Marie-Claude); M.J.B.M. van den Brand (Marcel); P.W.J.C. Serruys (Patrick)

    2005-01-01

    textabstractOBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo

  7. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions : an analysis from the RAVEL trial

    NARCIS (Netherlands)

    van Hout, BA; Serruys, PW; Lemos, PA; van den Brand, MJBM; van Es, GA; Lindeboom, WK; Morice, MC

    Objective: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL ( randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native

  8. Effect of pioglitazone on in-stent restenosis after coronary drug-eluting stent implantation: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ming-duo Zhang

    Full Text Available In-stent restenosis (ISR remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation.Randomized controlled trials (RCTs investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR, target lesion revascularization, myocardial infarction, stent thrombosis and death.Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20 with low heterogeneity (I2 = 13.3%, P = 0.32. For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01 and TVR (P = 0.04.The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed.

  9. Sustained Efficacy and Arterial Drug Retention by a Fast Drug Eluting Cross-Linked Fatty Acid Coronary Stent Coating

    Science.gov (United States)

    Artzi, Natalie; Tzafriri, Abraham R.; Faucher, Keith M.; Moodie, Geoffrey; Albergo, Theresa; Conroy, Suzanne; Corbeil, Scott; Martakos, Paul; Virmani, Renu; Edelman, Elazer R.

    2015-01-01

    The long held assumption that sustained drug elution from stent coatings over weeks to months is imperative for clinical efficacy has limited the choice for stent coating materials. We developed and evaluated an omega-3 fatty acid (O3FA) based stent coating that is 85% absorbed and elutes 97% of its Sirolimus analog (Corolimus) load within 8d of implantation. O3FA coated stents sustained drug levels in porcine coronary arteries similarly to those achieved by slow-eluting durable coated Cypher Select Plus Stents and with significantly lower levels of granuloma formation and luminal stenosis. Computational modeling confirmed that diffusion and binding constants of Corolimus and Sirolimus are identical and explained that the sustained retention of Corolimus was facilitated by binding to high affinity intracellular receptors (FKBP12). First in man outcomes were positive—unlike Cypher stents where late lumen loss drops over 6 month, there was a stable effect without diminution in the presence of O3FA. These results speak to a new paradigm whereby the safety of drug eluting stents can be optimized through the use of resorbable biocompatible coating materials with resorption kinetics that coincide with the dissociation and tissue elimination of receptor-bound drug. PMID:26314990

  10. Conformability in everolimus-eluting bioresorbable scaffolds compared with metal platform coronary stents in long lesions.

    Science.gov (United States)

    Fam, Jiang Ming; Ishibashi, Yuki; Felix, Cordula; Zhang, Bu Chun; Diletti, Roberto; van Mieghem, Nicolas; Regar, Evelyn; van Domburg, Ron; Onuma, Yoshinobu; van Geuns, Robert-Jan

    2017-12-01

    The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm -1 , p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (median diastolic curvature from 0.305 to 0.283 cm -1 , p = 0.056). Median Percentage relative change in diastolic curvature was lower in the BRS group compared with the MPS group (BRS vs. MPS: 7.48 vs. 29.4%, p = 0.013). By univariate analysis, use of MPS was an independent predictor of change in diastolic curvature (p = 0.022). In the deployment of long coronary scaffolds/stents (28 mm in length), BRS provides better conformability compared with MPS.

  11. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

    Science.gov (United States)

    de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

    2018-02-03

    MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

  12. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction

    DEFF Research Database (Denmark)

    Dangas, George D; Schoos, Mikkel M.; Steg, Philippe Gabriel

    2016-01-01

    BACKGROUND: Early stent thrombosis (ST) within 30 days after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction is a serious event. We sought to determine the predictors of and risk of mortality after early ST according to procedural antithrombotic therapy...... percutaneous coronary intervention with stent implantation at 188 international sites, randomized to either bivalirudin or heparin±a glycoprotein IIb/IIIa inhibitor (GPI). Early ST occurred in 100 patients (2.0%), 20 of whom (20.0%) died. Bivalirudin was associated with higher rates of early ST compared...... with bivalirudin compared with heparin±GPI because of increased ST within 4 hours after primary percutaneous coronary intervention. However, the mortality attributable to early ST was significantly lower after bivalirudin than after heparin±GPI. CLINICAL TRIAL REGISTRATION: URL: http...

  13. Contribution of quantitative coronary angiography in Palmaz-Schatz optimal stent liberation strategy for subacute occlusion control

    International Nuclear Information System (INIS)

    Sousa, Amanda Guerra de Moraes Rego

    1995-01-01

    This study examines whether a single method, quantitative coronary angiography with automated edge detection, could efficiently guide optimal stent liberation, assuring good clinical results and eliminating the need for anticoagulation therapy. This investigation includes 101 patients with optimal implantation of 104 Palmaz-stents. Their mean age was 58.62 years and 79.2% were male. Most of them presented unstable angina (61.39%) and had single vessel disease (85.15%) The treated vessel was the left anterior descending artery in 39.60%; the right coronary artery in 34.66%; the left circumflex artery in 7.92% and saphenous vein grafts in 17.82%. The mean reference diameter of the target vessel was 3.43 mm. Each implantation comprehended two phases: initial stent liberation and additional high pressure balloon inflation, guided by quantitative coronary angiography. Arterial quantification showed an important increase in the mean luminal diameter (p<0.001), characterized by an immediate gain of 2.37 mm [standard deviation (SD): 0.55 m]. Quantitative angiography permitted to identify a further gain in the luminal diameter following the high pressure balloon inflation, o.49 mm 9 SD:0.53 mm). Therefore, the total mean immediate gain was 2.85 mm (SD:0.64 mm). The mean diameter stenosis changed from 80.21% (SD:14.56%) to 11.81% (SD: 7.59% - p<0.001) after initial stent delivery; and to 0.16% (SD:3.45% - p<,0.001), after high pressure balloon inflation. Quantitative coronary angiography performed detailed measurements of the minimal caliber variations along the entire prosthesis due to the high pressure balloon inflations, similarly to the intracoronary ultrasound. This guided the optimal stent implantation and helped the clinical management of these cases. In this series, even maintained only under antiaggregant agents, no patient presented major ischemic complications and only one (0.99%) had a hemorrhage in the puncture site that required blood transfusion. The mean in

  14. Second-generation drug-eluting stents versus drug-coated balloons for the treatment of coronary in-stent restenosis: A systematic review and meta-analysis.

    Science.gov (United States)

    Kokkinidis, Damianos G; Prouse, Andrew F; Avner, Seth J; Lee, Joo Myung; Waldo, Stephen W; Armstrong, Ehrin J

    2017-10-10

    The benefit of drug-eluting stents (DES) versus drug-coated balloons (DCB) in coronary artery in-stent restenosis (ISR) for the prevention of target lesion revascularization (TLR), stent thrombosis, and mortality remains uncertain. Our aim was to synthesize the available evidence from randomized clinical trials (RCTs) and observational studies that directly compare second-generation drug-eluting stents (SG-DES) and DCB for the treatment of coronary ISR. Medline, Embase, and Cochrane Central were searched for RCTs or observational studies, published up to March 15, 2017. A random effects model meta-analysis investigating clinical and angiographic outcomes was conducted for RCTs and observational studies that compared SG-DES versus DCB for the treatment of ISR. Ten studies and 2,173 patients were included in this meta-analysis. The two treatment strategies were proven equal with regards to TLR, myocardial infarction, stent thrombosis, and cardiac mortality in both randomized and observational studies. No difference was found among RCTs for all-cause mortality, while in observational studies, patients who were treated with SG-DES had a lower mortality compared to DCB (OR: 0.47; 95% CI: 0.27-0.83). In the pooled analysis also (RCTs and observational studies), SG-DES were associated with lower all-cause mortality compared to DCB. Patients treated with SG-DES were also superior in terms of minimal lumen diameter (standardized mean difference: 0.39; 95% CI: 0.12-0.66). The two treatment strategies are equal for the treatment of ISR, while the difference in all-cause mortality might be potentially explained by baseline differences in the two groups among real-world studies. © 2017 Wiley Periodicals, Inc.

  15. ACTH- and cortisol-associated neutrophil modulation in coronary artery disease patients undergoing stent implantation.

    Directory of Open Access Journals (Sweden)

    Margit Keresztes

    Full Text Available Psychosocial stress and activation of neutrophil granulocytes are increasingly recognized as major risk factors of coronary artery disease (CAD, but the possible relationship of these two factors in CAD patients is largely unexplored. Activation of neutrophils was reported to be associated with stenting; however, the issue of neutrophil state in connection with percutaneous coronary intervention (PCI is incompletely understood from the aspect of stress and its hypothalamic-pituitary-adrenal axis (HPA background. Thus, we aimed to study cortisol- and ACTH-associated changes in granulocyte activation in patients undergoing PCI.Blood samples of 21 stable angina pectoris (SAP and 20 acute coronary syndrome (ACS patients were collected directly before (pre-PCI, after (post-PCI and on the following day of PCI (1d-PCI. Granulocyte surface L-selectin, CD15 and (neutrophil-specific lactoferrin were analysed by flow cytometry. Plasma cortisol, ACTH, and lactoferrin, IL-6 were also assayed. In both groups, pre- and post-PCI ratios of lactoferrin-bearing neutrophils were relatively high, these percentages decreased substantially next day; similarly, 1d-PCI plasma lactoferrin was about half of the post-PCI value (all p≤0.0001. Post-PCI ACTH was reduced markedly next day, especially in ACS group (SAP: p<0.01, ACS: p≤0.0001. In ACS, elevated pre-PCI cortisol decreased considerably a day after stenting (p<0.01; in pre-PCI samples, cortisol correlated with plasma lactoferrin (r∼0.5, p<0.05. In 1d-PCI samples of both groups, ACTH showed negative associations with the ratio of lactoferrin-bearing neutrophils (SAP: r = -0.601, p<0.005; ACS: r = -0.541, p<0.05 and with plasma lactoferrin (SAP: r = -0.435, p<0.05; ACS: r = -0.609, p<0.005.Pre- and post-PCI states were associated with increased percentage of activated/degranulated neutrophils indicated by elevated lactoferrin parameters, the 1d-PCI declines of which were associated with plasma

  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 3 mm in diameter. We analyzed the impact of stent length and stent diameter on in......-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability...... of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. CONCLUSION: In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt...

  17. Impact of final kissing balloon inflation after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome.

    Science.gov (United States)

    Kim, Tae-Hoon; Lee, Hyun Jong; Jang, Ho-Jun; Kim, Je Sang; Park, Jin Sik; Choi, Rak Kyeong; Choi, Young Jin; Shim, Won-Heum; Ro, Young Moo; Yu, Cheol Woong; Kwon, Sung Woo

    2014-12-20

    We sought to evaluate the impact of final kissing balloon inflation (FKBI) after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome (ACS). Whether FKBI should be mandatory after simple stent implantation for the treatment of coronary bifurcation lesion is controversial. Besides, ACS patients who have undergone bifurcation percutaneous coronary intervention with simple stent implantation may experience worse prognosis compared to stable angina pectoris patients. Two hundred and fifty one eligible patients (67.7% male, mean age 61.7 ± 10.4 years) were enrolled. The study population was divided into two groups according to the performance of FKBI. The primary end points were major adverse cardiac event (MACE); target lesion revascularization (TLR), non-fatal myocardial infarction (MI) and cardiac death during the follow-up period. Over a mean follow-up period of 3.0 ± 1.9 years, there were 29 MACEs (10 TLR, 6 non-fatal MI, and 13 cardiac deaths), representing an event rate of 11.6%. Kaplan-Meier survival analysis revealed that FBKI group had favorable outcome compared to non-FKBI group with regard to hard events (p = 0.010) as well as composite MACEs (p = 0.008). In multivariable analysis, FKBI was a significant predictor of composite MACEs [hazard ratio 0.398 (95% confidence interval 0.190-0.836, p = 0.015)] and hard events [hazard ratio 0.325 (95% confidence interval 0.130-0.811, p = 0.016)]. In terms of prognosis, performing FKBI after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions may be mandatory in ACS patients. Copyright © 2014. Published by Elsevier Ireland Ltd.

  18. An in silico study on the role of smooth muscle cell migration in neointimal formation after coronary stenting. Journal of the Royal Society Interface, 12(108), 20150358.

    NARCIS (Netherlands)

    H. Tahir (Hannan); I. Niculescu (Ioana); C. Bona-Casa; R.M.H. Merks (Roeland); A.G. Hoekstra

    2015-01-01

    htmlabstractExcessive migration and proliferation of smooth muscle cells (SMCs) has been observed as a major factor contributing to the development of in-stent restenosis after coronary stenting. Building upon the results from in vivo experiments, we formulated a hypothesis that the speed of the

  19. The influence of coronary plaque morphology assessed by optical coherence tomography on final microvascular function after stenting in patients with ST-elevation myocardial infarction.

    Science.gov (United States)

    De Maria, Giovanni L; Patel, Niket; Wolfrum, Mathias; Fahrni, Gregor; Kassimis, George; Porto, Italo; Dawkins, Sam; Choudhury, Robin P; Forfar, John C; Prendergast, Bernard D; Channon, Keith M; Kharbanda, Rajesh K; Garcia-Garcia, Hector M; Banning, Adrian P

    2017-05-01

    The index of microcirculatory resistance (IMR) provides a reproducible assessment of the status of coronary microvasculature in patients with ST-elevation myocardial infarction (STEMI). Frequency-domain optical coherence tomography (FD-OCT) enables detailed assessment of the morphology of coronary plaque.We sought to determine the influence of the initial culprit coronary plaque anatomy within the infarct-related artery on IMR after stenting in STEMI. In 25 STEMI patients IMR was measured immediately before and after stent implantation. FD-OCT imaging was performed at the same time points and atherothrombotic volume (ATV) before stenting, prolapsed+floating ATV after stenting and ΔATV was measured using three different strategies. There were no relationships between preprocedural IMR and FD-OCT parameters. Prestenting IMR was related only to pain to wire time (P: 0.02). Irrespective of the method adopted, the final IMR was related to prestenting ATV (ρ: 0.44, P: 0.03 for method I, ρ: 0.48, P: 0.02 for method II and ρ: 0.30, P: 0.06 for method III) and ΔATV (ρ: 0.41, P: 0.04 for method II and ρ: 0.44, P: 0.03 for method III). IMR measured before stenting is independent of the appearances of the culprit coronary plaque within the infarct-related artery. IMR after stenting, and more importantly, the change in IMR after stenting, reflect the degree of distal embolization during stent implantation.

  20. A framework for computational fluid dynamic analyses of patient-specific stented coronary arteries from optical coherence tomography images.

    Science.gov (United States)

    Migliori, Susanna; Chiastra, Claudio; Bologna, Marco; Montin, Eros; Dubini, Gabriele; Aurigemma, Cristina; Fedele, Roberto; Burzotta, Francesco; Mainardi, Luca; Migliavacca, Francesco

    2017-09-01

    The clinical challenge of percutaneous coronary interventions (PCI) is highly dependent on the recognition of the coronary anatomy of each individual. The classic imaging modality used for PCI is angiography, but advanced imaging techniques that are routinely performed during PCI, like optical coherence tomography (OCT), may provide detailed knowledge of the pre-intervention vessel anatomy as well as the post-procedural assessment of the specific stent-to-vessel interactions. Computational fluid dynamics (CFD) is an emerging investigational tool in the setting of optimization of PCI results. In this study, an OCT-based reconstruction method was developed for the execution of CFD simulations of patient-specific coronary artery models which include the actual geometry of the implanted stent. The method was applied to a rigid phantom resembling a stented segment of the left anterior descending coronary artery. The segmentation algorithm was validated against manual segmentation. A strong correlation was found between automatic and manual segmentation of lumen in terms of area values. Similarity indices resulted >96% for the lumen segmentation and >77% for the stent strut segmentation. The 3D reconstruction achieved for the stented phantom was also assessed with the geometry provided by X-ray computed micro tomography scan, used as ground truth, and showed the incidence of distortion from catheter-based imaging techniques. The 3D reconstruction was successfully used to perform CFD analyses, demonstrating a great potential for patient-specific investigations. In conclusion, OCT may represent a reliable source for patient-specific CFD analyses which may be optimized using dedicated automatic segmentation algorithms. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    Science.gov (United States)

    Dewilde, W; Verheugt, F W A; Breet, N; Koolen, J J; Ten Berg, J M

    2010-09-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment with aspirin and clopidogrel. Unfortunately, triple therapy is known to increase the bleeding risk. For this group of patients, the bottom line is to find the ideal therapy in patients with indications for both chronic anticoagulation therapy and percutaneous intervention to prevent thromboembolic complications such as stent thrombosis without increasing the risk of bleeding. (Neth Heart J 2010;18:444-50.).

  2. [Quality of life change and its influencing factors in patients with acute coronary syndrome after drug-eluting stent implantation].

    Science.gov (United States)

    Xue, Chao; Hu, Da-yi; Sun, Yi-hong; Ding, Rong-jing; Wang, Wei-min; Liu, Wen-ling; Li, Cui-lan; Li, Lei; Chen, Yu

    2012-04-01

    To prospectively evaluate the change of quality of life in patients with acute coronary syndrome following percutaneous coronary intervention (PCI) with drug-eluting stents and explore the influencing factors of quality of life. There hundred and thirty four consecutive patients with acute coronary syndrome receiving drug-eluting stents implantation between September 2008 and December 2009 were enrolled. Of them, two hundred and ninety three patients completed 36-item short form health survey at baseline and 6 months after PCI procedure. Change of quality of life and influencing factors on quality of life were analyzed. Compared with baseline, quality of life improved significantly after PCI in terms of both physical component summary and mental component summary [ (51.07 ± 20.39) scores vs. (61.69 ± 19.73) scores and (63.27 ± 20.00) scores vs. (68.81 ± 18.71) scores, respectively; all P Quality of life of acute coronary syndrome patients is significantly improved at 6 months after drug-eluting stents implantation. The predictors of physical quality of life improvement are female, diabetes, and ST-segment elevation myocardial infarction. Predictors of mental quality of life improvement are previous PCI and diabetes.

  3. The Role of Vascular Imaging in Guiding Routine Percutaneous Coronary Interventions: A Meta-Analysis of Bare Metal Stent and Drug-Eluting Stent Trials.

    Science.gov (United States)

    Alsidawi, Said; Effat, Mohamed; Rahman, Shahid; Abdallah, Mouhamad; Leesar, Massoud

    2015-12-01

    The routine use of vascular imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in guiding percutaneous coronary interventions (PCI) is still controversial especially when using drug-eluting stents. A meta-analysis of trials using bare metal stents was previously published. We conducted a meta-analysis of available published trials that compared imaging-guided PCI and angiography-guided PCI in patients undergoing routine PCI only. Trials that enrolled patients with acute coronary syndrome were excluded to decrease heterogeneity. We aimed to study both drug-eluting stents (DES) as well as bare metal stents (BMS). We identified seven randomized controlled trials on IVUS-guided bare metal stents. We also identified three randomized controlled trials on IVUS-guided drug-eluting stents. To improve the power of the drug-eluting stent data, we identified, and included, nine registries that compared IVUS-guided PCI to angiography-guided PCI in the drug-eluting stent era. Nonrandomized registries that included BMS only were excluded as there are multiple previous meta-analyses that studied these patients. Finally, we identified one registry that compared OCT-guided PCI to angiography-guided PCI using either a BMS or a DES. A total of 14,197 patients were studied overall. The meta-analysis was conducted using a random effect model. Imaging guidance was associated with a significantly larger postintervention minimal luminal diameter (SMD: 0.289. 95% CI: 0.213-0.365. P DES patients (odds ratio: 0.810. 95% CI: 0.719-0.912. P DES and BMS patients (odds ratio: 0.782. 95% CI: 0.686-0.890. P DES patients (odds ratio: 0.654. 95% CI: 0.468-0.916. P DES and BMS patients (odds ratio: 0.727. 95% CI: 0.540-0.980. P DES patients (odds ratio: 0.551. 95% CI: 0.363-0.837. P DES and BMS patients (odds ratio: 0.589. 95% CI: 0.425-0.816. P DES patients (odds ratio: 0.651. 95% CI: 0.499-0.850. P DES and BMS patients (odds ratio: 0.665. 95% CI: 0.513-0.862. P

  4. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial.

    Science.gov (United States)

    Ormiston, John A; Serruys, Patrick W; Regar, Evelyn; Dudek, Dariusz; Thuesen, Leif; Webster, Mark W I; Onuma, Yoshinobu; Garcia-Garcia, Hector M; McGreevy, Robert; Veldhof, Susan

    2008-03-15

    A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent. In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131. Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%. This study shows the feasibility of implantation of the bioabsorbable

  5. Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Tilsted, Hans Henrik

    2010-01-01

    with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non...

  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...... the national databases. The Academic Research Consortium definition of ST was used. RESULTS: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1...

  7. Frequency of Cardiac Death and Stent Thrombosis in Patients With Chronic Obstructive Pulmonary Disease Undergoing Percutaneous Coronary Intervention (from the BASKET-PROVE I and II Trials)

    DEFF Research Database (Denmark)

    Jatene, Tannas; Biering-Sørensen, Tor; Nochioka, Kotaro

    2017-01-01

    Chronic obstructive pulmonary disease (COPD) is associated with long-term all-cause death after percutaneous coronary intervention with bare-metal stents. Regarding other outcomes, previous studies have shown conflicting results and the impact of drug-eluting stent (DES) in this population...... is not well known. We analyzed 4,605 patients who underwent percutaneous coronary intervention with bare-metal stents (33.1%) or DES (66.9%) from the Basel Stent Kosten-Effektivitats Trial-Prospective Validation Examination trials I and II. COPD patients (n = 283, 6.1%), were older and had more frequently.......001); all-cause death: 11.7% versus 2.4% (p 3.5% versus 1.9% (p = 0.045); definite/probable/possible stent thrombosis: 2.5% versus 0.9% (p = 0.01); and major bleeding: 4.2% versus 2.1% (p = 0.014). After adjusting for confounders...

  8. Stent implantation for a totally occluded right coronary artery in a six-year-old boy after Kawasaki disease: a case report

    Directory of Open Access Journals (Sweden)

    Hsu Ya-Chi

    2012-04-01

    Full Text Available Abstract Introduction Coronary stenting has previously been considered to be less feasible in children under 12 years old due to the limitation of vascular access. We report the case of a six-year-old boy who successfully underwent stent implantation for his totally occluded right coronary artery. Case presentation A Taiwanese boy aged six years and nine months old was found to have giant aneurysms after an acute episode of Kawasaki disease. An angiography revealed that his middle right coronary artery was totally occluded. A 0.014-inch guidewire was advanced to cross the totally occluded site. After pre-dilating the middle portion of his right coronary artery with a 1.5 mm balloon, stenting of his right coronary artery was accomplished using a 2.5 × 28 mm and a 2.5 × 18 mm bare metal stent. A final angiography demonstrated no residual stenosis or dissection. Conclusion Coronary stenting could be a therapeutic option for children as young as six years old. Close follow-up is mandatory because the long-term outcome is still unclear, especially in a small child.

  9. Hydrophilic surface modification of coronary stent using an atmospheric pressure plasma jet for endothelialization.

    Science.gov (United States)

    Shim, Jae Won; Bae, In-Ho; Park, Dae Sung; Lee, So-Youn; Jang, Eun-Jae; Lim, Kyung-Seob; Park, Jun-Kyu; Kim, Ju Han; Jeong, Myung Ho

    2018-03-01

    The first two authors contributed equally to this study. Bioactivity and cell adhesion properties are major factors for fabricating medical devices such as coronary stents. The aim of this study was to evaluate the advantages of atmospheric-pressure plasma jet in enhancing the biocompatibility and endothelial cell-favorites. The experimental objects were divided into before and after atmospheric-pressure plasma jet treatment with the ratio of nitrogen:argon = 3:1, which is similar to air. The treated surfaces were basically characterized by means of a contact angle analyzer for the activation property on their surfaces. The effect of atmospheric-pressure plasma jet on cellular response was examined by endothelial cell adhesion and XTT analysis. It was difficult to detect any changeable morphology after atmospheric-pressure plasma jet treatment on the surface. The roughness was increased after atmospheric-pressure plasma jet treatment compared to nonatmospheric-pressure plasma jet treatment (86.781 and 7.964 nm, respectively). The X-ray photoelectron spectroscopy results showed that the surface concentration of the C-O groups increased slightly from 6% to 8% after plasma activation. The contact angle dramatically decreased in the atmospheric-pressure plasma jet treated group (22.6 ± 15.26°) compared to the nonatmospheric-pressure plasma jet treated group (72.4 ± 15.26°) ( n = 10, p atmospheric-pressure plasma jet on endothelial cell migration and proliferation was 85.2% ± 12.01% and 34.2% ± 2.68%, respectively, at 7 days, compared to the nonatmospheric-pressure plasma jet treated group (58.2% ± 11.44% in migration, n = 10, p atmospheric-pressure plasma jet method. Moreover, the atmospheric-pressure plasma jet might affect re-endothelialization after stenting.

  10. Therapeutic strategies after coronary stenting in chronically anticoagulated patients: the MUSICA study.

    Science.gov (United States)

    Sambola, A; Ferreira-González, I; Angel, J; Alfonso, F; Maristany, J; Rodríguez, O; Bueno, H; López-Minguez, J R; Zueco, J; Fernández-Avilés, F; San Román, A; Prendergast, B; Mainar, V; García-Dorado, D; Tornos, P

    2009-09-01

    To identify the therapeutic regimens used at discharge in patients receiving oral anticoagulant therapy (OAT) who undergo stenting percutaneous coronary intervention and stent implantation (PCI-S), and to assess the safety and efficacy associated with different therapeutic regimens according to thromboembolic risk. A prospective multicentre registry. In hospital, after discharge and follow-up by telephone call. 405 patients (328 male/77 female; mean (SD) age 71 (9) years) receiving OAT who underwent PCI-S between November 2003 and June 2006 from nine catheterisation laboratories of tertiary care teaching hospitals in Spain and one in the United Kingdom were included. Three therapeutic regimens were identified at discharge: triple therapy (TT) -- that is, any anticoagulant (AC) plus double antiplatelet therapy (DAT; 278 patients (68.6%); AC and a single antiplatelet (AC+AT; 46 (11.4%)) and DAT only (81 (20%)). At 6 months, patients receiving TT showed the greatest rate of bleeding events. No patients receiving DAT at low thromboembolic risk presented a bleeding event (14.8% receiving TT, 11.8% receiving AC+AT and 0% receiving DAT, p = 0.033) or cardiovascular event (6.7% receiving TT, 0% receiving AC+AT and 0% receiving DAT, p = 0.126). The combination of AC+AT showed the worst rate of adverse events in the whole cohort, especially in patients at moderate-high thromboembolic risk. In patients receiving OAT, TT was the most commonly used regimen after PCI-S. DAT was associated with the lowest rate of bleeding events and a similar efficacy to TT in patients at low thromboembolic risk. TT should probably be restricted to patients at moderate-high thromboembolic risk.

  11. 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.

  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. Bare-metal vs. drug-eluting stents in patients with atrial fibrillation undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Kiviniemi, Tuomas; Puurunen, Marja; Schlitt, Axel; Rubboli, Andrea; Karjalainen, Pasi; Nammas, Wail; Kirchhof, Paulus; Biancari, Fausto; Lip, Gregory Yh; Airaksinen, Ke Juhani

    2014-01-01

    We explored 12-month clinical outcomes of 929 patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with bare-metal stents (BMS) vs. drug-eluting stents (DES) from the prospective multicenter AFCAS (Atrial Fibrillation undergoing Coronary Artery Stenting) registry. METHODS AND RESULTS: Endpoints included the first occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of all-cause death, myocardial infarction (MI), target vessel revascularization, definite/probable stent thrombosis (ST), transient ischemic attack or stroke. Bleeding events were defined according to the Bleeding Academic Research Consortium criteria. Altogether, 673 (72.4%) patients received BMS and 220 (23.7%) at least one DES. Patients treated with DES more often had diabetes and prior ischemic events, and a longer stent length (Pheart failure and were more likely to present with acute ST-elevation MI (P<0.05 for both). At 12-month follow-up, rates and risks of MACCE and total bleeding events were comparable between the groups (22.0% with BMS vs. 19.5% with DES, P=0.51, hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.63-1.25 for DES) and (19.5% vs. 15.0%, respectively, P=0.16, HR 0.75, 95% CI 0.51-1.09 for DES). Definite/probable ST was more frequent in the BMS group (1.9% vs. 0%, respectively, P=0.046). In real-world patients with AF undergoing PCI, DES use was associated with outcomes comparable to those with BMS without excess bleeding complications. More ST was seen in BMS-treated patients.

  14. Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry

    International Nuclear Information System (INIS)

    Moscarella, Elisabetta; Varricchio, Attilio; Stabile, Eugenio; Franzone, Anna; Granata, Francesco; Rapacciuolo, Antonio; Galasso, Gennaro; Capozzolo, Claudia; Cirillo, Plinio

    2015-01-01

    Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial. - Highlights: • A safe therapeutic option for the treatment of diffuse ISR; • Technically feasible; • Associated to a low rate of restenosis recurrence at nine month.

  15. Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry

    Energy Technology Data Exchange (ETDEWEB)

    Moscarella, Elisabetta [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Varricchio, Attilio [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Stabile, Eugenio, E-mail: geko50@hotmail.com [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Franzone, Anna [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Granata, Francesco [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Rapacciuolo, Antonio; Galasso, Gennaro [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Capozzolo, Claudia [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Cirillo, Plinio [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); and others

    2015-10-15

    Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial. - Highlights: • A safe therapeutic option for the treatment of diffuse ISR; • Technically feasible; • Associated to a low rate of restenosis recurrence at nine month.

  16. Coronary Artery Stent Evaluation Using a Vascular Model at 64-Detector Row CT: Comparison between Prospective and Retrospective ECG-Gated Axial Scans

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Shigeru; Furui, Shigeru; Kaminaga, Tatsuro; Miyazawa, Akiyoshi; Ueno, Yasunari; Konno, Kumiko [Teikyo University School of Medicine, Tokyo (Japan); Kuwahara, Sadatoshi; Mehta, Dhruv [Philips Electronics Japan, Ltd. Medical Systems, Tokyo (Japan)

    2009-06-15

    We wanted to evaluate the performance of prospective electrocardiogram (ECG)-gated axial scans for assessing coronary stents as compared with retrospective ECG-gated helical scans. As for a vascular model of the coronary artery, a tube of approximately 2.5-mm inner diameter was adopted and as for stents, three (Bx-Velocity, Express2, and Micro Driver) different kinds of stents were inserted into the tube. Both patent and stenotic models of coronary artery were made by instillating different attenuation (396 vs. 79 Hounsfield unit [HU]) of contrast medium within the tube in tube model. The models were scanned with two types of scan methods with a simulated ECG of 60 beats per minute and using display field of views (FOVs) of 9 and 18 cm. We evaluated the in-stent stenosis visually, and we measured the attenuation values and the diameter of the patent stent lumen. The visualization of the stent lumen of the vascular models was improved with using the prospective ECG-gated axial scans and a 9-cm FOV. The inner diameters of the vascular models were underestimated with mean measurement errors of -1.10 to -1.36 mm. The measurement errors were smaller with using the prospective ECG-gated axial scans (Bx-Velocity and Express2, p < 0.0001; Micro Driver, p = 0.0004) and a 9-cm FOV (all stents: p < 0.0001), as compared with the other conditions, respectively. The luminal attenuation value was overestimated in each condition. For the luminal attenuation measurement, the use of prospective ECG-gated axial scans provided less measurement error compared with the retrospective ECG-gated helical scans (all stents: p < 0.0001), and the use of a 9-cm FOV tended to decrease the measurement error. The visualization of coronary stents is improved by the use of prospective ECG-gated axial scans and using a small FOV with reduced blooming artifacts and increased spatial resolution.

  17. 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.

  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. Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

    Science.gov (United States)

    Byrne, Robert A; Serruys, Patrick W; Baumbach, Andreas; Escaned, Javier; Fajadet, Jean; James, Stefan; Joner, Michael; Oktay, Semih; Jüni, Peter; Kastrati, Adnan; Sianos, George; Stefanini, Giulio G; Wijns, William; Windecker, Stephan

    2015-10-07

    The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  20. 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.

  1. A systematic review of outcomes in patients with staged carotid artery stenting and coronary artery bypass graft surgery.

    Science.gov (United States)

    Guzman, Luis A; Costa, Marco A; Angiolillo, Dominick J; Zenni, Martin; Wludyka, Peter; Silliman, Scott; Bass, Theodore A

    2008-02-01

    Although current guidelines state that carotid endarterectomy is probably recommended before or concomitant to coronary artery bypass grafting (CABG) in patients with carotid stenosis, significant controversies to this recommendation still persist. Carotid artery stenting has been recently introduced as an alternative revascularization modality in high-risk patients. The aim of this study was to define, based on the published information, if carotid artery stenting is beneficial in this setting. A search of MEDLINE and a manual search of the literature from selected articles were performed. A total of 6 studies with 277 patients reporting carotid stenting followed by staged CABG were available for this clinical outcome analysis. All were retrospective and single-center studies. The mean age was 69 years; 78% were males. Asymptomatic carotid stenosis was present in 76% of patients. The mean time to CABG was 32 days. The incidence of stroke and death associated with the stent procedure was 4.7%. Only 6 patients (2.2%) developed stroke associated with CABG. The overall combined 30-day event rate after CABG, including all events during carotid artery stenting, were as follows: minor stroke, 2.9%; major stroke, 3.2%; mortality, 7.6%; and combined death and any stroke, 12.3%. In this pooled analysis, the combined incidence of death and stroke in patients undergoing carotid artery stenting and staged CABG remains elevated. These results confirm that the presence of carotid stenosis is per se a marker of risk that might persists independent of its treatment. A systematic or randomized evaluation appears warranted.

