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.).
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