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LATE-BREAKING CLINICAL TRIAL

Does Addition of Estradiol Improve the Efficacy of a Rapamycin-Eluting Stent?

Results of the ISAR-PEACE Randomized Trial

Deutsches Herzzentrum, Technische Universtität, Munich, Germany.

Manuscript received February 12, 2007; accepted February 16, 2007.

^_* Reprint requests and correspondence: Dr. Julinda Mehilli, Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany. (Email: mehilli{at}dhm.mhn.de).

Objectives: This study aimed to assess the efficacy of a rapamycin plus 17-ß-estradiol–eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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 [ClinicalTrials.gov] )

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   ERES = estradiol plus rapamycin-eluting stent(s)   IVUS = intravascular ultrasound   PCI = percutaneous coronary intervention   RES = rapamycin-eluting stent(s)

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