Comparing Standby Cannulated ECMO and Prophylactic ECMO in Adults Undergoing High-Risk Percutaneous Coronary Intervention

What this Trial Is About

Researchers are comparing two strategies of veno-arterial extracorporeal membrane oxygenation VA-ECMO support during high-risk percutaneous coronary intervention PCI in patients with complex coronary artery disease or severely reduced heart function. The study aims to find out whether standby cannulated ECMO, where ECMO is initiated only if needed, improves outcomes compared to prophylactic ECMO, which is started before PCI. This trial addresses the challenge that ECMO support may cause complications like bleeding or limb ischemia, and some patients may not require ECMO during PCI. Participants will be randomly assigned to one of two groups standby cannulated ECMO or prophylactic ECMO. In the standby group, femoral cannulas are inserted and connected to a primed ECMO circuit with clamps on ECMO support is activated only if hemodynamic instability occurs during PCI. In the prophylactic group, ECMO is initiated immediately after cannula placement before PCI begins to maintain blood pressure and organ perfusion. Both approaches use either percutaneous or surgical insertion of femoral cannulas. During the trial, researchers will monitor participants for 30 days after PCI to track a combined rate of nine major adverse events including death, heart attack, stroke, bleeding, and others. Secondary measures include blood counts, inflammatory markers, duration of ECMO use, hospital stay length, costs, and need for additional heart support devices. The study enrolls adults aged 18 or older scheduled for high-risk PCI, with follow-up assessments to evaluate safety and clinical outcomes.

Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention