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

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ID: 322862
2026
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Abstract
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.
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Authors Gang Zhao, Shanshan Zhou, Zheyan Fang, Jianying Ma, Feng Tian, Dan Song, Chengyi Xu, Zuyi Yuan, Ning Guo, Lin Zhao, Tao Zhang, Jingping Wang, Jingyi Liu, Yi‐Ning Yang, Xiaolin Yu, Yan Li, Dongwei Zhang, Chuanyu Gao, Famin Ye, Cheng Zhang, Jianmin Yang, Jiancheng Xiu, Qiancheng Wang, Bo Luan, Jianhong Tao, Ming Bai, Renqiang Yang, Yansong Guo, Yan Wang, Min Dai, Jianan Wang, Juying Qian, Yundai Chen, Junbo Ge
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Journal european heart journal
Year 2026
DOI
10.1093/eurheartj/ehag520
URL
https://doi.org/10.1093/eurheartj/ehag520
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