A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: The PROTECT II Study

Nov 30, 2012
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Authors:
O’Neill WW, Kleiman NS, Moses J, et al.
Citation:
Circulation 2012;126:1717-1727.
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What is the clinical benefit of using Impella 2.5 versus an intra-aortic balloon pump (IABP) in patients undergoing high-risk nonemergent percutaneous coronary intervention (PCI)?

Methods:

The PROTECT II trial authors randomized 452 symptomatic patients with complex three-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to IABP (n = 226) or Impella 2.5 (n = 226) support during nonemergent high-risk PCI. The primary endpoint was the 30-day incidence of major adverse events.

Results:

Compared with an IABP, Impella 2.5 provided superior hemodynamic support (maximal decrease in cardiac power output from baseline of -0.14 ± 0.27 with IABP versus -0.04 ± 0.24 W with Impella, p = 0.001). There was no difference in the primary endpoint of 30-day major adverse events between the two groups (35.1% for Impella 2.5 vs. 40.1% for IABP, p = 0.227). At 90 days, a trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP(40.6% vs. 49.3%, p = 0.066 in the intent-to-treat population and 40.0% vs. 51.0%, p = 0.023 in the per-protocol population).

Conclusions:

The authors concluded that use of Impella 2.5 was associated with a similar 30-day major adverse event rate compared with an IABP in patients undergoing high-risk PCI.

Perspective:

This randomized study did not find a difference in outcome of patients treated with an IABP versus Impella 2.5 in patients undergoing high-risk PCI. However, there appeared to be divergence of outcome on 90-day follow-up, and there was a suggestion that patients who underwent Impella-supported PCI had better long-term outcome. These findings are similar to what was observed in the BCIS-I study, where patients undergoing IABP-supported PCI did not appear to have a reduction in early events, but longer follow-up suggests a benefit of IABP support.

Keywords: Heart Diseases, Incidence, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Ventricular Function, Left, Cardiac Output, Intra-Aortic Balloon Pumping, Angioplasty, Balloon, Coronary, Hemodynamics, Percutaneous Coronary Intervention


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