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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
452
Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients
Guideline-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.
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
1-year MACCE
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
Time frame: Up to 1 year after enrollment
Perioperative myocardial infarction
Time frame: Up to 48h after the index PCI procedure
Types 3, 4, and 5 bleeding as defined by MCS-ARC
Time frame: Up to 1 year after enrollment
Severe hemolysis related to the device
Time frame: Up to 72 hours after the implantation of the CorVad left ventricular assist system
Stent thrombosis
Time frame: Up to 1 year after the index PCI procedure
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