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This Article Figures Only Full Text Full Text (PDF) All Versions of this Article: j.jacc.2005.05.102v1 47/7/1356    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (22) Citing Articles via Google Scholar Google Scholar Articles by Ong, A. T.L. Articles by Serruys, P. W. Search for Related Content PubMed Articles by Ong, A. T.L. Articles by Serruys, P. W.

CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Sirolimus-Eluting Stents Remain Superior to Bare-Metal Stents at Two Years

Medium-Term Results From the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) Registry

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Manuscript received April 7, 2005; revised manuscript received May 12, 2005, accepted May 17, 2005.

^_* Reprint requests and correspondence: Prof. Patrick W. Serruys, Thoraxcenter, Ba-583, Dr. Molewaterplein 40, 3015-GD Rotterdam, the Netherlands. (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: The purpose of this study was to investigate the medium-term (two year) outcome of the unrestricted utilization of sirolimus-eluting stents (SES) in an all-comer population.

BACKGROUND: Despite the implantation of SES in over a million patients to date, limited data exist on long-term outcomes.

METHODS: Sirolimus-eluting stents were used as the default strategy as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. A total of 508 consecutive patients with de novo lesions exclusively treated with SES were compared with 450 patients who received bare stents in the immediately preceding period (pre-SES group).

RESULTS: Patients in the SES group more frequently had multivessel disease, more type C lesions, received more stents, and had more bifurcation stenting. At two years, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target vessel revascularization) was 15.4% in the SES group and 22.0% in the pre-SES group (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.50 to 0.91; p = 0.01). The two-year risk of target vessel revascularization in the SES group and in the pre-SES group was 8.2% and 14.8%, respectively (HR 0.53, 95% CI 0.36 to 0.79; p = 0.002).

CONCLUSIONS: In an unrestricted population, the beneficial effects of sirolimus-eluting stent implantation extend out to two years compared with bare-metal stents, driven by a reduction in re-intervention rates. These findings should be confirmed by the results of the large randomized trials.

Abbreviations and Acronyms   BMS = bare-metal stent   CI = confidence interval   HR = hazard ratio   MACE = major adverse cardiac event   MI = myocardial infarction   RAVEL = Randomized Study With the Sirolimus-Eluting Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions   RESEARCH = Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital   SES = sirolimus-eluting stent   TLR = target lesion revascularization   TVR = target vessel revascularization

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