  2. Effect of Bleeding Risk on Type of Stent Used in Patients Presenting With Acute Coronary Syndrome.

    Science.gov (United States)

    Alraies, M Chadi; Lee, Sang Yeub; Lipinski, Michael J; Buchanan, Kyle; Steinvil, Arie; Rogers, Toby; Koifman, Edward; Gai, Jiaxiang; Torguson, Rebecca; Ben-Dor, Itsik; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2017-10-15

    Patients at high bleeding risk (HBR) are at increased risk of bleeding following percutaneous coronary intervention (PCI) with drug-eluting stents (DES) due to the need for longer dual antiplatelet duration. We sought to evaluate the likelihood of receiving DES during PCI in HBR populations and to characterize DES utilization trends over time. Consecutive patients who underwent PCI from April 2003 to September 2015 were identified. HBR is defined as patients fulfilling 1 or more of the HBR criteria: age ≥75 years, anticoagulation use at discharge, history of stroke, cancer in previous 3 years, glucocorticoid use, hemoglobin (Hgb) HBR definition. When adjusting for known risk factors, HBR patients were less likely to receive a DES compared with non-HBR patients (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.54 to 0.62, p HBR patients, having 3 or more HBR criteria versus HBR criteria had lower likelihood of receiving a DES (OR 0.50, 95% CI 0.44 to 0.57, p HBR has a significant impact upon the decision to use DES. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.

    Science.gov (United States)

    Chevalier, Bernard; Moulichon, Robert; Teiger, Emmanuel; Brunel, Philippe; Metzger, Jean-Philippe; Pansieri, Michel; Carrie, Didier; Stoll, Hans-Peter; Wittebols, Kristel; Spaulding, Christian; Fajadet, Jean

    2012-12-01

     We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There

  4. Relation of body mass index to risk of stent thrombosis after percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Schmiegelow, Michelle; Torp-Pedersen, Christian; Gislason, Gunnar H

    2012-01-01

    (BMS or DES) implanted at the index PCI were included. Median follow-up period was 26 months (interquartile range 12 to 44) and definite stent thrombosis occurred in 78 patients. Hazard ratio of definite stent thrombosis adjusted for number of stents at the index PCI was 0.92 (95% confidence interval...... [CI] 0.86 to 0.97) for each increase in kilograms per square meter of BMI. There was no significant interaction between stent type and BMI (p = 0.48). Hazard ratios for probable stent thrombosis and possible stent thrombosis adjusted for numbers of stents at the index PCI were 1.01 (CI 0.99 to 1...... mass index (BMI) and stent thrombosis after PCI with bare-metal stent (BMS) or drug-eluting stent (DES). We followed 5,515 patients who underwent PCI with implantation of ≥1 BMS or DES at a high-volume tertiary invasive cardiology center from 2000 through 2006. Only patients with a single type of stent...

  5. Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies.

    Science.gov (United States)

    Ormiston, John A; Webster, Mark W I; El Jack, Seifeddin; Ruygrok, Peter N; Stewart, James T; Scott, Douglas; Currie, Erin; Panther, Monique J; Shaw, Bronwyn; O'Shaughnessy, Barbara

    2006-01-01

    The objective of this study was to bench-test provisional bifurcation stenting strategies to provide insights on how best to perform these with drug-eluting stents (DESs). Bifurcation stenting with DESs reduces restenosis compared with bare metal stents (BMSs). Outcomes with a single DES are better than with two DESs but if the main branch is stented, there needs to be a reliable strategy for provisionally stenting the side-branch with full ostial scaffolding and drug application. Stents were photographed in a phantom after deployment with different strategies. With provisional T-stenting, placement of the side-branch stent without gaps is difficult. The internal (or reverse) crush strategy fully scaffolds the side-branch ostium but is experimental. The culotte technique providing excellent side-branch ostial coverage is easier to perform with open-cell or large-cell stent design. In general, kissing balloon post-dilation improves stent expansion, especially at the ostium, and corrects distortion. However, a main-branch kissing balloon of smaller diameter than the deploying balloon causes distortion. Final main-branch postdilatation or sequential postdilatation prevents distortion after the internal crush strategy.

  6. Corrosion Behavior of Platinum-Enhanced Radiopaque Stainless Steel (PERSS®) for Dilation-Baloon Expandable Coronary Stents

    Energy Technology Data Exchange (ETDEWEB)

    Covino, Jr., Bernard S.; Craig, Charles H.; Cramer, Stephen D.; Bullard, Sophie J.; Ziomek-Moroz, Margaret; Jablonski, Paul D.; Turner, Paul C.; Radisch, Jr., Herbert R.; Gokcen, Nev A.; Friend, Clifford M.; Edwards, Michael R.

    2002-05-01

    Dilation-balloon expandable coronary stents are commonly made of implant grade stainless steels conforming to ASTM F138/F139, e.g., Biodur? 316LS (UNS S31673). Typical of such stents is the Boston Scientific/Interventional Technologies? (BS/IVT) LP-StentTM. In 2000, BS/IVT determined that the addition of 5 to 6 wt % platinum to Biodur 316LS produced a stainless steel with enhanced radiopacity to make their stents more visible radiographically and thus more effective clinically. A goal of the program was to ensure platinum additions would not adversely affect the corrosion resistance of Biodur 316LS. The corrosion resistance of 5-6 wt % PERSS? alloys and Biodur 316LS was determined using electrochemical tests for general, pitting, crevice and intergranular corrosion. Experimental methods included ASTM A262E, F746, F2129, and potentiodynamic polarization. The 6 wt % PERSS? alloy (IVT 78) had a resistance to pitting, crevice and intergranular corrosion that was similar to the Biodur 316LS base material. IVT 78 was a single-phase austenitic alloy with no evidence of inclusions or precipitates. It was more resistant to pitting corrosion than 5 wt % PERSS? alloys. Performance of the PERSS? alloys was not a function of alloy oxygen content in the range 0.01 to 0.03 wt %.

  7. Stent thrombosis with second-generation drug-eluting stents compared with bare-metal stents: network meta-analysis of primary percutaneous coronary intervention trials in ST-segment–elevation myocardial infarction [corrected].

    Science.gov (United States)

    Philip, Femi; Agarwal, Shikhar; Bunte, Matthew C; Bunte, Matthew; Goel, Sachin S; Tuzcu, E Murat; Ellis, Stephen; Kapadia, Samir R

    2014-02-01

    The relative safety of drug-eluting stents (DESs) and bare-metal stents (BMSs) with respect to stent thrombosis (ST) continues to be debated. There are limited data comparing safety and efficacy of second-generation DES to BMS. We compared the clinical outcomes between second-generation DES and BMS for primary percutaneous coronary intervention using network meta-analysis. Randomized controlled trials comparing stent types (first-generation DES, second-generation DES or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of the international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second-generation DES to BMS) and indirect evidence (first-generation DES with BMS and second-generation DES) from the randomized trials. Twenty-one trials comparing all stents types, including 12 866 patients randomly assigned to treatment groups, were analyzed. A significantly lower incidence of ST was noted with the use of second-generation DES as early as 30 days (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.15-0.82) and between 31 days and 1 year (OR, 0.49; 95% CI, 0.30-0.79) when compared with BMS. Second-generation DES was associated with significantly lower incidence of definite ST at 1 year (OR, 0.3; 95% CI, 0.11-0.83) and myocardial infarction (OR, 0.3; 95% CI, 0.17-0.54) and target vessel revascularization at 1 year (OR, 0.54; 95% CI, 0.80-0.98) when compared with BMS. There was no difference in mortality at 30 days (OR, 0.84; 95% CI, 0.45-1.59) or 1 year (OR, 0.80; 95% CI, 0.56-1.14) with the use of second-generation DES versus BMS. The small number of events may influence the precision of the analysis. Network meta-analysis of randomized trials of primary percutaneous coronary intervention demonstrated lower incidence of ST, myocardial infarction, and target vessel revascularization

  8. Expansion of the Multi-Link Frontier™ Coronary Bifurcation Stent: Micro-Computed Tomographic Assessment in Human Autopsy and Porcine Heart Samples

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A.; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Background Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Methodology/Principal Findings Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm2 vs. 12.84±1.38 mm2, p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Conclusions/Significance Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated

  9. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Directory of Open Access Journals (Sweden)

    Stefan Kralev

    Full Text Available BACKGROUND: Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. METHODOLOGY/PRINCIPAL FINDINGS: Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively, corresponding opening areas (PA, DA, SBA and the mean stent length (L were assessed by micro-computed tomography (micro-CT. PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2 vs. 12.84±1.38 mm(2, p = 0.034, respectively and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014. L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32, and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015. CONCLUSIONS/SIGNIFICANCE: Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow

  10. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2) vs. 12.84±1.38 mm(2), p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or

  11. Prospective versus retrospective ECG gating for dual source CT of the coronary stent: Comparison of image quality, accuracy, and radiation dose

    Energy Technology Data Exchange (ETDEWEB)

    Zhao Lei, E-mail: zhaolei219@sohu.com [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China); Zhang Zhaoqi; Fan Zhanming; Yang Lin; Du Jing [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China)

    2011-03-15

    Objective: To compare image quality, diagnostic accuracy and radiation dose of prospective and retrospective electrocardiogram (ECG) gated dual source computed tomography (DSCT) for the evaluation of the coronary stent, using conventional coronary angiography (CA) as a standard reference. Design, setting and patients: Sixty patients (heart rates {<=}70 bpm) with previous stent implantation who were scheduled for CA were divided in two groups, receiving either prospective or retrospective ECG gated DSCT separately. Two reviewers scored coronary stent image quality and evaluated stent lumen. Results: There was no significant difference in image quality between the two groups. In the prospective group, there were 86.4% (51/59) stents with interpretable images, in the retrospective group, there were 87.5% (49/56) stents with interpretable images. Image quality was not influenced by age, body mass index or heart rate in either group, but heart rate variability had a weak impact on the image quality of the prospective group. Image noise was higher in the prospective group, but this difference reached statistical significance only by using a smooth kernel reconstruction. Per-stent based sensitivity, specificity, and positive and negative predictive value were 100%, 84.1%, 68.2%, and 100%, respectively, in the prospective CT angiography group and 94.4%, 86.8%, 77.3%, and 97.1%, respectively, in the retrospective CT angiography group. There was a significant difference in the effective radiation dose between the two groups, mean effective dose in the prospective and retrospective group was 2.2 {+-} 0.5 mSv (1.5-3.2 mSv) and 14.6 {+-} 3.3 mSv (10.0-20.4 mSv) (p < .001) respectively. Conclusions: Compared with retrospective CT angiography, prospective CT angiography has a similar performance in assessing coronary stent patency, but a lower effective dose in selected patients with regular heart rates {<=}70 bpm.

  12. Long-Term Results After Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions Nordic Bifurcation Study 5-Year Follow-Up Results

    DEFF Research Database (Denmark)

    Maeng, M.; Holm, N. R.; Erglis, A.

    2013-01-01

    Objectives This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. Background Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. Methods...... complex strategy of planned stenting of both the main vessel and the side branch. (C) 2013 by the American College of Cardiology Foundation...

  13. Snuggle T and protrusion (S-TAP) technique for coronary bifurcation stenting: A step-by-step angiographic and illustration demonstration.

    Science.gov (United States)

    Dahdouh, Ziad; Fadel, Bahaa M; Roule, Vincent; Sarkis, Antoine; Grollier, Gilles

    2017-09-01

    T and small protrusion (TAP) is a stenting technique that is utilized for the management of coronary bifurcation lesions when using a two-stent strategy. This technique is also useful whenever stenting of a main vessel (MV) jeopardizes a side branch (SB) or when a sub-optimal result is encountered in a daughter vessel after starting with one-stent approach. The conversion from one-stent strategy to TAP could be achieved smoothly and often leads to good results. Technically, optimal positioning of the SB stent to achieve the required protrusion into the lumen of the MV remains a challenge. Toward that goal we propose an added step that involves inflating a balloon in the MV to serve as an anvil with simultaneous pullback of the SB stent, to be followed by stent deployment. We refer to this approach as the snuggle T and protrusion (S-TAP) technique owing to close contact between the SB stent and the MV balloon during simultaneous inflation. In this manuscript, we detail this interventional technique and provide a demonstrative case study. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents for patients with coronary artery disease: an update meta-analysis.

    Science.gov (United States)

    Wang, Yanyu; Dong, Pingshuan; Li, Ling; Li, Xiaoling; Wang, Hongyun; Yang, Xuming; Wang, Shaoxin; Li, Zhuanzhen; Shang, Xiyan

    2014-08-01

    Permanent polymer drug-eluting stents (DES) are associated with a higher risk of late and very late stent thrombosis (ST); biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are not completely clear. We undertook a meta-analysis of randomized studies identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database. Eligible studies were those that compared BP-DES with second-generation permanent polymer DES in patients undergoing percutaneous coronary intervention. Five studies (8,740 patients) with a mean follow-up of 19.2 months were included. Overall, BP-DES were associated with a broadly equivalent risk of definite and probable ST (odds ratio [OR], 1.07; 95 % confidence interval [CI], 0.67 to 1.71; P = 0.76; I (2) = 5.0 %), target vessel revascularization (OR, 1.04; 95 % CI, 0.87 to 1.24; P = 0.68; I (2) = 38.0 %), all-cause mortality (OR, 1.10; 95 % CI, 0.87 to 1.41; P = 0.42; I (2) = 0.0 %), and major adverse cardiac events (OR, 1.03; 95 % CI, 0.88 to 1.20; P = 0.74; I (2) = 0.0 %) when compared with second-generation DES. However, BP-DES significantly decreased in-stent late luminal loss (standard mean difference [SMD], -0.01; 95 % CI, -0.12 to 0.11; P = 0.93; I (2) = 0.0 %) and in-segment late luminal loss (SMD, -0.06; 95 % CI, -0.17 to 0.05; P = 0.27; I (2) = 0.0 %) compared with second-generation DES. Compared with second-generation permanent polymer DES, biodegradable stents appear to have equivalent short- to medium-term clinical benefits, and it remains unclear whether they reduce the incidence of very late ST.

  15. PlA polymorphism and platelet reactivity following clopidogrel loading dose in patients undergoing coronary stent implantation.

    Science.gov (United States)

    Angiolillo, Dominick J; Fernandez-Ortiz, Antonio; Bernardo, Esther; Alfonso, Fernando; Sabaté, Manel; Fernández, Cristina; Stranieri, Chiara; Trabetti, Elisabetta; Pignatti, Pier Franco; Macaya, Carlos

    2004-01-01

    The PlA polymorphism (Leu33Pro) of the platelet glycoprotein (GP) IIIa gene has been suggested to play an important role in coronary thrombosis. In vitro studies have shown differences for this polymorphism in platelet sensitivity towards antiplatelet drugs (aspirin and abciximab), suggesting a pharmacogenetic modulation. The aim of the study was to assess the modulatory effect of the PlA polymorphism on clopidogrel-induced antiplatelet effects in 38 patients undergoing coronary stent implantation receiving a 300 mg clopidogrel loading-dose. Platelet reactivity was assessed as GPIIb/IIIa activation and P-selectin expression in platelets stimulated with 2 micromol/l adenosine diphosphate using whole blood flow cytometry. The distribution of the homozygous PlA1/A1 and heterozygous PlA1/A2 genotypes were 74 and 26%, respectively. PlA2 carriers had a higher degree of GPIIb/IIIa activation (P = 0.05) and P-selectin expression (P = 0.02) during the overall study time course and a lower antiplatelet effect to a 300 mg clopidogrel loading-dose up to 24 h following intervention (P < 0.05). In conclusion, the Pl polymorphism of the GPIIIa gene modulates platelet reactivity towards clopidogrel front loading in patients undergoing coronary stenting. This suggests the need for individualized antithrombotic regimens to optimally inhibit platelet reactivity. Copyright 2004 Lippincott Williams and Wilkins

  16. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    Directory of Open Access Journals (Sweden)

    Wehrenberg Scott

    2010-01-01

    Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

  17. Angioplastia con stent vs. cirugía de revascularización coronaria en enfermedad multivaso (ACIRE Coronary angioplasty with stenting vs. coronary bypass revascularization surgery in multivessel disease

    Directory of Open Access Journals (Sweden)

    Andrés Fernández

    2009-04-01

    ón evaluada, con enfermedad coronaria de dos o más vasos, la cirugía de revascularización ofrece un riesgo significativamente mayor de morbilidad intra-hospitalaria sin comprometer la mortalidad posterior hasta doce meses. En este grupo de pacientes, la angioplastia con stent ofrece mejor perfil de morbilidad post-procedimiento y mayor tasa de reintervención del vaso por falla a 12 meses de seguimiento. Tanto la cirugía como la angioplastia con stent, ofrecen tasas equivalentes de mortalidad hasta los doce meses de seguimiento.Multivessel coronary heart disease is a common cause of revascularization procedures either surgical or by percutaneous intervention with angioplasty and stenting. Clinical outcomes of patients treated by any of these strategies have been addressed in different randomized clinical trials with diverse results favoring one or another procedure. This is a prospective cohort clinical trial aiming to analyze clinical outcomes of 400 patients with coronary heart disease involving two or more vessels comparing the outcomes between surgery and percutaneous intervention with coronary stenting. Baseline clinical characteristics were comparable between these groups. Results: in-hospital mortality rate at 1, 6 and 12 months is similar in both revascularization procedures. Nevertheless, in-hospital morbidity is significantly higher in the coronary artery bypass graft group with higher immediate post-procedural infarct-rate compared to that of the percutaneous coronary intervention (PCI group (4,5% vs. 0%; p = 0,005, a higher infection rate (15,8% vs. 1,6%; p = 0,001 and an extended in-hospital stay in the intensive care unit (21.8% vs. 1,1%; p = 0,001. MACE in-hospital rate associated to revascularization surgery is signifficantly higher than that found in the percutaneous group (8,9% and 10,4% respectively for the surgical group and 5,7% and 15,5% for the percutaneous group; p = NS. MACE rate at 12 months was lower in the surgical group (11,9% when compared to

  18. Can phone-based motivational interviewing improve medication adherence to antiplatelet medications after a coronary stent among racial minorities? A randomized trial.

    Science.gov (United States)

    Palacio, Ana M; Uribe, Claudia; Hazel-Fernandez, Leslie; Li, Hua; Tamariz, Leonardo J; Garay, Sylvia D; Carrasquillo, Olveen

    2015-04-01

    Minorities have lower adherence to cardiovascular medications and have worst cardiovascular outcomes post coronary stent placement The aim of this study is to compare the efficacy of phone-delivered Motivational Interviewing (MINT) to an educational video at improving adherence to antiplatelet medications among insured minorities. This was a randomized study. We identified minorities with a recently placed coronary stent from an administrative data set by using a previously validated algorithm. MINT subjects received quarterly phone calls and the DVD group received a one-time mailed video. Outcome variables were collected at baseline and at 12-month post-stent, using surveys and administrative data. The primary outcome was antiplatelet (clopidogrel and prasugrel) adherence measured by Medication Possession Ratio (MPR) and self- reported adherence (Morisky score). We also measured appropriate adherence defined as an MPR ≥ 0.80. We recruited 452 minority subjects with a new coronary stent (44 % Hispanics and 56 % Black). The patients had a mean age of 69.5 ± 8.8, 58 % were males, 78 % had an income lower than $30,000 per year and only 22 % had achieved high school education or higher. The MPR for antiplatelet medications was 0.77 for the MINT group compared to 0.70 for the DVD group (p motivational interview is effective at improving adherence to antiplatelet medications post coronary stent placement. Phone-based MINT seems to be a promising and cost-effective strategy to modify risk behaviors among minority populations at high cardiovascular risk.

  19. Meta-Analysis of Percutaneous Coronary Intervention With Drug-Eluting Stent Versus Coronary Artery Bypass Grafting for Isolated Proximal Left Anterior Descending Coronary Disease.

    Science.gov (United States)

    Kinnaird, Tim; Kwok, Chun Shing; Narain, Aditya; Butler, Rob; Ossei-Gerning, Nicholas; Ludman, Peter; Moat, Neil; Anderson, Richard; Mamas, Mamas A

    2016-10-15

    We performed a meta-analysis of the studies comparing the efficacy and safety of coronary artery bypass surgery against percutaneous coronary intervention with drug-eluting stents (PCI-DES) in patients with isolated LAD disease. Because of the limited randomized trial data, the optimal revascularization strategy for patients with isolated LAD disease remains uncertain. Using MEDLINE and EMBASE to source data, 11 studies (3 randomized trials and 8 cohort studies) including 5,044 participants were identified. No significant difference in mortality between PCI-DES and coronary artery bypass surgery (CABG; 111 of 2,122 [5.2%] and 120 of 2,574 [4.7%]; relative risk [RR] 1.23; 95% confidence interval [CI] 0.90 to 1.69) was detected. For MACE, PCI-DES was associated with significant increase in adverse events (RR 1.41; 95% CI 1.03 to 1.93, 8 studies, 4,230 participants). There were no significant differences in the risk of myocardial infarction (RR 0.86; 95% CI 0.58 to 1.26) or stroke (RR 2.36; 95% CI 0.54 to 10.43) between the 2 groups. There were 239 target vessel revascularization (TVR) events among 2,237 participants in the PCI-DES group (10.7%) and 145 TVR events among 2,793 participants in the CABG group (5.2%) with a significant increased risk of TVR in the PCI group (RR 2.52; 95% CI 1.69 to 3.77, 5,030 participants) compared with CABG. In conclusion, for patients with isolated disease of the LAD, meta-analysis of the available data suggests revascularization with a PCI-DES strategy offers similar mortality, MI, and stroke rates to CABG at the expense of increased TVR. Much of the data are derived from registries using first-generation DES, and further randomized trials with more contemporary platforms are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. The value of matrix metalloproteinase in predicting the in-stent restenosis after percutaneous coronary intervention procedure

    International Nuclear Information System (INIS)

    Xu Zhaoyan; Yang Xili

    2011-01-01

    Objective: To discuss the relationship between the concentration of matrix metalloproteinase (MMP-1, MMP-9) and the in-stent restenosis after percutaneous coronary intervention procedure (PCI). Methods: During the period from June 2006 to June 2008, PCI procedure was carried out in 206 patients with coronary artery disease in authors' hospital. After the procedure, both coronary angiography and intravascular ultrasonography (IVUS) were conducted during follow-up period. Base on the angiographic findings, in-stent restenosis (ISR) was confirmed in 32 cases with a total of 38 lesions (ISR group), while no in-stent restenosis (non-ISR) was seen in 174 cases with a total of 229 lesions (non-ISR group). Before and after the treatment, the cross-sectional area of extra-elastic membrane, plaque area, minimal lumen area (MLA), and intima proliferation area were determined. The changes in MMP-1 and MMP-9 levels after PCI in each group were compared. Based on the MLA, the patients were divided into three groups: MLA > 5 mm 2 group, MLA (3∼5) mm 2 group and MLA 2 group. The MMP-1 and MMP-9 levels were compared among three groups. Results: Both the plaque area and intima proliferation area were significantly larger, while the MLA was significantly smaller, in ISR group than those in non-ISR group (P 5 mm 2 group, MLA (3∼5) mm 2 group and MLA 2 group was (1.45±0.32) ng/ml, (2.93±0.45) ng/ml and (3.09±0.65) ng/ml respectively, but no significant difference in MMP-9 concentration existed between MLA (3∼5) mm 2 group and MLA 2 group (P>0.05). Conclusion: After PCI the increase of MMP-9 concentration bears a close relationship to the degree of restenosis. (authors)

  1. 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.

  2. Reliability of mechanical and phased-array designs for serial intravascular ultrasound examinations--animal and clinical studies in stented and non-stented coronary arteries.

    Science.gov (United States)

    Tardif, J C; Bertrand, O F; Mongrain, R; Lespérance, J; Grégoire, J; Paiement, P; Bonan, R

    2000-10-01

    Both mechanical and multi-element intravascular ultrasound designs have potential advantages and limitations that may impact on their value for clinical and research purposes. Determination of the reproducibility of measurements is critical before a given system can be used in studies such as regression of atherosclerosis trials. We performed serial intravascular ultrasound imaging with catheters using mechanical and phased-array designs in stented and non-stented coronary arteries in dogs and in patients. Both systems correlated well for areas (r > or = 0.90, p or = 0.84. p mechanical designs for measurements of area (mean difference in dogs and in patients: -0.24 and 0.96 mm2, p mechanical system (r > or = 0.96 for all measurements). The differences in absolute and relative variability between the mechanical and phased-array designs, both for reanalysis of same frames and serial pullbacks, were very small. Although multi-element and mechanical intravascular ultrasound designs are not strictly interchangeable, their similar reproducibility and the small differences in measurements demonstrate that both designs are acceptable alternatives for trials of regression of atherosclerosis. Determination of the variability for serial pullbacks of both designs was also important to assess the statistical power of such trials.

  3. Prasugrel vs. clopidogrel in contemporary Western European patients with acute coronary syndromes receiving drug-eluting stents

    DEFF Research Database (Denmark)

    Wein, Bastian; Coslovsky, Michael; Jabbari, Reza

    2017-01-01

    events of 2 "sister" multicenter stent trials, BASKET-PROVE (BP) I with clopidogrel and BPII with prasugrel (for 12months each) were used in a hybrid analysis. Medication costs were 2015 sales prices, event costs modelled for Denmark (DNK), Germany (GER) and Switzerland (SUI) and quality adjusted life......BACKGROUND: Clinical and cost-effectiveness of prasugrel vs. clopidogrel in acute coronary syndrome (ACS) was only evaluated using TRITON-TIMI 38 event rates. A comparative analysis of both drugs in contemporary European ACS patients is lacking. METHODS: To address this issue, cardiac and bleeding......=0.255), but more major bleedings (4.0% vs. 1.7%, pcost...

  4. Comparing coronary stent material performance on a common geometric platform through simulated bench testing.

    Science.gov (United States)

    Grogan, J A; Leen, S B; McHugh, P E

    2012-08-01

    Absorbable metallic stents (AMSs) are a newly emerging cardiovascular technology which has the potential to eliminate long-term patient health risks associated with conventional permanent stents. AMSs developed to date have consisted of magnesium alloys or iron, materials with inferior mechanical properties to those used in permanent stents, such as stainless steel and cobalt-chromium alloys. However, for AMSs to be feasible for widespread clinical use it is important that their performance is comparable to modern permanent stents. To date, the performances of magnesium, iron, and permanent stent materials have not been compared on a common stent platform for a range of stent performance metrics, such as flexibility, radial strength, and recoil. In this study, this comparison is made through simulated bench testing, based on finite-element modelling. The significance of this study is that it allows potential limitations in current AMS performance to be identified, which will aid in focusing future AMS design. This study also allows the identification of limitations in current AMS materials, thereby informing the on-going development of candidate biodegradable alloys. The results indicate that the AMSs studied here can match the recoil characteristics and radial strength of modern permanent stents; however, to achieve this, larger strut dimensions are required. It is also predicted that the AMSs studied are inferior to permanent stents in terms of maximum absolute curvature and longitudinal stiffness. Copyright © 2012 Elsevier Ltd. All rights reserved.

  5. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. 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

    . Notably, definite stent thrombosis was more frequent in female than male STEMI patients (81.8% vs. 56.8%, p=0.09), and in very late STEMIs (p=0.06). Female sex (OR 3.53 [1.01-12.59]) and clopidogrel (OR 4.43 [1.03-19.01]) was associated with increased for definite stent thrombosis, whereas age, time since...... treated with coronary stents in the randomized SORT OUT II trial (mean age 63.6 yrs. 74.8% men). Patients who following stent implantation were readmitted with STEMI were included and each patient was categorized ranging from definite-to ruled-out stent thrombosis according to the Academic Research...... Consortium definitions. Multivariate logistic regression was performed on selected covariates to assess odds ratios (ORs) for definite stent thrombosis. Results: 85 patients (4.1%), mean age 62.7 years, 77.1% men, were admitted with a total of 96 STEMIs, of whom 60 (62.5%) had definite stent thrombosis...

  7. Biodegradable polymer Biolimus-eluting stent (Nobori® for the treatment of coronary artery lesions: review of concept and clinical results

    Directory of Open Access Journals (Sweden)

    Schurtz G

    2014-02-01

    Full Text Available Guillaume Schurtz,1,2 Cédric Delhaye,1 Christopher Hurt,1,2 Henri Thieuleux,1,2 Gilles Lemesle1–3 1Centre Hémodynamique et Unité des Soins Intensifs de Cardiologie, Hôpital Cardiologique, Centre Hospitalier Régional et Universitaire de Lille, Lille, France; 2Faculté de Médecine de Lille, Lille, France; 3Unité INSERM UMR744, Institut Pasteur de Lille, Lille, France Abstract: First-generation drug-eluting stents have raised concerns regarding the risk of late and very late stent thrombosis compared with bare metal stents and require prolonged dual antiplatelet therapy. Despite extensive investigations, the physiopathology of these late events remains incompletely understood. Aside from patient- and lesion-related risk factors, stent polymer has been cited as one of the potential causes. In fact, the persistence of durable polymer after complete drug release has been shown to be responsible for local hypersensitivity and inflammatory reactions. Third-generation drug-eluting stents with more biocompatible or biodegradable polymers have subsequently been developed to address this problem. In this article, we evaluate and discuss the concept and clinical results (safety and efficacy of a third-generation drug-eluting stent with biodegradable polymer: the Nobori® stent. Keywords: percutaneous coronary intervention, stent thrombosis, antiplatelet therapy

  8. Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study.

    Science.gov (United States)

    Xu, Ya-Wei; Wei, Yi-Dong; Tang, Kai; Chen, Yan-Qing; Li, Wei-Ming; Yu, Xue-Jing; Qin, Yong-Wen; Qi, Guo-Xian; Qu, Peng; Hou, Yu-Qing; Jain, Ashok; Grant, Parvez; Ramesh, Gudapati; Ramesh, Basavappa; Piamsomboon, Chumpol; Kuanprasert, Srun; Gwon, Hyeon-Cheol; Cho, Yoon Haeng; Kamar, Haizal Haroon; Huang, Cong-Xin

    2007-06-20

    Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents (BMS)-Multi-link (ML) Vision/ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease (CAD) after implanting the Multi-link Vision or MiniVision stent were investigated in this study. An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS-ML Vision/ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization (TLR) at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study. The average reference diameter of the lesions was (3.0 +/- 0.5) mm, and the mean length was (15.7 +/- 5.0) mm. The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization (TVR) were 6.8%, 3.5% and 1.4% respectively. The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.

  9. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V)

    DEFF Research Database (Denmark)

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

    2013-01-01

    Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer...

  10. Spontaneous Coronary Artery Dissection: Diagnosis and Management.

    Science.gov (United States)

    Yeo, Ilhwan; Feldman, Dmitriy N; Kim, Luke K

    2018-03-17

    Spontaneous coronary artery dissection (SCAD) is a non-iatrogenic and non-traumatic separation of the coronary arterial wall. While SCAD represents an important cause of myocardial infarction, optimal diagnostic and therapeutic options remain challenging. We sought to review recent studies and provide an update on diagnosis and management of SCAD. Coronary angiography is the first-line diagnostic modality for SCAD, with three angiographic features commonly observed in SCAD: type 1 (pathognomonic angiographic appearance with contrast staining of the arterial wall), type 2 (long coronary stenosis), and type 3 (focal tubular stenosis). In addition, adjunctive intracoronary imaging can aid in identifying coronary dissections. Conservative management with beta-blockers and aspirin remains the mainstay of therapy. However, patients with high-risk features and recurrent symptoms may require revascularization. Several techniques have been reported, such as long stents to seal the entire length of the dissection, stepwise stenting starting at the distal edge followed by proximal edge stenting, use of bioabsorbable stents, and cutting balloon angioplasty. Furthermore, cardiac rehabilitation appears to be safe and offers significant benefits for patients with SCAD. Coronary angiographic classification contributed to the increased recognition of SCAD in recent years. Selecting the most suitable and appropriate therapy based on accurate diagnosis is the cornerstone of management in SCAD. Further studies are needed to establish optimal treatment of SCAD depending on anatomical and/or clinical features.

  11. Inflammatory markers in dependence on the plasma concentration of 37 fatty acids after the coronary stent implantation.

    Science.gov (United States)

    Handl, Jiří; Meloun, Milan; Mužáková, Vladimíra

    2018-02-05

    Using the regression model building the relationships between the concentration of 37 fatty acids of blood plasma phospholipids of 41 patients with coronary artery disease after coronary stent implantation, the inflammatory response and oxidative stress markers were estimated. The dynamics of the inflammatory response and the oxidative stress was indicated by measuring plasma concentrations of highly sensitive C-reactive protein, interleukin-6, serum amyloid A and malondialdehyde before, 24h after stent implantation. The multiple linear regression analysis was preceded by an exploratory data analysis, principal component analysis, factor analysis and cluster analysis, which proved a hidden internal relation of 37 fatty acids. The concentration of cerotic acid (C26:0) has been positively associated with an increase of malondialdehyde concentration after stent implantation, while the concentrations of tetracosatetraenoic (C24:4 N6) and nonadecanoic (C19:0) acids were associated with decrease of lipoperoxidation. The increase of interleukin-6 during the 24h after implantation was associated with higher levels of pentadecanoic acid (C15:0) and lower levels of α-linolenic acid (C18:3 N3). Regression models found several significant fatty acids at which the strength of the parameter β for each fatty acid on selected markers of C-reactive protein, malondialdehyde, interleukin-6 and serum amyloid A was estimated. Parameter β testifies to the power of the positive or negative relationship of the fatty acid concentration on the concentration of selected markers. The influencing effect of the cerotic acid (C26:0) concentration in plasma phospholipids exhibiting parameter β=140.4 is, for example, 3.5 times higher than this effect of n-3 tetracosapentaenoic acid (C24:5 N3) with β=40.0. Composition of fatty acids in plasma phospholipids shows spectrum of fatty acids available for intercellular communication in systemic inflammatory response of organism and should affect

  12. 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.

