- Question
- Does elective percutaneous left ventricular unloading with a microaxial flow pump improve clinical outcomes in patients with severe left ventricular dysfunction undergoing complex, high-risk percutaneous coronary intervention (PCI)?
- Design
- Randomized 1:1, open-label (no masking), phase 3 trial of 300 patients, funded by the U.K. NIHR. Median follow-up was 22 months (interquartile range, 16 to 30), with a minimum of 12 months.
- Population
- Patients with severe left ventricular dysfunction and extensive coronary artery disease scheduled for complex PCI.
- Intervention
- A strategy of elective unloading with a microaxial flow pump (percutaneous left ventricular assist device) inserted at the start of the procedure before PCI, with maximal support during the procedure and subsequent weaning (148 patients).
- Control
- Planned complex PCI with standard care and no elective left ventricular unloading; other mechanical circulatory support could be used if needed (152 patients).
- Primary outcome
- Hierarchical composite of death from any cause, disabling stroke, spontaneous myocardial infarction, hospitalization for cardiovascular causes, and periprocedural myocardial injury, analyzed with a win ratio at a minimum of 12 months.
- Results
- 36.6% of pairwise comparisons favored the microaxial flow pump and 43.0% favored standard care (win ratio, 0.85; 95% CI, 0.63 to 1.15; difference, -6.4 percentage points; P = 0.30). Death from any cause occurred in 47 patients in the pump group and 33 in the standard-care group (HR 1.54; 95% CI, 0.99 to 2.41).
- Safety
- There was no material between-group difference in the risk of bleeding or vascular complications.
- Conclusion
- In patients with severe left ventricular dysfunction undergoing complex PCI, elective unloading with a microaxial flow pump did not reduce the risk of major adverse clinical outcomes at a minimum of 12 months.
- Why it matters
- It challenges routine use of elective mechanical circulatory support in high-risk PCI and suggests that systematic use has no demonstrated clinical benefit in this setting.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026