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Sample records for elective stenting trial

  1. Elective implantation of covered stents for coarctation and recoarctation in adolescents and adults.

    Science.gov (United States)

    Alcibar, Juan; Blanco, Roberto; Fernandez, Luis; Arriola, Josune; Garcia, Koldobika; Peña, Natividad; Inguanzo, Ramón; Voces, Roberto; Castellanos, Enrique; Montes, Pedro M

    2013-06-01

    Stent implantation is an effective therapy for aortic coarctation and recoarctation. However, in adolescents and adults, aortic wall rupture and dissection can occur, as well as aneurysms during follow-up. In order to reduce these complications, we electively implant covered stents. Since 2005, we have performed the procedure using femoral access in 17 patients (2 adolescents and 15 adults), 16 electively and 1 as a rescue procedure. We used the Mullins technique in all cases, implanting a NuMED(®) covered stent. Good stent apposition was achieved in all 17 procedures; 8 patients required a distal flare. Gradient was reduced from 40 (16) mmHg to 2 (2) mmHg (P<.001) and lumen diameter increased from 4 (2) mm to 19 (3) mm (P<.001). Two exceptional cases are discussed: one patient with aortic wall rupture who underwent a rescue procedure using a stent within a covered stent and another patient with total obstruction and intercostal aneurysm in whom the outcome was fatal at 48 h postprocedure (autopsy is shown). Four-year clinical follow-up included Doppler echocardiography; an additional imaging technique was required in 13 patients. All patients recovered well and there were no complications. Covered stents are effective in treating coarctation and recoarctation in adolescents and adults, are the treatment of choice in patients with complex anatomy, and must be available in the operating room as a rescue device when implanting a conventional stent. Copyright © 2012 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  2. Emergency and elective implantation of covered stent systems in iatrogenic arterial injuries

    International Nuclear Information System (INIS)

    Goltz, J.P.; Kickuth, R.; Bastuerk, P.; Hoppe, H.; Triller, J.

    2011-01-01

    Purpose: To evaluate the effectiveness and safety of covered stents for the management of iatrogenic arterial injury. Materials and Methods: Between 03/1998 and 12/2009, 31 patients underwent selective covered stent implantation after iatrogenic arterial injury. 12/31 of these patients (38.7 %) were hemodynamically unstable. Six different endovascular covered stent types were utilized. The primary endpoints of this study were technical and clinical success and rates of minor and major complications. Results: Initial angiograms demonstrated active extravasation in 19 (61.3 %) patients and pseudoaneurysms in 12 (38.7 %) patients. The following sites of bleeding origin were detected: axillary artery, subclavian artery, common iliac artery, external iliac artery, internal iliac artery, common femoral artery, superficial femoral artery, popliteal and fibular artery, femoro-popliteal and popliteo-crural bypasses, common hepatic artery, aberrant hepatic artery, cystic and gastroduodenal artery. In all patients bleeding was effectively controlled by covered stent implantation resulting in an immediate technical success of 100 %. Clinical success attributed to covered stent implantation was documented in 30 of the 31 patients (96.8 %). Major complications included death in four patients (11.1 %), acute thrombosis with arm ischemia in one patient (2.8 %) and stent fracture with associated pseudoaneurysm in another patient (2.8 %). In 2/31 patients (6.5 %) covered stent failure was detected and successfully treated by implantation of a second covered stent. Conclusion: Emergency and elective implantation of covered stents may be used for minimally invasive and effective management of iatrogenic arterial injury. (orig.)

  3. Long-term follow-up of aneurysms treated electively with woven stent-assisted coiling.

    Science.gov (United States)

    Cheung, Nicholas K; Chiu, Albert Hy; Cheung, Andrew K; Wenderoth, Jason D

    2017-12-15

    Preliminary short-term results for stent-assisted coil embolization (SACE) using woven/braided stents have been promising. However, evidence supporting mid- to long-term efficacy and durability is lacking. To report the long-term results for the durability of elective intracranial aneurysms treated with woven stents. Between May 2012 and May 2015, 98 consecutive patients with 103 aneurysms underwent elective woven SACE across three Australian neurovascular centres. All patients had immediate, 6- and 18-month clinical and radiological follow-up. Radiological assessment was performed with modified Raymond-Roy occlusion scores based on angiography results, while clinical assessment was based on the modified Rankin Scale. Six-month follow-up was available in 100 aneurysms, and an 18-month follow-up in 97 aneurysms. Total occlusion rates of 82% were achieved at inception, 82% at 6 months, and 90% at 18 months. Satisfactory occlusion with small neck remnants was present in 17% at inception, 16% at 6 months, and 9% at 18 months. Good neurological outcomes were achieved in 95% at 18 months. Intraprocedural thromboembolic events were recorded in 3% and delayed events in 1% (all in patients taking clopidogrel). Aneurysm recurrence occurred in one patient (1%). Technical complications occurred in 5%. The total complication rate was 10%. Woven SACE is safe, efficacious, and durable at long-term 18-month follow-up, with very low recurrence and re-treatment rates. Preliminary results appear better than those for traditional laser-cut stents. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  5. Acute Thrombosis after Elective Direct Intracoronary Stenting in Primary Antiphospholipid Syndrome: A Case Report

    Directory of Open Access Journals (Sweden)

    Ho-Ming Su

    2003-04-01

    Full Text Available Antiphospholipid syndrome (APS is an uncommon prothrombotic disorder that has been increasingly recognized in recent years. The diagnosis of APS must be associated with venous or arterial thrombosis or both. Patients with APS usually present with recurrent deep vein thrombosis, pulmonary thromboembolism, thromboembolic stroke, or myocardial infarction. Here, we report a case of a 61-year-old female who presented with a 3-month history of increasingly frequent retrosternal chest tightness. After treadmill test and thallium-201 myocardial perfusion scan, she was admitted and underwent elective coronary angiography but developed acute thrombosis after direct intracoronary stenting. She was successfully rescued with repeat percutaneous transluminal coronary angioplasty and prolonged heparin and glycoprotein IIb/IIIa antagonist use. Laboratory data showed prolongation of partial thromboplastin time and positive anti-cardiolipin antibody. These findings satisfied the criteria for APS; the patient was diagnosed with primary APS because she had neither typical symptoms nor signs of systemic lupus erythematosus or other immunologic disorders. Thereafter, long-term oral anticoagulant appeared to be effective. To our knowledge, this is the first report of acute stent thrombosis in a patient with primary APS.

  6. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  7. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  8. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  9. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  10. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  11. 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....

  12. 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 ...

  13. Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

    Science.gov (United States)

    Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

    2016-06-27

    This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by

  14. 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

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

  15. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

    Science.gov (United States)

    Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

    2016-06-25

    The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

  16. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  17. Low-profile stent system for treatment of atherosclerotic renal artery stenosis : The GREAT trial

    NARCIS (Netherlands)

    Sapoval, Marc; Zahringer, Markus; Pattynama, Peter; Rabbia, Claudio; Vignali, Claudio; Maleux, Geert; Boyer, Louis; Szczerbo-Trojanowska, Malgorzata; Jaschke, Werner; Hafsahl, Geir; Downes, Mark; Beregi, Jean Paul; Veeger, Nic; Talen, Aly

    PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly

  18. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

    Science.gov (United States)

    Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

    2015-12-01

    To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

  19. 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

    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...

  20. 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.

  1. 111 ELECTION PETITION CASES AND THE RIGHT TO FAIR TRIAL ...

    African Journals Online (AJOL)

    Fr. Ikenga

    Section 36(1)2 gives to every person the right to have his civil rights and ... The procedure for challenging an election under the Electoral Act 2010 is by way of an election ..... buying and under – age voting, adding that INEC's selectivity, and.

  2. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

    Science.gov (United States)

    Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

    2011-06-01

    Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), 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 (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; Ppolymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

  3. Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX) : Rationale and design of the randomized TWENTE IV multicenter trial

    NARCIS (Netherlands)

    van der Heijden, Liefke C.; Kok, Marlies M.; Zocca, Paolo; Jessurun, Gillian A.J.; Schotborgh, Carl E.; Roguin, Ariel; Benit, Edouard; Aminian, Adel; Danse, Peter W.; Löwik, Marije M.; Linssen, Gerard C.M.; van der Palen, Job; Doggen, Carine J.M.; von Birgelen, Clemens

    2018-01-01

    Aim: The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent. Methods and results: The BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an

  4. Differentiated analysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial.

    Science.gov (United States)

    Khattab, Ahmed A; Richardt, Gert; Verin, Vitali; Kelbaek, Henning; Macaya, Carlos; Berland, Jacques; Miquel-Hebert, Karine; Dorange, Cécile; Serruys, Patrick W

    2008-03-01

    Restenosis is higher among certain subpopulations when subjected to percutaneous coronary interventions even when using drug-eluting stents. The randomised SPIRIT II trial demonstrated the superiority of the XIENCE V Everolimus Eluting Coronary Stent System over the TAXUS Paclitaxel-Eluting Stent System in terms of in-stent late loss at six months among 300 patients treated for de novo native coronary artery lesions. In this post-hoc analysis of SPIRIT II we focused on six-month angiographic outcomes of diabetic patients (n=69), left anterior descending arteries (n=149), long lesions >20 mm (n=43), small vessels B2 and C lesions (n=233). In-stent late loss was consistently less among all subgroups when treated by everolimus-eluting stents compared to paclitaxel-eluting stents: diabetics 0.15+/-0.26 mm versus 0.39+/-0.34 mm, p=0.006; LAD 0.12+/-0.23 mm versus 0.44+/-0.37 mm, pB2/C lesions 0.12+/-0.31 mm versus 0.36+/-0.36 mm, pSPIRIT II trial population.

  5. Self-expandable metallic stent as a bridge to elective surgery versus emergency surgery for acute malignant colorectal obstruction.

    Science.gov (United States)

    Li, Zhi-Xiong; Wu, Xiao-Hua; Wu, Hai-yan; Chang, Wen-Ju; Chang, Xiu-juan; Yi, Tuo; Shi, Qiang; Chen, Jing-Wen; Feng, Qing-Yang; Zhu, De-Xiang; Wei, Ye; Zhong, Yun-Shi; Xu, Jian-Min

    2016-03-01

    The efficacy and safety of self-expandable metallic stents (SEMSs) as a bridge for patients with acute malignant colorectal obstructions (AMCOs) are still controversial. We conducted this study to evaluate the outcomes of patients with AMCOs treated by different strategies. From January 2010 to March 2014, a total of 171 patients with AMCOs from Zhongshan Hospital were retrospectively enrolled in this study. One hundred twenty patients successfully received stent placement followed by one-stage laparoscopic or open resection in the stent group, and 51 patients received emergency operations in the emergency group. The operation duration and postoperative hospital stay were significantly shorter in the stent group (114.51 ± 28.65 vs. 160.39 ± 58.94 min, P stent group also had significantly reduced intraoperative blood loss and the incidence of postoperative complications compared with the emergency group (61.00 ± 43.70 vs. 121.18 ± 85.90 ml, P stent group was significantly longer than that in the emergency group (53 vs. 41 months, P = 0.034). In subgroup analysis of stent group, the stent laparoscopy group had significantly decreased postoperative complications (P = 0.025), and similar long-term survival (P = 0.81). Stent placement as a bridge to surgery is a safe and feasible procedure and provides significant advantages in terms of short-term outcomes and favorable prognoses for patients with AMCOs. Laparoscopic surgery could be considered as an optimal treatment after stent placement.

  6. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

    Science.gov (United States)

    Citerio, Giuseppe; Franzosi, Maria Grazia; Latini, Roberto; Masson, Serge; Barlera, Simona; Guzzetti, Stefano; Pesenti, Antonio

    2009-04-06

    Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaesthesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III) and Glasgow Coma Scale (GCS) equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score > or = 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement of urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anaesthesia; intraoperative

  7. Design of the exhale airway stents for emphysema (EASE) trial : an endoscopic procedure for reducing hyperinflation

    NARCIS (Netherlands)

    Shah, Pallav L.; Slebos, Dirk-Jan; Cardoso, Paulo F. G.; Cetti, Edward J.; Sybrecht, Gerhard W.; Cooper, Joel D.

    2011-01-01

    Background: Airway Bypass is a catheter-based, bronchoscopic procedure in which new passageways are created that bypass the collapsed airways, enabling trapped air to exit the lungs. The Exhale Airway Stents for Emphysema (EASE) Trial was designed to investigate whether Exhale (R) Drug-Eluting

  8. Trial of self-expandable metallic stents in the palliation of tracheo ...

    African Journals Online (AJOL)

    Trial of self-expandable metallic stents in the palliation of tracheo-oesophageal fistula in carcinoma of the oesophagus. ... Over half of the patients in the TOF group had concomitant pneumonia at presentation with decreased survival (p = 0.010) and a hazard ratio of 10.86. Two patients died, on days 4 and 7 respectively.

  9. Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

    Science.gov (United States)

    Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

    2018-01-01

    This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

  10. The Bolton Treovance abdominal stent-graft: European clinical trial design.

    Science.gov (United States)

    Chiesa, R; Riambau, V; Coppi, G; Zipfel, B; Llagostera, S; Marone, E M; Kahlberg, A

    2012-10-01

    Endovascular aortic repair (EVAR) has emerged as a promising, less invasive alternative to conventional open surgery for the treatment of infrarenal abdominal aortic aneurysms (AAAs). In the last 20 years, the application rate of EVAR and its clinical results have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary re-interventions. The Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain) is a new-generation endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. In particular, it is provided with some innovative features as a double layer of proximal barbs (suprarenal and infrarenal) for supplemental fixation, dull barbs between modules to avoid potential leg disconnections, detachable outer sheath provided with a new-design hemostatic valve, and a double improved mechanism (slow motion and "pin and pull") for precise stent-graft deployment. A European prospective, non-randomized, multi-institutional, "first-in-human" trial (the ADVANCE trial) was conducted from March to December 2011 to assess the safety and performance of the Treovance stent-graft system before commercialization. Thirty patients with anatomically suitable non-ruptured AAAs were enrolled at five clinical sites in Italy, Spain, and Germany. EVAR was completed successfully in all patients. The stent-graft was delivered and deployed safely even in heavily angulated or calcified anatomies. No 30-day device-related complications nor deaths were observed. Preliminary experience with the Treovance abdominal stent-graft within the ADVANCE trial was satisfactory with regard to technical success and perioperative clinical results. Follow-up data are needed to assess mid- and long-term clinical outcomes, along with durability of this new-generation endovascular device.

  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. Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial

    NARCIS (Netherlands)

    Homs, Marjolein Y. V.; Steyerberg, Ewout W.; Eijkenboom, Wilhelmina M. H.; Tilanus, Hugo W.; Stalpers, Lukas J. A.; Bartelsman, Joep F. W. M.; van Lanschot, Jan J. B.; Wijrdeman, Harm K.; Mulder, Chris J. J.; Reinders, Janny G.; Boot, Henk; Aleman, Berthe M. P.; Kuipers, Ernst J.; Siersema, Peter D.

    2004-01-01

    Background Both single-dose brachytherapy and self-expanding metal stent placement are commonly used for palliation of oesophageal obstruction due to inoperable cancer, but their relative merits are unknown. We under-took a randomised trial to compare the outcomes of brachytherapy and stent

  13. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

    Science.gov (United States)

    Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

    2013-01-01

    Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

  14. [Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

    Science.gov (United States)

    Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

    2016-02-14

    Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

  15. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

    Directory of Open Access Journals (Sweden)

    Guzzetti Stefano

    2009-04-01

    Full Text Available Abstract Background Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA with volatile-based neuroanaesthesia (VA has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. Methods/Design NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III and Glasgow Coma Scale (GCS equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil. The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point. Two statistical comparisons have been planned: 1 sevoflurane + fentanyl vs. propofol + remifentanil; 2 sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a measurement of urinary catecholamines and plasma and urinary cortisol and (b estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded

  16. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms.

    Science.gov (United States)

    El-Nahas, Ahmed R; Tharwat, Mohamed; Elsaadany, Mohamed; Mosbah, Ahmed; Gaballah, Mohamed A

    2016-07-01

    To compare the effectiveness of tamsulosin and solifenacin in relieving ureteral stents related symptoms. A randomized controlled trial was conducted between January 2013 and July 2014. Inclusion criteria were patients aged 20-50 years who underwent temporary unilateral ureteral stent for drainage of calcular upper tract obstruction or after ureteroscopic lithotripsy. Patients with history of lower urinary tract symptoms before stent placement, stents that were fixed after open or laparoscopic procedures, and those who developed complications related to the primary procedure were not included. Eligible patients were randomly assigned to 1 of 3 groups using computer-generated random tables. Patients in group 1 received placebo, patients in group 2 received tamsulosin 0.4 mg once daily, and those in group 3 received solifenacin 5 mg once daily. Ureteral Stent Symptom Questionnaire (USSQ) was answered by all patients 1-2 weeks after stent placement. The primary outcome was the comparison of total score of USSQ between all groups. The study included 131 patients. All baseline characteristics (age, sex, side, indication, length, and duration of stent) were comparable for all groups. Total USSQ score was 61 in solifenacin group, 76 in tamsulosin group, and 83 in control group (P tamsulosin group (P tamsulosin alone or solifenacin alone in patients with ureteral stents can improve the quality of life by decreasing ureteral stent-related symptoms. Solifenacin was better than tamsulosin. CLINICALTRIAL. NCT01880619.

  17. 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

  18. Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

    Science.gov (United States)

    Dhar, Anjan; Close, Helen; Viswanath, Yirupaiahgari K; Rees, Colin J; Hancock, Helen C; Dwarakanath, A Deepak; Maier, Rebecca H; Wilson, Douglas; Mason, James M

    2014-01-01

    AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures. METHODS: This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures. Patients were randomised using a multicentre, blinded assessor design, comparing a biodegradable stent (BS) with endoscopic dilatation (ED). The primary endpoint was the average dysphagia score during the first 6 mo. Secondary endpoints included repeat endoscopic procedures, quality of life, and adverse events. Secondary analysis included follow-up to 12 mo. Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values. Nonparametric tests were used. RESULTS: Although both groups improved, the average dysphagia scores for patients receiving stents were higher after 6 mo: BS-ED 1.17 (95%CI: 0.63-1.78) P = 0.029. The finding was robust under different estimation methods. Use of additional endoscopic procedures and quality of life (QALY) estimates were similar for BS and ED patients at 6 and 12 mo. Concomitant use of gastrointestinal prescribed medication was greater in the stent group (BS 5.1, ED 2.0 prescriptions; P dysphagia, co-medication and adverse events. Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology. PMID:25561787

  19. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial.

    Science.gov (United States)

    Lal, Brajesh K; Beach, Kirk W; Roubin, Gary S; Lutsep, Helmi L; Moore, Wesley S; Malas, Mahmoud B; Chiu, David; Gonzales, Nicole R; Burke, J Lee; Rinaldi, Michael; Elmore, James R; Weaver, Fred A; Narins, Craig R; Foster, Malcolm; Hodgson, Kim J; Shepard, Alexander D; Meschia, James F; Bergelin, Robert O; Voeks, Jenifer H; Howard, George; Brott, Thomas G

    2012-09-01

    In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63-1·29; p=0·58). Female sex (1·79, 1·25-2·56), diabetes (2·31, 1·61-3·31

  20. Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial).

    Science.gov (United States)

    Waksman, Ron; Ghali, Magdi; Goodroe, Randy; Ryan, Thomas; Turco, Mark; Ring, Michael; McGarry, Thomas; Dobies, David; Shammas, Nicolas; Steinberg, Daniel H; Swymelar, Stacy; Kaneshige, Kimberly; Torguson, Rebecca

    2012-10-15

    Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. 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.

  2. Stent Placement in a Neonate with Sano Modification of the Norwood using Semi-Elective Extracorporeal Membrane Oxygenation

    Directory of Open Access Journals (Sweden)

    Mustafa Gulgun

    Full Text Available Abstract Extracorporeal membrane oxygenation (ECMO is a well-established tool of cardiopulmonary circulatory support for cardiopulmonary failure in children and adults. It has been used as a supportive strategy during interventional procedures in neonates with congenital heart disease. Herein, we describe a neonate with hypoplastic left heart syndrome who underwent stenting of the Sano shunt and left pulmonary artery after Norwood Sano operation using intra-procedural ECMO support. The use of ECMO as a bridge to recovery might be a feasible and reasonably safe adjunctive approach in the treatment of complications in selective case of neonates having undergone the Norwood Sano procedure.

  3. Effect of white-matter lesions on the risk of periprocedural stroke after carotid artery stenting versus endarterectomy in the International Carotid Stenting Study (ICSS): a prespecified analysis of data from a randomised trial

    NARCIS (Netherlands)

    Ederle, J.; Davagnanam, I.; Worp, H.B. van der; Venables, G.S.; Lyrer, P.A.; Featherstone, R.L.; Brown, M.M.; Jager, H.R.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2013-01-01

    BACKGROUND: Findings from randomised trials have shown a higher early risk of stroke after carotid artery stenting than after carotid endarterectomy. We assessed whether white-matter lesions affect the perioperative risk of stroke in patients treated with carotid artery stenting versus carotid

  4. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.

    Science.gov (United States)

    Serruys, Patrick W; Farooq, Vasim; Kalesan, Bindu; de Vries, Ton; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Wijns, William; Morice, Marie Claude; Di Mario, Carlo; Corti, Roberto; Antoni, Diethmar; Sohn, Hae Y; Eerdmans, Pedro; Rademaker-Havinga, Tessa; van Es, Gerrit-Anne; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

    2013-08-01

    This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority 1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. 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...

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

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Maeng, Michael; Thayssen, Per

    2013-01-01

    OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients. BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent...... implantation due to intimal hyperplasia (IH). METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available...... in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0...

  7. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

    Science.gov (United States)

    Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

    2011-10-01

    This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the

  8. Stent parameters predict major adverse clinical events and the response to platelet glycoprotein IIb/IIIa blockade: findings of the ESPRIT trial.

    Science.gov (United States)

    Tcheng, James E; Lim, Ing Haan; Srinivasan, Shankar; Jozic, Joseph; Gibson, C Michael; O'Shea, J Conor; Puma, Joseph A; Simon, Daniel I

    2009-02-01

    Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet glycoprotein IIb/IIIa blockade by stent parameters. In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of or=30 mm), and total stented vessel area (by quartiles of area or=292 mm(2)). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to or=30 mm (OR, 0.43; 95% CI, 0.25 to 0.75; P=0.003), stent diameters of >2.5 to <3.5 mm (OR, 0.56; 95% CI, 0.39 to 0.82; P=0.002), and with 2 stents implanted (OR, 0.39; 95% CI, 0.22 to 0.69; P=0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P<0.001); these gradients were flattened in the eptifibatide group (P=0.005 for stent length). Stent parameters predict MACE after percutaneous coronary intervention. Glycoprotein IIb/IIIa blockade mitigates much of the hazard of increasing procedural complexity.

  9. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study.

    Science.gov (United States)

    Rusinaru, Dan; Vrolix, Mathias; Verheye, Stefan; Chowdhary, Saqib; Schoors, Danny; Di Mario, Carlo; Desmet, Walter; Donohoe, Dennis J; Ormiston, John A; Knape, Charlene; Bezerra, Hiram; Lansky, Alexandra; Wijns, William

    2015-12-01

    We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES). First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion. This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES). Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction. © 2015 Wiley Periodicals, Inc.

  10. Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial.

    Science.gov (United States)

    O'Shea, J C; Hafley, G E; Greenberg, S; Hasselblad, V; Lorenz, T J; Kitt, M M; Strony, J; Tcheng, J E

    2001-05-16

    The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000. Ninety-two tertiary care centers in the United States and Canada. A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of

  11. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents.

    Science.gov (United States)

    El-Hayek, Georges; Bangalore, Sripal; Casso Dominguez, Abel; Devireddy, Chandan; Jaber, Wissam; Kumar, Gautam; Mavromatis, Kreton; Tamis-Holland, Jacqueline; Samady, Habib

    2017-03-13

    The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months), the strut thickness of the BP-DES (thin 100 μm), or the DAPT duration (≥6 months vs. ≥12 months). BP-DES have similar safety and efficacy profiles to second-generation DP-DES. Published by Elsevier Inc.

  12. Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial)

    NARCIS (Netherlands)

    A.J.J. IJsselmuiden (Alexander); C. Simsek (Cihan); Van Driel, A.G. (A. G.); Bouchez, D. (D.); G. Amoroso (Giovanni); P. Vermeersch (Paul); Karjalainen, P.P. (P. P.)

    2018-01-01

    textabstractAims To describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs). Methods and Results A randomised controlled trial was performed in four hospitals in three European countries between

  13. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

    Science.gov (United States)

    Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

    2015-02-07

    Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

  14. Elective repeat cesarean delivery compared with trial of labor after a prior cesarean delivery: a propensity score analysis

    NARCIS (Netherlands)

    Kok, N.; Ruiter, L.; Lindeboom, R.; de Groot, C.; Pajkrt, E.; Mol, B. W.; Kazemier, B. M.

    2015-01-01

    To determine neonatal and short term maternal outcomes according to intentional mode of delivery following a cesarean delivery (CD). Women pregnant after CD between January 2000 and December 2007 were categorized according to whether they had an elective repeat CD (ERCD) or a Trial of Labor (TOL).

  15. A Comparison of Stent Implant versus Medical Treatment for Severe Symptomatic Intracranial Stenosis: A Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Rezao Mohammadian

    2012-11-01

    Full Text Available Background: Atherosclerotic stenosis of the major intracranial arteries is the most common cause of ischemic stroke. There are limited treatments for severe intracranial stenosis, and stent placement versus medical treatment remains controversial. The aim of this study was to compare functional outcomes of these two modalities in patients with severe symptomatic intracranial stenosis. Methods: At a single center, between 2008 and 2011, patients with angiographically demonstrated severe (70–90% symptomatic intracranial atherosclerosis were divided into two groups: group A, which received only medical treatment, and group B, which underwent endovascular stent implant treatment. The severity and location of the stenosis was determined by digital subtraction angiography and the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID trial criteria in all patients. The exclusion criteria were: specific causes other than atherosclerosis, such as artery dissection, fibromuscular dysplasia, vasculitis, radiation and intracranial hemorrhage, focal neurological deficit that did not correlate to internal carotid artery or middle cerebral artery stenosis. All procedures were done under light anesthesia. Technical success was defined as the reduction of stenosis to Results: Overall, 63 patients (29 in group A and 34 in group B were evaluated and followed for a mean period of 15.22 months (range 6–25. The technical success rate was 97% in a total of 34 stents in 34 patients. There was no difference between the early (within 30 days adverse event rates of the two groups. The median follow-up duration for the stent implant patients was 15 months (range 6–25, and for the medically treated cohort it was 14 months (range 8–25. The re-stenosis rate was 5.8% and the total number of late (>30 days adverse events, including stroke, myocardial infarction and death, was 1 (2.9% and 6 (20.7% in the stent implant and medical groups, respectively (p = 0.042. The

  16. Predictors of early stent occlusion among plastic biliary stents.

    Science.gov (United States)

    Khashab, Mouen A; Kim, Katherine; Hutfless, Susan; Lennon, Anne Marie; Kalloo, Anthony N; Singh, Vikesh K

    2012-09-01

    A major disadvantage of plastic biliary stents is their short patency rates. The aim of this study was to identify predictors of early stent occlusion among patients receiving conventional plastic biliary stents. Early stent occlusion was defined as worsening cholestatic liver test results of a severity sufficiently significant to warrant ERCP with stent exchange prior to the planned stent exchange, or as symptoms of cholangitis. The association of cumulative stent diameter, demographics, stricture location, procedure indication, Charlson comorbidity index, history of prior early stent occlusion, presence of gallbladder, and performance of sphincteromy with the occurrence of early stent occlusion was studied using logistic regression and multivariate analysis. Our patient cohort comprised 343 patients (mean age 59.3 years) who underwent 561 ERCP procedures with the placement of one or more plastic biliary stents (mean number of stents per procedure 1.2, mean total diameter of stents per procedure 12 Fr). Early stent occlusion occurred in 73 (13 %) procedures. Female gender was protective against early stent occlusion (adjusted OR 0.54, 95 % CI 0.32-0.90, p = 0.02), while hilar stricture location was independently associated with a significantly increased risk of early stent occlusion (adjusted OR 3.41, 95 % CI 1.68-6.90, p = 0.0007). Early occlusion of conventional biliary stents occurred in 13 % of cases. While female gender decreased the risk of early stent occlusion, hilar stricture location was a significant predictor of early stent occlusion. Our results suggest that physicians should consider early elective stent exchange in patients with hilar strictures.

  17. Laparoscopic elective cholecystectomy with and without drain: A controlled randomised trial

    Directory of Open Access Journals (Sweden)

    Gouda El-labban

    2012-01-01

    Full Text Available Background : Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Routine drainage after laparoscopic cholecystectomy is an issue of considerable debate. Therefore, a controlled randomised trial was designed to assess the value of drains in elective laparoscopic cholecystectomy. Materials and Methods: During a two-year period (From April 2008 to January 2010, 80 patients were simply randomised to have a drain placed (group A, an 8-mm pentose tube drain was retained below the liver bed, whereas 80 patients were randomised not to have a drain (group B placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, wound infection and hospital stay between the two groups. Results : There was no mortality in either group and no statistically significant difference in postoperative pain, nausea and vomiting, wound infection or abdominal collection between the two groups. However, hospital stay was longer in the drain group than in group without drain and it is appearing that the use of drain delays hospital discharge. Conclusion : The routine use of a drain in non-complicated laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with longer hospital stay.

  18. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial.

    Science.gov (United States)

    Tolleson, Thaddeus R; O'Shea, J Conor; Bittl, John A; Hillegass, William B; Williams, Kathryn A; Levine, Glenn; Harrington, Robert A; Tcheng, James E

    2003-02-05

    We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation. Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin. The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events. No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients. Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

  19. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

    2016-06-27

    The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy.

    Science.gov (United States)

    Longbottom, Mary E; Roberts, Jamie N; Tom, Meelee; Hughes, Susan E; Howard, Virginia J; Sheffet, Alice J; Meschia, James F; Brott, Thomas G

    2012-08-01

    Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  1. 3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

    2018-05-28

    This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

  2. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).

    Science.gov (United States)

    Vilain, Katherine R; Magnuson, Elizabeth A; Li, Haiyan; Clark, Wayne M; Begg, Richard J; Sam, Albert D; Sternbergh, W Charles; Weaver, Fred A; Gray, William A; Voeks, Jenifer H; Brott, Thomas G; Cohen, David J

    2012-09-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated similar rates of the primary composite end point between carotid artery stenting (CAS) and carotid endarterectomy (CEA), although the risk of stroke was higher with CAS, and the risk of myocardial infarction was higher with CEA. Given the large number of patients who are candidates for these procedures, an understanding of their relative cost and cost-effectiveness may have important implications for health care policy and treatment guidelines. We performed a formal economic evaluation alongside the CREST trial. Costs were estimated from all trial participants over the first year of follow-up using a combination of resource use data and hospital billing data. Patient-level health use scores were obtained using data from the SF-36. We then used a Markov disease-simulation model calibrated to the CREST results to project 10-year costs and quality-adjusted life expectancy for the 2 treatment groups. Although initial procedural costs were $1025/patient higher with CAS, postprocedure costs and physician costs were lower such that total costs for the index hospitalization were similar for the CAS and CEA groups ($15 055 versus $14 816; mean difference, $239/patient; 95% CI for difference, -$297 to $775). Neither follow-up costs after discharge nor total 1-year costs differed significantly. For the CREST population, model-based projections over a 10-year time horizon demonstrated that CAS would result in a mean incremental cost of $524/patient and a reduction in quality-adjusted life expectancy of 0.008 years compared with CEA. Probabilistic sensitivity analysis demonstrated that CEA was economically attractive at an incremental cost-effectiveness threshold of $50 000/quality-adjusted life-year gained in 54% of samples, whereas CAS was economically attractive in 46%. Despite slightly lower in-trial costs and lower rates of stroke with CEA compared with CAS, projected 10-year outcomes

  3. FFR-guided multivessel stenting reduces urgent revascularization compared with infarct-related artery only stenting in ST-elevation myocardial infarction: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Gupta, Ankur; Bajaj, Navkaranbir S; Arora, Pankaj; Arora, Garima; Qamar, Arman; Bhatt, Deepak L

    2018-02-01

    Randomized controlled trials (RCTs) have shown fractional flow reserve-guided (FFR) multivessel stenting to be superior to infarct-related artery (IRA) only stenting in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease. This effect was mainly driven by a reduction in overall repeat revascularization. However, the ability to assess the effect of this strategy on urgent revascularization or reinfarction was underpowered in individual trials. We searched Pubmed, EMBASE, Cochrane CENTRAL, and Web of Science for RCTs of FFR-guided multivessel stenting versus IRA-only stenting in STEMI with multivessel disease. The outcomes of interest were death, reinfarction, urgent, and non-urgent repeat revascularization. Risk ratios (RR) were pooled using the DerSimonian and Laird random-effects model. After review of 786 citations, 2 RCTs were included. The pooled results demonstrated a significant reduction in the composite of death, reinfarction, or revascularization in the FFR-guided multivessel stenting group versus IRA-only stenting group (RR [95%, Confidence Interval]: 0.49 [0.33-0.72], p<0.001). This risk reduction was driven mainly by a reduction in repeat revascularization, both urgent (0.41 [0.24-0.71], p=0.002) and non-urgent revascularization (0.31 [0.19-0.50], p<0.001). Pooled RR for reinfarction was lower in the FFR-guided strategy, but was not statistically significant (0.71[0.39-1.31], p=0.28). This systematic review and meta-analysis suggests that a strategy of FFR-guided multivessel stenting in STEMI patients reduces not only overall repeat revascularization but also urgent revascularization. The effect on reinfarction needs to be evaluated in larger trials. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  4. Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

    Energy Technology Data Exchange (ETDEWEB)

    Lammer, Johannes, E-mail: jlammer@gmx.at, E-mail: johannes.lammer@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); Zeller, Thomas, E-mail: thomas.zeller@universitaets-herzzentrum.de [Universitaets-Herzzentrum Freiburg-Bad Krozingen, Department of Angiology (Germany); Hausegger, Klaus A., E-mail: klaus.hausegger@lkh-klu.at [Klinikum Klagenfurt, The Department of Diagnostic and Interventional Radiology (Austria); Schaefer, Philipp J., E-mail: jp.schaefer@rad.uni-kiel.de [University Clinics Schleswig-Holstein, The Department of Radiology (Germany); Gschwendtner, Manfred, E-mail: manfred.gschwendtner@elisabethinen.or.at [Elisabethinen Hospital, The Department of Diagnostic and Interventional Radiology (Austria); Mueller-Huelsbeck, Stefan, E-mail: muehue@diako.de [Diakonissen Hospital, The Department of Diagnostic and Interventional Radiology (Germany); Rand, Thomas, E-mail: thomas.rand@wienkav.at [Hietzing Hospital, The Department of Radiology (Austria); Funovics, Martin, E-mail: martin.funovics@meduniwien.ac.at; Wolf, Florian, E-mail: florian.wolf@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); Rastan, Aljoscha, E-mail: aljoscha.rastan@universitaets-herzzentrum.de [Universitaets-Herzzentrum Freiburg-Bad Krozingen, Department of Angiology (Germany); Gschwandtner, Michael, E-mail: michael.gschwandtner@meduniwien.ac.at [Medical University Vienna, The Department of Angiology (Austria); Puchner, Stefan, E-mail: stefan.puchner@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); and others

    2015-02-15

    PurposeThe hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.MethodsA prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN{sup ®} Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN{sup ®} versus 17.3 ± 6.6 cm in the BMS group.ResultsThe 24-month primary patency rates in the VIABAHN{sup ®} and BMS group were: intention-to-treat 63.1 (95 % CI 0.52–0.76) versus 41.2 % (95 % CI 0.29–0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58–0.83) versus 40.0 % (95 % CI 0.28–0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70–0.90) versus 73.0 % (95 % CI 0.63–0.85) for VIABAHN{sup ®} versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50–0.85) versus 26.7 % (95 % CI 0.12–0.59; log rank p = 0.004) for VIABAHN{sup ®} versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68–0.94) versus 61.9 % (95 % CI 0.44–0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN{sup ®} versus the BMS group, respectively.ConclusionAt 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244)

  5. 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.

  6. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

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

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  7. 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

    BACKGROUND: 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 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...... Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial...

  8. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...

  9. Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

    Science.gov (United States)

    Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

    2015-01-01

    Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a

  10. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial) : randomised, sham-controlled, multicentre trial

    NARCIS (Netherlands)

    Shah, P. L.; Slebos, D-J; Cardoso, P. F. G.; Cetti, E.; Voelker, K.; Levine, B.; Russell, M. E.; Goldin, J.; Brown, M.; Cooper, J. D.; Sybrecht, G. W.

    2011-01-01

    Background Airway bypass is a bronchoscopic lung-volume reduction procedure for emphysema whereby transbronchial passages into the lung are created to release trapped air, supported with paclitaxel-coated stents to ease the mechanics of breathing. The aim of the EASE (Exhale airway stents for

  11. Early Ventricular Tachycardia or Fibrillation in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention and Impact on Mortality and Stent Thrombosis (from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial).

    Science.gov (United States)

    Kosmidou, Ioanna; Embacher, Monica; McAndrew, Thomas; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

    2017-11-15

    The prevalence and impact of early ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) occurring before mechanical revascularization for acute ST segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention are poorly understood. We sought to investigate the association between early VT/VF and long-term clinical outcomes using data from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Among 3,602 patients with STEMI, 108 patients (3.0%) had early VT/VF. Baseline clinical characteristics were similar in patients with versus without early VT/VF. Patients with early VT/VF had shorter symptom-to-balloon times and lower left ventricular ejection fraction and underwent more frequent thrombectomy compared with patients without early VT/VF. Adjusted 3-year rates of all-cause death (15.7% vs 6.5%; adjusted hazard ratio 2.62, 95% confidence interval 1.48 to 4.61, p stent thrombosis (13.7% vs 5.7%; adjusted hazard ratio 2.74, 95% confidence interval 1.52 to 4.93, p Stents in Acute Myocardial Infarction trial, VT/VF occurring before coronary angiography and revascularization in patients with STEMI was strongly associated with increased 3-year rates of death and stent thrombosis. Further investigation into the mechanisms underlying the increased risk of early stent thrombosis in patients with early VT/VF is required. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  13. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  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 INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

    Science.gov (United States)

    Pratesi, Giovanni; Pratesi, Carlo; Chiesa, Roberto; Coppi, Gioacchino; Scheinert, Dierk; Brunkwall, Jan S; van der Meulen, Stefaan; Torsello, Giovanni

    2017-10-01

    This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. The INCRAFT® AAA Stent

  16. Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

    2014-10-22

    The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on

  17. 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

    NARCIS (Netherlands)

    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.

    2018-01-01

    Background 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

  18. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  19. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris; Sabharwal, Tarun; Siablis, Dimitris

    2013-01-01

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better

  20. Ureteral Stenting after Uncomplicated Ureteroscopy for Distal Ureteral Stones: A Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Y. El Harrech

    2014-01-01

    Full Text Available Objectives. We compared outcome and complications after uncomplicated ureteroscopic treatment of distal ureteral calculi with or without the use of ureteral stents. Materials and Methods. 117 patients, prospectively divided into three groups to receive a double j stent (group 1, 42 patients, ureteral stent (group 2, 37 patients, or no stent (group 3, 38 patients, underwent ureteroscopic treatment of distal ureteral calculi. Stone characteristics, operative time, postoperative pain, lower urinary tract symptoms (LUTS, analgesia need, rehospitalization, stone-free rate, and late postoperative complications were all studied. Results. There were no significant differences in preoperative data. There was no significant difference between the three groups regarding hematuria, fever, flank pain, urinary tract infection, and rehospitalisation. At 48 hours and 1 week, frequency/urgency and dysuria were significantly less in the nonstented group. When comparing group 1 and group 3, patients with double j stents had statistically significantly more bladder pain (P=0.003, frequency/urgency (P=0.002, dysuria (P=0.001, and need of analgesics (P=0.001. All patients who underwent imaging postoperatively were without evidence of obstruction or ureteral stricture. Conclusions. Uncomplicated ureteroscopy for distal ureteral calculi without intraoperative ureteral dilation can safely be performed without placement of a ureteral stent.

