Rationale and methods of the advanced R2Eperfusion STrategies for refractory cardiac ARREST (ARREST) trial

Abstract Background Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has emerged as a prominent therapy for patients with refractory cardiac arrest. However, optimal time of initiation remains unknown. Aim Assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of-hospital cardiac arrest (OHCA) treated with one of two local standards of care: 1) early VA-ECMO facilitated resuscitation for circulatory support and percutaneous coronary intervention (PCI), when needed, or 2) standard ACLS resuscitation. Materials and Methods. Design Phase II, single center, partially blinded, prospective, intention to treat, safety and efficacy clinical trial. Population Adults (aged 18–75), initial OHCA rhythm of VF/VT, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and transfer time of Setting Hospital-based. Outcomes: Primary Survival to hospital discharge Secondary: Safety, survival and functional assessment at hospital discharge, 3, and 6 months, and cost. Sample size Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of 0.05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients. Conclusions The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation (ECPR), informing broader implementation and a definitive Phase III clinical trial.