Five-Year Results Published From the COMPARE II Trial of Terumo's Nobori Biodegradable DES
June 26, 2017—The final 5-year report from the COMPARE II trial of an abluminal biodegradable polymer biolimus-A9–eluting stent (BP-BES) versus a durable polymer everolimus-eluting stent (DP-EES) was published by Georgios J. Vlachojannis, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
The COMPARE II trial was a prospective, randomized, multicenter, all-comers trial composed of 2,707 patients undergoing percutaneous coronary intervention (PCI) who were randomly allocated (2:1) to BP-BES (Nobori, Terumo Interventional Systems), or DP-EES (Xience, Xience-V, Xience-Prime [Abbott Vascular], or Promus [Boston Scientific]). The prespecified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization.
As summarized in JACC: Cardiovascular Interventions, 5-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (P = .26). The rate of the combined safety endpoint of all-cause death or myocardial infarction was 15% in the BP-BES group versus 14.8% in the DP-EES group (P = .9), whereas the efficacy measure of target vessel revascularization was 10.6% versus 9% (P = .18), respectively. The investigators noted that definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs 0.9% for DP-EES; P = 0.17).
The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and midterm results regarding similar safety and efficacy outcomes in this all-comers PCI population, concluded the investigators in JACC: Cardiovascular Interventions.