Am J Cardiol. 2026 Apr 2:S0002-9149(26)00203-1. doi: 10.1016/j.amjcard.2026.03.060. Online ahead of print.
ABSTRACT
Traditional cardiovascular trials combine adverse events into composites, ignoring the clinical importance and weight of endpoints. The Win Ratio ("WR") is a contemporary statistical technique overcoming these limitations. We aimed to evaluate outcomes of high-risk percutaneous coronary intervention supported with Impella® versus intra-aortic balloon pump (IABP), by pooling data from the PROTECT-II and PROTECT-III studies, using the win ratio. All patients from PROTECT-II RCT ("P-II") and patients from PROTECT-III ("P-III") who met P-II inclusion/exclusion criteria were pooled. The WR was based on independently adjudicated major adverse cardiac and cerebrovascular events (MACCE) at 90 days with following hierarchy: (1) Mortality; (2) Stroke; (3) Spontaneous Myocardial Infarction (sMI); 4) Re-Hospitalization; and (5) Peri-Procedural MI (pMI). All MACCE were analyzed as time-to-event outcomes, except pMI (binary endpoint). Sub-analyses included: 1) complex cases: patients with atherectomy or unprotected left main or chronic total occlusion, 2) all patients excluding firsts from P-II ("learning cases"); and 3) Impella P-II and P-III cohorts separately. Win statistics (WR, net benefit (NB), and win odds (WO)) were calculated. The primary analysis (719 Impella and 211 IABP-supported PCI) yielded a WR of 1.691 in favor of Impella (1.314-2.176, p<0.001), with NB of 0.166 (0.084-0.247, p<0.001) and WO of 1.398 (1.187-1.645, p<0.001). The WR, NB and WO for complex cases remained statistically significant in favor of Impella. Excluding first patients resulted in increased win statistics compared to primary analysis. In conclusion, pooled WR analyses from P-II and P-III studies demonstrated improved HRPCI outcomes up to 90 days with Impella compared to IABP.
PMID:41935767 | DOI:10.1016/j.amjcard.2026.03.060