Study protocol for a multicenter randomized controlled trial comparing standby versus prophylactic extracorporeal membrane oxygenation in high-risk percutaneous coronary intervention (ECMO-READY trial)

Background: Although prophylactic veno-arterial extracorporeal membrane oxygenation (VA-ECMO) may provide hemodynamic stability during high-risk percutaneous coronary intervention (PCI), it is also associated with potential complications and may not be necessary in most cases. In this context, we proposed a pre-cannulated standby ECMO strategy and designed the ECMO-READY trial to evaluate the comparative effectiveness of pre-cannulated standby versus prophylactic ECMO strategies in patients undergoing high-risk PCI. Methods: The ECMO-READY trial is a prospective, multicenter, open-label, randomized controlled trial conducted in 8 sites in China. A total of 176 patients scheduled to undergo high-risk PCI will be randomly assigned in a 1:1 ratio to either a pre-cannulated standby ECMO strategy or a prophylactic ECMO strategy. The primary outcome is the 30-day incidence of major adverse events, including death, myocardial, infarction, repeat revascularization, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy. Secondary outcomes include post-procedural hemoglobin decline, post-procedural platelet count decline, red blood cell transfusion rate, peak post-procedural interleukin-6 level, use of intra-aortic balloon pump, duration of ECMO support, length of hospital stay, hospitalization cost, and each component of the composite primary outcome. Enrollment began in March 2025 and is anticipated to be completed by December 2026. Discussion: The ECMO-READY trial will provide prospective randomized evidence regarding ECMO support strategies in patients undergoing high-risk PCI and may help inform future clinical practice. Trial registration: ClinicalTrials.gov NCT06274411. Registered on February 23, 2024. Keywords Percutaneous coronary intervention, High-risk, Extracorporeal membrane oxygenation, Ready, Standby, prophylactic, Major adverse events