Author + information
- Received March 9, 2011
- Revision received September 1, 2011
- Accepted September 7, 2011
- Published online January 1, 2012.
- Alexandre Abizaid, MD, PhD⁎,⁎ (, )
- J. Ribamar Costa Jr, MD⁎,
- Adrian Banning, MD†,
- Antonio L. Bartorelli, MD‡,
- Vladimir Dzavik, MD§,
- Stephen Ellis, MD∥,
- Runlin Gao, MD, PhD#,
- David R. Holmes Jr, MD¶,
- Muyng Ho Jeong, MD, PhD⁎⁎,
- Victor Legrand, MD††,
- Franz-Josef Neumann, MD§§,
- Maria Nyakern, PhD‡‡,
- Amy Orlick, MPH‡‡,
- Christian Spaulding, MD∥∥,
- Stephen Worthley, MD¶¶,
- Philip M. Urban, MD##,
- e-SELECT Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Alexandre Abizaid, Instituto Danta Pazzanese de Cardiologia, Department of Interventional Cardiology, Av. Dante Pazzanese 500, Ibirapuera, CEP 04012-909, São Paulo, Brazil
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.
Dr. Banning has received research funding from Boston Scientific and Cordis Corporation. Dr. Bartorelli is a member of the scientific advisory board of Abbott Vascular. Dr. Dzavik is a consultant for Abbott Vascular and has received educational funds from Cordis Corporation. Dr. Legrand is a consultant for Cordis Corporation and a member of the scientific advisory board of Abbott Vascular, and has a consultancy agreement with Johnson & Johnson. Dr. Nyakern is a salaried consultant for Cordis Corporation, Johnson and Johnson. Ms. Orlick is an employee of Cordis Corporation. Dr. Spaulding has received research funding from Cordis Corporation, Abbott Vascular, Stentys, and Eli Lilly; has received speaker fees from Cordis Corporation, Eli Lilly, Pfizer Inc.; was on the scientific advisory board of Cordis Corporation; and has been a full-time employee of Cordis Corporation since July 1, 2010. Dr. Urban is a consultant for Cordis Corporation, Johnson & Johnson and for Biosensors International, and received speaker fees from Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 9, 2011.
- Revision received September 1, 2011.
- Accepted September 7, 2011.
- American College of Cardiology Foundation