Nine‐monthangiographic and2‐yearclinical outcomes of theRECOVERYtrial: A randomized study of the biodegradable polymersirolimus‐eluting COMBO dual‐therapystent versus apolymer‐free sirolimus‐elutingstent in Chinese patients

Abstract Objectives We evaluated the safety and efficacy of the novel dual‐therapy sirolimus‐eluting and endothelial progenitor cell (EPC) capture COMBO stent. Background (Very) late stent thrombosis (ST) and neo‐atherosclerosis limit the performance of drug‐eluting stents. The capture of EPCs accelerates stent re‐endothelialization, thereby potentially decreasing the risk of restenosis and ST. Methods In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer‐free sirolimus‐eluting stent (n = 220). The primary endpoint was the 9‐month angiographic in‐segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient‐oriented composite endpoint (PoCE), and ST. Results At 9 months, the COMBO in‐segment LLL (0.29 ± 0.46 mm) was non‐inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; p non‐inferiority < .0001). Clinical outcomes were also similar between the COMBO and Nano stents, with TLF rates of 9.3% and 7.9% ( p = .61) at 12 months, and 9.4% and 8.0% ( p = .62) at 24 months, respectively. The PoCE rate was 14.8% and 10.6% ( p = .19) at 12 months, and 16.0% and 11.3% ( p = .16) at 24 months, respectively. Ischemia‐driven target lesion revascularization rates were 6.0% and 3.7% ( p = .26) at 12 months, and 6.2% and 3.8% ( p = .26) at 24 months, respectively. No case of ST occurred in either group. Conclusions The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non‐inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.