Twelve-month follow-up of complex patients treated with the Xience VTM everolimus drug-eluting stents in daily practice – results of the BRAVO Brazilian Registry

Abstract

Background

The Xience V^TM everolimus-eluting stent is a new generation drug-eluting stent (DES) that incorporates a low profile cobalt-chromium platform (81 μm) and a highly biocompatible polymer (fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience V^TM in the treatment of real-world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol.

Methods

The BRAVO Registry was a prospective, non-randomized, single-arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drug- eluting stent Xience V^TM in Brazilian daily practice.

Results

Overall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C). The mean length and the nominal stent diameter were 19.9 ± 5.3 mm and 3.0 ± 0.4 mm, respectively. The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months.

Conclusions

The drug-eluting stent Xience V^TM demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice.