In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP). During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter. There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients. The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
262
The microaxial flow pump (The CorVad percutaneous ventricular assist system device) is a microaxial rotary blood pump that expels blood from the left ventricle into the ascending aorta, thus unloading the left ventricle. The CorVad system device can be introduced through a femoral percutaneous approach (14Fr) and can deliver an output of up to 4-6 L/min.
Veno-arterial extracorporeal Membrane Oxygenation (VA-ECMO) is a device originally created to replace heart and lung function. Venous deoxygenated blood is mechanically suctioned from a large central vein through a venous cannula by a centrifugal pump. It is then oxygenated, warmed, and restored into systemic circulation through an arterial cannula.
Ling Tao
Xi'an, Shannxi, China
Major adverse event
Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation
Time frame: 1 month
All-cause death
Time frame: 1, 3, 12, 24, 36, and 60 months
Stroke
Time frame: 1, 3, 12, 24, 36, and 60 months
Myocardial infarction
Time frame: 1, 3, 12, 24, 36, and 60 months
Revascularization
Time frame: 1, 3, 12, 24, 36, and 60 months
Cardiovascular hospitalization
Rehospitalization due to cardiovascular reasons
Time frame: 1, 3, 12, 24, 36, and 60 months
MCS-ARC defined type 3, 4, 5 bleeding
Bleeding is defined by the "Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium" (MRC-ARC)
Time frame: 1 month
Acute kidney injury
Time frame: 1 month
Serious device-related adverse events
Including but not limited to cardiac structural impairment, severe limb ischemia (pale, pulseless, and necrotic), infection, aortic and aortic valve impairment, hemolysis, peri-procedural complications that cause death, permanent/severe disability to the subject, or significantly prolonged hospital stay or need for surgical intervention
Time frame: 1 month
Cardiopulmonary resuscitation
Time frame: 1 month
Hospitalization time
Time frame: 1 month
Intensive care unit (ICU/CCU) stay time
Time frame: 1 month
ECMO/Corvad utilization time
Time frame: 1 month
Hemodynamic disorder
Hemodynamic disorder is defined as average arterial pressure (MAP) below 60 mmHg for more than 10 minutes with the requirement of additional vasoactive medications
Time frame: 1 month
Transfusion rate
Transfusion rate is defined as patients who had transfusion / all enrolled patients.
Time frame: 1 month
Units of transfusion
Time frame: 1 month
Major adverse event
Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation
Time frame: 3, 12, 24, 36, and 60 months
Major Adverse Cardiovascular and Cerebrovascular Events
Major Adverse Cardiovascular and Cerebrovascular Events is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization
Time frame: 1, 3, 12, 24, 36, and 60 months
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