  13. 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

  14. Meta-analysis of 14 trials comparing bypass grafting vs drug-eluting stents in diabetic patients with multivessel coronary artery disease

    NARCIS (Netherlands)

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

    2014-01-01

    BACKGROUND AND AIM: Clinical trials have reported lower mortality and repeated revascularization rate in diabetic patients treated with coronary artery bypass grafting (CABG) as compared to percutaneous revascularization. However, these studies were conducted in the era of bare-metal stents.

  15. TCT-318 Ten-year All-cause Mortality after Simple versus Complex Stenting of Coronary Artery Bifurcation Lesions in the Randomized Nordic Bifurcation Study

    DEFF Research Database (Denmark)

    Steigen, Terje K; Holm, Niels; Kumsars, Indulis

    2016-01-01

    . Methods Patients with stable or unstable angina pectoris, or stabilized myocardial infarction, and a coronary bifurcation lesion with a reference diameter in the main vessel ≥3.0 mm and side branch ≥2.25 mm were eligible. A total of 413 patients were randomized to stenting of the main vessel and optional...

  16. Functional comparison between BuMA Supreme biodegradable polymer sirolimus-eluting and durable polymer zotarolimus-eluting coronary stents using Quantitative Flow Ratio: PIONEER QFR substudy

    NARCIS (Netherlands)

    Asano, Taku; Katagiri, Yuki; Collet, Carlos; Tenekecioglu, Erhan; Miyazaki, Yosuke; Sotomi, Yohei; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter; Wykrzykowska, Joanna J.; Ribeiro, Vasco Gama; Periera, Helder; da Silva, Pedro Canas; Piek, Jan J.; Reiber, Johan H. C.; von Birgelen, Clemens; Sabaté, Manel; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a

  17. Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Ong, Andrew T L; Lemos, Pedro A

    2006-01-01

    In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men....

  18. Re-examining minimal luminal diameter relocation and quantitative coronary angiography - Intravascular ultrasound correlations in stented saphenous vein grafts: Methodological insights from the randomised RRISC trial

    NARCIS (Netherlands)

    O. Semeraro (Oscar); P. Agostoni (Pierfrancesco); S. Verheye (Stefan); G.J.J. van Langenhove (Glenn); P.A. van den Heuvel (Paul); C. Convens (Carl); F. van den Branden (Frank); N. Bruining (Nico); P. Vermeersch (Paul)

    2009-01-01

    textabstractAims: Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated. Methods and results: Using quantitative coronary angiography (QCA)

  19. Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

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

    2008-01-01

    BACKGROUND: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis......, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. METHODS AND RESULTS: A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart...... RR=1.13; 95% CI=0.81 to 1.59; P=0.47). All-cause 2-year mortality was 7.8% in the DES group and 11.4% in BMS group (P7.2% in the DES group and 8.7% in the BMS group (P=0.09; adjusted RR...

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

    International Nuclear Information System (INIS)

    Patra, Soumya; Chakraborty, Rabindra Nath; Pande, Arindam; Banerjee, Suvro; Jena, Manabhanjan; Mandal, Prakash Chandra; De, Swapan Kumar; Khan, Aftab; Das, Sankha Suvro; Ghosh, Debashish; Nag, Raja

    2017-01-01

    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

  1. 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

  2. Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

    2013-01-01

    Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated...... with BMS in patients with diabetes who undergo primary percutaneous coronary intervention for STEMI. Published reports were scanned by formal searches of electronic databases (MEDLINE and CENTRAL). All completed randomized trials of DES for STEMI were examined. No language restrictions were enforced...

  3. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

    Science.gov (United States)

    Kaul, Upendra; Bhagwat, Ajit; Pinto, Brian; Goel, Praveen K; Jagtap, Prashant; Sathe, Shireesh; Wander, Gurpreet S; Arambam, Priyadarshini; Bangalore, Sripal

    2017-11-20

    The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

  4. [Ability to Overcome the Thrombocyte Resistance to Acetylsalicylic Acid in Patients With Coronary Artery Disease After Myocardial Revascularization With Coronary Stenting].

    Science.gov (United States)

    Pershukov, I V; Ostaschenko, S L; Kuznetsova, T N; Scherbo, S N; Karben, Z A; Sokryukina, E V; Omarov, A A; Ramazanov, D M; Bosak, N V; Shulzhenko, L V; Kalmatov, R K; Batyraliev, T A; Sidorenko, B A

    2016-07-01

    Resistance to acetylsalicylic acid (ASA) in patients with coronary artery disease is a poor predictor for the development of atherothrombotic complications. In 277 patients with coronary artery disease suffered uncomplicated coronary angioplasty with stent implantation, we was estimated arachidon-induced platelet aggregation during treatment with acetylsalicylic acid by bedside VerifyNow Assay test at 28-90 days after the intervention. It was found that 18.9% of the 144 patients receiving a combination of ASA 75 mg with 15.2 mg of magnesium hydroxide had true (laboratory) resistance to ASA. At the same time on the original enteric coated ASA 100 mg, we can found only 0.8% resistance to ASA among 129 patients. We made switch from combination of ASA 75 mg with 15.2 mg of magnesium hydroxide to original enteric coated ASA 100 mg and repeat VerifyNow Assay test at 2-4 days and found lost of resistance in 92% of 28 patients. Thus, resistance to the ASA is not constant, it depends on the form and the applied dose of ASA, and eliminating more than 92% when ASA changes from ineffective to effective form.

  5. Stenting of Anomalous Left Main Coronary Artery Stenosis in an Adult with a Retroaortic Course

    Directory of Open Access Journals (Sweden)

    Lanjewar Charan

    2011-01-01

    Full Text Available Coronary bypass graft has been the conventional treatment of choice in anomalous left man coronary artery stenosis. We are reporting an interesting case with anomalous left main coronary artery originating from right aortic sinus having retroaortic course complicated by significant atherosclerotic narrowing of the vessel and its percutaneous management.

  6. Steam-deformed Judkins-left guiding catheter with use of the GuideLiner® catheter to deliver stents for anomalous right coronary artery

    Science.gov (United States)

    Kuno, Toshiki; Fujisawa, Taishi; Yamazaki, Hiroyuki; Motoda, Hiroyuki; Kodaira, Masaki; Numasawa, Yohei

    2015-01-01

    Objective: Percutaneous coronary intervention for anomalous right coronary artery (RCA) originating from the left coronary cusp is challenging because of our current inability to coaxially engage the guiding catheter. Methods: We report a case of an 88-year-old woman with non-ST segment elevation myocardial infarction, with an anomalous RCA origin. Using either the Judkins-Left catheter or Amplatz-Left catheter was difficult because of RCA ostium tortuosity. Thus, we used steam to deform the Judkins-Left catheter, but back-up support was insufficient to deliver the stent. Results: We used GuideLiner®, a novel pediatric catheter with rapid exchange/monorail systems, to enhance back-up support. Conclusions: We were able to successfully stent with both the deformed Judkins-Left guiding catheter and GuideLiner® for an anomalous RCA origin. PMID:27489700

  7. A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study

    Directory of Open Access Journals (Sweden)

    Jacek Legutko

    2013-07-01

    Conclusions: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.

  8. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

    Energy Technology Data Exchange (ETDEWEB)

    Erbel, Raimund, E-mail: erbel@uk-essen.de [Department of Cardiology, University of Duisburg-Essen, Essen (Germany); Eggebrecht, Holger [Cardioangiological Center Bethanien (CCB), Frankfurt (Germany); Roguin, Ariel [Department of Cardiology, Rambam Medical Center, Haifa (Israel); Schroeder, Erwin [Division of Cardiovascular Medicine, Cliniques Universitaires de Mont-Godinne, Yvoir (Belgium); Philipp, Sebastian [Department Internal Medicine/Cardiology, Elbe Klinikum Stade, Stade (Germany); Heitzer, Thomas [Department of Cardiology, Heart Center Dortmund, Dortmund (Germany); Schwacke, Harald [Department of Internal Medicine, Diakonissen-Stiftungs- Krankenhaus Speyer (Germany); Ayzenberg, Oded [The Heart Institute, Kaplan Medical Center, Rehovot (Israel); Serra, Antonio [Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, España (Spain); Delarche, Nicolas [Cardiology unit, Pau General Hospital, Pau (France); Luchner, Andreas [Department of Internal Medicine/Cardiology, Universitätsklinikum Regensburg (Germany); Slagboom, Ton [Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam (Netherlands)

    2014-11-15

    Background: Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. Purpose: The ENERGY registry aimed to assess the safety and benefits of a cobalt–chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. Methods and materials: This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. Results: More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5 ± 6.5 mm and mean reference vessel diameter 3.2 ± 0.5 mm. MACE rates at 6, 12 and 24 months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24 months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. Conclusion: The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt–chromium thin strut bare metal stent with a passive coating showed very good results up to 24 months. (ClinicalTrials.gov:NCT01056120) Summary for annotated table of contents: The ENERGY international registry evaluated the safety and benefits of a cobalt–chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2 years. Results were encouraging with a low composite rate of cardiac death

  9. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

    International Nuclear Information System (INIS)

    Erbel, Raimund; Eggebrecht, Holger; Roguin, Ariel; Schroeder, Erwin; Philipp, Sebastian; Heitzer, Thomas; Schwacke, Harald; Ayzenberg, Oded; Serra, Antonio; Delarche, Nicolas; Luchner, Andreas; Slagboom, Ton

    2014-01-01

    Background: Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. Purpose: The ENERGY registry aimed to assess the safety and benefits of a cobalt–chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. Methods and materials: This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. Results: More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5 ± 6.5 mm and mean reference vessel diameter 3.2 ± 0.5 mm. MACE rates at 6, 12 and 24 months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24 months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. Conclusion: The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt–chromium thin strut bare metal stent with a passive coating showed very good results up to 24 months. (ClinicalTrials.gov:NCT01056120) Summary for annotated table of contents: The ENERGY international registry evaluated the safety and benefits of a cobalt–chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2 years. Results were encouraging with a low composite rate of cardiac death

  10. Impact of kissing balloon inflation on the main vessel stent volume, area, and symmetry after side-branch dilation in patients with coronary bifurcation lesions: a serial volumetric intravascular ultrasound study.

    Science.gov (United States)

    Rahman, Shahid; Leesar, Tara; Cilingiroglu, Mehmet; Effat, Mohamed; Arif, Imran; Helmy, Tarek; Leesar, Massoud A

    2013-09-01

    Intravascular ultrasound (IVUS) was performed to investigate the impact of kissing balloon inflation (KBI) on the main vessel (MV) stent volume, area, and symmetry after side-branch (SB) dilation in patients with coronary bifurcation lesions (CBL). It remains controversial whether KBI would restore the MV stent area and symmetry loss after SB dilation. A total of 88 serial IVUS examinations of the MV were performed after MV angioplasty, MV stenting, SB dilation, and KBI in 22 patients with CBL. The MV stent was divided into proximal, bifurcation, and distal segments; the stent volume index (SVI), minimal stent area (MSA), stent symmetry index (SSI), and external elastic membrane (EEM) volume index were measured in 198 stent segments and compared after MV stenting, SB dilation, and KBI. In the bifurcation segment, SVI, MSA, and SSI were significantly smaller after SB dilation than after MV stenting and KBI (SVI was 6.10 ± 1.50 mm(3)/mm vs. 6.68 ± 1.60 mm(3)/mm and 6.57 ± 1.60 mm(3)/mm, respectively, p impact on the MV stent volume or symmetry. This is the first comprehensive volumetric IVUS analysis of CBL, to our knowledge, demonstrating that KBI restores the MV stent volume, area, and symmetry loss after SB dilation in the bifurcation segment, and induces asymmetric stent expansion in the proximal segment. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Effect of PlA1/A2 glycoprotein IIIa gene polymorphism on the long-term outcome after successful coronary stenting

    Directory of Open Access Journals (Sweden)

    Riddell John

    2007-11-01

    Full Text Available Abstract Aim To prospectively determine the role of platelet glycoprotein IIIa (GP IIIa gene PlA1/PlA2 polymorphism on the long-term clinical outcome in patients with coronary artery disease undergoing coronary stenting. Design and setting Prospective observational study in the University Hospital of Caen (France. Patients and methods 1 111 symptomatic consecutive Caucasian patients treated with percutaneous coronary intervention including stent implantation underwent genotyping for GP IIIa PlA1/A2. Main outcome measures Long-term clinical outcome in terms of the rate of major adverse cardiac events (MACE, ie death from any cause, non-fatal Q wave or non Q wave myocardial infarction, and need for coronary revascularisation was obtained and subsequently stratified according to the GP IIIa PlA1/A2 polymorphism. Results Three groups of patients were determined according to the GP IIIa PlA1/A2 polymorphism (71.6% had the A1/A1, 25.8% had the A1/A2 and 2.6% had the A2/A2 genotype. These three groups were comparable for all clinical characteristics including sex ratio, mean age, vascular risk factors, previous coronary events, baseline angiographic exam, indication for the percutaneous coronary intervention and drug therapy. The incidence of MACE was similar in these 3 groups of patients during a mean follow-up period of 654+/-152 days. Independent risk factors for MACE were a left ventricular ejection fraction Conclusion The GP IIIa PlA1/A2 polymorphism does not influence the clinical long-term outcome in patients with symptomatic coronary disease undergoing percutaneous coronary intervention with stent implantation.

  12. Safety of hydrophilic guidewires used for side-branch protection during stenting and proximal optimization technique in coronary bifurcation lesions

    Energy Technology Data Exchange (ETDEWEB)

    Chatterjee, Arka [Division of Cardiology, University of Alabama-Birmingham (United States); Brott, Brigitta C. [Division of Cardiology, University of Alabama-Birmingham (United States); Department of Biomedical Engineering, University of Alabama-Birmingham (United States); Foley, Robin [Department of Material Science and Engineering, University of Alabama-Birmingham (United States); Alli, Oluseun; Sasse, Mark; Ahmed, Mustafa; Al Solaiman, Firas; Reddy, Gautam; Ather, Sameer [Division of Cardiology, University of Alabama-Birmingham (United States); Leesar, Massoud A., E-mail: mleesar@uab.edu [Division of Cardiology, University of Alabama-Birmingham (United States)

    2016-10-15

    Background and propose: In coronary bifurcation lesions (CBL), hydrophilic guidewires used for side-branch (SB) protection can be withdrawn from underneath the stent easier than other wires. However, the safety of which has not been investigated. Methods/materials: We performed scanning electron microscopic (SEM) examination of hydrophilic wires – the Whisper and Runthrough wires – used for SB protection during stenting and proximal optimization technique (POT) in 30 patients with CBL. The distal 15 cm of the wire was examined every 1 mm by SEM and 4500 segments were analyzed to investigate for wire fracture, polymer shearing (PS), and its correlations with post-stenting creatine kinase (CK)-MB release. Results: SEM examination showed no evidence for wire fracture. The total area of PS and the largest defect on the wire were significantly larger with the Whisper wire versus the Runthrough wire (0.15 ± 0.04 mm{sup 2} vs. 0.026 ± 0.01 mm{sup 2} and 0.04 ± 0.05 mm{sup 2} vs. 0.01 ± 0.01 mm{sup 2}; P < 0.05, respectively). The total length of PS and the longest defect on the wire were significantly longer with the Whisper wire vs. the Runthrough wire (12.1 ± 14.5 mm vs. 2.7 ± 3.0 mm and 2.9 ± 4.2 mm vs. 1.0 ± 1.2 mm; P < 0.05, respectively), but there were weak correlations between the extents of PS with CK-MB release. Conclusions: Hydrophilic guidewires may be safely used for SB protection during stenting and POT in CBLs. The extent of PS was significantly greater with the Whisper wire than with the Runthrough wire, but its correlation with post-stenting CK-MB release was weak. - Highlights: • There was no wire fracture by jailing hydrophilic wires. • There was no wire entrapment by jailing hydrophilic wires. • There were weak correlations between polymer shearing and creatine kinase-MB levels. • The impact of polymer shearing on myocardial infraction warrants future studies.

  13. Optical coherence tomography at follow-up after percutaneous coronary intervention: relationship between procedural dissections, stent strut malapposition and stent healing

    DEFF Research Database (Denmark)

    Radu, Maria; Jørgensen, Erik; Kelbæk, Henning

    2011-01-01

    To analyse the relationship between strut apposition as visualised with optical coherence tomography (OCT) at follow-up and clinical and procedural characteristics at stent implantation, and to examine the relationship between strut apposition and stent healing.......To analyse the relationship between strut apposition as visualised with optical coherence tomography (OCT) at follow-up and clinical and procedural characteristics at stent implantation, and to examine the relationship between strut apposition and stent healing....

  14. Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

    Science.gov (United States)

    Lee, Pil Hyung; Lee, Jong-Young; Lee, Cheol Whan; Kim, Seon-Ok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2018-01-01

    The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation. © 2018 American Heart Association, Inc.

  15. Meta-Analysis of Randomized Control Trials Comparing Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Significant Left Main Coronary Narrowing.

    Science.gov (United States)

    Qian, Cheng; Feng, Hong; Cao, Jianlei; Wei, Baozhu; Wang, Yanggan

    2017-05-01

    Previous meta-analyses showed that drug-eluting stent (DES) implantation may serve as an alternative to coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) stenosis, largely driven by data from registries. Hence, we performed a meta-analysis of randomized controlled trials (RCTs) to overcome this limitation. PubMed, the Cochrane Library, and Scopus were systematically searched through October 2016 to identify eligible RCTs. The primary outcomes were major adverse cardiac and cerebrovascular events (MACCE) at 1-year and long-term (≥3 years) follow-ups. This meta-analysis included 5 RCTs, totaling 4,595 patients with ULMCA disease. Compared with CABG, DES showed similar 1-year rates of MACCE (risk ratio [RR] 1.14, 95% confidence interval [CI] 0.91-1.42), all-cause death, and myocardial infarction, with a higher incidence of revascularization (RR 1.68, 95% CI 1.24-2.27) and lower incidence of stoke (RR 0.43, 95% CI 0.23-0.78). At long-term follow-up, DES placement was inferior to CABG in terms of MACCE (RR 1.27, 95% CI 1.13-1.43) and revascularization (RR 1.70, 95% CI 1.43-2.01). There was no difference in long-term risk of other outcomes between these 2 strategies. In conclusion, DES stenting and CABG for ULMCA disease yield comparable rates of MACCE at 1-year follow-up; however, CABG is associated with a decreased risk of long-term MACCE compared with DES, exclusively driven by the considerable reduction in revascularization events. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Clinical outcome of drug-eluting versus bare-metal stents in patients with calcified coronary lesions: a meta-analysis.

    Science.gov (United States)

    Zhang, B-C; Wang, C; Li, W-H; Li, D-Y

    2015-02-01

    The relative safety and efficacy of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with calcified coronary lesions is still debated. To evaluate clinical outcome of DES versus BMS in patients with calcified coronary lesions using a meta-analysis of the current literature. We performed a systematic literature search using Medline, Embase, Cochrane and several other databases. Randomised controlled trials, prospective and retrospective cohort studies with a mean follow-up period >6 months were included. Primary efficacy was target lesions revascularisation (TLR) and primary end-point for safety was stent thrombosis. Secondary end-points were cardiac death and recurrent myocardial infarction (MI). Five trials were included in the meta-analysis, including 2440 patients (1230 in the DES group, 1210 in the BMS group). TLR was significantly lower in patients treated with DES as compared with patients treated with BMS (8.5% vs 16.0%; odds ratio (OR) = 0.50; 95% confidence interval (CI) 0.38-0.65; P DES versus BMS. DES significantly reduces TLR rates as compared with BMS in patients with calcified coronary lesions, with non-significant differences in terms of stent thrombosis, cardiac death and MI. © 2014 Royal Australasian College of Physicians.

  17. 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

  18. Clinical results with the Resolute zotarolimus-eluting stent in total coronary occlusions

    DEFF Research Database (Denmark)

    Kelbæk, Henning; Holmvang, Lene; Richardt, Gert

    2015-01-01

    Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods and resu......Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods...

  19. 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.

  20. First- Versus Second-Generation Drug-Eluting Stents in Acute Coronary Syndromes (Katowice-Zabrze Registry).

    Science.gov (United States)

    Kawecki, Damian; Morawiec, Beata; Dola, Janusz; Wanha, Wojciech; Smolka, Grzegorz; Pluta, Aleksandra; Marcinkiewicz, Kamil; Ochała, Andrzej; Nowalany-Kozielska, Ewa; Wojakowski, Wojciech

    2016-05-01

    There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.

  1. FACTORES DE RIESGO CARDIOVASCULAR Y CALIDAD DE VIDA EN MUJERES REVASCULARIZADAS CON STENT CORONARIOS / Cardiovascular risk factors and quality of life in women who under-went revascularization with coronary stenting

    Directory of Open Access Journals (Sweden)

    José C. Castillo Núñez

    2013-10-01

    Full Text Available Resumen Introducción: Los factores de riesgo cardiovascular son responsables directos de la elevada mortalidad por enfermedad coronaria aterosclerótica en la mujer. Objetivo: Describir dichos factores, la evolución clínica y la calidad de vida en las féminas tras realizarle angioplastia coronaria. Método: Estudio descriptivo, longitudinal y prospectivo en 62 mujeres revascularizadas con angioplastia e implante de stent en el período de enero a junio de 2011. Se realizó seguimiento clínico durante 180 días a través de las consultas médicas. Resultados: La edad media fue de 52,8 años y el factor de riesgo cardiovascular más frecuente, la hipertensión arterial (66,1 %, y la diabetes (24,2 %, el menos prevalente. La enfermedad coronaria aterosclerótica de un vaso fue la de mayor frecuencia (87,1 % y la de tres vasos (1,6 %, la menos representada. En 75,8 % de los pacientes se utilizó un stent, solo uno requirió de tres. El 83,9 % de ellos valoraron su calidad de vida como buena, 14,5 % la consideraron aceptable y uno la estimó como pobre. En 93,5 % de los pacientes no se evidenciaron acontecimientos cardiovasculares durante el seguimiento clínico. La diabetes y la categoría calidad de vida pobre, mostraron una asociación estadísticamente significativa con la extensión de la enfermedad coronaria aterosclerótica, el número de stents utilizados y los acontecimientos cardiovasculares. Conclusiones: Las mujeres con enfermedad coronaria aterosclerótica, revascularizadas con stents coronarios, tienen una elevada frecuencia de factores de riesgo, una evolución clínica favorable y un predominio de las percepciones positivas sobre su calidad de vida. / Abstract Introduction: Cardiovascular risk factors are directly responsible for the high mortality from atherosclerotic coronary artery disease in women. Objective: To describe these risk factors, the clinical course and quality of life in women after coronary angioplasty. Method: A

  2. Nine-month Angiographic and Two-year Clinical Follow-up of Novel Biodegradable-polymer Arsenic Trioxide-eluting Stent Versus Durable-polymer Sirolimus-eluting Stent For Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Li Shen

    2015-01-01

    Full Text Available Background: Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES, compared with traditional sirolimus-eluting stent (SES. Methods: Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF, and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR by telephone visit and late luminal loss (LLL at 9-month by angiographic follow-up. Results: From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980. Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028. There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008. Conclusions: After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.

  3. Coronary artery bypass grafting versus drug-eluting stents in patients with severe coronary artery disease and diabetes mellitus: systematic review and meta-analysis.

    Science.gov (United States)

    Wu, Yi-Cheng; Su, Ting-Wei; Zhang, Jian-Feng; Shen, Wei-Feng; Ning, Guang; Kong, Ye

    2015-03-01

    A comprehensive meta-analysis was performed to evaluate the comparative benefits of coronary artery bypass grafting (CABG) versus drug-eluting stents (DES) in patients with diabetes mellitus and severe coronary artery disease (CAD). A comprehensive literature search of PubMed, Embase, and ScienceDirect was undertaken. References cited with the papers were also checked to identify relevant articles. In all, four randomized controlled trials, two prospective registries, and 11 retrospective studies were identified for review. Pooled analysis demonstrated that DES was associated with lower all-cause mortality at Day 30. However, there was no significant difference between CABG and DES in mortality at 12 months and at maximum follow-up. Furthermore, DES was associated with lower overall and major adverse cardiac and cerebrovascular events (MACCE)-free survival, as well as a higher incidence of myocardial infarction and repeat revascularization. In contrast, CABG was associated with an increased risk of stroke. For patients with diabetes mellitus and severe CAD, CABG is superior to DES in that it significantly improves overall and MACCE-free survival and reduces the incidence of myocardial infarction and repeat revascularization in the long term, although it is associated with greater perioperative risk and a higher incidence of stroke. Therefore, CABG should remain the gold standard for these patients. © 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  4. Prospective ECG-triggered axial CT at 140-kV tube voltage improves coronary in-stent restenosis visibility at a lower radiation dose compared with conventional retrospective ECG-gated helical CT

    Energy Technology Data Exchange (ETDEWEB)

    Horiguchi, Jun; Fujioka, Chikako; Kiguchi, Masao; Kohno, Shingo [Hiroshima University Hospital, Department of Clinical Radiology, Hiroshima (Japan); Yamamoto, Hideya; Kitagawa, Toshiro [Hiroshima University, Department of Molecular and Internal Medicine, Division of Clinical Medical Science, Programs for Applied Biomedicine, Graduate School of Biomedical Sciences, Hiroshima (Japan); Ito, Katsuhide [Hiroshima University, Department of Radiology, Division of Medical Intelligence and Informatics, Programs for Applied Biomedicine, Graduate School of Biomedical Sciences, Hiroshima (Japan)

    2009-10-15

    The purpose of this study was to compare coronary 64-slice CT angiography (CTA) protocols, specifically prospective electrocardiograph (ECG)-triggered and retrospective ECG-gated CT acquisition performed using a tube voltage of 140 kV and 120 kV, regarding intracoronary stent imaging. Coronary artery stents (n=12) with artificial in-stent restenosis (50% luminal reduction, 40 HU) on a cardiac phantom were examined by CT at heart rates of 50-75 beats per minute (bpm). The subjective visibility of in-stent restenosis was evaluated with a three-point scale (1 clearly visible, 2 visible, and 3 not visible), and artificial lumen narrowing [(inner stent diameter - measured lumen diameter)/inner stent diameter], lumen attenuation increase ratio [(in-stent attenuation - coronary lumen attenuation)/coronary lumen attenuation], and signal-to-noise ratio of in-stent lumen were determined. The effective dose was estimated. The artificial lumen narrowing (mean 43%), the increase of lumen attenuation (mean 46%), and signal-to-noise ratio (mean 7.8) were not different between CT acquisitions (p=0.12-0.91). However, the visibility scores of in-stent restenosis were different (p<0.05) between ECG-gated CTA techniques: (a) 140-kV prospective (effective dose 4.6 mSv), 1.6; (b) 120-kV prospective (3.3 mSv), 1.8; (c) 140-kV retrospective (16.4-18.8 mSv), 1.9; and (d) 120-kV retrospective (11.0-13.4 mSv), 1.9. Thus, 140-kV prospective ECG-triggered CTA improves coronary in-stent restenosis visibility at a lower radiation dose compared with retrospective ECG-gated CTA. (orig.)

  5. Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Bligaard, Niels; Thuesen, Leif; Saunamäki, Kari

    2014-01-01

    patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years. RESULTS: The primary end-point; the composite of cardiac death, myocardial infarction...

  6. Novel nanocrystalline diamond coating of coronary stents reduces neointimal hyperplasia in pig model

    Czech Academy of Sciences Publication Activity Database

    Kočka, V.; Jirásek, T.; Taylor, Andrew; Fendrych, František; Rezek, Bohuslav; Šimůnková, Z.; Mrázová, I.; Toušek, P.; Mistrík, J.; Mandys, V.; Nesládek, M.

    2014-01-01

    Roč. 20, č. 1 (2014), s. 65-76 ISSN 1205-6626 R&D Projects: GA AV ČR KAN200100801 Institutional support: RVO:68378271 Keywords : stents * nanotechnology * restenosis * optical coherence tomography * diamond Subject RIV: BM - Solid Matter Physics ; Magnetism Impact factor: 0.758, year: 2013

  7. Incidence and predictors of target lesion failure in a multiethnic Asian population receiving the SYNERGY coronary stent: A prospective all-comers registry.

    Science.gov (United States)

    Ananthakrishna, Rajiv; Kristanto, William; Liu, Li; Chan, Siew-Pang; Loh, Poay Huan; Tay, Edgar L; Chan, Koo Hui; Chan, Mark Y; Lee, Chi-Hang; Low, Adrian F; Tan, Huay Cheem; Loh, Joshua P

    2018-03-07

    To evaluate the target lesion failure (TLF) rate of the SYNERGY stent in all-comers, multiethnic Asian population. Currently, most drug eluting stents deliver anti-proliferative drugs from a durable polymer which is associated with a risk of late stent thrombosis. The novel everolimus-eluting, platinum chromium SYNERGY stent is coated with a bioabsorbable abluminal polymer that resolves within 4 months. This was a prospective, single center registry of consecutive patients treated with the SYNERGY stent between December 2012 and April 2015. The primary outcome was the incidence of TLF, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR) at 1 year. A total of 807 patients received the SYNERGY stent during the study period. One-year clinical outcome data was available for 765 patients (94.8%) and were considered for statistical analysis. The mean age was 60.7 ± 10.8 years, and 83.4% were males. Patients with acute myocardial infarction consisted of 50.3% (ST-segment elevation myocardial infarction: 23.0%, Non-ST-segment elevation myocardial infarction: 27.3%) of the study population. The treated lesions were complex (ACC/AHA type B2/C: 72.7%). The primary end point of TLF at 1 year was 5.8%. Rates of cardiac mortality, target vessel myocardial infarction, and TLR were 4.2, 1.0, and 1.3%, respectively, at 1 year. Predictors of the incidence and time to early TLF were female gender, Malay ethnicity, diabetes mellitus, acute myocardial infarction at presentation, a prior history of coronary artery bypass surgery and the presence of lesion calcification. The incidence of definite stent thrombosis was 0.4% at 1 year. In this registry, the use of the SYNERGY stent was associated with low rates of TLF at 1 year. © 2018 Wiley Periodicals, Inc.

  8. Clinical Outcome of Double Kissing Crush Versus Provisional Stenting of Coronary Artery Bifurcation Lesions: The 5-Year Follow-Up Results From a Randomized and Multicenter DKCRUSH-II Study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions).

    Science.gov (United States)

    Chen, Shao-Liang; Santoso, Teguh; Zhang, Jun-Jie; Ye, Fei; Xu, Ya-Wei; Fu, Qiang; Kan, Jing; Zhang, Feng-Fu; Zhou, Yong; Xie, Du-Jiang; Kwan, Tak W

    2017-02-01

    Provisional stenting is effective for anatomic simple bifurcation lesions. Double kissing crush stenting reduces the 1-year rate of target lesion revascularization. This study aimed to investigate the 5-year clinical results of the DKCRUSH-II study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions). A total of 370 patients with coronary bifurcation lesions who were randomly assigned to either the double kissing crush or provisional stenting group in the DKCRUSH-II study were followed for 5 years. The primary end point was the occurrence of a major adverse cardiac event at 5 years. Patients were classified by simple and complex bifurcation lesions according to the DEFINITION criteria (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents). At 5 years, the major adverse cardiac event rate (23.8%) in the provisional stenting group was insignificantly different to that of the double kissing group (15.7%; P=0.051). However, the difference in the target lesion revascularization rate between 2 groups was sustained through the 5-year follow-up (16.2% versus 8.6%; P=0.027). The definite and probable stent thrombosis rate was 2.7% in each group (P=1.0). Complex bifurcation was associated with a higher rate of target lesion revascularization (21.6%) at 5 years compared with 11.1% in patients with a simple bifurcation (P=0.037), with an extremely high rate in the provisional stenting group (36.8% versus 12.5%, P=0.005) mainly because of final kissing balloon inflation (19.4% versus 5.2%; P=0.036). The double kissing crush stenting technique for coronary bifurcation lesions is associated with a lower rate of target lesion revascularization. The optimal stenting approach based on the lesions' complexity may improve the revascularization for patients with complex bifurcations. URL: http://www.chictr.org. Unique

  9. Meta-Analysis of Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Coronary Narrowing.

    Science.gov (United States)

    Sardar, Partha; Giri, Jay; Elmariah, Sammy; Chatterjee, Saurav; Kolte, Dhaval; Kundu, Amartya; Nairooz, Ramez; Aronow, Wilbert S; Owan, Theophilus; Mukherjee, Debabrata; Feldman, Dmitriy N; Abbott, J Dawn

    2017-06-01

    Patients with unprotected left main coronary artery (ULMCA) disease are increasingly treated with percutaneous coronary intervention (PCI) using new-generation drug-eluting stents (DES); however, the benefits of DES compared with coronary artery bypass grafting (CABG) in ULMCA remain controversial. This meta-analysis evaluated the effects of PCI with DES compared with CABG for the treatment of ULMCA stenosis. Databases were searched through November 30, 2016. Randomized controlled trials (RCTs) comparing DES with PCI versus CABG for ULMCA stenosis were identified. We calculated summary odds ratios (ORs) and 95% CIs with the random-effects model. The primary outcome was major adverse cardiovascular events, defined as a composite of death from any cause, stroke, or myocardial infarction (MI). The analysis included 4,612 patients from 5 RCTs. Compared with CABG, patients assigned to PCI had a similar rate of major adverse cardiovascular events (OR 1.06, 95% CI 0.79 to 1.43), all-cause mortality (OR 1.03, 95% CI 0.79 to 1.35), cardiovascular death (OR 1.03, 95% CI 0.73 to 1.45), stroke (OR 0.81, 95% CI 0.38 to 1.76), and MI (OR 1.47, 95% CI 0.87 to 2.47). The risk of any repeat revascularization was significantly greater in the PCI group than that in the CABG group (OR 1.85, 95% CI 1.53 to 2.24). In conclusion, our meta-analysis of RCTs suggest that PCI with DES results in comparable mortality, stroke, and MI compared with CABG for revascularization of ULMCA stenosis, with PCI associated with higher rates of repeat revascularization. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. 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.

  11. Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY).

