Does addition of estradiol improve the efficacy of a rapamycin-eluting stent? Results of the ISAR-PEACE randomized trial.

Abstract

This study aimed to assess the efficacy of a rapamycin plus 17-beta-estradiol-eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease. Estradiol promotes rapid re-endothelialization of coronary stents in animal models, but it is not known whether combining this drug with rapamycin represents an improved drug-eluting stent technology in terms of reduced lumen renarrowing. In this randomized study, we enrolled 502 patients with de novo lesions in native coronary arteries who were randomly assigned to receive either a polymer-free, estradiol plus rapamycin-eluting stent (ERES) (n = 252) or a polymer-free, rapamycin-eluting stent (RES) (n = 250). The primary end point was in-stent late lumen loss in the follow-up angiography. Secondary end points were binary angiographic restenosis, target lesion revascularization, combined incidence of death and myocardial infarction, and incidence of stent thrombosis during 1 year after randomization. The study was designed to test for the superiority of the ERES compared with the RES with respect to in-stent late lumen loss. Late lumen loss (0.52 +/- 0.58 mm vs. 0.51 +/- 0.58 mm, p = 0.83), the incidence of binary angiographic restenosis (17.6% vs. 16.9%, p = 0.85), the incidence of target lesion revascularization (14.3% vs. 13.2%, p = 0.72), the combined incidence of death and myocardial infarction (7.9% vs. 8.0%, p = 0.98), and the incidence of stent thrombosis (0.8% vs. 1.2%, p = 0.99) were not significantly different between the ERES group and the RES group. No apparent beneficial effect is obtained by adding estradiol to a polymer-free rapamycin-eluting stent during the first year after the procedure. (The ISAR-PEACE trial; http://clinicaltrials.gov/ct/show/NCT00402636?order=1; NCT00402636).