Long-Term Clinical Outcomes and Thrombosis Rates of Sirolimus- Eluting Versus Paclitaxel-Eluting Stents in an Unselected Population With Coronary Artery Disease (REWARDS Registry) Ron Waksman, MD*, Ashesh N. Buch, MBChB, MRCP, Rebecca Torguson, BS, Zhenyi Xue, MS, Kimberly Smith, BS, Aamir Javaid, MBBS, William W. Chu, MD, PhD, Lowell F. Satler, MD, Kenneth M. Kent, MD, PhD, and Augusto D. Pichard, MD Sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) significantly decrease the need for repeat interventions compared with bare metal stents. Comparative outcome data from randomized, controlled, head-to-head trials using these systems in a selected group of patients and lesions are conflicting; therefore, we compared clinical outcomes of unselected patients who underwent contemporary percutaneous coronary intervention with SES or PES implantation. In the REWARDS registry, 1-year clinical outcomes of 1,925 patients who received SESs were compared with 844 patients who received PESs. Out- comes at 30 days and 6 months were similar between groups, with a trend toward higher rates of stent thrombosis in the SES group compared with the PES group. Stent thrombosis rate at 12 months was significantly higher in the SES than in the PES group, with cumulative stent thrombosis rates of 1.9% in the SES group and 0.8% in the PES group (p  0.034). However, overall rates of major adverse cardiac events (MACEs) were similar in the 2 groups at 12 months. After adjusting for significant multivariate predictors of MACEs, the hazard ratio at 1 year was 1.06 (95% confidence interval 0.85 to 1.33, p  0.607) and the major predictors for MACEs were a history of renal failure, diabetes, previous myocardial infarction, cardiogenic shock, class III or IV heart failure, type C lesions, and saphenous vein grafts. In conclusion, use of SESs and PESs in unrestricted, contemporary practice had comparable outcomes in terms of low rates of revascularization and clinical events. Stent thrombosis continues to be a major concern for SESs and PESs. © 2007 Elsevier Inc. All rights reserved. (Am J Cardiol 2007;100:45–51) Drug-eluting stents significantly decrease rates of resteno- sis-driven target lesion revascularization and target vessel revascularization compared with bare metal stents. 1–6 The sirolimus-eluting stent (SES; Cypher, Johnson & Johnson Cordis, Miami, Florida) and the paclitaxel-eluting stent (PES; Taxus, Boston Scientific, Natick, Massachusetts) are the 2 drug-eluting stents most extensively studied thus far. These stents are associated with the need for repeat revas- cularization compared with bare metal stents but questions about safety remain, specifically regarding the incidence of late stent thrombosis. 7,8 These 2 systems differ in stent design, polymer, and drug properties. These differences raise the question of whether there are fundamental differ- ences between these 2 stent systems when used for contem- porary percutaneous coronary intervention. Over the previ- ous 2 years several randomized studies have been conducted to address the question of superiority of 1 system over the other. These studies deepen the debate regarding the relative efficacies of these 2 drug-eluting stents. 9 –16 Methods Patient population: All consecutive patients who pre- sented with coronary artery disease and had drug-eluting stent implantation at our institution have had their demo- graphic, clinical, and procedural data entered into the Reg- istry Experience at the WAshington hospital centeR with Drug-eluting Stents (REWARDS) databases starting in April 2003 for SESs and March 2004 for PESs. We ana- lyzed and compared the registry data of 1,925 patients who had SESs implanted and had completed 1-year clinical follow-up with records of 844 patients who had PESs im- planted and also had 1-year clinical follow-up. This study was conducted under the approval of the local independent review board. Procedure and postprocedural care: More than 20 at- tending interventionalists use the cardiac catheterization fa- cilities at our institution and data are derived from percuta- neous coronary intervention procedures performed by all. Contemporary percutaneous coronary intervention was per- formed according to guidelines current at the time of im- plantation. In all cases, the interventional strategy, including the use of direct stenting, before/after dilatation, intravas- cular ultrasound, choice of periprocedural adjunctive anti- platelet therapy, and use of ablative devices was at the discretion of the responsible physician. Angiographic suc- cess was defined as stenosis 30% with a Thrombolysis In Division of Cardiology, Washington Hospital Center, Washington, DC. Manuscript received October 31, 2006; revised manuscript received and accepted February 6, 2007. *Corresponding author: Tel: 202-877-2812; fax: 202-877-2715. E-mail address: ron.waksman@medstar.net (R. Waksman). 0002-9149/07/$ – see front matter © 2007 Elsevier Inc. All rights reserved. www.AJConline.org doi:10.1016/j.amjcard.2007.02.051