Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: A randomized PIPA trial

Objectives : To compare the safety and efficacy of the new Coroflex? Please stents with conventional Taxus? Liberte stents in patients with coronary artery lesions. Background : The Coroflex? Please stent is a new version of paclitaxel‐eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first‐generation stents. However, it has not been directly compared with the early generation paclitaxel‐eluting stents in a multicenter, prospective, and randomized study. Methods : We randomly assigned 319 patients to receive Coroflex? Please stents (159 patients; 198 lesions) or Taxus? Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in‐segment late luminal loss at 9 months. Results : Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex? Please and Taxus? Liberte stents showed similar in‐segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in‐segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow‐up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target‐lesion revascularization (7.5% vs. 7.5%, P = 0.99). Conclusions : The Coroflex? Please stent resulted in similar angiographic and clinical outcomes as the Taxus? Liberte stent in patients with coronary artery lesions. © 2012 Wiley Periodicals, Inc.