Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial.
Gang Zhao, Shanshan Zhou, Zheyan Fang et al.
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In 30 seconds
This prospective, multicentre, randomised, open-label non-inferiority trial compared prophylactic SynFlow 3.0 micro-axial flow pump support with VA-ECMO during non-emergent high-risk PCI in patients with complex coronary disease and LVEF ≤ 35%. At 30 days, major adverse events occurred in 8 of 109 patients (7.34%) with the pump and 13 of 113 (11.5%) with VA-ECMO; the pump met the trial’s non-inferiority criterion (P for non-inferiority < .001). Pump support was also associated with shorter post-procedural hospital stay and fewer device-related adverse events.
Key findings
- Thirty-day major adverse events occurred in 7.34% with SynFlow 3.0 and 11.5% with VA-ECMO; non-inferiority was demonstrated (P for non-inferiority < .001).
- Average post-procedural hospital stay was 4.1 days with SynFlow 3.0 versus 5.2 days with VA-ECMO (P = .047).
- Device-related adverse events were 3.7% with SynFlow 3.0 and 11.5% with VA-ECMO (P = .041).
- Anaemia occurred in 9.2% with SynFlow 3.0 versus 20.4% with VA-ECMO (P = .023).
Why it matters
For patients with severely reduced LVEF undergoing complex, non-emergent high-risk PCI, the choice of prophylactic circulatory support may affect short-term complications and recovery. This trial found the micro-axial pump non-inferior to VA-ECMO for 30-day major adverse events, with shorter hospital stay and fewer device-related adverse events, providing comparative evidence to inform support-device discussions.
What to keep in mind
The trial was open-label, and the reported comparison concerns 30-day outcomes in patients undergoing non-emergent high-risk PCI; longer-term outcomes are not provided in the abstract.