Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial

Abstract

Aims: We performed a multicenter, randomized controlled trial to determine the noninferiority of a novel biodegradable polymer drug-eluting stent (BP-DES), the EXCEL 2 stent, to the first-generation BP-DES, the EXCEL stent.

Methods and results: Patients (n = 419) scheduled to undergo percutaneous coronary intervention (PCI) were randomized to receive either the EXCEL 2 stent (n = 208) or the EXCEL stent (n = 211) from 15 Chinese centers. At 9 months, primary endpoint in-stent late loss (LL) difference was -0.03 mm (95% confidence interval: -0.09 mm to 0.04 mm) between the EXCEL 2 group (0.14 ± 0.26 mm) and the EXCEL group (0.16 ± 0.36 mm), demonstrating the noninferiority of EXCEL 2 to EXCEL in terms of in-stent LL (P for noninferiority < .0001). Besides, target lesion failure (TLF) was statistically lower in EXCEL 2 group compared with EXCEL through 1 year (HR [95%CI] = 0.45 [0.20,0.98], P_log-rank = .04). Definite/probable ST was observed in 0.0% vs 1.9% (P = .12) of EXCEL 2 vs EXCEL-treated subjects.

Conclusions: The second-generation BP-DES (EXCEL 2) was noninferior to the first-generation BP-DES (EXCEL) for the primary endpoint of in-stent LL at 9 months. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02057978.

Keywords: biodegradable-polymer; drug-eluting stent; interventional cardiology; randomized trial.