A Prospective Randomized Clinical Trial of Hemodynamic Support with Impella 2.5TM versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: the PROTECT II Study
Background—While coronary artery bypass (CABG) is generally preferred in symptomatic patients with severe, complex multivessel or left main disease, some patients present with clinical features that make CABG clinically unattractive. Percutaneous coronary revascularization (PCI) with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication.
Methods and Results—We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon (IABP) (n=226) or Impella 2.5TM (n=226) support during non-emergent high risk PCI. The primary endpoint was the 30-day incidence of major adverse events (MAE). A 90 day follow-up was required as well by protocol. Impella 2.5 provided superior hemodynamic support compared to IABP, with maximal decrease in cardiac power output from baseline of -0.04 ± 0.24 Watts compared with -0.14 ± 0.27 Watts for IABP (P=0.001). The primary endpoint (30 day MAE) was not statistically different between groups: 35.1% for Impella 2.5 vs. 40.1% for IABP, P=0.227 in the intent-to-treat (ITT) population and 34.3% vs. 42.2%, P=0.092 in the per protocol (PP) population. At 90 days, a strong trend toward decreased MAE was observed in Impella 2.5-supported patients compared to IABP: 40.6% vs 49.3%, P=0.066 in ITT and 40.0% vs 51.0%, P=0.023 in PP populations, respectively.
Conclusions—The 30-day incidence of MAE was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90-days.
Clinical Trial Registration Information—www.clinicaltrials.gov; Identifier: NCT00562016.
- complex coronary artery disease
- intra-aortic balloon pump
- multi-vessel coronary artery disease
- percutaneous left ventricular assist devices
- Received March 7, 2012.
- Accepted August 20, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited