Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial.

BACKGROUND AND AIMS: The efficacy of prophylactic mechanical circulatory support with micro-axial flow pump or veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with severely reduced left ventricular ejection fraction (LVEF) undergoing high-risk percutaneous coronary intervention (PCI) remains unclear.

METHODS

Patients with complex three-vessel disease, unprotected left main coronary disease or last patent conduit and LVEF ≤ 35% were assigned to receive either a micro-axial flow pump (SynFlow 3.0) or VA-ECMO support during a non-emergent high-risk PCI procedure in this prospective, multicentre, randomized, open-label, non-inferiority trial. The primary endpoint was the incidence of 30-day major adverse events, defined as any of: all-cause death, myocardial infarction, stroke/transient ischaemic attack, repeat revascularization, major bleeding, acute kidney injury, cardiopulmonary resuscitation/cardioversion, cardiac surgery/limb ischaemia, or serious device-related complications. Safety endpoints included adverse events and serious adverse events.

RESULTS

The primary endpoint, 30-day major adverse events, occurred in 8 of 109 patients (7.34%) in the SynFlow 3.0 group and 13 of 113 patients (11.5%) in the VA-ECMO group (absolute difference adjusted for centre effect, -4.6%; 95% confidence interval, -12.6% to 3.5%; P for non-inferiority < .001). Patients with SynFlow 3.0 had shorter post-procedural hospital stay (4.1 days vs 5.2 days on average, P = .047) and fewer device-related adverse events (3.7% vs 11.5%; P = .041). Anaemia occurred more often with VA-ECMO than with SynFlow 3.0 (20.4% vs 9.2%; P = .023).

CONCLUSIONS

The prophylactic use of a micro-axial flow pump during high-risk PCI procedures was non-inferior to VA-ECMO in the incidence of 30-day major adverse events. The use of a micro-axial flow pump was associated with shorter post-procedural hospital stay and fewer device-related adverse events.