Percutaneous ventricular assist devices for percutaneous coronary interventions in older patients with heart failure: a target trial emulation

BACKGROUND: Percutaneous ventricular assist devices (pVAD) have been increasingly used to support haemodynamics during percutaneous coronary interventions (PCI). Since older patients with coronary artery disease and heart failure (HF) are less likely to undergo open heart surgery, given the higher risk of perioperative complications, the analyses on the benefits of pVAD for older patients with HF receiving PCI will be informative. METHODS: We included Medicare fee-for-service beneficiaries aged 65-99 years with systolic HF receiving PCI from 2017 to 2020. Using a target trial emulation framework, we followed the patients from the date of the index PCI to the maximum of 1 year and examined the incidence of major adverse cardiovascular events (MACE: composite of all-cause mortality, HF readmission, acute myocardial infarction, and stroke), as well as in-hospital outcomes, including postprocedural transfusions, of patients treated with PCI plus pVAD versus PCI plus intra-aortic balloon pump (IABP). We used the propensity score matching approach to control for 58 baseline covariates and applied a Cox regression model to estimate adjusted hazard ratio (aHR). RESULTS: We included 5823 patients, from whom 2096 patients were matched. The risk of 1-year MACE was 55.4% (95% CI 52.2-58.5) in the pVAD group versus 54.7% (95% CI 51.4 to 57.8) in the IABP group, with aHR of 0.95 (95% CI 0.83 to 1.10). We did not find evidence that other outcomes differed between patients treated with PCI plus pVAD versus PCI plus IABP, including 1-year mortality (aHR, 0.94; 95% CI,0.79 to 1.12) and postprocedural transfusions (adjusted risk ratio, 1.07; 95% CI 0.75 to 1.52). Our findings were consistent across several sensitivity analyses. CONCLUSIONS: This observational study using the Medicare databases in the USA did not find evidence that clinical outcomes differed between older patients with systolic HF receiving PCI with pVAD vs PCI plus IABP.