    Science.gov (United States)

    Valgimigli, Marco; Campo, Gianluca; Percoco, Gianfranco; Monti, Monia; Ferrari, Fabrizio; Tumscitz, Carlo; Zuffi, Andrea; Colombo, Federico; Kubbajeh, Moh'd; Cavazza, Caterina; Cangiano, Elisa; Tebaldi, Matteo; Minarelli, Monica; Arcozzi, Chiara; Scalone, Antonella; Frangione, Alice; Borghesi, Marco; Marchesini, Jlenia; Parrinello, Giovanni; Ferrari, Roberto

    2010-11-01

    The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy. Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment. PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%. The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency. Copyright © 2010 Mosby, Inc. All rights reserved.

  12. Comparison of immediate results and follow-up of patients with single-vessel and multivessel coronary artery disease younger than 50 years of age undergoing coronary stent implantation

    Directory of Open Access Journals (Sweden)

    Anello Alexandre L.

    2003-01-01

    Full Text Available OBJECTIVE: To assess the in-hospital results and clinical follow-up of young patients (< 50 years with multivessel coronary artery disease undergoing stent implantation in native coronary arteries and to compare their results with those of patients with single-vessel coronary artery disease. METHODS: We retrospectively studied 462 patients undergoing coronary stent implantation. Patients were divided into 2 groups: group I (G-I - 388 (84% patients with single-vessel coronary artery disease; and group II (G-II - 74 (16% patients with multivessel coronary artery disease. RESULTS: The mean age of the patients was 45±4.9 years, and the clinical findings at presentation and demographic data were similar in both groups. The rate of clinical success was 95% in G-I and 95.8% in G-II (P=0.96, with no difference in regard to in-hospital evolution between the groups. Death, acute myocardial infarction, and the need for myocardial revascularization during clinical follow-up occurred in 10.1% and 11.2% (P=0.92 in G-I and G-II, respectively. By the end of 24 months, the actuarial analysis showed an event-free survival of 84.6 % in G-I and 81.1% in G-II (P=0.57. CONCLUSION: Percutaneous treatment with coronary stent implantation in young patients with multivessel disease may be safe with a high rate of clinical success, a low incidence of in-hospital complications, and a favorable evolution in clinical follow-up.

  13. Evaluation of coronary in-stent restenosis by 64-slice computed tomography in patients with optimal heart rate control by systematic administration of beta-blocker drugs.

    Science.gov (United States)

    Martuscelli, Eugenio; Romagnoli, Andrea; D'eliseo, Alessia; Sperandio, Massimiliano; Di Luozzo, Marco; De Angelis, Barbara; Romeo, Francesco; Simonetti, Giovanni

    2010-06-01

    Imaging artifacts due to metallic stent struts can reduce the diagnostic accuracy of multislice computed tomography (MSCT) in the evaluation of in-stent restenosis (ISR). Our aim was to determine the accuracy of binary ISR exclusion using a 64-slice MSCT scanner and a systematic administration of beta-blockers having an aggressive heart rate (HR) control. We performed 64-slice MSCT in 218 consecutive patients revascularized by stenting. All patients were treated with oral/intravenous beta-blocker drugs in order to obtain a HR less than 65 beats/min in the prescan phase. Coronary stents were evaluated by two experienced observers in order to rule out the presence of significant (>50%) ISR. Quantitative conventional coronary angiography (CCA) served as a standard for reference. Five patients (2.3%) were excluded from the analysis; mean HR was 59 +/- 3 beats/min in the prescan phase and 62 +/- 5 beats/min during acquisition. In the 321 stented coronary segments, CCA found 27 significant ISRs. MSCT correctly diagnosed 26 significant ISRs, with two false-positive and one false-negative case. In a per-segment analysis, the sensitivity was 96%, specificity 99%, positive predictive value (PPV) 92.8%, and negative predictive value (NPV) 99%. In a per-patient analysis, the sensitivity was 100%, specificity 98.9%, PPV 92.8%, and NPV 100%. In our study, the evaluation of significant ISR by MSCT showed an excellent diagnostic accuracy with a PPV of 92.8% and a NPV of 99%. Selection criteria and radiation exposure can be considered a limitation of the method.

  14. Three-Year Major Clinical Outcomes of Angiography-Guided Single Stenting Technique in Non-Complex Left Main Coronary Artery Diseases.

    Science.gov (United States)

    Kim, Yong Hoon; Her, Ae-Young; Rha, Seung-Woon; Choi, Byoung Geol; Shim, Minsuk; Choi, Se Yeon; Byun, Jae Kyeong; Li, Hu; Kim, Woohyeun; Kang, Jun Hyuk; Choi, Jah Yeon; Park, Eun Jin; Park, Sung Hun; Lee, Sunki; Na, Jin Oh; Choi, Cheol Ung; Lim, Hong Euy; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog; Oh, Dong Joo

    2017-10-12

    There is limited long-term comparative clinical outcome data concerning angiography- versus intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in non-complex left main coronary artery (LMCA) disease treated with the single stenting technique in the drug-eluting stent (DES) era.The aim of this study was to investigate whether angiography-guided stenting is comparable to IVUS-guided stenting during 3-year clinical follow-up periods in patients with non-complex LM disease treated with the single stenting technique.A total of 196 patients treated with either angiography-guided (n = 74) or IVUS-guided (n = 122) PCI were included. The primary outcome was the occurrence of major adverse cardiac events (MACE) defined as total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target vessel revascularization (Non-TVR). To adjust for any potential confounders, propensity score (PS) adjusted analysis was performed.During 3-year follow-up, the PS adjusted Cox-proportional hazard ratio (HR) was not significantly different between the two groups for total death, cardiac death, and MI. Also, TLR and the combined rates of TVR and non-TVR were not significantly different. Finally, MACE was not significantly different between the two groups (HR: 0.63, 95% Confidence interval (CI): 0.33-1.17; P = 0.149).Angiography-guided PCI for non-complex LMCA diseases treated with the single stenting technique showed comparable results compared with IVUS-guided PCI in reducing clinical events during 3-year clinical follow-up in the DES era. Although IVUS guided PCI is the ideal strategy, angiography-guided PCI can be an option for LMCA PCI in some selected cases.

  15. Alterations in regional vascular geometry produced by theoretical stent implantation influence distributions of wall shear stress: analysis of a curved coronary artery using 3D computational fluid dynamics modeling

    Directory of Open Access Journals (Sweden)

    Warltier David C

    2006-06-01

    Full Text Available Abstract Background The success of stent implantation in the restoration of blood flow through areas of vascular narrowing is limited by restenosis. Several recent studies have suggested that the local geometric environment created by a deployed stent may influence regional blood flow characteristics and alter distributions of wall shear stress (WSS after implantation, thereby rendering specific areas of the vessel wall more susceptible to neointimal hyperplasia and restenosis. Stents are most frequently implanted in curved vessels such as the coronary arteries, but most computational studies examining blood flow patterns through stented vessels conducted to date use linear, cylindrical geometric models. It appears highly probable that restenosis occurring after stent implantation in curved arteries also occurs as a consequence of changes in fluid dynamics that are established immediately after stent implantation. Methods In the current investigation, we tested the hypothesis that acute changes in stent-induced regional geometry influence distributions of WSS using 3D coronary artery CFD models implanted with stents that either conformed to or caused straightening of the primary curvature of the left anterior descending coronary artery. WSS obtained at several intervals during the cardiac cycle, time averaged WSS, and WSS gradients were calculated using conventional techniques. Results Implantation of a stent that causes straightening, rather than conforms to the natural curvature of the artery causes a reduction in the radius of curvature and subsequent increase in the Dean number within the stented region. This straightening leads to modest skewing of the velocity profile at the inlet and outlet of the stented region where alterations in indices of WSS are most pronounced. For example, time-averaged WSS in the proximal portion of the stent ranged from 8.91 to 11.7 dynes/cm2 along the pericardial luminal surface and 4.26 to 4.88 dynes/cm2 along

  16. Scanning electron microscopy of drug-eluting coronary artery stent devices

    Czech Academy of Sciences Publication Activity Database

    Robinson, K. A.; Otsuka, Y.; Zablocki, J.; Rypáček, František; Chronos, N.; Apkarian, R. P.

    2006-01-01

    Roč. 28, č. 24 (2006), s. 114-114 ISSN 0161-0457. [Nanotechnology Conference Scanning 2006. Washington, 25.04.2006-27.04.2006] Institutional research plan: CEZ:AV0Z40500505 Keywords : scanning electron microscopy * polymer layer * stent Subject RIV: CE - Biochemistry Impact factor: 0.462, year: 2006 http://www3.interscience.wiley.com/cgi-bin/fulltext/113509466/PDFSTART

  17. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study

    Directory of Open Access Journals (Sweden)

    Ranjan Shetty

    2016-01-01

    Full Text Available Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF, including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58±11 years, with 51.3% (97/189 of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18±0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%, 6 (3.2%, and 10 (5.3%, respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent.

  18. Estudo comparativo randomizado do implante de Stent de aço inoxidável recoberto por carbono semelhante ao diamante versus não recoberto em pacientes com doença arterial coronariana Randomized comparative study of diamond-like carbon coated stainless steel stent versus uncoated stent implantation in patients with coronary artery disease

    Directory of Open Access Journals (Sweden)

    George César Ximenes Meireles

    2007-04-01

    Full Text Available OBJETIVO: Comparar as taxas de reestenose e de eventos cardíacos maiores em um e seis meses pós-implante de stents recobertos com CSD com os não-recobertos. MÉTODOS: Estudo comparativo, prospectivo, randomizado, de 180 pacientes com diagnóstico de insuficiência coronária, submetidos a implante de stent recoberto com CSD (Phytis® ou stent não-recobertos (Penta®, no período de janeiro de 2003 a julho de 2004. Foram critérios de inclusão: lesão de novo com porcentual de estenose em diâmetro > 50% em artéria coronária com diâmetro de referência > 2,5 mm e OBJECTIVE: To compare restenosis and major cardiac event rates at one and six months after DLC-coated stent implantation with those of uncoated stents. METHODS: Randomized, prospective, comparative study of 180 patients with coronary insufficiency undergoing DLC coated stent (Phytis™ or uncoated stent (Penta™ implantation, from January, 2003 to July, 2004. Inclusion criteria were: de novo lesion with >50% diameter stenosis in a coronary artery with reference diameter > 2,5 mm and < 4 mm, and length < 20 mm. Exclusion criteria were: left main coronary artery and bifurcation lesions, chronic total occlusion, and in-stent restenosis. RESULTS: Clinical and angiographic baseline characteristics of the groups were similar. Procedural success was achieved in 98.9% of the patients in both groups. One cardiac death occurred in each group during hospitalization. Reference diameter and acute gain were greater in the Penta™ group (3.21±0.37 mm vs. 3.34±0.8 mm, p=0.02 and 2.3±0.5 vs. 2.49±0.5, p=0.009, respectively. Angiographic follow-up at six months showed similar rates of restenosis (24.3% vs. 21.8%, p=0.84 and of major cardiac events (16.8% vs. 17.5%, p=1. CONCLUSION: DLC coated stents did not provide better outcomes in relation to uncoated stents.

  19. Role of deferred stenting in patients with ST elevation myocardial infarction treated with primary percutaneous coronary intervention: A systematic review and meta-analysis.

    Science.gov (United States)

    De Maria, Giovanni Luigi; Alkhalil, Mohammad; Oikonomou, Evangelos K; Wolfrum, Mathias; Choudhury, Robin P; Banning, Adrian P

    2017-06-01

    We conducted a meta-analysis of studies comparing deferred stenting strategy versus the conventional approach with immediate stenting in patients with ST elevation myocardial infarction. Deferring stent after mechanical flow restoration has been proposed as a strategy to reduce the risk of "no reflow" in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). Conflicting evidence is available currently, especially after the recent publication of three randomized clinical trials. Searches in electronic databases were performed. Comparisons between the two strategies were performed for both hard clinical endpoints (all cause-mortality, cardiovascular mortality, unplanned revascularization, myocardial infarction and readmission for heart failure) and surrogate angiographic endpoints (TIMI flow < 3 and myocardial blush grade (MBG) < 2). Eight studies (three randomized and five non-randomized) were deemed eligible, accounting for a total of 2101 patients. No difference in terms of hard clinical endpoints was observed between deferred and immediate stenting (OR [95% CI]: 0.79 [0.54-1.15], for all-cause mortality; odds ratio (OR) [95% CI]: 0.79 [0.47-1.31] for cardiovascular mortality; OR [95% CI]: 0.95 [0.64-1.41] for myocardial infarction; OR [95% CI]: 1.37 [0.87-2.16], for unplanned revascularization and OR [95% CI]: 0.50 [0.21-1.17] for readmission for heart failure). Notably, the deferred stenting approach was associated with improved outcome of the surrogate angiographic endpoints (OR [95% CI]: 0.43 [0.18-0.99] of TIMI flow < 3 and OR [95% CI]: 0.25 [0.11-0.57] for MBG < 2. A deferred stenting strategy could be a feasible alternative to the conventional approach with immediate stenting in "selected" STEMI patients undergoing pPCI. © 2017, Wiley Periodicals, Inc.

  20. 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.

    Science.gov (United States)

    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) <30 mL/min/1.73 m 2 , or the need for HD. The following outcome variables were compared among the three 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.

  1. Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

    DEFF Research Database (Denmark)

    Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik

    2015-01-01

    -polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat...

  2. Drug eluting balloon versus drug eluting stent in percutaneous coronary interventions: insights from a meta-analysis of 1462 patients.

    Science.gov (United States)

    Lupi, Alessandro; Rognoni, Andrea; Secco, Gioel Gabrio; Porto, Italo; Nardi, Federico; Lazzero, Maurizio; Rossi, Lidia; Parisi, Rosario; Fattori, Rossella; Genoni, Giulia; Rosso, Roberta; Stella, Pieter R; Sheiban, Imad; Bolognese, Leonardo; Liistro, Francesco; Bongo, Angelo Sante; Agostoni, Pierfrancesco

    2013-10-12

    Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting stents (DES), but clinic results of various DEB studies are still not consistent. Thus, we performed a meta-analysis to compare outcomes of DEB and DES for the treatment of coronary artery disease (CAD). Medline/Web databases were searched for studies comparing DEB and DES for obstructive CAD, reporting late lumen loss (LLL) and rates for overall mortality, myocardial infarction (MI), stent thrombosis (ST) and target lesion revascularization (TLR). 8 studies (1462 patients) were included in the meta-analysis. Compared with DES, DEB treated patients showed non-significantly higher LLL (weighted mean difference [WMD] 0.32, 95% confidence interval [CI] -0.15 to 0.78, P=0.18) and non-significantly higher rate of binary restenosis (odds ratio [OR] 1.40 [0.68-2.48], P=0.36). Mortality (OR 1.13[0.54-2.37], P=0.74), MI (OR 0.95, [0.50-1.80], P=0.87), ST (OR 1.12, [0.34-4.19], P=0.77) and TLR rates (OR 1.19[0.60-2.38], P=0.61) were similar between the 2 treatments. A pre-specified meta-regression analysis showed that LLL WMD and TLR OR were inversely correlated to the prevalence of diabetes (Pmeta-analysis showed that compared to DES, DEB use resulted in similar clinical efficacy and safety. Thus DEB could be considered a reasonable alternative to DES for the treatment of CAD in selected clinical settings (Clinicaltrials.gov identifier: NCT01760200). © 2013.

  3. Metallic intratracheal stent application on relapsing polychondritis with severe tracheobronchial malacia

    International Nuclear Information System (INIS)

    Ao Guokun; Zhao Weiguo; Guo Qinyun; Huang Qin

    2007-01-01

    Objective: To evaluate the therapeutic and adverse effects of metallic intratracheal stent placement in relapsing polychondritis with severe tracheobronchial malaeia. Methods: Five tracheal stents had been implanted in three patients with tracheobronchial malaeia. One patient was implanted with two tubular stents in trachea and one 'Y' shaped stent for bilateral bronchi. Another patient used a tubular stent in total tracheal segment. The last patient used a tubular stent in the upper segment of trachea. Results: All the stents were implanted successfully with obvious improvement of dyspnea after the treatment. Conclusions: Metallic intratracheal stent placement can really relieve symptoms and improve the life quality in patients with tracheobronchial malacia caused by relapsing polychondritis. (authors)

  4. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis)

    DEFF Research Database (Denmark)

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis

    2017-01-01

    centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. RESULTS Procedural success in the intention-to-treat population was 100 The primary safety endpoint was target lesion failure (TLF) (cardiac death...... and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. CONCLUSIONS This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes...

  5. Predictors and variability of drug-eluting vs bare-metal stent selection in contemporary percutaneous coronary intervention: Insights from the PRISM study.

    Science.gov (United States)

    Shafiq, Ali; Gosch, Kensey; Amin, Amit P; Ting, Henry H; Spertus, John A; Salisbury, Adam C

    2017-08-01

    Drug-eluting stents (DES) reduce risk of in-stent restenosis after percutaneous coronary intervention (PCI) but require dual antiplatelet therapy (DAPT) for a longer term than bare-metal stents (BMS). Few studies have examined clinical predictors of DES vs BMS, and variability in provider selection between DES and BMS in clinical practice has not been well described. These insights can inform our understanding of current practice and may identify opportunities to improve decision-making stent selection decinsion-making. In a multicenter registry, 3295 consecutive patients underwent PCI by 158 interventional cardiologists across 10 US sites. Eighty percent of patients with treated with DES. Using hierarchical regression, diabetes mellitus, multivessel disease, health insurance, and white race were independently associated with greater DES use, whereas increasing age, history of hypertension, anticipated surgery, use of warfarin, lower hemoglobin, prior history of bleeding, and treatment of right coronary and left circumflex artery lesions as compared with PCI of left anterior descending artery were associated with lower likelihood of receiving DES. Adjusted rates of DES use across providers varied from 52.3% to 94.6%, and adjusted median odds ratio for DES selection was 1.69. DES selection appeared to reflect physicians' attempts to balance benefits of DES against risks of prolonged DAPT. Nevertheless, marked residual variability in DES selection across providers persisted after adjusting for predictors of restenosis, bleeding, and other factors. Further studies are needed to better understand drivers of this variability and identify the impact of patient and provider preferences on stent selection at the time of PCI. © 2017 Wiley Periodicals, Inc.

  6. Restoration of myocardial blood flow following percutaneous coronary balloon dilatation and stent implantation: Assessment with qualitative and quantitative contrast-enhanced magnetic resonance imaging

    International Nuclear Information System (INIS)

    Sensky, P.R.; Samani, N.J.; Horsfield, M.A.; Cherryman, G.R.

    2002-01-01

    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 -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 i ); index of myocardial perfusion reserve (MPRI) = stressK i / restK 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)

  7. Platelet aggregation according to body mass index in patients undergoing coronary stenting: should clopidogrel loading-dose be weight adjusted?

    Science.gov (United States)

    Angiolillo, Dominick J; Fernández-Ortiz, Antonio; Bernardo, Esther; Barrera Ramírez, Carlos; Sabaté, Manel; Fernandez, Cristina; Hernández-Antolín, Rosana; Escaned, Javier; Alfonso, Fernando; Macaya, Carlos

    2004-04-01

    A 300 mg clopidogrel loading-dose (LD) is widely used as an adjunct antithrombotic treatment to reduce the risk of thrombotic events early after coronary stenting (CS). Antithrombotic drugs commonly used during percutaneous coronary interventions, such as heparin and platelet glycoprotein IIb/IIIa inhibitors, but not clopidogrel LD, are weight-adjusted, and few data are available on which is the most effective clopidogrel LD regimen. The aim of this study was to assess whether body mass index (BMI) influenced platelet response to clopidogrel LD in patients undergoing CS. Adenosine diphosphate (ADP)-induced platelet aggregation (PA) was assessed by light transmittance aggregometry in 48 patients on aspirin treatment undergoing CS receiving a 300 mg clopidogrel LD at intervention time. PA was assessed at baseline and up to 24 hours after intervention. Patients were divided into 2 groups according to BMI: overweight (BMI greater than or equal to 25 kg/m2; 29 patients) and normal weight (BMI<25 kg/m2; 19 patients). PA was significantly higher in overweight than in normal weight patients at baseline (60.1+/-18.6%; versus 47.6+/-13.5%; p=0.01), at 24 hours (42.3+/-18.4% versus 38.5+/-18.3%; p=0.02) and during the overall study time (p=0.025). Percentage of inhibition of PA 24 hours following clopidogrel LD was suboptimal (<40%) in 59% and 26% of overweight and normal weight patients, respectively (p=0.04). An elevated BMI was the only independent predictor of suboptimal platelet response. These data suggest that overweight patients may need a higher loading-dose of clopidogrel and/or an adjunct antithrombotic treatment to adequately inhibit platelet aggregation early after CS.

  8. Incidence and classification of neointimal proliferation and in-stent restenosis in post-stenting patients at 1-year interval: Findings from non-invasive coronary computed tomography angiography

    International Nuclear Information System (INIS)

    Xu, Nan; Zhang, Jiayin; Li, Minghua; Pan, Jingwei; Lu, Zhigang

    2014-01-01

    Highlights: • The incidence of silent in-stent restenosis at 1-year as revealed by CT is 7.6%. • The incidence of neointimal proliferation at 1-year as revealed by CT is 12.6%. • Diabetes are associated with higher incidence of neointimal proliferation. - Abstract: Objectives: To evaluate the incidence of coronary in-stent restenosis (ISR) and neointimal proliferation by coronary CT angiography (CCTA) at 1-year follow-up in asymptomatic patients. Methods: 234 patients (mean age: 67 ± 10.2 years, range 39–88 years, 180 males and 54 females) with 379 stents were prospectively enrolled in this study. Binary ISR was classified by CCTA into 4 types using Mehran classification. Neointimal proliferation was similarly classified into focal and diffuse types. All patients with CCTA-revealed ISR or neointimal proliferation underwent further invasive coronary angiography (ICA) for validation. Fisher's exact test was used for comparison. Results: ICA revealed patent stents with neointimal proliferation in 39 patients (16.7%, 39/234) and binary ISR in 23 patients (9.8%, 23/234). Lesion-based analysis showed 12 type I ISR lesions, 4 type II ISR lesions, 1 type III ISR lesion and 7 type IV ISR lesions. Among cases with neointimal proliferation, 27 lesions were classified as focal type whereas 13 lesions were classified as diffuse type. Patients with diabetes mellitus were associated with higher incidence of CCTA-revealed neointimal proliferation (21/77 vs. 18/157, p = 0.002) as well as ISR (12/77 vs. 11/157, p = 0.038), compared to patients without diabetes. CCTA was found to have good diagnostic performance for neointimal proliferation and ISR detection as well as classification, with an overall accuracy of 84.4% (54/64). Conclusions: Silent ISR as well as neointimal proliferation is not uncommon findings in asymptomatic post-stenting patients at 1-year interval, as revealed by CCTA. Patients with diabetes are prone to have higher incidence of neointimal

  9. Incidence and classification of neointimal proliferation and in-stent restenosis in post-stenting patients at 1-year interval: Findings from non-invasive coronary computed tomography angiography

    Energy Technology Data Exchange (ETDEWEB)

    Xu, Nan, E-mail: southmuch@hotmail.com [Department of Radiology, East Hospital, Tongji University School of Medicine, No. 150, Jimo Road, Shanghai 200120 (China); Zhang, Jiayin, E-mail: andrewssmu@msn.com [Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Li, Minghua, E-mail: drliminghua@gmail.com [Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Pan, Jingwei, E-mail: drpanjingwei@gmail.com [Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Lu, Zhigang, E-mail: drluzhigang@gmail.com [Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China)

    2014-10-15

    Highlights: • The incidence of silent in-stent restenosis at 1-year as revealed by CT is 7.6%. • The incidence of neointimal proliferation at 1-year as revealed by CT is 12.6%. • Diabetes are associated with higher incidence of neointimal proliferation. - Abstract: Objectives: To evaluate the incidence of coronary in-stent restenosis (ISR) and neointimal proliferation by coronary CT angiography (CCTA) at 1-year follow-up in asymptomatic patients. Methods: 234 patients (mean age: 67 ± 10.2 years, range 39–88 years, 180 males and 54 females) with 379 stents were prospectively enrolled in this study. Binary ISR was classified by CCTA into 4 types using Mehran classification. Neointimal proliferation was similarly classified into focal and diffuse types. All patients with CCTA-revealed ISR or neointimal proliferation underwent further invasive coronary angiography (ICA) for validation. Fisher's exact test was used for comparison. Results: ICA revealed patent stents with neointimal proliferation in 39 patients (16.7%, 39/234) and binary ISR in 23 patients (9.8%, 23/234). Lesion-based analysis showed 12 type I ISR lesions, 4 type II ISR lesions, 1 type III ISR lesion and 7 type IV ISR lesions. Among cases with neointimal proliferation, 27 lesions were classified as focal type whereas 13 lesions were classified as diffuse type. Patients with diabetes mellitus were associated with higher incidence of CCTA-revealed neointimal proliferation (21/77 vs. 18/157, p = 0.002) as well as ISR (12/77 vs. 11/157, p = 0.038), compared to patients without diabetes. CCTA was found to have good diagnostic performance for neointimal proliferation and ISR detection as well as classification, with an overall accuracy of 84.4% (54/64). Conclusions: Silent ISR as well as neointimal proliferation is not uncommon findings in asymptomatic post-stenting patients at 1-year interval, as revealed by CCTA. Patients with diabetes are prone to have higher incidence of neointimal

  10. 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.

  11. Intravascular ultrasound-guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials.

    Science.gov (United States)

    Bavishi, Chirag; Sardar, Partha; Chatterjee, Saurav; Khan, Abdur Rahman; Shah, Arpit; Ather, Sameer; Lemos, Pedro A; Moreno, Pedro; Stone, Gregg W

    2017-03-01

    The relative outcomes of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI with drug-eluting stent (DES) in complex lesions have not been established. We sought to compare the efficacy and safety of IVUS-guided PCI with angiography-guided PCI in patients with complex coronary lesions treated with DES. Electronic databases were searched to identify all randomized trials comparing IVUS-guided vs angiography-guided DES implantation. We evaluated major adverse cardiac events (MACE), all-cause and cardiovascular death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis outcomes at the longest reported follow-up. Random-effects modeling was used to calculate pooled relative risk (RR) and 95% CIs. Eight trials comprising 3,276 patients (1,635 IVUS-guided and 1,641 angiography-guided) enrolling only patients with complex lesions were included. Mean follow-up was 1.4±0.5years. Compared with angiography-guided PCI, patients undergoing IVUS-guided PCI had significantly lower MACE (RR 0.64, 95% CI 0.51-0.80, P=.0001), TLR (RR 0.62, 95% CI 0.45-0.86, P=.004), and TVR (RR 0.60, 95% CI 0.42-0.87, P=.007). There were no significant differences for stent thrombosis, cardiovascular death, or all-cause death. In meta-regression analysis, IVUS-guided PCI was of greatest benefit in reducing MACE in patients with acute coronary syndromes, diabetes, and long lesions. The present meta-analysis demonstrates a significant reduction in MACE, TVR, and TLR with IVUS-guided DES implantation in complex coronary lesions. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Relation of Nickel Allergy with in-Stent Restenosis in Patients Treated with Cobalt Chromium Stents

    OpenAIRE

    Aliağaoğlu, Cihangir; Turan, Hakan; Erden, İsmail; Albayrak, Hülya; Özhan, Hakan; Başar, Cengiz; Gürlevik, Zehra; Alçelik, Ayşegül

    2012-01-01

    Background 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. Objective We aimed to investigate the association betw...

  13. Grade III Coronary Artery Perforation Following PCI and Unusual Stent Graft Delivery System

    Directory of Open Access Journals (Sweden)

    Sreckovic Miodrag

    2014-06-01

    Full Text Available Koronarne perforacije su retke ali izuzetno neugodne komlikacije perkutanih intervencija. Perforacije koronarnh arterija trećeg stepena po Elisu predstvaljaju najozbiljniju formu perforacija i zahtevaju hitno zbrinjavanje. Često je neophodno uraditi perikardiocentezu i primeniti brojne interventne tehnike kako bismo rešili perforaciju. Stentovi prekriveni politetrafluoroetilenom(PTFE postali su jedno od najčešće korišćenih perkutanih rešenja, ali su njihove mane visoki profil i slaba fleksibilnost. U našem slučaju, pokušali smo da poboljšamo plasiranje PTFE stenta montiranjem na metalni stent, koji smo iskoristili kao nosač.

  14. Real-World Bioresorbable Vascular Scaffold Experience Compared With Second-Generation Metallic Drug-Eluting Stents in Complex Coronary Lesions.

    Science.gov (United States)

    Okamoto, Naotaka; Ueda, Hiroshi; Yoshimura, Takahiro; Chamaria, Surbhi; Bhatheja, Samit; Vengrenyuk, Yuliya; Rabiei, Samaneh; Barrientos, Yonandy; Kapur, Vishal; Barman, Nitin; Sweeny, Joseph; Baber, Usman; Mehran, Roxana; Sharma, Samin K; Kini, Annapoorna S

    2018-04-15

    The aim of the study was to compare the acute outcomes of Absorb bioresorbable vascular scaffolds (BVS) and second-generation drug-eluting stent (DES) implantation in routine clinical practice. There is a paucity of data regarding BVS use in a real-world patient population. The study population comprised 40 consecutive patients who underwent percutaneous coronary intervention (PCI) with BVS implantation at a tertiary-care center in New York, New York between July and December of 2016. An optimal implantation technique including adequate lesion preparation, mandatory postdilation, and optical coherence tomography (OCT) imaging was used in all cases. De novo lesions treated with BVS were compared to lesions treated with DES matched by OCT calcium arc, scaffold/stent size, use of atherectomy device, and lesion postdilation. Acute lumen gain, minimal device area, malapposition, eccentricity, and symmetry index were assessed using OCT. We analyzed OCT images of 40 BVS cases and 40 matching DES cases from 35 and 40 patients, respectively. Compared to the DES group, the BVS group demonstrated similar acute lumen gain, minimal scaffold/stent area, eccentricity index, and symmetry index after PCI. There were fewer malapposed struts detected after BVS implantation; however, malapposition distance and length were not different between the groups. BVS implantation in a real-world patient population with optimal implantation technique resulted in similar stent expansion and better strut apposition compared to DES implantation.

  15. 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.

  16. The effects of intra-aortic balloon pump in coronary stenting for high risk patients

    International Nuclear Information System (INIS)

    Zhang Qi; Shen Weifeng; Zhang Jianshen; Zhang Ruiyan; Hu Jian; Zhang Xian

    2003-01-01

    Objective: To evaluate the therapeutic efficacy of intra-aortic balloon supporting in coronary interventions for high risk patients with coronary artery disease (CAD). Methods: Sixteen high risk CAD patients accepted percutaneous coronary intervention assisted by intra-aortic balloon pumping together with clinical variables, procedural and follow-up informations were recorded and evaluated. Results: All patients presented with severe left ventricular dysfunction, multi-vessel disease and high jeopardy scores. 12 patients acquired complete revascularization. Mean duration of balloon pumping was (31 ± 17) minutes. Aortic diastolic and mean pressures were increased during balloon pumping [diastolic: (69±11) mmHg pre. vs (131±15) mmHg post.; mean: (82±13) mmHg pre. vs (111±7) mmHg post., P<0.001]. With average of 2 years follow-up, one patient died from pump failure but no MACE reaching survival rate of 75%. The ejection fraction and the NYHA grade were significantly improved. Conclusions: Intra-aortic balloon pumping is a safe and effective method in treating high risk CAD patients obtaining rather fare prognosis

  17. 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; Tilsted, Hans-Henrik

    2011-01-01

    Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first......-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...... cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated...

  18. 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.

    Science.gov (United States)

    von Birgelen, Clemens; 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, Salah A M; Nienhuis, Mark B; Verhorst, Patrick M J; Basalus, Mounir W Z; Doggen, Carine J M; Tandjung, Kenneth

    2014-02-01

    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 patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial. In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707. Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned

  19. A correlation found between gold concentration in blood and patch test reactions in patients with coronary stents.

    Science.gov (United States)

    Ekqvist, Susanne; Svedman, Cecilia; Lundh, Thomas; Möller, Halvon; Björk, Jonas; Bruze, Magnus

    2008-09-01

    Patients with dental gold restorations are known to have a higher level of gold concentration in blood (B-Au). To further investigate, in a study on patients with intracoronary stents and contact allergy to metals, the gold and nickel release from stainless steel stent with (Au stent) and without (Ni stent) gold plating. A total of 460 patients treated with stenting underwent patch testing with metals, and information on gold and nickel exposure and blood samples were collected. About 200 blood samples were randomly selected and the analysis of B-Au and nickel concentration in blood (B-Ni) was made using inductively coupled plasma mass spectrometry. There was a correlation between the intensity of Au patch test reaction and B-Au (P stent gave a fivefold higher B-Au than a Ni stent. Gold is released from the Au stent and patients with a Au stent have a fivefold higher B-Au than patients with an Ni stent. The patch test reactions for gold were correlated with B-Au.

  20. Treatment of a Coronary Bifurcation Lesion Using One Dedicated Sirolimus Eluting Bifurcation Stent in Combination with a Bioresorbable Vascular Scaffold: A Novel Option for Coronary Bifurcation Approach

    Directory of Open Access Journals (Sweden)

    Javier Benezet

    2016-01-01

    Full Text Available We present a complex bifurcation lesion treated with a new two-stent strategy combining a dedicated sirolimus eluting bifurcation stent, BiOSS Lim, with a bioresorbable vascular scaffold (BVS. The advantages of this strategy compared with the conventional two-stent approach are as follows: the dedicated stent protects the carina from being damaged, the large cell at the middle zone of the BiOSS Lim gives possibility to enter easily into the side branch (SB with any standard size conventional device, and, finally, the additional use of BVS in the SB could have a long-term benefit in terms of restenosis.

