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

Abstract

Objectives: To compare the safety and efficacy of the new Coroflex (TM) Please stents with conventional Taxus (TM) Liberte stents in patients with coronary artery lesions. Background: The Coroflex (TM) 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 (TM) Please stents (159 patients; 198 lesions) or Taxus (TM) 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 (TM) Please and Taxus (TM) 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 (TM) Please stent resulted in similar angiographic and clinical outcomes as the Taxus (TM) Liberte stent in patients with coronary artery lesions. (c) 2012 Wiley Periodicals, Inc.