The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.
Abizaid, Alexandre; Costa, J. Ribamar Jr; Banning, Adrianet al.
2012 • In JACC. Cardiovascular Interventions, 5 (1), p. 64-71
[en] OBJECTIVES: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. BACKGROUND: There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. METHODS: The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. RESULTS: Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). CONCLUSIONS: Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Abizaid, Alexandre
Costa, J. Ribamar Jr
Banning, Adrian
Bartorelli, Antonio L.
Dzavik, Vladimir
Ellis, Stephen
Gao, Runlin
Holmes, David R. Jr
Jeong, Muyng Ho
Legrand, Victor ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie
The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.
Publication date :
2012
Journal title :
JACC. Cardiovascular Interventions
ISSN :
1936-8798
eISSN :
1876-7605
Publisher :
Elsevier, Netherlands
Volume :
5
Issue :
1
Pages :
64-71
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright (c) 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
F. Alfonso, J.M. Augé, J. Zueco RIBS Investigators Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study J Am Coll Cardiol 46 2005 756 760 (Pubitemid 41224795)
S.W. Lee, S.W. Park, M.K. Hong Comparison of angiographic and clinical outcomes between rotational atherectomy and cutting balloon angioplasty followed by radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis Am Heart J 150 2005 577 582
P. Montorsi, S. Galli, F. Fabbiocchi, D. Trabattoni, P.M. Ravagnani, A.L. Bartorelli Randomized trial of conventional balloon angioplasty versus cutting balloon for in-stent restenosis Acute and 24-hour angiographic and intravascular ultrasound changes and long-term follow-up Ital Heart J 5 2004 271 279
R. Waksman, A.E. Ajani, R.L. White Two-year follow-up after beta and gamma intracoronary radiation therapy for patients with diffuse in-stent restenosis Am J Cardiol 88 2001 425 428 (Pubitemid 32823309)
M.N. Babapulle, L. Joseph, P. Bélisle, J.M. Brophy, M.J. Eisenberg A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents Lancet 364 2004 583 591 (Pubitemid 39094175)
C. Roiron, P. Sanchez, A. Bouzamondo, P. Lechat, G. Montalescot Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart 92 2006 641 649
T.F. Boyden, B.K. Nallamothu, M. Moscucci Meta-analysis of randomized trials of drug-eluting stents versus bare metal stents in patients with diabetes mellitus Am J Cardiol 99 2007 1399 1402 (Pubitemid 46686640)
J.E. Sousa, M.A. Costa, A. Abizaid Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study Circulation 107 2003 24 27 (Pubitemid 36070927)
K. Tanabe, P.W. Serruys, E. Grube Taxus III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation Circulation 107 2003 559 564 (Pubitemid 36176804)
M. Degertekin, E. Regar, K. Tanabe Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience J Am Coll Cardiol 41 2003 184 189 (Pubitemid 36092181)
P. Urban, A. Abizaid, A. Banning, A.L. Bartorelli e-SELECT Investigators Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry J Am Coll Cardiol 57 2011 1445 1454
M.A. Costa, D.I. Simon Molecular basis of restenosis and drug-eluting stents Circulation 111 2005 2257 2273 (Pubitemid 40632443)
M.B. Leon, P.S. Teirstein, J.W. Moses Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting N Engl J Med 344 2001 250 256 (Pubitemid 32108529)
R. Waksman, E. Cheneau, A.E. Ajani Long WRIST Investigators Intracoronary radiation therapy improves the clinical and angiographic outcomes of diffuse in-stent restenotic lesions: results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies Circulation 107 2003 1744 1749 (Pubitemid 36418354)
R. Waksman, A.E. Ajani, R.L. White Two-year follow-up after beta and gamma intracoronary radiation therapy for patients with diffuse in-stent restenosis Am J Cardiol 88 2001 425 428 (Pubitemid 32823309)
F. Feres, J. Munoz, A. Abizaid Angiographic and intravascular ultrasound findings of the late catch-up phenomenon after intracoronary beta-radiation for the treatment of in-stent restenosis J Invasive Cardiol 17 2005 473 477
M. Sabaté, G. Pimentel, C. Prieto Intracoronary brachytherapy after stenting de novo lesions in diabetic patients: results of a randomized intravascular ultrasound study J Am Coll Cardiol 44 2004 520 527 (Pubitemid 39078173)
A. Kastrati, J. Mehilli, N. von Beckerath ISAR-DESIRE Study Investigators Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial JAMA 293 2005 165 171 (Pubitemid 40095867)
F. Alfonso, M.J. Pérez-Vizcayno, R. Hernandez RIBS-I and RIBS-II Investigators Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies Catheter Cardiovasc Interv 72 2008 459 467
D.R. Holmes Jr., P. Teirstein, L. Satler SISR Investigators Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial JAMA 295 2006 1264 1273
G.W. Stone, S.G. Ellis, C.D. O'Shaughnessy TAXUS V ISR Investigators Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial JAMA 295 2006 1253 1263
P.A. Lemos, C.A. van Mieghem, C.A. Arampatzis Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes Circulation 109 2004 2500 2502 (Pubitemid 38720546)
M. Abe, T. Kimura, T. Morimoto j-Cypher Registry Investigators Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: insights from the j-Cypher Registry Circulation 122 2010 42 51
J. Mehilli, R.A. Byrne, K. Tiroch ISAR-DESIRE 2 Investigators Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study J Am Coll Cardiol 55 2010 2710 2716
K.W. Baran, J.M. Lasala, D.A. Cox ARRIVE Investigators A clinical risk score for the prediction of very late stent thrombosis in drug eluting stent patients EuroIntervention 6 2011 949 954
J.R. Costa Jr., A. Sousa, A.C. Moreira Incidence and predictors of very late (> or = 4 years) major cardiac adverse events in the DESIRE (Drug-Eluting Stents in the Real World)-Late registry J Am Coll Cardiol Intv 3 2010 12 18
L.O. Jensen, M. Maeng, P. Thayssen Long-term outcomes after percutaneous coronary intervention in patients with and without diabetes mellitus in Western Denmark Am J Cardiol 105 2010 1513 1519
J. Ribamar Costa, A.G. Sousa, A. Moreira Comparison of the very long term (>1 year) outcomes of drug-eluting stents for the treatment of bare-metal and drug-eluting stent restenosis EuroIntervention 5 2009 448 453