  1. Peri-interventional antibiotic prophylaxis only vs continuous low-dose antibiotic treatment in patients with JJ stents: a prospective randomised trial analysing the effect on urinary tract infections and stent-related symptoms.

    Science.gov (United States)

    Moltzahn, Felix; Haeni, Katharina; Birkhäuser, Frédéric D; Roth, Beat; Thalmann, George N; Zehnder, Pascal

    2013-02-01

    To evaluate the antibiotic treatment regime in patients with indwelling JJ stents, the benefits and disadvantages of a peri-interventional antibiotic prophylaxis were compared with those of a continuous low-dose antibiotic treatment in a prospective randomised trial. In all, 95 patients were randomised to either receive peri-interventional antibiotic prophylaxis during stent insertion only (group A, 44 patients) or to additionally receive a continuous low-dose antibiotic treatment until stent removal (group B, 51). Evaluations for urinary tract infections (UTI), stent-related symptoms (SRSs) and drug side-effects were performed before stent insertion and consecutively after 1, 2 and 4 weeks and/or at stent withdrawal. All patients received a peri-interventional antibiotic prophylaxis with 1.2 g amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (625 mg) once daily was administered for continuous low-dose treatment (group B). Primary endpoints were the overall rates of UTIs and SRSs. Secondary endpoints were the rates and severity of drug side-effects. Neither the overall UTI rates (group A: 9% vs group B: 10%), nor the rates of febrile UTIs (group A: 7% vs group B: 6%) were different between the groups. Similarly, SRS rates did not differ (group A: 98% vs group B: 96%). Antibiotic side-effect symptoms were to be increased in patients treated with low-dose antibiotics. A continuous antibiotic low-dose treatment during the entire JJ stent-indwelling time does not reduce the quantity or severity of UTIs and has no effect on SRSs either compared with a peri-interventional antibiotic prophylaxis only. © 2012 BJU International.

  2. Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.

    Science.gov (United States)

    Myla, Subbarao; Bacharach, J Michael; Ansel, Gary M; Dippel, Eric J; McCormick, Daniel J; Popma, Jeffrey J

    2010-05-01

    The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). Copyright 2010 Wiley-Liss, Inc.

  3. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

  4. The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

    Science.gov (United States)

    Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

    2018-05-11

    The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

  5. Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

    Science.gov (United States)

    Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

    2017-06-26

    This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  6. Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

    Science.gov (United States)

    Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

    2014-12-01

    To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled

  7. The Dresden in-stent restenosis radiation trial (DIRRT) with liquid-filled 188Re balloon

    International Nuclear Information System (INIS)

    Kropp, J.; Runge, R.R.; Reynen, K.; Koeckeritz, U.; Schmeisser, A.; Strasser, R.H.

    2002-01-01

    Full text: In some studies intracoronary radiation therapy (IRT) to minimize the restenosis rate after PTCA proved to be effective. We evaluated the performance, safety and effectiveness of IRT with 188 Re-perrhenate filled into a standard PTCA balloon. This kind of IRT allows a self-centering homogenous dose distribution to the vessel wall. 107 patients (pts) with a mean age of 63 years (81 m, 26 fin) with in-stent restenosis (type B in 39 %, type C in 61 %) and proven ischemia were included. After routine re-PTCA with or without additional stent implantation a second standard balloon was placed into the PTCA area and filled with β - -emitting liquid 188 Re at 3 atm. Irradiation time was 525 ± 167 sec to achieve a dose of 30 Gy at 0.5 mm depth of the vessel wall. In only one procedure there was a disconnection of the 188 Re containing system and the catheter but no contamination of the cath table or lab was measured. In 16 coronaries 21 stents were additionally implanted. In the follow-up 4 stent thromboses (1 day, 37 days, 2 x 6 months) with subsequent myocardial infarction were noticed, all in pts with additionally implanted stents. 57 pts had control angiography after 4 to 6 months after therapy and 41 after one year. Restenosis (stenosis > 50 % of luminal diameter) was shown in 9 out of 12 pts (75 %) with additionally implanted stents but only in 4 out of 24 pts (17 %) with PTCA alone. Reocclusion was noticed in 3 (25 %) pts with additional stent but only in 1 pt (4 %) without. No re-restenosis occurred in 20 patients which were without finding after 6 months. Intracoronary radiation therapy (IRT) with β - -emitting liquid-filled 188 Re balloon is a safe and effective therapy method which might be used routinely. Long-term results seem satisfactory in a patient group with in-stent restenosis and high risk of re-restenosis. But the positive effect of irradiation is abolished if an additional stent after PTCA is needed. (author)

  8. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

    NARCIS (Netherlands)

    Bonati, L.H.; Dobson, J.; Featherstone, R.L.; Ederle, J.; Worp, H.B. van der; Borst, G.J. de; Mali, W.P.; Beard, J.D.; Cleveland, T.; Engelter, S.T.; Lyrer, P.A.; Ford, G.A.; Dorman, P.J.; Brown, M.M.; Leeuw, F.E. de; et al.,

    2015-01-01

    BACKGROUND: Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. METHODS: Patients with symptomatic carotid

  9. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

    NARCIS (Netherlands)

    Bonati, Leo H.; Dobson, Joanna; Featherstone, Roland L.; Ederle, Jörg; van der Worp, H. Bart; de Borst, Gert J.; Mali, Willem P. Th M.; Beard, Jonathan D.; Cleveland, Trevor; Engelter, Stefan T.; Lyrer, Philippe A.; Ford, Gary A.; Dorman, Paul J.; Brown, Martin M.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Coward, L.; Dobson, J.; Doig, D.; Ederle, J.; Featherstone, R. F.; Kennedy, F.; Tindall, H.; Turner, E.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Koelemay, M. J. W.; Nederkoorn, P. J.; Reekers, J. A. A.; Roos, Y. B. W. E. M.

    2015-01-01

    Background Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Methods Patients with symptomatic carotid stenosis

  10. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  11. A pilot randomized trial of pentoxifylline for the reduction of periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention.

    Science.gov (United States)

    Aslanabadi, Naser; Shirzadi, Hamid Reza; Asghari-Soufi, Hossein; Dousti, Samaneh; Ghaffari, Samad; Sohrabi, Bahram; Mashayekhi, Simin Ozar; Hamishehkar, Hadi; Entezari-Maleki, Taher

    2015-02-01

    Periprocedural myocardial injury (PMI) following percutaneous coronary intervention (PCI) has received great attention due to its significant association with mortality and morbidity. Accordingly, cardioprotection during PCI is one of the important therapeutic concerns. Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI. A randomized clinical trial on 85 patients undergoing elective PCI was performed. The intervention group (n = 41) received 1200 mg pentoxifylline in divided doses plus the standard treatment before PCI, while the control group (n = 44) received the standard treatment. For assessing myocardial damage during PCI, the levels of CK-MB and troponin-I were measured at baseline, 8, and 24 h after the procedure. Then, patients were followed up for a 1-month period regarding the major adverse cardiac effect. Comparing with the control group, no significant change of CK-MB at 8 (p = 0.315) and 24 h (p = 0.896) after PCI was documented in pentoxifylline group. Similarly, no significant change was found in troponin-I at 8 (p = 0.141) and 24 h (p = 0.256) after PCI. This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI. However, the trend was toward the potential benefit of pentoxifylline.

  12. 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

  13. Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

    Science.gov (United States)

    Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

    2015-01-01

    OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

  14. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction

    NARCIS (Netherlands)

    van Berkel, A. M.; Boland, C.; Redekop, W. K.; Bergman, J. J.; Groen, A. K.; Tytgat, G. N.; Huibregtse, K.

    1998-01-01

    Clogging of biliary stents continues to be a major clinical problem. Different polymer materials may have different effects on clogging. In vitro studies have shown a direct relation between the frictional coefficient of a polymer and the amount of encrusted material. Teflon appeared to be the best

  15. Radioactive metallic stent for the treatment of esophageal cancer in animal model and clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Park, K. B. [Korea Atomic Energy Research Institute, Taejeon (Korea); Lee, J. D. [Yonsei Univ., Seoul (Korea)

    2000-03-01

    The purpose of this study is to evaluate tissue response of self-expandable metallic stent covered Ho-166 in normal canine esophagus. Ho-166 was incorporated within polyurethan and covered over the outer surface of self-expandable metallic stents(diameter ; 18mm, length ; 40mm). Metallic stents with radioactivity of 4.0-7.8mCi (Group A), 1.0-1.8mCi (Group B) and 0.5-0.7mCi (Group C) were placed in normal mid-esophagus in twelve dogs (Group A), five (Group B) and another five dogs (Group C) respectively. Estimated radiation dose was 200-392Gy in Group A, 50-90Gy in Group B, and 25-35 Gy in Group C. The dogs were sacrified at two or three months later. In group A, mid-esophagus stricture, mucosal ulceration were found. Sereve fibrosis and degeneration of muscular propria, outer one half were found in three and complete fibrosis of esophageal wall in seven and fibrosis of esophageal wall and periesophageal soft tissue in two. In group B, glandular atrophy and submucosal fibrosis were found but muscular layer was intact. In group C, no histological change was demonstrated in three but submucosal inflammation and glandular atrophy with intact mucosa in two. Self-expandable metallic stent covered with Ho-166 may be used safely in esophagus without complication. 21 refs., 17 figs., 2 tabs. (Author)

  16. Comparing Stent Thrombosis associated with Zotarolimus Eluting Stents versus Everolimus Eluting Stents at 1 year follow up: a systematic review and meta-analysis of 6 randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Yanamala, Chandra Mouli; Huang, Wei-Qiang

    2017-03-16

    Two thousand fifteen has been a winning year for Drug Eluting Stents (DES). Increase in the number of patients with cardiovascular diseases treated by Percutaneous Coronary Intervention (PCI) has resulted to a high demand for second generation DES. This current analysis aimed to compare the different types of Stent Thrombosis (ST) associated with Zotarolimus Eluting Stents (ZES) versus Everolimus Eluting Stents (EES) at 1 year follow up. Electronic databases were searched for studies comparing ZES with EES. Different types of ST reported at 1 year follow up were considered as the primary endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were used as the statistical parameters and the pooled analyses were carried out by the RevMan 5 · 3 software. A total number of 10,512 patients were included in this analysis. No significant difference in any definite ST, acute definite ST, subacute definite ST, and late definite ST were observed between ZES and EES, at 1 year follow up with OR: 1.70, 95% CI: 0.92 - 3.16; P = 0.09, OR: 3.44, 95% CI: 0.82 - 14.43; P = 0.09, OR: 1.13, 95% CI: 0.43 - 2.95; P = 0.80 and OR: 2.39, 95% CI: 0.83 - 6.85; P = 0.11 respectively. Moreover, any definite or probable ST and definite/probable/possible ST were also not significantly different with OR: 1.39, 95% CI: 0.89 - 2.17; P = 0.15 and OR: 1.19, 95% CI: 0.84 - 1.70; P = 0.33 respectively. In addition, any probable ST, acute probable ST, late probable ST and possible ST were also not significantly different at 1 year follow up with OR: 1.11, 95% CI: 0.60 - 2.05; P = 0.75, OR: 0.53, 95% CI: 0.12 - 2.40; P = 0.41, OR: 1.67, 95% CI: 0.35 - 7.86; P = 0.52 and OR: 1.08, 95% CI: 0.64 - 1.82; P = 0.78 respectively. At 1 year follow up, ZES were not associated with significantly lower or higher definite and probable ST compared to EES. In addition, no significant difference was observed in acute, subacute and late

  17. 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)

  18. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting : A meta-analysis of pooled patient data from four randomised trials

    NARCIS (Netherlands)

    Howard, George; Roubin, Gary S.; Jansen, Olav; Hendrikse, Jeroen; Halliday, Alison; Fraedrich, Gustav; Eckstein, Hans Henning; Calvet, David; Bulbulia, Richard; Bonati, Leo H.; Becquemin, Jean Pierre; Algra, Ale; Brown, Martin M.; Ringleb, Peter A.; Brott, Thomas G.; Mas, Jean Louis

    2016-01-01

    Background: Age was reported to be an effect-modifier in four randomised controlled trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA), with better CEA outcomes than CAS outcomes noted in the more elderly patients. We aimed to describe the association of age with

  19. 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.

  20. Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

    Science.gov (United States)

    Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

    2014-03-01

    We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

  1. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.

    Science.gov (United States)

    McElhinney, Doff B; Cheatham, John P; Jones, Thomas K; Lock, James E; Vincent, Julie A; Zahn, Evan M; Hellenbrand, William E

    2011-12-01

    Among patients undergoing transcatheter pulmonary valve (TPV) replacement with the Melody valve, risk factors for Melody stent fracture (MSF) and right ventricular outflow tract (RVOT) reintervention have not been well defined. From January 2007 to January 2010, 150 patients (median age, 19 years) underwent TPV implantation in the Melody valve Investigational Device Exemption trial. Existing conduit stents from a prior catheterization were present in 37 patients (25%, fractured in 12); 1 or more new prestents were placed at the TPV implant catheterization in 51 patients. During follow-up (median, 30 months), MSF was diagnosed in 39 patients. Freedom from a diagnosis of MSF was 77±4% at 14 months (after the 1-year evaluation window) and 60±9% at 39 months (3-year window). On multivariable analysis, implant within an existing stent, new prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (Pbioprosthetic valve was associated with lower risk of MSF and reintervention.

  2. An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: a pooled analysis from the SPIRIT II and SPIRIT III trials.

    Science.gov (United States)

    Bartorelli, Antonio L; Serruys, Patrick W; Miquel-Hébert, Karine; Yu, Shui; Pierson, Wes; Stone, Gregg W

    2010-07-01

    To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control. Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. (c) 2010 Wiley-Liss, Inc.

  3. Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: A pilot randomized controlled trial

    NARCIS (Netherlands)

    Oosting, E.; Jans, M.P.; Dronkers, J.J.; Naber, R.H.; Dronkers-Landman, C.M.; Appelman-De Vries, S.M.; Meeteren, N.L. van

    2012-01-01

    Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: a pilot randomized controlled trial. Objective: To investigate the feasibility and preliminary effectiveness of a home-based intensive exercise

  4. Stent-protected angioplasty versus carotid endarterectomy in patients with carotid artery stenosis: meta-analysis of randomized trial data

    International Nuclear Information System (INIS)

    Wiesmann, Martin; Schoepf, Veronika; Brueckmann, Hartmut; Jansen, Olav

    2008-01-01

    Stent-protected angioplasty of carotid artery stenosis may be an alternative to surgical endarterectomy. Results published so far are indecisive, with evidence both in favour of and against this procedure. After the recent publication of two large European multicentre trials (SPACE and EVA-3S) almost 3,000 patients have been included in randomized studies. For this report, we therefore conducted a systematic review of randomized studies that compared endovascular treatment with surgery for carotid stenosis. We evaluated seven trials including 2,973 patients. In our meta-analysis endovascular treatment seemed to carry a slightly higher risk for stroke or death within 30 days after the procedure as compared with surgery (8.2% vs. 6.2%; p = 0.04; OR 1.35), whereas the rates of disabling stroke or death within 30 days did not differ significantly (p = 0.47; n.s.). On the other hand, surgery carried a significantly higher risk for cranial nerve palsy (4.7% vs. 0.2%; p < 0.0001; OR 0.17) and myocardial infarction (2.3% vs. 0.9%; p = 0.03; OR 0.37). Long-term effects of both methods still need to be evaluated. Two other large multicentre trials (ICSS and CREST) are ongoing. Results of these studies will increase the database to about 7,000 randomized patients. Future meta-analyses should then allow definitive treatment recommendations. (orig.)

  5. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial.

    Science.gov (United States)

    Ali, Ziad A; Maehara, Akiko; Généreux, Philippe; Shlofmitz, Richard A; Fabbiocchi, Franco; Nazif, Tamim M; Guagliumi, Giulio; Meraj, Perwaiz M; Alfonso, Fernando; Samady, Habib; Akasaka, Takashi; Carlson, Eric B; Leesar, Massoud A; Matsumura, Mitsuaki; Ozan, Melek Ozgu; Mintz, Gary S; Ben-Yehuda, Ori; Stone, Gregg W

    2016-11-26

    Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural

  6. 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...

  7. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial.

    Science.gov (United States)

    Chen, Shao-Liang; Zhang, Jue-Jie; Han, Yaling; Kan, Jing; Chen, Lianglong; Qiu, Chunguang; Jiang, Tiemin; Tao, Ling; Zeng, Hesong; Li, Li; Xia, Yong; Gao, Chuanyu; Santoso, Teguh; Paiboon, Chootopol; Wang, Yan; Kwan, Tak W; Ye, Fei; Tian, Nailiang; Liu, Zhizhong; Lin, Song; Lu, Chengzhi; Wen, Shangyu; Hong, Lang; Zhang, Qi; Sheiban, Imad; Xu, Yawei; Wang, Lefeng; Rab, Tanveer S; Li, Zhanquan; Cheng, Guanchang; Cui, Lianqun; Leon, Martin B; Stone, Gregg W

    2017-11-28

    Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS

  8. Feasibility of Protective Ventilation During Elective Supratentorial Neurosurgery: A Randomized, Crossover, Clinical Trial.

    Science.gov (United States)

    Ruggieri, Francesco; Beretta, Luigi; Corno, Laura; Testa, Valentina; Martino, Enrico A; Gemma, Marco

    2017-06-30

    Traditional ventilation approaches, providing high tidal volumes (Vt), produce excessive alveolar distention and lung injury. Protective ventilation, employing lower Vt and positive end-expiratory pressure (PEEP), is an attractive alternative also for neuroanesthesia, when prolonged mechanical ventilation is needed. Nevertheless, protective ventilation during intracranial surgery may exert dangerous effects on intracranial pressure (ICP). We tested the feasibility of a protective ventilation strategy in neurosurgery. Our monocentric, double-blind, 1:1 randomized, 2×2 crossover study aimed at studying the effect size and variability of ICP in patients undergoing elective supratentorial brain tumor removal and alternatively ventilated with Vt 9 mL/kg-PEEP 0 mm Hg and Vt 7 mL/kg-PEEP 5 mm Hg. Respiratory rate was adjusted to maintain comparable end-tidal carbon dioxide between ventilation modes. ICP was measured through a subdural catheter inserted before dural opening. Forty patients were enrolled; 8 (15%) were excluded after enrollment. ICP did not differ between traditional and protective ventilation (11.28±5.37, 11 [7 to 14.5] vs. 11.90±5.86, 11 [8 to 15] mm Hg; P=0.541). End-tidal carbon dioxide (28.91±2.28, 29 [28 to 30] vs. 28.00±2.17, 28 [27 to 29] mm Hg; Pprotective ventilation. Blood pressure, heart rate, and body temperature did not differ between ventilation modes. Dural tension was "acceptable for surgery" in all cases. ICP differences between ventilation modes were not affected by ICP values under traditional ventilation (coefficient=0.067; 95% confidence interval, -0.278 to 0.144; P=0.523). Protective ventilation is a feasible alternative to traditional ventilation during elective neurosurgery.

  9. Coronary artery aneurysm after stent implantation: acute and long-term results after percutaneous treatment with a stent graft.

    Science.gov (United States)

    Rubartelli, Paolo; Terzi, Giacomo; Borgo, Lorenzo; Giachero, Corinna

    2002-03-01

    A patient with unstable angina was treated with elective Palmaz-Schatz stent implantation on a focal stenosis of the left circumflex artery. One year later, a large (13 mm in diameter) coronary artery aneurysm was diagnosed at angiography in the stented site. Intravascular ultrasound examination confirmed the presence of a true aneurysm located at the proximal end of the stent. The aneurysm was successfully treated with a Jostent Graft (Jomed Implantate) consisting of two slotted tube stainless steel stents supporting a polytetrafluoroethylene tube. The stent graft was implanted under intravascular ultrasound guidance. The 18-month angiographic follow-up showed good patency of the stent graft and complete exclusion of the aneurysm.

  10. Renal PTA stenting

    International Nuclear Information System (INIS)

    Tsetis, D.

    2012-01-01

    Full text: Renal artery stenosis (RAS) is a common condition that may lead to hypertension, progressive renal dysfunction and cardiovascular morbidity. Catheter-based therapy for symptomatic, haemodynamically significant, RAS has become the preferred method of revascularization. Balloon angioplasty has been the traditional treatment of choice for fibromuscular dysplasia, however stents are increasingly used for the treatment of atheromatous lesions; in many cases-such as in ostial lesions-, direct stenting is strongly indicated. Despite the increased use of endovascular therapy for renal artery stenosis, there is still controversy regarding the optimal management and the net benefit of this treatment. Several randomized trials of balloon angioplasty or stenting for renal artery stenosis compared with medical therapy alone have been conducted, however these could not show definite advantage of endovascular therapy. Problems encountered with those trials include enrollment of small number of patients, frequent crossover from medical to interventional therapy compromising the intention-to-treat results, or selection of patients that are not expected to show clear benefit. The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) is the most important of these trials; however, it,s study design was faulty and therefore did not provide conclusive evidence to answer the question of whether angioplasty and stenting or medical therapy is the best treatment for haemodynamically significant RAS. All expectations are now focused on the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial which was designed to answer the same question, and its methodologies took into consideration the weaknesses of the ASTRAL trial. Regarding stent device itself, it seems that the optimal design is probably a stainless steel, laser cut, open-cells stent mounted on a rapid exchange delivery balloon catheter compatible with 0.014-in and 0.018-in guidewire. As a future

  11. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients : A secondary analysis of a randomized clinical trial

    NARCIS (Netherlands)

    Von Birgelen, Clemens; Van Der Heijden, Liefke C.; Basalus, Mounir Welson Zakhary; Kok, Marlies M.; Sen, Hanim; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, Carine J.M.; Van Der Palen, Job; Löwik, Marije M.

    2017-01-01

    IMPORTANCE: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. OBJECTIVE: To assess 5-year safety and efficacy

  12. High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Ahmad Shavakhi

    2011-01-01

    Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

  13. The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial

    Science.gov (United States)

    vanderVaart, Sondra; Berger, Howard; Tam, Carolyn; Goh, Y Ingrid; Gijsen, Violette M G J; de Wildt, Saskia N; Taddio, Anna

    2011-01-01

    Introduction Approximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section. Methods In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1–3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs. Results AUC for pain was not significantly different in the distant reiki and control groups (mean±SD; 212.1±104.7 vs 223.1±117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3±8.1 bpm vs 79.8±7.9 bpm, p=0.003) and blood pressure (106.4±9.7 mm Hg vs 111.9±11.0 mm Hg, p=0.02) post surgery. Conclusion Distant reiki had no significant effect on pain following an elective C-section. Clinical Trial Registration

  14. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial.

    Science.gov (United States)

    Echevarría, Ghislaine C; Altermatt, Fernando R; Paredes, Sebastian; Puga, Valentina; Auad, Hernán; Veloso, Ana M; Elgueta, María F

    2018-05-01

    Postoperative vomiting (POV) is a frequent complication of tonsillectomy in children. In adult patients undergoing abdominal surgeries, the use of intravenous lidocaine infusion can prevent POV. To evaluate the anti-emetic effect of an intravenous lidocaine infusion used as an adjuvant to general anaesthesia, in children undergoing elective ear, nose and throat surgery. Double-blind, randomised, controlled study. Hospital-based, single-centre study in Chile. ASA I-II children, aged 2 to 12 years, scheduled for elective tonsillectomy. We standardised the induction and maintenance of anaesthesia. Patients were randomly allocated to lidocaine (1.5 mg kg intravenous lidocaine over 5 min followed by 2 mg kg h) or 0.9% saline (at the same rate and volume). Infusions were continued until the end of the surgery. Presence of at least one episode of vomiting, retching or both in the first 24 h postoperatively (POV). Plasma concentrations of lidocaine and postoperative pain. Ninety-two children were enrolled. Primary outcome data were available for 91. In the Lidocaine group, 28 of 46 patients (60.8%) experienced POV, compared with 37 of 45 patients (82.2%) in the Saline group [difference in proportions 21.3% (95% confidence interval (CI) 2.8 to 38.8), P = 0.024]. The intention-to-treat analysis showed that when we assumed that the patient in the Saline group lost to follow-up did not have POV, the difference in proportions decreased to 19.6% (95% CI, 0.9 to 37.2), with an unadjusted odds ratio of 0.38 (95% CI, 0.15 to 0.97, P = 0.044). The odds of having POV were 62% less likely in those patients receiving lidocaine compared with patients in the Saline group. The mean lidocaine plasma concentration was 3.91 μg ml (range: 0.87 to 4.88). Using an intravenous lidocaine infusion as an adjuvant to general anaesthesia decreased POV in children undergoing elective tonsillectomy. ClinicalTrials.gov Identifier: NCT01986309.

  15. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

    Science.gov (United States)

    Dippel, Eric J; Makam, Prakash; Kovach, Richard; George, Jon C; Patlola, Raghotham; Metzger, D Christopher; Mena-Hurtado, Carlos; Beasley, Robert; Soukas, Peter; Colon-Hernandez, Pedro J; Stark, Matthew A; Walker, Craig

    2015-01-01

    The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study

  16. Polymer-Free Drug-Coated Coronary Stents Are Cost-Effective in Patients at High Bleeding Risk: Economic Evaluation of the LEADERS FREE Trial.

    Science.gov (United States)

    Filipovic-Pierucci, Antoine; Durand-Zaleski, Isabelle; Butel, Thibault; Greene, Samantha; Hovasse, Thomas; Iñiguez, Andres; Nazzaro, Marco Stefano; Oldroyd, Keith G; Talwar, Suneel; Richardt, Gert; Windhovel, Ute; Urban, Philip; Morice, Marie-Claude

    2018-02-20

    In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS. The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;pcosts for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional €300 per DCS stent, ranged from €4,664-8,593 for DCS and €4,845-9,742 for BMS and were lower in the DCS group (England:€-428, France:€-137, Germany:€-33, Italy:€-522, Scotland:€-298, Spain:€-854). The probability that DCS dominated BMS was >50% in all countries. At a threshold of €10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.

  17. Preliminary Report of Carotid Artery Stenting Using a Tapered Stent

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Chang Woo; Kim, Dong Hyun; Hong, Seung; Jeong; Kim, Young Suk; Byun, Joo Nam; Oh, Jae Hee [Dept. of Radiology, Chosun University College of Medicine, Gwangju (Korea, Republic of); Ahn, Seong Hwan [Dept. of Neurology, Chosun University College of Medicine, Gwangju (Korea, Republic of)

    2011-10-15

    To analyze the results of carotid artery stenting using a tapered stent and to evaluate the effectiveness of the tapered stent compared to previously reported studies using non-tapered stents. From October 2008 to August 2010, elective carotid artery stenting using a tapered stent was attempted in 39 lesions from 36 consecutive patients. Post-procedural complications were evaluated by neurologic symptoms and magnetic resonance imaging. Restenosis or occlusion was evaluated by carotid Doppler ultrasound and computerized tomography with angiography. Newly developed neurologic symptoms were evaluated clinically. The self-expandable tapered stent was placed across the carotid artery stenosis. A total stroke was noted in 3 patients, while a major stroke was noted in 1 patient. On diffusion weighted imaging, new lesions were observed in 15 patients, but 13 patients were clinically silent. Follow-up imaging studies were performed in the 13 clinically silent lesions, and no evidence of restenosis or occlusion was found any of the 13 lesions. During clinical follow-up in 34 lesions from 31 patients, there were newly developed neurological symptoms in only 1 patient.

  18. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

    Science.gov (United States)

    Clair, Daniel G; Adams, Julie; Reen, Bernard; Feldman, Robert; Starr, Jean; Diaz-Cartelle, Juan; Dawkins, Keith D

    2014-04-01

    To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%). The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

  19. Removal of retrievable self-expandable urethral stents: experience in 58 stents

    International Nuclear Information System (INIS)

    Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung; Ko, Heung-Kyu; Kim, Yong Jae; Woo, Chul-Woong; Kim, Tae-Hyung; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo; Park, Hyungkeun

    2006-01-01

    The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8±42.9 days (range, 1-177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use. (orig.)

  20. Removal of retrievable self-expandable urethral stents: experience in 58 stents

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung; Ko, Heung-Kyu; Kim, Yong Jae; Woo, Chul-Woong; Kim, Tae-Hyung; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo [Asan Medical Center, Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Seoul (Korea); Park, Hyungkeun [Asan Medical Center, Department of Urology, University of Ulsan College of Medicine, Seoul (Korea)

    2006-09-15

    The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8{+-}42.9 days (range, 1-177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use. (orig.)

  1. Stent underexpansion in angiographic guided percutaneous coronary intervention, despite adjunctive balloon post-dilatation, in drug eluting stent era

    Directory of Open Access Journals (Sweden)

    Mehrdad Taherioun

    2014-01-01

    Full Text Available BACKGROUND: Stent underexpansion is the most powerful predictor of long-term stent patency and clinical outcome. The purpose of this study was to evaluate the incidence and predictors of stent underexpansion despite adjunctive post-dilatation with non-compliant balloon. METHODS: After elective coronary stent implantation and adjunctive post-dilatation with non-compliant balloon and optimal angiographic result confirmed by the operator, intravascular ultrasound (IVUS was performed for all the treated lesions. If the treated lesions fulfilled the IVUS criteria, they are considered as the optimal stent group; if not, they are considered as the suboptimal group. RESULTS: From 50 patients enrolled in this study 39 (78% had optimal stent deployment and 11 (22% had suboptimal stent deployment. In the suboptimal group 7 (14% had underexpansion, 2 (4% malposition, and 2 (4% had asymmetry. There were no stent edge dissections detected by IVUS. We did not find any correlation between lesion calcification, ostial lesions, stent length, and stent underexpansion. Stent diameter ≤ 2.75 mm had a strong correlation with stent underexpansion. CONCLUSION: Despite adjunctive post-dilatation with noncompliant balloon, using a relatively small stent diameter was a strong predictor for underexpansion. IVUS guided percutaneous coronary intervention (PCI may be considered for drug eluting stent (DES implantation in relatively small vessels.   Keywords: Stent, Percutaneous Coronary Intervention, Ultrasound, Post-dilatation 

  2. At what price? A cost-effectiveness analysis comparing trial of labour after previous caesarean versus elective repeat caesarean delivery.

    Directory of Open Access Journals (Sweden)

    Christopher G Fawsitt

    Full Text Available BACKGROUND: Elective repeat caesarean delivery (ERCD rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. METHODS: Using a decision analytic model, a cost-effectiveness analysis (CEA was performed where the measure of health gain was quality-adjusted life years (QALYs over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations. RESULTS: Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively, and QALYs were modestly higher (0.84 versus 0.70. Our findings were supported by probabilistic sensitivity analysis. CONCLUSIONS: Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

  3. Optimised anaesthesia to reduce post operative cognitive decline (POCD in older patients undergoing elective surgery, a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    Full Text Available BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls, mild (χ(2 = 17.9 p<0.0001, moderate (χ(2 = 7.8 p = 0.005 and severe (χ(2 = 5.1 p = 0.02 POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control. In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, χ(2 = 5.1 p = 0.02 and χ(2 = 5.9 p = 0.015, and moderate POCD was reduced at 1 and 52 weeks (χ(2 = 4.4 p = 0·037 and χ(2 = 5.4 p = 0.02. In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005, in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001, and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019. CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION

  4. Carotid Stenting in Patients With High Risk Versus Standard Risk for Open Carotid Endarterectomy (REAL-1 Trial).

    Science.gov (United States)

    De Haro, Joaquin; Michel, Ignacio; Bleda, Silvia; Cañibano, Cristina; Acin, Francisco

    2017-07-15

    Carotid stenting (CAS) has been mainly offered to those patients considered at "high risk" for open carotid endarterectomy based on available data from large randomized clinical trials. However, several recent studies have called medical "high risk" into question for CAS indication. The REAL-1 trial evaluated the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with "high-risk" criteria treated with CAS and proximal protection device (MOMA) compared with those with standard surgical-risk features. This nonrandomized double-arm registry included 125 patients (40% symptomatic), 71 (56%) with "standard-risk" and 54 (44%) with "high-risk" criteria. The primary end point was the cumulative incidence of any major adverse event, a composite of stroke, myocardial infarction, and death within 30 days after the intervention or ipsilateral stroke after 30 days and up to 4 years. There was no significant difference in primary end point rate at 30 days between patients at "standard risk" and those with "high risk" (1.4% vs 1.9% respectively; hazard ratio for "standard risk" 1.1; 95% CI 0.8 to 1.2, p = 0.77) nor estimated 4-year rate of ipsilateral stroke (1.3% vs 1.8%; hazard ratio for "standard risk" 1.05, 95% CI 0.86 to 1.14, p = 0.9). In conclusion, 4-year postprocedure results demonstrated that CAS with proximal device (MOMA) is safe and effective for patients with and without "high-risk" for carotid endarterectomy. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Expandable stents.

    Science.gov (United States)

    Nesbitt, J C; Carrasco, H

    1996-05-01

    Expandable metallic stents are effective in selected patients with malignant or benign airway stenoses. When used for malignant lesions, the primary purpose of the stent is to improve the quality of life; stents are usually chosen for palliation of symptoms in recognition of the low likelihood of success for other therapy. For patients with benign stenoses, the stents provide a permanent source of structural support to alleviate the narrowed segment. The advantages of the expandable metallic stents are as follows: (1) they can be inserted through an endotracheal tube or under local anesthesia with relative simplicity under fluoroscopic guidance; (2) they do not impair the drainage of sputum because ciliary movement is not interrupted; (3) over a period of a few weeks, the meshwork is gradually covered with mucosa as the stent becomes incorporated into the airway wall; (4) ventilation usually is not impaired if the metallic mesh stent covers another nonstenosed bronchus, because the interstices of the stent are nonobstructive; and (5) they are dynamic and continue to expand over time, particularly if concurrent treatment achieves an effect on the lesion that caused stenosis. Disadvantages of the expandable stent include (1) they often are only temporarily effective for tracheobronchial stenosis due to intraluminal tumor or granulation tissue, both of which can grow between the wires; (2) they are considered permanent stents because removal is difficult; and (3) they can be poorly positioned during placement or can become displaced by progressive migration after placement, and they cannot be repositioned. A relative contraindication to insertion is an inflammatory process or infection that can predispose to granulation formation, particularly at the points of maximal contact pressure of the stent to the airway mucosa. In the presence of inflammation, it may be better to use a silicone prosthesis until the inflammatory process subsides and fibrosis occurs. Granulation

  6. Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

    International Nuclear Information System (INIS)

    Chalmers, Nicholas; Walker, Paul T.; Belli, Anna-Maria; Thorpe, Anthony P.; Sidhu, Paul S.; Robinson, Graham; Ransbeeck, Mariella van; Fearn, Steven A.

    2013-01-01

    To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life. A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5–22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire. Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months’ follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % (p = 0.84) and 40.8 versus 46.7 % (p = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life. Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.

  7. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials.

    Science.gov (United States)

    Kedhi, Elvin; Stone, Gregg W; Kereiakes, Dean J; Serruys, Patrick W; Parise, Helen; Fahy, Martin; Simonton, Charles A; Sudhir, Krishnankutty; Sood, Poornima; Smits, Pieter C

    2012-09-01

    Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint. The incidence of stent thrombosis, as well as the impact of dual antiplatelet therapy (DAPT) discontinuation during the first two years following everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) deployment were therefore analysed from a pooled, patient-level database derived from four randomised clinical trials. Data from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials (n=6,789 patients) were analysed. Two-year ST rates were determined using time-to-event methods and compared with the log-rank test. ST rates were also determined after DAPT discontinuation. EES compared to PES significantly reduced the two-year rates of ST (0.7% versus 2.3%, p=0.0001), including the interval rates of ST up to 30 days (0.2% versus 1.0%, p<0.0001), between 31 days and one year (0.2% versus 0.6%, p=0.02), and after one year (0.3% versus 0.8%, p=0.001). EES also reduced the two-year composite rate of cardiac death or MI (4.0% versus 6.6%, p=0.0001). Increased rates of ST after DAPT discontinuation beyond six months were observed in the PES cohort, but not in the EES cohort. In this large pooled analysis from four randomised trials, treatment with EES compared to PES significantly reduced the rates of ST through two years of follow-up, with a concomitant reduction in cardiac death or MI. DAPT discontinuation beyond six months may be safe with EES.

  8. Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kruse, Christina; Müller, Sascha A; Warschkow, René; Lüthi, Cornelia; Brunner, Walter; Marti, Lukas; Sulz, Michael Christian; Schmied, Bruno M; Tarantino, Ignazio; Beutner, Ulrich

    2016-04-04

    Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will

  9. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials.

    Science.gov (United States)

    Sabaté, Manel; Räber, Lorenz; Heg, Dik; Brugaletta, Salvatore; Kelbaek, Henning; Cequier, Angel; Ostojic, Miodrag; Iñiguez, Andrés; Tüller, David; Serra, Antonio; Baumbach, Andreas; von Birgelen, Clemens; Hernandez-Antolin, Rosana; Roffi, Marco; Mainar, Vicente; Valgimigli, Marco; Serruys, Patrick W; Jüni, Peter; Windecker, Stephan

    2014-01-01

    This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up. Copyright © 2014 American

  10. Expandable metal stents for tracheal obstruction: permanent or temporary? A cautionary tale.

    OpenAIRE

    Hind, C R; Donnelly, R J

    1992-01-01

    An expandable metal stent inserted via a long term tracheostomy successfully relieved life threatening respiratory obstruction due to benign tracheal stenosis. Later the patient's tracheostomy suction catheter became stuck on the stent and dislodged it. The stent was removed electively, without damaging the trachea, with a rigid biopsy forceps.

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  12. Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

    Science.gov (United States)

    de Waha, Suzanne; Allali, Abdelhakim; Büttner, Heinz-Joachim; Toelg, Ralph; Geist, Volker; Neumann, Franz-Josef; Khattab, Ahmed A; Richardt, Gert; Abdel-Wahab, Mohamed

    2016-03-01

    In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

  13. 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.)

  14. Airway stents

    Science.gov (United States)

    Keyes, Colleen

    2018-01-01

    Stents and tubes to maintain the patency of the airways are commonly used for malignant obstruction and are occasionally employed in benign disease. Malignant airway obstruction usually results from direct involvement of bronchogenic carcinoma, or by extension of carcinomas occurring in the esophagus or the thyroid. External compression from lymph nodes or metastatic disease from other organs can also cause central airway obstruction. Most malignant airway lesions are surgically inoperable due to advanced disease stage and require multimodality palliation, including stent placement. As with any other medical device, stents have significantly evolved over the last 50 years and deserve an in-depth understanding of their true capabilities and complications. Not every silicone stent is created equal and the same holds for metallic stents. Herein, we present an overview of the topic as well as some of the more practical and controversial issues surrounding airway stents. We also try to dispel the myths surrounding stent removal and their supposed use only in central airways. At the end, we come to the long-held conclusion that stents should not be used as first line treatment of choice, but after ruling out the possibility of curative surgical resection or repair. PMID:29707506

  15. Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.

    Science.gov (United States)

    Therasse, Eric; Donath, David; Elkouri, Stéphane; Lespérance, Jacques; Giroux, Marie-France; Oliva, Vincent L; Guertin, Marie-Claude; Bouchard, Louis; Perreault, Pierre; Gilbert, Patrick; Soulez, Gilles

    2016-06-01

    The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only. In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test. The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations. A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  16. 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 we...

  17. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

    Science.gov (United States)

    Ansel, Gary M; Hopkins, L Nelson; Jaff, Michael R; Rubino, Paolo; Bacharach, J Michael; Scheinert, Dierk; Myla, Subbarao; Das, Tony; Cremonesi, Alberto

    2010-07-01

    The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) 2010 Wiley-Liss, Inc.

