OBJECTIVESWe investigated the efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected patients. BACKGROUND Both SES and PES have been separately shown to be efficacious when compared to bare stents. In unselected patients, no direct comparison between the two devices has been performed.
METHODSPaclitaxel-eluting stents have been used as the stent of choice for all percutaneous coronary interventions in the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry. A total of 576 consecutive patients with de novo coronary artery disease exclusively treated with PES were compared with 508 patients treated with SES from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.
RESULTSThe PES patients were more frequently male, more frequently treated for acute myocardial infarction, had longer total stent lengths, and more frequently received glycoprotein IIb/IIIa inhibitors. At one year, the raw cumulative incidence of major adverse cardiac events was 13.9% in the PES group and 10.5% in the SES group (unadjusted hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.95 to 1.88, p ϭ 0.1). Correction for differences in the two groups resulted in an adjusted HR of 1.16 (95% CI 0.81 to 1.64, p ϭ 0.4, using significant univariate variables) and an adjusted HR of 1.20 (95% CI 0.85 to 1.70, p ϭ 0.3, using independent predictors). The one-year cumulative incidence of clinically driven target vessel revascularization was 5.4% versus 3.7%, respectively (HR 1.38, 95% CI 0.79 to 2.43, p ϭ 0.3). CONCLUSIONS The universal use of PES in an unrestricted setting is safe and is associated with a similar adjusted outcome compared to SES. The inferior trend in crude outcome seen in PES was due to its higher-risk population. A larger, randomized study enrolling an unselected population may assist in determining the relative superiority of either device. (J Am Coll Cardiol 2005;45:1135-41) © 2005 by the American College of Cardiology FoundationSirolimus-eluting stents (SES, Cypher, Cordis, Johnson and Johnson, Miami Lakes, Florida) (1) and paclitaxeleluting stents (PES, TAXUS, Boston Scientific Corp., Natick, Massachusetts) (2) have both been independently shown to reduce the need for repeat intervention when compared to bare-metal stents (BMS) in separate randomized clinical trials. The Food and Drug Administration approvals for these devices were granted in 2003 and 2004, respectively, and it is estimated that drug-eluting stents (DES) currently comprise 70% of the stent market in the U.S. The randomized controlled trials on which approval was granted enrolled highly selected patients with single lesions that could be covered with one DES and were compared against BMS which is not representative of daily clinical practice. Our group has previously published the results of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry, which demonstrated that routine impla...