TCT-967 Impella® Protected PCI Outcomes Compared With Intra-Aortic Balloon Pump (IABP) in High-Risk PCI (HRPCI): A Contemporary View
Recommended Citation
Panoulas V, Schreiber T, Tsintzos S, Holy C, Almedhychy A, Moses J, O'Neill WW. TCT-967 Impella® Protected PCI Outcomes Compared With Intra-Aortic Balloon Pump (IABP) in High-Risk PCI (HRPCI): A Contemporary View. J Am Coll Cardiol 2025; 86(17):B413.
Document Type
Conference Proceeding
Publication Date
10-28-2025
Publication Title
J Am Coll Cardiol
Abstract
Background: Traditional trials combine events of varying severity into composites; this may inadequately reflect severity, inherently emphasizes first events, and thus conceals important later signals (particularly in time-to-first-event analytics). Win-Ratio (WR) is a contemporary statistical technique introduced to overcome limitations in reporting composites, and lower sample size needs to demonstrate significance. The Controlled trial of High-Risk Coronary Intervention with Percutaneous Left Ventricular Unloading (CHIP-BCIS3) trial utilizes WR. We analyzed prior trials to compare Impella® Protected PCI to supporting high-risk PCI (HRPCI) with intra-aortic balloon pumps (IABPs), using a WR mimicking the CHIP-BCIS3 definition. Methods: We propensity-matched PROTECT II RCT (P-II) patients with PROTECT III (P-III) Post-Approval Study (PAS) patients who met P-II inclusion criteria to create our Protected PCI cohort. Randomized P-II patients undergoing IABP-supported HRPCI formed the comparator. Major Adverse Cardiac and Cerebrovascular Events (MACCE) in P-II and P-III were independently adjudicated and available fully to 90-days post-PCI. Faithful to CHIP-BCIS3, our WR was defined as follows: Mortality; Stroke; Spontaneous Myocardial Infarction; Re-Hospitalization; and, Peri-Procedural MI. MIs were defined as new Q-waves or CK-MB Elevation ≥8x. All MACCE were analyzed as time-to-event, except Peri-Procedural MIs. Net Benefit (difference between wins and losses, NB) and Win Odds (relative likelihood of winning, WO) are also reported. Results: 719 Protected PCI and 211 IABP HRPCI were included. The WR was 1.691 favoring Impella (95% CI 1.314-2.176, p<0.001*), with NB 0.166 (95% CI 0.084-0.247, p<0.001*) and WO 1.398 (95% CI 1.187-1.645, p<0.001*). Additional reporting can be found in Table 1. [Formula presented] Conclusion: This analysis demonstrates improved Impella Protected PCI outcomes at 90 days, compared to IABP-supported HRPCI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP)
Volume
86
Issue
17
First Page
B413
