Coronary disease & ACSRandomised controlled trial
Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial
- Randomised controlled trial
- prospective
- multicentre
- open-label
- non-inferiority
Authors' conclusion
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.
Study context
- Population
- Patients with complex three-vessel disease, unprotected left main disease or last patent conduit and left ventricular ejection fraction (LVEF) ≤ 35% undergoing non-emergent high-risk percutaneous coronary intervention (PCI)
- Participants
- 109 vs 113
- Comparison
- Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during high-risk PCI
- SynFlow 3.0n = 109
- VA-ECMOn = 113reference
- Primary endpoint
- Major adverse events:
- All-cause death
- MI
- Stroke/TIA
- Repeat revascularization
- Major bleeding
- Acute kidney injury
- CPR/cardioversion
- Cardiac surgery/limb ischaemia
- Serious device-related complications
- Follow-up
- 30 days
Primary result
As reported in the abstract
Absolute difference
−4.6%
95% CI −12.6% to 3.5%
P < 0.001 for non-inferiority
Events by treatment group
SynFlow 3.0 vs VA-ECMO
absolute difference −4.6% (95% CI −12.6% to 3.5%); P for non-inferiority < 0.001
Further findings
Post-procedural hospital stay
- Post-procedural hospital stay: P = .047
Safety
Device-related adverse events
Anaemia
- Device-related adverse events: P = .041
- Anaemia: P = .023
Original publication
Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial. Eur Heart J. Published 29 July 2026. doi:10.1093/eurheartj/ehag520
Summarised from the published abstract; every number is checked against it