  1. 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

  2. Comparative vascular responses three months after paclitaxel and everolimus-eluting stent implantation in streptozotocin-induced diabetic porcine coronary arteries

    Directory of Open Access Journals (Sweden)

    Sheehy Alexander

    2012-06-01

    Full Text Available Abstract Background Diabetes remains a significant risk factor for restenosis/thrombosis following stenting. Although vascular healing responses following drug-eluting stent (DES treatment have been characterized previously in healthy animals, comparative assessments of different DES in a large animal model with isolated features of diabetes remains limited. We aimed to comparatively assess the vascular response to paclitaxel-eluting (PES and everolimus-eluting (EES stents in a porcine coronary model of streptozotocin (STZ-induced type I diabetes. Method Twelve Yucatan swine were induced hyperglycemic with a single STZ dose intravenously to ablate pancreatic β-cells. After two months, each animal received one XIENCE V® (EES and one Taxus Liberte (PES stent, respectively, in each coronary artery. After three months, vascular healing was assessed by angiography and histomorphometry. Comparative in vitro effects of everolimus and paclitaxel (10-5 M–10-12 M after 24 hours on carotid endothelial (EC and smooth muscle (SMC cell viability under hyperglycemic (42 mM conditions were assayed by ELISA. Caspase-3 fluorescent assay was used to quantify caspase-3 activity of EC treated with everolimus or paclitaxel (10-5 M, 10-7 M for 24 hours. Results After 3 months, EES reduced neointimal area (1.60 ± 0.41 mm, p vs. 0.08 ± 0.05, greater medial necrosis grade (0.52 ± 0.26 vs. 0.0 ± 0.0, and persistently elevated fibrin scores (1.60 ± 0.60 vs. 0.63 ± 0.41 with PES compared to EES (p In vitro, paclitaxel significantly increased (p -7 M, while everolimus did not affect EC/SMC apoptosis/necrosis within the dose range tested. In ECs, paclitaxel (10-5 M significantly increased caspase-3 activity (p  Conclusion After 3 months, both DES exhibited signs of delayed healing in a STZ-induced diabetic swine model. PES exhibited greater neointimal area, increased inflammation, greater medial necrosis, and

  3. Bioresorbable Scaffold vs. Second Generation Drug Eluting Stent in Long Coronary Lesions requiring Overlap: A Propensity-Matched Comparison (the UNDERDOGS study).

    Science.gov (United States)

    Biscaglia, Simone; Ugo, Fabrizio; Ielasi, Alfonso; Secco, Gioel Gabrio; Durante, Alessandro; D'Ascenzo, Fabrizio; Cerrato, Enrico; Balghith, Mohammed; Pasquetto, Giampaolo; Penzo, Carlo; Fineschi, Massimo; Bonechi, Francesco; Templin, Christian; Menozzi, Mila; Aquilina, Matteo; Rognoni, Andrea; Capasso, Piera; Di Mario, Carlo; Brugaletta, Salvatore; Campo, Gianluca

    2016-04-01

    Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p=0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p=0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p=0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p=0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p=0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p=0.001, p=0.001 and p=0.01, respectively). Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1year if compared to second generation DES. Further and larger studies are on demand to confirm our findings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Serum Level of Interleukin-18 to Interleukin-10 Ratio after Percutaneous Coronary Intervention: A New Predictor of In-Stent Restenosis

    Directory of Open Access Journals (Sweden)

    Nozar Givtaj

    2016-10-01

    Full Text Available Despite advanced techniques of stent placement which cause fewer traumas to the vessel walls; as well as introduction of drug-eluting stents which result in the least induction of immune response, in-stent restenosis (ISR is still one of the common and severe complications after PCI and stent placement. Intimal hyperplasia following immuno- inflammatory response of the arterial wall to balloon injury has been proposed as main mechanism of ISR. In a prospective study, we assessed the predictive role of Interleukin (IL-18 and tumor necrosis factor alpha (TNF-α as pro-inflammatory cytokines and IL-10 as anti-inflammatory cytokine and high sensitive C-reactive protein (hs-CRP for ISR. 128 patients (mean age=59±10.2, female/male: 41/87who underwent percutaneous coronary intervention (PCI and stent implantation. Venous blood samples were obtained before and 24 hours after PCI. IL-18, IL-10, TNF-αand hs-CRP levels were determined. We followed the patients for 24 months and measured the incidence of ISR via angiography. Results were compared between ISR and non-ISR patients. 20 patients (15.6% developed ISR. Serum level of IL-18, TNF-α and hs-CRP have been increased in all patients 24 hours after PCI. Serum level of IL-18 at 24-hours was not different between ISR and non-ISR patients (p=0.239, while serum level of IL-10 was significantly higher in non-ISR group (p<0.001. IL-18/IL-10 was significantly higher in ISR patients than in non-ISR patients (p<0.001. IL-18/IL-10 can be applied as predictive factors for ISR.

  5. Comparative angiographic quantitative analysis of the immediate efficacy of coronary atherectomy with balloon angioplasty, stenting, and rotational ablation

    NARCIS (Netherlands)

    V.A.W.M. Umans (Victor); B.H. Strauss (Bradley); B.J.W.M. Rensing (Benno); P.P.T. de Jaegere (Peter); P.J. de Feyter (Pim); P.W.J.C. Serruys (Patrick)

    1991-01-01

    markdownabstractAbstract Interventional cardiology has branched in two directions: devices that primarily dilate coronary stenoses and those that debulk coronary tissue. Presently the optimum coronary intervention has not been found. While patients are awaiting randomized trials, a comparison

  6. Rationale and design of amphilimus sirolimus-eluting stents versus zotarolimus-eluting stents in all-comers requiring percutaneous coronary intervention (ReCre8): A multicenter randomized clinical trial.

    Science.gov (United States)

    Rozemeijer, Rik; Stein, Mèra; Frambach, Peter; Voskuil, Michiel; Kraaijeveld, Adriaan O; Rodríguez-Olivares, Ramón; Timmers, Leo; Pereira, Bruno; Rittersma, Saskia Z; Agostoni, Pierfrancesco; Doevendans, Pieter A; Stella, Pieter R

    2018-02-15

    Amphilimus sirolimus-eluting stents (A-SES) represent a novel elution technology in the current era of drug-eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A-SES as compared to new-generation drug-eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A-SES as compared with zotarolimus-eluting stents (ZES) in a real-world, all-comers setting. ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A-SES as compared with ZES in all-comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A-SES or ZES. On-site block-randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1-month of dual antiplatelet therapy (DAPT) when troponin-negative, or 12-months of DAPT when troponin-positive. The primary endpoint is target-lesion failure at 1-year follow-up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A-SES with at least 80% power, a noninferiority margin of 3.5% and a type-I-error of 0.05. ReCre8 (NCT02328898) is the first randomized multicenter trial with a head-to-head comparison of A-SES as compared with ZES to investigate the clinical safety and efficacy of these new-generation DES in a real-world, all-comers population. © 2017 Wiley Periodicals, Inc.

  7. 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans-Henrik; Jensen, Lisette Okkels

    2012-01-01

    This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.......This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice....

  8. Impact of 6-month angiographic restenosis inside bare-metal stents on long-term clinical outcome in patients with coronary artery disease

    International Nuclear Information System (INIS)

    Chen Yunglung; Chen Miencheng; Wu Chiungjen

    2007-01-01

    This study enrolled 536 patients who underwent successful coronary stenting with bare-metal stents and 6-month angiographic follow-up examinations between 1998 and 2000. Baseline characteristics and angiographic and procedural parameters for these patients were obtained. Primary endpoints were all-cause mortality and nonfatal myocardial infarction. Patients were assigned to instent restenosis or non-instent restenosis groups based on 6-month angiographic follow-up results. Restenosis inside a bare-metal stent was defined as more than 50% stenosis at the intervention site. In total, 178 (33.2%) patients had restenosis inside bare-metal stents, while 358 (66.8%) patients were without. At mean follow-up of 56.8±20.3 months, 36 (6.7%) patients had a primary endpoint event while 500 (93.3%) patients had no primary endpoint event. Survival rates for patients free from primary endpoints in the instent restenosis and non-instent restenosis groups were 96.0 versus 99.4% at 1 year and 89.8% versus 94.8% at 5 years, respectively (P=0.0033). Survival rates for patients free of all-cause mortality in the instent restenosis and non-instent restenosis groups were 96.0% versus 99.4% at 1 year and 91.6% versus 96.3% at 5 years, respectively (P=0.0079). Multivariate Cox regression analysis showed that restenosis inside bare-metal stents was an independent predictor of primary endpoint events (odds ratio: 2.053; 95% CI: 1.048-4.022; P=0.036) and was a predictor of total mortality with borderline significance (odds ratio: 2.036; 95% CI: 0.936-4.431; P=0.073). In conclusion, in this study, restenosis inside bare-metal stents at 6-month angiographic follow-up was an independent predictor of long-term outcome-all-cause mortality and nonfatal myocardial infarction. Thus, this study provides clinical evidence that patients with restenosis inside bare-metal stents at 6-month angiographic follow-up likely warrant aggressive follow-up. (author)

  9. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

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

    2015-01-01

    -coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. DESIGN: The multicenter SORT OUT VII trial (NCT01879358...

  10. 2-year outcome after biodegradable polymer sirolimus- and biolimus- eluting coronary stents.From the randomized SORT OUT VII trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Raungaard, Bent

    2018-01-01

    AIMS: The SORT OUT VII trial compared the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent with a slow polymer degradation and the thicker-strut stainless steel biolimus-eluting Nobori stent with a moderate-term polymer degradation in an all-comer patient population. METHODS AND RESULTS...

  11. Relationship between clopidogrel-induced platelet P2Y12 inhibition and stent thrombosis or myocardial infarction after percutaneous coronary intervention-a case-control study.

    Science.gov (United States)

    Varenhorst, Christoph; Koul, Sasha; Erlinge, David; Lagerqvist, Bo; Siegbahn, Agneta; Wallentin, Lars; James, Stefan

    2011-08-01

    Insufficient platelet inhibition is a major determinant of stent thrombosis (STh), although the etiology is multifactorial. On-clopidogrel platelet reactivity was investigated in patients with previous angiographically confirmed STh, myocardial infarction (MI), and controls. Using the Swedish Coronary Angiography and Angioplasty Registry, we identified patients with angiographically confirmed STh (n = 48) or MI (n = 30) while on dual antiplatelet therapy within 6 months of percutaneous coronary intervention (PCI) and matched control patients (n = 78). On-clopidogrel platelet reactivity was measured with VerifyNow P2Y12 and vasodilator-stimulated phosphoprotein (VASP) phosphorylation assay. The mean P2Y12 reaction units (PRU) was higher (246.8 ± 75.9 vs 200.0 ± 82.7, P = .001) in STh patients compared with controls. The optimal cutoff for STh was 222 PRU or higher (area under the curve 0.69, P STh or MI. STh was associated with high on-clopidogrel platelet reactivity measured with VerifyNow (cutoff level of PRU ≥222) but spontaneous MI in stented patients on clopidogrel treatment was not. There was, however, a substantial overlap in on-clopidogrel platelet reactivity between patients with and without on-treatment STh questioning the clinical use of platelet function testing to identify patients at high risk for STh. Copyright © 2011 Mosby, Inc. All rights reserved.

  12. A review with meta-analysis of observational studies for survival following off-pump coronary artery bypass versus drug-eluting stent implantation.

    Science.gov (United States)

    Takagi, Hisato; Watanabe, Taku; Mizuno, Yusuke; Kawai, Norikazu; Umemoto, Takuya

    2014-06-01

    To determine whether off-pump coronary artery bypass (OPCAB) improves survival over drug-eluting stent (DES) implantation, we performed a review with meta-analysis of exclusive OPCAB versus DES. Databases including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched through October 2013 using Web-based search engines (PubMed and OVID). Studies that met the following criteria were considered for inclusion: the design was a randomized controlled trial or observational comparative study; the study population was patients with any coronary artery disease; patients were assigned to OPCAB versus DES and outcomes included all-cause mortality at ≥1 years. Our exhaustive search identified no randomized trial and 10 observational studies of OPCAB versus DES. A pooled analysis demonstrated no statistically significant difference in all-cause mortality between OPCAB and DES (hazard ratio, 0.94; 95% confidence interval, 0.76-1.15; P = 0.55). In general, exclusion of any single study from the analysis did not substantially alter the overall result of our analysis. There was no evidence of significant publication bias. In conclusion, OPCAB may not improve survival over DES despite greater number of treated vessels in OPCAB than in DES or greater number of distal anastomosis in OPCAB than that of implanted stents in DES. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. Acute thrombosis during left main stenting using tap technique in a patient presenting with non-ST-segment elevation acute coronary syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Natarajan, Deepak, E-mail: deepaknatarajan@me.com

    2015-06-15

    This case reports the sudden development of large burden of thrombi in the left anterior descending coronary artery immediately following distal left main stenting using TAP technique in a middle aged man who presented with non ST-segment elevation acute coronary syndrome despite having been administered 7,500 units of unfractionated heparin and being given 325 mg of aspirin and 60 mg of prasugrel prior to the procedure. The thrombi were managed effectively by giving an intra-coronary high bolus dose of tirofiban (25 mcg/kg) without the need for catheter thrombus extraction. Tirofiban intra-venous infusion was maintained for 18 hours, and the patient was discharged in stable condition on the third day. Importantly there is no controlled study on upstream administration of glycoprotein IIb/IIIa inhibitors in addition to the newer more potent anti-platelet agents in patients with unprotected distal left main disease presenting with non ST-segment elevation acute coronary syndrome, nor is there any data on safety and efficacy of mandatory usage of injectable anti-platelet agents at the start of a procedure in a catheterization laboratory in such a setting.

  14. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

    Science.gov (United States)

    Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L; Baux, Ana Cebrian; Džavík, Vladimír; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen

    2011-03-29

    The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  15. Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.

    Science.gov (United States)

    Tcheng, James E; Crowley, Jay; Tomes, Madris; Reed, Terrie L; Dudas, Joseph M; Thompson, Kweli P; Garratt, Kirk N; Drozda, Joseph P

    2014-10-01

    Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration. An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data. Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management. This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information. Copyright © 2014 Mosby, Inc. All rights reserved.

  16. Novel management strategy for coronary steal syndrome: case report of occlusion of a LIMA graft side branch with a combination of drug-eluting and covered-stent deployment.

    LENUS (Irish Health Repository)

    Hynes, Brian G

    2009-11-01

    We report a novel percutaneous therapeutic approach to the management of suspected coronary artery steal syndrome resulting from a large side branch of the left internal mammary artery bypass graft, using a combination of coated and drug-eluting stents. We demonstrate the feasibility and long-term efficacy of this strategy in a case report.

  17. Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization: From the WIN-DES Collaborative Patient-Level Pooled Analysis

    NARCIS (Netherlands)

    Giustino, Gennaro; Baber, Usman; Aquino, Melissa; Sartori, Samantha; Stone, Gregg W.; Leon, Martin B.; Genereux, Philippe; Dangas, George D.; Chandrasekhar, Jaya; Kimura, Takeshi; Salianski, Olga; Stefanini, Giulio G.; Steg, Gabriel; Windecker, Stephan; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; Galatius, Soren; von Birgelen, Clemens; Saporito, Robert; Jeger, Raban V.; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

    2016-01-01

    Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women

  18. 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.

  19. [Efficacy comparison between drug-eluting stents versus cutting balloon angioplasty followed by bare metal stents for the treatment of ostial lesions of the left anterior descending coronary artery].

    Science.gov (United States)

    Chen, Ji-lin; Gao, Li-jian; Gao, Run-lin; Yang, Yue-jin; Qin, Xue-wen; Qiao, Shu-bin; Xu, Bo; Yao, Min; Liu, Hai-bo; Wu, Yong-jian; Yuan, Jin-qing; Chen, Jue

    2008-08-01

    To compare the short and long-term clinical and angiographic outcomes of drug-eluting stents (DES) versus cutting balloon angioplasty followed by bare metal stents (CBA + BMS) for the treatment of ostial lesions of the left anterior descending coronary artery (LAD). A total of 51 consecutive patients with LAD ostial lesions were treated by DES and all patients had completed 2-year clinical follow-up, 50 consecutive patients with LAD ostial lesions treated by CBA + BMS and followed up for 2 years prior to the DES era (May 2000 to November 2003) served as control group. In DES group, one patient experienced acute myocardial infarction (AMI) during hospitalization, the in-hospital major adverse cardiac event (MACE) was 1.96% (1/51), angiography follow-up data at 6-8 months were available in 29 patients and the in-DES restenosis was 10.3% (3/29), at 2-year clinical follow-up, 1 patient died, 4 patients received target lesion revascularization. Total MACE rate was 9.8% (5/51). In CBA + BMS group, there was no in-hospital death and AMI. Angiographic follow-up at 6-8 months was completed in 28 cases and in-stent restenosis rate was 17.9% (5/28). During 2-year follow-up, there was no death and AMI and 6 patients underwent target lesion revascularization. MACE rate was 12% (6/50) in this group. This study showed that both clinical and angiographic outcomes were comparable between DES and CBA + BMS treated patients with LAD ostial lesions during the 2-year follow up period.

  20. Tubular combustion

    CERN Document Server

    Ishizuka, Satoru

    2014-01-01

    Tubular combustors are cylindrical tubes where flame ignition and propagation occur in a spatially confined, highly controlled environment, in a nearly flat, elongated geometry. This allows for some unique advantages where extremely even heat dispersion is required over a large surface while still maintaining fuel efficiency. Tubular combustors also allow for easy flexibility in type of fuel source, allowing for quick changeover to meet various needs and changing fuel pricing. This new addition to the MP sustainable energy series will provide the most up-to-date research on tubular combustion--some of it only now coming out of private proprietary protection. Plentiful examples of current applications along with a good explanation of background theory will offer readers an invaluable guide on this promising energy technology. Highlights include: * An introduction to the theory of tubular flames * The "how to" of maintaining stability of tubular flames through continuous combustion * Examples of both small-scal...

  1. Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

    2018-01-05

    Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

  2. Comparative angiographic quantitative analysis of the immediate efficacy of coronary atherectomy with balloon angioplasty, stenting, and rotational ablation

    NARCIS (Netherlands)

    V.A.W.M. Umans (Victor); B.H. Strauss (Bradley); B.J.W.M. Rensing (Benno); P.P.T. de Jaegere (Peter); P.J. de Feyter (Pim); P.W.J.C. Serruys (Patrick)

    1991-01-01

    textabstractInterventional cardiology has branched in two directions: devices that primarily dilate coronary stenoses and those that debulk coronary tissue. Presently the optimum coronary intervention has not been found. While patients are awaiting randomized trials, a comparison based on matched

  3. Contribution of quantitative coronary angiography in Palmaz-Schatz optimal stent liberation strategy for subacute occlusion control; Contribuicao da angiografia coronaria quantitativa na estrategia de liberacao otima da endoprotese de Palmaz-Schatz para o controle da oclusao subaguda

    Energy Technology Data Exchange (ETDEWEB)

    Sousa, Amanda Guerra de Moraes Rego

    1995-07-01

    This study examines whether a single method, quantitative coronary angiography with automated edge detection, could efficiently guide optimal stent liberation, assuring good clinical results and eliminating the need for anticoagulation therapy. This investigation includes 101 patients with optimal implantation of 104 Palmaz-stents. Their mean age was 58.62 years and 79.2% were male. Most of them presented unstable angina (61.39%) and had single vessel disease (85.15%) The treated vessel was the left anterior descending artery in 39.60%; the right coronary artery in 34.66%; the left circumflex artery in 7.92% and saphenous vein grafts in 17.82%. The mean reference diameter of the target vessel was 3.43 mm. Each implantation comprehended two phases: initial stent liberation and additional high pressure balloon inflation, guided by quantitative coronary angiography. Arterial quantification showed an important increase in the mean luminal diameter (p<0.001), characterized by an immediate gain of 2.37 mm [standard deviation (SD): 0.55 m]. Quantitative angiography permitted to identify a further gain in the luminal diameter following the high pressure balloon inflation, o.49 mm 9 SD:0.53 mm). Therefore, the total mean immediate gain was 2.85 mm (SD:0.64 mm). The mean diameter stenosis changed from 80.21% (SD:14.56%) to 11.81% (SD: 7.59% - p<0.001) after initial stent delivery; and to 0.16% (SD:3.45% - p<,0.001), after high pressure balloon inflation. Quantitative coronary angiography performed detailed measurements of the minimal caliber variations along the entire prosthesis due to the high pressure balloon inflations, similarly to the intracoronary ultrasound. This guided the optimal stent implantation and helped the clinical management of these cases. In this series, even maintained only under antiaggregant agents, no patient presented major ischemic complications and only one (0.99%) had a hemorrhage in the puncture site that required blood transfusion. The mean in

  4. Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Kongyong Cui

    Full Text Available Drug-eluting balloon (DEB has become an alternative option to drug-eluting stent (DES for the treatment of in-stent restenosis (ISR. However, the effect of drug-eluting balloon with regular bare-mental stent (BMS in de novo coronary artery disease (CAD is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.Randomized controlled trials (RCTs assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs and late lumen loss (LLL. Secondary endpoints included death, myocardial infarction (MI, target lesion revascularization (TLR, stent thrombosis (ST, binary restenosis, and minimum lumen diameter (MLD. Dichotomous and continuous data were presented as odds ratios (ORs and mean differences (MDs with 95% confidence intervals (CIs, respectively, and analyzed using a random-effects model.A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04 and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001 compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004, LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003, TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003, and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003.This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES should be recommended for patients with de novo CAD.

  5. Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials.

    Science.gov (United States)

    Cui, Kongyong; Lyu, Shuzheng; Song, Xiantao; Yuan, Fei; Xu, Feng; Zhang, Min; Wang, Wei; Zhang, Dongfeng; Dai, Jing

    2017-01-01

    Drug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD. Randomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis, and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively, and analyzed using a random-effects model. A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003). This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES) should be recommended for patients with de novo CAD.

  6. Coronary surgery is superior to drug eluting stents in multivessel disease. Systematic review and meta-analysis of contemporary randomized controlled trials.

    Science.gov (United States)

    Benedetto, Umberto; Gaudino, Mario; Ng, Colin; Biondi-Zoccai, Giuseppe; D'Ascenzo, Fabrizio; Frati, Giacomo; Girardi, Leonard N; Angelini, Gianni D; Taggart, David P

    2016-05-01

    Current randomized controlled trials (RCTs) comparing percutaneous coronary intervention with drug eluting stent (DES-PCI) with coronary artery bypass grafting (CABG) in multivessel disease are underpowered to detect a difference in hard clinical end-points such as mortality, myocardial infarction and stroke. We aimed to overcome this limitation by conducting a meta-analysis of contemporary RCTs. A systematic literature search was conducted for all RCTs comparing DES-PCI versus CABG in multivessel disease published through May 2015. Inverse variance weighting was used to pool data from individual studies (DES-PCI and >1 CABG favouring surgery). A total of five randomized trials including 4563 subjects were analysed. After an average follow-up of 3.4 years, DES-PCI was associated with a significantly increased risk of overall mortality (HR 1.51; 95%CI 1.23-1.84; PDES-PCI. In patients with multivessel coronary disease, CABG was found to be superior to DES-PCI by reducing the risk of mortality and subsequent myocardial infarction at the expense of a marginally increased risk of stroke. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

    Science.gov (United States)

    Lu, Huangling; Grundeken, Maik J; Vos, Nicola S; IJsselmuiden, Alexander J J; van Geuns, Robert-Jan; Wessely, Rainer; Dengler, Thomas; La Manna, Alessio; Silvain, Johanne; Montalescot, Gilles; Spaargaren, René; Tijssen, Jan G P; Amoroso, Giovanni; de Winter, Robbert J; Koch, Karel T

    2017-08-04

    The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI. We aimed to evaluate the long-term clinical outcomes of the APPOSITION III registry. This was an international, prospective, multicentre post-marketing registry. The study population consisted of 965 STEMI patients. The primary endpoint, major adverse cardiac events (MACE), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR). At two years, MACE occurred in 11.2%, cardiac death occurred in 2.3%, TV-MI occurred in 2.3% and CD-TLR in 9.2% of patients. The two-year definite stent thrombosis (ST) rate was 3.3%. Incremental event rates between one- and two-year follow-up were 1.0% for TV-MI, 1.8% for CD-TLR, and 0.5% for definite ST. Post-dilation resulted in significantly reduced CD-TLR and ST rates at 30-day landmark analyses. Results were equivalent between the BMS and PES STENTYS subgroups. This registry revealed low rates of adverse events at two-year follow-up, with an incremental ST rate as low as 0.5% in the second year, demonstrating that the self-apposing technique is feasible in STEMI patients on long-term follow-up while using post-dilatation.

  8. A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

    Directory of Open Access Journals (Sweden)

    А. Н. Кудряшов

    2017-04-01

    Full Text Available The review deals with the evolution of interventional coronary procedures and development of the state-of-art coronary stent market. Emphasis in the review is placed on comprehensive analysis of technical characteristics of the world’s most popular coronary stents versus a Russian bioresorbable sirolimus-eluting stent “Calipso”.Received 13 January 2017. Accepted 17 March 2017.Conflict of interest: Kudryashov A.N., Trebushat D.V. are “Angioline” Company employees, the producer of “Kalipso” coronary stent. Kretov E.I. served as executive editor of “Endovascular surgery” section. All other authors declare no conflict of interest.

  9. 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....

  10. Clinical outcomes after final kissing balloon inflation compared with no final kissing balloon inflation in bifurcation lesions treated with a dedicated coronary bifurcation stent.

    Science.gov (United States)

    Grundeken, Maik J; Lesiak, Maciej; Asgedom, Solomon; Garcia, Eulogio; Bethencourt, Armando; Norell, Michael S; Damman, Peter; Woudstra, Pier; Koch, Karel T; Vis, M Marije; Henriques, Jose P; Tijssen, Jan G; Onuma, Yoshinobu; Foley, David P; Bartorelli, Antonio L; Stella, Pieter R; de Winter, Robbert J; Wykrzykowska, Joanna J

    2014-03-01

    We evaluated differences in clinical outcomes between patients who underwent final kissing balloon inflation (FKBI) and patients who did not undergo FKBI in bifurcation treatment using the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina, USA). Clinical outcomes were defined as target vessel failure (composite of cardiac death, any myocardial infarction and clinically indicated target vessel revascularisation), cardiac death, myocardial infarction (MI), clinically indicated target vessel revascularisation and stent thrombosis. Cumulative event rates were estimated using the Kaplan-Meier method. A multivariable logistic regression analysis was performed to evaluate which factors were potentially associated with FKBI performance. Follow-up data was available in 717 (96%) patients with a median follow-up of 190 days. Cardiac death at 1 year occurred more often in the no-FKBI group (1.7% vs 4.6%, respectively, p=0.017), although this difference was no longer observed after excluding patients presenting with ST segment elevation MI (1.6% vs 3.3%, p=0.133). No significant differences were observed concerning the other clinical outcomes. One-year target vessel failure rates were 10.1% in the no-FKBI group and 9.2% in the FKBI group (p=0.257). Multivariable logistic regression analysis identified renal dysfunction, ST segment elevation MI as percutaneous coronary intervention indication, narrow (<30°) bifurcation angle and certain stent platforms as being independently associated with unsuccessful FKBI. A lower cardiac death rate was observed in patients in whom FKBI was performed compared with a selection of patients in whom FKBI could not be performed, probably explained by an unbalance in the baseline risk profile of the patients. No differences were observed regarding the other clinical outcomes.

  11. Percutaenous mitral valve: A non-stented coronary sinus device for the treatment of functional mitral regurgitation in heart failure patients.

    Science.gov (United States)

    Sack, Stefan; Kahlert, Philipp; Erbel, Raimund

    2009-01-01

    Functional mitral regurgitation in heart failure limits survival in a severity-graded fashion. Even mild mitral regurgitation doubles mortality risk. We report the use of a non-stented coronary sinus device to reduce mitral annulus dimension in order to re-establish mitral valve competence. The device (PTMA, Viacor, Inc., Wilmington, MA, USA) consists of a multi-lumen PTFE (Teflon) PTMA catheter in which Nitinol (nickel-titanium alloy) treatment rods are advanced. For individual use up to three rods of different length and stiffness can be used. Therefore dimension reduction can be performed in an incremental fashion. Fluoroscopy and 3 D echocardiography are performed throughout the procedure to visiualize the positioning and confirm maximum treatment effect. The case describes the use and the effect of PTMA treatment. Safety and efficacy of the PTMA device will be investigated in the upcoming PTOLEMY 2 trial.

  12. Stent implantation and vascular healing of a spontaneous coronary artery dissection assessed by optical coherence tomography in a patient with acute coronary syndrome

    DEFF Research Database (Denmark)

    Hansen, Kirstine Nørregaard; Antonsen, Lisbeth; Jensen, Lisette Okkels

    2018-01-01

    A 60-year old woman with non-ST-segment elevation myocardial infarction, underwent coronary angiogram combined with optical coherence tomography (OCT) revealing a long dissection in the right coronary artery. The patient experienced peri-procedural chest pain, the electrocardiogram showed ST...

  13. 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.

  14. Predictive factors for in-stent late loss and coronary lesion progression in patients with type 2 diabetes mellitus randomized to rosiglitazone or placebo.

    Science.gov (United States)

    Finn, Aloke V; Oh, Jae S; Hendricks, Michael; Daher, Maureen; Cagliero, Enrico; Byrne, Raphael M; Nadelson, Jeffrey; Crimins, Johanna; Kastrati, Adnan; Schömig, Albert; Bruskina, Olga; Palacios, Igor; John, Michael C; Gold, Herman K

    2009-02-01

    Type 2 diabetics (DM2) are at increased risk for restenosis as well as nonculprit coronary artery lesion (NCCL) progression. Rosiglitazone (RSG) favorably modifies many of the altered biologic processes in DM2, although recent reports have questioned its safety. We conducted a double-blind randomized trial to assess the effects of RSG versus placebo on in-stent late lumen loss (LL) and angiographic progression of NCCL. A total of 65 DM2 were randomized to RSG (4 mg/d) (n = 32) or placebo (n = 33) at the time of stenting and underwent clinical and laboratory analysis at 1 and 4 months and 8-month angiography (n = 46 patients). Rapid angiographic progression (RAP) was defined as > or =20% diameter reduction of preexisting NCCL by quantitative coronary angiography, or a new narrowing > or =30%. Mean LL in RSG (n = 33 lesions) was not different from that of placebo (0.62 +/- 0.59 vs 0.70 +/- 0.67, P = NS). Seven (13.5%) of 52 NCCLs have RAP in RSG versus 9 (16.1%) of 56 in placebo (P = NS). High-sensitivity C-reactive protein (hs-CRP) was the only predictor of RAP. Patients with a 120-day hs-CRP > or =75th percentile had an OR of 7.35 (95% CI 2.35-23) for RAP versus those below. Although RSG treatment also lowered log (hs-CRP) at 4 months (RSG 0.10 +/- 0.37 vs placebo 0.26 +/- 0.49, P = .06), it did not decrease the likelihood of plaque progression while also raising LDL and N-terminal brain naturetic peptide. Rosiglitazone appears not to lower LL or reduce angiographic progression of NCCL in DM2 and had complex effects on markers of cardiac risk.

  15. Late thrombosis after double versus single drug-eluting stent in the treatment of coronary bifurcations: a meta-analysis of randomized and observational Studies.

    Science.gov (United States)

    Zimarino, Marco; Corazzini, Alessandro; Ricci, Fabrizio; Di Nicola, Marta; De Caterina, Raffaele

    2013-07-01

    This study sought to hypothesize that the higher risk of myocardial infarction (MI) documented after a routine double drug-eluting stent (DES) strategy (DDS) compared with a single DES strategy (SDS) with provisional stenting in percutaneous coronary interventions (PCI) of bifurcation lesions is driven by an increased rate of DES thrombosis. The results of currently available randomized, controlled trials (RCTs) were inconclusive in the choice between SDS and DDS. Meta-analyses have shown an increased risk of MI in the DDS group, without identifying the underlying mechanism(s). We performed a meta-analysis of 12 major (>100 patients) studies of bifurcation DES PCI: 5 RCTs and 7 nonrandomized observational studies, for a total of 6,961 patients. Random-effects models were used to calculate summary risk ratios (RRs). As a primary endpoint, we assessed the RRs and 95% confidence intervals (CIs) of definite DES thrombosis; death, MI, and target vessel revascularization (TVR) were evaluated as secondary endpoints. Compared with SDS, DDS had an increased risk of DES thrombosis (RR: 2.31; 95% CI: 1.33 to 4.03) and MI (RR: 1.86; 95% CI: 1.34 to 2.60). Mortality (RR: 1.18; 95% CI: 0.85 to 1.65) and TVR (RR: 1.02; 95% CI: 0.80 to 1.30) were similar. The RRs of MI and DES thrombosis were associated (p = 0.040). In PCI of coronary bifurcations, SDS should be the preferred approach, as DDS is associated with an increased risk of MI, likely driven by DES thrombosis. Copyright © 2013. Published by Elsevier Inc.

  16. Final kissing balloon inflation for coronary bifurcation lesions treated with single-stent technique : A meta-analysis.

    Science.gov (United States)

    Liu, G; Ke, X; Huang, Z-B; Wang, L-C; Huang, Z-N; Guo, Y; Long, M; Liao, X-X

    2017-11-27

    The efficacy of final kissing balloon (FKB) inflation in one-stent techniques for bifurcation lesions is controversial. The goal of the present study was to investigate the impact of FKB on long-term clinical outcomes in one-stent strategies. A literature search of the PubMed, Embase, and Cochrane Library databases was undertaken through August 2017. The primary outcome was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization. Overall hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using the random-effects model. Ten studies comprising 7364 patients treated with a one-stent technique were included in the analysis. Overall, FKB did not demonstrate a significant reduction in MACE compared with non-FKB in both randomized trials (HR: 1.13; 95% CI: 0.65-1.98) and observational studies (HR: 0.86; 95% CI: 0.61-1.20). The risk of cardiac death (HR: 0.89; 95% CI: 0.53-1.49), myocardial infarction (HR: 0.76; 95% CI: 0.53-1.09), and target lesion revascularization (HR: 0.96; 95% CI: 0.74-1.23) was also similar in both groups. FKB may not be mandatory and a selective FKB strategy might be more justified in one-stent techniques for bifurcation lesions.

