Impella Protected Percutaneous Coronary Intervention Outcomes Compared With Intra-aortic Balloon Pump: A Contemporary View.

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, by pooling data from the PROTECT-II and PROTECT-III studies, using the WR. 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 at 90 days with following hierarchy: (1) mortality; (2) stroke; (3) spontaneous myocardial infarction; (4) rehospitalization; and (5) peri-procedural myocardial infarction. All major adverse cardiac and cerebrovascular events were analyzed as time-to-event outcomes, except peri-procedural myocardial infarction (binary endpoint). Sub-analyzes 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, and win odds) were calculated. The primary analysis (719 Impella and 211 intra-aortic balloon pump-supported PCI) yielded a WR of 1.691 in favor of Impella (1.314 to 2.176, p < 0.001), with net benefit of 0.166 (0.084 to 0.247, p < 0.001) and win odds of 1.398 (1.187 to 1.645, p < 0.001). The WR, net benefit and win odds 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 analyzes from P-II and P-III studies demonstrated improved high risk PCI outcomes up to 90 days with Impella compared to intra-aortic balloon pump.