Nine‐month angiographic and 2‐year clinical outcomes of the RECOVERY trial: A randomized study of the biodegradable polymer sirolimus‐eluting COMBO dual‐therapy stent versus a polymer‐free sirolimus‐eluting stent in Chinese patients. (19th February 2021)

• Record Type: Journal Article
• Authors: Tao, Ling; Li, Zhanquan; Yin, Zhiyong; Lin, Wenhua; Liu, Yin; Li, Hui; Yu, Bo; Li, Wei; Xu, Bo
• Other Names: Gao Runlin guestEditor.; Xu Bo guestEditor.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 97(2021)Supplement 2
• Page Start: 966
• Page End: 975
• Publication Date: 2021-02-19
• Subjects: drug‐eluting stent -- percutaneous coronary intervention -- progenitor endothelial cells; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.29553
• Languages: English
• ISSNs: 1522-1946

Abstract

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.