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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.

Publication ,  Journal Article
O'Neill, WW; Kleiman, NS; Moses, J; Henriques, JPS; Dixon, S; Massaro, J; Palacios, I; Maini, B; Mulukutla, S; Dzavík, V; Popma, J; Ohman, M ...
Published in: Circulation
October 2, 2012

BACKGROUND: Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention 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 pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in comparison with -0.14±0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively. CONCLUSIONS: The 30-day incidence of major adverse events 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: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00562016.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

October 2, 2012

Volume

126

Issue

14

Start / End Page

1717 / 1727

Location

United States

Related Subject Headings

  • Survival Rate
  • Risk Factors
  • Prospective Studies
  • Postoperative Complications
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Intra-Aortic Balloon Pumping
  • Humans
  • Hemodynamics
 

Citation

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O’Neill, W. W., Kleiman, N. S., Moses, J., Henriques, J. P. S., Dixon, S., Massaro, J., … Ohman, M. (2012). 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. Circulation, 126(14), 1717–1727. https://doi.org/10.1161/CIRCULATIONAHA.112.098194
O’Neill, William W., Neal S. Kleiman, Jeffrey Moses, Jose P. S. Henriques, Simon Dixon, Joseph Massaro, Igor Palacios, et al. “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.Circulation 126, no. 14 (October 2, 2012): 1717–27. https://doi.org/10.1161/CIRCULATIONAHA.112.098194.
O’Neill, William W., et al. “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.Circulation, vol. 126, no. 14, Oct. 2012, pp. 1717–27. Pubmed, doi:10.1161/CIRCULATIONAHA.112.098194.
O’Neill WW, Kleiman NS, Moses J, Henriques JPS, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavík V, Popma J, Douglas PS, Ohman M. 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. Circulation. 2012 Oct 2;126(14):1717–1727.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

October 2, 2012

Volume

126

Issue

14

Start / End Page

1717 / 1727

Location

United States

Related Subject Headings

  • Survival Rate
  • Risk Factors
  • Prospective Studies
  • