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J Am Coll Cardiol, 2003; 41:2093-2099, doi:10.1016/S0735-1097(03)00429-7 © 2003 by the American College of Cardiology Foundation |
* Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
Manuscript received February 12, 2003; revised manuscript received March 15, 2003, accepted March 20, 2003.
* Reprint requests and correspondence: Prof. Patrick W. Serruys, Thoraxcenter, Bd 406, Dr. Molewaterplein 40, NL-3015 GD Rotterdam, Netherlands.
p.w.j.c.serruys{at}erasmusmc.nl
OBJECTIVES: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES).
BACKGROUND: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown.
METHODS: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention).
RESULTS: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97).
CONCLUSIONS: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.
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