Article (Scientific journals)
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, Adrian et al.
2012In JACC. Cardiovascular Interventions, 5 (1), p. 64-71
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Keywords :
Angioplasty, Balloon, Coronary; Coronary Restenosis/mortality/prevention & control; Databases, Factual; Drug-Eluting Stents/adverse effects/statistics & numerical data; Europe; Female; Health Status Indicators; Humans; Immunosuppressive Agents/therapeutic use; Internationality; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Product Surveillance, Postmarketing; Registries; Sirolimus/therapeutic use; Statistics as Topic
Abstract :
[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
Neumann, Franz-Josef
Nyakern, Maria
Orlick, Amy
Spaulding, Christian
Worthley, Stephen
Urban, Philip M.
More authors (6 more) Less
Language :
English
Title :
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.
Available on ORBi :
since 26 May 2014

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