  17. Off-label use of coronary drug-eluting stents : Occurrence, safety, and effectiveness in 'real world' clinical practice

    NARCIS (Netherlands)

    Roszek BR; de Water R; Pot JWGA; van Domburg RT; Geertsma RE; BMT; vgc

    2012-01-01

    Het gebruik van drug-eluting stents (DES) voor een ander doel dan het indicatiegebied (off-label gebruik), kan leiden tot een belasting van deze hulpmiddelen buiten de grenzen van het ontwerp en mogelijk tot verhoogde risico's. Anderzijds kan een dergelijke behandelmethode klinisch relevant zijn,

  18. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) : Angiographic Results and 1-Year Clinical Outcomes

    NARCIS (Netherlands)

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco|info:eu-repo/dai/nl/34169276X; Cornelis, Kristoff; Janssens, Luc P F; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter|info:eu-repo/dai/nl/304814717

    2017-01-01

    Objectives The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Background Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR

  19. 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

    ): cardiac death, myocardial infarction (MI), stent thrombosis, or target vessel revascularisation within 18 months. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for the endpoints. At 18-month follow-up, patients with ACS had higher rates of MACE compared to patients with SAP (8...

  20. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients.

    Science.gov (United States)

    Lupi, Alessandro; Rognoni, Andrea; Secco, Gioel Gabrio; Lazzero, Maurizio; Nardi, Federico; Fattori, Rossella; Bongo, Angelo Sante; Agostoni, Pierfrancesco; Sheiban, Imad

    2014-04-01

    Biodegradable polymer drug eluting stents (BP-DES) have been developed to overcome the limitations of first generation durable polymer DES (DP-DES) but the clinical results of different BP-DES are not consistent. We performed a meta-analysis to compare the outcomes of BP-DES and DP-DES in the treatment of coronary artery disease (CAD). Online databases including MEDLINE were searched for studies comparing BP-DES and DP-DES for obstructive CAD that reported rates for overall mortality, myocardial infarction (MI), late stent thrombosis (LST), target lesion revascularization (TLR) and late lumen loss (LLL) with a follow-up of ≥ 6 months. Ten studies (5834 patients) with a 1-year median follow-up were included in the meta-analysis. When comparing patients treated with DP-DES and BP-DES those treated with BP-DES had lower LLL (in-stent: weighted mean difference (WMD) -0.10 mm, 95% CI = -0.17 to -0.03 mm, p = 0.004; in-segment: WMD -0.06 mm, 95% CI = -0.10 to -0.01 mm, p = 0.01) with lower TLR rates (OR 0.67, 95% CI = 0.47 to 0.98, p = 0.04). However, BP-DES did not improve mortality (OR 0.97, 95% CI = 0.73 to 1.29, p = 0.83), MI (OR 1.13, 95% CI = 0.87 to 1.46, p = 0.36) or LST rates (OR 0.64, 95% CI = 0.36 to 1.16, p = 0.14). A pre-specified subgroup analysis of Biolimus BP-DES confirmed significant LLL reduction without differences in other clinical endpoints. Meta-regression analysis demonstrated a strong significant inverse correlation between LLL and reference coronary diameter (p meta-analysis showed that BP-DES when compared with DP-DES significantly reduced LLL and TVR but without clear benefits on mortality, MI and LST rates. (Clinicaltrials.gov identifier: NCT01466634).

  1. The optimal discontinuation of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention with drug-eluting stents: A meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Wei; Liu, Jing; Fang, Jingxue; Liu, Yang; An, Tong; Zou, Meijuan; Cheng, Gang

    2017-05-15

    Current guidelines recommend prolonged dual antiplatelet therapy (DAPT) for patients with drug-eluting stents (DES) implantation. Nevertheless, optimal discontinuation of DAPT remains a controversy. We performed a meta-analysis of all randomized controlled trials (RCTs) that evaluate optimal discontinuation of DAPT in patients undergoing percutaneous coronary intervention (PCI) with DES. We searched electronic databases including PubMed, Cochrane Library, EMBASE and ClinicalTrials.gov from database RCTs that reported different modes of discontinuation of DAPT in patients with DES. The primary endpoints were all-cause death, cardiovascular death, myocardial infarction (MI) and probably or definite stent thrombosis (ST). Secondary endpoints were repeat revascularization, stroke, major bleeding and net adverse clinical events (NACE). We included 13 RCTs meeting the criteria with a total of 36,749 patients. No significant difference was observed in all-cause death (RR [95% CI]=0.87 [0.75, 1.01], P=0.07, I 2 =0%), cardiovascular death (RR [95% CI]=0.97 [0.79, 1.19], P=0.76, I 2 =0%), repeat revascularization (RR [95% CI]=1.07 [0.92, 1.25], P=0.36, I 2 =0%), and stroke (RR [95% CI]=1.01 [0.80, 1.28], P=0.94, I 2 =0%). Compared with shorter DAPT, longer DAPT was associated with a significant reduction in MI (RR [95% CI]=1.46 [1.26, 1.69], PDES implantation (RR [95% CI]=2.58 [1.85, 3.58], I 2 =0%) and everolimus-eluting stents (EES, RR [95% CI]=1.54 [1.12, 2.11], I 2 =0%). Conversely, there was no difference in thrombotic events in patients with zotarolimus-eluting stents (ZES, RR [95% CI]=1.17 [0.83, 1.63], I 2 =75%) and biodegradable polymer DES (BP-DES, RR [95% CI]=1.15 [0.74, 1.79]). 1) Compared with shorter DAPT, longer DAPT was associated with a significant reduction in thrombotic events (MI and ST) and a higher rate of major bleeding. 2) By the assessment of the trade-off between thrombotic and hemorrhagic events, shorter DAPT was non-inferior to longer DAPT. 3) The

  2. Axillary artery to left anterior descending coronary artery bypass with an externally stented graft: a technical report

    Directory of Open Access Journals (Sweden)

    Salvador Loris

    2008-02-01

    Full Text Available Abstract With the proliferation of minimally invasive cardiac surgery a number of alternative inflow sites for coronary artery bypass grafting have been utilized, especially in higher risk patients. The use of axillary-coronary artery bypass is a safe and effective alternative especially in the case of patients requiring redo coronary revascularization. However, the length and convoluted course of the axillary-coronary vein graft makes is susceptible to twisting, trauma and neointimal hyperplasia. We therefore report a case of an axillary-coronary artery bypass in a high risk patient in which a Dacron conduit was used to externally support and protect the vein graft to the left anterior descending artery. Surgical technique and considerations are presented and discussed.

  3. A quantitative coronary angiography-matched comparison between a prospective randomised multicentre cutting balloon angioplasty and bare metal stent trial (REDUCE III) and the Rapamycin-Eluting Stent Evaluation At Rotterdam Cardiology Hospital (RESEARCH) study.

    Science.gov (United States)

    Ozaki, Yukio; Lemos, Pedro A; Yamaguchi, Tetsu; Suzuki, Takahiko; Nakamura, Masato; Ismail, Tevfik F; Kitayama, Michihiko; Nishikawa, Hideo; Kato, Osamu; Serruys, Patrick W

    2010-08-01

    There remains significant concern about the long-term safety of drug-eluting stents (DES). However, bare metal stents (BMS) have been used safely for over two decades. There is therefore a pressing need to explore alternative strategies for reducing restenosis with BMS. This study was designed to examine whether IVUS-guided cutting balloon angioplasty (CBA) with BMS could convey similar restenosis rates to DES. In the randomised REstenosis reDUction by Cutting balloon angioplasty Evaluation (REDUCE III) study, 521 patients were divided into four groups based on device and IVUS use before BMS (IVUS-CBA-BMS: 137 patients; Angio-CBA-BMS: 123; IVUS-BA-BMS: 142; and Angio-BA-BMS: 119). At follow-up, the IVUS-CBA-BMS group had a significantly lower restenosis rate (6.6%) than the other groups (p=0.016). We performed a quantitative coronary angiography (QCA) based matched comparison between an IVUS-guided CBA-BMS strategy (REDUCE III) and a DES strategy (Rapamycin-Eluting-Stent Evaluation At Rotterdam Cardiology Hospital, the RESEARCH study). We matched the presence of diabetes, vessel size, and lesion severity by QCA. Restenosis (>50% diameter stenosis at follow-up) and target vessel revascularisation (TVR) were examined. QCA-matched comparison resulted in 120-paired lesions. While acute gain was significantly greater in IVUS-CBA-BMS than DES (1.65±0.41 mm vs. 1.28±0.57 mm, p=0.001), late loss was significantly less with DES than with IVUS-CBA-BMS (0.03±0.42 mm vs. 0.80±0.47 mm, p=0.001). However, no difference was found in restenosis rates (IVUS-CBA-BMS: 6.6% vs. DES: 5.0%, p=0.582) and TVR (6.6% and 6.6%, respectively). An IVUS-guided CBA-BMS strategy yielded restenosis rates similar to those achieved by DES and provided an effective alternative to the use of DES.

  4. Very late bare-metal stent thrombosis, rare but stormy!

    LENUS (Irish Health Repository)

    Ali, Mohammed

    2011-08-01

    Recurrent in-stent thrombosis is rarely reported, with catastrophic clinical consequences of either acute coronary syndrome or death. We present a case of recurrent in-stent thrombosis with its outcome and a concise literature review.

  5. Clinical outcomes after treatment of multiple lesions with zotarolimus-eluting versus sirolimus-eluting coronary stents (a SORT OUT III substudy)

    DEFF Research Database (Denmark)

    Thim, Troels; Maeng, Michael; Lassen, Jens Flensted

    2012-01-01

    Data on clinical outcomes among patients treated with the zotarolimus-eluting Endeavor™ stent versus the sirolimus-eluting Cypher™ stent favor the sirolimus-eluting stent. However, a separate comparison of clinical outcome among patients treated for multiple lesions with these stents is lacking. We...

  6. 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

    ultrasound (IVUS). RESULTS: By histomorphometry, lumen (median (quartiles); AMS: 1.75 mm2 (1.07-3.26), Cypher 2.52 mm2 (2.22-5.01), BMS 4.55 mm2 (3.2-7.44); p = 0.013) and external elastic membrane area (AMS: 5.56 mm2 (4.09-6.95), Cypher 7.95 mm2 (6.45-10.92), BMS 9.08 mm2 (7.85-11.63); p = 0.014) were...... smallest after AMS implantation. By IVUS, external elastic membrane area at follow-up was smallest (AMS: 7.5 (2.8) mm2, Cypher 9.1 (2.7) mm2, BMS 9.9 (3.1) mm2; p = 0.33) and change in external elastic membrane area from index intervention to follow-up (remodelling; AMS: -1.0 (3.1) mm2, Cypher 1.0 (0.8) mm......2, BMS 0.9 (1.2) mm2; p = 0.30) was greatest in the AMS group. In a dichotomised IVUS assessment of vascular remodelling, six AMS stents were remodelled (negative remodelling: n = 5; positive remodelling: n = 1) at 90-day follow-up (AMS versus Cypher + BMS: p = 0.001). Neointima formation...

  7. 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.

  8. 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

  9. 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...... after third-generation biolimus-eluting stent implantation....

  10. Comparison of a Drug‐Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3‐Year Follow‐Up

    OpenAIRE

    Yahagi, Kazuyuki; Yang, Yi; Torii, Sho; Mensah, Johanne; White, Roseann M.; Mathieu, Marion; Pacheco, Erica; Nakano, Masataka; Barakat, Abdul; Sharkawi, Tahmer; Vert, Michel; Joner, Michael; Finn, Aloke V.; Virmani, Renu; Lafont, Antoine

    2017-01-01

    Background Arterial Remodeling Technologies bioresorbable scaffold (ART‐BRS), composed of l‐ and d‐lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long‐term performance remains unknown. The aim of this study was to evaluate the ART‐BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years. Methods and Results Eighty‐two ART‐BRS and 66 BMS were implanted in 64 Yucatan swine, and animals were euthanatized at ...

  11. Comparison of a Drug-Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3-Year Follow-Up.

    Science.gov (United States)

    Yahagi, Kazuyuki; Yang, Yi; Torii, Sho; Mensah, Johanne; White, Roseann M; Mathieu, Marion; Pacheco, Erica; Nakano, Masataka; Barakat, Abdul; Sharkawi, Tahmer; Vert, Michel; Joner, Michael; Finn, Aloke V; Virmani, Renu; Lafont, Antoine

    2017-06-09

    Arterial Remodeling Technologies bioresorbable scaffold (ART-BRS), composed of l- and d-lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long-term performance remains unknown. The aim of this study was to evaluate the ART-BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years. Eighty-two ART-BRS and 66 BMS were implanted in 64 Yucatan swine, and animals were euthanatized at intervals of 1, 3, 6, 9, 12, 18, 24, and 36 months to determine the vascular response using quantitative coronary angiography, optical coherence tomography, light and scanning electron microscopy, and molecular weight analysis. Lumen enlargement was observed in ART-BRS as early as 3 months, which progressively increased up to 18 months, whereas BMS showed no significant difference over time. Percentage area stenosis by optical coherence tomography was greater in ART-BRS than in BMS at 1 and 3 months, but this relationship reversed beyond 3 months. Inflammation peaked at 6 months and thereafter continued to decrease up to 36 months. Complete re-endothelialization was observed at 1 month following implantation in both ART-BRS and BMS. Scaffold dismantling started at 3 months, which allowed early vessel enlargement, and bioresorption was complete by 24 months. ART-BRS has the unique quality of early programmed dismantling accompanied by vessel lumen enlargement with mild to moderate inflammation. The main distinguishing feature of the ART-BRS from other scaffolds made from poly-l-lactic acid may result in early and long-term vascular restoration. © 2017 The Authors and Arterial Remodeling Technologies. Published on behalf of the American Heart Association, Inc., by Wiley.

  12. Final results of a self-apposing paclitaxel-eluting stent fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries study

    DEFF Research Database (Denmark)

    Naber, Christoph K; Pyxaras, Stylianos A; Nef, Holger

    2016-01-01

    AIMS: We aimed to evaluate the long-term safety and efficacy of the STENTYS self-apposing paclitaxeleluting stent (STENTYS-PES) in bifurcation lesions in routine clinical practice. METHODS AND RESULTS: The primary endpoint of the study was the composite major adverse cardiac events (MACE: cardiac...... (13.0%). CONCLUSIONS: The long-term results of OPEN II show that the STENTYS-PES is safe and effective in the treatment of all-comers with coronary bifurcation lesions....

  13. Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter "real-world" registry

    OpenAIRE

    Imori, Yoichi; D'Ascenzo, Fabrizio; Gori, Tommaso; Münzel, Thomas; Fabrizio, Ugo; Campo, Gianluca; Cerrato, Enrico; Napp, L Christian; Iannaccone, Mario; Ghadri, Jelena R; Kazemian, Elycia; Binder, Ronald K; Jaguszewski, Milosz; Csordas, Adam; Capasso, Piera

    2016-01-01

    BACKGROUND: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. METHODS: Consecutive ACS patients undergoing BRS implantation in 8 centers were com-pared with those with EES before and after prope...

  14. 5A/6A Polymorphism of the Stromelysin-1 Gene and Angiographic Restenosis After Coronary Artery Stenting

    Directory of Open Access Journals (Sweden)

    Kuan-Rau Chiou

    2005-11-01

    Conclusion: There is a low frequency of the stromelysin-1 promoter 5A allele in the Chinese population in Taiwan. How stromelysin-1 5A/6A polymorphism affects ISR appears to be linked to angina status. These results merit further study to identify patients carrying genotypes which put them at increased risk of ISR, and which matrix metalloproteinase inhibitors or drug-eluting stents are more effective for those at risk.

  15. Optimal conjugation of catechol group onto hyaluronic acid in coronary stent substrate coating for the prevention of restenosis.

    Science.gov (United States)

    Lih, Eugene; Choi, Seul Gi; Ahn, Dong June; Joung, Yoon Ki; Han, Dong Keun

    2016-01-01

    Although endovascular stenting has been used as an interventional therapy to treat cardio- and cerebro-vascular diseases, it is associated with recurrent vascular diseases following stent thrombosis and in-stent restenosis. In this study, a metallic stent was coated with dopamine-conjugated hyaluronic acid with different ratios of catechol group to improve hemocompatibility and re-endothelialization. Especially, we were interested in how much amount of catechol group is appropriate for the above-mentioned purposes. Therefore, a series of dopamine-conjugated hyaluronic acid conjugates with different ratios of catechol group were synthesized via a carbodiimide coupling reaction. Dopamine-conjugated hyaluronic acid conjugates were characterized with 1 H-nuclear magnetic resonance and Fourier transform infrared spectroscopy, and the amount of catechol group in dopamine-conjugated hyaluronic acid was measured by ultraviolet spectrometer. Co-Cr substrates were polished and coated with various dopamine-conjugated hyaluronic acid conjugates under pH 8.5. Dopamine-conjugated hyaluronic acid amounts on the substrate were quantified by micro-bicinchoninic acid assay. Surface characteristics of dopamine-conjugated hyaluronic-acid-coated Co-Cr were evaluated by water contact angle, scanning electron microscopy, and atomic force microscopy. The hemocompatibility of the surface-modified substrates was assessed by protein adsorption and platelet adhesion tests. Adhesion and activation of platelets were confirmed with scanning electron microscopy and lactate dehydrogenase assay. Human umbilical vein endothelial cells were cultured on the substrates, and the viability, adhesion, and proliferation were investigated through cell counting kit-8 assay and fluorescent images. Obtained results demonstrated that optimal amounts of catechol group (100 µmol) in the dopamine-conjugated hyaluronic acid existed in terms of various properties such as hemocompatibility and cellular responses.

  16. 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

    NARCIS (Netherlands)

    Lemmert, M.E.; Oldroyd, K.; Barragan, P.; Lesiak, M.; Byrne, R.A.; Merkulov, E.; Daemen, J.; Onuma, Y.; Witberg, K.; Geuns, R.J.M. van

    2017-01-01

    BACKGROUND: 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

  17. Stent thrombosis and adverse cardiovascular outcomes observed between six months and five years with sirolimus-eluting stents and other drug-eluting stents in patients with Type 2 diabetes mellitus complicated by coronary artery disease

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Soogund, M. Zafooruddin Sani; Pursun, Manish; Chen, Meng-Hua

    2016-01-01

    Abstract This study aimed to compare 6 months to 5 years stent thrombosis (ST) and adverse cardiovascular outcomes associated with sirolimus-eluting stents (SES) and other drug-eluting stents (DES) in patients with type 2 diabetes mellitus (T2DM). Electronic databases were searched for studies comparing SES with other DES in patients with T2DM. Total ST, definite ST, probable ST, and other adverse cardiovascular outcomes reported between 6 months and 5 years were considered as the clinical end points in this study. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for categorical variables and the pooled analyses were performed with RevMan 5.3 software. Twenty-nine studies involving a total number of 25,729 patients with diabetes were included in this meta-analysis. SES were not associated with significantly higher total, definite, and probable STs with OR: 0.95, 95% CI: 0.77–1.17, P = 0.62; OR: 0.94, 95% CI: 0.65–1.37, P = 0.76; and OR: 1.05, 95% CI: 0.77–1.45, P = 0.74, respectively. SES were also noninferior to the other non-sirolimus eluting drug eluting stents (non-SE DES) in terms of all-cause mortality, cardiac death, myocardial infarction, and stroke with OR: 0.92, 95% CI: 0.82–1.03, P = 0.16; OR: 1.09, 95% CI: 0.88–1.35, P = 0.44; OR: 0.92, 95% CI: 0.80–1.06, P = 0.26; and OR: 0.79, 95% CI: 0.49–1.28, P = 0.43, respectively. Target vessel revascularization, target lesion revascularization, and major adverse cardiac events were also similarly reported between SES and non-SE DES with OR: 1.04, 95% CI: 0.83–1.31, P = 0.72; OR: 1.25, 95% CI: 0.95–1.64, P = 0.11; and OR: 1.06, 95% CI: 0.90–1.25, P = 0.49, respectively. During this particular follow-up period, SES were not associated with any increase in ST among these patients with T2DM. Mortality and other adverse cardiovascular outcomes were also not significantly different between these 2 groups. Hence, SES should be considered neither superior nor inferior to other

  18. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette Okkels; Galloe, Anders Michael

    2008-01-01

    The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients...... stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel...

  19. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease.

    Science.gov (United States)

    Costopoulos, Charis; Latib, Azeem; Naganuma, Toru; Sticchi, Alessandro; Figini, Filippo; Basavarajaiah, Sandeep; Carlino, Mauro; Chieffo, Alaide; Montorfano, Matteo; Naim, Charbel; Kawaguchi, Masanori; Giannini, Francesco; Colombo, Antonio

    2013-11-01

    This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm). The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited. We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone. A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84). DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Does intravascular ultrasound provide clinical benefits for percutaneous coronary intervention with bare-metal stent implantation? A meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Lodi-Junqueira Lucas

    2012-09-01

    Full Text Available Abstract Background The role of intravascular ultrasound (IVUS in percutaneous coronary interventions (PCI is still controversial despite several previously published meta-analyses. A meta-analysis to evaluate the controversial role of IVUS-guided PCI with bare-metal stenting was performed and a previous published meta-analysis was re-evaluated in order to clarify the discrepancy between results of these studies. Methods A systematic review was performed by an electronic search of the PubMed, Embase and Web of Knowledge databases and by a manual search of reference lists for randomized controlled trials published until April 2011, with clinical outcomes and, at least, six months of clinical follow-up. A meta-analysis based on the intention to treat was performed with the selected studies. Results Five studies and 1,754 patients were included. There were no differences in death (OR = 1.86; 95% CI = 0.88-3.95; p = 0.10, non-fatal myocardial infarction (OR = 0.65; 95% CI = 0.27-1.58; p = 0.35 and major adverse cardiac events (OR = 0.74; 95% CI = 0.49-1.13; p = 0.16. An analysis of the previous published meta-analysis strongly suggested the presence of publication bias. Conclusions There is no evidence to recommend routine IVUS-guided PCI with bare-metal stent implantation. This may be explained by the paucity and heterogeneity of the studies published so far.

  1. Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis.

    Science.gov (United States)

    Nairooz, Ramez; Saad, Marwan; Sardar, Partha; Aronow, Wilbert S

    2017-07-01

    Data regarding long-term clinical outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) versus second-generation drug-eluting stents (DES) are scarce. We searched online databases until October 2016 for studies comparing BVS versus DES reporting outcomes at 2 years of follow-up. We performed a meta-analysis comparing BVS with DES across the spectrum of coronary artery disease (CAD). Random effects model OR was calculated for outcomes of interest including device-oriented composite events (DOCE; defined as composite of cardiac mortality, target vessel myocardial infarction (TV-MI), and ischaemia-driven target lesion revascularisation (TLR)), all-cause mortality, definite stent thrombosis, TV-MI and TLR. A total of 2360 patients enrolled in five studies met criteria for inclusion in this analysis. At 2 years, BVS was associated with higher rates of DOCE (6.9% vs 4.5%, OR=1.53; 95% CI 1.06 to 2.23; p=0.02), absolute risk increase (ARI) 2.4%, relative risk increase (RRI) 53%, TV-MI (4% vs 1.8%, OR=1.94; 95% CI 1.02 to 3.67; p=0.04), ARI 2.2%, RRI 122% and definite stent thrombosis (2.1% vs 0.6%, OR=3.39; 95% CI 1.46 to 7.88; p=0.005), ARI 1.5%, RRI 250% compared with DES. No differences in all-cause mortality (OR=0.86; 95% CI 0.26 to 2.81; p=0.80) and TLR (OR=1.44; 95% CI 0.81 to 2.54; p=0.21) were observed between both groups. BVS may be associated with worse long-term clinical outcomes compared with DES. Randomised clinical trials are encouraged to expeditiously report long-term safety and efficacy outcomes and identify predictors of adverse events with BVS compared with DES. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study

    DEFF Research Database (Denmark)

    Behan, Miles W; Holm, Niels R; Curzen, Nicholas P

    2011-01-01

    Background— Controversy persists regarding the correct strategy for bifurcation lesions. Therefore, we combined the patient-level data from 2 large trials with similar methodology: the NORDIC Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study (BBC ONE). Methods and Results— B...

  3. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial

    DEFF Research Database (Denmark)

    Galløe, Anders M; Thuesen, Leif; Kelbaek, Henning

    2008-01-01

    Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.......Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients....

  4. Safety and efficacy of a second-generation coronary sirolimus-eluting stent with biodegradable polymers in daily clinical practice: a 12-month follow-up of the ALEX registry.

    Science.gov (United States)

    Hawranek, Michał; Desperak, Piotr; Ciślak, Aneta; Gąsior, Paweł; Gierlotka, Marek; Wąs, Tomasz; Chodór, Piotr; Kowalczyk, Jacek; Lekston, Andrzej; Gąsior, Mariusz

    2016-03-01

    Second-generation drug-eluting stents (DESs) have shown higher safety and efficacy compared with first-generation DESs. This effect was achieved by improving biocompatibility using an interalia cobalt-chromium construction, thinner stent struts and biodegradable polymers. To assess clinical and angiographic outcomes of patients receiving a novel second-generation cobalt-chromium sirolimus-eluting stent. A total of 424 consecutive patients who received an Alex stent were enrolled in the registry from January to December 2012. The primary outcome measure was the occurrence of 12-month major cardiac adverse events, defined as cases of death, nonfatal myocardial infarction and target lesion revascularization. Quantitative coronary angiography for 240 randomly selected patients was performed by an independent Corelab. The primary endpoint occurred in 31 of 424 patients (7.3%). The rates of death, nonfatal myocardial infarction and target lesion revascularization were 3.3, 2.6 and 3.5%, respectively. According to the definition established by the Academic Research Foundation, definitive and probable stent thrombosis (ST) occurred in 1.6% (7/424) of patients, including six cases of early ST and one case of late ST. The acute device success rate was 98.5%. The ALEX Registry provides evidence for the safety and effectiveness of the study device in a relevant population. Quantitative analysis showed a satisfactory performance of the study device for complex coronary lesions. The 12-month rates of major cardiac adverse event and ST were similar to those of other second-generation DES registries.

  5. Therapies targeting inflammation after stent implantation.

    Science.gov (United States)

    Okura, Hiroyuki; Takagi, Tsutomu; Yoshida, Kiyoshi

    2013-07-01

    Since the introduction of coronary vessel scaffold by metallic stent, percutaneous coronary intervention has become widely performed all over the world. Although drug-eluting stent technology has further decrease the incidence of in-stent restenosis, there still remaining issues related to stent implantation. Vessel inflammation is one of the causes that may be related to stent restenosis as well as stent thrombosis. Therefore, systemic therapies targeting inflammation emerged as adjunctive pharmacological intervention to improve outcome. Statins, corticosteroids, antiplatelets, and immunosuppresive or anti-cancer drugs are reported to favorably impact outcome after bare-metal stent implantation. In type 2 diabetic patients, pioglitazone may be the most promising drug that can lower neointimal proliferation and, as a result, lower incidence of restenosis and target lesion revascularization. On the other hand, several new stent platforms that might decrease inflammatory response after drug-eluting stent implantation have been introduced. Because durable polymer used in the first generation drug-eluting stents are recognized to be responsible for unfavorable vessel response, biocompatible or bioabsorbable polymer has been introduce and already used clinically. Furthermore, polymer-free drug-eluting stent and bioresorbable scaffold are under investigation. Although vessel inflammation may be reduced by using these new drug-eluting stents or scaffold, long-term impact needs to be investigated further.

  6. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

    DEFF Research Database (Denmark)

    Galløe, Anders M.; Kelbæk, Henning; Thuesen, Leif

    2017-01-01

    of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention. METHODS: A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES...

  7. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials.

    Science.gov (United States)

    Gao, Zhan; Zhang, Ruiyan; Xu, Bo; Yang, Yuejin; Ma, Changsheng; Li, Hui; Chen, Shaoliang; Han, Yaling; Yuan, Zuyi; Lansky, Alexandra J; Guan, Changdong; Leon, Martin B; Gao, Runlin

    2015-03-01

    We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients. Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2-year follow-up. The 12-month rate of TLF in 1,003 patients (follow-up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P < 0.0001). The 24-month rates of TLF, PoCE (a composite of all-cause death, all MI, or any revascularization), and ARC definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (≥ 30 mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P < 0.01). This pooled, patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile. © 2015 Wiley Periodicals, Inc.

  8. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials.

    Science.gov (United States)

    Sotomi, Yohei; Onuma, Yoshinobu; Cavalcante, Rafael; Ahn, Jung-Min; Lee, Cheol Whan; van Klaveren, David; de Winter, Robbert J; Wykrzykowska, Joanna J; Farooq, Vasim; Morice, Marie-Claude; Steyerberg, Ewout W; Park, Seung-Jung; Serruys, Patrick W

    2017-05-01

    The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations. To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death ( I 2 >50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio (percutaneous coronary intervention) 2.213; 95% confidence interval, 1.242-3.943; P =0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial ( P interaction =0.019) but not in the Asian trials (PRECOMBAT P interaction =0.469 and BEST P interaction =0.472; I 2 =58%). The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be

  9. Quality assurance of high-dose i.v. heparin treatment exemplified by patients implanted with coronary Palmaz-Schatz stents.

    Science.gov (United States)

    Haushofer, A; Halbmayer, W M; Prachar, H; Fischer, M

    1995-04-01

    The need to standardize treatment with high-dose IV standard heparin by using activated partial thromboplastin time (APTT) reagents tested for their heparin sensitivity and by establishing a standard treatment schedule led to the development of the "Lainz concept" of heparin management. The determination of heparin sensitivity of the 2 APTT reagents used (APTT Micronized Silica and APTT Actin FSL), their good agreement (r = .9977; P = .000), and their therapeutic APTT ratio of 1.5-2.5 fold of baseline APTT (therapeutic range, forty-five to seventy-five seconds) equivalent to 0.3-0.7 antifactor Xa units are presented. The "Lainz concept" was tested in 29 patients receiving high-dose heparin after coronary artery stenting. A mean dose of 1,273 U of standard heparin/hour (15.7 U/kg body weight/hour) was shown to produce APTTs in the therapeutic range. From the introduction of the "Lainz concept" 81% of the APTTs were kept within the therapeutic range by using a defined heparin-monitoring schedule based on a guideline protocol for controlling heparin treatment. Only 19% of the APTTs were below the therapeutic range. Factors underlying subtherapeutic APTTs are discussed. The reduction in the rate of subtherapeutic APTTs to less than 3% seen after the introduction of the "Lainz concept" constitutes an important contribution toward quality assurance in high-dose heparin treatment.

  10. Comparison of drug-eluting balloon versus drug-eluting stent for treatment of coronary artery disease: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Liu, Lulu; Liu, Bin; Ren, Jiajun; Hui, Gang; Qi, Chao; Wang, Junnan

    2018-03-02

    Drug-eluting balloons (DEB) have significant value for treating coronary artery disease (CAD). However, the merits of using DEB versus drug-eluting stents (DES) to treat CAD remain controversial. Herein, we conducted a meta-analysis to compare the safety and efficacy of DEB and DES for treatment of CAD. We searched MEDLINE, EMBASE, and CENTRAL databases for eligible trials comparing DEB with DES for treatment of CAD. The primary endpoint was major adverse cardiac events (MACE); the secondary endpoints included in-lesion late lumen loss (LLL), binary restenosis (BR), myocardial infarction (MI), target lesion revascularization (TLR) and mortality. Twenty-three trials with a total of 2712 patients were included. There were no significant differences in the primary endpoint of MACE between the DEB and DES groups (Risk Ratio (RR) 1.19; 95% confidence interval (CI) (0.87, 1.63); P = 0.27), or in the clinical outcomes of each of MACE's components, including TLR, MI and mortality. However, efficacy was significantly different between the DEB and DES groups, especially when we compared DEB to second-generation DES: in-lesion LLL (Mean Difference (MD) 0.11; (0.01, 0.22); P = 0.03); binary restenosis (RR 1.46; (1.00, 2.13); P = 0.05). DEB is equivalent to DES in terms of safety for managing CAD, and DEB may be considered as an alternative choice for treatment of CAD.

  11. 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

  12. The Relationships between Polymorphisms in Genes Encoding the Growth Factors TGF-β1, PDGFB, EGF, bFGF and VEGF-A and the Restenosis Process in Patients with Stable Coronary Artery Disease Treated with Bare Metal Stent.

    Directory of Open Access Journals (Sweden)

    Tadeusz Osadnik

    Full Text Available Neointima forming after stent implantation consists of vascular smooth muscle cells (VSMCs in 90%. Growth factors TGF-β1, PDGFB, EGF, bFGF and VEGF-A play an important role in VSMC proliferation and migration to the tunica intima after arterial wall injury. The aim of this paper was an analysis of functional polymorphisms in genes encoding TGF-β1, PDGFB, EGF, bFGF and VEGF-A in relation to in-stent restenosis (ISR.265 patients with a stable coronary artery disease (SCAD hospitalized in our center in the years 2007-2011 were included in the study. All patients underwent stent implantation at admission to the hospital and had another coronary angiography performed due to recurrence of the ailments or a positive result of the test assessing the coronary flow reserve. Angiographically significant ISR was defined as stenosis >50% in the stented coronary artery segment. The patients were divided into two groups-with angiographically significant ISR (n = 53 and without significant ISR (n = 212. Additionally, the assessment of late lumen loss (LLL in vessel was performed. EGF rs4444903 polymorphism was genotyped using the PCR-RFLP method whilst rs1800470 (TGFB1, rs2285094 (PDGFB rs308395 (bFGF and rs699947 (VEGF-A were determined using the TaqMan method.Angiographically significant ISR was significantly less frequently observed in the group of patients with the A/A genotype of rs1800470 polymorphism (TGFB1 versus patients with A/G and G/G genotypes. In the multivariable analysis, LLL was significantly lower in patients with the A/A genotype of rs1800470 (TGFB1 versus those with the A/G and G/G genotypes and higher in patients with the A/A genotype of the VEGF-A polymorphism versus the A/C and C/C genotypes. The C/C genotype of rs2285094 (PDGFB was associated with greater LLL compared to C/T heterozygotes and T/T homozygotes.The polymorphisms rs1800470, rs2285094 and rs6999447 of the TGFB1, PDGFB and VEGF-A genes, respectively, are associated with LLL

  13. Comparison of Efficacy and Safety between First and Second Generation Drug-eluting Stents in Patients with Stable Coronary Artery Disease: A Single-center Retrospective Study.