  18. TCT-584 Nine Month Imaging and Twelve Month Clinical Results from the DESSOLVE II Randomized Trial of the MiStent® SES with Absorbable Polymer

    OpenAIRE

    Wijns, William; Vrolix, Mathias; Verheye, Stefan; Schoors, Danny; Slagboom, Ton; Gosselink, Marcel; Benit, Edouard; Desmet, Walter; Chowdhary, Saquib; Lansky, Alexandra; Bezerra, Hiram; Fitzgerald, Peter; Kandzari, David; Ormiston, John

    2012-01-01

    Background : The MiStent SES (Micell Technologies, Durham, NC) is an investigational drug-eluting stent (DES) developed to adress unfavorable late-term outcomes such as stent thrombosis. These events are hypothesized to be associated in part with durable polymers of current DES. The MiStent SES uses a unique combination of components, a crystalline formulation of sirolimus and a fully absorbable polymer on a thinstrut, cobalt chromium stent platform. The polymer coating is eliminated from the...

  19. Colorectal Stenting in Malignant Large Bowel Obstruction: The Learning Curve

    Directory of Open Access Journals (Sweden)

    D. Williams

    2011-01-01

    Full Text Available Aim. Self-expanding metal stents (SEMSs are increasingly used for the palliation of metastatic colorectal cancer and as a bridge to surgery for obstructing tumours. This case series analyses the learning curve and changes in practice of colorectal stenting over a three year period. Methods. A study of 40 patients who underwent placement of SEMS for the management of colorectal cancer. Patients spanned the learning curve of a single surgeon endoscopist. Results. Technical success rates increased from 82% initially, using an average of 1.7 stents per procedure, to a 94% success rate where all patients were stented using a single stent. There has been a change in practice from elective palliative stenting toward emergency preoperative stenting. Conclusion. There is a steep learning curve for the use of SEMS in the management of malignant colorectal bowel obstruction. We suggest that at least 20 cases are required for an operator to be considered experienced.

  20. Neuropsychological outcome after percutaneous coronary intervention or coronary artery bypass grafting: results from the Stent or Surgery (SoS) Trial.

    Science.gov (United States)

    Währborg, Peter; Booth, Jean E; Clayton, Tim; Nugara, Fiona; Pepper, John; Weintraub, William S; Sigwart, Ulrich; Stables, Rod H

    2004-11-30

    Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome. In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups. We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

  1. Palestinian Elections

    National Research Council Canada - National Science Library

    Pina, Aaron D

    2006-01-01

    .... In 2002, the Palestinian Authority (PA), under increasing internal and external pressure, announced a so-called 100-Day Reform Plan for institutional reform and elections in order to rejuvenate PA leadership...

  2. Clinical effectiveness of elective single versus double embryo transfer: meta-analysis of individual patient data from randomised trials

    NARCIS (Netherlands)

    McLernon, D. J.; Harrild, K.; Bergh, C.; Davies, M. J.; de Neubourg, D.; Dumoulin, J. C. M.; Gerris, J.; Kremer, J. A. M.; Martikainen, H.; Mol, B. W.; Norman, R. J.; Thurin-Kjellberg, A.; Tiitinen, A.; van Montfoort, A. P. A.; van Peperstraten, A. M.; van Royen, E.; Bhattacharya, S.

    2010-01-01

    Objective To compare the effectiveness of elective single embryo transfer versus double embryo transfer on the outcomes of live birth, multiple live birth, miscarriage, preterm birth, term singleton birth, and low birth weight after fresh embryo transfer, and on the outcomes of cumulative live birth

  3. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

    2014-01-01

    BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

  4. Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

    Science.gov (United States)

    Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

    2013-06-01

    The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All

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

    NARCIS (Netherlands)

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

    2005-01-01

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

  6. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Ruygrok, Peter; Neuzner, Jörg; Piek, Jan J.; Seth, Ashok; Schofer, Joachim J.; Richardt, Gert; Wiemer, Marcus; Carrié, Didier; Thuesen, Leif; Boone, Els; Miquel-Herbert, Karine; Daemen, Joost

    2006-01-01

    Background: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.Methods: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting

  7. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  8. Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstruction: tumor ingrowth in uncovered stents and migration of covered stents.

    Science.gov (United States)

    Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Ban, Tesshin; Natsume, Makoto; Okumura, Fumihiro; Nakazawa, Takahiro; Takada, Hiroki; Hirano, Atsuyuki; Jinno, Naruomi; Togawa, Shozo; Ando, Tomoaki; Kataoka, Hiromi; Joh, Takashi

    2017-10-01

    Endoscopic metallic stenting is widely accepted as a palliation therapy for malignant gastric outlet obstruction (GOO). However, the predictors of stent dysfunction have not been clarified. We aimed to evaluate the predictors, especially tumor ingrowth in uncovered self-expandable metallic stents (U-SEMS) and migration of covered self-expandable metallic stents (C-SEMS), which are the main causes related to the stent characteristics. In this multicenter retrospective study, we compared patients with U-SEMS and C-SEMS in terms of clinical outcomes, and predictors of stent dysfunction. In total, 252 patients (126 with U-SEMS and 126 with C-SEMS) were enrolled. There were no significant differences in technical success, clinical success, GOO score, or time to stent dysfunction. Tumor ingrowth was significantly more frequent in U-SEMS (U-SEMS, 11.90% vs. C-SEMS, 0.79%; p = 0.002), and stent migration was significantly more frequent for C-SEMS (C-SEMS, 8.73% vs. U-SEMS, 0.79%; p = 0.005). Karnofsky performance status (p = 0.04), no presence of ascites (p = 0.02), and insufficient (stent expansion (p = 0.003) were significantly associated with tumor ingrowth in U-SEMS. Meanwhile, a shorter stent length (p = 0.05) and chemotherapy (p = 0.03) were predictors of C-SEMS migration. Both U-SEMS and C-SEMS are effective with comparable patencies. Tumor ingrowth and stent migration are the main causes of stent dysfunction for U-SEMS and C-SEMS, respectively. With regard to stent dysfunction, U-SEMS might be a good option for patients receiving chemotherapy, while C-SEMS with longer stents for patients in good condition. (Clinical trial registration number: UMIN000024059).

  9. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  10. Effectiveness of Positioning Stents in Radiation-Induced Xerostomia in Patients with Tongue Carcinoma: A Randomized Controlled Trial.

    Science.gov (United States)

    Mall, Priyanka; Chand, Pooran; Singh, Balendra Pratap; Rao, Jitendra; Siddarth, Ramashanker; Srivastava, Kirti

    2016-01-01

    The aim of this study was to perform an objective and subjective evaluation of the efficacy of positioning stents in radiation-induced xerostomia in patients with tongue carcinoma. A total of 30 patients with tongue carcinoma and undergoing conventional radiotherapy were randomly assigned to control (n = 15) and study (n = 15) groups, without and with a positioning stent, respectively. Assessment of salivary output reduction was done before and after radiotherapy, at 3- and 6-month intervals, by measurement of unstimulated and stimulated salivary flow rates (objective evaluation). Xerostomia (subjective evaluation) was noted using six items from the Quality of Life Head and Neck Module (QLQ-H&N35) as proposed by the European Organization for Research and Treatment of Cancer. The significance level was set at .05. Mean unstimulated and stimulated salivary flow rates at 3- and 6-month intervals revealed significantly (P xerostomia and its symptoms.

  11. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

    Energy Technology Data Exchange (ETDEWEB)

    Bosiers, Marc, E-mail: marc.bosiers@telenet.be [A.Z. Sint-Blasius, Department of Vascular Surgery (Belgium); Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de [Park Hospital, Center for Vascular Medicine-Angiology and Vascular Surgery (Germany); Mathias, Klaus, E-mail: k.mathias@asklepios.com [Klinikum Dortmund GmbH (Germany); Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de [Sankt Gertrauden-Krankenhaus (Germany); Mudra, Harald, E-mail: haraldmudra@aol.com [Klinikum Neuperlach (Germany); Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com [One Boston Scientific Place, Boston Scientific Corporation (United States)

    2015-04-15

    PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.

  12. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

    International Nuclear Information System (INIS)

    Bosiers, Marc; Scheinert, Dierk; Mathias, Klaus; Langhoff, Ralf; Mudra, Harald; Diaz-Cartelle, Juan

    2015-01-01

    PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  14. The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

    Science.gov (United States)

    Suwannasom, Pannipa; Sotomi, Yohei; Ishibashi, Yuki; Cavalcante, Rafael; Albuquerque, Felipe N; Macaya, Carlos; Ormiston, John A; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Tijssen, Jan G; Wykrzykowska, Joanna J; de Winter, Robbert J; Chevalier, Bernard; Serruys, Patrick W; Onuma, Yoshinobu

    2016-06-27

    The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p 0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American

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

    Science.gov (United States)

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

    2014-11-04

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

  16. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. 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/

  17. The Effect of Cilostazol on the Angiographic Outcome of Drug-Eluting Coronary Stents Angiographic Analysis of the CILON-T (Influence of CILostazol-Based Triple Antiplatelet Therapy ON Ischemi Complication after Drug-Eluting StenT Implantation) Trial.

    Science.gov (United States)

    Suh, Jung-Won; Lee, Seung-Pyo; Park, KyungWoo; Kang, Hyun-Jae; Koo, Bon-Kwon; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho; Choi, Dong-Ju; Rha, Seung-Woon; Bae, Jang-Ho; Kwon, Taek-Geun; Bae, Jang-Whan; Cho, Myeong-Chan; Kim, Hyo-Soo

    2017-12-12

    It is not clear if anti-restonotic effect of cilostazol is consistent for different types of drug-eluting stents (DES).The purpose of this study was to compare the anti-proliferative effect of cilostazol between DAT and TAT with consideration of confounding influences of DES type.Nine hundred and fifteen patients were randomized to either dual antiplatelet therapy (DAT; aspirin and clopidogrel) or triple antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol) in the previous CILON-T trial. After excluding 70 patients who received both or neither stents, we analyzed 845 patients who received exclusively PES or ZES, and compared in-stent late loss at 6 months between both antiplatelet regimens (DAT versus TAT).Baseline angiographic and clinical characteristics were similar between the DAT (656 lesions in 425 patients) and the TAT group (600 lesions in 420 patients). The 6-month follow-up angiography was completed in 745 patients (88.2%). Quantitative coronary angiography showed that TAT significantly reduced in-stent late loss (DAT 0.62 ± 0.62 mm versus TAT 0.54 ± 0.49 mm, P = 0.015). Stent type, diabetes or lesion length did not interact with difference of late loss. However, reduction of late loss by cilostazol did not lead to a significant reduction in the rate of target lesion revascularization (TLR) (DAT 7.8% versus TAT 6.9%, P = 0.69) due to a nonlinear relationship found between late loss and TLR.The TAT group showed less in-stent late loss as compared to the DAT group. This was consistently observed regardless of DES type, lesion length, or diabetic status. However, reduction of late loss by cilostazol did not lead to a significant reduction in TLR.

  18. Dedicated bifurcation stents

    Directory of Open Access Journals (Sweden)

    Ajith Ananthakrishna Pillai

    2012-03-01

    Full Text Available Bifurcation percutaneous coronary intervention (PCI is still a difficult call for the interventionist despite advancements in the instrumentation, technical skill and the imaging modalities. With major cardiac events relate to the side-branch (SB compromise, the concept and practice of dedicated bifurcation stents seems exciting. Several designs of such dedicated stents are currently undergoing trials. This novel concept and pristine technology offers new hope notwithstanding the fact that we need to go a long way in widespread acceptance and practice of these gadgets. Some of these designs even though looks enterprising, the mere complex delivering technique and the demanding knowledge of the exact coronary anatomy makes their routine use challenging.

  19. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract.

    Science.gov (United States)

    Yang, Zhiping; Wu, Qiong; Wang, Fang; Ye, Xiaofei; Qi, Xingshun; Fan, Daiming

    2013-01-01

    Self-expandable metal stents (SEMS) are widely used for the palliative treatment of malignant gastrointestinal obstruction. Our aim was to evaluate the evidence comparing covered and bare SEMS in the digestive tract using meta-analytical techniques. A literature search was performed using PubMed, Cochrane Library, and Embase databases for comparative studies assessing the two types of stents. The primary outcomes of interest were stent patency and patient survival; second outcomes included technical success, clinical success, tumor ingrowth, tumor overgrowth, and stent migration. A random-effects model was conducted. Pooled analysis was done separately based on the different segments of the digestive tract. Eleven studies (8 randomized controlled trials and 3 prospective cohort studies) including a total of 1376 patients were identified. Covered SEMS were equivalent to bare SEMS in terms of technical success, clinical success, stent patency (gastroduodenal obstruction: HR =0.87, 95% CI 0.53-1.42; colorectal obstruction: HR =0.89, 95% CI 0.18-4.45; biliary obstruction: HR =0.73, 95% CI 0.41-1.32) and survival rates (esophageal obstruction: HR =1.80, 95% CI 0.73-4.44; gastroduodenal obstruction: HR =0.83, 95% CI 0.55-1.26; biliary obstruction: HR =0.99, 95% CI 0.77-1.28), although bare stents were more prone to tumor ingrowth (esophageal obstruction: RR =0.10, 95% CI 0.01-0.77; gastroduodenal obstruction: RR =0.12, 95% CI 0.03-0.55; colorectal obstruction: RR =0.21, 95% CI 0.06-0.70; biliary obstruction: RR =0.21, 95% CI 0.06-0.69), whereas covered stents had the higher risk of stent migration (gastroduodenal obstruction: RR =5.01, 95% CI 1.53-16.43; colorectal obstruction: RR =11.70, 95% CI 2.84-48.27; biliary obstruction: RR =8.11, 95% CI 1.47-44.76) and tumor overgrowth (biliary obstruction: RR =2.03, 95% CI 1.08-3.78). Both covered and bare SEMS are comparable in efficacy for the palliative treatment of malignant obstruction in the digestive tract. Each type of

  20. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

    Science.gov (United States)

    Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

    2014-02-01

    Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

  1. Electronic Elections

    DEFF Research Database (Denmark)

    Schürmann, Carsten

    2009-01-01

    Electronic voting technology is a two edged sword. It comes with many risks but brings also many benefits. Instead of flat out rejecting the technology as uncontrollably dangerous, we advocate in this paper a different technological angle that renders electronic elections trustworthy beyond...... the usual levels of doubt. We exploit the trust that voters currently have into the democratic process and model our techniques around that observation accordingly. In particular, we propose a technique of trace emitting computations to record the individual steps of an electronic voting machine...... for a posteriori validation on an acceptably small trusted computing base. Our technology enables us to prove that an electronic elections preserves the voter’s intent, assuming that the voting machine and the trace verifier are independent....

  2. Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial.

    Science.gov (United States)

    de Bernardis, Ricardo Caio Gracco; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  3. [Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial].

    Science.gov (United States)

    Bernardis, Ricardo Caio Gracco de; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary...... implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI. Thus, DES use improves both efficacy and safety. These findings support the use of DES in NSTE-ACS patients....

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

    Directory of Open Access Journals (Sweden)

    Donnenfeld ED

    2015-11-01

    Full Text Available Eric D Donnenfeld,1 Kerry D Solomon,2 Lilit Voskanyan,3 David F Chang,4 Thomas W Samuelson,5 Iqbal Ike K Ahmed,6 L Jay Katz7 1Ophthalmic Consultants of Long Island, Rockville Centre, NY, 2Carolina Eyecare Physicians, Mt Pleasant, SC, USA; 3S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 4Altos Eye Physicians, Los Altos, CA, 5Minnesota Eye Consultants, Minneapolis, MN, USA; 6University of Toronto, Toronto, ON, Canada; 7Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA Purpose: To evaluate 3-year safety and intraocular pressure (IOP following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG not controlled on preoperative medication. Patients and methods: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4% achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg, or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2

  6. Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

    Science.gov (United States)

    Puma, Joseph A; Banko, Lesan T; Pieper, Karen S; Sacchi, Terrence J; O'Shea, J Conor; Dery, Jean Pierre; Tcheng, James E

    2006-02-21

    In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

  7. Complementary effects of thienopyridine pretreatment and platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention; results from the ESPRIT trial.

    Science.gov (United States)

    Dery, Jean-Pierre; Campbell, Mark E; Mathias, Jasmine; Pieper, Karen S; Harrington, Robert A; Madan, Mina; Gibson, C Michael; Tolleson, Thaddeus R; O'Shea, J Conor; Tcheng, James E

    2007-07-01

    This analysis sought to investigate the complementary effect of thienopyridine pretreatment and platelet glycoprotein (GP) IIb/IIIa integrin blockade in coronary stent intervention. Definitive evidence supporting combined antiplatelet therapy consisting of thienopyridine pretreatment and GP IIb/IIIa receptor blockade in patients undergoing percutaneous coronary intervention (PCI) with stent implantation is limited. We retrospectively analyzed clinical outcomes by thienopyridine use in the 2,040 patients randomized to eptifibatide or placebo who underwent PCI in the ESPRIT trial. A total of 901 patients received a loading dose of thienopyridine before PCI (group 1), 123 received thienopyridine pretreatment without a loading dose (group 2), and 1,016 were not treated with thienopyridine before PCI (group 3). The composite incidence of death or myocardial infarction at 30 days was significantly lower in group 1 than in groups 2 and 3 combined (OR, 0.71 [95%CI, 0.52-0.99]; P = 0.0417). A similar trend was seen for the composite of death, myocardial infarction, or urgent target vessel revascularization (unadjusted OR, 0.77 [0.57-1.05]; P = 0.1025). After adjusting for baseline characteristics, these differences were no longer significant. No interactions were identified with eptifibatide assignment for any of the group comparisons. Pretreatment with a loading dose of thienopyridine lowers the rate of ischemic complications regardless of treatment with a GP IIb/IIIa inhibitor. Conversely, the efficacy of eptifibatide is maintained whether or not a loading dose of a thienopyridine is administered. Optimal outcomes are achieved in patients receiving thienopyridine pretreatment along with platelet GP IIb/IIIa inhibitor therapy. (c) 2007 Wiley-Liss, Inc.

  8. Trust in Internet Election

    DEFF Research Database (Denmark)

    Markussen, Randi; Ronquillo, Lorena; Schürmann, Carsten

    2014-01-01

    This paper discusses the Decryption and Counting Ceremony held in conjunction with the internet voting trial on election day in the Ministry of Local Government and Regional Development of Norway in 2013. We examine the organizers' ambition of making the decryption and counting of electronic votes...... public in order to sustain trust in internet voting. We introduce a pragmatic approach to trust that emphasises the inseparability of truth from witnessing it. Based on this and on a description of how the event was made observable and how the complexities in the counting process were disclosed, we...... discuss what we term economy of truth from the perspective of the IT community involved in the ceremony. We claim that broadening the economy of truth by including more explicitly social and political perspectives in the ceremony, and in internet elections in general, and how witnessing is brought about...

  9. Symptomatic stent cast.

    LENUS (Irish Health Repository)

    Keohane, John

    2012-02-03

    Biliary stent occlusion is a major complication of endoscopic stent insertion and results in repeat procedures. Various theories as to the etiology have been proposed, the most frequently studied is the attachment of gram negative bacteria within the stent. Several studies have shown prolongation of stent patency with antibiotic prophylaxis. We report the case of stent occlusion from a cast of a previously inserted straight biliary stent; a "stent cast" in an 86-year-old woman with obstructive jaundice. This was retrieved with the lithotrypter and she made an uneventful recovery. This is the first reported case of a biliary stent cast.

  10. Bioabsorbable coronary stents--are these the next big thing in coronary angioplasty?

    Science.gov (United States)

    Balla, Sudarshan; Aggarwal, Kul; Nistala, Ravi

    2010-06-01

    The role of percutaneous coronary intervention (PCI) in the treatment of coronary artery disease has grown at an astronomical pace. Drug eluting stents (DES) offer advantages over bare metal stents (BMS) such as reduction in early in-stent restenosis rates. However, they have disadvantages like from increased late stent thrombosis when compared with BMS. Furthermore, recent data suggest endothelial dysfunction in the DES stented segments of the arteries. Currently, bioabsorbable stents are under development to avert the complications of DES such as stent thrombosis via degradation of the stent over time. The hypothetical advantage of leaving behind a natural vessel and restoring vasoreactivity may be the almost normal physiology which can be achieved after an intervention with a stent. The ABSORB and the PROGRESS AMS are two of the recent clinical trials that have looked at the outcomes of using bioabsorbable stents. So far, data from these and other studies has yielded mixed results in terms of angiographic and clinical outcomes. Newer stents such as REVA and WHISPER are presently being tested in preclinical and clinical trials. The landscape for bioabsorbable stents is constantly evolving through continued improvisation on existing technology and emergence of new technology. Large scale randomized trials are still needed with adequate long term follow-up for safety and benefits to have mainstream application in coronary artery disease, bioabsorbable stents are a promising innovation in the field of PCI. We review some of the patents and the data that is emerging on bioabsorbable stents in addition to currently ongoing clinical trials.

  11. Do pregnant women prefer timing of elective cesarean section prior to versus after 39 weeks of gestation? Secondary analyses from a randomized controlled trial.

    Science.gov (United States)

    Glavind, J; Henriksen, T B; Kindberg, S F; Uldbjerg, N

    2014-11-01

    To evaluate women's preferences for timing of elective cesarean section (ECS) scheduled prior to versus after 39 completed weeks. Secondary analyses from a randomized controlled open-label trial were conducted at seven Danish tertiary hospitals from March 2009 to June 2011 with inclusion of singleton pregnant women with a healthy fetus. The women were allocated by a computerized telephone system to ECS scheduled at 38(+3) weeks or 39(+3) weeks of gestation. Dissatisfaction with timing of ECS and preferred timing of the procedure in a proposed future ECS delivery were evaluated. Data analyses were done by intention-to-treat, using logistic regression. A total of 1196 women (94%) completed an online questionnaire at follow-up eight weeks postpartum. In the 38 weeks group, 61 (10%) women 601 were dissatisfied with the timing of their ECS, whereas in the 39 weeks group 157 (26%) of 595 were dissatisfied (adjOR 3.18, 95% CI 2.30; 4.40). The proportion of women who preferred the same timing in a future ECS were 272 (45%) in the 38 weeks group compared to 232 (39%) in the 39(+3) weeks group (adjOR 0.75, 95% CI 0.60; 0.95). The women in this trial preferred ECS scheduled prior to 39 weeks of gestation.

  12. Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.

    Science.gov (United States)

    Clark, Nathan P; Douketis, James D; Hasselblad, Vic; Schulman, Sam; Kindzelski, Andrei L; Ortel, Thomas L

    2018-01-01

    The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors. We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9). In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon® 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Directory of Open Access Journals (Sweden)

    Montgomery Alan A

    2009-08-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml. A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management

  14. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon®) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Science.gov (United States)

    Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R

    2009-01-01

    Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  15. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  16. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2009-01-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  17. Stenting of the Lower Gastrointestinal Tract: Current Status

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Sabharwal, Tarun; Adam, Andreas

    2011-01-01

    Colon obstruction due to colorectal cancer is a major surgical emergency. Patients with acute bowel obstruction are usually poor surgical candidates with 10–20% operative mortality and 40–50% operative morbidity rates. Colorectal stenting is an image-guided, minimally invasive procedure, and typical indications include either palliation of inoperable malignant disease or temporary bowel decompression as a bridge to surgery. Colorectal stenting allows the patient to recover before definite elective surgical resection, reducing perioperative morbidity and mortality, overall hospital stay, and associated health care costs. Palliative stenting improves quality of life compared to surgery. A concise review is provided of contemporary stenting practice of the lower gastrointestinal tract, the colon in particular, and both palliative and preoperative adjuvant procedures are evaluated in terms of relevant patient oncology, insertion technique, available stent designs, technical and clinical outcomes, associated complications, and cost–benefit analysis.

  18. A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

    2011-01-01

    Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

  19. 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

    group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.......8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite...

  20. Long-Term Follow-up of the PADI Trial : Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

    NARCIS (Netherlands)

    Spreen, Marlon I; Martens, Jasper M; Knippenberg, Bob; van Dijk, Lukas C; De Vries, Jean-Paul P. M.; Vos, Jan Albert; de Borst, Gert Jan; Vonken, Evert-Jan P A; Bijlstra, Okker D; Wever, Jan J; Statius van Eps, Randolph G; Mali, Willem P Th M; van Overhagen, Hendrik

    2017-01-01

    BACKGROUND: Clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA-BMS) through midterm follow-up in patients with critical limb ischemia.

  1. 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...

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  3. 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

    data of the long-term outcome of patients with complex coronary artery lesions. METHODS: We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. RESULTS: At 3 years, major...... performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient. CONCLUSIONS: A continued...

  4. Impact of the New American Heart Association/American Stroke Association Definition of Stroke on the Results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.

    Science.gov (United States)

    Al Kasab, Sami; Lynn, Michael J; Turan, Tanya N; Derdeyn, Colin P; Fiorella, David; Lane, Bethany F; Janis, L Scott; Chimowitz, Marc I

    2017-01-01

    An American Heart Association/American Stroke Association (AHA/ASA) writing committee has recently recommended that tissue evidence of cerebral infarction associated with temporary symptoms (CITS) lasting Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. We compared outcomes in the medical (n = 227) and stenting (n = 224) groups in SAMMPRIS using the following primary end point (new components in bold): any stroke, CITS, or death within 30 days after enrollment or within 30 days after a revascularization procedure for the qualifying lesion during follow-up; or ischemic stroke or CITS in the territory of the qualifying artery beyond 30 days. We also compared the use of brain magnetic resonance imaging (MRI) after transient ischemic attacks (TIAs) in both treatment groups. By considering CITS as equivalent to stroke, the number of primary end points increased from 34 to 43 in the medical group and from 52 to 66 in the stenting group of SAMMPRIS. The Kaplan-Meier curves for the primary end points in the 2 groups were significantly different (P = .009). The percentage of patients with reported TIAs who underwent brain MRI was 69% in the medical group and 61% in the stenting group (P = .40). Using the AHA/ASA definition of stroke resulted in a substantially higher primary end point rate in both treatment groups and an even higher benefit from medical therapy over stenting than originally shown in SAMMPRIS. The higher rate of CITS in the stenting group was not due to ascertainment bias. Published by Elsevier Inc.

  5. Palliative brachytherapy with or without primary stent placement in patients with oesophageal cancer, a randomised phase III trial

    International Nuclear Information System (INIS)

    Amdal, Cecilie Delphin; Jacobsen, Anne-Birgitte; Sandstad, Berit; Warloe, Trond; Bjordal, Kristin

    2013-01-01

    Purpose: To investigate whether a combination of self-expanding metal stent (SEMS) and brachytherapy provided more rapid and prolonged effect on dysphagia without increased pain compared to brachytherapy alone in patients with incurable oesophageal cancer. Methods: 41 Patients were randomised to SEMS followed by brachytherapy, 8 Gy × 3 (n = 21) or brachytherapy alone, 8 Gy × 3 (n = 20). Change in dysphagia and pain three and seven weeks after randomisation (FU1 and FU2) was assessed by patient-reported outcome. Dysphagia, other symptoms and health-related quality of life were assessed every four weeks thereafter. The study was closed before the estimated patient-number was reached due to slow recruitment. Results: Patients receiving SEMS followed by brachytherapy had significantly improved dysphagia at FU1 compared to patients receiving brachytherapy alone (n = 35). Difference in pain was not observed. At FU2, patients in both arms (n = 21) had less dysphagia. Four patients in the combined treatment arm experienced manageable complications, no complications occurred after brachytherapy alone. Conclusion: For the relief of dysphagia, SEMS followed by brachytherapy is preferable and safe for patients in need of immediate alleviation, while brachytherapy with or without preceding SEMS provides relief within a few weeks after treatment

  6. Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation

    DEFF Research Database (Denmark)

    Kristensen, Søren Lund; Galløe, Anders M; Thuesen, Leif

    2014-01-01

    Background: The widespread use of coronary stents has exposed a growing population to the risk of stent thrombosis, but the importance in terms of risk of ST-segment elevation myocardial infarctions (STEMIs) remains unclear. Methods: We studied five years follow-up data for 2,098 all-comer patients...... 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. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial.

    Science.gov (United States)

    Comajuncosas, Jordi; Hermoso, Judit; Jimeno, Jaime; Gris, Pere; Orbeal, Rolando; Cruz, Antonio; Parés, David

    2017-01-01

    Laparoscopic cholecystectomy is the gold standard treatment for gallbladder stones. Complications due to laparoscopic procedure are rare, but rate of wound infection in some studies is about 8 %. From January 2007 to December 2008, 320 laparoscopic cholecystectomies were performed at our hospital, and in 4.7 % of them, wound infection of the umbilical trocar was identified. We believe that this infection rate could be lower and that it is necessary to implement a new technique to reduce the wound infection. The aim of the study was to evaluate the benefits of bag extraction of gallbladder to prevent the wound infection. Two-arm, parallel, 1:1, randomised controlled trial (ISRCTN38095251). All patients suffering from symptomatic gallbladder stones of low risk were enrolled for this study and were divided into two groups in basics gallbladder extraction: with (80 patients) or, as usually, without bag (76 patients). All patients with cholecystitis or accidental gallbladder perforation were excluded. We compared all the results to establish whether meaningful differences were found. The final sample analysed (156 patients) consisted of 121 women and 35 men; there were 80 in the control group and 76 in the study group. There were 15 (9.6 %) diagnosed wound infections, eight cases in the study group and seven in the control group. There were no statistically significant differences. The determinant of wound infection in elective laparoscopic cholecystectomy is not the direct contact of the gallbladder with the wound; therefore, bag extraction is not necessary.

  8. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Georgopoulou Stavroula

    2010-02-01

    Full Text Available Abstract Background Cardiac surgery is a major consumer of blood products, and hemodilution increases transfusion requirements during cardiac surgery under CPB. As intraoperative parenteral fluids contribute to hemodilution, we evaluated the hypothesis that intraoperative fluid restriction reduces packed red-cell (PRC use, especially in transfusion-prone adults undergoing elective cardiac surgery. Methods 192 patients were randomly assigned to restrictive (group A, 100 pts, or liberal (group B, 92 pts intraoperative intravenous fluid administration. All operations were conducted by the same team (same surgeon and perfusionist. After anesthesia induction, intravenous fluids were turned off in Group A (fluid restriction patients, who only received fluids if directed by protocol. In contrast, intravenous fluid administration was unrestricted in group B. Transfusion decisions were made by the attending anesthesiologist, based on identical transfusion guidelines for both groups. Results 137 of 192 patients received 289 PRC units in total. Age, sex, weight, height, BMI, BSA, LVEF, CPB duration and surgery duration did not differ between groups. Fluid balance was less positive in Group A. Fewer group A patients (62/100 required transfusion compared to group B (75/92, p Conclusions Our data suggest that fluid restriction reduces intraoperative PRC transfusions without significantly increasing postoperative transfusions in cardiac surgery; this effect is more pronounced in transfusion-prone patients. Trial registration NCT00600704, at the United States National Institutes of Health.

  9. Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial.

    Science.gov (United States)

    Blanchard, Pierre; Faivre, Laura; Lesaunier, François; Salem, Naji; Mesgouez-Nebout, Nathalie; Deniau-Alexandre, Elisabeth; Rolland, Frédéric; Ferrero, Jean-Marc; Houédé, Nadine; Mourey, Loïc; Théodore, Christine; Krakowski, Ivan; Berdah, Jean-François; Baciuchka, Marjorie; Laguerre, Brigitte; Davin, Jean-Louis; Habibian, Muriel; Culine, Stéphane; Laplanche, Agnès; Fizazi, Karim

    2016-01-01

    The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS). A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (PENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity. This unplanned analysis of a randomized trial failed to demonstrate a benefit of pelvic ENI on bPFS in high-risk localized prostate cancer patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Omitting elective nodal irradiation during thoracic irradiation in limited-stage small cell lung cancer--evidence from a phase II trial.

    Science.gov (United States)

    Colaco, Rovel; Sheikh, Hamid; Lorigan, Paul; Blackhall, Fiona; Hulse, Paul; Califano, Raffaele; Ashcroft, Linda; Taylor, Paul; Thatcher, Nicholas; Faivre-Finn, Corinne

    2012-04-01

    Omitting elective nodal irradiation (ENI) in limited-stage disease small cell lung cancer (LD-SCLC) is expected to result in smaller radiation fields. We report on data from a randomised phase II trial that omitted ENI in patients receiving concurrent chemo-radiotherapy for LD-SCLC. 38 patients with LD-SCLC were randomised to receive once-daily (66 Gy in 33 fractions) or twice-daily (45 Gy in 30 fractions) radiotherapy (RT). 3D-conformal RT was given concurrently with cisplatin and etoposide starting with the second cycle of a total of four cycles. The gross tumour volume was defined as primary tumour with involved lymph nodes (nodes ≥1 cm in short axis) identifiable with CT imaging. ENI was not used. Six recurrence patterns were identified: recurrence within planning target volume (PTV) only, recurrence within PTV+regional nodal recurrence and/or distant recurrence, isolated nodal recurrence outside PTV, nodal recurrence outside PTV+distant recurrence, distant metastases only and no recurrence. At median follow-up 16.9 months, 31/38 patients were evaluable and 14/31 patients had relapsed. There were no isolated nodal recurrences. Eight patients relapsed with intra-thoracic disease: 2 within PTV only, 4 within PTV and distantly and 2 with nodal recurrence outside PTV plus distant metastases. Rates of grade 3+ acute oesophagitis and pneumonitis in the 31 evaluable patients were 23 and 3% respectively. In our study of LD-SCLC, omitting ENI based on CT imaging was not associated with a high risk of isolated nodal recurrence, although further prospective studies are needed to confirm this. Routine ENI omission will be further evaluated prospectively in the ongoing phase III CONVERT trial (NCT00433563). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  11. [Drug-eluting stent thrombosis and its pharmacological prevention].

    Science.gov (United States)

    Pershukov, I V; Batyraliev, T A

    2007-01-01

    The problem of drug eluting stents (DES) safety has been actively discussed throughout 2006 because of increase of frequency of development of late stent thromboses which were noted during almost 2 years after stenting. In December 2006 US Food and Drug Administration (FDA) advisory panel acknowledged increase of development of late stent thrombosis. At the same time FDA accepted new definition of stent-thrombosis suggested by the Academic Research Consortium. According to this definition thrombosis can be definite, probable and possible. Any unexplained death before end of follow-up in a trial should be considered thrombosis related. Recalculation of thrombosis rate using this definition caused pronounced increase of this parameter in previously conducted trials. Thrombosis rate rose from 0,6 to 3,3% for bare metal stents, from 0,8 to 3,6% for sirolimus eluting stents and from 1,3 to 3,5% for paclitaxel eluting stents. Professional cardiological and angiographical societies (ACC, AHA, SCAI) responding to FDA advisory panel published their proofs and vision of the problem of stent thrombosis. In February 2007 ACC, AHA, SCAI, American College of Surgeons and Association of Dentists published scientific bulletin in which described preventive measures aimed at lowering of risk of thrombosis development. This document contains strict recommendation to continue double antithrombotic therapy with aspirin and clopidogrel for 12 months after implantation of DES or abandonment of the use of this type of stents when long term double antithrombotic therapy is not possible.

  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

    -EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials. SELECTION...... 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...

  13. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene MH

    2017-01-01

    Background Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. Objective The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). Methods The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child’s postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. Results The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. Conclusions To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool

  14. Elections to Staff Council

    CERN Multimedia

    Saff Association

    2013-01-01

    2013 Elections to Staff Council   Vote! Make your voice heard and be many to elect the new Staff Council. More details on the elections can be found on the Staff Association web site (https://ap-vote.web.cern.ch/elections-2013).   Timetable elections Monday 28 October to Monday 11 November, 12:00 am voting Monday 18 and Monday 25 November, publication of the results in Echo Tuesday 19 November, Staff Association Assizes Tuesday 3 December, first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee.

  15. Effects of Intrathecal Clonidine on Spinal Analgesia during Elective Cesarean Delivery: A Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Houshang Talebi

    2016-05-01

    Full Text Available In order To investigate the effect of addition of clonidine to lidocaine on duration of spinal analgesia and need for postoperative analgesics after Caesarean section delivery, this randomized case-controlled double-blind clinical trial was designed and conducted. 166 eligible women were randomly allocated to either case or control group (n=83, Spinal anesthesia was done by 75-100 mg lidocaine 0.5% in control group and by 75-100 mg lidocaine 0.5% plus 75µg clonidine in case group. Onset of analgesia, Blood pressure, Hypotension, Bradycardia, and Neonates Apgar scores were recorded during surgery. After surgery, duration of sensory and motor functions, Intensity of post-operative nausea and vomiting, Total analgesic consumption and time to first analgesic request were assessed. Data were analyzed by SPSS and an alpha level < 0.05 was considered to be statistically significant. Onset of analgesia, Duration of Motor and sensory block, mothers’ systolic blood pressure and pulse rate in different recorded times, and Total Analgesic consumption in case group showed a statically significant difference in comparison to the control group. Analgesia demanding, Time of first request for analgesics, Intensity of Nauseas and vomiting, Apgar score showed no significant difference. We have demonstrated that addition of 75 µg clonidine to lidocaine extends spinal analgesia along with sensory and motor block after Caesarean section and improves early analgesia without clinically significant maternal or neonatal side-effects. This single 75 µg intrathecal clonidine dose also reduced the amount of subsequent analgesic consumption during the first 12 hours after delivery.

  16. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting: a meta-analysis of pooled patient data from four randomised trials.

    Science.gov (United States)

    Howard, George; Roubin, Gary S; Jansen, Olav; Hendrikse, Jeroen; Halliday, Alison; Fraedrich, Gustav; Eckstein, Hans-Henning; Calvet, David; Bulbulia, Richard; Bonati, Leo H; Becquemin, Jean-Pierre; Algra, Ale; Brown, Martin M; Ringleb, Peter A; Brott, Thomas G; Mas, Jean-Louis

    2016-03-26

    Age was reported to be an effect-modifier in four randomised controlled trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA), with better CEA outcomes than CAS outcomes noted in the more elderly patients. We aimed to describe the association of age with treatment differences in symptomatic patients and provide age-specific estimates of the risk of stroke and death within narrow (5 year) age groups. In this meta-analysis, we analysed individual patient-level data from four randomised controlled trials within the Carotid Stenosis Trialists' Collaboration (CSTC) involving patients with symptomatic carotid stenosis. We included only trials that randomly assigned patients to CAS or CEA and only patients with symptomatic stenosis. We assessed rates of stroke or death in 5-year age groups in the periprocedural period (between randomisation and 120 days) and ipsilateral stroke during long-term follow-up for patients assigned to CAS or CEA. We also assessed differences between CAS and CEA. All analyses were done on an intention-to-treat basis. Collectively, 4754 patients were randomly assigned to either CEA or CAS treatment in the four studies. 433 events occurred over a median follow-up of 2·7 years. For patients assigned to CAS, the periprocedural hazard ratio (HR) for stroke and death in patients aged 65-69 years compared with patients younger than 60 years was 2·16 (95% CI 1·13-4·13), with HRs of roughly 4·0 for patients aged 70 years or older. We noted no evidence of an increased periprocedural risk by age group in the CEA group (p=0·34). These changes underpinned a CAS-versus CEA periprocedural HR of 1·61 (95% CI 0·90-2·88) for patients aged 65-69 years and an HR of 2·09 (1·32-3·32) for patients aged 70-74 years. Age was not associated with the postprocedural stroke risk either within treatment group (p≥0·09 for CAS and 0·83 for CEA), or between treatment groups (p=0·84). In these RCTs, CEA was clearly superior to CAS in

  17. A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).

    Science.gov (United States)

    Schofer, Joachim; Musiałek, Piotr; Bijuklic, Klaudija; Kolvenbach, Ralf; Trystula, Mariusz; Siudak, Zbigniew; Sievert, Horst

    2015-08-17

    This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting. The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period. A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland. The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan. The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. 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...

