Efficacy and Safety of CorVad System in Coronary Intervention for Complex High‐Risk and Indicated Patients

BACKGROUND: Due to the heightened risks and complications associated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in complex high-risk and indicated patients (CHIPs), percutaneous ventricular assist system during PCI might offer a novel alternative. AIMS: We aimed to evaluate the efficacy and safety of the CorVad percutaneous ventricular assist system in CHIPs. METHODS: One hundred and eighteen CHIPs with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled for CorVad support during elective PCI. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) including death, new myocardial infarction, stroke, and target vessel revascularization at 30 days. Performance goal (PG) was set at 22.5%. Additionally, patients underwent CABG in Fuwai Hospital with LVEF ≤ 40% were selected as historical controls. RESULTS: In the intention to treat (ITT) cohort, there were five MACCE (4.2%, 95% CI 1.4%-9.6%) within 30 days, achieving the prespecified PG. The CorVad system was successfully implanted in all patients. Compared with baseline, the LVEF had a significant increase in 48 h (30.95 ± 4.84% vs. 35.96 ± 5.84%, p < 0.001) and 30 days after PCI (30.95 ± 4.84% vs. 39.78 ± 7.82%, p < 0.001). No patient had evidence of hemolysis after PCI. Compared with CABG historical controls, there were no significant differences in the incidence of MACCE at 30 days (after propensity score matching PSM: 3.8% vs. 1.3%, p = 0.341) and 90 days (after PSM: 3.8% vs. 1.3%, p = 0.307). CONCLUSIONS: The CorVad percutaneous ventricular assist system is safe and effective in assisting CHIPs-PCI.