    Science.gov (United States)

    Liu, Ru; Xiong, Fei; Wen, Yuan; Ma, Yuan-Liang; Yao, Yi; Gao, Zhan; Xu, Bo; Yang, Yue-Jin; Qiao, Shu-Bin; Gao, Run-Lin; Yuan, Jin-Qing

    2017-07-20

    Lots of trials demonstrate that second-generation drug-eluting stents (G2-DES), with their improved properties, offer significantly superior efficacy and safety profiles compared to first generation DES (G1-DES) for patients with coronary artery disease (CAD) receiving percutaneous coronary intervention (PCI). This study aimed to verify the advantage of G2-DES over G1-DES in Chinese patients with stable CAD (SCAD). For this retrospective observational analysis, 2709 SCAD patients with either G1-DES (n = 863) or G2-DES (n = 1846) were enrolled consecutively throughout 2013. Propensity score matching (PSM) was applied to control differing baseline factors. Two-year outcomes, including major adverse coronary events as well as individual events, including target vessel-related myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, and cardiogenic death were evaluated. The incidence of revascularization between G1- and G2-DES showed a trend of significant difference with a threshold P - value (8.6% vs. 6.7%, χ2 = 2.995, P = 0.084). G2-DES significantly improved TLR-free survival compared to G1-DES (96.6% vs. 97.9%, P = 0.049) and revascularization-free survival curve showed a trend of improvement of G2-DES (92.0% vs. 93.8%, P = 0.082). These differences diminished after PSM. Multivariate Cox proportional hazard regression analysis showed a trend for G1-associated increase in revascularization (hazard ratio: 1.28, 95% confidence interval: 0.95-1.72, P = 0.099) while no significance was found after PSM. Other endpoints showed no significant differences after multivariate adjustment regardless of PSM. G1-DES showed the same safety as G2-DES in this large Chinese cohort of real-world patients. However, G2-DES improved TLR-free survival of SCAD patients 2 years after PCI. The advantage was influenced by baseline clinical factors. G1-DES was associated with a trend of increase in revascularization risk and was not an independent

  14. Long-Term Percutaneous Coronary Intervention Outcomes of Patients with Chronic Kidney Disease in the Era of Second-Generation Drug-Eluting Stents.

    Science.gov (United States)

    Wańha, Wojciech; Kawecki, Damian; Roleder, Tomasz; Pluta, Aleksandra; Marcinkiewicz, Kamil; Morawiec, Beata; Dola, Janusz; Gładysz, Sylwia; Pawłowski, Tomasz; Smolka, Grzegorz; Ochała, Andrzej; Nowalany-Kozielska, Ewa; Wojakowski, Wojciech

    2017-02-01

    The following registry (Katowice-Zabrze retrospective registry) aimed to assess the influence of a chronic kidney disease (CKD) on long-term clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) using either first-generation (DES-I) or second-generation (DES-II) drug-eluting stents. The study group consisted of 1,908 consecutive patients, of whom 331 (17.3%) had CKD. CKD was defined as an estimated glomerular filtration rate of <60 mL/min/m 2 . We evaluated the major adverse cardiac and cerebral events (MACCE), i.e., the composite of death, myocardial infarction (MI), stroke, and target vessel revascularization at the 12-month follow-up. CKD patients had a lower left ventricular ejection fraction and more often a history of MI and PCI. Coronary angiography revealed that multivessel coronary artery disease, intracoronary thrombus, and extensive calcifications were more frequent in patients with CKD. However, the SYNTAX score did not vary between patients with or without CKD. There was a higher rate of in-hospital bleedings requiring blood transfusion in patients with CKD. At the 1-year follow-up, MACCE (17.8 vs. 12.6%, HR = 1.46 [95% CI 1.05-2.03], p = 0.009) and death (8.4 vs. 2.3%, HR = 3.9 [95% CI 2.0-7.5], p < 0.001) were more often observed in CKD patients. Multivariable Cox analysis revealed that CKD was an independent risk predictor of death after PCI at the 1-year follow-up (HR = 2.1 [95% CI 1.2-3.6], p = 0.004). In comparison to DES-I, the use of DES-II did not decrease the adverse effect of CKD on MACCE. CKD patients had an increased risk of in-hospital bleeding requiring blood transfusion and a higher risk of MACCE and death at the 12-month follow-up. The use of second-generation DES did not improve clinical outcomes in patients with CKD at the 12-month follow-up.

  15. Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention

    NARCIS (Netherlands)

    Luca, G. De; Dirksen, M.T.; Spaulding, C.; Kelbaek, H.; Schalij, M.; Thuesen, L.; Hoeven, B. van der; Vink, M.A.; Kaiser, C.; Musto, C.; Chechi, T.; Spaziani, G.; Llera, L.S. Diaz de la; Pasceri, V.; Lorenzo, E. Di; Violini, R.; Suryapranata, H.; Stone, G.W.; et al.,

    2013-01-01

    Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated

  16. Anatomical and functional assessment of Tryton bifurcation stent before and after final kissing balloon dilatation: Evaluations by three-dimensional coronary angiography, optical coherence tomography imaging and fractional flow reserve.

    Science.gov (United States)

    Pyxaras, Stylianos A; Toth, Gabor G; Di Gioia, Giuseppe; Ughi, Giovanni J; Tu, Shengxian; Rusinaru, Dan; Adriaenssens, Tom; Reiber, Johan H C; Leon, Martin B; Bax, Jeroen J; Wijns, William

    2017-07-01

    To assess the anatomical and functional impact of final kissing balloon inflation (FKBI) after implantation of a dedicated bifurcation stent system. Current evidence suggests clinical benefit of FKBI in patients undergoing bifurcation dilatation using the Tryton side branch stent (Tryton-SBS). We hypothesized that FKBI improves anatomical reconstruction and functional results of bifurcation treated by Tryton-SBS. An unselected group of patients with complex bifurcation coronary lesions undergoing percutaneous coronary intervention (PCI) with Tryton-SBS underwent paired anatomical assessment with two- and three-dimensional quantitative coronary analysis (2D- and 3D-QCA), and optical coherence tomography (OCT), including 3D reconstruction before and after FKBI. Functional assessment by fractional flow reserve (FFR) was performed in the main branch (MB) and side branch (SB) before and after FKBI. Paired pre- and post-FKBI data were obtained in 10 patients. By OCT imaging, FKBI increased both the SB ostial area (4.93 ± 2.81 vs. 7.43 ± 2.87 mm 2 , P system, FKBI is associated with improved anatomical and functional results at the SB level, without compromising the result at the MB. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  17. Acute Coronary Syndrome

    Science.gov (United States)

    ... illustration of coronary arteries ). A stent, a wire mesh tube, may be permanently placed in the artery ... Changes Recovery FAQs • Heart Attack Tools & Resources • Support Network Heart Attack Tools & Resources My Cardiac Coach What ...

  18. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction

    DEFF Research Database (Denmark)

    Räber, Lorenz; Kelbæk, Henning; Ostojic, Miodrag

    2012-01-01

    The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)....

  19. Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention: a pre-specified analysis from the PRODIGY study (PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY).

    Science.gov (United States)

    Valgimigli, Marco; Tebaldi, Matteo; Borghesi, Marco; Vranckx, Pascal; Campo, Gianluca; Tumscitz, Carlo; Cangiano, Elisa; Minarelli, Monica; Scalone, Antonella; Cavazza, Caterina; Marchesini, Jlenia; Parrinello, Giovanni

    2014-01-01

    This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMS), zotarolimus-eluting Endeavor Sprint stents (ZES-S), paclitaxel-eluting stents (PES), or everolimus-eluting stents (EES) (Medtronic Cardiovascular, Santa Rosa, California) in all-comer patients undergoing percutaneous coronary intervention. Few studies have directly compared second-generation drug-eluting stents with each other or with BMS. We randomized 2,013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24 months of clopidogrel therapy. The key efficacy endpoint was the 2-year major adverse cardiac event (MACE) including any death, myocardial infarction, or target vessel revascularization, whereas the cumulative rate of definite or probable stent thrombosis (ST) was the key safety endpoint. Clinical follow-up at 2 years was complete for 99.7% of patients. The MACE rate was lowest in EES (19.2%; 95% confidence interval [CI]: 16.0 to 22.8), highest in BMS (32.1%; 95% CI: 28.1 to 36.3), and intermediate in PES (26.2%; 95% CI: 22.5 to 30.2) and ZES-S (27.8%; 95% CI: 24.1 to 31.9) groups (chi-square test = 18.9, p = 0.00029). The 2-year incidence of ST in the EES group (1%; 95% CI: 0.4 to 2.2) was similar to that in the ZES-S group (1.4%; 95% CI: 0.7 to 2.8), whereas it was lower compared with the PES (4.6%, 95% CI: 3.1 to 6.8) and BMS (3.6%; 95% CI: 2.4 to 5.6) groups (chi-square = 16.9; p = 0.0001). Our study shows that cumulative MACE rate, encompassing both safety and efficacy endpoints, was lowest for EES, highest for BMS, and intermediate for PES and ZES-S groups. EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST. (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]; NCT00611286). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All

  20. 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...... databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1...

  1. Local Delivery of Antiproliferative Agents via Stents

    Directory of Open Access Journals (Sweden)

    Hyuck Joon Kwon

    2014-03-01

    Full Text Available A stent is a medical device for serving as an internal scaffold to maintain or increase the lumen of a body conduit. Stent placement has become a primary treatment option in coronary artery disease for more than the last two decades. The stenting is also currently used for relieving the symptoms of narrowed lumen of nonvascular organs, such as esophagus, trachea and bronchi, small and large intestines, biliary, and urinary tract. Local delivery of active pharmaceutical agents via the stents can not only enhance healing of certain diseases, but it can also help decrease the potential risk of the stenting procedure to the surrounding tissue. In this review, we focus on reviewing a variety of drug-impregnated stents and local drug delivery systems using the stents.

  2. 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

  3. 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...

  4. One-Year Results of the Use of Absorb Bioresorbable Vascular Scaffold in Patients with Different Forms of Coronary Artery Disease as Compared to a Drug-Eluting Stent

    Directory of Open Access Journals (Sweden)

    Nabijon P. Yuldashev

    2018-03-01

    Full Text Available The aim of this study was to evaluate the immediate and long-term (12 months clinical and angiographic efficacy of myocardial revascularization using Absorb GT1 Bioresorbable Vascular Scaffold (BVS in comparison to second-generation drug-eluting stent (DES in patients with various forms of coronary artery disease (CAD. Material and Methods: The study included 152 patients with CAD. There were 131 men and 32 women with an average age of 54.6±10.4 years. Patients' data were evaluated retrospectively from the medical records. Results: •\tImplantation of BVS in patients with different forms of CAD did not cause any angiographic or clinical complications, either at the hospital or at 12-month observation stages, and the results were comparable to those of the DES group. •\tThe technique of implanting BVS and the reception of dual antiplatelet therapy are the key factors for achieving positive results in real clinical practice. •\tThe use of BVS-frameworks contributes to improving clinical, functional and laboratory indicators, while the observed positive dynamics are comparable to similar data of the DES group. •\tRegardless of the type of implanted stents, the survival rate among CAD patients within 12 months after stenting was 100%, while none of the respondents during this time developed acute MI or recurrence of angina attacks.

  5. Bronchial stents

    Directory of Open Access Journals (Sweden)

    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

  6. Head-to-head comparison of a drug-free early programmed dismantling polylactic acid bioresorbable scaffold and a metallic stent in the porcine coronary artery: six-month angiography and optical coherence tomographic follow-up study.

    Science.gov (United States)

    Durand, Eric; Sharkawi, Tahmer; Leclerc, Guy; Raveleau, Marine; van der Leest, Machiel; Vert, Michel; Lafont, Antoine

    2014-02-01

    We aimed to evaluate a new drug-free fully bioresorbable lactic acid-based scaffold designed to allow early dismantling synchronized with artery wall healing in comparison with a bare metal stent (BMS). Twenty-three BMS (3.0×12 mm) and 36 lactic acid-based bioresorbable scaffolds (BRS, 3.0×11 mm) were implanted in porcine coronary arteries. QCA and optical coherence tomographic analyses were performed immediately after implantation and repeated after 1, 3, and 6 months. Microcomputed tomography was used to detect scaffold dismantling. Polymer degradation was evaluated throughout the study. The primary end-point was late lumen loss, and the secondary end-points were scaffold/stent diameter and acute recoil. Acute recoil was low and comparable between the BRS and the BMS groups (4.6±6.7 versus 4.6±5.1%; P=0.98). BRS outer diameter increased significantly from 1 to 6 months indicating late positive scaffold remodeling (PBRS group (P=0.003) without significant difference between BRS and BMS groups at 6 months (P=0.68). Microcomputed tomography identified BRS dismantling starting at 3 months, and weight-average molar masses of scaffold parts were 20% and 14% of their initial values at 3 and 6 months. BRS and BMS have similar 6-month outcomes in porcine coronary arteries. Interestingly, BRS dismantling was detected from 3 months and resulted in late lumen enlargement by increased scaffold diameter at 6 months.

  7. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent.

    Science.gov (United States)

    Dávila-Fajardo, Cristina Lucía; Sánchez-Ramos, Jesús; Villamarín, Xando Diaz-; Martínez-González, Luis Javier; Frías, Pablo Toledo; Huertas, Susana Martínez; Gómez, Francisco Burillo; Borrego, Juan Caballero; Pavés, Alicia Bautista; Guzmán, Mª Carmen Marín; Hernández, José Antonio Ramirez; Vilches, Concepción Correa; Barrera, Jose Cabeza

    2017-02-01

    This article contains data related to the research article entitled "Results of genotype-guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent" (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype-guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33).

  8. Nanotechnology-based gene-eluting stents.

    Science.gov (United States)

    Goh, Debbie; Tan, Aaron; Farhatnia, Yasmin; Rajadas, Jayakumar; Alavijeh, Mohammad S; Seifalian, Alexander M

    2013-04-01

    Cardiovascular disease is one of the major causes of death in the world. Coronary stenting in percutaneous coronary intervention (PCI) has revolutionized the field of cardiology. Coronary stenting is seen as a less invasive procedure compared to coronary artery bypass graft (CABG) surgery. Two main types of stents currently exist in the market: bare-metal stents (BMS) and drug-eluting stents (DES). DES were developed in response to problems associated with BMS use, like neointimal hyperplasia leading to restenosis. However, the use of DES engendered other problems as well, like late stent thrombosis (ST), which is a serious and lethal complication. Gene-eluting stents (GES) have recently been proposed as a novel method of circumventing problems seen in BMS and DES. Utilizing nanotechnology, sustained and localized delivery of genes can mitigate problems of restenosis and late ST by accelerating the regenerative capacity of re-endothelialization. Therefore this review seeks to explore the realm of GES as a novel alternative to BMS and DES, and its potential implications in the field of nanotechnology and regenerative medicine.

  9. Comparing of Light Transmittance Aggregometry and Modified Thrombelastograph in Predicting Clinical Outcomes in Chinese Patients Undergoing Coronary Stenting with Clopidogrel

    Directory of Open Access Journals (Sweden)

    Xiao-Fang Tang

    2015-01-01

    Full Text Available Background: Several platelet function tests are currently used to measure responsiveness to antiplatelet therapy. This study was to compare two tests, light transmittance aggregometry (LTA and modified thrombelastography (mTEG, for predicting clinical outcomes in Chinese patients after percutaneous coronary intervention (PCI. Methods: Prospective, observational, single-center study of 789 Chinese patients undergoing PCI was enrolled. This study was investigated the correlations between the two tests and performed receiver operating characteristic curve (ROC analysis for major adverse cardiovascular events (MACEs at 1-year follow-up. Results: MACEs occurred in 32 patients (4.1%. Correlations were well between the two tests in the adenosine diphosphate induced platelet reactivity (Spearman r = 0.733, P < 0.001. ROC-curve analysis demonstrated that LTA (area under the curve [AUC]: 0.677; 95% confidence interval [CI]: 0.643-0.710; P = 0.0009, and mTEG (AUC: 0.684; 95% CI: 0.650-0.716; P = 0.0001 had moderate ability to discriminate between patients with and without MACE. MACE occurred more frequently in patients with high on-treatment platelet reactivity (HPR when assessed by LTA (7.4% vs. 2.7%; P < 0.001, and by TEG (6.7% vs. 2.6%; P < 0.001. Kaplan-Meier analysis demonstrated that HPR based on the LTA and mTEG was associated with almost 3-fold increased risk of MACE at 1-year follow-up. Conclusions: The correlation between LTA and mTEG is relatively high in Chinese patients. HPR measured by LTA and mTEG were significantly associated with MACE in Chinese patients undergoing PCI.

  10. Prognostic implications of atrio-ventricular block in patients undergoing primary coronary angioplasty in the stent era.

    Science.gov (United States)

    Gómez-Talavera, Sandra; Vivas, David; Perez-Vizcayno, María Jose; Hernández-Antolín, Rosana; Fernández-Ortíz, Antonio; Bañuelos, Camino; Escaned, Javier; Jiménez-Quevedo, Pilar; Viliani, Dafne; Vilacosta, Isidre; Macaya, Carlos; Alfonso, Fernando

    2014-03-01

    Conduction disorders in patients with ST-segment elevation myocardial infarction (STEMI) are associated with high mortality. Previous studies have analyzed the implications of AVB in acute coronary syndrome treated with fibrinolysis. However, the implications of AVB in patients with STEMI treated with primary angioplasty have not been sufficiently studied. 913 patients with STEMI treated with primary angioplasty. All clinical, electrocardiographic and angiographic variables were collected. AVB was documented in 115 patients (12.6%). On admission, AVB was present in 70 (7.7%), and persistent at hospital discharge in 36 (3.9 %). Within these, first-degree AVB was present in 29 (3.2%), second-degree in 27 (3%) and third-degree in 73 (8%). AVB was more frequent in women, elderly, hypertensive, diabetic, with worse functional class (Killip class > 2) and with higher incidence at inferior infarctions (P < 0.05). AVB in general and, more specifically, third-degree AVB was associated with a higher mortality (20.5% versus 5.7%; P < 0.001), re-infarction (8.2% versus 3.6%; P = 0.06) and a greater incidence of cardiogenic shock (33.3% versus 14%; P < 0.001). Interestingly, these events were more common in patients who had persistent AVB at hospital discharge than in those with transitory AVB or present at admission AVB. In the multivariate analysis, persistent AVB at hospital discharge proved to be an independent predictor of cardiovascular events (death and recurrent infarction), not the rest of AVB. AVB in patients who underwent primary angioplasty is associated with a worse prognosis while is in-hospital. This risk is particularly high in patients who had persistent AVB at hospital discharge.

  11. Propensity score matched lesion-based comparison of long-term clinical and angiographic outcomes after placement of sirolimus (Cypher Bx Velocity) and paclitaxel (TAXUS Express)-eluting stents for de novo native coronary stenosis.

    Science.gov (United States)

    Nakano, Yosuke; Ishikawa, Tetsuya; Hino, Shoryoku; Mutoh, Makoto

    2014-04-01

    Long-term clinical and angiographic outcomes after sirolimus (SES: Cypher Bx Velocity) and paclitaxel (PES: TAXUS Express)-eluting stent implantation were firstly compared in Japan. During PES-available period from May 2007 to February 2009, 1068 nonrandomized consecutive de novo native coronary lesions treated either with a PES (682 lesions) or SES were enrolled in this study, and a retrospective examination was conducted in April 2013. During that interval, the use ratio of drug-eluting stent (i.e. SES plus PES) was 94.2 %. By adjusting the baselines with a propensity score matching analysis produced 383 lesions in each arm, the incidence of the clinical endpoint (1500-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of SES (2.1 %; mean follow-up, 1400 ± 290 days) was not significantly different from that in the PES group (2.6 %; 1394 ± 325 days, p = 0.637). SES did not relate to the clinical endpoint (hazard ratio 1.04; 95 % CI 0.29-3.76; p = 0.949). In the baseline-adjusted angiographic followed up lesions (n = 234 in each arm), the incidence of binary restenosis (percent diameter stenosis [%DS] >50 %) in the SES group (12.0 %; mean follow-up, 477 ± 281 days) was not significantly different from that in the PES group (14.5 %; 497 ± 341 days, p = 0.431). SES did not relate to binary restenosis (Odds ratio 0.73; 95 % CI 0.40-1.32; p = 0.295). In conclusion, the present propensity score matched lesion-based analysis firstly showed the statistical equivalent long-term clinical and angiographic outcomes after either SES or PES placement for de novo native coronary lesion in Japanese patients in a daily practice environment.

  12. Successful management of a giant unruptured mycotic coronary artery aneurysm after coronary angioplasty

    Directory of Open Access Journals (Sweden)

    Pankaj Aggarwal

    2016-09-01

    Full Text Available Coronary artery stent infection has been reported with both bare metal stent and drug eluting stent and can present as mycotic coronary artery aneurysm, pseudoaneurysm, myocardial abscess, pericarditis or exudative effusion. Infection at the site of coronary stent implantation is rare and is believed to result typically from either direct stent contamination at the time of delivery or transient bacteraemia from access site. Introduction of drug-eluting stent (DES has led to a marked reduction in the problem of in-stent restenosis across all patient subsets and lesions complexities. Recently, several case reports of pseudoaneurysm formation after DES implantation have been reported in the literature. We describe the successful surgical management of giant mycotic pseudoaneurysm of left anterior descending artery (LAD presenting as fever of unknown origin. This report illustrates the importance of early detection and prompt management of these rare coronary pseudoaneurysms, which is a highly lethal condition.

  13. Second-generation drug-eluting stents in the elderly patients with acute coronary syndrome: the in-hospital and 12-month follow-up of the all-comer registry.

    Science.gov (United States)

    Wańha, Wojciech; Kawecki, Damian; Roleder, Tomasz; Morawiec, Beata; Gładysz, Sylwia; Kowalówka, Adam; Jadczyk, Tomasz; Adamus, Barbara; Pawłowski, Tomasz; Smolka, Grzegorz; Kaźmierski, Maciej; Ochała, Andrzej; Nowalany-Kozielska, Ewa; Wojakowski, Wojciech

    2017-10-01

    Katowice-Zabrze registry provides data that can be used to evaluate clinical outcomes of percutaneous coronary interventions in elderly patients (≥70 y/o) treated with either first- (DES-I) or second-generation (DES-II) drug-eluting stents (DES). The registry consisted of data from 1916 patients treated with coronary interventions using either DES-I or DES-II stents. For our study, we defined patients ≥70 years of age as elderly. We evaluated any major adverse cardiac and cerebral events (MACCE) at 12-month follow-up. Coronary angiography revealed a higher incidence of multivessel coronary artery disease in this elderly patient population. There were no differences in acute and subacute stent thrombosis (0.4 vs. 0.6%, p = 0.760; 0.4 vs. 0.4%; p = 0.712). Elderly patients experienced more in-hospital bleeding complications requiring blood transfusion (2.0 vs. 0.9%; p = 0.003). Resuscitated cardiac arrests (2.0 vs. 0.9%; p = 0.084) were observed more often in this elderly patients during hospitalization. The composite in-hospital MACCE rates did not differ statistically between both groups (1.4 vs. 1.1%; p = 0.567). Data from a twelve-month follow-up disclosed that mortality was higher (7.1 vs. 1.8%; p < 0.001) in the elderly, with no difference in TVR (7.2 vs. 9.9%, p = 0.075), MI (6.0 vs. 4.8%, p = 0.300), stroke (0.8 vs. 0.6%, p = 0.600) and composite MACCE (15.0 vs. 13.4%, p = 0.324). The age of 70 years or over was an independent predictor of death [HR = 2.55 (95% CI 1.49-4.37); p < 0.001]. The use of DES-II reduced the risk of MI [HR = 0.40 (95% CI 0.19-0.82); p = 0.012] in the elderly. This elderly patient population had an increased risk of in-hospital bleeding complications requiring blood transfusion and a higher risk of death at 12-month follow-up. The use of new-generation DES reduced the risk of MI in the elderly population.

  14. First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

    Science.gov (United States)

    von Birgelen, Clemens; Asano, Taku; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter C; Wykrzykowska, Joanna J; Ribeiro, Vasco Gama; Pereira, Hélder; da Silva, Pedro Canas; Piek, Jan J; Onuma, Yoshinobu; Serruys, Patrick W; Sabaté, Manel

    2018-04-20

    A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

  15. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    Science.gov (United States)

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  16. Treatment of malignant gastroduodenal obstruction with using a newly designed complex expandable nitinol stent: initial experiences

    International Nuclear Information System (INIS)

    Jung, Mi Hee; Ko, Ji Ho; Lee, Eun Jung; Oh, Kyeng Seung; Huh, Jin Do; Cho, Young Duk; Park, Seun Ja; Jung, Gyoo Sik

    2005-01-01

    We wanted to evaluate the usefulness of a new type of a complex expandable nitinol stent that was designed to reduce the stent's propensity to migration during the treatment of malignant gastroduodenal obstructions. Two types of expandable nitinol stent were constructed by weaving a single thread of 0.2mm nitinol wire in a tubular configuration: an uncovered stent 18mm in diameter and a covered stent 16mm in diameter. Both ends of the covered stent were fabricated by coaxially inserting the covered stent into the tubular uncovered stent and then attaching the two stents together with using nylon monofilament. Under fluoroscopic guidance, the stent was placed in 29 consecutive patients (20 men and 9 women, mean age: 65 years) who were suffering with malignant gastric outlet obstruction (n=20), duodenal obstruction (n=6) or combined obstruction (n=3). Clinical improvement was assessed by comparing the food intake capacity before and after the procedure. The complications were investigated during the follow up period. Stent placement was successful in all the patients. After stent placement, the symptoms improved in all but one patient. During the follow up, stent migration occurred in one patient (3%) at 34 days after the procedure. Despite the stent migration, the patient was able to resume a soft diet. Six patients developed recurrent symptoms of obstruction with tumor overgrowth at a mean of 145 days after the procedure; all the patients underwent coaxial placement of an additional stent with good results. One patient showed recurrence of obstruction due to tumor in-growth, and this was treated by placement of a second stent. Two patients with stent placement in the duodenum suffered from jaundice 26 days and 65 days, respectively, after their procedures. Placement of the newly designed complex expandable nitinol stent seems to be effective for the palliative treatment of malignant gastroduodenal obstructions. The new stent also seems to help overcome the

  17. Treatment of malignant gastroduodenal obstruction with using a newly designed complex expandable nitinol stent: initial experiences

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Mi Hee; Ko, Ji Ho; Lee, Eun Jung; Oh, Kyeng Seung; Huh, Jin Do; Cho, Young Duk; Park, Seun Ja [College of Medicine, Kosin University, Busan (Korea, Republic of); Jung, Gyoo Sik [Ulsan Hospital, Ulsan (Korea, Republic of)

    2005-12-15

    We wanted to evaluate the usefulness of a new type of a complex expandable nitinol stent that was designed to reduce the stent's propensity to migration during the treatment of malignant gastroduodenal obstructions. Two types of expandable nitinol stent were constructed by weaving a single thread of 0.2mm nitinol wire in a tubular configuration: an uncovered stent 18mm in diameter and a covered stent 16mm in diameter. Both ends of the covered stent were fabricated by coaxially inserting the covered stent into the tubular uncovered stent and then attaching the two stents together with using nylon monofilament. Under fluoroscopic guidance, the stent was placed in 29 consecutive patients (20 men and 9 women, mean age: 65 years) who were suffering with malignant gastric outlet obstruction (n=20), duodenal obstruction (n=6) or combined obstruction (n=3). Clinical improvement was assessed by comparing the food intake capacity before and after the procedure. The complications were investigated during the follow up period. Stent placement was successful in all the patients. After stent placement, the symptoms improved in all but one patient. During the follow up, stent migration occurred in one patient (3%) at 34 days after the procedure. Despite the stent migration, the patient was able to resume a soft diet. Six patients developed recurrent symptoms of obstruction with tumor overgrowth at a mean of 145 days after the procedure; all the patients underwent coaxial placement of an additional stent with good results. One patient showed recurrence of obstruction due to tumor in-growth, and this was treated by placement of a second stent. Two patients with stent placement in the duodenum suffered from jaundice 26 days and 65 days, respectively, after their procedures. Placement of the newly designed complex expandable nitinol stent seems to be effective for the palliative treatment of malignant gastroduodenal obstructions. The new stent also seems to help overcome the

  18. 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.

  19. Short Duration vs Standard Duration of Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents - A Systematic Review, Meta-Analysis, and Meta-Regression Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Wassef, Anthony W A; Khafaji, Hadi; Syed, Ishba; Yan, Andrew T; Udell, Jacob A; Goodman, Shaun G; Cheema, Asim N; Bagai, Akshay

    2016-12-01

    Current guidelines recommend 12 months of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Whether the duration of DAPT can be safely shortened with use of second-generation DESs is unclear. We conducted a meta-analysis of randomized controlled trials comparing short duration (SD) (3-6 months) with standard longer duration (LD) (≥12 months) DAPT in patients treated with primarily second-generation DES implantation. Meta-regression was performed to explore the relationship between acute coronary syndrome (ACS) and the effect of DAPT duration. Six studies were included, with 12,752/13,928 (91.5%) patients receiving second-generation DESs. A total of 5367 patients (39%) had PCI in the setting of ACS. There was no difference in all-cause mortality (1.1% vs 1.2%; odds ratio [OR], 0.86; 95% confidence interval [CI], 0.63-1.18; P=.36) or cardiac mortality (0.9% vs 1.0%; OR, 0.92; 95% CI, 0.61-1.39; P=.69) with SD-DAPT vs LD-DAPT, respectively. Definite/probable stent thrombosis (0.5% vs 0.3%; OR, 1.33; 95% CI, 0.75-2.34; P=.51), myocardial infarction (1.5% vs 1.3%; OR, 1.17; 95% CI, 0.88-1.56; P=.29), and stroke (0.4% vs 0.4%; OR, 1.04; 95% CI, 0.60-1.81; P=.88) were similar between the groups. Compared with LD-DAPT, SD-DAPT was associated with lower clinically significant bleeding (0.9% vs 1.4%; OR, 0.64; 95% CI, 0.46-0.89; P=.01). Meta-regression analysis showed no significant association between the proportion of ACS patients in trials and duration of DAPT for the outcomes of mortality (P=.95), myocardial infarction (P=.98), or stent thrombosis (P=.89). In low-risk patients treated with contemporary second-generation DES implantation, SD-DAPT has similar rates of mortality, myocardial infarction, and stent thrombosis, with lower rates of bleeding compared with LD-DAPT.

  20. Role of stent type and of duration of dual antiplatelet therapy in patients with chronic kidney disease undergoing percutaneous coronary interventions. Is bare metal stent implantation still a justifiable choice? A post-hoc analysis of the all comer PRODIGY trial.

    Science.gov (United States)

    Crimi, Gabriele; Leonardi, Sergio; Costa, Francesco; Adamo, Marianna; Ariotti, Sara; Valgimigli, Marco

    2016-06-01

    Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60ml/min/1.73m(2), was found in 373 patients (18.8%). The incidence of ST at 2years was 5.1% in CKD and 2.1% in non-CKD patients (HR 2.57, 95% confidence interval (CI) 1.46 to 4.52, p<0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: adjusted HR=0.288, 95% CI [0.107-0.778, p=0.014] and HR=0.394, 95% CI [0.164-0.947, p=0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4% as compared to BMS 35.1%, ZES-S 33.0%, or PES 35.7% patients, p=0.551. All-cause death was lowest in ZES-S group 10.6% as compared to BMS 18.1%, PES 25.5% and EES 14.9%, p=0.040. We found no significant interaction between DAPT duration (6 vs 24months) and stent type on primary outcome, PINT=0.47 for BMS, PINT=0.57 for PES, PINT

  1. 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...

  2. 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 (pnickel allergy than the control group. Nickel allergy may play role in restenosis pathophysiology.

  3. 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.

  4. Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter "real-world" registry.

    Science.gov (United States)

    Imori, Yoichi; D'Ascenzo, Fabrizio; Gori, Tommaso; Münzel, Thomas; Fabrizio, Ugo; Campo, Gianluca; Cerrato, Enrico; Napp, L Christian; Iannaccone, Mario; Ghadri, Jelena R; Kazemian, Elycia; Binder, Ronald K; Jaguszewski, Milosz; Csordas, Adam; Capasso, Piera; Biscaglia, Simone; Conrotto, Fedrico; Varbella, Ferdinando; Garbo, Roberto; Gaita, Fiorenzo; Erne, Paul; Lüscher, Thomas F; Moretti, Claudio; Frangieh, Antonio H; Templin, Christian

    2016-01-01

    Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. Consecutive ACS patients undergoing BRS implantation in 8 centers were com-pared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were com-pared after matching, and 117 (55.2%) BRS patients were treated with postdilatation. After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). How-ever, after sensitivity analysis, MACE rates in BRS patients with postdilatation were signifi-cantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045). Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation.

  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

    allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite...... stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478. FINDINGS: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow...... for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; pdefinite...