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

    Science.gov (United States)

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

    2017-01-01

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

  20. A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

    Science.gov (United States)

    Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

    2016-09-01

    Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute

  1. Relationship between Risk Factor Control and Compliance with a Lifestyle Modification Program in the Stenting Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis Trial.

    Science.gov (United States)

    Turan, Tanya N; Al Kasab, Sami; Nizam, Azhar; Lynn, Michael J; Harrell, Jamie; Derdeyn, Colin P; Fiorella, David; Janis, L Scott; Lane, Bethany F; Montgomery, Jean; Chimowitz, Marc I

    2018-03-01

    Lifestyle modification programs have improved the achievement of risk factor targets in a variety of clinical settings, including patients who have previously suffered a stroke or transient ischemic attack and those with multiple risk factors. Stenting Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) was the first vascular disease prevention trial to provide a commercially available lifestyle modification program to enhance risk factor control. We sought to determine the relationship between compliance with this program and risk factor control in SAMMPRIS. SAMMPRIS aggressive medical management included a telephonic lifestyle modification program provided free of charge to all subjects (n = 451) during their participation in the study. Subjects with fewer than 3 expected lifestyle-coaching calls were excluded from these analyses. Compliant subjects (n = 201) had  greater than or equal to 78.5% of calls (median % of completed/expected calls). Noncompliant subjects (n = 200) had less than 78.5% of calls or refused to participate. Mean risk factor values or % in-target for each risk factor was compared between compliant versus noncompliant subjects, using t tests and chi-square tests. Risk factor changes from baseline to follow-up were compared between the groups to account for baseline differences. Compliant subjects had better risk factor control throughout follow-up for low-density lipoprotein, systolic blood pressure (SBP), hemoglobin A1c (HgA1c), non-high-density lipoprotein, nonsmoking, and exercise than noncompliant subjects, but there was no difference for body mass index. After adjusting for baseline differences between the groups, compliant subjects had a greater change from baseline than noncompliant subjects for SBP did at 24 months and HgA1c at 6 months. SAMMPRIS subjects who were compliant with the lifestyle modification program had better risk factor control during the study for almost

  2. 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.

  3. Carotid Angioplasty and Stenting

    Science.gov (United States)

    Carotid angioplasty and stenting Overview Carotid angioplasty (kuh-ROT-id AN-jee-o-plas-tee) and stenting ... to better see and examine the blood vessels. Food and medications You'll receive instructions on what ...

  4. 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

  5. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial.

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene Mh; Utens, Elisabeth Mwj

    2017-09-11

    Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child's postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both

  6. Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard, Pierre, E-mail: pierre.blanchard@gustaveroussy.fr [Radiation Oncology, Gustave Roussy Cancer Center, Villejuif (France); University of Paris-Sud, Cancer Campus, Villejuif (France); Faivre, Laura [Biostatistics, Gustave Roussy Cancer Center, Villejuif (France); Lesaunier, François [Radiation Oncology, Centre Francois Baclesse, Caen (France); Salem, Naji [Radiation Oncology, Institut Paoli Calmette, Marseille (France); Mesgouez-Nebout, Nathalie [Radiation Oncology, Institut de Cancérologie de l' Ouest, Angers (France); Deniau-Alexandre, Elisabeth [Centre Hospitalier La Roche sur Yon, La Roche sur Yon (France); Rolland, Frédéric [Medical Oncology, Institut de Cancérologie de l' Ouest, Nantes (France); Ferrero, Jean-Marc [Medical Oncology, Centre Antoine Lacassagne, Nice (France); Houédé, Nadine [Medical Oncology, Institut Bergonié, Bordeaux (France); Mourey, Loïc [Institut Claudius Regaud, Toulouse (France); Théodore, Christine [Hospital Foch, Suresnes (France); Krakowski, Ivan [Centre Alexis Vautrin, Vandoeuvre-lès-Nancy (France); Berdah, Jean-François [Clinique Sainte Marguerite, Hyeres (France); Baciuchka, Marjorie [Centre Hospitalier de la Timone, Marseille (France); Laguerre, Brigitte [Centre Eugène Marquis, Rennes (France); Davin, Jean-Louis [Clinique Sainte Catherine, Avignon (France); Habibian, Muriel [R& D UNICANCER, Paris (France); UNICANCER, Paris (France); Culine, Stéphane [Department of Medical Oncology, Hopital Saint-Louis, APHP, Paris (France); and others

    2016-01-01

    Purpose: The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. Methods and Materials: Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS). Results: A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity. Conclusions: This unplanned analysis of

  7. Mechanisms of biliary stent clogging: confocal laser scanning and scanning electron microscopy.

    Science.gov (United States)

    van Berkel, A M; van Marle, J; Groen, A K; Bruno, M J

    2005-08-01

    Endoscopic insertion of plastic biliary endoprostheses is a well-established treatment for obstructive jaundice. The major limitation of this technique is late stent occlusion. In order to compare events involved in biliary stent clogging and identify the distribution of bacteria in unblocked stents, confocal laser scanning (CLS) and scanning electron microscopy (SEM) were carried out on two different stent materials - polyethylene (PE) and hydrophilic polymer-coated polyurethane (HCPC). Ten consecutive patients with postoperative benign biliary strictures were included in the study. Two 10-Fr stents 9 cm in length, one made of PE and the other of HCPC, were inserted. The stents were electively exchanged after 3 months and examined using CLS and SEM. No differences were seen between the two types of stent. The inner stent surface was covered with a uniform amorphous layer. On top of this layer, a biofilm of living and dead bacteria was found, which in most cases was unstructured. The lumen was filled with free-floating colonies of bacteria and crystals, surrounded by mobile laminar structures of mucus. An open network of large dietary fibers was seen in all of the stents. The same clogging events occurred in both PE and HCPC stents. The most remarkable observation was the identification of networks of large dietary fibers, resulting from duodenal reflux, acting as a filter. The build-up of this intraluminal framework of dietary fibers appears to be a major factor contributing to the multifactorial process of stent clogging.

  8. Low-profile stent placement with the monorail technique for treatment of renal artery stenosis: midterm results of a prospective trial.

    Science.gov (United States)

    Müller-Hülsbeck, Stefan; Frahm, Christian; Behm, Charlotte; Schäfer, Phillip Jobst; Bolte, Hendrik; Heller, Martin; Jahnke, Thomas

    2005-07-01

    To determine feasibility, safety, and midterm patency of a monorail balloon stent device for the treatment of renal artery stenosis (RAS). During a period of 30 months, 47 patients (with severe hypertension, n=45; renal insufficiency, n=20) with 50 cases of RAS and indications for stent implantation (calcified ostial lesion, n=41; insufficient percutaneous transluminal angioplasty, n=6; dissection, n=3) were enrolled into the prospective evaluation. After predilation, 59 stents (Rx-Herculink 4 mm, n=2; 5 mm, n=19; 6 mm, n=35; 7 mm, n=3) were implanted under manometer control with use of the long-sheath technique (5 F; 6 F for 7-mm stents) via a femoral (n=44) or transbrachial approach (n=6). Parameters of hypertension and renal insufficiency were determined before and after the procedure and for a maximum of 18 months. Restenosis rate was determined with color duplex ultrasonography. Renal artery stent placement (mean diameter, 5.7 mm; mean length, 16 mm) was technically successful in all cases (100%). Mean blood pressure and serum creatinine level decreased from 177/93 mm Hg to 145/78 mm Hg and from 1.8 mg/dL to 1.5 mg/dL, respectively. Within 48 hours after the implantation, acute occlusions occurred in two patients, supposedly triggered by cholesterol embolization. Primary and primary assisted patency rates were 87% and 92% at 6 months and 75% and 84% at 18 months. Renal artery stent placement with the rapid-exchange monorail system is a safe procedure with promising patency rates. In combination with the long-sheath technique, adequate control of stent deployment is guaranteed during the entire intervention. The low profile of the device facilitates the use of small sheaths (5 F) to minimize access-site complications.

  9. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

    Science.gov (United States)

    Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

    2015-01-01

    Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

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

    Science.gov (United States)

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

    2017-12-26

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

  11. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.

  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. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

    Science.gov (United States)

    Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

    2012-04-14

    The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare

  14. Potential advantages and limitations of the Leo stent in endovascular treatment of complex cerebral aneurysms

    Energy Technology Data Exchange (ETDEWEB)

    Lv Xianli; Li Youxiang; Jiang Chuhan; Yang Xinjian [Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, 6, Tiantan Xili, 100050 Hebei, Beijing (China); Wu Zhongxue, E-mail: ttyyzjb@sina.com [Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, 6, Tiantan Xili, 100050 Hebei, Beijing (China)

    2011-08-15

    Objective: The Leo self-expandable stent is a new retractable stent that is delivered via a conventional catheter. The aim of this study was to evaluate the use of this stent for endovascular treatment of complex aneurysms. Methods: Twenty-eight complex cerebral aneurysms (27 saccular and 1 fusiform) in 28 patients were treated electively. They were located at the internal carotid artery (17), basilar trunk (3), anterior cerebral artery (1), anterior communicating artery (3), vertebral artery (2) and middle cerebral artery (2). One aneurysm exhibited recanalization after primary endovascular treatment without stent. Clinical outcome was assessed with the modified Glasgow Outcome Scale. Results: Deployment of Leo stent was successful in 26 lesions, and difficulties in stent positioning due to tortuous cerebral circulation in 2 cases, which were treated with Neuroform stent. Additional coil embolization was performed in 26 lesions. No permanent neurological deficits were encountered consequent to endovascular procedure. Complete or partial occlusion immediately after stent deployment was achieved in all aneurysms. There was no immediate coil embolization was chosen in 3 cases because of subsequent reduced filling of the aneurysms with contrast agent on angiograms. There were 3 asymptomatic parent artery occlusion related to the deployment of the Leo stent, one stent migration. Follow-up revealed patent stents in the remaining cases. No angiographic recurrences arose. Conclusion: The Leo stent is very useful for endovascular treatment of complex cerebral aneurysms because it is easy to navigate and place precisely. A drawback is that in-stent thrombosis caused by stent placement and stiffer delivery catheters to place larger stents.

  15. Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

    Science.gov (United States)

    Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

    2006-01-01

    To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

  16. Bailout use of platelet glycoprotein IIb-IIIa inhibition during coronary stent implantation: observations from the ESPRIT trial.

    Science.gov (United States)

    Cantor, Warren J; Madan, Mina; O'Shea, J Conor; Chisholm, Robert J; Lui, Henry K; Cohen, David J; Feldman, Robert L; Green, Robert; Hellkamp, Anne S; Kitt, Michael M; Tcheng, James E

    2005-07-01

    Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention, rather than as prophylactic treatment. We sought to identify the characteristics and outcomes of patients requiring bailout treatment. The ESPRIT trial randomized 2,064 patients to receive eptifibatide or placebo starting immediately before percutaneous coronary intervention (PCI). Bailout therapy was used in 77 patients: 43 (4.2%) randomized to placebo and 34 (3.3%) to eptifibatide (p = 0.3). Bailout therapy for thrombosis was used more often in the placebo group (2.1% versus 1.0%; p = 0.03). Multivariable predictors of bailout included a greater than or equal to 90% stenosis, or visible thrombus on the baseline angiogram, and no aspirin pre-treatment before PCI. However, overall the model predicted bailout poorly (c-index = 0.64). The need for bailout cannot be reliably predicted using baseline characteristics. Patients experiencing complications have poor clinical outcomes despite bailout use of GP IIb/IIIa inhibitors.

  17. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    International Nuclear Information System (INIS)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-01-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  18. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

    2013-02-15

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  19. 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...

  20. Covered duodenal self-expandable metal stents prolong biliary stent patency in double stenting: The largest series of bilioduodenal obstruction.

    Science.gov (United States)

    Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Kondo, Hiromu; Yoshida, Michihiro; Shimizu, Shuya; Hirano, Atsuyuki; Okumura, Fumihiro; Ando, Tomoaki; Jinno, Naruomi; Takada, Hiroki; Togawa, Shozo; Joh, Takashi

    2018-03-01

    Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (P = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent group than in the U-SEMS group (P = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (P = 0.724). Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. The covered self-expandable metal stent is the preferred type of duodenal SEMS in patients with DS (Clinical trial registration number: UMIN000027606). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  1. Preoperative intravenous ibuprofen does not influence postoperative narcotic use in patients undergoing elective hernia repair: a randomized, double-blind, placebo controlled prospective trial

    Directory of Open Access Journals (Sweden)

    Sparber LS

    2017-07-01

    Full Text Available Lauren S Sparber,1 Christine SM Lau,1,2 Tanya S Vialet,1 Ronald S Chamberlain1–4 1Department of Surgery, Saint Barnabas Medical Center, Livingston, NJ, USA; 2Saint George’s University School of Medicine, Grenada, West Indies; 3Department of Surgery, Banner MD Anderson Cancer Center, Gilbert, AZ, USA; 4Department of Surgery, New Jersey Medical School, Rutgers University, Newark, NJ, USA Introduction: Inguinal and umbilical hernia repairs are among the most common surgical procedures performed in the US. Optimal perioperative pain control regimens remain challenging and opioid analgesics are commonly used. Preoperative nonsteroidal anti-inflammatory drug (NSAID administration has been shown to reduce postoperative narcotic requirements. This study sought to evaluate the efficacy of perioperative intravenous (IV ibuprofen on postoperative pain level and narcotic use in patients undergoing open or laparoscopic inguinal and/or umbilical hernia repair.Methods: A single center, randomized, double-blind placebo-controlled trial involving patients ≥18 years undergoing inguinal and/or umbilical hernia repair was performed. Patients were randomized to receive 800 mg of IV ibuprofen or placebo preoperatively. Outcomes assessed included postoperative pain medication required and visual analog scale (VAS pain scores.Results: Forty-eight adult male patients underwent inguinal and/or umbilical hernia repair. Patients receiving IV ibuprofen used more oxycodone/acetaminophen (32% vs 13% and IV hydromorphone (12% vs 8.7%, and fewer combinations of pain medications (44% vs 65.2% in the first two postoperative hours compared to placebo (p=0.556. The IV ibuprofen group had more patients pain free (28% vs 8.7%, p=0.087 and lower VAS scores (3.08±2.14 vs 3.95±1.54, p=0.134 at 2 hours postoperatively, compared to the placebo group, however, this was not statistically significant. Similar pain levels at 1, 3, and 7 days, postoperative and similar use of rescue

  2. Serbian Elections 2016

    Directory of Open Access Journals (Sweden)

    Dušan Pavlović

    2016-06-01

    Full Text Available Elections in Serbia have been held quite often over the past 26 years. Yet, of all elections that have taken place since the introduction of the multiparty system in 1990, the elections held on April 24 2016, were the most confusing. They were held early, but were neither a product of political, nor economic crisis. So why were they necessary?

  3. Election '88: Teacher Packet.

    Science.gov (United States)

    North Carolina State Dept. of Public Instruction, Raleigh. Div. of Social Studies Education.

    This materials packet contains information on teaching about the electoral process and the elections of 1988, and on participation in a mock election for students whose schools would take part in the 1988 North Carolina Mock Election. Suggestions for teachers' preparations are given, including a classroom skit and a mock candidates' election…

  4. Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

    Science.gov (United States)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-02-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  5. Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

    Science.gov (United States)

    Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

    2016-06-01

    Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

  6. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

    Science.gov (United States)

    Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

    2015-05-01

    Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

  7. Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.

    Science.gov (United States)

    Costa, J Ribamar; Chamié, Daniel; Abizaid, Alexandre A C; Ribeiro, Expedito; Meireles, George C; Prudente, Maurício; Campos, Carlos A; Castro, Juliana P; Costa, Ricardo; Lemos, Pedro A

    2017-02-01

    We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

  8. Circumferential Stent Fracture: Novel Detection and Treatment with the Use of StentBoost

    OpenAIRE

    Ramegowda, Raghu T.; Chikkaswamy, Srinivas B.; Bharatha, Ashalatha; Radhakrishna, Jayashree; Krishnanaik, Geetha B.; Nanjappa, Manjunath C.; Panneerselvam, Arunkumar

    2012-01-01

    Circumferential stent fracture is extremely uncommon, and in rare cases, it can cause stent thrombosis. Recognizing stent fracture can be difficult on conventional fluoroscopy because of poor stent radiopacity. We found that StentBoost image acquisition yields improved visibility of stent struts, enabling the identification of stent fracture and the precise positioning of new stents over previously stented segments.

  9. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution

    Science.gov (United States)

    Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart

    2017-01-01

    IMPORTANCE Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. OBJECTIVE To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. DESIGN, SETTING, AND PARTICIPANTS Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. INTERVENTIONS Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. MAIN OUTCOMES AND MEASURES Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. RESULTS There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P stents was rejected. The mean number of ERCPs to achieve resolution

  10. Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

    Directory of Open Access Journals (Sweden)

    Vleggaar Frank P

    2009-12-01

    Full Text Available Abstract Background Benign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred. Methods A systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications. Results In total, 47 studies (1116 patients on outcome of stent placement were identified. No randomized controlled trials (RCTs, one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS, 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3% followed by uSEMS (79,5% and single plastic stents (59.6%. Complications occurred more frequently with uSEMS (39.5% compared with single plastic stents (36.0% and multiple plastic stents (20,3%. Conclusion Based on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication.

  11. Direct comparison of Neuroform and Enterprise stents in the treatment of wide-necked intracranial aneurysms

    International Nuclear Information System (INIS)

    Durst, C.R.; Khan, P.; Gaughen, J.; Patrie, J.; Starke, R.M.; Conant, P.; Liu, K.C.; Jensen, M.E.; Evans, A.J.

    2014-01-01

    Aim: To compare the complications and outcomes of Neuroform and Enterprise stents in the treatment of unruptured wide-necked aneurysms. Materials and methods: Under the auspices of the institutional review board, a review of a prospectively collected patient log identified 130 patients who underwent elective stent-assisted coil embolization of a wide-necked aneurysm, including 53 patients treated with an Enterprise stent and 77 patients treated with a Neuroform stent. Immediate and long-term clinical and radiographic outcomes were recorded for all patients. All patient data were handled in accordance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. Results: The technical success rate was 94%. Overall morbidity was 15% with Enterprise stents and 3% with Neuroform stents (p = 0.020). However, the type of stent used was not predictive of clinical outcomes as measured by the modified Rankin scale. In a multivariate analysis, the use of a Neuroform stent was one of the predictors of retreatment (p = 0.034). Conclusion: Multivariate analyses identified the use of Neuroform stents as an independent predictor of the need for retreatment and the use of Enterprise stents as an independent predictor of morbidity. However, the type of stent was not predictive of clinical outcome as measured by the modified Rankin scale. - Highlights: • The use of Enterprise stents was an independent predictor of morbidity. • The use of Neuroform stents was an independent predictor for retreatment. • The type of stent was not predictive of clinical outcome as measured by the mRS

  12. A review on biodegradable materials for cardiovascular stent application

    Science.gov (United States)

    Hou, Li-Da; Li, Zhen; Pan, Yu; Sabir, MuhammadIqbal; Zheng, Yu-Feng; Li, Li

    2016-09-01

    A stent is a medical device designed to serve as a temporary or permanent internal scaffold to maintain or increase the lumen of a body conduit. The researchers and engineers diverted to investigate biodegradable materials due to the limitation of metallic materials in stent application such as stent restenosis which requires prolonged anti platelet therapy, often result in smaller lumen after implantation and obstruct re-stenting treatments. Biomedical implants with temporary function for the vascular intervention are extensively studied in recent years. The rationale for biodegradable stent is to provide the support for the vessel in predicted period of time and then degrading into biocompatible constituent. The degradation of stent makes the re-stenting possible after several months and also ameliorates the vessel wall quality. The present article focuses on the biodegradable materials for the cardiovascular stent. The objective of this review is to describe the possible biodegradable materials for stent and their properties such as design criteria, degradation behavior, drawbacks and advantages with their recent clinical and preclinical trials.

  13. SU-F-P-52: A Meta-Analysis of Controlled Clinical Trials Comparing Elective Nodal Irradiation with Involved-Field Irradiation for Conformal Or Intensity-Modulated Radiotherapy in Patients with Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bai, W; Zhang, R; Zhou, Z; Qiao, X [The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei (China)

    2016-06-15

    Purpose: To compare elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer by a metaanalysis. Methods: Wanfang, CNKI, VIP, CBM databases, PubMed, Embase and Cochrane Library were searched to identify the controlled clinical trials of elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. The obtained data were analyzed using Stata 11.0. The difference between two groups was estimated by calculating the odds ratio (OR) with 95% confidence interval (95% CI). Results: A total of 12 controlled clinical trials involving 1095 esophageal cancer patients, which were selected according to inclusion and exclusion criteria, were included in this meta-analysis. The meta-analysis showed that the elective nodal irradiation group reduced the rates of out-field failure comparing with involved-field irradiation group (OR=3.727, P=0.007). However, the rates of ≥grades 3 acute radiation pneumonitis and esophagitis were significantly higher in the elective nodal irradiation group than in the involved-field irradiation group (OR=0.348, P=0.001, OR=0.385, P=0.000). 1-, 2-, 3-year local control rates (OR=0.966, P=0.837, OR=0.946, P=0.781; OR=0.732P=0.098) and 1-, 3-, 5-year survival rates were similar in the two groups ( OR=0.966, P=0.837; OR=0.946, P=0.781; OR=0.732, P=0.098; OR=0.952, P=0.756; OR=1.149, P=0.422; OR=0.768, P=0.120). It is the same with the rates of distant metastasis (OR=0.986, P=0.937). Conclusion: Compared with involved-field irradiation, the elective nodal irradiation can reduce the rates of out-field failure for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. However, its advantage of local control and survival rates is not obvious and it increases the incidence

  14. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

  15. Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial.

    Science.gov (United States)

    Vranckx, Pascal; Lewalter, Thorsten; Valgimigli, Marco; Tijssen, Jan G; Reimitz, Paul-Egbert; Eckardt, Lars; Lanz, Hans-Joachim; Zierhut, Wolfgang; Smolnik, Rüdiger; Goette, Andreas

    2018-02-01

    The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was noninferior to a vitamin K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and cardiovascular death in patients with nonvalvular AF. The effects of edoxaban in combination with single- or dual-antiplatelet therapy in the setting of PCI are unexplored. The ENTRUST-AF PCI trial is a multinational, multicenter, randomized, open-label phase 3b trial with blinded end point evaluation involving 1,500 patients on oral anticoagulation for AF. Patients are randomized between 4 hours and 5 days after successful PCI to either an edoxaban-based strategy (experimental arm; 60 mg [or 30 mg according to dose reduction criteria] once daily plus a P2Y 12 antagonist [default clopidogrel, 75 mg once daily] for 12 months) or a VKA-based strategy (control arm; VKA plus a P2Y 12 antagonist [as above] plus acetylsalicylic acid [100 mg once daily] for 30 days to 12 months). The primary safety end point is the incidence of International Society on Thrombosis and Haemostasis-defined major or clinically relevant nonmajor bleeding. The main efficacy end point is the composite of cardiovascular death, stroke, systemic embolic events, spontaneous myocardial infarction, and definite stent thrombosis. The ENTRUST-AF PCI trial tests the hypothesis that an edoxaban-based antithrombotic strategy reduces the risk of bleeding complications after PCI compared with VKA plus conventional dual-antiplatelet therapy in patients with AF in need of oral anticoagulation. The relative risk of ischemic events between groups will be compared. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  16. Invention of a nasolacrimal stent retrieval hook

    International Nuclear Information System (INIS)

    Kim, Tae Hyung; Kim, Yeong Kyun; Park, Sang Soo; Song, Ho Young

    1997-01-01

    To evaluate the clinical usefulness of a nasolacrimal stent retrieval hook The retrieval hook consisted of two parts, a hook and pusher. The head of the hook part was made of 0.7mm stainless steel wire and was question mark-shaped, while the body of this part was constructed by soldering together four stainless steel pipes ranging in thickness from 1.25 to 3.5mm, serially. The pusher part was made of two plastic tubes and was designed in such a way that the hook grasped the stent tightly. The device was used to remove 46 stents in 40 patients, and tested for 1) average number of trials;2) success rate;and 3) average time of the procedure. The average number of trials, success rate, and average time taken to remove the stent was 4.7, 91%, and 1.8 minutes, respectively. In the removal of nasolacrimal stents, the retrieval hook was easy to use, useful and effective

  17. Treatment of cuff-related tracheal stenosis with a fully covered retrievable expandable metallic stent

    International Nuclear Information System (INIS)

    Chen, G.; Wang, Z.; Liang, X.; Wang, Y.; Wang, Y.; Wang, Z.; Xian, J.

    2013-01-01

    Aim: To investigate the clinical effectiveness, complications, and optimal duration of use of covered retrievable expandable metallic stents in the management of cuff-related tracheal stenosis. Materials and methods: Twenty-one patients with cuff-related tracheal stenosis, Meyer–Cotton grade II (29%) and III (71%), who underwent fluoroscopically guided placement of covered retrievable expandable metallic stents were studied. Sixty-four-section computed tomography (CT) and bronchovideoscopy were performed prior to stent insertion, 1 month after stent insertion, in the case of stent-related complications, and after stent removal. Clinical manifestations, Hugh–Jones classification, and forced expiratory volume in 1 s (FEV1) were used to evaluate respiratory function before and after stent insertion and removal. The diameter of the stricture and FEV1 changes before insertion and after removal were analysed using the paired samples t-test. A p-value of ≤0.05 was considered statistically significant. Results: Twenty-one patients had 27 covered retrievable expandable metallic stents placed. Stents were electively removed from 20 patients. The median duration of stent placement was 5 months (range 4–12 months). One stent was not removed due to mucopolysaccharidosis type II (MPS II or Hunter syndrome) with tracheomalacia. After stent removal, airway dimensions increased and airway occlusion was symptomatically relieved in all patients. CT and bronchovideoscopy showed patent lumens with increased dimensions. Stent-related complications occurred in 19 (91%) patients, including granulation tissue formation (n = 18, 86%), stent migration and stent expectoration (n = 2, 10%), mucus plugging (n = 1, 5%), and halitosis (n = 6, 29%). Some patients experienced multiple complications, which were all managed effectively while the stent was still in place. There was a statistically significant difference in the diameter of the stricture and FEV1 between the time of stent

  18. Treatment of cuff-related tracheal stenosis with a fully covered retrievable expandable metallic stent.

    Science.gov (United States)

    Chen, G; Wang, Z; Liang, X; Wang, Y; Wang, Y; Wang, Z; Xian, J

    2013-04-01

    To investigate the clinical effectiveness, complications, and optimal duration of use of covered retrievable expandable metallic stents in the management of cuff-related tracheal stenosis. Twenty-one patients with cuff-related tracheal stenosis, Meyer-Cotton grade II (29%) and III (71%), who underwent fluoroscopically guided placement of covered retrievable expandable metallic stents were studied. Sixty-four-section computed tomography (CT) and bronchovideoscopy were performed prior to stent insertion, 1 month after stent insertion, in the case of stent-related complications, and after stent removal. Clinical manifestations, Hugh-Jones classification, and forced expiratory volume in 1 s (FEV1) were used to evaluate respiratory function before and after stent insertion and removal. The diameter of the stricture and FEV1 changes before insertion and after removal were analysed using the paired samples t-test. A p-value of ≤0.05 was considered statistically significant. Twenty-one patients had 27 covered retrievable expandable metallic stents placed. Stents were electively removed from 20 patients. The median duration of stent placement was 5 months (range 4-12 months). One stent was not removed due to mucopolysaccharidosis type II (MPS II or Hunter syndrome) with tracheomalacia. After stent removal, airway dimensions increased and airway occlusion was symptomatically relieved in all patients. CT and bronchovideoscopy showed patent lumens with increased dimensions. Stent-related complications occurred in 19 (91%) patients, including granulation tissue formation (n = 18, 86%), stent migration and stent expectoration (n = 2, 10%), mucus plugging (n = 1, 5%), and halitosis (n = 6, 29%). Some patients experienced multiple complications, which were all managed effectively while the stent was still in place. There was a statistically significant difference in the diameter of the stricture and FEV1 between the time of stent insertion and removal. An improvement in

  19. Stenting in the treatment of acute ischemic stroke: literature review.

    Directory of Open Access Journals (Sweden)

    Edgar A Samaniego

    2011-12-01

    Full Text Available Recanalization of acute large artery occlusions is a strong predictor of good outcome. The development of thrombectomy devices resulted in a significant improvement in recanalization rates compared to thrombolytics alone. However, clinical trials and registries with these thrombectomy devices in acute ischemic stroke (AIS have shown recanalization rates in the range of 40-81%. The last decade has seen the development of nickel titanium self-expandable stents (SES. These stents, in contrast to balloon-mounted stents, allow better navigability and deployment in tortuous vessels and therefore are optimal for the cerebral circulation. SES were initially used for stent-assisted coil embolization of intracranial aneurysms and for treatment of intracranial stenosis. However, a few authors have recently reported feasibility of deployment of SES in AIS. The use of these devices yielded higher recanalization rates compared to traditional thrombectomy devices. Encouraged by these results, retrievable SES systems have been recently used in AIS. These devices offer the advantage of resheathing and retrieving of the stent even after full deployment. Some of these stents can also be detached in case permanent stent placement is needed. Retrievable SES are being used in Europe and currently tested in clinical trials in the United States. We review the recent literature in the use of stents for the treatment of AIS secondary to large vessel occlusion.

  20. First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries).

    Science.gov (United States)

    Ormiston, John; Webster, Mark; Stewart, James; Vrolix, Mathias; Whitbourn, Robert; Donohoe, Dennis; Knape, Charlene; Lansky, Alexandra; Attizzani, Guilherme F; Fitzgerald, Peter; Kandzari, David E; Wijns, William

    2013-10-01

    This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent. Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events. We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up. The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction. At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Chevalier, Bernard; Dudek, Dariusz; Cequier, Angel; Carrié, Didier; Iniguez, Andres; Dominici, Marcello; van der Schaaf, René J.; Haude, Michael; Wasungu, Luc; Veldhof, Susan; Peng, Lei; Staehr, Peter; Grundeken, Maik J.; Ishibashi, Yuki; Garcia-Garcia, Hector M.; Onuma, Yoshinobu

    2015-01-01

    Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an

  2. Covered metal stent or multiple plastic stents for refractory pancreatic ductal strictures in chronic pancreatitis: a systematic review.

    Science.gov (United States)

    Shen, Yonghua; Liu, Mingdong; Chen, Min; Li, Yunhong; Lu, Ying; Zou, Xiaoping

    2014-01-01

    Refractory chronic pancreatitis has been proposed as a challenge for endoscopists following routine single plastic stenting. However, data on the efficacy and safety of further endoscopic stenting are still controversial. The current systematic review aimed to assess the efficacy and safety of placement of fully covered self-expandable metal stent (FCSEMS) and multiple plastic stents. Databases including MEDLINE, EMBASE, the Cochrane Library, CBM, CNKI, VIP, and WANFANG Database were used to search relevant trials. Published studies were assessed by using well-defined inclusion and exclusion criteria. The process was independently performed by two investigators. A total of 5 studies provided data of 80 patients. Forest plots and publication bias were not carried out because few studies were relevant and screened studies were all case series. The technical success rate was 100% both in placement of FCSEMS and multiple plastic stents. The functional success rate after placement of FCSEMS was 100%, followed by multiple plastic stents (94.7%). Complications occurred 26.2% after FCSEMS placement, which was not described in detail in multiple plastic stents. The stent migration rate was 8.2% for FCSEMS and 10.5% for multiple plastic stents. Reintervention rate was 9.8% for FCSEMS and 15.8% for multiple plastic stents. Pain improvement rate was 85.2% for FCSEMS and 84.2% for multiple plastic stents. FCSEMS appeared to be no significant difference with multiple plastic stents in treatment of refractory chronic pancreatitis. We need to develop more investigations. Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  3. 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

    BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety...... and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent. METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All......-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...

  4. Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation

    DEFF Research Database (Denmark)

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

    2013-01-01

    on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long...

  5. Modified nasolacrimal duct stenting

    International Nuclear Information System (INIS)

    Tian Min; Jin Mei; Chen Huanjun; Li Yi

    2008-01-01

    Objective: Traditional nasolacrimal duct stenting possesses some shortcoming including difficulty of pulling ball head guide wire from the nasal cavity with turbinate hypertrophy and nasal septal deviation. The new method of nose-oral tube track establishment can overcome the forementioned and increase the successful rate. Methods: 5 F catheter and arterial sheath were modified to be nasolacrimal duct stent delivery device respectively. Antegrade dacryocystography was taken firstly to display the obstructed site and followed by the modified protocol of inserting the guide wire through nasolacrimal duct and nasal cavity, and establishing the stent delivery track for retrograde stent placement. Results: 5 epiphora patients with failure implantation by traditional method were all succeeded through the modified stenting (100%). During 6-mouth follow-up, no serious complications and reocclusion occurred. Conclusion: The establishment of eye-nose-mouth-nose of external nasal guide wire track can improve the successful rate of nasolacrimal duct stenting. (authors)

  6. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

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

    2014-01-01

    BACKGROUND: Cardiovascular heart disease is one of the leading health issues in the present era and requires considerable health care resources to prevent it. The present study was focused on the development of a new coronary stent based on novel auxetic geometry which enables the stent to exhibit...... a negative Poisson's ratio. Commercially available coronary stents have isotropic properties, whereas the vascular system of the body shows anisotropic characteristics. This results in a mismatch between anisotropic-isotropic properties of the stent and arterial wall, and this in turn is not favorable...... for mechanical adhesion of the commercially available coronary stents with the arterial wall. It is believed that an auxetic coronary stent with inherent anisotropic mechanical properties and negative Poisson's ratio will have good mechanical adhesion with the arterial wall. METHODS: The auxetic design...

  7. Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

    Science.gov (United States)

    Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

    2018-06-12

    Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

  8. A critical assessment of the effects of tamsulosin and solifenacin as monotherapies and as a combination therapy for the treatment of ureteral stent-related symptoms: a 2 × 2 factorial randomized trial.

    Science.gov (United States)

    Park, Jinsung; Yoo, Changhee; Han, Deok Hyun; Shin, Dong Wook

    2015-11-01

    To assess the efficacy of tamsulosin, solifenacin, and combination therapy of both agents for the treatment of ureteral stent-related symptoms (SRSs). An open-label, randomized controlled trial was conducted with 112 patients who underwent unilateral ureteral stent insertion following ureteroscopic stone surgery. Patients were randomized with a 2 × 2 factorial design to one of four groups, i.e., A (control), B (tamsulosin 0.2 mg once daily), C (solifenacin 5 mg once daily), and D (both active treatments). Patients were evaluated at week 2 by the ureteral stent symptom questionnaire (USSQ). The primary efficacy outcome was the urinary symptom score of the USSQ, and the secondary efficacy outcomes were the scores in the other five USSQ domains, the Euro-QOL score, and oral analgesic requirements during the 2 weeks. Efficacy outcomes were primarily analyzed for the per-protocol set population. The four groups were generally well balanced in terms of baseline characteristics. Eighty-one patients (72.3 %) completed the study protocol. Comparison of the six USSQ domain scores at week 2 showed no differences between the four groups. Similarly, comparison of the domain scores stratified by tamsulosin or solifenacin medication showed no differences for either medication. The other secondary outcomes were also similar in the group comparisons. Neither tamsulosin nor solifenacin medications provide beneficial effects for relieving various SRSs. In addition, the combination therapy did not have beneficial effects. Further studies are warranted to determine the benefit of medical therapy for the treatment of SRSs and to determine the optimal management strategy for SRSs.

  9. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

    Science.gov (United States)

    Haapamäki, Carola; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Grönroos, Juha; Saarela, Arto; Mustonen, Harri; Halttunen, Jorma

    2015-07-01

    The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747). © Georg Thieme Verlag KG Stuttgart · New York.

  10. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.

    Science.gov (United States)

    Saxon, Richard R; Chervu, Arun; Jones, Paul A; Bajwa, Tanvir K; Gable, Dennis R; Soukas, Peter A; Begg, Richard J; Adams, John G; Ansel, Gary M; Schneider, Darren B; Eichler, Charles M; Rush, Michael J

    2013-02-01

    To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency. In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%. The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes. Copyright © 2013 SIR. Published by Elsevier Inc. All rights reserved.

  11. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    OpenAIRE

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Meth...

  12. Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

    Directory of Open Access Journals (Sweden)

    Essam Shalaby

    2013-01-01

    Full Text Available Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (, no treatment was given (control group, group II ( received tamsulosin 0.4 mg daily, group III ( received solifenacin 10 mg daily, and group IV ( received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS, quality of life component of the IPSS (IPSS/Qol, Overactive Bladder Questionnaire (OAB-q, and Visual Analogue Pain Scale (VAPS questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group ( value < 0.005. Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III ( value < 0.001. Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.

  13. A Randomized Controlled Trial to Compare the Safety and Efficacy of Tadalafil and Tamsulosin in Relieving Double J Stent Related Symptoms

    Directory of Open Access Journals (Sweden)

    Satinder Pal Aggarwal

    2015-01-01

    Full Text Available Objectives. To evaluate the safety and efficacy of Tadalafil and Tamsulosin in treating Double J stent related symptoms. Methods. In a prospective study, 161 patients with DJ related symptoms were randomized into 3 groups: Group A patients (54, Group B patients (53, and Group C patients (54. They were given Tadalafil, Tamsulosin, and placebo, respectively, at 1st week till removal of DJ stent at 3rd week. All patients completed Ureteral Stent Symptom Questionnaire (USSQ at 1st week and at 3rd week. The statistical significant difference among groups was determined by the t-test, Kruskal-Wallis test and multivariate analysis were used to assess association of the variables within the three groups, and the level of significance was set at P<0.05. Results. Tadalafil and Tamsulosin were comparable in relieving urinary symptoms, general health, and work performance (OR = 0.65, 1.8, and 0.92. But Tadalafil was more effective in relieving body pain, sexual problems, and additional problems than Tamsulosin (OR = 5.95, 19.25, and 2.69 and was statistically significant as P<0.05. Conclusion. Tadalafil was as effective as Tamsulosin in relieving urinary symptom but more effective in relieving sexual symptoms and body pain.

