Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention

Clinical Snapshot

Key Findings

• P Value: P = 0.30

• Effect Size: Win ratio 0.85 favouring standard care

• Primary Outcome: Hierarchical composite outcome showed no significant difference

• Nnt Or Sensitivity: Number needed to harm approximately 7 patients for one additional death

• Confidence Interval: 95% CI 0.63 to 1.15

Clinical Application

Limited to centres with mechanical circulatory support expertise and resources Relevant to Australian tertiary cardiac centres; device availability through TGA approval required; cost-effectiveness considerations for PBS listing would be unfavourable given lack of benefit Patients with severe LV dysfunction requiring complex PCI in tertiary cardiac centres

Abstract

BACKGROUND: Complex percutaneous coronary intervention (PCI) in patients with severely impaired left ventricular function carries a high risk of death and complications. Whether percutaneous left ventricular unloading improves outcomes remains unclear. METHODS: We randomly assigned 300 patients with severe left ventricular dysfunction and extensive coronary artery disease in a 1:1 ratio to a strategy of elective unloading with a microaxial flow pump or to standard care during planned complex PCI. The primary outcome was a hierarchical composite that included death from any cause, disabling stroke, spontaneous myocardial infarction, hospitalization for cardiovascular causes, or periprocedural myocardial injury at a minimum of 12 months, as analyzed according to a win ratio. RESULTS: A total of 148 patients were assigned to receive a microaxial flow pump and 152 to receive standard care. At a median of 22 months (interquartile range, 16 to 30), 36.6% of pairwise comparisons favored the microaxial flow pump, and 43.0% favored standard care (win ratio, 0.85; 95% confidence interval [CI], 0.63 to 1.15; difference, -6.4 percentage points; P = 0.30). Death from any cause occurred in 47 patients in the microaxial-flow-pump group and 33 in the standard-care group (hazard ratio, 1.54; 95% CI, 0.99 to 2.41). There was no material between-group difference in the risk of bleeding or vascular complications. CONCLUSIONS: Among patients with severely impaired left ventricular function undergoing complex PCI, elective left ventricular unloading with a microaxial flow pump did not reduce the risk of major adverse clinical outcomes at a minimum of 12 months. (Funded by the U.K. National Institute for Health and Care Research; CHIP-BCIS3 ClinicalTrials.gov number, NCT05003817.).

References

1. 1.Perera, D., Ryan, M., Ezad, S. M., Khan, S. Q., Webb, I., O'Kane, P. D., Weerackody, R., Dodd, M., Kwok, M., Laidlaw, L., Van Dyck, L., Wrigley, B., Strange, J. W., Bagnall, A., Fath-Ordoubadi, F., Panoulas, V. F., Ladwiniec, A., Davies, J. R., Chase, A., Owens, C. G., Watkins, S., Rahman, H., Pareek, N., Rathod, K., Rawlins, J., Evans, R., Hoole, S. P., Stables, R. H., Curzen, N., & Clayton, T. (2026). Left ventricular unloading in high-risk percutaneous coronary intervention. *New England Journal of Medicine*. https://doi.org/10.1056/NEJMoa2515704