  6. Beta-radiation therapy for long lesions in native coronary vessels A matched comparison between de novo and in-stent restenotic lesions

    International Nuclear Information System (INIS)

    Stankovic, Goran; Orlic, Dejan; Di Mario, Carlo; Corvaja, Nicola; Airoldi, Flavio; Chieffo, Alaide; Amato, Antonio; Orecchia, Roberto; Colombo, Antonio

    2003-01-01

    Objective: The purpose of this study was to evaluate effectiveness and to compare clinical outcome of intracoronary beta-radiation to treat long lesions (>20 mm) in patients with de novo stenosis vs. patients with in-stent restenosis (ISR). Methods: A matched comparison of 44 patients with 63 de novo lesions and 48 patients with 63 ISR lesions (>20 mm) treated with intracoronary beta-radiation was performed. Results: Stents were implanted in 65.1% of de novo and 19% of ISR lesions (P=.001). Radiation doses delivered were 17.2±3.0 vs. 20.3±3.0 Gy at 2 mm from the source center for de novo and ISR lesions. There was no difference in the incidence of in-hospital events. Clinical follow-up at 16.4±6.7 months showed no difference in major adverse cardiac events (MACE) between de novo and ISR patients (27.3% vs. 25%, P=.8). Late total occlusions (LTOs) occurred in eight patients (four in each group) treated with stents at the time of radiation and after discontinuation of ticlopidine. By multivariate analysis, stent implantation was the only predictor of late occlusions (OR 8.25, 95% CI 1.73-38.46, P<.008). Restenosis rates were similar for de novo and ISR lesions (29.3% vs. 23.2%, P=.46), as well as target lesion revascularization (TLR) and target vessel revascularization (TVR) rates (22.7% vs. 22.9% and 29.5% vs. 29.2%, respectively). Conclusions: Intracoronary beta-radiation gives comparable results when used to treat de novo or ISR lesions provided new stent implantation can be avoided. Long-term combined antiplatelet therapy is mandatory for patients who receive new stents at the time of radiation treatment

  7. Comparison of mid-term clinical outcomes after treatment of ostial right coronary artery lesions with early and new generation drug-eluting stents: Insights from an international multicenter registry.

    Science.gov (United States)

    Mitomo, Satoru; Jabbour, Richard J; Watanabe, Yusuke; Mangieri, Antonio; Ancona, Marco; Regazzoli, Damiano; Tanaka, Akihito; Nakajima, Akihiro; Naganuma, Toru; Giannini, Francesco; Latib, Azeem; Nakamura, Sunao; Colombo, Antonio

    2018-03-01

    There are only a limited number of studies comparing clinical outcomes after treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with early (E-) and new (N-) generation drug-eluting stents (DES). From January 2005 to December 2013, 334 de novo RCA AO lesions treated with DES (E-:142 lesions, N-:192 lesions) at 2 high-volume centers (Italy and Japan) were included in this study. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction, and target lesion revascularization (TLR). Baseline and lesion characteristics were well balanced between the 2 groups. The size of the stents deployed (3.35±0.37mm vs 3.39±0.33mm, p=0.29) and non-compliant balloons used for post-dilatation (3.55±0.38mm vs 3.62±0.47mm, p=0.21) were similar between the two groups. The median follow-up period was 1432 (IQR: 703-2197) days in total population. The cumulative rate of TLF at 3years was significantly higher in E-DES group when compared with N-DES group (37.7% vs 14.2%, prights reserved.

  8. Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries

    DEFF Research Database (Denmark)

    Jeger, Raban; Pfisterer, Matthias; Alber, Hannes

    2012-01-01

    In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal sten...... (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known....

  9. Clinical outcomes after final kissing balloon inflation compared with no final kissing balloon inflation in bifurcation lesions treated with a dedicated coronary bifurcation stent

    NARCIS (Netherlands)

    Grundeken, Maik J.; Lesiak, Maciej; Asgedom, Solomon; Garcia, Eulogio; Bethencourt, Armando; Norell, Michael S.; Damman, Peter; Woudstra, Pier; Koch, Karel T.; Vis, M. Marije; Henriques, Jose P.; Tijssen, Jan G.; Onuma, Yoshinobu; Foley, David P.; Bartorelli, Antonio L.; Stella, Pieter R.; de Winter, Robbert J.; Wykrzykowska, Joanna J.

    2014-01-01

    We evaluated differences in clinical outcomes between patients who underwent final kissing balloon inflation (FKBI) and patients who did not undergo FKBI in bifurcation treatment using the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina, USA). Clinical outcomes were defined as

  10. Clinical outcomes after final kissing balloon inflation compared with no final kissing balloon inflation in bifurcation lesions treated with a dedicated coronary bifurcation stent

    NARCIS (Netherlands)

    M.J. Grundeken (Maik); M. Lesiak (MacIej); S. Asgedom (Solomon); E. Garcia (Eulogio); A. Bethencourt (Armando); M.S. Norell (Michael); K. Damman (Kevin); E. Woudstra (Evert); K. Koch (Karel); M.M. Vis (Marije); J.P.S. Henriques (Jose); J.G.P. Tijssen (Jan); Y. Onuma (Yoshinobu); D.P. Foley (David); A. Bartorelli (Antonio); P.R. Stella (Pieter); R.J. de Winter (Robbert); J.J. Wykrzykowska (Joanna)

    2014-01-01

    textabstractObjective We evaluated differences in clinical outcomes between patients who underwent final kissing balloon inflation (FKBI) and patients who did not undergo FKBI in bifurcation treatment using the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina, USA). Methods Clinical

  11. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    disease who were receiving routine clinical care with no direct follow-up. METHODS: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five...

  12. 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...... 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; P... coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. CONCLUSIONS: This meta-analysis offers evidence that compared with bare metal stents the use of cobalt...

  13. 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

  14. Safety of an abbreviated duration of dual antiplatelet therapy (≤6 months) following second-generation drug-eluting stents for coronary artery disease: A systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Ziada, Khaled M; Abdel-Latif, Ahmed K; Charnigo, Richard; Moliterno, David J

    2016-03-01

    Dual antiplatelet therapy (DAPT) is recommended for ≥12 months following coronary drug-eluting stents (DES) to reduce risk of major adverse ischemic events. Randomized trials suggest an abbreviated DAPT duration (≤6 months) is adequately protective. However, these trials are individually underpowered to detect differences in rare but serious events such as stent thrombosis (ST). We performed a meta-analysis of published randomized trials to define the impact of abbreviated DAPT (≤6 months) on death, myocardial infarction (MI), stent thrombosis (ST), and bleeding complications compared to standard-duration DAPT (≥12 months). Seven randomized controlled trials comparing abbreviated vs. standard DAPT regimens following DES use were identified by two independent investigators. Study characteristics were reviewed and clinical endpoint data were abstracted and analyzed in aggregate using fixed and random-effects models. The seven trials included 15,874 randomized patients. Second-generation DES were used in most patients. Compared to standard-duration DAPT, abbreviated DAPT was not associated with an increase in mortality (OR 0.93; CI: 0.73 to 1.17; P = 0.52), MI (OR 1.14; CI: 0.89 to 1.45; P = 0.30) or ST (OR 1.25; CI: 0.81 to 1.93; P = 0.31). Abbreviated DAPT was associated with significantly fewer major bleeding complications (OR 0.52; CI: 0.34 to 0.82; P = 0.005). The results were consistent between fixed and random-effects models, with no heterogeneity. Sensitivity analyses adjusting for inclusion of bare metal stents, 1st generation DES and/or abbreviated DAPT regimens of 3 months resulted in similar conclusions. In a meta-analysis of >15,000 patients primarily treated with second-generation DES, abbreviated-duration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of a significant increase in risk of death, MI or ST. Accordingly, abbreviated DAPT should be strongly considered

  15. Safety of an Abbreviated Duration of Dual Antiplatelet Therapy (≤ Six Months) Following Second-Generation Drug-Eluting Stents for Coronary Artery Disease: A Systematic Review and Meta-Analysis of Randomized Trials

    Science.gov (United States)

    Charnigo, Richard; Moliterno, David J.

    2015-01-01

    Background Dual antiplatelet therapy (DAPT) is recommended for ≥12 months following coronary drug-eluting stents (DES) to reduce risk of major adverse ischemic events. Randomized trials suggest an abbreviated DAPT duration (≤6 months) is adequately protective. However, these trials are individually underpowered to detect differences in rare but serious events such as stent thrombosis (ST). Objectives We performed a meta-analysis of published randomized trials to define the impact of abbreviated DAPT (≤6 months) on death, myocardial infarction (MI), stent thrombosis(ST) and bleeding complications compared to standard-duration DAPT (≥12 months). Methods Seven randomized controlled trials comparing abbreviated vs. standard DAPT regimens following DES use were identified by 2 independent investigators. Study characteristics were reviewed and clinical endpoint data were abstracted and analyzed in aggregate using fixed and random-effects models. Results The 7 trials included 15,874 randomized patients. Second-generation DES were used in most patients. Compared to standard-duration DAPT, abbreviated DAPT was not associated with an increase in mortality (OR 0.93; CI: 0.73 to 1.17; p = 0.52), MI (OR 1.14; CI: 0.89 to 1.45; p = 0.30) or ST (OR 1.25; CI: 0.81 to 1.93; p = 0.31). Abbreviated DAPT was associated with significantly fewer major bleeding complications (OR 0.52; CI: 0.34 to 0.82; p = 0.005). The results were consistent between fixed and random-effects models, with no heterogeneity. Sensitivity analyses adjusting for inclusion of bare metal stents, 1st generation DES and/or abbreviated DAPT regeimens of 3 months resulted in similar conclusions. Conclusions In a meta-analysis of >15,000 patients primarily treated with second-generation DES, abbreviated-duration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of a significant increase in risk of death, MI or ST. Accordingly, abbreviated DAPT

  16. Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease: an update.

    Science.gov (United States)

    Lupi, Alessandro; Gabrio Secco, Gioel; Rognoni, Andrea; Lazzero, Maurizio; Fattori, Rossella; Sheiban, Imad; Sante Bongo, Angelo; Bolognese, Leonardo; Agostoni, Pierfrancesco; Porto, Italo

    2014-05-01

    To perform an updated meta-analysis comparing biodegradable polymer drug eluting stents (BP-DES) and durable polymer drug eluting stents (DP-DES). BP-DES have been suggested to reduce late stent thrombosis (LST) rates as compared to first generation DP-DES. Recently, second generation DP-DES have replaced older DES, but comparison of these stents with BP-DES has not yielded consistent results. Medline/Web databases were searched for studies comparing BP-DES and DP-DES, and reporting rates of overall/cardiac mortality, myocardial infarction (MI), LST, target lesion revascularization (TLR) and target vessel revascularization (TVR) and late lumen loss (LLL), with a follow-up ≥6 months. Twenty studies (20,005 patients) were included in the meta-analysis. Median follow-up time was 1 year. Compared with DP-DES, BP-DES showed lower LLL (in stent: weighted mean difference WMD -0.45 mm, 95% CI -0.66 to -0.24 mm, P = 0.00001; in segment: WMD -0.15 mm, 95% CI = -0.24 to -0.06 mm, P = 0.001) and lower rates of LST (OR 0.51, 95% CI = 0.30 to 0.86, P = 0.01), although they did not improve mortality, MI, TLR, and TVR rates. BP-DES coated with sirolimus or novolimus, in comparison with biolimus or paclitaxel, were associated with reduced LLL (P DES, BP-DES significantly reduce LLL and LST rates, without clear benefits on harder endpoints. The efficacy of BP-DES in preserving lumen patency seems larger for sirolimus and novolimus DES. Copyright © 2014 Wiley Periodicals, Inc.

  17. 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.

  18. Stent-assisted angioplasty for intracranial atherosclerosis

    International Nuclear Information System (INIS)

    Nakahara, Toshinori; Sakamoto, Shigeyuki; Hamasaki, Osamu; Sakoda, Katsuaki

    2002-01-01

    We report on two patients with intracranial atherosclerosis of the carotid artery or vertebral artery treated with stent-assisted angioplasty. Both patients have severe intracranial atherosclerosis (>70%) with refractory symptoms despite optimal medical treatment. In both patients, a coronary balloon-expandable stent was successfully placed using a protective balloon technique without procedural complications. The patients were asymptomatic and neurologically intact at a mean clinical follow-up of 13 months. Follow-up angiograms did not show restenosis 3 or 4 months after procedure, respectively. Stent-assisted angioplasty for intracranial atherosclerosis in the elective patient has proven effective, with an acceptable low rate of morbidity and mortality. (orig.)

  19. Usefulness of preprocedure high-sensitivity C-reactive protein to predict death, recurrent myocardial infarction, and stent thrombosis according to stent type in patients with ST-segment elevation myocardial infarction randomized to bare metal or drug-eluting stenting during primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Schoos, Mikkel Malby; Kelbæk, Henning; Kofoed, Klaus F

    2011-01-01

    It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on implanted stent type. We investigated the prognostic value of hs-CRP in relation to type of stent implanted in patients with ST-segment elevation myocardial infarction (STEMI). Immediately before......, preprocedure hs-CRP predicts outcome after pPCI in patients with STEMI. Our hypothesis-generating data indicate that BMS implantation should be preferred when hs-CRP is ≤2 mg/L and DES when hs-CRP is >2 mg/L to decrease long-term adverse outcomes including stent thrombosis in patients with STEMI treated with p...

  20. Usefulness of preprocedure high-sensitivity C-reactive protein to predict death, recurrent myocardial infarction, and stent thrombosis according to stent type in patients with ST-segment elevation myocardial infarction randomized to bare metal or drug-eluting stenting during primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Schoos, Mikkel Malby; Kelbæk, Henning; Kofoed, Klaus F

    2011-01-01

    It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on implanted stent type. We investigated the prognostic value of hs-CRP in relation to type of stent implanted in patients with ST-segment elevation myocardial infarction (STEMI). Immediately before......, preprocedure hs-CRP predicts outcome after pPCI in patients with STEMI. Our hypothesis-generating data indicate that BMS implantation should be preferred when hs-CRP is =2 mg/L and DES when hs-CRP is >2 mg/L to decrease long-term adverse outcomes including stent thrombosis in patients with STEMI treated with p...

  1. Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Five Year Clinical Outcome in The Nordic-Baltic Bifurcation Study III

    DEFF Research Database (Denmark)

    Niemelä, Matti; Holm, Niels R; Kervinen, Kari

    2015-01-01

    Background- It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting...... angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http...

  2. Effect of cytochrome P450 2C19 polymorphism on adverse cardiovascular events after drug-eluting stent implantation in a large Hakka population with acute coronary syndrome receiving clopidogrel in southern China.

    Science.gov (United States)

    Zhong, Zhixiong; Hou, Jingyuan; Zhang, Qifeng; Li, Bin; Li, Cunren; Liu, Zhidong; Yang, Min; Zhong, Wei; He, Xuebo; Wu, Hesen; Zhong, Miaocai; Zhao, Pingsen

    2018-04-01

    The objective of this study is to evaluate the effects of cytochrome P450 2C19 (CYP2C19) polymorphism on adverse cardiovascular events (MACE) in Hakka patients with acute coronary syndrome (ACS) receiving clopidogrel who had undergone coronary drug-eluting stent placement after percutaneous coronary intervention (PCI) in southern China. Genotyping of CYP2C19 and MACE of 934 ACS patients with PCI on clopidogrel maintenance therapy were analyzed. Patients who carried loss-of-function CYP2C19 were treated with a 150-mg maintenance dose of clopidogrel or 90 mg of ticagrelor antiplatelet therapy, and patients who were non-carriers received clopidogrel therapy daily at a maintenance dose of 75 mg and the patients were followed-up for at least 12 months. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, and target vessel revascularization and stroke. The allelic frequency of CYP2C19*2 and CYP2C19*3 of Hakka patients in the current study was 31.64 and 5.19%, respectively. The CYP2C19 wild-type homozygotes (*1/*1) were the most predominant among the patients (40.36%), followed by the CYP2C19*2 heterozygotes (*1/*2) (40.26%). The distribution of CYP2C19 phenotypes was divided into extensive metabolizers (EM; 40.36%), intermediate metabolizers (IM; 45.61%), and poor metabolizers (PM; 14.03%). Based on the genotype-guided antiplatelet therapy, there was no significant association between the carrier status and the clinical outcome at 1, 6, and 12 months. In addition, no significant difference in the rates of bleeding was found among the three groups. After logistic regression analysis, hypertension was the only independent predictor of cardiovascular events (relative risk, 1.501; 95% CI, 1.011 to 2.229; P = 0.044). Our results shed new light on the important benefit of testing CYP2C19 polymorphisms before prescribing clopidogrel in patients treated with drug-eluting stent implantation after PCI. The testing may help to

  3. 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...... emotions and tend not to express these emotions in social interactions....

  4. Comparison of Acute Recoil between Bioabsorbable Poly-L-lactic Acid XINSORB Stent and Metallic Stent in Porcine Model

    Directory of Open Access Journals (Sweden)

    Yizhe Wu

    2012-01-01

    Full Text Available Objective. To investigate acute recoil of bioabsorbable poly-L-lactic acid (PLLA stent. Background. As newly developed coronary stent, bioabsorbable PLLA stent still encountered concern of acute stent recoil. Methods. Sixteen minipigs were enrolled in our study. Eight PLLA XINSORB stents (Weite Biotechnology Co., Ltd., China and eight metallic stents (EXCEL, Jiwei Co., Ltd. China were implanted into coronary arteries. Upon quantitative coronary angiography analysis, acute absolute recoil was defined as the difference between mean diameter of inflated balloon (X and mean lumen diameter of stent immediately after deployment (Y, while acute percent recoil was defined as (X−Y/X and expressed as a percentage. Intravascular ultrasound (IVUS was performed immediately after implantation and 24 hours later to compare cross-sectional area (CSA between two groups and detect stent malapposition or collapse. Results. Acute absolute recoil in XINSORB and EXCEL was 0.02±0.13 mm and −0.08±0.08 mm respectively (P=0.19. Acute percent recoil in XINSORB and EXCEL was 0.66±4.32% and −1.40±3.83%, respectively (P=0.45. CSA of XINSORB was similar to that of EXCEL immediately after implantation, so was CSA of XINSORB at 24-hours followup. Within XINSORB group, no difference existed between CSA after implantation and CSA at 24-hours followup. No sign of acute stent malapposition was detected by IVUS. Conclusions. The acute stent recoil of XINSORB is similar to that of EXCEL. No acute stent malapposition or collapse appeared in both kinds of stent. This preclinical study was designed to provide preliminary data for future studies of long-term efficacy and safety of XINSORB stent.

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

    DEFF Research Database (Denmark)

    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...... by intravascular ultrasound assessment of the minimum lumen area (4·32 mm(2) [SD 1·48] vs 5·38 mm(2) [1·51]; p

  6. [Drug eluting stents as the new direction of cardiovascular prothesis research].

    Science.gov (United States)

    Guzik, Łukasz; Nasternak, Magdalena; Maciejewski, Michał

    2010-04-01

    In 1986 Puel and Sigwart placed first coronary stent in human body and therefore have opened a new chapter in percutaneous coronary intervention (PCI). In the beginning, stenting was performed during balloon angioplasty complications. However, 10 years after first implantation, PCI has become a widely used independent technique of widening the lumen of coronary arteries and fighting against coronary arteriosclerosis. Currently this method is rapidly developing, moreover, research centres have proposed its several improvements. A significant modification of the technique was the introduction of Drug Eluting Stents (DES) coated with active substances what enabled to prevent. In 2002 first stent coated with sirolimus was marketed in Europe and a year later was approved by FDA (Food and Drug Administration). Since then DES has lead the way of coronary artery stenting.

  7. Social inhibition modulates the effect of negative emotions on cardiac prognosis following percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Denollet, Johan; Pedersen, Susanne S.; Ong, Andrew T L

    2006-01-01

    Negative emotions have an adverse effect on cardiac prognosis. We investigated whether social inhibition (inhibited self-expression in social interaction) modulates the effect of negative emotions on clinical outcome following percutaneous coronary intervention (PCI).......Negative emotions have an adverse effect on cardiac prognosis. We investigated whether social inhibition (inhibited self-expression in social interaction) modulates the effect of negative emotions on clinical outcome following percutaneous coronary intervention (PCI)....

  8. Coronary stenting in the elderly: longitudinal results in a wide spectrum of patients treated with a new and more practical approach.

    Science.gov (United States)

    Bage, M D; Bauman, W B; Gupta, R; Berkovitz, K E; Ormond, A P; Grigera, F; Josephson, R A

    1998-08-01

    One hundred-twelve intracoronary stents (83 Palmaz-Schatz, 25 biliary, and 4 Gianturco-Roubin) were placed in 87 (51.7% male) patients aged > or = 70 years (70-93; mean 76.1) during a 1-year period. All stents were deployed using high-pressure inflation (mean 17.4 +/- 2 atm) without intravascular ultrasound. All patients received antiplatelet therapy with aspirin and ticlopidine. Seven patients additionally received warfarin at the physician's discretion. No patient was excluded from analysis regardless of presentation (40% acute myocardial infarction and 12.6% bailout) or complication. There were four deaths and two target vessel reinterventions in-hospital. One reintervention (a bailout) developed a non-Q-wave myocardial infarction. Bleeding, vascular complications, and length of stay were all greater for the warfarin group. The event-free survival rate was 83.9%, at an average of 8.6 months follow-up. A wide range of elderly patients can thus undergo stenting without intravascular ultrasound, usually without warfarin, yielding results comparable to those with more standard therapy in select populations.

  9. Long-term Outcomes of Paclitaxel-Eluting Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: A Meta-Analysis

    International Nuclear Information System (INIS)

    Kong, J.; Liu, P.; Fan, X.; Wen, J.; Zhang, J.; Zhen, Y.; Li, J.; Cui, Y.; Zheng, X.; Ye, Z.

    2017-01-01

    The relative long-term efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) in multiple comparative studies remains controversial. This report evaluates 29 randomized trials with 18,379 patients in whom long-term (more than 1 year) outcomes were evaluated. The primary outcomes were target lesion revascularization (TLR) and the secondary end points were death, cardiac death, myocardial infarction (MI), major adverse cardiac events (MACEs), target vessel revascularization (TVR)and stent thrombosis (ST). In comparison with PES, SES significantly reduced the long-term risk of TLR (RR=0.68; 95% CI=0.57 to 0.80, p<0.001), TVR (RR=0.69; 95% CI= 0.60 to 0.79, p<0.001) and MACE (RR=0.82; 95% CI= 0.77 to 0.88, p<0.001), while there were no significant difference with respect to death, cardiac death, MI and ST between the two groups. SES performance was significantly better for reducing the former three outcomes and comparable for the majority of the secondary end points when compared against PES. (author)

  10. Coronary Artery Aneurysm After Bioresorbable Scaffold Implantation in a Woman With an Acute Coronary Syndrome.

    Science.gov (United States)

    Cereda, Alberto F; Canova, Paolo A; Oreglia, Jacopo A; Soriano, Francesco S

    2017-07-01

    We herein report the case of an ST-elevation myocardial infarction due to bioresorbable vascular scaffold (BRS) failure. Optical coherence tomography (OCT) revealed the exact mechanism of late BRS stent thrombosis due to an acquired coronary aneurysm related to BRS. A drug eluting OCT-guided stenting over a failed BRS in the context of an acute coronary syndrome, with the simultaneous presence of a BRS thrombosis and coronary artery aneurysm, proved to be effective.

  11. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

    Science.gov (United States)

    Sambola, Antonia; Montoro, J Bruno; Del Blanco, Bruno García; Llavero, Nadia; Barrabés, José A; Alfonso, Fernando; Bueno, Héctor; Cequier, Angel; Serra, Antonio; Zueco, Javier; Sabaté, Manel; Rodríguez-Leor, Oriol; García-Dorado, David

    2013-10-01

    Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications. © 2013.

  12. Bioresorbable scaffolds in the treatment of coronary artery disease

    NARCIS (Netherlands)

    Y. Zhang (Yaojun); C.V. Bourantas (Christos); V. Farooq (Vasim); T. Muramatsu (Takashi); R. Diletti (Roberto); Y. Onuma (Yoshinobu); H.M. Garcia-Garcia (Hector); P.W.J.C. Serruys (Patrick)

    2013-01-01

    textabstractDrug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has

  13. Gastrointestinal stenting

    International Nuclear Information System (INIS)

    Zollikofer, C.L.; Schoch, E.; Jost, R.; Decurtins, M.

    2000-01-01

    Acute obstructions of the gastric outlet, the duodenum, or the large bowel require rapid treatment to relieve symptoms of retention or ileus. Large-caliber stents of 16 to 22 mm offer a new non-surgical alternative for treating these patients with minimal risks and high success rates. For gastroduodenal outlet obstructions palliated by self-expanded metal stents, clinical success rates are in the range of 80-100 %. Preoperative treatment of colorectal obstructions successfully relieves acute symptoms of ileus in 87-100 % allowing primary anastomosis and thereby reducing the costs caused by multiple operations and the need of intensive care by approximately 25 %. It is the purpose of this review to familiarize the reader with the indications, possibilities, and limits of intestinal stenting. (orig.)

  14. Stented Vessels: A Challenge for Histological Preparation and Microscopy

    Directory of Open Access Journals (Sweden)

    Andrea Nolte

    2013-06-01

    Full Text Available Objective: The first procedure to treat blocked coronary arteries was coronary artery bypass graft surgery. In 1977, Andreas Gruntzig introduced percutaneous transluminal coronary angioplasty (PTCA. Today, several stent systems exist ranging from bare metal stents to various drug-eluting stents. Unfortunately, our understanding of the arterial reaction to stent implantation is incomplete – primarily due to technical limitations in the histological study of stented vascular tissue. Methods: In our study, we examined different histological preparation methods based on the embedding material methacrylate. The procedure of embedding and sectioning stented porcine arteries was optimized for the specific requirements, like histochemistry, immunohistochemistry or pre-stained fluorescence. Furthermore, we used a microscopical technique described as fluorescence intensity decay shape analysis microscopy (FIDSAM to eliminate auto-fluorescence from fluorescently labeled tissue. Results: The sections were suitable for histochemical and immunohistochemical staining. Additionally, pre-labeled fluorescence in the porcine tissue was not lost by the embedding process. The evaluation of arterial cross sections with FIDSAM technology gave new, very important insights into the examination possibilities of fluorescently labeled tissue. Conclusions: Future studies of the vascular response to a variety of new stent materials will provide important clues to the pathogenesis resulting in restenosis and occlusion of stents. [J Interdiscipl Histopathol 2013; 1(3.000: 104-112

  15. [Changes in antithrombin III, prothrombin fragment 1 + 2 and thrombin-antithrombin III complex following implantation of a coronary Palmaz-Schatz stent].

    Science.gov (United States)

    Dittel, M; Haushofer, A; Spiel, R; Halbmayer, W M; Prachar, H; Fischer, M; Mlczoch, J

    1995-01-01

    To detect changes in the clotting parameters antithrombin III (AT III), prothrombin-fragment 1 + 2 (F 1 + 2) and thrombin-antithrombin-III-complex (TAT) after implantation of Palmaz Schatz stents, coagulation was monitored at standardized time points in 35 patients for 10 days. All patients were anticoagulated using a combination of heparin, phenprocoumon, and acetyl salicylic acid. Heparin therapy was guided by APTT levels (normal range 25-35 s), which were still within the therapeutic range (median 49.6 s (25%/75% percentiles 41.6/54.4) on day 10. Simultaneous oral anticoagulation was found to be effective on day 8 on average (INR median 2.24 (1.93/2.50)). The AT III activity dropped significantly (p < 0.0001) after a heparin loading dose of 15,000 IU during stenting. As the heparin dose was reduced on the following days, AT III levels increased significantly (p < 0.0001) during the observation time. There was a highly significant (p < 0.001) negative correlation between AT III and heparin levels. On days 4 and 5 F 1 + 2 values were significantly (p < 0.001 and p < 0.05) higher than on the day of stenting (median 1.07 (0.90/1.31) 1.13 nmol/l and 1.06 (0.85/1.23) nmol/l vs. 0.97 (0.69/1.15) nmol/l) and dropped during anticoagulation. F 1 + 2 levels showed a significant negative correlation (p < 0.0005) with APTT values. TAT values showed no significant changes during the observation period.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Drug-Eluting vs Bare-Metal Stents in Patients With Chronic Kidney Disease and Coronary Artery Disease: Insights From a Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Volodarskiy, Alexander; Kumar, Sunil; Pracon, Radoslaw; Sidhu, Mandeep; Kretov, Evgeny; Mazurek, Tomasz; Bockeria, Olga; Kaul, Upendra; Bangalore, Sripal

    2018-01-01

    Most drug-eluting stent (DES) trials have excluded patients with chronic kidney disease (CKD). The efficacy of DES implantation in patients with CKD is therefore not known. To evaluate the outcomes with DES vs bare-metal stent (BMS) implantation in patients with CKD. MEDLINE, EMBASE, and CENTRAL were searched for studies including at least 100 patients with CKD (estimated glomerular filtration rate ≤60 mL/min/1.73 m² or on dialysis) treated with DES or BMS and followed for at least 1 month and reporting outcomes of all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), target-vessel revascularization (TVR), and stent thrombosis (ST). Thirty-one studies (5 randomized) with 91,817 participants (49,081 DES and 42,736 BMS) fulfilled the inclusion criteria. DES was associated with lower all-cause mortality (relative risk [RR], 0.77; 95% confidence interval [CI], 0.71-0.84), CV mortality (RR, 0.51; 95% CI, 0.38-0.70), MI (RR, 0.90; 95% CI, 0.86-0.95), TVR (RR, 0.61; 95% CI, 0.47-0.80), and numerically lower ST (RR, 0.75; 95% CI, 0.55-1.01) when compared with BMS. Analysis by study type (RCTs vs non-RCTs) showed similar results for most outcomes (Pinteraction>.05) except all-cause mortality, where there was no difference between DES vs BMS in RCTs (Pinteraction=.04). The effects were greater with 2nd-generation DES vs BMS (for example, ST: RR, 0.38; 95% CI, 0.20-0.72). In patients with CKD, the available evidence, largely from observational studies, suggests significantly fewer events with DES vs BMS with even a lower ST rate with 2nd-generation DES. These findings should be tested in large, randomized trials.

  17. 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; Kaltoft, Anne Kjer

    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....

  18. 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

    (s). A final OCT was performed in case of reintervention. Six-month OCT follow-up was available in 85 patients. Twenty-three (46%) OCT-guided patients had additional postdilation or stenting. The percentage of acutely malapposed struts was substantially lower in the OCT-guided group (3.4% [interquartile range......, 0.3-7.6] versus 7.8% [interquartile range, 2.3-19.4]; Pinterquartile range, 1.2-9.8] versus 9.0% [interquartile range, 5.5-14.5], P

  19. Bioresorbable scaffolds in the treatment of coronary artery disease

    OpenAIRE

    Zhang, Yaojun; Bourantas, Christos; Farooq, Vasim; Muramatsu, Takashi; Diletti, Roberto; Onuma, Yoshinobu; Garcia-Garcia, Hector; Serruys, Patrick

    2013-01-01

    textabstractDrug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of t...

  20. Tricuspid valved stent implantation: novel stent with a self-expandable super-absorbent polymer.

    Science.gov (United States)

    Iino, Kenji; Lozonschi, Lucian; Metzner, Anja; Marczynski-Bühlow, Martin; Renner, Jochen; Cremer, Jochen; Lutter, Georg

    2011-08-01

    Trans-catheter aortic and pulmonary valve replacement procedures can result in favorable outcomes in selected patients. The aim of this study was to investigate the functioning of a novel self-expanding valved stent with super-absorbent polymer (SAP) for minimally invasive replacement of the tricuspid valve. A newly designed nitinol stent with SAP was specially designed for the tricuspid annulus. This device was composed of right atrial anchoring elements, a left ventricular tubular stent, and a trileaflet bovine pericardial valve. The stent was coated with a waterproof material, and a pouch containing SAP for minimizing paravalvular leakage was placed beneath the atrial element. Seven pigs underwent minimally invasive off-pump tricuspid valved stent implantation. This was performed through a lower ministernotomy using a transventricular approach under transesophageal echocardiographic guidance. After 1 and 6h, a complete echocardiographic evaluation and hemodynamics (Swan-Ganz catheter) were performed. Six of seven pigs exhibited normal hemodynamics immediately after tricuspid valved stent implantation and maintained stability for the entire period of monitoring. In one pig, a part of the atrial stent elements was deployed into the right ventricle, leading to significant paravalvular leakage, and died very soon. All subsequent animals survived with good results in the observation period. Accurate positioning of the valved stent was documented in six of seven pigs. SAP expanded and filled the gap between the stent and the native annulus in all animals. Mild paravalvular leakage was found in two of the six animals. Nevertheless, the observed leakage decreased to trace levels 6h after implantation. In the additional four pigs, only trace tricuspid regurgitation was revealed. No right ventricular outflow tract obstruction was detected. Trans-apical off-pump tricuspid valved stent implantation is feasible in an acute experimental setting, and SAP may help to reduce

  1. Polymer-free versus permanent polymer drug eluting stents in coronary artery disease: A meta-analysis of 10 RCTs with 6575 patients.

    Science.gov (United States)

    Wu, De-Wei; Yu, Meng-Yue; Gao, Hai-Yang; Zhang, Li; Song, Fei; Zhang, Xin-Yue; Wu, Yong-Jian

    2015-12-01

    Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer, which may delay intimal healing. Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES. However, the safety and efficacy of PF-DES remains controversial. Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE, Excerpta Medica Database (EMBASE) and Cochrane Library. Studies reporting late lumen loss (LLL), all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed. Ten studies enrolling 6575 patients were included in this meta-analysis. The PF-DES showed a benefit in reducing all-cause death ( OR  = 0.77, 95% CI : 0.61 to 0.98, P  = 0.03) and long-term LLL (weighted mean difference (WMD) -0.16 mm, 95% CI : -0.22 to -0.11 mm, P  DES showed benefits in reducing long-term LLL and mortality compared with PP-DES, but no superiority was found in short-term LLL, MI, TLR and LST. These findings provide a sound basis for the wide application of PF-DES in the future.

  2. Randomized comparison of deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents

    DEFF Research Database (Denmark)

    Thuesen, Leif; Galløe, Anders; Thayssen, Per

    2005-01-01

    in a native coronary artery were included in the study. There were 494 (664) patients (treated lesions) in the BxSonic(R), 499 (657) in the Express(R) and 500 (658) in the Flexmaster(R) groups. The groups were well matched with regard to age, sex, diabetes, smoking, hypercholesterol