  14. Coronary Stents in Diabetic Patients: State of the Knowledge.

    Science.gov (United States)

    Codner, Pablo; Gurm, Hitinder Singh; Motivala, Apurva

    2017-04-01

    This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

  15. Agreement of duplex ultrasonography vs. computed tomography angiography for evaluation of native and in-stent SFA re-stenosis—Findings from a randomized controlled trial

    International Nuclear Information System (INIS)

    Langenberger, Herbert; Schillinger, Martin; Plank, Christina; Sabeti, Schila; Dick, Petra; Cejna, Manfred; Lammer, Johannes; Minar, Erich; Loewe, Christian

    2012-01-01

    Background: Multidetector CT angiography (CTA) is a non-invasive imaging technique for evaluation of peripheral vascular disease. CTA might be particularly useful for assessment of intermediate- and long-term morphological outcome after endovascular treatment. Validation of CTA vs. the current imaging standard, colour Doppler ultrasonography (CDUS), for quantification of native and in-stent re-stenosis in the superficial femoral artery (SFA) is required. Methods: Seventy randomized patients who underwent stent implantation (n = 47) or balloon angioplasty (n = 23) underwent 6-month follow-up with CDUS and CTA. CTA was compared with CDUS in both sub-groups of patients in terms of binary re-stenosis (>50% lumen narrowing) and re-occlusion. Agreement between CTA and CDUS was assessed using Kappa (κ) statistics with 95% confidence intervals, and correlation coefficients. Results: Binary re-stenosis was detected in 16/70 (22.9%) patients by CTA and 17/70 (24.3%) patients by CDUS (κ = 0.88, 95% CI: 0.80–0.96). Re-stenosis rates after balloon angioplasty were 39.1% (9/23) on CTA and CDUS (κ = 0.82, 95% CI: 0.66–0.98), and after stent implantation 14.9% (7/47) on CTA and 17.0% (8/47) on CDUS (κ = 0.92, 95% CI: 0.84–1.00). Re-occlusions were detected in 3/70 (4.3%) patients by both CTA and CDUS (κ = 0.65; 95% CI 0.54–0.76). Significant correlations (r = 0.85, p < 0.001) were noted between degree of re-stenosis on CTA and peak velocity ratio on CDUS. The correlation coefficient was higher in patients after balloon angioplasty (r = 0.94, p < 0.001) than in patients after stent implantation (r = 0.71, p < 0.001). Conclusion: CTA and CDUS show excellent agreement for evaluation of native and in-stent re-stenosis after endovascular treatment of SFA obstructions. CTA is an appropriate non-invasive imaging modality for follow-up after endovascular therapy

  16. Surveillance Duplex Ultrasonography of Stent Grafts for Popliteal Aneurysms.

    Science.gov (United States)

    Pineda, Danielle M; Troutman, Douglas A; Dougherty, Matthew J; Calligaro, Keith D

    2016-05-01

    Stent grafts, also known as covered stents, have become an increasingly acceptable treatment for popliteal artery aneurysms. However, endovascular exclusion confers lower primary patency compared to traditional open bypass and exclusion. The purpose of this study was to evaluate whether duplex ultrasonography (DU) can reliably diagnose failing stent grafts placed for popliteal artery aneurysms prior to occlusion. Between June 5, 2007, and March 11, 2014, 21 stent grafts (Viabahn; Gore, Flagstaff, Arizona) were placed in 19 patients for popliteal artery aneurysms. All patients had at least 1 follow-up duplex scan postoperatively. Mean follow-up was 28.9 months (9-93 months). Postoperative DU surveillance was performed in our Intersocietal Accreditation Commission noninvasive vascular laboratory at 1 week postprocedure and every 6 months thereafter. Duplex ultrasonography measured peak systolic velocities (PSVs) and ratio of adjacent PSVs (Vr) every 5 cm within the stent graft and adjacent arteries. We retrospectively classified the following factors as "abnormal DU findings": focal PSV > 300 cm/s, uniform PSVs 3.0. These DU criteria were derived from laboratory-specific data that we previously published on failing stent grafts placed for lower extremity occlusive disease. Four of the 21 stent grafts presented with symptomatic graft thrombosis within 6 months of a normal DU. Three of these 4 patients presented with rest pain and underwent thrombectomy (2) or vein bypass (1), and 1 elected for nonintervention for claudication. Our results suggest that surveillance DU using criteria established for grafts placed for occlusive disease may not be useful for predicting stent graft failure in popliteal artery aneurysms. © The Author(s) 2016.

  17. 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

  18. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

    Science.gov (United States)

    Lammer, Johannes; Zeller, Thomas; Hausegger, Klaus A; Schaefer, Philipp J; Gschwendtner, Manfred; Mueller-Huelsbeck, Stefan; Rand, Thomas; Funovics, Martin; Wolf, Florian; Rastan, Aljoscha; Gschwandtner, Michael; Puchner, Stefan; Ristl, Robin; Schoder, Maria

    2013-10-08

    The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare

  19. StentBoost Visualization for the Evaluation of Coronary Stent Expansion During Percutaneous Coronary Interventions

    OpenAIRE

    Cura, Fernando; Albertal, Mariano; Candiello, Alfonsina; Nau, Gerardo; Bonvini, Victor; Tricherri, Hernan; Padilla, Lucio T.; Belardi, Jorge A.

    2013-01-01

    Introduction Inadequate stent implantation is associated with stent thrombosis and restenosis. StentBoost can enhance stent visualization and evaluate stent expansion. Currently, there are limited comparison studies between StentBoost and intravascular ultrasound (IVUS). We aimed to test the correlation and agreement between IVUS and StentBoost measurements. Methods From December 2010 to December 2011, 38 patients (54 stents) were analyzed using IVUS and StentBoost. Minimal stent diameter and...

  20. Influence of covered stent versus bare stent on long-term efficacy of transjugular intrahepatic portosystemic shunt: a meta-analysis

    Directory of Open Access Journals (Sweden)

    XU Lu

    2016-10-01

    Full Text Available Objective To investigate the long-term postoperative efficacy of transjugular intrahepatic portosystemic shunt (TIPS using polytetrafluoroethylene (PTFE-covered stent or bare stent, and to provide a basis of evidence-based medicine for the selection of stent in TIPS. Methods CBM, Wanfang Data, CNKI, VIP, MEDLINE, and PubMed were searched for controlled trials on TIPS in the treatment of cirrhotic portal hypertension published form 1989 to 2015; the studies which met the inclusion criteria were selected, and quality assessment was performed for these articles. RevMan 5.3 software was used to analyze the incidence rates of stent dysfunction and hepatic encephalopathy and 1-year survival rate after TIPS, and funnel plots were used to analyze publication bias. Results A total of 11 studies were included, consisting of 698 patients in PTFE-covered stent group and 1283 patients in bare stent group. The results of the meta-analysis showed that the PTFE-covered stent group showed a significantly lower incidence rate of stent dysfunction than the bare stent group (14.8% vs 47.0%, OR=0.18, 95% CI: 0.13-0.24, P<0.001. There was no significant difference in the incidence rate of hepatic encephalopathy between the two groups (23.5% vs 25.7%, OR=0.88, 95% CI: 0.66-1.17, P=0.37. The PTFE-covered stent group had a significantly higher 1-year survival rate than the bare stent group (76.9% vs 62.7%, OR=2.10, 95% CI: 1.54-2.85, P<0.001. The funnel plots which were plotted based on the incidence rates of stent dysfunction and hepatic encephalopathy and 1-year survival rate lacked symmetry, which suggested that a certain degree of publication bias might exist. Conclusion Compared with the bare stent, the PTFE-covered stent can improve stent dysfunction and 1-year survival rate after TIPS, while there is no significant change in the incidence rate of hepatic encephalopathy. Therefore, the PTFE-covered stent has certain advantages over the bare stent in TIPS. In

  1. 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

  2. Role of Esophageal Metal Stents Placement and Combination Therapy in Inoperable Esophageal Carcinoma: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Lai, Andrew; Lipka, Seth; Kumar, Ambuj; Sethi, Sajiv; Bromberg, David; Li, Nanxing; Shen, Huafeng; Stefaniwsky, Lilia; Brady, Patrick

    2018-04-01

    More than 50% of patients with esophageal cancer already have inoperable disease at the time of diagnosis. Controversy surrounds the outcomes of patients with advanced esophageal cancer who receive palliative care by either stent alone or stent plus an additional modality. We set out to perform a systematic review and meta-analysis of studies assessing the use of metal stents as treatment options for symptomatic improvement, survival, and adverse events. We searched Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until January 14, 2016, as well as other databases for randomized controlled trials (RCTs) comparing esophageal stent versus either esophageal stent plus brachytherapy, radiotherapy, or chemotherapy. For quality assurance purposes throughout the systematic review, multiple independent extractions were performed, and the process was executed as per the standards of the Cochrane collaboration. Primary outcomes were mean change in dysphagia score, overall survival, and quality of life. Secondary outcomes were adverse events including fever, severe pain, aspiration, fistula, stent migration, perforation, and restenosis. Eight RCTs enrolling 732 patients were included with three distinct comparisons: stents combination therapy vs stents alone (5 studies, n = 417), stents alone versus brachytherapy alone (2 studies, n = 274), and stents + brachytherapy vs brachytherapy alone (1 study, n = 41). Stents combination therapy was defined as stents plus radiotherapy, chemotherapy, or both. Mean change in dysphagia scores favored stents combination therapy versus stents alone, and the effect was seen in patients surviving longer than 3 months. Stents combination therapy was also associated with a more favorable overall survival. The risks of stent migration, aspiration pneumonia, and restenosis were lower in the stents combination group compared to stents alone, while the risks of severe pain, hemorrhage, and

  3. Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention

    OpenAIRE

    Baschet, Louise; Bourguignon, Sandrine; Marque, S?bastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

    2016-01-01

    Objective To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. Methods A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117?762 patient-years with 76 randomised trials. The main effectiveness criterion was major c...

  4. Spectral Imaging for Intracranial Stents and Stent Lumen.

    Science.gov (United States)

    Weng, Chi-Lun; Tseng, Ying-Chi; Chen, David Yen-Ting; Chen, Chi-Jen; Hsu, Hui-Ling

    2016-01-01

    Application of computed tomography for monitoring intracranial stents is limited because of stent-related artifacts. Our purpose was to evaluate the effect of gemstone spectral imaging on the intracranial stent and stent lumen. In vitro, we scanned Enterprise stent phantom and a stent-cheese complex using the gemstone spectral imaging protocol. Follow-up gemstone spectral images of 15 consecutive patients with placement of Enterprise from January 2013 to September 2014 were also retrospectively reviewed. We used 70-keV, 140-keV, iodine (water), iodine (calcium), and iodine (hydroxyapatite) images to evaluate their effect on the intracranial stent and stent lumen. Two regions of interest were individually placed in stent lumen and adjacent brain tissue. Contrast-to-noise ratio was measured to determine image quality. The maximal diameter of stent markers was also measured to evaluate stent-related artifact. Two radiologists independently graded the visibility of the lumen at the maker location by using a 4-point scale. The mean of grading score, contrast/noise ratio and maximal diameter of stent markers were compared among all modes. All results were analyzed by SPSS version 20. In vitro, iodine (water) images decreased metallic artifact of stent makers to the greatest degree. The most areas of cheese were observed on iodine (water) images. In vivo, iodine (water) images had the smallest average diameter of stent markers (0.33 ± 0.17mm; P stent lumen (160.03 ±37.79; P stent-related artifacts of Enterprise and enhance contrast of in-stent lumen. Spectral imaging may be considered a noninvasive modality for following-up patients with in-stent stenosis.

  5. Percutaneous Ureteral stent insertion

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Yup; Sung, Dong Wook; Choi, Woo Suk; Lee, Dong Ho; Ko, Young Tae; Lee, Sun Wha; Lim, Jae Hoon [Kyung Hee University Hospital, Seoul (Korea, Republic of)

    1990-10-15

    Percutaneous ureteral stent insertion is a treatment of permanent or temporary urinary diversion to maintain continuity and function of the obstructed and injured ureter. We performed 31 cases of percutaneous double pig tall ureteral stent insertion in 21 patients, included 13 patients with malignant ureteral obstruction and eight patients with injured ureter as well as benign inflammatory stricture. Satisfactory resulted was obtained in all patients but one, who need percutaneous nephrostomy on week later for urinary diversion. No significant complication was encountered. The authors concluded that percutaneous ureteral stent insertion, an interventional procedure alternative to urologic retrograde method, is an effective method for urinary diversion.

  6. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

    Science.gov (United States)

    Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

    2015-01-06

    Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

  7. Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS)

    DEFF Research Database (Denmark)

    Kosonen, Petteri; Vikman, Saila; Jensen, Lisette Okkels

    2012-01-01

    This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST...... is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial....

  8. Elective course planning

    DEFF Research Database (Denmark)

    Kristiansen, Simon; Sørensen, Matias; Stidsen, Thomas Riis

    2011-01-01

    Efficient planning increasingly becomes an indispensable tool for management of both companies and public organizations. This is also the case for high school management in Denmark, because the growing individual freedom of the students to choose courses makes planning much more complex. Due...... to reforms, elective courses are today an important part of the curriculum, and elective courses are a good way to make high school education more attractive for the students. In this article, the problem of planning the elective courses is modeled using integer programming and three different solution...... for the Elective Course Planning Problem has been described in the literature before. The proposed algorithms are tested on data sets from 98 of the 150 high schools in Denmark. The tests show that for the majority of the problems, the optimal solution can be obtained within the one hour time bound. Furthermore...

  9. 2016 Presidential Election Durham

    Data.gov (United States)

    City and County of Durham, North Carolina — Voting totals for the 2016 Presidential Election by voting method and precinct. Voting Method Definitions: PROV = Provisional IN-PERSON = In PersonABS-1STOP =...

  10. 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.

  11. Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] Trial).

    Science.gov (United States)

    Labinaz, Marino; Madan, Mina; O'Shea, J O'Conor; Kilaru, Rakhi; Chin, Wai; Pieper, Karen; McGuire, Darren K; Saucedo, Jorge F; Talley, J David; Lui, Henry; Kitt, Michael M; Califf, Robert M; Tcheng, James T

    2002-09-15

    For patients undergoing nonurgent coronary stent implantation, blockade of the glycoprotein IIb/IIIa receptor with eptifibatide reduces the incidence of ischemic complications. We evaluated the interaction of eptifibatide with diabetes in patients who underwent this procedure by analyzing the 1-year outcomes of those enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial (466 diabetic and 1,595 nondiabetic patients). At 1 year, the composite end point of death, myocardial infarction (MI), or target vessel revascuarlization (TVR) was higher in diabetic patients (24.5% vs 18.4%; p = 0.008). At 1 year, eptifibatide had a similar effect on the composite end point of death, MI, or TVR in diabetic (hazards ratio [HR] 0.71, 95% confidence interval [CI] 0.49 to 1.04) and nondiabetic patients (HR 0.80, 95% CI 0.63 to 0.99). A similar treatment effect was also seen on death or MI in both groups. The 1-year mortality rate for diabetic patients assigned to placebo was 3.5% versus 1.3% for patients receiving eptifibatide (HR 0.37, 95% CI 0.10 to 1.41); the latter rate was similar to the mortality rate of 1.4% for nondiabetic patients in the eptifibatide group. However, eptifibatide did not have a significant effect on TVR in diabetic patients (HR 0.90, 95% CI 0.57 to 1.41). Our data suggest that treatment with eptifibatide is associated with a similar relative reduction in adverse ischemic complications in diabetic and nondiabetic patients undergoing coronary stent implantation. There is no evidence of a statistical interaction in the treatment effect of eptifibatide between patients with and without diabetes.

  12. Delay of surgery after stent placement for resectable malignant colorectal obstruction is associated with higher risk of recurrence

    DEFF Research Database (Denmark)

    Broholm, Malene; Kobborg, Martin; Frostberg, Erik

    2017-01-01

    BACKGROUND: Self-expanding metal stents can be used as bridge to elective surgery for acute malignant colonic obstruction. However, the impact on long-term oncological outcome and the optimal timing of surgery are still unknown. METHOD: This was a retrospective multicenter study performed at four...... colorectal centers. Patients undergoing stent placement as bridge to surgery, between January 2010 and December 2013, were included in the study. Primary outcomes were survival and recurrence rates along with location of the metastases. Additionally, we recorded time from stent placement to elective surgery....... Secondary outcomes were postoperative complication rates. Complications were classified according to the Clavien-Dindo classification score. A logistic regression model was used to describe impact of delayed stent removal on risk of recurrence. RESULTS: This study included 112 patients, with a median follow...

  13. Percutaneous placement of ureteral stent

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Seung Hyup; Park, Jae Hyung; Han, Joon Koo; Han, Man Chung [Seoul National University College of Medicine, Seoul (Korea, Republic of)

    1990-12-15

    Antegrade placement of ureteral stents has successfully achieved in 41 of 46 ureters. When it was difficult to advance ureteral stents through the lesion, it was facilitated by retrograde guide-wire snare technique through urethra. Complications associated with the procedure were non-function of ureteral stent by occlusion, upward migration,and spontaneous fracture of ureteral stent. These complications were managed by percutaneous nephrostomy and removal of ureteral stents by guide-wire snare technique and insertion of a new ureteral stent. While blood cell in urine was markedly increased in about 50% of patients following the procedure.

  14. Advantages and disadvantages of biodegradable platforms in drug eluting stents.

    Science.gov (United States)

    Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

    2011-03-26

    Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

  15. Self-Expandable Metal Stents for Colorectal Cancer: From Guidelines to Clinical Practice

    Directory of Open Access Journals (Sweden)

    Maria Pia Costa Santos

    2016-11-01

    Conclusions: In this study, stent placement was an effective procedure in obstructive colorectal cancer. It was mainly used as a bridge to elective surgery. However, a significant rate of silent perforation was observed, which may compromise the oncological outcome of these potentially curable patients. Prospective real life studies are warranted for a better definition of actual recommendations.

  16. Drug-eluting stents to prevent stent thrombosis and restenosis.

    Science.gov (United States)

    Im, Eui; Hong, Myeong-Ki

    2016-01-01

    Although first-generation drug-eluting stents (DES) have significantly reduced the risk of in-stent restenosis, they have also increased the long-term risk of stent thrombosis. This safety concern directly triggered the development of new generation DES, with innovations in stent platforms, polymers, and anti-proliferative drugs. Stent platform materials have evolved from stainless steel to cobalt or platinum-chromium alloys with an improved strut design. Drug-carrying polymers have become biocompatible or biodegradable and even polymer-free DES were introduced. New limus-family drugs (such as everolimus, zotarolimus or biolimus) were adopted to enhance stent performances. As a result, these new DES demonstrated superior vascular healing responses on intracoronary imaging studies and lower stent thrombotic events in actual patients. Recently, fully-bioresorbable stents (scaffolds) have been introduced, and expanding their applications. In this article, the important concepts and clinical results of new generation DES and bioresorbable scaffolds are described.

  17. 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

    To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial.......To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial....

  18. Drug eluting stents and modern stent technologies for in-stent restenosis.

    Science.gov (United States)

    Werner, Martin

    2017-08-01

    The implantation of metallic stents has become a standard procedure to improve the outcome after angioplasty of peripheral vessels. However, the occurrence of in-stent restenosis is hampering the long-term efficacy of these procedures and is associated with re-occurrence of symptoms. The optimal treatment modality for in-stent-restenosis in the peripheral vasculature is not well examined. This review discusses the existing evidence for the treatment of in-stent restenosis with drug eluting stents and modern stent technologies.

  19. Impact of gender on infarct size, ST-segment resolution, myocardial blush and clinical outcomes after primary stenting for acute myocardial infarction: Substudy from the EMERALD trial.

    Science.gov (United States)

    Ng, Vivian G; Mori, Ken; Costa, Ricardo A; Kish, Mitra; Mehran, Roxana; Urata, Hidenori; Saku, Keijiro; Stone, Gregg W; Lansky, Alexandra J

    2016-03-15

    Women with AMI may have worse outcomes than men. However, it is unclear if this is related to differences in treatment, treatment effect or gender specific factors. We sought to determine whether primary percutaneous intervention (PCI) has a differential impact on infarct size, myocardial perfusion and ST segment resolution in men and women with acute myocardial infarction (AMI). A total of 501 AMI patients were prospectively enrolled in the EMERALD study and underwent PCI with or without distal protection. Post hoc gender subset analysis was performed. 501 patients (108 women, 393 men) with ST-segment elevation AMI presenting within 6h underwent primary (or rescue) PCI with stenting and a distal protection device. Women were older, had more hypertension, less prior AMI, smaller BSA, and smaller vessel size, but had similar rates of diabetes (30% versus 20.2%, p=0.87), LAD infarct, and time-to-reperfusion compared to men. Women more frequently had complete ST-resolution (>70%) at 30days (72.8% versus 59.8%, p=0.02), and smaller infarct size compared to males (12.2±19.6% versus 18.4±18.5%, p=0.006). At 6months, TLR (6.9% versus 5.2%) and MACE (11.4% versus 10.3%) were similar for women and men. Despite worse comorbidities, women with AMI treated with primary PCI with stenting showed similar early and midterm outcomes compared to men. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI). Methods and results......: All patients who underwent stent implantation from 2002 to 2005 were identified in the Western Denmark Heart Registry. The hazard ratio (HR) for death associated with stent thrombosis or in-stent restenosis was estimated with a Cox regression analysis with stent thrombosis or in-stent restenosis...... 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...

  1. Future developments in biliary stenting

    Science.gov (United States)

    Hair, Clark D; Sejpal, Divyesh V

    2013-01-01

    Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting. PMID:23837001

  2. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Rezaei, Yousef; Khademvatani, Kamal; Rahimi, Behzad; Khoshfetrat, Mehran; Arjmand, Nasim; Seyyed-Mohammadzad, Mir-Hossein

    2016-03-15

    Contrast medium-induced acute kidney injury (CIAKI) is a leading cause of acquired renal impairment. The effects of antioxidants have been conflicting regarding the prevention of CIAKI. We performed a study of vitamin E use to decrease CIAKI in patients undergoing elective coronary angiography. In a placebo-controlled randomized trial at 2 centers in Iran, 300 patients with chronic kidney disease-defined as estimated glomerular filtration rate vitamin E 12 hours before plus 400 mg vitamin E 2 hours before coronary angiography or to receive placebo. The primary end point was the development of CIAKI, defined as an increase ≥0.5 mg/dL or ≥25% in serum creatinine that peaked within 72 hours. Based on an intention-to-treat analysis, CIAKI developed in 10 (6.7%) and 21 (14.1%) patients in the vitamin E and placebo groups, respectively (P=0.037). Change in white blood cell count from baseline to peak value was greater in the vitamin E group compared with the placebo group (-500 [-1500 to 200] versus 100 [-900 to 600]×10(3)/mL, P=0.001). In multivariate analysis, vitamin E (odds ratio 0.408, 95% CI 0.170-0.982, P=0.045) and baseline Mehran score (odds ratio 1.257, 95% CI 1.007-1.569; P=0.043) predicted CIAKI. Prophylactic short-term high-dose vitamin E combined with 0.9% saline infusion is superior to placebo for prevention of CIAKI in patients undergoing elective coronary angiography. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02070679. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  3. 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...... ratio, 0.50; 95% CI, 0.37 to 0.69; Pbleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet...

  4. Electives during Medical Internship

    International Nuclear Information System (INIS)

    Al-Sultan, Ali I.; Parashar, Shyam K; Al-Ghamdi, Abulmohsin A.

    2003-01-01

    The purpose of study was to find out the reasons for selecting elective rotations during a rotating medical internship.One hundred and seventy-eight medical interns in the College of Medicine, King Faisal University,Dammam, Kingdom of Saudi Arabia during the period March 2001 to August 2002 completed a questionnaire for their selection reasons with responses on a scale of 1-5.The study comprised 60% males and 98.3% Saudis. The most frequently chosen elective is Dermatology 28.1% ,radiology 20.8%, anesthesia 9.6% and otorhinolaryngology (ear, nose and throat [ENT]) 9%. Significantly, more males (89.2%) chose radiology rotation and more females (75%) chose ENT rotation.The leading reasons to choose an elective rotations are;1, to gain broad medical training and education,2, to assist in choice of future speciality and,3, being relevant to future speciality .The mean score for ENT and dermatology is higher than radiology and anesthesia for the response to participate in medical practice in different institute , while dermatology is higher than anesthesia for response to help for getting aceptance for job in the same instituteand radiology is higher than ENT and anesthesia for the response i t has infrequent or no night duties . The reason chosen reflect the educational value of electives and their important role in choosing future career. Dermatology and radiology rotations are most popular electives ,with additional and though different reasons. (author)

  5. Future developments in biliary stenting

    Directory of Open Access Journals (Sweden)

    Hair CD

    2013-06-01

    Full Text Available Clark D Hair,1 Divyesh V Sejpal21Department of Medicine, Section of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, USA; 2Department of Medicine, Section of Gastroenterology, Hofstra North Shore-LIJ School of Medicine, North Shore University Hospital, Manhasset, NY, USAAbstract: Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting.Keywords: plastic stents, self-expandable metal stents, drug eluting stents, bioabsorbable stents, malignant biliary strictures, benign biliary strictures

  6. Stent sizing strategies in renal artery stenting: the comparison of conventional invasive renal angiography with renal computed tomographic angiography.

    Science.gov (United States)

    Kadziela, Jacek; Michalowska, Ilona; Pregowski, Jerzy; Janaszek-Sitkowska, Hanna; Lech, Katarzyna; Kabat, Marek; Staruch, Adam; Januszewicz, Andrzej; Witkowski, Adam

    2016-01-01

    Randomized trials comparing invasive treatment of renal artery stenosis with standard pharmacotherapy did not show substantial benefit from revascularization. One of the potential reasons for that may be suboptimal procedure technique. To compare renal stent sizing using two modalities: three-dimensional renal computed tomography angiography (CTA) versus conventional angiography. Forty patients (41 renal arteries), aged 65.1 ±8.5 years, who underwent renal artery stenting with preprocedural CTA performed within 6 months, were retrospectively analyzed. In CTA analysis, reference diameter (CTA-D) and lesion length (CTA_LL) were measured and proposed stent diameter and length were recorded. Similarly, angiographic reference diameter (ANGIO_D) and lesion length (ANGIO_LL) as well as proposed stent dimensions were obtained by visual estimation. The median CTA_D was 0.5 mm larger than the median ANGIO_D (p < 0.001). Also, the proposed stent diameter in CTA evaluation was 0.5 mm larger than that in angiography (p < 0.0001). The median CTA_LL was 1 mm longer than the ANGIO_LL (p = NS), with significant correlation of these variables (r = 0.66, p < 0.0001). The median proposed stent length with CTA was equal to that proposed with angiography. The median diameter of the implanted stent was 0.5 mm smaller than that proposed in CTA (p < 0.0005) and identical to that proposed in angiography. The median length of the actual stent was longer than that proposed in angiography (p = 0.0001). Renal CTA has potential advantages as a tool adjunctive to angiography in appropriate stent sizing. Careful evaluation of the available CTA scans may be beneficial and should be considered prior to the planned procedure.

  7. Self-expandable metal stents for obstructing colonic and extracolonic cancer

    DEFF Research Database (Denmark)

    van Hooft, Jeanin E; van Halsema, Emo E; Vanbiervliet, Geoffroy

    2014-01-01

    as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). 3 For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered......, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 Prophylactic colonic...... stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence). 2 Colonic self-expandable metal stent (SEMS) placement...

  8. Safety and efficacy of self-expandable metal stents for obstructive proximal and distal large bowel cancer.

    Science.gov (United States)

    Mitra, V; Hu, M; Majumdar, D; Krishnan, V; Chaudhury, B; Hancock, J; Dwarakanath, D

    2017-03-01

    Self-expandable metal stents are often used to treat obstructive large bowel cancers. This study assessed the safety and efficacy of colonic stent insertion carried out in a district general hospital. Methods A retrospective review was carried out between 1 January 2007 and 28 February 2014 to identify patients who underwent stent insertion for malignant colorectal obstruction. Results Seventy-five patients (median age 75.2 years, 70.6% male) with primary colorectal cancer underwent stent insertion - 53 underwent semi-elective self-expanded metal stent insertion (for subacute bowel obstruction) and 22 had emergency stent inserted (for acute bowel obstruction). The majority (88%) had self-expanded metal stents inserted for palliation. Technical and clinical success rates were 98.7% and 91.2%, respectively. One patient had stent-related perforation; there was no procedure-related mortality. Conclusion This study shows that self-expanded metal stent insertion in malignant colorectal obstruction is safe and effective and can be successfully delivered in a district general hospital with high technical and clinical success rates.

  9. Heterogeneous Intravascular Ultrasound Findings of Stent Thrombosis

    OpenAIRE

    Morofuji, Toru; Inaba, Shinji; Aisu, Hiroe; Takahashi, Kayo; Saito, Makoto; Higashi, Haruhiko; Yoshii, Toyofumi; Sumimoto, Takumi

    2017-01-01

    Objective The underlying mechanisms of stent thrombosis are not completely understood. Methods We experienced 12 definite stent thrombosis cases (1 early, 1 late, and 10 very late) at our hospital from July 2011 to April 2016 and evaluated the possible causes of stent thrombosis by intravascular ultrasound (IVUS). Results Five different potential morphological causes of stent thrombosis (neoatherosclerosis, stent malapposition, stent fracture, edge dissection, and stent underexpansion) were d...

  10. Endoscopic Dilatation versus Oesophageal Stent in Benign Oesophageal Stricture

    Directory of Open Access Journals (Sweden)

    Hadyanto Caputra

    2016-09-01

    Full Text Available Aim: Oesophageal stricture is one of the causes of dysphagia. It is a condition in which the lumen of oesophagus is narrowed by fibrotic tissue in the oesophageal wall. It is usually caused by inflammation or any other cause that leads to necrotizing of tissue. It is mainly differentiated into benign or malignant. The aim of this article is to answer the clinical question on the effectiveness of oesophageal stenting compared to endoscopic dilatation in patient with benign oesophageal stricture due to ingestion of corrosive substances, who had undergone several endoscopic dilatations. Method: We conducted search of relevant articles using PubMed search engine to answer the clinical question. Keywords being used during the search process were: ("oesophageal stricture"[All Fields] OR "oesophageal stenosis"[All Fields] AND (("dilatation"[All Fields] AND ("stents"[MeSH Terms] OR "stents"[All Fields] OR "stent"[All Fields]. Results were further converged by adding specific filters, which were full text articles and clinical trial. Results: The chosen article was further appraised in order to identify its validity and eligibility to answer the clinical question. We chose to use CONSORT (statement to improve the quality of reporting of RCTs to facilitate the critical appraisal and interpretation of RCTs. Conclusion: Stenting was associated with greater dysphagia, co-medication and adverse events. No randomized controlled trials which compared biodegradable stents with other stents or with balloon dilatation was identified. Lack of adequately robust evidence for effectiveness and cost-effectiveness formed the rationale of this trial.

  11. Long term follow-up of bifurcation aneurysms treated with braided stent assisted coiling and complex T- and Y- stent constructs.

    Science.gov (United States)

    Cheung, Nicholas K; Chiu, Albert Hy; Cheung, Andrew; Wenderoth, Jason D

    2018-06-01

    Stent assisted coil embolization (SACE) of bifurcation aneurysms is challenging. Heterogeneous results have been achieved to date, but largely for laser cut stents. While braided stents offer multiple technical advantages, their long term efficacy has yet to be validated. To report the first long term 18 month results for the durability of bifurcation aneurysms treated with braided stents. Over a 4 year period, 59 consecutive patients with 60 bifurcation aneurysms underwent elective braided SACE across three Australian neurovascular centers. 17 of these aneurysms underwent T- or Y-shaped stent constructs. All patients had immediate, 6 month and 18 month clinical and radiological follow-up. Radiological assessment was made on modified Raymond-Roy occlusion scores while clinical assessment was based on the modified Rankin Scale. Subgroup analysis of 17 aneurysms treated with multi-stent constructs was conducted. 6 month follow-up data were available for 59 aneurysms and 18 month follow-up data for 58 aneurysms. Satisfactory aneurysm occlusion was achieved in 97% at inception and at 6 months, and 98% at 18 months. Good neurological outcomes were achieved in 95% at 18 months. Similar satisfactory results were achieved with the multi-stent construct cohort. Intraprocedural thromboembolic events were recorded in 5% and delayed events in 2%. Technical complications were found in 5%. All complication rate was 13%. Braided SACE was safe, efficacious, and durable at the long term 18 month follow-up, including for multi-stent constructs. Preliminary results indicate favorable clinical and radiological outcomes compared with laser cut stents. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Extraction Strings for Ureteric Stents: Is There an Increased Risk for Urinary Tract Infections?

    Science.gov (United States)

    Fröhlich, Maryna; Fehr, Jan; Sulser, Tullio; Eberli, Daniel; Mortezavi, Ashkan

    To evaluate urinary tract infections associated with placement of ureteric stents, we performed a retrospective study and compared rates between patients with and patients without an extraction string attached to the ureteric stent. Indwelling ureteric stents are routinely removed by cystoscopy. If an extraction string has been connected to the stent at the time of placement, however, the removal can be performed without an invasive procedure. Concerns exist regarding the risk for an unintentional dislocation, increased stent-related discomfort, or an increase of the post-operative urinary tract infection rate. All elective transurethral ureteric stent placements performed between November 2011 and December 2012 in our department were included for this investigation. Urinary tract infection was defined according to the Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) surveillance definition of health-care-associated infections. Patients with an existing urinary tract infection at the time of admission were excluded from the analysis. A total of 342 patients receiving ureteric stents were evaluated regarding post-operative urinary tract infections. Of these patients, 127 (37.1%) had an extraction string and 215 (62.9%) a stent without a string. The total urinary tract infection rate was 6.4% with no significant difference between the two groups (7.9% vs. 5.6%, p = 0.49). In the present study, we did not observe an increased rate of post-operative urinary tract infections in patients with an extraction string attached to the ureteral stent. Extraction string is a good option for patients to avoid cystoscopic stent removal.

  13. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction).

    Science.gov (United States)

    Stone, Gregg W; Clayton, Tim; Deliargyris, Efthymios N; Prats, Jayne; Mehran, Roxana; Pocock, Stuart J

    The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. 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

    Directory of Open Access Journals (Sweden)

    Cristina Lucía Dávila-Fajardo

    2017-02-01

    Full Text Available 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.

  15. Vote. Election Program.

    Science.gov (United States)

    Illinois State Board of Education, Springfield.

    This election-education program is designed to help develop an informed electorate and to instill in future voters an appreciation of the importance of the right to vote. It provides a framework for discussions of the electoral process and gives students an opportunity to face the responsibilities and challenges associated with citizenship and…

  16. Elections to Staff Council

    CERN Multimedia

    Staff Association

    2011-01-01

    Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 31st of October to the 14th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months and will keep the next Staff Council very busy. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (staff.association@cern.ch). Do not forget to vote * * * * * * * Vote Make your voice heard and be many to elect the new Staff Council. More details on the election...

  17. Theoretical approaches to elections defining

    OpenAIRE

    Natalya V. Lebedeva

    2011-01-01

    Theoretical approaches to elections defining develop the nature, essence and content of elections, help to determine their place and a role as one of the major national law institutions in democratic system.

  18. Theoretical approaches to elections defining

    Directory of Open Access Journals (Sweden)

    Natalya V. Lebedeva

    2011-01-01

    Full Text Available Theoretical approaches to elections defining develop the nature, essence and content of elections, help to determine their place and a role as one of the major national law institutions in democratic system.

  19. 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

  20. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Gade, Josephine; Wilkens, Trine Levring; Hillingsø, Jens

    2016-01-01

    Major gastrointestinal surgery is associated with immune suppression and a high risk of postoperative complications. The aim of this open, randomized controlled trial was to examine the effect of supplementary per oral immunonutrition (IN) seven days before surgery for pancreatic cancer (PC......) on postoperative complications and length of hospital stay (LOS). Secondary outcomes were the changes in functional capability and body weight (BW). Consecutive patients referred for surgery for diagnosed or plausible PC were included. The patients in the intervention group received supplementary IN (Oral Impact...

  1. Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

    Science.gov (United States)

    Elmunzer, B Joseph; Higgins, Peter D R; Saini, Sameer D; Scheiman, James M; Parker, Robert A; Chak, Amitabh; Romagnuolo, Joseph; Mosler, Patrick; Hayward, Rodney A; Elta, Grace H; Korsnes, Sheryl J; Schmidt, Suzette E; Sherman, Stuart; Lehman, Glen A; Fogel, Evan L

    2013-03-01

    A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

  2. 'Stent in a stent'--an alternative technique for removing partially covered stents following sleeve gastrectomy complications.

    Science.gov (United States)

    Vasilikostas, Georgios; Sanmugalingam, Nimalan; Khan, Omar; Reddy, Marcus; Groves, Chris; Wan, Andrew

    2014-03-01

    Endoscopic stenting is a relatively new technique for the treatment of post sleeve gastrectomy complications. Partially covered stents are used in this method to minimise the risk of migration but they are associated with difficulties with removal. Patients requiring emergency stenting following sleeve gastrectomy underwent insertion of a partially covered metallic stent. One month later, if the stent was not easily removable, a fully covered overlapping stent was inserted and the patient was readmitted 2 weeks later for removal of both stents. Four patients required stenting following sleeve gastrectomy leaks, and one patient required stenting for a stricture. In these cases, a 'stent in a stent' technique was used for removal. This technique allows the safe removal of partially covered stents inserted following sleeve gastrectomy complications.

  3. Serial assessment by optical coherence tomography of early and late vascular responses after implantation of an absorbable-coating Sirolimus-Eluting stent (from the first-in-human DESSOLVE I trial).

    Science.gov (United States)

    Attizzani, Guilherme F; Bezerra, Hiram G; Ormiston, John; Wang, Wei; Donohoe, Dennis; Wijns, William; Costa, Marco A

    2013-11-15

    The initial enthusiasm caused by the potent antirestenotic effect of early generation drug-eluting stents was recently plagued by concerns regarding their safety profile. Investigators worldwide were stimulated, therefore, to seek for improvement in drug-eluting stent technology, such as eliminating their permanent polymer blamed for vascular inflammation and delayed healing. Optical coherence tomography (OCT) assessments of stent-vessel interactions are used as a surrogate for vessel healing after DES implantation. Herewith, we report serial OCT assessments of vascular reactions to the implantation of a novel absorbable polymer sirolimus-eluting stent (MiStent). In total, 30 patients were included. At 4-, 6-, and 8-month follow-up, different groups of 10 patients underwent OCT imaging, whereas all the patients had OCT assessments scheduled at 18-month follow-up. A total of 13,569 stent struts were analyzed. Low rates of uncovered (14.34 ± 15.35%, 6.62 ± 10.93%, 3.51 ± 2.87%, and 0.84 ± 1.15%, respectively, p stent struts coupled with thin and increasingly homogenous neointimal proliferation were demonstrated. Neointimal area increased from 4- to 8-month follow-up (0.46 ± 0.29 and 1.12 ± 0.73 mm(2), respectively, p stent struts (8.8%, 3.1%, 0.3%, and 0%, respectively, p absorbable polymer sirolimus-eluting stent-vessel interactions up to 18-month follow-up. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Angioplasty and stent placement - carotid artery

    Science.gov (United States)

    ... medlineplus.gov/ency/article/002953.htm Angioplasty and stent placement - carotid artery To use the sharing features ... to remove plaque buildup ( endarterectomy ) Carotid angioplasty with stent placement Description Carotid angioplasty and stenting (CAS) is ...

  5. High-Dose Statin Pretreatment Decreases Periprocedural Myocardial Infarction and Cardiovascular Events in Patients Undergoing Elective Percutaneous Coronary Intervention: A Meta-Analysis of Twenty-Four Randomized Controlled Trials

    Science.gov (United States)

    Wang, Le; Peng, Pingan; Zhang, Ou; Xu, Xiaohan; Yang, Shiwei; Zhao, Yingxin; Zhou, Yujie

    2014-01-01

    Background Evidence suggests that high-dose statin pretreatment may reduce the risk of periprocedural myocardial infarction (PMI) and major adverse cardiac events (MACE) for certain patients; however, previous analyses have not considered patients with a history of statin maintenance treatment. In this meta-analysis of randomized controlled trials (RCTs), we reevaluated the efficacy of short-term high-dose statin pretreatment to prevent PMI and MACE in an expanded set of patients undergoing elective percutaneous coronary intervention. Methods We searched the PubMed/Medline database for RCTs that compared high-dose statin pretreatment with no statin or low-dose statin pretreatment as a prevention of PMI and MACE. We evaluated the incidence of PMI and MACE, including death, spontaneous myocardial infarction, and target vessel revascularization at the longest follow-up for each study for subgroups stratified by disease classification and prior low-dose statin treatment. Results Twenty-four RCTs with a total of 5,526 patients were identified. High-dose statin pretreatment was associated with 59% relative reduction in PMI (odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.34–0.49; Pstatin pretreatment on MACE was significant for statin-naive patients (OR: 0.69; 95% CI: 0.50–0.95; P = 0.02) and prior low dose statin-treated patients (OR: 0.28; 95% CI: 0.12–0.65; P = 0.003); and for patients with acute coronary syndrome (OR: 0.52; 95% CI: 0.34–0.79; P = 0.003), but not for patients with stable angina (OR: 0.71; 95% CI 0.45–1.10; P = 0.12). Long-term effects on survival were less obvious. Conclusions High-dose statin pretreatment can result in a significant reduction in PMI and MACE for patients undergoing elective PCI. The positive effect of high-dose statin pretreatment on PMI and MACE is significant for statin-naïve patients and patients with prior treatment. The positive effect of high-dose statin pretreatment on MACE is significant for

  6. The Effect of Stent Cell Geometry on Carotid Stenting Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Alparslan, Burcu, E-mail: burcu.alparslan@gmail.com [Yozgat State Hospital, Radiology Clinic (Turkey); Nas, Omer Fatih, E-mail: omerfatihnas@gmail.com [Uludag University Faculty of Medicine, Department of Radiology (Turkey); Eritmen, Ulku Turpcu, E-mail: drulkutur@hotmail.com.tr [Special Eregli Anatolia Hospital, Radiology Clinic (Turkey); Duran, Selcen, E-mail: selcenduran16@hotmail.com [Yerkoy State Hospital, Neurology Clinic (Turkey); Ozkaya, Guven, E-mail: ozkaya@uludag.edu.tr [Uludag University Faculty of Medicine, Department of Biostatistics (Turkey); Hakyemez, Bahattin, E-mail: bhakyemez@uludag.edu.tr [Uludag University Faculty of Medicine, Department of Radiology (Turkey)

    2016-04-15

    PurposeThe aim of this study was to investigate the effect of stent cell geometry on midterm results of carotid artery stenting (CAS).Materials and MethodOne hundred fifty-five patients underwent CAS between February 2010 and December 2012. Ninety-one open- and 84 closed-cell stents were used in this non-randomized, retrospective study. Periprocedural complications were defined as the ones happened during the procedure or within 30 days afterwards. Starting from the 6th month after the procedure, in-stent restenosis was detected with multidetector computed tomography angiography and classified into four groups from focal restenosis to occlusion.ResultsEleven complications were encountered in the periprocedural period (four on the open- and seven on the closed-cell group). Total complication rate was 6.3 % (11/175). No significant difference was detected in terms of periprocedural complications between two groups (p = 0.643). There was statistically significant difference between stent design groups in regard to radiological findings (p = 0.002). Sixteen of open-cell stents and three of closed-cell stents had focal restenosis. One closed-cell stent had diffuse proliferative restenosis and one open-cell stent had total occlusion.ConclusionIn-stent restenosis was more common in open-cell stent group, which have larger free cell area than closed-cell stents. Although our radiologic findings promote us to use closed-cell design if ‘possible’, no difference was detected in terms of clinical outcomes.

