Clinical outcomes of different first- and second-generation drug-eluting stents in routine clinical practice: results from the prospective multicenter German DES.DE registry.

BACKGROUND: Second-generation drug-eluting stents (DES) have provided better results over both bare-metal stents and first-generation DES. However, comparative data of different first- and second-generation DES in a clinical setting of all-comers have not been well studied.

METHODS AND RESULTS: Baseline clinical and angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events (MACCE), as well as target vessel revascularization (TVR) was used as the primary end point. Between May 2007 and May 2009, 10,852 patients subjected to drug-eluting stent implantation were enrolled at 74 sites. 3,032 patients (27.9 %) were treated with Taxus™, 4,382 (40.4 %) with Cypher™, 1,012 (9.3 %) with Endeavor™, 1,693 (15.6 %) with Xience V™ and 733 (6.8 %) with Promus™ during this period. At 1-year follow-up, the comparison between groups revealed no significant differences with respect to overall death, MACCE, definite stent thrombosis, TVR, stroke and major bleeding. After adjustment for risk factors in final regression models, a modestly significant association of DES type to MACCE was observed (p = 0.046); however, this association could not be attributed to one particular DES. An impact of DES type on TVR was not seen after risk adjustment.

CONCLUSION: Data generated from the prospective German drug-eluting stent (DES.DE) registry confirm that safety and efficacy of different first- and second-generation DES are clinically equivalent in the first year of follow-up, even in a more complex setting.