The Mega combo collaboration: an individual patient data pooled analysis of patients undergoing PCI with combo stent

ABSTRACT

BACKGROUND COMBO (OrbusNeich Medical) is a dual-therapy coro nary stent featuring sirolimus as the antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collabora tion aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI) METHODS Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry, and MASCOT studies were pooled together. The primary end point was 1-year target lesion fail ure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). Event rates were estimated with the Kaplan-Meier method. Predictors of TLF were obtained from multi variate Cox regression, with stepwise selection of candidate variables RESULTS A total of 6,753 patients (median age » 64 years, 23% women) were included. Baseline characteristics are summarized in Figure 1A. At 1 year, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and ID-TLR were 1.3%, 1.8%, and 2.5%, respectively. Independent predictors for TLF are reported in Figure 1B. CONCLUSION This large patient-level pooled analysis provides a comprehensive overview of the safety and efficacy of the dual-ther apy COMBO stent. The rate of TLF observed at 1 year was low, making this stent technology a potential alternative to other contemporary drug-eluting stent platforms.