  7. Self-expandable metalic endotracheal stent

    International Nuclear Information System (INIS)

    Do, Young Soo; Cho, Dae Soon; Cho, Kyung Ja; Lee, Young Soo; Lee, Mi Jae

    1993-01-01

    Six bare stents and six covered stents were inserted in the trachea of 12 dogs under general anesthesia. After 1-10 weeks of observation, the dogs were killed, and the trachea and lung were examined grossly and histologically. Pneumonia and stent migration were observed more frequently at covered stent group. Inflammatory change of the trachea was more severe at covered stent group. In conclusion, we believe that it is inadequate to insert silicone covered stent in the tracheobronchial tree. (Author)

  8. Self-expandable metalic endotracheal stent

    Energy Technology Data Exchange (ETDEWEB)

    Do, Young Soo; Cho, Dae Soon; Cho, Kyung Ja; Lee, Young Soo; Lee, Mi Jae [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

    1993-01-01

    Six bare stents and six covered stents were inserted in the trachea of 12 dogs under general anesthesia. After 1-10 weeks of observation, the dogs were killed, and the trachea and lung were examined grossly and histologically. Pneumonia and stent migration were observed more frequently at covered stent group. Inflammatory change of the trachea was more severe at covered stent group. In conclusion, we believe that it is inadequate to insert silicone covered stent in the tracheobronchial tree. (Author).

  9. And after the elections!

    CERN Multimedia

    Staff Association

    2015-01-01

    What happens to the newly elected, and the re-elected delegates after the election of the new Staff Council? (see Écho No 47-48 / 2016). It is the outgoing Staff Council which is responsible for preparing the new staff representatives to take on their new roles. To do this, information days are organized in the form of assizes. This year they took place on November 23 in the afternoon; as well as on November 24, bringing together the new Staff Council. These days mainly aim to inform delegates about the role of the Staff Association (SA) at CERN, ist the organs, committees, forums, etc.; with whom the SA interacts, how the work of the Staff Association is organization, the issues on which it works (e.g., the Five-Yearly Review..). These days are like a kind of "induction". Inform, but not only! Assizes are also aiming to integrate the newcomers, inviting them to discover the various internal committees of the SA, explaining to them the challenges ahead as well as defining the act...

  10. And after the Elections!

    CERN Multimedia

    Staff Association

    2017-01-01

    What happens to the newly elected, and the re-elected delegates after the election of the new Staff Council? It is the outgoing Staff Council which is responsible for preparing the new staff representatives to take on their new roles. To do this, information days are organized in the form of assizes. This year they will take place on November 27 in the morning; as well as on November 28, bringing together the new Staff Council. These days mainly aim to inform delegates about the role of the Staff Association (SA) at CERN, the bodies, committees, forums, etc.; with whom the SA interacts, how the work of the SA is organized, the issues on which it works. These days are like a kind of "induction". Inform, but not only! Assizes are also aiming to integrate the newcomers, inviting them to discover the various internal committees of the SA, explaining to them the challenges ahead as well as defining the action plan for 2018. They offer new delegates, if they wish, a godparent (a kind of mentor). I...

  11. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents.

    Science.gov (United States)

    Cohen, José E; Gomori, John Moshe; Moscovici, Samuel; Leker, Ronen R; Itshayek, Eyal

    2014-07-01

    We assessed the frequency and severity of changes in stent configuration and location after the treatment of intracranial aneurysms, and patterns of in-stent stenosis. We retrospectively reviewed data for consecutive aneurysm patients managed with endovascular implantation of flow-diverter stents (Silk Flow Diverter [Balt Extrusion, Montmorency, France] and Pipeline Embolization Device [ev3/Coviden, Minneapolis, MN, USA]) from October 2011 to July 2012. Routine 2, 6, 9-12, and 16-20 month follow-up angiograms were compared, with a focus on changes in stent configuration and location from immediately after deployment to angiographic follow-up, and the incidence and development of in-stent stenosis. Thirty-four patients with 42 aneurysms met inclusion criteria. The Silk device was implanted in 16 patients (47%, single device in 15), the Pipeline device in 18 (53%, single device in 16). On first follow-up angiography, in-stent stenosis was observed in 38% of Silk devices and 39% of Pipeline devices. In-stent stenosis was asymptomatic in 12 of 13 patients. One woman presented with transient ischemic attacks and required stent angioplasty due to end tapering and mild, diffuse in-stent stenosis. Configuration and location changes, including stent creeping and end tapering were seen in 2/16 patients (13%) with Silk devices, and 0/18 patients with Pipeline devices. We describe stent creeping and end tapering as unusual findings with the potential for delayed clinical complications. In-stent stenosis, with a unique behavior, is a frequent angiographic finding observed after flow-diverter stent implant. The stenosis is usually asymptomatic; however, close clinical and angiographic monitoring is mandatory for individualized management. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Nigerian Election Management Bodies and their Associated Election Challenges

    Directory of Open Access Journals (Sweden)

    Moses Etila Shaibu

    2018-01-01

    Full Text Available The paper examined the challenges that confront Election Management Bodies (EMBs in conducting free and fair elections in Nigeria. It aligns with the position of extant literature on the subject that elections in Nigeria have been anything but free and fair, and argues that all the EMBs that have so far conducted elections in Nigeria are complicit in perpetrating electoral malpractices. In other words, though there are external factors that undermine the conduct of free, fair and credible elections in Nigeria, EMBs in Nigeria also present themselves as willing tools in the hands of politicians to compromise the integrity of the electoral process. The number of litigations and level of both international and local denunciations that attend every election in Nigeria underscores the magnitude of electoral malfeasance inherent in the elections conducted by successive EMBs in Nigeria. The paper analysed the major challenges that inhibit the conduct of free and fair elections in Nigeria and proffered solutions to them. Relying heavily on the documentary methods of data collection, the paper concludes that until all these challenges confronting EMBs in Nigeria in the conduct of free and fair elections are comprehensively addressed, credible elections will continue to be a mirage in the country.

  13. Angioplasty and stent - heart - discharge

    Science.gov (United States)

    Drug-eluting stents - discharge; PCI - discharge; Percutaneous coronary intervention - discharge; Balloon angioplasty - discharge; Coronary angioplasty - discharge; Coronary artery angioplasty - discharge; Cardiac ...

  14. Indications for stenting during thrombolysis

    DEFF Research Database (Denmark)

    Bækgaard, N; Broholm, R; Just, Sven Richardt Lundgren

    2013-01-01

    of a stent in this position is the treatment of choice facilitating the venous flow into an unobstructed outflow tract either from the femoral vein or the deep femoral vein or both. The stent, made of stainless steel or nitinol, has to be self-expandable and flexible with radial force to overcome...... the challenges in this low-pressure system. The characteristics of the anatomy with external compression and often a curved vein segment with diameter difference make stent placement necessary. Ballooning alone has no place in this area. The proportion of inserted stents varies in the published materials...

  15. Risk of Stroke or Death Is Associated With the Timing of Carotid Artery Stenting for Symptomatic Carotid Stenosis: A Secondary Data Analysis of the German Statutory Quality Assurance Database.

    Science.gov (United States)

    Tsantilas, Pavlos; Kuehnl, Andreas; Kallmayer, Michael; Knappich, Christoph; Schmid, Sofie; Breitkreuz, Thorben; Zimmermann, Alexander; Eckstein, Hans-Henning

    2018-03-27

    Subgroup analyses from randomized trials indicate that the time interval between the neurologic index event and carotid artery stenting is associated with periprocedural stroke and death rates in patients with symptomatic carotid stenosis. The aim of this article is to analyze whether this observation holds true under routine conditions in Germany. Secondary data analysis was done on 4717 elective carotid artery stenting procedures that were performed for symptomatic carotid stenosis. The patient cohort was divided into 4 groups according to the time interval between the index event and intervention (group I 0-2, II 3-7, III 8-14, and IV 15-180 days). Primary outcome was any in-hospital stroke or death. For risk-adjusted analyses, a multilevel multivariable regression model was used. The in-hospital stroke or death rate was 3.7% in total and 6.0%, 4.4%, 2.4%, and 3.0% in groups I, II, III, and IV, respectively. Adjusted analysis showed a decreased risk for any stroke or death in group III, a decreased risk for any major stroke or death in groups III and IV, and a decreased risk for any death in groups II and III compared to the reference group I. A short time interval between the neurologic index event and carotid artery stenting of up to 7 days is associated with an increased risk for stroke or death under routine conditions in Germany. Although results cannot prove causal relationships, carotid artery stenting may be accompanied by an increased risk of stroke or death during the early period after the index event. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  16. The stenting strategy of drug-eluting stents for coronary artery disease in patients on dialysis

    Directory of Open Access Journals (Sweden)

    Hiroshi Fujita

    2014-12-01

    Full Text Available Background: Reports regarding the relationship between the length and diameter of implanted drug-eluting stents and clinical and angiographic outcomes in dialysis patients are limited. Aim: We investigated the efficiency of drug-eluting stents for coronary artery disease in patients on dialysis from the viewpoint of stent sizing. Methods: Sirolimus-eluting stents were implanted in 88 lesions and bare metal stents were implanted in 43 lesions. We compared stenting strategy, major adverse cardiac events, and angiographic results between sirolimus-eluting stent and bare metal stent groups. Results: Stent diameter was smaller and stent length was longer in the sirolimus-eluting stent group than in the bare metal stent group in our routine practices. There was no significant between-group difference in late diameter loss. Rates of angiographic restenosis and target lesion revascularization were significantly higher in the sirolimus-eluting stent group than in the bare metal stent group. Although stent length was significantly longer and stent diameter was smaller in the sirolimus-eluting stent group, sirolimus-eluting stents did not improve the subsequent clinical and angiographic results compared with bare metal stents in dialysis patients. Conclusion: In dialysis patients, a longer length and/or smaller diameter sirolimus-eluting stent implantation was associated with high rates of restenosis and target lesion revascularization compared with bare metal stents.

  17. Complication rate in unprotected carotid artery stenting with closed-cell stents

    International Nuclear Information System (INIS)

    Tietke, Marc W.K.; Kerby, Tina; Alfke, Karsten; Riedel, Christian; Rohr, Axel; Jensen, Ulf; Jansen, Olaf; Zimmermann, Phillip; Stingele, Robert

    2010-01-01

    The discussion on the use of protection devices (PDs) in carotid artery stenting (CAS) is gaining an increasing role in lowering the periprocedural complication rates. While many reviews and reports with retrospective data analysis do promote the use of PDs the most recent multi-centre trials are showing advantages for unprotected CAS combined with closed-cell stent designs. We retrospectively analysed 358 unprotected CAS procedures performed from January 2003 to June 2009 in our clinic. Male/female ratio was 2.68/1. The average age was 69.3 years. Seventy-three percent (261/358) showed initial neurological symptoms. All patients were treated on a standardised interventional protocol. A closed and small-sized cell designed stent was implanted in most cases (85.2%). One hundred seventy-one (47.8%) were controlled by Doppler ultrasonography usually at first in a 3-month and later in 6-month intervals. The peri-interventional and 30-day mortality/stroke rate was 4.19% (15/358). These events included three deaths, five hyperperfusion syndromes (comprising one death by a secondary fatal intracranial haemorrhage), one subarachnoid haemorrhage and seven ischaemic strokes. Only 20% (3/15) of all complications occurred directly peri-interventional. The overall peri-interventional complication rate was 0.8% (3/358). Most complications occurred in initial symptomatic patients (5.36%). The in-stent restenosis rate for more than 70% was 7% (12/171) detected at an average of 9.8 month. Our clinical outcome demonstrates that unprotected CAS with small cell designed stents results in a very low procedural complication rate, which makes the use of a protection device dispensable. (orig.)

  18. Comparison of the efficacy of pharmacoinvasive management for ST-segment elevation myocardial infarction in smokers versus non-smokers (from the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction).

    Science.gov (United States)

    Tan, Nigel S; Goodman, Shaun G; Cantor, Warren J; Tan, Mary K; Yan, Raymond T; Bagnall, Alan J; Mehta, Shamir R; Fitchett, David; Strauss, Bradley H; Yan, Andrew T

    2014-10-01

    Compared with non-smokers, cigarette smokers with ST-segment elevation myocardial infarctions derive greater benefit from fibrinolytic therapy. However, it is not known whether the optimal treatment strategy after fibrinolysis differs on the basis of smoking status. The Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) randomized patients with ST-segment elevation myocardial infarctions to a routine early invasive (pharmacoinvasive) versus a standard (early transfer only for rescue percutaneous coronary intervention or delayed angiography) strategy after fibrinolysis. The efficacy of these strategies was compared in 1,051 patients on the basis of their smoking status. Treatment heterogeneity was assessed between smokers and non-smokers, and multivariable analysis was performed to evaluate for an interaction between smoking status and treatment strategy after adjusting for baseline Global Registry of Acute Coronary Events (GRACE) risk score. Smokers (n=448) were younger, had fewer cardiovascular risk factors, and had lower GRACE risk scores. They had a lower rate of the primary composite end point of 30-day mortality, reinfarction, recurrent ischemia, heart failure, or cardiogenic shock and fewer deaths or reinfarctions at 6 months and 1 year. Smoking status was not a significant predictor of either primary or secondary end points in multivariable analysis. Pharmacoinvasive management reduced the primary end point compared with standard therapy in smokers (7.7% vs 13.6%, p=0.04) and non-smokers (13.1% vs 19.7%, p=0.03). Smoking status did not modify treatment effect on any measured outcomes (p>0.10 for all). In conclusion, compared with non-smokers, current smokers receiving either standard or early invasive management of ST-segment elevation myocardial infarction after fibrinolysis have more favorable outcomes, which is likely attributable to their better baseline risk profile. The

  19. Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

    Science.gov (United States)

    Campos, Carlos M; Caixeta, Adriano; Franken, Marcelo; Bartorelli, Antonio L; Whitbourn, Robert J; Wu, Chiung-Jen; Li Paul Kao, Hsien; Rosli, Mohd Ali; Carrie, Didier; De Bruyne, Bernard; Stone, Gregg W; Serruys, Patrick W; Abizaid, Alexandre

    2018-02-15

    to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  20. Influence of stent design and use of protection devices on outcome of carotid artery stenting: a pooled analysis of individual patient data.

    Science.gov (United States)

    Wodarg, Fritz; Turner, Elisabeth L; Dobson, Joanna; Ringleb, Peter A; Mali, Willem P; Fraedrich, Gustav; Chatellier, Gilles; Bequemin, Jean-Pierre; Brown, Martin M; Algra, Ale; Mas, Jean-Louis; Jansen, Olav; Bonati, Leo H

    2018-04-19

    Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk. We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting. Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables. In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. 2017 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2017-01-01

    Make your voice heard, support your candidates! We hope that you will be many to vote and to elect the new Staff Council! By doing so, you can support and encourage the women and men, who will represent you over the next two years. The voting takes place from 23 October to 13 November, at noon at https://ap-vote.web.cern.ch/elections-2017. Elections Timetable Monday 13 November, at noon Closing date for voting Tuesday 21 November and Tuesday 5 December Publication of the results in Echo Monday 27 and Tuesday 28 November Staff Association Assizes Tuesday 5 December (afternoon) First meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 21 November and 5 December. Candidates for the 2017 Elections

  2. 2011 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2011-01-01

    Vote Elections to fill all seats in the Staff Council are being organized this month. Voting will begin on Monday 31 October. Make your voice heard and be many to elect the new Staff Council. By doing so, you will be encouraging the men and women who will  represent you over the next two years and they will doubtless appreciate your gratitude. More details on the elections can be found on the Staff Association web site. (http://association.web.cern.ch) Elections Timetable Monday 31 October, at noon start date for voting Monday 14 November, at noon closing date for voting Monday 21 November, publication of the results in Echo Tuesday 22 and Wednesday 29 November Staff Association Assizes Tuesday 6 December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee. 

  3. 2015 Elections to Staff Council

    CERN Multimedia

    Staff Asscociation

    2015-01-01

    Make your voice heard, support your candidates! Be many to vote and to elect the new Staff Council. By doing so, you will be encouraging the men and women who will represent you over the next two years and they will without doubt appreciate your gratitude. The voting takes place from the 26th of October to the 9th of November, at noon at https://ap-vote.web.cern.ch/elections-2015.   Elections Timetable Monday 9 November, at noon Closing date for voting Monday 16 and Monday 23 November, publication of the results in Echo Tuesday 8 December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 16 and 24 November. Candidates for the 2015 elections

  4. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

    Science.gov (United States)

    Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

    2015-10-01

    This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Usefulness of CT angiography after metallic stent implantation of the internal carotid artery

    International Nuclear Information System (INIS)

    Yoon, Man Won; Kim, Hyeon Chul; Kim, Jae Kyu; Seo, Jeong Jin; Jeong, Gwang Woo; Kang, Heoung Keun

    1999-01-01

    To evaluate the usefulness of CT angiography in patients with implantation of metallic stent for stenosed internal carotid artery. Seven patients with atherosclerotic stenosis of the internal carotid artery underwent metallic stent implantation. All were male and their ages ranged from 36 to 69 years. A total of seven stents were placed in the internal carotid artery in five patients and in the carotid bifurcation in two. Spiral CT scans were obtained and CT angiographic images were reconstructed using MPR or curved MPR techniques at a workstation. The interval between CT and conventional angiography did not exceed six days except in one patient, in whom it was 61days. CT and conventional angiography were compared for stent position with respect to the carotid bifurcation, stent deformation, intraluminal filling defect, and luminal caliber and outflow. Luminal patency of the implanted stent was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial) criteria, and statistically processed (p>.05). The presence or absence of intrastent thrombus and vascular wall calcification was determined using axial source images. In all patients, CT angiographic findings matched those obtained by conventional angiography. Complications such as migration or deformation of an implanted stent, intraluminal filling defect, change of luminal caliber or outflow of implanted stent were not observed in any patient. In two studies in which Wilcoxon signed rank test was used, degree of stent expansion correlated closely(p=0.237). Axial source images showed that in no patient was an intrastent thrombus present, though in five, vascular wall calcification of internal carotid arteries outside the stent was noted. CT angiography is useful for the assessment of positional change, occlusion, and luminal patency of a stent-implanted internal carotid artery

  6. Germany after Federal elections

    International Nuclear Information System (INIS)

    Niedzballa, G.

    2010-01-01

    The political, economical and social situation in Germany after the election and attitude to nuclear energy are summarised. The Coalition agreement include: 1.Extension of the remaining lifetimes of the nuclear power plants (Nuclear Power considered as “Bridging technology”; Safety first; Skimming of additional profits) 2. No nuclear new builds in Germany 3. Approval and promotion (loan guarantees) of nuclear exports 4. Reversal of the moratorium regarding the exploration of Gorleben salt dome (Completion of the exploration; International Peer Review Group) 5.Further research regarding competence preservation and safety

  7. Applied Formal Methods for Elections

    DEFF Research Database (Denmark)

    Wang, Jian

    development time, or second dynamically, i.e. monitoring while an implementation is used during an election, or after the election is over, for forensic analysis. This thesis contains two chapters on this subject: the chapter Analyzing Implementations of Election Technologies describes a technique...... process. The chapter Measuring Voter Lines describes an automated data collection method for measuring voters' waiting time, and discusses statistical models designed to provide an understanding of the voter behavior in polling stations....

  8. Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

    International Nuclear Information System (INIS)

    Wang Zhongmin; Chen Kemin; Gong Ju; Zheng Yunfeng; Wang Tianxiang

    2009-01-01

    .38 to 1.48 (p < 0.01). There were no short-term complications. Late complications including hematemesis (n = 3), migration (n = 12), and stent occlusion due to tumor overgrowth (n = 5) were evenly distributed between the groups. In the DIT group chemotherapy-induced neutropenia and transient renal dysfunction were detected in six patients, which improved after symptomatic management. Mean survival time after the procedure was 5.9 and 11.1 months for MSI and DIT, respectively (P < 0.001). In conclusion, both MSI and DIT offer effective palliation for malignant gastroduodenal obstruction, but DIT appears to offer superior survival over MSI alone. Ideally, a prospective randomized trial comparing these two techniques should be carried out to validate this result.

  9. Intravascular stent graft with polyurethane and metallic stent: experimental study

    International Nuclear Information System (INIS)

    Do, Young Soo; Lee, Won Jae; Kim, Boo Kyung Han; Park, Jae Hyung; Lee, Hak Jong; Lee, Sang Hyun; Kim, Sung Hyun; Kim, Jong Won; Ha, Jongwon

    1997-01-01

    To evaluate the usefulness of a new model of the stent graft, and of tissue response related to placement of the stent graft. The stent graft was constructed from polyurethane (Pellethane) graft and Hanaro stent(12mm in diameter, 45mm in length, 10 bends). A stent grafts was inserted into the lower thoracic aorta in each of six adult mongrel dogs(body weight, 12-16kg). At one, two, four, and six months, follow-up studies of angiography and spiral CT angiography were preformed to evaluate wascular patency, vascular stenosis, and thrombus formation. Two dogs were sacrificed at 1month, 2months, and 6months after insertion of the stent graft and macroscopic, light microscopic, and scanning electron microscopic examinations of the aortic segment including the stent graft were performed to evaluate intimal hyperplasia, endothelial growth to the graft, and thrombus formation. During follow-up at one, two, four, and six months, angiography or spiral CT angiography showed 20-100% luminal stenosis or occlusion of the lower thoracic aorta by the thrombus and perigraft leaks in three dogs(50%), and collateral vessels caused by occlusion of the aorta in two (33.3%). On gross examination, there were thrombi of 1-5mm thickness at the graft portions in all dogs, and this thickness gradually increased. The mean thickness of intimal hyperplasia at the stent portion gradually increased from 120μm to 227μm and the mean thickness of intimal hyperplasia at the graft portion from 93μm to 914μm. This thickness was greater at the graft portion than at the stent portion. Scanning electron microscopy showed elliptical endothelial lining on the neointimal surfaces at each end of the graft. Thrombi caused stenosis or occlusion of the stent graft. In order for such a graft to be ideal, further study is needed

  10. Stent fabric fatigue of grafts supported by Z-stents versus ringed stents: an in vitro buckling test.

    Science.gov (United States)

    Lin, Jing; Wang, Lu; Guidoin, Robert; Nutley, Mark; Song, Ge; Zhang, Ze; Du, Jia; Douville, Yvan

    2014-03-01

    Stent-grafts externally fitted with a Z-shaped stents were compared to devices fitted with ringed stents in an in vitro oscillating fatigue machine at 200 cycles per minute and a pressure of 360 mmHg for scheduled durations of up to 1 week. The devices fitted with Z-stents showed a considerably lower endurance limit to buckling compared to the controls. The contact between the apexes of adjacent Z-stents resulted in significant damage to the textile scaffolds and polyester fibers due to the sharp angle of the Z-stents. The ringed stents did not cause any fraying in the textile scaffolds.

  11. Engineering Radioactive Stents for the Prevention of Restenosis

    International Nuclear Information System (INIS)

    Bruce Thomadsen; Nickles, Robert J.; Larry DeWerd; Douglass Henderson; Jonathan Nye; Wes Culberson; Stephen Peterson; Michael Meltsner; Liyong Lin

    2004-01-01

    Radiation has become an accepted treatment for the prevention of restenosis (re-blockage) of coronary arteries following angioplasty. Radioactive stents could be the easiest method of delivery for the radiation, although clinical trials were disappointing. One likely reason was the choice of P-32 as the radionuclide, which fails to match the biological needs of the problem. What radionuclide would perform best remains unknown. This project established the physical infrastructure necessary for a rational investigation to determine the optimum radiological characteristics for radioactive stents in the prevention of restenosis following angioplasty. The project investigated methods to activate coronary stents with radionuclides that spanned a range of energies and radiation types that could provide a mapping of the biological response. The project also provided calibration methods to determine the strength of the stents, an a process to calculate the dose distribution actually delivered to the patient's artery--quantities necessary for any future scientific study to improve the effectiveness of radioactive stents. Such studies could benefit the thousands of patients who receive angioplasty each year

  12. Transanal stent in anterior resection does not prevent anastomotic leakage

    DEFF Research Database (Denmark)

    Bülow, Steffen; Bulut, O; Christensen, Ib Jarle

    2006-01-01

    OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS AND METH....... On this basis it was decided to discontinue the study prematurely for ethical reasons. CONCLUSION: Decompression of the anastomosis with a transanal stent does not reduce the risk of anastomotic leakage after anterior resection.......OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS...... AND METHODS: Randomized open trial of 194 patients operated in 11 hospitals during September 2000 to September 2003 with anterior resection for a mobile rectal tumour, 115 men and 79 women, median age 68 years (range 37-90 years). The surgeon decided upon the use of a protective ileostomy, and after...

  13. ELECTIONS - Pension Fund

    CERN Multimedia

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact with staf...

  14. ELECTIONS - Pension Fund

    CERN Multimedia

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact with staff...

  15. ELECTIONS - Pension Fund

    CERN Multimedia

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact ...

  16. ELECTIONS PENSION FUND

    CERN Multimedia

    2001-01-01

    ORGANISATION EUROPEENNE POUR LA RECHERCHE NUCLEAIRE CERN EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH CAISSE DE PENSIONS / PENSION FUND Caisse de Pensions - ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate : Name : CHIAVERI First Name : Enrico I have been a CERN staff member since 1973 and have always been interested in our working conditions. As a member of the Executive Committee of the Staff Association I participated from 1980 to 1984 in the Working Group on Pensions mandated by the CERN Council. This commitment led to my becoming a member of the Governing Board of the Pension Fund in 1983, since when I have taken an active part in various commissions and working groups (Real Estate Asset Management Committee, Working Group on Actuarial Matters etc.); in so doing I have gained a thorough knowledge of different areas of the Pension Fund. Since ...

  17. Elections to Staff Council

    CERN Multimedia

    Staff Association

    2013-01-01

    Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 28 of October to the 11th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months, and in particular the Five-yearly-Review 2015, subject of the questionnaire that you probably recently filled out. All this will keep the next Staff Council very busy indeed. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (staff.association@cern.ch). Do not forget to v...

  18. Percutaneous biliary drainage and stenting

    International Nuclear Information System (INIS)

    Totev, M.

    2012-01-01

    Full text: Percutaneous transhepatic cholangiography (PTC) is an X-ray or US guided procedure that involves the injection of a contrast material directly into the bile ducts inside the liver to produce pictures of them. If a blockage or narrowing is found, additional procedures may be performed: 1. insertion of a catheter to drain excess bile out of the body or both - internal and external; 2. plastic endoprothesis placement; 3. self-expandable metal stents placement to help open bile ducts or to bypass an obstruction and allow fluids to drain. Current percutaneous biliary interventions include percutaneous transhepatic cholangiography (PTC) and biliary drainage to manage benign and malignant obstructions. Internal biliary stents are either plastic or metallic, and various types of each kind are available. Internal biliary stents have several advantages. An external tube can be uncomfortable and have a psychological disadvantage. An internal stent prevents the problems related to external catheters, for example, pericatheter leakage of bile and the need for daily flushing. The disadvantages include having to perform endoscopic retrograde cholangiopancreatography (ERCP) or new PTC procedures to obtain access in case of stent obstruction. Better patency rates are reported with metallic than with plastic stents in cases of malignant obstruction, though no effect on survival is noted. Plastic internal stents are the cheapest but reportedly prone to migration. Metallic stents are generally not used in the treatment of benign disease because studies have shown poor long-term patency rates. Limited applications may include the treatment of patients who are poor surgical candidates or of those in whom surgical treatment fails. Most postoperative strictures are treated surgically, though endoscopic and (less commonly) percutaneous placement of nonmetallic stents has increasingly been used in the past few years. Now there are some reports about use of biodegradable biliary

  19. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

    Science.gov (United States)

    Rubboli, Andrea; Sciahbasi, Alessandro; Briguori, Carlo; Saia, Francesco; Palmieri, Cataldo; Moroni, Luigi Andrea; Calabrò, Paolo; Leone, Antonio Maria; Franco, Nicoletta; Valgimigli, Marco; Varani, Elisabetta; Santi, Michela; Pasqualini, Paola; Capecchi, Alessandro; Piccalò, Giacomo; Margheri, Massimo; di Pasquale, Giuseppe; Galvani, Marcello; Bolognese, Leonardo; Gonzini, Lucio; Maggioni, Aldo Pietro

    2013-04-01

    The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.

  20. Endotracheal expandable metallic stent placement in dogs

    Energy Technology Data Exchange (ETDEWEB)

    Sawada, S; Tanabe, Y; Fujiwara, Y; Koyama, T; Tanigawa, N; Kobayashi, M; Katsube, Y; Nakamura, H [Tottori Univ. School of Medicine, Yonago (Japan). Dept. of Radiology Research Inst. for Microbial Diseases, Osaka (Japan). Dept. of Radiology

    1991-01-01

    Various types of Gianturco zig-zag wire stent were implanted into the tracheas of 4 dogs to define the suitable characteristics of the endotracheal wire stent in these animals. These stents were constructed of 0.45, and 0.33 mm stainless steel wire. The diameter of the fully expanded stents was 3 cm and their lengths were 2, 3, and 4 cm. The 2 cm stent constructed of 0.33 mm wire showed minimum pathologic changes of the trachea of the dog compared to the other stents, and at the same time had a complete covering of ciliated columnar epithelium over the stent surface. (orig.).

  1. Effect of cilostazol on in-stent neointimal hyperplasia after coronary artery stenting. A quantitative coronary angiography and volumetric intravascular ultrasound study

    International Nuclear Information System (INIS)

    Min, Pil-Ki; Jung, Jae-Hun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Shim, Won-Heum

    2007-01-01

    This study was designed to investigate the efficacy of cilostazol on the prevention of in-stent neointimal hyperplasia as measured by both quantitative coronary angiography (CAG) and volumetric intravascular ultrasound (IVUS). Fifty-nine patients (39 men, age 62 years) undergoing elective coronary stenting were randomly assigned to receive aspirin plus clopidogrel or ticlopidine (Group I, n=28, 30 lesions) or aspirin plus clopidogrel or ticlopidine plus cilostazol (Group II, n=31, 35 lesions). CAG and IVUS were performed and repeated at 6 months to assess the primary endpoints of minimal luminal diameter (MLD) and in-stent neointimal hyperplasia volume. Follow-up CAG was performed on all patients and follow-up IVUS study was available for 50 lesions in 48 patients (24 lesions in Group I, 26 in Group II). There were no significant differences in the baseline angiographic data between the 2 groups. At 6 months follow-up, in-stent MLD was 1.90±0.76 mm in Group I and 2.41±0.85 mm in Group II (p=0.006). Volumetric IVUS at 6 months demonstrated that in-stent intimal hyperplasia volume per stent length was 2.2±1.4 mm 3 /mm in Group I and 1.0±0.5 mm 3 /mm in Group II (p=0.001). Triple antiplatelet therapy including cilostazol seems to be more effective at preventing in-stent neointimal hyperplasia than a dual antiplatelet regimen. (author)

  2. Radial force measurement of endovascular stents: Influence of stent design and diameter.

    Science.gov (United States)

    Matsumoto, Takuya; Matsubara, Yutaka; Aoyagi, Yukihiko; Matsuda, Daisuke; Okadome, Jun; Morisaki, Koichi; Inoue, Kentarou; Tanaka, Shinichi; Ohkusa, Tomoko; Maehara, Yoshihiko

    2016-04-01

    Angioplasty and endovascular stent placement is used in case to rescue the coverage of main branches to supply blood to brain from aortic arch in thoracic endovascular aortic repair. This study assessed mechanical properties, especially differences in radial force, of different endovascular and thoracic stents. We analyzed the radial force of three stent models (Epic, E-Luminexx and SMART) stents using radial force-tester method in single or overlapping conditions. We also analyzed radial force in three thoracic stents using Mylar film testing method: conformable Gore-TAG, Relay, and Valiant Thoracic Stent Graft. Overlapping SMART stents had greater radial force than overlapping Epic or Luminexx stents (P stents was greater than that of all three endovascular stents (P stents, site of deployment, and layer characteristics. In clinical settings, an understanding of the mechanical characteristics, including radial force, is important in choosing a stent for each patient. © The Author(s) 2015.

  3. Is fasting necessary for elective cerebral angiography?

    Science.gov (United States)

    Kwon, O-K; Oh, C W; Park, H; Bang, J S; Bae, H-J; Han, M K; Park, S-H; Han, M H; Kang, H-S; Park, S-K; Whang, G; Kim, B-C; Jin, S-C

    2011-05-01

    In order to prevent unexpected events such as aspiration pneumonia, cerebral angiography has been performed under fasting in most cases. We investigated prospectively the necessity of fasting before elective cerebral angiography. The study is an open-labeled clinical trial without random allocation. In total, 2554 patients who underwent elective cerebral angiography were evaluated on development of nausea, vomiting, and pulmonary aspiration during and after angiography. Potential risks and benefits associated with fasting were provided in written documents and through personal counseling to patients before the procedure. The patients chose their fasting or nonfasting option. No restriction in diet was given after angiography. The patients were observed for 24 hours. Nausea and vomiting during and within 1 hour after angiography was considered as a positive event associated with cerebral angiography. The overall incidence of nausea and vomiting during and within 1 hour after angiography was 1.05% (27/2554 patients). There was no patient with pulmonary aspiration. No statistical difference in nausea and vomiting development between the fasting and the diet groups was found. The incidence of nausea and vomiting associated with cerebral angiography is low and not affected by diet or fasting. Pulmonary aspiration had no difference between the diet and the fasting group. Our study suggests that fasting may not be necessary for patients who undergo elective cerebral angiography.

  4. All quiet on election day? International election observation and incentives for pre-election violence in African elections

    NARCIS (Netherlands)

    Daxecker, U.E.

    2014-01-01

    This article argues that the increasing international interest in elections as exemplified by the rise of international election monitoring induces temporal shifts in the use of violent intimidation by political actors. The presence of international electoral missions lowers the potential for

  5. Women, Politics, Elections, and Citizenship.

    Science.gov (United States)

    Webster, Gerald R.

    2000-01-01

    Outlines the historical development of women's legal and political status in the United States, focusing on suffrage, the three "waves" of women's movements, and access to elected office. Discusses three impediments of electing women candidates to public office: (1) solidarity; (2) political culture; and (3) the impact of the single-member…

  6. [Organising an instrumental elective abortion].

    Science.gov (United States)

    Brûlé, Annie

    2015-12-01

    Family planning centres are structures designed to receive and care for women requesting elective abortions. Here the specially trained, dedicated teams offer personalised care. The instrumental elective abortion is prepared in the same way as a surgical procedure and is subject to the same monitoring. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  7. Multidisciplinary approach to carotid stenting.

    Science.gov (United States)

    Mak, C S; Chambers, B R; Clark, D J; Molan, M; Brooks, M; Roberts, N; Fell, G; Roberts, A K; New, G; Donnan, G A

    2011-11-01

    Stroke neurologists, vascular surgeons, interventional neuroradiologists and interventional cardiologists have embraced carotid angioplasty and stenting (CAS) because of potential advantages over carotid endarterectomy (CEA). At Austin Health, a multidisciplinary neuro-interventional group was formed to standardise indications and facilitate training. The aims of this study were to describe our organisational model and to determine whether 30-day complications and early outcomes were similar to those of major trials. A clinical protocol was developed to ensure optimal management. CAS was performed on patients with high medical risk for CEA, with technically difficult anatomy for CEA, or who were randomised to CAS in a trial. From October 2003 to May 2008, 47 patients (34 male, mean age 71.5) underwent CAS of 50 carotid arteries. Forty-three cases had ipsilateral carotid territory symptoms within the previous 12 months. The main indications for CAS were high risk for CEA (n= 17) and randomised to CAS (n= 21). Interventionists were proctored in 27 cases. The procedural success rate was 94% with two cases abandoned because of anatomical problems and one because of on-table angina. Hypotension requiring vasopressor therapy occurred in 12 cases (24%). The duration of follow up was one to 44 months (mean 6.8 months). The 30-day rate of peri-procedural stroke or death was 6% and the one-year rate of peri-procedural stroke or death or subsequent ipsilateral stroke was 10.6%. Restenosis occurred in 13% (all asymptomatic). A multidisciplinary approach is a useful strategy for initiating and sustaining a CAS programme. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  8. 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

    artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion......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......-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. METHODS: The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary...

  9. Bayesian inference on proportional elections.

    Directory of Open Access Journals (Sweden)

    Gabriel Hideki Vatanabe Brunello

    Full Text Available Polls for majoritarian voting systems usually show estimates of the percentage of votes for each candidate. However, proportional vote systems do not necessarily guarantee the candidate with the most percentage of votes will be elected. Thus, traditional methods used in majoritarian elections cannot be applied on proportional elections. In this context, the purpose of this paper was to perform a Bayesian inference on proportional elections considering the Brazilian system of seats distribution. More specifically, a methodology to answer the probability that a given party will have representation on the chamber of deputies was developed. Inferences were made on a Bayesian scenario using the Monte Carlo simulation technique, and the developed methodology was applied on data from the Brazilian elections for Members of the Legislative Assembly and Federal Chamber of Deputies in 2010. A performance rate was also presented to evaluate the efficiency of the methodology. Calculations and simulations were carried out using the free R statistical software.

