Abstract

The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc., Danvers, MA) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared to historical data (PROTECT II) but lacks a direct comparison to the HR-PCI cohort without Impella support. We retrospectively identified patients meeting PROTECT III inclusion criteria for HR-PCI and compared this group (NonIMP) to the outcomes data from the PROTECT III registry (IMP). Baseline differences were balanced using inverse propensity weighting (IPW). The co-primary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 high-risk patients who did not receive Impella support; 200 patients had at 90-day event ascertainment and were included in the IPW analysis and compared with 504 patients in the IMP group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs. 4.8%, p=0.403) but lower in NonIMP at 90 days (7.5% vs. 13.8%, p=0.033). Periprocedural vascular complications, bleeding, and transfusion rate were not different between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs. 5.4%, p=0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort demonstrated similar MACE in-hospital but lower MACE at 90 days, while there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for HR-PCI patients.

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