Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump） for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction. Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled. The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy. This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.
The subject is aged ≥18 years;
The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction <35%;
After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
The subject has signed an informed consent form approved by the ethics committee, has good compliance after discharge, and is willing to undergo clinical follow-up.
Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
Patients with cardiogenic shock or hemodynamic instability;
Parallel
Microaxial pump-supported PCI
DeviceUse CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients
Optimal medical therapy (OMT)
DrugGuideline-directed OMT will be determined by the heart failure team at each center. OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities. Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat.
1-year MACCE
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
Perioperative myocardial infarction
Types 3, 4, and 5 bleeding as defined by MCS-ARC
Severe hemolysis related to the device
Stent thrombosis
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