  10. Drug-eluting stents appear superior to bare metal stents for vein-graft PCI in vessels up to a stent diameter of 4 mm

    Directory of Open Access Journals (Sweden)

    Oliver P. Guttmann

    2016-05-01

    Full Text Available BackgroundResearch trials have shown improved short-term outcome with drug-eluting stents (DES over bare metal stents (BMS in saphenous vein graft (SVG percutaneous coronary intervention (PCI, primarily by reducing target vessel revascularization (TVR for in-stent restenosis. We compared the outcomes in patients undergoing SVG stent implantation treated with DES or BMS. In exploratory analyses we investigated the influence of stent generation and diameter.MethodsData were obtained from a prospective database of 657 patients who underwent PCI for SVG lesions between 2003 and 2011. A total of 344 patients had PCI with BMS and 313 with DES. Propensity scores were developed based on 15 observed baseline covariates in a logistic regression model with stent type as the dependent variable. The nearest-neighbour-matching algorithm with Greedy 5-1 Digit Matching was used to produce two patient cohorts of 313 patients each. We assessed major adverse cardiac events (MACE out to a median of 3.3 years (interquartile range: 2.1-4.1. MACE was defined as all-cause mortality, myocardial infarction (MI, TVR and stroke.ResultsThere was a significant difference in MACE between the two groups in favour of DES (17.9% DES vs. 31.2% BMS group; p = 0.0017 over the 5-year follow-up period. MACE was driven by increased TVR in the BMS group. There was no difference in death, MI or stroke. Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.75 (95% confidence interval (CI 0.52-0.94, with no difference in the hazard of all-cause mortality (hazard ratio: 1.08; 95% CI: 0.77-1.68. However, when looking at stent diameters greater than 4 mm, no difference was seen in MACE rates between BMS and DES.ConclusionsOverall in our cohort of patients who had PCI for SVG disease, DES use resulted in lower MACE rates compared with BMS over a 5-year follow-up period; however, for stent diameters over 4 mm no difference in MACE rates was seen.

  11. 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......, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty...... 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...

  12. Angiographic CT: in vitro comparison of different carotid artery stents-does stent orientation matter?

    Science.gov (United States)

    Lettau, Michael; Bendszus, Martin; Hähnel, Stefan

    2013-06-01

    Our aim was to evaluate the in vitro visualization of different carotid artery stents on angiographic CT (ACT). Of particular interest was the influence of stent orientation to the angiography system by measurement of artificial lumen narrowing (ALN) caused by the stent material within the stented vessel segment to determine whether ACT can be used to detect restenosis within the stent. ACT appearances of 17 carotid artery stents of different designs and sizes (4.0 to 11.0 mm) were investigated in vitro. Stents were placed in different orientations to the angiography system. Standard algorithm image reconstruction and stent-optimized algorithm image reconstruction was performed. For each stent, ALN was calculated. With standard algorithm image reconstruction, ALN ranged from 19.0 to 43.6 %. With stent-optimized algorithm image reconstruction, ALN was significantly lower and ranged from 8.2 to 18.7 %. Stent struts could be visualized in all stents. Differences in ALN between the different stent orientations to the angiography system were not significant. ACT evaluation of vessel patency after stent placement is possible but is impaired by ALN. Stent orientation of the stents to the angiography system did not significantly influence ALN. Stent-optimized algorithm image reconstruction decreases ALN but further research is required to define the visibility of in-stent stenosis depending on image reconstruction.

  13. Safety and Effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial

    Directory of Open Access Journals (Sweden)

    Martín Beatriz

    2011-10-01

    Full Text Available Abstract Background In cardiopulmonary bypass (CPB patients, fibrinolysis may enhance postoperative inflammatory response. We aimed to determine whether an additional postoperative dose of antifibrinolytic tranexamic acid (TA reduced CPB-mediated inflammatory response (IR. Methods We performed a randomized, double-blind, dose-dependent, parallel-groups study of elective CPB patients receiving TA. Patients were randomly assigned to either the single-dose group (40 mg/Kg TA before CPB and placebo after CPB or the double-dose group (40 mg/Kg TA before and after CPB. Results 160 patients were included, 80 in each group. The incident rate of IR was significantly lower in the double-dose-group TA2 (7.5% vs. 18.8% in the single-dose group TA1; P = 0.030. After adjusting for hypertension, total protamine dose and temperature after CPB, TA2 showed a lower risk of IR compared with TA1 [OR: 0.29 (95% CI: 0.10-0.83, (P = 0.013]. Relative risk for IR was 2.5 for TA1 (95% CI: 1.02 to 6.12. The double-dose group had significantly lower chest tube bleeding at 24 hours [671 (95% CI 549-793 vs. 826 (95% CI 704-949 mL; P = 0.01 corrected-P significant] and lower D-dimer levels at 24 hours [489 (95% CI 437-540 vs. 621(95% CI: 563-679 ng/mL; P = 0.01 corrected-P significant]. TA2 required lower levels of norepinephrine at 24 h [0.06 (95% CI: 0.03-0.09 vs. 0.20(95 CI: 0.05-0.35 after adjusting for dobutamine [F = 6.6; P = 0.014 corrected-P significant]. We found a significant direct relationship between IL-6 and temperature (rho = 0.26; P P P P P P P Conclusions Prolonged inhibition of fibrinolysis, using an additional postoperative dose of tranexamic acid reduces inflammatory response and postoperative bleeding (but not transfusion requirements in CPB patients. A question which remains unanswered is whether the dose used was ideal in terms of safety, but not in terms of effectiveness. Current Controlled Trials number ISRCTN: ISRCTN84413719

  14. Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

    Science.gov (United States)

    Sawaya, Fadi J; Morice, Marie-Claude; Spaziano, Marco; Mehran, Roxana; Didier, Romain; Roy, Andrew; Valgimigli, Marco; Kim, Hyo-Soo; Woo Park, Kyung; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Colombo, Antonio; Chieffo, Alaide; Giustino, Gennaro; Stone, Gregg W; Bhatt, Deepak L; Palmerini, Tullio; Gilard, Martine

    2017-02-01

    Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  15. 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.

  16. Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos).

    Science.gov (United States)

    de la Torre-Hernández, José M; Alfonso, Fernando; Hernández, Felipe; Elizaga, Jaime; Sanmartin, Marcelo; Pinar, Eduardo; Lozano, Iñigo; Vazquez, Jose M; Botas, Javier; Perez de Prado, Armando; Hernández, Jose M; Sanchis, Juan; Nodar, Juan M Ruiz; Gomez-Jaume, Alfredo; Larman, Mariano; Diarte, Jose A; Rodríguez-Collado, Javier; Rumoroso, Jose R; Lopez-Minguez, Jose R; Mauri, Josepa

    2008-03-11

    This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice. The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality. The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

  17. Comparative analysis of intraluminal radiation stent in treatment of advanced esophageal carcinoma

    International Nuclear Information System (INIS)

    Guo Jinhe; Teng Gaojun; Zhu Guangyu; He Shicheng; Fang Wen; Deng Gang; Li Guozhao

    2007-01-01

    Objective: To compare the clinical effectiveness of intraluminal radiation stent with that of common covered stent to palliate dysphagia in advanced esophageal cancer. Methods: Fifty three cases were randomly assigned to the experimental group (Group A, n=27) and the control group (Group B, n26). Radiation stents were placed in Group A and common covered stents were placed in Group B. A randomized trial was performed to compare the two groups with respect to complications, relief of dysphagia, and overall survival period. Results: The placement of stents were successful in all the 53 patients. In Group A, no leakage of radiation source was observed through ECT examination, and no displacement of radiation seeds was found through radiography. The follow-up CT showed reduced lesion size compared to presurgical lesion. Three of the 5 patients who underwent uncovered radiation stent placement showed complete necrosis and inflammatory hyperblastosis in tumor tissue adjacent to radiation particles at 2 months follow-up. The lumen of the stents were smooth and had no overgrowth of tumor tissue. Granulation hyperplasia was found at both ends of the stents, prominent at the proximal ends, The incidence of stent- related complications had no significant difference between group A and group B (test, P>0.05). Dysphasia resolved significantly after stent placement in both groups. The improvement of dysphasia was more significant in Group A than in Group B after 2 months of stent placement (1.37±0.56 in group A, 1.82±0.50 in group B,P=0.004). The median survival period was longer in Group A than in Group B (7 months vs 4 months ). The mean survival period was also longer in Group A than in Group B (8.3 months vs 3.5 months). There was a statistically significant difference in the survival period between the two groups (P<0.01). Conclusion: Intraluminal radiation esophageal stent can not only palliate dysphagia but also restrain tumor growth. Palliation period of dysphagia and

  18. Management of acute malignant colorectal obstruction with a novel self-expanding metallic stent as a bridge to surgery

    International Nuclear Information System (INIS)

    Li Yongdong; Cheng Yingsheng; Li Minghua; Fan Youben; Chen Niwei; Wang Yu; Zhao Jungong

    2010-01-01

    Purpose: To prospectively evaluate the safety and clinical efficacy of a newly designed self-expandable metallic stent (SEMS) in the treatment of patients with acute malignant colorectal obstruction. Methods: Between April 2001 and October 2007, 52 patients with acute malignant colorectal obstruction were treated with a new designed SEMS as an investigational bridge to surgery. Patients were prospectively followed and relevant data collection was collected, including details regarding technique, clinical symptoms, complications, need for elective surgery, and overall survival. Results: Stent placement was technically successful in all but two patients (due to complete obstruction) with no procedure-related complications. Complications included stent migration (n = 4), anal pain (n = 2) and stool impaction (n = 1). Clinical success was achieved in 49 (98%) of 50 patients with resolution of bowel obstruction within 2 days of stent placement. In one patient with stool impaction 2 days after stent placement, endoscopic disimpaction was successfully performed. An elective one-stage surgical procedure was performed in all 50 patients who successfully received a SEMS as a bridge to surgery within a mean of 8 ± 2 days (range: 4-11 days) after stent placement. Mean follow-up time was 36 ± 12 months (range 3-70 months), and all patients remained alive at the time of this report. Conclusion: The newly designed SEMS placement as a bridge to surgery was a safe and effective intervention for colonic decompression in patients with acute malignant colorectal obstruction and allowed a high proportion of patients to be successfully proceeded to elective surgery.

  19. Management of acute malignant colorectal obstruction with a novel self-expanding metallic stent as a bridge to surgery

    Energy Technology Data Exchange (ETDEWEB)

    Li Yongdong [Department of Radiology and Research Institute of Radiology, Sixth Affiliated People' s Hospital, Shanghai Jiao Tong University, No. 600, Yi Shan Road, Shanghai 200233 (China); Cheng Yingsheng [Department of Radiology and Research Institute of Radiology, Sixth Affiliated People' s Hospital, Shanghai Jiao Tong University, No. 600, Yi Shan Road, Shanghai 200233 (China); Department of Radiology, Tenth Affiliated People' s Hospital, Shanghai Tong Ji University, No. 301, Middle Yan Chang Road, Shanghai 200072 (China)], E-mail: chengys@sh163.net; Li Minghua [Department of Radiology and Research Institute of Radiology, Sixth Affiliated People' s Hospital, Shanghai Jiao Tong University, No. 600, Yi Shan Road, Shanghai 200233 (China); Fan Youben; Chen Niwei; Wang Yu [Department of Gastroenterology, Sixth Affiliated People' s Hospital, Shanghai Jiao Tong University (China); Zhao Jungong [Department of Radiology and Research Institute of Radiology, Sixth Affiliated People' s Hospital, Shanghai Jiao Tong University, No. 600, Yi Shan Road, Shanghai 200233 (China)

    2010-03-15

    Purpose: To prospectively evaluate the safety and clinical efficacy of a newly designed self-expandable metallic stent (SEMS) in the treatment of patients with acute malignant colorectal obstruction. Methods: Between April 2001 and October 2007, 52 patients with acute malignant colorectal obstruction were treated with a new designed SEMS as an investigational bridge to surgery. Patients were prospectively followed and relevant data collection was collected, including details regarding technique, clinical symptoms, complications, need for elective surgery, and overall survival. Results: Stent placement was technically successful in all but two patients (due to complete obstruction) with no procedure-related complications. Complications included stent migration (n = 4), anal pain (n = 2) and stool impaction (n = 1). Clinical success was achieved in 49 (98%) of 50 patients with resolution of bowel obstruction within 2 days of stent placement. In one patient with stool impaction 2 days after stent placement, endoscopic disimpaction was successfully performed. An elective one-stage surgical procedure was performed in all 50 patients who successfully received a SEMS as a bridge to surgery within a mean of 8 {+-} 2 days (range: 4-11 days) after stent placement. Mean follow-up time was 36 {+-} 12 months (range 3-70 months), and all patients remained alive at the time of this report. Conclusion: The newly designed SEMS placement as a bridge to surgery was a safe and effective intervention for colonic decompression in patients with acute malignant colorectal obstruction and allowed a high proportion of patients to be successfully proceeded to elective surgery.

  20. [Coronary stents: 30 years of medical progress].

    Science.gov (United States)

    Silvain, Johanne; Cayla, Guillaume; Collet, Jean-Philippe; Fargeot, Catherine; Montalescot, Gilles

    2014-03-01

    The history of interventional cardiology has been marked by several technologic revolutions since the late 1970s. The first key step was the use of inflatable balloon angioplasty as an alternative to CABG surgery for coronary revascularization, followed by intracoronary delivery of bare metal stent (BMS) and drug eluting stents (DES) to drastically reduce intracoronary restenosis observed with BMS. Improved stents platforms and polymers (absorbable or biocompatible) led to a dramatic reduction in the rate of late stent thrombosis. Self-expanding stents are now available to improve stent a position especially in acute myocardial infarction. The emergence of new fully bioabsorbable stents that can be combined with antiproliferative drugs is the ongoing revolution. A new generation of stents is continuously improving and likely to become the ideal stent for coronary revascularization in the near future. © 2014 médecine/sciences – Inserm.

  1. Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2009-10-01

    Endovascular treatment (angioplasty with or without stenting) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke. We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS).

  2. First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Kandzari, D.; Lansky, A.; Gorny, B.; Koltowski, L.; Waksman, R.; Berti, S.; Musumeci, G.; Limbruno, U.; Schaaf, R.J. van der; Kelm, M.; Kubica, J.; Suryapranata, H.

    2014-01-01

    BACKGROUND: First-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to their long-term safety. Second-generation DES were designed to overcome

  3. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Chevalier, Bernard; Sotomi, Yohei; Cequier, Angel; Carrié, Didier; Piek, Jan J.; van Boven, Ad J.; Dominici, Marcello; Dudek, Dariusz; McClean, Dougal; Helqvist, Steffen; Haude, Michael; Reith, Sebastian; de Sousa Almeida, Manuel; Campo, Gianluca; Iñiguez, Andrés; Sabaté, Manel; Windecker, Stephan; Onuma, Yoshinobu

    2016-01-01

    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 as a result of

  4. Certification of ICTs in Elections

    DEFF Research Database (Denmark)

    Schürmann, Carsten; Barrat, Jordi; Bolo, Eden

    2015-01-01

    Information and communication technologies play a critical role in the administration and organization of modern elections. Any breakdown of an election technology, security breach or programming error can incur tremendous cost for the electoral management body (EMB)—and may undermine voters’ trust......, starting during the feasibility study, and especially if it is bound by law to provide such a certification. The evaluation reports and related documents can also be used to increase the transparency of the election, improve the dialogue between EMBs and voters, and increase the EMB’s credibility....

  5. Stenting of major airway constriction

    International Nuclear Information System (INIS)

    Wu Xiaomei

    2002-01-01

    Objective: To investigate the correlated issues in the stenting treatment of major airway constriction. Methods: Nineteen cases of major airway stenting procedure were studied retrospectively. The clinical choice of stents of different advantages or deficiencies were discussed. The importance of intravenous anesthesia supporting, life-parameters monitoring during the procedures and the prevention of complications were analysed. Results: Under intravenous and local anesthesia, 19 Wallstents had been successively placed and relieved 19 cases of major airway constrictions due to malignant or benign diseases (15 of tumors, 3 of tuberculosis, 1 of tracheomalacia). Intravenous anesthesia and life-parameters monitoring had made the procedures more safe and precise. Conclusions: Major airway stenting is an reliable method for relieving tracheobronchial stenosis; and intravenous anesthesia supporting and life-parameters monitoring guarantee the satisfactions of procedures

  6. Carotid angioplasty and stenting in the elderly

    International Nuclear Information System (INIS)

    Kadkhodayan, Yasha; Cross, DeWitte T.; Moran, Christopher J.; Derdeyn, Colin P.

    2007-01-01

    To investigate the technical success rate as well as the procedural and mid-term complication rates of carotid angioplasty and stenting in elderly patients, a group excluded from large randomized endarterectomy trials given their perceived high surgical risk. Of 200 consecutive carotid angioplasty and/or stenting procedures performed between March 1996 and March 2005, 21 procedures were performed without cerebral protection devices in 20 patients over the age of 79 years (mean age: 83 years, 12 men, eight women). These patients' medical records were retrospectively reviewed for vascular imaging reports and available clinical follow-up. Procedural and mid-term complication rates were calculated and compared to a previously published cohort of 133 consecutive patients ≤79 years of age who also underwent endovascular treatment at our institution. Carotid stenosis was reduced from a mean of 82% to no significant stenosis in all procedures. The procedural stroke rate was zero of 21 procedures. The procedural transient ischemic attack rate (TIA) was one of 21 procedures (4.8%). Mean follow-up was 24.6 months (range: 1.0-79.5 months) with at least a 30-day follow-up for 20 of the 21 procedures (95.2%). There were no new strokes. There was one recurrent ipsilateral TIA at 1.9 months. In five cases with follow-up carotid ultrasonography, no hemodynamically significant restenosis had occurred. There were three myocardial infarctions (MI) occurring at 0.5, 2.1, and 15.2 months, of which the last MI was fatal. The composite 30-day stroke and death rate was zero of 21 procedures (95% confidence interval: 0-14%). No significant difference was found in the 30-day rate of stroke, TIA, MI, or death between the elderly and younger patients. Carotid angioplasty and stenting in elderly patients can be performed successfully with acceptable procedural and mid-term complication rates comparable to younger patients. (orig.)

  7. Right Ventricular Outflow Tract Stenting in Tetralogy of Fallot Infants With Risk Factors for Early Primary Repair.

    Science.gov (United States)

    Sandoval, Juan Pablo; Chaturvedi, Rajiv R; Benson, Lee; Morgan, Gareth; Van Arsdell, Glen; Honjo, Osami; Caldarone, Christopher; Lee, Kyong-Jin

    2016-12-01

    Tetralogy of Fallot with cyanosis requiring surgical repair in early infancy reflects poor anatomy and is associated with more clinical instability and longer hospitalization than those who can be electively repaired later. We bridged symptomatic infants with risk factors for early primary repair by right ventricular outflow tract stenting (stent). Four groups of tetralogy of Fallot with confluent central pulmonary arteries were studied: stent group (n=42), primary repair (aged 3mo group; n=45). Stent patients had the smallest pulmonary arteries with a median (95% credible intervals) Nakata index (mm 2 /m 2 ) of 79 (66-85) compared with the early-PA 139 (129-154), early-PS 136 (121-153), and surg>3mo 167 (153-200) groups. Only stent infants required unifocalization of aortopulmonary collaterals (17%). Stent and early-PA infants had younger age and lower weight than early-PS infants. Stent infants had the most multiple comorbidities. Stenting allowed deferral of complete surgical repair to an age (6 months), weight (6.3 [5.8-7.0] kg), and Nakata index (147 [132-165]) similar to the low-risk surg>3mo group. The 3 early treatment groups had similar intensive care unit/hospital stays and high reintervention rates in the first 12 months after repair, compared with the surg>3mo group. Right ventricular outflow tract stenting of symptomatic tetralogy of Fallot with poor anatomy (small pulmonary arteries) and adverse factors (multiple comorbidities, low weight) relieves cyanosis and defers surgical repair. This allowed pulmonary arterial and somatic growth with clinical results comparable to early surgical repair in more favorable patients. © 2016 American Heart Association, Inc.

  8. Elections in November

    CERN Multimedia

    Staff Association

    2011-01-01

    Become a delegate, it’s simple! CERN’s employment conditions have had a rather hard time over the past few years. The Staff Association, with the support of the staff, has managed to avoid the worst on many occasions. The next few years will be decisive, which is why we must continue to be on the scene, active, a source of proposals, and a real negotiating partner. The Staff Association is your only formal representative vis-à-vis the Management and the Member States, and the Staff Council your voice. A rapidly evolving Staff Association In November, all 60 seats in the Staff Council must be filled. All delegates are therefore outgoing. About a dozen current delegates have informed us that they will not stand for election again, which corresponds to a standard turnover. We thank these outgoing delegates for their past investment. If you are interested in the work of the Staff Association, become involved. We need new, talented, enthusiastic people who are willing to inv...

  9. PENSION FUND - ELECTIONS

    CERN Multimedia

    2000-01-01

    This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund.   Candidate: Name: MAURIN First Name: Guy I have been a member of the personnel since 1967 and as early as 1972 I was involved, in my capacity as President of the Staff Association, in the improvement of the Pension Fund benefits. As for most of us the Pension Fund is the only social provident scheme to which we belong, it is important to ensure that it is well managed and in balance. As a member of the Governing Board since 1974 and Vice-Chairman of this Board since 1977, I have continued to pursue these objectives. One of the main responsibilities of the Governing Board is our asset investment policy. The Investment Committee, of which I am Chairman, must have an overall view of the management of our 4 billion Swiss francs and seek the best yield with minimum risk. The investment structure must continuously be adapted i...

  10. PENSION FUND - ELECTIONS

    CERN Multimedia

    2000-01-01

    This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund.   Candidate: Name: RANJARD First Name: Florence Having been a member of the Governing Board of the Pension Fund since 1983 as Guy Maurin’s alternate, I am standing for a further 3-year term of office. Over the past few years work has concentrated essentially on following items: Monitoring of the work of the fund managers and their performances. The three-yearly study of the Fund’s actuarial situation. The pension guarantees ­ second phase. The Fund is approaching its maturity: the level of benefits exceeds contributions. In this context it has to strike a suitable balance between management of the risk from a dynamic investment policy, while by a prudent policy avoiding any significant loss of its capital. These will be my concerns within the Governing Board of the Pension Fund if you give me your support.

  11. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction?

    International Nuclear Information System (INIS)

    Uthappa, M.C.; Cowan, N.C.

    2005-01-01

    AIM: To determine the optimum approach for double-pigtail stent placement in malignant ureteric obstruction. PATIENTS AND METHODS: Retrograde stent placement was attempted in a consecutive series of patients presenting with malignant ureteric obstruction. If retrograde stent placement was unsuccessful, percutaneous nephrostomy was performed immediately followed by elective antegrade stent placement. Identical digital C-arm fluoroscopy for image-guidance and conditions for anaesthesia and analgesia were employed for both retrograde and antegrade procedures. Identical 8 Fr (20-26 cm) double-pigtail hydrophilic coated stents were used for each approach. RESULTS: Retrograde placement was attempted in 50 ureters in 30 patients {19 male, 11 female, average age 61.4 yr (range 29-90 yr)} over a 24-month period. The success rate for retrograde ureteric stent placement was 50% (n=25/50). Technical failures were due to failure to identify the ureteric orifice (n=22), failure to cross the stricture (n=1), failure to pass the stent (n=1) and failure to pass a 4 Fr catheter (n=1). Antegrade placement was attempted in 25 ureters with a success rate of 96% (n=24/25). Failure in the one case was due to inability to cross an upper third stricture secondary to pyeloureteritis cystica. CONCLUSION: It is suggested that retrograde route should be the initial approach if imaging shows no involvement of ureteric orifice (UO), when nephrostomy is technically very difficult or in cases of solitary kidney. The antegrade route is preferred if imaging shows tumour occlusion of the UO or if there is a tight stricture very close to the uretero-vesical junction (UVJ) making purchase within the ureter difficult for crossing the stricture

  12. Iraq: Politics, Elections, and Benchmarks

    National Research Council Canada - National Science Library

    Katzman, Kenneth

    2009-01-01

    Iraq's political system, the result of a U.S.-supported election process, is increasingly exhibiting peaceful competition but continues to be riven by sectarianism and ethnic and factional infighting...

  13. Iraq: Politics, Elections, and Benchmarks

    National Research Council Canada - National Science Library

    Katzman, Kenneth

    2008-01-01

    .... The Administration is expressing optimism that the passage of key laws in 2008, including a law to govern new provincial elections to held in early 2009, will heal remaining rifts and continue to reduce violence...

  14. Dynamic elections and ideological polarization

    Czech Academy of Sciences Publication Activity Database

    Nunnari, S.; Zápal, Jan

    2017-01-01

    Roč. 25, č. 4 (2017), s. 505-534 ISSN 1047-1987 Institutional support: RVO:67985998 Keywords : elections * political polarization Subject RIV: AH - Economics OBOR OECD: Economic Theory Impact factor: 3.361, year: 2016

  15. Dynamic elections and ideological polarization

    Czech Academy of Sciences Publication Activity Database

    Nunnari, S.; Zápal, Jan

    2017-01-01

    Roč. 25, č. 4 (2017), s. 505-534 ISSN 1047-1987 Institutional support: Progres-Q24 Keywords : elections * political polarization Subject RIV: AH - Economics OBOR OECD: Economic Theory Impact factor: 3.361, year: 2016

  16. [Internal drainage in cancer patients: optimizing treatment of stent-related symptoms].

    Science.gov (United States)

    Martov, A G; Ergakov, D V; Novikov, A B; Muzhetskaya, N G; Esen'yan, G L

    2016-04-01

    The so-called stent-related symptoms caused mainly by detrusor overactivity due to distal ("cystic") curl of the internal stent are common among patients with this type of drainage. The need for long-term stenting makes the quality of life of cancer patients one of the challenging problems of modern urology. The aim of this study was to optimize treatment of stent-related symptoms in cancer patients with internal long-term stents by complementing the treatment regimen with m-anticholinergic solifenacin. From November 2013 to November 2015 68 cancer patients (26 males, 42 females, age 36-79 years) underwent elective internal ureteral stenting for drainage of the upper urinary tract (UUT) with special long-term stents coated with the hydrogel. The urinary tract obstruction was caused by urological (24), gynecological (26) and colorectal (18) cancers. Before deciding on urinary tract drainage, all patients were treated with radiation or chemotherapy, 28 (41.2%) patients underwent surgery, but on admission all of them had contraindications to radical surgery for different reasons. In 52 (76.5%) patients UUT stenting was performed using transurethral access, in 12 (17.6%) by percutaneous access and in another 4 (5.9%) by the combined access with patients in the supine position. Percutaneous and combined access was used in cases of impracticability (failure) of transurethral stenting. Patients in group 1 (n=32) after stent placement received standard therapy co-administered with solifenacin 5 mg daily, group 2 (n=36) - only standard therapy. The data analyzed were the technical features of the internal drainage, optimal access and registered solifenacin-related adverse events. Control examinations were scheduled once in 3 months after stent placement according to the following algorithm: ultrasound scanning, laboratory test monitoring and, if indicated, plain urography. To objectify the severity of stent-related symptoms, a survey of patients using a special

  17. Teaching about Presidential Elections. ERIC Digest.

    Science.gov (United States)

    Vontz, Thomas S.; Nixon, William A.

    Although elections are an annual theme in many social studies classrooms, presidential election years prompt increased interest among students in the electoral process and offer an opportunity to teach about a national election as it happens. This ERIC Digest describes the legal requirements and traditions of U.S. presidential elections, processes…

  18. 5 CFR 2422.28 - Runoff elections.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Runoff elections. 2422.28 Section 2422.28... FEDERAL LABOR RELATIONS AUTHORITY REPRESENTATION PROCEEDINGS § 2422.28 Runoff elections. (a) When a runoff may be held. A runoff election is required in an election involving at least three (3) choices, one of...

  19. Getting elections right? Measuring electoral integrity

    NARCIS (Netherlands)

    van Ham, C.T.

    2015-01-01

    Holding elections has become a global norm. Unfortunately, the integrity of elections varies strongly, ranging from “free and fair” elections with genuine contestation to “façade” elections marred by manipulation and fraud. Clearly, electoral integrity is a topic of increasing concern. Yet electoral

  20. 5 CFR 847.303 - Election forms.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Election forms. 847.303 Section 847.303...) ELECTIONS OF RETIREMENT COVERAGE BY CURRENT AND FORMER EMPLOYEES OF NONAPPROPRIATED FUND INSTRUMENTALITIES Procedures for Elections Under the Retroactive Provisions § 847.303 Election forms. (a) Eligible employees...

  1. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

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

    2018-01-01

    Background: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have...... designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention. Methods: The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro...... stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion...

  2. Stent migration after right ventricular outflow tract stenting in the severe cyanotic Tetralogy of Fallot case

    Directory of Open Access Journals (Sweden)

    Tamaki Hayashi

    2017-01-01

    Full Text Available We report our experience with a stent migration after right ventricle outflow tract stenting and converted to patent ductus arteriosus stenting in Tetralogy of Fallot (TOF with severe infundibular stenosis. Finally, the patient achieved to TOF repair, and the migrated stent was removed without any complication.

  3. 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

  4. Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries

    Institute of Scientific and Technical Information of China (English)

    WU Chao; QIU Hong; HU Xiao-ying; RUAN Ying-mao; TIAN Yi; CHU Yan; XU Xin-lin

    2013-01-01

    Background To overcome the drawbacks of permanent stents,biodegradable stents have been studied in recent years.The bioabsorbable polymer vascular scaffold (BVS) was the first bioabsorbable stent to undergo clinical trials,demonstrating safety and feasibility in the ABSORB studies.Iron can potentially serve as the biomaterial for biodegradable stents.This study aimed to assess the short-term safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries.Methods Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine,respectively.Two stents of the same metal base were implanted into one animal.At 28 days the animals were sacrificed after coronary angiography,and histopathological examinations were performed.Results Histomorphometric measurements showed that mean neointimal thickness ((0.46±0.17) mm vs.(0.45±0.18)mm,P=0.878),neointimal area ((2.55±0.91) mm2 vs.(3.04±1.15) mm2,P=0.360) and percentage of area stenosis ((44.50±11.40)% vs.(46.00±17.95)%,P=0.845) were not significantly different between the iron stents and VISION stents.There was no inflammation,thrombosis or necrosis in either group.The scanning electron microscopy (SEM) intimal injury scores (0.75±1.04 vs.0.88±0.99,P=0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups.The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38±14.50)% vs.(65.00±22.04)%,P=0.057),but the difference was not statistically significant.Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge,consistent with iron degradation.No abnormal histopathological changes were detected in coronary arteries or major organs.Conclusions The biodegradable iron stent has

  5. 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

    BACKGROUND: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide......-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...... will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N...

  6. Endovascular stent-graft management of thoracic aortic diseases

    International Nuclear Information System (INIS)

    Dake, Michael D.

    2001-01-01

    The traditional standard therapy for descending thoracic aortic aneurysm (TAA) is open operative repair with graft replacement of the diseased aortic segment. Despite important advances in surgical techniques, anesthetic management, and post-operative care over the last 30 years, the mortality and morbidity of surgery remains considerable, especially in patients at high risk for thoracotomy because of coexisting severe cardiopulmonary abnormalities or other medical diseases. The advent of endovascular stent-graft technology provides an alternative to open surgery for selected patients with TAA. The initial experience suggests that stent-graft therapy potentially may reduce the operative risk, hospital stay and procedural expenses of TAA repair. These potential benefits are especially attractive for patients at high risk for open TAA repair. Current results of endovascular TAA therapy document operative mortalities of between 0 and 4%, aneurysm thrombosis in 90 and 100% of cases, and paraplegia as a complication in 0 and 1.6% of patients. The early success of stent-graft repair of TAA has fostered the application of these devices for the management of a wide variety of thoracic aortic pathologies, including acute and chronic dissection, intramural hematoma, penetrating ulcer, traumatic injuries, and other diseases. The results of prospective controlled trials that compare the outcomes of stent-graft therapy with those of surgical treatment in patients with specific types of aortic disease are anxiously awaited before recommendations regarding the general use of these new devices can be made with confidence

  7. [Fully absorbable drug eluting coronary stent: where do we stand in 2014?].

    Science.gov (United States)

    Kočka, Viktor; Toušek, Petr; Lisa, Libor; Buděšínský, Tomáš

    2014-04-01

    Coronary stent is routinely used in majority percutaneous coronary interventions for a long time. They have an important role, especially, in the first months after intervention. We can consider as a breakthrough point the development of stent which has ability to absorb in intervened artery after a few years. The review presents current techniques of fully absorbable coronary stents and also provides clinical trials and experiences available in 2014. The article continues with discussion between supporters and opponents of this new technique, but definitive conclusion can't be done yet. The authors conclude the review with their own opinion. There are many encouraging data in patients with good clinical outcome after implantation of absorbable stents in more than 10 years follow-up.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...... rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR...... in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)....

  9. 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

    received two different types of drug-eluting stents. METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug......-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...

  10. Mechanisms of Biliary Plastic Stent Occlusion and Efforts at Prevention

    Directory of Open Access Journals (Sweden)

    Chang-Il Kwon

    2016-03-01

    Full Text Available Biliary stenting via endoscopic retrograde cholangiopancreatography has greatly improved the quality of patient care over the last 30 years. Plastic stent occlusion limits the life span of such stents. Attempts to improve plastic stent patency duration have mostly failed. Metal stents (self-expandable metal stents [SEMSs] have therefore replaced plastic stents, especially for malignant biliary strictures. SEMS are at least 10 times more expensive than plastic stents. In this focused review, we will discuss basic mechanisms of plastic stent occlusion, along with a systematic summary of previous efforts and related studies to improve stent patency and potential new techniques to overcome existing limitations.

  11. Angioplasty and stent placement - carotid artery - discharge

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000235.htm Angioplasty and stent placement - carotid artery - discharge To use the sharing ... the hospital. You may have also had a stent (a tiny wire mesh tube) placed in the ...

  12. Angioplasty and stent placement - peripheral arteries - discharge

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000234.htm Angioplasty and stent placement - peripheral arteries - discharge To use the sharing ... peripheral artery). You may have also had a stent placed. To perform the procedure: Your doctor inserted ...

  13. Angioplasty and stent placement - peripheral arteries

    Science.gov (United States)

    ... medlineplus.gov/ency/article/007393.htm Angioplasty and stent placement - peripheral arteries To use the sharing features ... inside the arteries and block blood flow. A stent is a small, metal mesh tube that keeps ...

  14. Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

    Directory of Open Access Journals (Sweden)

    Sergio Puértolas

    2013-01-01

    Full Text Available Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears.

  15. Self-expandable metal stents for malignant colonic obstruction: data from a retrospective regional SIED-AIGO study.

    Science.gov (United States)

    Di Mitri, Roberto; Mocciaro, Filippo; Traina, Mario; Montalbano, Luigi Maria; Familiari, Luigi; D'Amore, Fabio; Raimondo, Dario; Virgilio, Clara; Tarantino, Ilaria; Barresi, Luca; Giunta, Marco; Borina, Eleonora; Borruto, Antonino; Marino, Antonino

    2014-03-01

    Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery. To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction. Two hundred and four patients (male 54.9%, mean age of 69.5 ± 14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed. Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p=0.003), and chemotherapy with a lower risk of stent ingrowth (p=0.009). This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  16. International electives in neurology training

    Science.gov (United States)

    Lyons, Jennifer L.; Coleman, Mary E.; Engstrom, John W.

    2014-01-01

    Objective: To ascertain the current status of global health training and humanitarian relief opportunities in US and Canadian postgraduate neurology programs. Background: There is a growing interest among North American trainees to pursue medical electives in low- and middle-income countries. Such training opportunities provide many educational and humanitarian benefits but also pose several challenges related to organization, human resources, funding, and trainee and patient safety. The current support and engagement of neurology postgraduate training programs for trainees to pursue international rotations is unknown. Methods: A survey was distributed to all program directors in the United States and Canada (December 2012–February 2013) through the American Academy of Neurology to assess the training opportunities, institutional partnerships, and support available for international neurology electives. Results: Approximately half of responding programs (53%) allow residents to pursue global health–related electives, and 11% reported that at least 1 trainee participated in humanitarian relief during training (survey response rate 61%, 143/234 program directors). Canadian programs were more likely to allow residents to pursue international electives than US programs (10/11, 91% vs 65/129, 50%, p = 0.023). The number of trainees participating in international electives was low: 0%–9% of residents (55% of programs) and 10%–19% of residents (21% of programs). Lack of funding was the most commonly cited reason for residents not participating in global health electives. If funding was available, 93% of program directors stated there would be time for residents to participate. Most program directors (75%) were interested in further information on global health electives. Conclusions: In spite of high perceived interest, only half of US neurology training programs include international electives, mostly due to a reported lack of funding. By contrast, the majority

  17. Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review.

    Science.gov (United States)

    Ma, Jun; Zhao, Nan; Betts, Lexxus; Zhu, Donghui

    2016-09-01

    Biodegradable magnesium (Mg) alloy stents are the most promising next generation of bio-absorbable stents. In this article, we summarized the progresses on the in vitro studies, animal testing and clinical trials of biodegradable Mg alloy stents in the past decades. These exciting findings led us to propose the importance of the concept "bio-adaption" between the Mg alloy stent and the local tissue microenvironment after implantation. The healing responses of stented blood vessel can be generally described in three overlapping phases: inflammation, granulation and remodeling. The ideal bio-adaption of the Mg alloy stent, once implanted into the blood vessel, needs to be a reasonable function of the time and the space/dimension. First, a very slow degeneration of mechanical support is expected in the initial four months in order to provide sufficient mechanical support to the injured vessels. Although it is still arguable whether full mechanical support in stented lesions is mandatory during the first four months after implantation, it would certainly be a safety design parameter and a benchmark for regulatory evaluations based on the fact that there is insufficient human in vivo data available, especially the vessel wall mechanical properties during the healing/remodeling phase. Second, once the Mg alloy stent being degraded, the void space will be filled by the regenerated blood vessel tissues. The degradation of the Mg alloy stent should be 100% completed with no residues, and the degradation products (e.g., ions and hydrogen) will be helpful for the tissue reconstruction of the blood vessel. Toward this target, some future research perspectives are also discussed.

  18. Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review

    Science.gov (United States)

    Ma, Jun; Zhao, Nan; Betts, Lexxus; Zhu, Donghui

    2016-01-01

    Biodegradable magnesium (Mg) alloy stents are the most promising next generation of bio-absorbable stents. In this article, we summarized the progresses on the in vitro studies, animal testing and clinical trials of biodegradable Mg alloy stents in the past decades. These exciting findings led us to propose the importance of the concept “bio-adaption” between the Mg alloy stent and the local tissue microenvironment after implantation. The healing responses of stented blood vessel can be generally described in three overlapping phases: inflammation, granulation and remodeling. The ideal bio-adaption of the Mg alloy stent, once implanted into the blood vessel, needs to be a reasonable function of the time and the space/dimension. First, a very slow degeneration of mechanical support is expected in the initial four months in order to provide sufficient mechanical support to the injured vessels. Although it is still arguable whether full mechanical support in stented lesions is mandatory during the first four months after implantation, it would certainly be a safety design parameter and a benchmark for regulatory evaluations based on the fact that there is insufficient human in vivo data available, especially the vessel wall mechanical properties during the healing/remodeling phase. Second, once the Mg alloy stent being degraded, the void space will be filled by the regenerated blood vessel tissues. The degradation of the Mg alloy stent should be 100% completed with no residues, and the degradation products (e.g., ions and hydrogen) will be helpful for the tissue reconstruction of the blood vessel. Toward this target, some future research perspectives are also discussed. PMID:27698548

  19. A preliminary report on the effects of paclitaxel-impregnated stents on sheep nasal mucosa.

    Science.gov (United States)

    Herrmann, Brian W; Citardi, Martin J; Vogler, George; Gardner, Laura; Smith, Greg; Javer, Amin R; Burt, Helen M; Jackson, John; Kuhn, Frederick A

    2004-01-01

    Traditional frontal sinus stents serve only as mechanical devices. It has been proposed that stents also may serve as drug-delivery systems for the topical application of drugs that minimize postoperative scarring. Paclitaxel (Taxol), which has recognized antiscarring effects, may be incorporated via a polymeric formulation into standard rubber stents. The impact of topically applied paclitaxel on the morphology of the nasal mucosa is unknown. An adult sheep model was used for this study. A modified rubber T-tube stent (incorporating paclitaxel at varying dosages) was secured to each side of the septum in four animals (eight sides). An unmodified T-tube was placed on each side of one animal, a T-tube with the drug carrier (but no paclitaxel) was placed on each side of the second animal, and T-tubes with varying paclitaxel were placed on each side of the final two animals. After 4 weeks, animals were killed and the nasal mucosa was harvested. The nasal mucosa was sectioned and stained with hematoxylin and eosin. A pathologist then assessed the nasal mucosa for vascular congestion, glandular atrophy, chronic inflammation, mucosal metaplasia, and mucosal ulceration. No consistent histopathological differences were noted in the specimens. All specimens showed varying degrees of vascular congestion, glandular atrophy, chronic inflammation, and mucosal metaplasia; the paclitaxel-impregnated stents were not consistently associated with more severe mucosal injury. Finally, mucosal ulceration was noted to be very rare in all specimens. This preliminary report describes the impact of paclitaxel-impregnated stents on sheep nasal mucosa, which tolerated these stents very well. Because paclitaxel minimizes scarring reactions at very low concentrations, paclitaxel-impregnated stents may prove useful in clinical situations in which frontal sinus stenting is deemed necessary. Additional investigations with animal models, as well as clinical trials, may be warranted.

  20. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)

    DEFF Research Database (Denmark)

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

    2012-01-01

    was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were.......71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0...

  1. Management of stent dislodgment in coarctoplasty of aorta with three overlapping self-expandable nitinol stents.

    Science.gov (United States)

    Ghazi, Payam; Haji-Zeinali, Ali-Mohammad

    2010-01-01

    We describe a case of native coarctation of aorta managed with three self-expandable nitinol stents. After balloon pre-dilation, the first and second stents were dislodged. The coarcted area was successfully treated with the third stent overlapped with the previous stents. During follow up (30 months), the patient was free of complications. It seems that implantation of multiple overlapping self-expandable stents in aortic coarctation patients, if needed, is safe and possible.

  2. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Kelbaek, Henning; Thuesen, Leif

    2010-01-01

    The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).......The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI)....

  3. Plastic biliary stents for malignant biliary diseases

    NARCIS (Netherlands)

    Huibregtse, Inge; Fockens, Paul

    2011-01-01

    Plastic biliary endoprostheses have not changed much since their introduction more than 3 decades ago. Although their use has been challenged by the introduction of metal stents, plastic stents still remain commonly used. Much work has been done to improve the problem of stent obstruction but

  4. 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.

  5. 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...

  6. 21 CFR 876.4620 - Ureteral stent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ureteral stent. 876.4620 Section 876.4620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4620 Ureteral stent. (a) Identification. A ureteral stent...

  7. 21 CFR 884.3900 - Vaginal stent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to...

  8. North American SOLITAIRE Stent-Retriever Acute Stroke Registry: choice of anesthesia and outcomes.

    Science.gov (United States)

    Abou-Chebl, Alex; Zaidat, Ossama O; Castonguay, Alicia C; Gupta, Rishi; Sun, Chung-Huan J; Martin, Coleman O; Holloway, William E; Mueller-Kronast, Nils; English, Joey D; Linfante, Italo; Dabus, Guilherme; Malisch, Timothy W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Micahel T; Badruddin, Aamir; Nguyen, Thanh N; Taqi, Muhammad; Abraham, Michael G; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Yoo, Albert J; Chen, Peng R; Britz, Gavin W; Kaushal, Ritesh; Nanda, Ashish; Issa, Mohammad A; Nogueira, Raul G

    2014-05-01

    Previous work that predated the availability of the safer stent-retriever devices has suggested that general anesthesia (GA) may have a negative impact on outcomes in patients with acute ischemic stroke undergoing endovascular therapy. We reviewed demographic, clinical, procedural (GA versus local anesthesia [LA], etc), and site-adjudicated angiographic and clinical outcomes data from consecutive patients treated with the Solitaire FR device in the investigator-initiated North American SOLITAIRE Stent-Retriever Acute Stroke (NASA) Registry. The primary outcomes were 90-day modified Rankin Scale, mortality, and symptomatic intracranial hemorrhage. A total of 281 patients from 18 centers were enrolled. GA was used in 69.8% (196/281) of patients. Baseline demographic and procedural factors were comparable between the LA and GA groups, except the former demonstrated longer time-to-groin puncture (395.4±254 versus 337.4±208 min; P=0.04), lower National Institutes of Health Stroke Scale (NIHSS; 16.2±5.8 versus 18.8±6.9; P=0.002), lower balloon-guide catheter usage (22.4% versus 49.2%; P=0.0001), and longer fluoroscopy times (39.5±33 versus 28±22.8 min; P=0.008). Recanalization (thrombolysis in cerebral infarction ≥2b; 72.94% versus 73.6%; P=0.9) and rate of symptomatic intracranial hemorrhage (7.1% versus 11.2%; P=0.4) were similar but modified Rankin Scale ≤2 was achieved in more LA patients, 52.6% versus 35.6% (odds ratio, 1.4 [1.1-1.8]; P=0.01). In multivariate analysis, hypertension, NIHSS, unsuccessful revascularization, and GA use (odds ratio, 3.3 [1.6-7.1]; P=0.001) were associated with death. When only anterior circulation and elective GA patients were included, there was a persistent difference in good outcomes in favor of LA patients (50.7% versus 35.5%; odds ratio, 1.3 [1.01-1.6]; P=0.04). The NASA Registry has demonstrated that clinical outcomes and survival are significantly better in patients treated with LA, without increased symptomatic

  9. Metallic ureteral stents in malignant ureteral obstruction: clinical factors predicting stent failure.

    Science.gov (United States)

    Chow, Po-Ming; Hsu, Jui-Shan; Huang, Chao-Yuan; Wang, Shuo-Meng; Lee, Yuan-Ju; Huang, Kuo-How; Yu, Hong-Jheng; Pu, Yeong-Shiau; Liang, Po-Chin

    2014-06-01

    To provide clinical outcomes of the Resonance metallic ureteral stent in patients with malignant ureteral obstruction, as well as clinical factors predicting stent failure. Cancer patients who have received Resonance stents from July 2009 to March 2012 for ureteral obstruction were included for chart review. Stent failure was detected by clinical symptoms, image studies, and renal function tests. Survival analysis for stent duration was used to estimate patency rate and factors predicting stent failure. A total of 117 stents were inserted successfully into 94 ureteral units in 79 patients. There were no major complications. These stents underwent survival analysis and proportional hazard regression. The median duration for the stents was 5.77 months. In multivariate analysis, age (P=0.043), preoperative serum creatinine level (P=0.0174), and cancer type (P=0.0494) were significant factors associated with stent failure. Cancer treatment before and after stent insertion had no effect on stent duration. Resonance stents are effective and safe in relieving malignant ureteral obstructions. Old age and high serum creatinine level are predictors for stent failure. Stents in patients with lower gastrointestinal cancers have longer functional duration.

  10. Coronary and peripheral stenting in aorto-ostial protruding stents: The balloon assisted access to protruding stent technique.

    Science.gov (United States)

    Helmy, Tarek A; Sanchez, Carlos E; Bailey, Steven R

    2016-03-01

    Treatment of aorto-ostial in-stent restenosis lesions represents a challenge for interventional cardiologists. Excessive protrusion of the stent into the aorta may lead to multiple technical problems, such as difficult catheter reengagement of the vessel ostium or inability to re-wire through the stent lumen in repeat interventions. We describe a balloon assisted access to protruding stent technique in cases where conventional coaxial engagement of an aorto-ostial protruding stent with the guide catheter or passage of the guide wire through the true lumen is not feasible. This technique is applicable both in coronary and peripheral arteries. © 2015 Wiley Periodicals, Inc.

  11. A new fully covered metal stent with anti-migration features for the treatment of malignant dysphagia.

    Science.gov (United States)

    Walter, Daisy; van den Berg, Maarten W; van Hooft, Jeanin E; Boot, Henk; Scheffer, Robert C H; Vleggaar, Frank P; Siersema, Peter D

    2014-12-01

    A new esophageal stent with two anti-migration features was developed to minimize migration. The aim of this study was to evaluate the clinical efficacy and safety of this stent in patients with malignant dysphagia. A total of 40 patients with dysphagia due to a malignant obstruction of the esophagus were prospectively enrolled in this cohort study. Stent placement was technically successful in 39 patients (98 %). The median dysphagia-free time after stent placement was 220 days (95 % confidence interval 94 - 345 days). Nine patients (23 %) experienced recurrent dysphagia due to tissue overgrowth (n = 2), stent fracture (n = 1), and partial (n = 5) or complete (n = 1) stent migration. A total of 16 serious adverse events occurred in 14 patients (36 %), with hemorrhage (n = 3) and severe nausea or vomiting (n = 3) being the most common causes. This new stent design was effective for the palliation of malignant dysphagia and had a low rate of recurrent dysphagia. However, despite the anti-migration features, stent migration was still a major cause of recurrent dysphagia. Furthermore, treatment was associated with a high adverse event rate. Dutch Trial Registration (NTR 3313). © Georg Thieme Verlag KG Stuttgart · New York.

  12. 2017 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2017-01-01

    Make your voice heard, support your candidates! After verification by the Electoral Commission, all candidates for the elections to the Staff Council have been registered. It is now up to you, members of the Staff Association, to vote for the candidate(s) of your choice. We hope that you will be many to vote and to elect the new Staff Council! By doing so, you can support and encourage the women and men, who will represent you over the next two years. We are using an electronic voting system; all you need to do is click the link below and follow the instructions on the screen. https://ap-vote.web.cern.ch/elections-2017 The deadline for voting is Monday, 13 November at midday (12 pm). Elections Timetable Monday 13 November, at noon Closing date for voting Tuesday 21 November and Tuesday 5 December Publication of the results in Echo Monday 27 and Tuesday 28 November Staff Association Assizes Tuesday 5 December (afternoon) First meeting of the new Staff Council and election of the new Executive Committee The ...

  13. Experimental absorbable stent permits airway remodeling.

    Science.gov (United States)

    Liu, Kuo-Sheng; Liu, Yun-Hen; Peng, Yi-Jie; Liu, Shih-Jung

    2011-02-01

    Despite metallic and silicone stents being effective in treating various airway lesions, many concerns still remain. A bioresorbable stent that scaffolds the airway lumen and dissolves after the remodeling process is completed has advantages over metallic and silicone stents. We designed and fabricated a new mesh-type bioresorbable stent with a backbone of polycaprolactone (PCL), and evaluated its safety and biocompatibility in a rabbit trachea model. The PCL stent was fabricated by a laboratory-made microinjection molding machine. In vitro mechanical strength of the PCL stents was tested and compared to that of commercial silicone stents. The bioresorbable stents were surgically implanted into the cervical trachea of New Zealand white rabbits (n=6). Animals received bronchoscopic examination at 1, 2, 4, 8, and 12 weeks after surgery. Histological examination was completed to evaluate the biocompatibility of the stents. No animals died during the period of study. Distal stent migration was noted in 1 rabbit. In-stent secretion accumulation was found in 2 rabbits. Histological examination showed intact ciliated epithelium and marked leukocyte infiltration in the submucosa of the stented area at 10 and 28 weeks. Stent degradation was minimal, and the mechanical strength was well preserved at the end of 33 weeks. These preliminary findings showed good safety and biocompatibility of the new PCL stent when used in the airway remodeling. PCL could be a promising bioresorbable material for stent design if prolonged degradation time is required. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  14. First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

    Science.gov (United States)

    Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

    2018-05-25

    A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

  15. A psychodynamic perspective on elections.

    Science.gov (United States)

    Clemens, Norman A

    2010-11-01

    In a democracy, elections are the way in which the collective thought processes of the voters arrive at a decision to direct their government. The author explores how the individual voter assesses and resolves many conflicting internal and external forces to arrive at a vote. The midterm elections of 2010 illustrate the parallel between individual resolution of conflicting forces and the process of a campaign leading to the outcome of an election. The psychodynamic concepts of conflict and compromise, affects, aggression, unconscious forces, mechanisms of defense, superego, and the ego's integrative functions are evident in both the individual voter and the collective electoral process. The author expresses concern about the historical vulnerability of democracies and the unbalancing effect of allowing limitless infusion of anonymous corporate money to pour into campaigns.

  16. Microvascular stent anastomosis using N-fibroin stents: feasibility, ischemia time, and complications.

    Science.gov (United States)

    Smeets, Ralf; Vorwig, Oliver; Wöltje, Michael; Gaudin, Robert; Luebke, Andreas M; Beck-Broichsitter, Benedicta; Rheinnecker, Michael; Heiland, Max; Grupp, Katharina; Gröbe, Alexander; Hanken, Henning

    2016-05-01

    To evaluate a novel microvascular anastomosis technique using N-fibroin stents. Cylinder stents of 1 mm diameter and 5 mm length were fabricated using N-fibroin from silkworms. In 22 rats, aortas were dissected, and the stent was inserted into the two ends of the aorta and fixed using methylmethacrylate. Stent anastomosis was successful in 21 (96%) rats. The mean ischemia time was 7.4 minutes, significantly shorter than the 15.9 minutes in the control group with conventional sutures (P stent anastomosis cases, and marked host rejection was evident at the stent anastomosis sites. Around the stents, thrombi were frequent (52%). Our study demonstrated the basic feasibility of stent anastomosis using N-fibroin stents and reduced ischemia time. However, thrombus formation, frequent and severe abdominal infections, and heavy host rejection remain critical issues. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Endoscopic stent suture fixation for prevention of esophageal stent migration during prolonged dilatation for achalasia treatment.

    Science.gov (United States)

    Rieder, E; Asari, R; Paireder, M; Lenglinger, J; Schoppmann, S F

    2017-04-01

    The aim of this study is to compare endoscopic stent suture fixation with endoscopic clip attachment or the use of partially covered stents (PCS) regarding their capability to prevent stent migration during prolonged dilatation in achalasia. Large-diameter self-expanding metal stents (30 mm × 80 mm) were placed across the gastroesophageal junction in 11 patients with achalasia. Stent removal was scheduled after 4 to 7 days. To prevent stent dislocation, endoscopic clip attachment, endoscopic stent suture fixation, or PCS were used. The Eckardt score was evaluated before and 6 months after prolonged dilatation. After endoscopic stent suture fixation, no (0/4) sutured stent migrated. When endoscopic clips were used, 80% (4/5) clipped stents migrated (p = 0.02). Of two PCS (n = 2), one migrated and one became embedded leading to difficult stent removal. Technical adverse events were not seen in endoscopic stent suture fixation but were significantly correlated with the use of clips or PCS (r = 0.828, p = 0.02). Overall, 72% of patients were in remission regarding their achalasia symptoms 6 months after prolonged dilatation. Endoscopic suture fixation of esophageal stents but not clip attachment appears to be the best method of preventing early migration of esophageal stents placed at difficult locations such as at the naive gastroesophageal junction. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Angulated Stents-A Novel Stent Improvisation to Manage Difficult Post-tuberculosis Bronchial Stenosis.

    Science.gov (United States)

    Tay, Chee Kiang; Jeong, Byeong-Ho; Kim, Hojoong

    2017-10-18

    Post-tuberculosis bronchostenosis (PTBS), a complication of endobronchial tuberculosis is currently treated by bronchial stenting. However, in cases of angulated bronchial stenoses, difficulty is often encountered in stent insertion and maintenance, resulting in stent migration, granulation tissue overgrowth, and restenosis. To accommodate the angulated alignment of the stenosis, we devised an "angulated stent"-a novel improvisation of the conventional stent via splicing and suturing to achieve a resultant angulated shape. A retrospective review was undertaken to evaluate the performance of this stent. Among 283 PTBS patients who underwent interventional bronchoscopy at our center from 2004 to 2014, 21 were treated with at least one angulated stent. Clinical outcomes, including the stenting duration were investigated. After a median follow-up of 26 months, stent removal was successful in 7 (33.3%) out of 21 patients. In patients managed with angulated stents, the median duration to stent change or eventual removal was longer than those treated with straight tube stents (392 days vs. 86 days; p < 0.05). Angulated stents are a feasible treatment option in patients with angulated PTBS by reducing complications and prolonging the stent-changing interval.

  19. Primary and revision efficacy of cross-wired metallic stents for endoscopic bilateral stent-in-stent placement in malignant hilar biliary strictures.

    Science.gov (United States)

    Lee, T H; Moon, J H; Kim, J H; Park, D H; Lee, S S; Choi, H J; Cho, Y D; Park, S H; Kim, S J

    2013-01-01

    Endoscopic bilateral drainage for inoperable malignant hilar biliary strictures (HBS) using metal stents is considered to be technically difficult. Furthermore, endoscopic revision of bilateral stenting after occlusion can be challenging. This study was performed to evaluate the long-term efficacy of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents in high-grade malignant HBS and planned endoscopic bilateral revision. A total of 84 patients with inoperable high-grade malignant HBS were enrolled from three academic tertiary referral centers. Two cross-wired metal stents were inserted using a bilateral stent-in-stent placement method. Bilateral endoscopic revision was also performed during follow-up using either identical metal stents or plastic stents. The main outcome measurements were technical and functional success, complications, stent patency, and endoscopic revision efficacy. The technical and clinical success rates of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents were 95.2% (80/84) and 92.9% (78/84), respectively. Median patency (range) and survival were 238 days (10-429) and 256 days (10-1130), respectively. Obstruction of primary bilateral stents occurred in 30.8% (24/78) of patients with functionally successful stent placement. The technical and clinical success rates of planned bilateral endoscopic revision for occluded stents were 83.3% (20/24) and 79.2% (19/24), respectively. For revision, bilateral metallic stents were placed in 11 patients (55.0%); the remaining patients received plastic stents. Palliative endoscopic bilateral stent-in-stent placement of cross-wired metallic stents was effective in patients with inoperable HBS. Revision endoscopic bilateral stenting may be feasible and successful in cases where the primary deployed metal stents are occluded. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Russia's parliamentary elections and energy

    International Nuclear Information System (INIS)

    Matveeva, Anna

    1999-01-01

    This article examines the effects of Russia's parliamentary elections on the Russian energy sector and gives details of Russia's legislation concerning Production Sharing Agreement (PSA). The importance of party politics, use of the energy sector as a ready source of cash for electoral campaigns, the government's strengthening of its representation on the board of Gazprom, the role of foreign investors, the bankruptcy of the Siberian Far Eastern Oil Company (Sidanko), the postponement of reforms, and the wait-and-see attitude of investors especially with the forthcoming presidential and Duma elections are discussed. (UK)

  1. Mechanical bowel preparation for elective colorectal surgery

    DEFF Research Database (Denmark)

    Guenaga, Katia K F G; Matos, Delcio; Wille-Jørgensen, Peer

    2009-01-01

    BACKGROUND: The presence of bowel contents during surgery has been related to anastomotic leakage, but the belief that mechanical bowel preparation (MBP) is an efficient agent against leakage and infectious complications is based on observational data and expert opinions only. OBJECTIVES...... with no MBP. Primary outcomes included anastomosis leakage - both rectal and colonic - and combined figures. Secondary outcomes included mortality, peritonitis, reoperation, wound infection, extra-abdominal complications, and overall surgical site infections. DATA COLLECTION AND ANALYSIS: Data were......: Four new trials were included at this update (total 13 RCTs with 4777 participants; 2390 allocated to MBP (Group A), and 2387 to no preparation (Group B), before elective colorectal surgery) .Anastomotic leakage occurred:(i) in 10.0% (14/139) of Group A, compared with 6.6% (9/136) of Group B for low...

  2. Endobronchial Occlusion Stent: A Preliminary Experimental Study

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Yo Won; Jeong, Woo Kyoung; Lee, Seoung Hoon; Heo, Jeong Nam; Jeon, Seok Chol [Hanyang University College of Medicine, Seoul (Korea, Republic of); Ko, Gi Young; Song, Ho Young [University of Ulsan College of Medicine, Ulsan (Korea, Republic of)

    2010-04-15

    To evaluate the safety and the technical feasibility of the use of an endobronchial occlusion stent and to get preliminary data for the development of the optimal material required for endobronchial occlusions. A commercialized, self-expandable tracheobronchial stent was modified; one half had a polyurethane cover with an occluded end and the other half was uncovered with a flaring configuration. The occluded end was placed such that it would face the distal lung. Under fluoroscopic guidance, seven stents were placed at the lower lobar bronchus in 6 mini-pigs. The bronchial obstruction was examined immediately after stent placement. Chest radiographs were taken at days 1, 7, 14, and 28 after stent placement and the removed airways from two, two, one, and one mini-pigs sacrificed on corresponding days were examined for the maintenance of bronchial obstruction. Stents were successfully placed and induced the immediate bronchial obstruction in all mini-pigs. Five of seven airways with occlusion stents maintained an obstruction until the mini-pigs were sacrificed. Proximal stent migration occurred in two mini-pigs (29%), and pulmonary consolidations were observed distal to four of the stents (57%). The placement of an endobronchial occlusion stent and the obstruction of targeted bronchi seem to be feasible, but an add-on check valve should be considered to prevent stent migration and obstructive pneumonia

  3. 2014 Election forecast - a post-election analysis

    CSIR Research Space (South Africa)

    Ittmann, HW

    2017-06-01

    Full Text Available General elections are held every five years in South Africa. During the 12 to 24 hour period after the close of the voting booths, the expected final results are of huge interest to the electorate and politicians. In the past, the Council...

  4. [Absorbable coronary stents. New promising technology].

    Science.gov (United States)

    Erbel, Raimund; Böse, Dirk; Haude, Michael; Kordish, Igor; Churzidze, Sofia; Malyar, Nasser; Konorza, Thomas; Sack, Stefan

    2007-06-01

    Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal. The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated. Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion

  5. Metallic stent placement for the management of acute colorectal obstruction caused by colorectal carcinomas: its effect on scheduled surgery

    International Nuclear Information System (INIS)

    Cao Yan; Liu Bingyan; Mao Aiwu; Yin Xiang; Gao Zhongdu

    2011-01-01

    Objective: To prospectively evaluate the safety and clinical efficacy of a newly designed self-expandable metallic stent (SEMS) placement in the treatment of patients with acute malignant colorectal obstruction due to colorectal carcinomas. Methods: During the period from April 2001 to October 2007, a total of 52 patients with acute malignant colorectal obstruction were treated with stent placement by using a new designed SEMS, which was employed as a preoperative transit means. All the patients were followed up and the relevant data, including technical success rate, clinical efficacy, complications and overall survival rate, were documented. The results were analyzed. Results: Stent placement was successfully carried out in all patients except for two patients who showed complete colorectal obstruction. No procedure-related complications occurred. Technical success rate was 96% (50/52). Two days after the treatment, the relief rate of colorectal obstruction was 98% (49/50). Postoperative complications included stent migration (n=4), anal pain (n=2) and stool impaction (n=1). The stool impaction seen in one patient was successfully removed away with endoscopic manipulation two days after stent placement. An elective one-stage surgical procedure was performed in all 50 patients who successfully received a SEMS placement within a mean interval of (8±2) days (ranged 4-11 days) after stent placement. Mean follow-up time was (36±12) months with a range of (3-70) months. All patients remained alive at the time of this report. Conclusion: The newly designed SEMS placement used as a preoperative transit means is a safe and effective intervention for colonic decompression in patients with acute malignant colorectal obstruction due to colorectal carcinomas. It can reliably ensure most of patients with colorectal carcinomas to successfully accomplish an elective surgery. (authors)

  6. A comparative evaluation of early stent occlusion among biliary conventional versus wing stents.

    Science.gov (United States)

    Khashab, Mouen A; Hutfless, Susan; Kim, Katherine; Lennon, Anne Marie; Canto, Marcia I; Jagannath, Sanjay B; Okolo, Patrick I; Shin, Eun Ji; Singh, Vikesh K

    2012-06-01

    Conventional plastic stents with a lumen typically have limited patency. The lumenless wing stent was engineered to overcome this problem. The objective of this study was to compare the incidence of early stent occlusion (symptomatic occlusion/cholangitis necessitating re-insertion within 90 days) for wing stents and conventional plastic stents. Patients with biliary pathology treated with plastic biliary stenting during the period 2003-2009 comprised the study cohort. Patients who had at least one biliary wing stent placed comprised the wing stent group, whereas patients who underwent only conventional stent plastic placement comprised the conventional stent group. Patients were stratified by indication: benign biliary strictures (group 1), malignant biliary strictures (group 2), or benign biliary non-stricture pathology (group 3). The association of stent type with the occurrence of primary outcome by indication was analyzed by use of multivariable logistic regression. Three-hundred and forty-six patients underwent 612 ERCP procedures with placement of plastic biliary stent(s). On multivariate analysis, early stent occlusion did not differ between the wing and conventional groups in groups 1, 2, and 3. Among patients who achieved primary outcome in group 2, significantly fewer patients in the wing group had cholangitis (6.7% vs. 39.1%, P = 0.03). Among patients who achieved primary outcome in group 3, significantly fewer patients in the wing group had cholangitis (10% vs. 50%, P = 0.03). Early stent occlusion was similar for wing stents and conventional plastic stents. Wing stents, however, were associated with a lower incidence of cholangitis in patients with malignant biliary obstruction and benign non-stricturing biliary pathology.

  7. 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.

    Science.gov (United States)

    Zbinden, Rainer; von Felten, Stefanie; Wein, Bastian; Tueller, David; Kurz, David J; Reho, Ivano; Galatius, Soren; Alber, Hannes; Conen, David; Pfisterer, Matthias; Kaiser, Christoph; Eberli, Franz R

    2017-02-01

    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 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. 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 curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; Pstent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. 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 the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels 15 mm length. © 2016 John Wiley & Sons Ltd.

  8. Recurrence of Subacute Stent Thrombosis and In-Stent Restenosis during Five Months after Stent Implantation in the LAD. A Case Report.

    OpenAIRE

    島田, 弘英; 大和, 眞史; 櫻井, 俊平; 疋田, 博之; 池田, 修一

    2001-01-01

    A coronary stent was deployed in the left anterior descending artery of an 82-year-old woman with unstable angina.Recurrence of subacute stent thrombosis and in-stent restenosis occurred frequently during the five months after initial stent implantation.Balloon angioplasty and cutting balloon angioplasty failed to prevent these complications,but they ceased after re-stenting in the initial stent.In this case,tissue protrusion through the stent strut, deformation of the coil stent and inadequa...

  9. Long-term Outcome of Short Metallic Stents for Lobar Airway Stenosis.

    Science.gov (United States)

    Fruchter, Oren; Abed El Raouf, Bayya; Rosengarten, Dror; Kramer, Mordechai R

    2017-07-01

    Whereas stents are considered an excellent treatment for proximal central major airway stenosis, the value of stenting for distal lobar airway stenosis is still controversial. Our aim was to explore the short-term and long-term outcome of metallic stents placed for benign and malignant lobar airway stenosis. Between July 2007 and July 2014, 14 patients underwent small airway stent insertion. The clinical follow-up included serial semiannual physical examinations, pulmonary function tests, imaging, and bronchoscopy. The etiologies for airway stenosis were: early post-lung transplantation bronchial stenosis (N=5), sarcoidosis (N=1), amyloidosis (N=1), anthracofibrosis (N=1), right middle lobe syndrome due to external lymph node compression (N=1), lung cancer (N=4), and stenosis of the left upper lobe of unknown etiology (N=1). Stents were placed in the right upper lobe bronchus (N=2), right middle lobe bronchus (N=6), left upper lobe bronchus (N=4), linguar bronchus (N=1), and left lower lobe bronchus (N=1). The median follow-up period ranged from 2 to 72 months (median 18 mo). Immediate relief of symptoms was achieved in the vast majority of patients (13/14, 92%). Out of 10 patients with benign etiology for stenosis, 9 (90%) experienced sustained and progressive improvement in pulmonary function tests and clinical condition. We describe our positive experience with small stents for lobar airway stenosis; further prospective trials are required to evaluate the value of this novel modality of treatment.

  10. External pancreatic duct stent reduces pancreatic fistula: a meta-analysis and systematic review.

    Science.gov (United States)

    Patel, Krishen; Teta, Anthony; Sukharamwala, Prashant; Thoens, Jonathan; Szuchmacher, Mauricio; DeVito, Peter

    2014-01-01

    Postoperative pancreatic fistula formation (POPF) remains one of the most common and detrimental complications following pancreaticojejunostomy (PJ). The aim of this meta-analysis is to analyze the efficacy of external pancreatic duct stent placement in preventing POPF formation following PJ. The primary end-point was the incidence of POPF formation following pancreaticoduodenectomy (PD) in the presence and absence of external stent placement. Secondary outcomes examined were the incidence of perioperative mortality, delayed gastric emptying, postoperative wound infection, operative time, blood loss, and length of hospital stay. Four trials were included comprising 416 patients. External pancreatic duct stenting was found to reduce the incidence of both any grade POPF formation (OR 0.37, 95% CI = 0.23 to 0.58, p = 0.0001) and clinically significant (grade B or C) POPF formation (OR 0.50, 95% CI = 0.30 to 0.84, p = 0.0009) following PD. The use of an external stent was also found to significantly lessen length of hospital stay (SMD -0.39, 95% CI = -0.63 to -0.15, p = 0.001). This analysis has shown that external pancreatic duct stenting is indeed efficacious in the incidence of both any grade as well as clinically significant POPF formation following PD. Length of hospital stay was also found to be significantly less by external duct stenting. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Clinical experience in coronary stenting with the Vivant Z Stent.

    Science.gov (United States)

    Chee, K H; Siaw, F S; Chan, C G; Chong, W P; Imran, Z A; Haizal, H K; Azman, W; Tan, K H

    2005-06-01

    This single centre study was designed to demonstrate feasibility, safety and efficacy of the Vivant Z stent (PFM AG, Cologne, Germany). Patients with de novo lesion were recruited. Coronary angioplasty was performed with either direct stenting or after balloon predilatation. Repeated angiogram was performed 6 months later or earlier if clinically indicated. Between January to June 2003, a total of 50 patients were recruited (mean age 55.8 +/- 9 years). A total of 52 lesions were stented successfully. Mean reference diameter was 2.77 mm (+/-0.59 SD, range 2.05-4.39 mm) with mean target lesion stenosis of 65.5% (+/-11.6 SD, range 50.1-93.3%). Forty-six lesions (88.5%) were American College of Cardiologist/American Heart Association class B/C types. Direct stenting was performed in 18 (34.6%) lesions. Mean stent diameter was 3.18 mm (+/-0.41 SD, range 2.5-4 mm), and mean stent length was 14.86 mm (+/-2.72 SD, range 9-18 mm). The procedure was complicated in only one case which involved the loss of side branch with no clinical sequelae. All treated lesions achieved Thrombolysis In Myocardial Infarction 3 flow. Mean residual diameter stenosis was 12.2% (+/-7.55 SD, range 0-22.6%) with acute gain of 1.72 mm (+/-0.50 SD, range 0.5-2.8). At 6 months, there was no major adverse cardiovascular event. Repeated angiography after 6 months showed a restenosis rate of 17% (defined as >50% diameter restenosis). Mean late loss was 0.96 mm (+/-0.48 SD) with loss index of 0.61 (+/-0.38 SD). The restenosis rate of those lesions less than 3.0 mm in diameter was 22.2% compared with 6.25% in those lesions more than 3.0 mm in diameter. The Vivant Z stent was shown to be safe and efficacious with low restenosis rate in de novo coronary artery lesion.

  12. A method to determine the kink resistance of stents and stent delivery systems according to international standards

    Directory of Open Access Journals (Sweden)

    Brandt-Wunderlich Christoph

    2016-09-01

    Full Text Available The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius.

  13. 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.

  14. An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents

    Directory of Open Access Journals (Sweden)

    Jing Lin

    2016-02-01

    Full Text Available Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

  15. 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.

  16. An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents.

    Science.gov (United States)

    Lin, Jing; Guidoin, Robert; Du, Jia; Wang, Lu; Douglas, Graeham; Zhu, Danjie; Nutley, Mark; Perron, Lygia; Zhang, Ze; Douville, Yvan

    2016-02-16

    Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

  17. Long-term results after carotid artery stenting. Restenosis after carotid artery stenting using self-expandable stent

    International Nuclear Information System (INIS)

    Matsumoto, Yasushi; Furui, Eisuke; Tsuboi, Ken; Takahashi, Akira; Ezura, Masayuki

    2008-01-01

    Carotid artery stenting has emerged as an acceptable treatment alternative in patients with carotid artery stenosis. Although early clinical results of carotid artery stenting have shown promise, long, term clinical results remain less certain. We report the frequency, management, and clinical results of in-stent restenosis after carotid artery stenting using a self-expandable stent. Between August 1998 and September 2004, 80 carotid artery stenting procedures in 78 patients were performed. We evaluated 76 of the 80 procedures in 75 of the 78 patients treated during this period who had a minimum 6-month clinical and imaging (ultrasound and/or magnetic resonance angiography) follow-up. Recurrent stenosis (≥50%) after carotid artery stenting occurred in 3 (3.9%) patients. The recurrent stenosis occurred within one year after the procedure in all cases. The low rate of in-stent restenosis using self-expandable stent suggested that carotid artery stenting may be an effective alternative treatment for carotid artery stenosis, but more data of long-term follow-up are required. (author)

  18. Visualizing Elections Using Saari Triangles

    Science.gov (United States)

    Alfaro, Ricardo; Han, Lixing; Schilling, Kenneth; Birgen, Mariah

    2010-01-01

    Students sometimes have difficulty calculating the result of a voting system applied to a particular set of voter preference lists. Saari triangles offer a way to visualize the result of an election and make this calculation easier in the case of several important voting systems.

  19. 2015 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2015-01-01

    Elections Timetable Monday 26 October, at noon Start date for voting Monday 9 November, at noon Closing date for voting Monday 16 and Monday 23 November, publication of the results in Echo Monday 23 and Tuesday 24 November Staff Association Assizes Tuesday 1st December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 16 and 24 November. During its meeting of March 17 2015, the Staff Council approved the election rules, which define the allocation of seats in each department, as follows:   Number of seats in the electoral colleges Departments BE EN TE DG/DGS FP GS HR/PF IT PH Career paths AA - D 2 3 3 1 1 2 1 1 2 Career paths E - G 2 2 2 1 1 1 1 2 3   Global CERN Career paths AA - G 14     Number of seats for fellows representatives Global CERN 5 For more informat...

  20. 2015 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2015-01-01

    Elections Timetable Monday 21 September, at noon Start date for receipt of the application Friday 16 October, at noon Closing date for receipt of the applications Monday 26 October, at noon Start date for voting Monday 9 November, at noon Closing date for voting Monday 16 and Monday 23 November, publication of the results in Echo Monday 23 and Tuesday 24 November Staff Association Assizes Tuesday 1st December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 16 and 24 November. During its meeting of March 17 2015, the Staff Council approved the election rules, which define the allocation of seats in each department, as follows:   Number of seats in the electoral colleges Departments BE EN TE DG/DGS FP GS HR/PF IT PH Career paths AA - D 2 3 3 1 1 2 1 1 2 Career paths E - G 2 2 2 1 1 1 1 2 3   ...

  1. Political Broadcast Advertising and Primary Election Voting

    Science.gov (United States)

    Wanat, John

    1974-01-01

    Results of a research project which hypothisized that: Other things being equal, the heavier a candidate's usage of broadcast advertising in a primary election campaign, the greater will be his share of the votes in the election. (Author/HB)

  2. 5 CFR 1601.13 - Elections.

    Science.gov (United States)

    2010-01-01

    ...Line, or by completing and filing the appropriate paper TSP form with the TSP record keeper in... elections for different sources of contributions; (3) A participant who elects for the first time to invest...

  3. LATTE - Log and Time Tracking for Elections

    Data.gov (United States)

    Office of Personnel Management — LATTE - Log and Time Tracking for Elections is a time tracking and voucher preparation system used to schedule employees to cover elections, to document their time...

  4. Elections and Electoral Tribunal in Nigeria

    African Journals Online (AJOL)

    User

    2011-04-19

    Apr 19, 2011 ... 'pulpits' were angels that may shun the acceptance of gratification to uphold or upturn ..... INEC in the 2007 election, it will be out of place for election tribunal to use .... Democratic theory and practice: The Nigerian experience.

  5. Strengthening Democratic Governance through ICTs : Post Election ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Strengthening Democratic Governance through ICTs : Post Election ... has had several consequences, culminating in the disputed general elections of December 2007. ... Linking research to urban planning at the ICLEI World Congress 2018.

  6. Comparison of a New Polytetrafluoroethylene-Covered Metallic Stent to a Noncovered Stent in Canine Ureters

    International Nuclear Information System (INIS)

    Chung, Hwan-Hoon; Lee, Seung Hwa; Cho, Sung Bum; Park, Hong Suk; Kim, Young Sik; Kang, Byung Chul; Frisoli, Joan K.; Razavi, Mahmood K.

    2008-01-01

    The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first six dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted

  7. MR Angiography of Peripheral Arterial Stents: In Vitro Evaluation of 22 Different Stent Types

    Directory of Open Access Journals (Sweden)

    Matthias C. Burg

    2011-01-01

    Full Text Available Purpose. To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid stents using magnetic resonance angiography in vitro. Materials and Methods. 21 different stents and one stentgraft (10 nitinol, 7 316L, 2 tantalum, 1 cobalt superalloy, 1 PET + cobalt superalloy, and 1 platinum alloy were examined in a vessel phantom (vessel diameters ranging from 5 to 13 mm filled with a solution of Gd-DTPA. Stents were imaged at 1.5 Tesla using a T1-weighted 3D spoiled gradient-echo sequence. Image analysis was performed measuring three categories: Signal intensity in the stent lumen, lumen visibility of the stented lumen, and homogeneity of the stented lumen. The results were classified using a 3-point scale (good, intermediate, and poor results. Results. 7 stents showed good MR lumen visibility (4x nitinol, 2x tantalum, and 1x cobalt superalloy. 9 stents showed intermediate results (5x nitinol, 2x 316L, 1x PET + cobalt superalloy, and 1x platinum alloy and 6 stents showed poor results (1x nitinol, and 5x 316L. Conclusion. Stent lumen visibility varies depending on the stent material and type. Some products show good lumen visibility which may allow the detection of stenoses inside the lumen, while other products cause artifacts which prevent reliable evaluation of the stent lumen with this technique.

  8. Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature

    Science.gov (United States)

    van Halsema, Emo E; van Hooft, Jeanin E

    2015-01-01

    AIM: To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. METHODS: The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. RESULTS: Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave’s syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. CONCLUSION: The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign

  9. Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature.

    Science.gov (United States)

    van Halsema, Emo E; van Hooft, Jeanin E

    2015-02-16

    To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave's syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign esophageal leaks, perforations and

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

    DEFF Research Database (Denmark)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres

    2015-01-01

    AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential...... to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES...... was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition...

  11. Polymeric Biodegradable Stent Insertion in the Esophagus

    Directory of Open Access Journals (Sweden)

    Kai Yang

    2016-04-01

    Full Text Available Esophageal stent insertion has been used as a well-accepted and effective alternative to manage and improve the quality of life for patients diagnosed with esophageal diseases and disorders. Current stents are either permanent or temporary and are fabricated from either metal or plastic. The partially covered self-expanding metal stent (SEMS has a firm anchoring effect and prevent stent migration, however, the hyperplastic tissue reaction cause stent restenosis and make it difficult to remove. A fully covered SEMS and self-expanding plastic stent (SEPS reduced reactive hyperplasia but has a high migration rate. The main advantage that polymeric biodegradable stents (BDSs have over metal or plastic stents is that removal is not require and reduce the need for repeated stent insertion. But the slightly lower radial force of BDS may be its main shortcoming and a post-implant problem. Thus, strengthening support of BDS is a content of the research in the future. BDSs are often temporarily effective in esophageal stricture to relieve dysphagia. In the future, it can be expect that biodegradable drug-eluting stents (DES will be available to treat benign esophageal stricture, perforations or leaks with additional use as palliative modalities for treating malignant esophageal stricture, as the bridge to surgery or to maintain luminal patency during neoadjuvant chemoradiation.

  12. 29 CFR 44.3 - Election process.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Election process. 44.3 Section 44.3 Labor Office of the Secretary of Labor PROCESS FOR ELECTING STATE AGENCY EMPLOYMENT STATISTICS REPRESENTATIVES FOR CONSULTATIONS WITH DEPARTMENT OF LABOR § 44.3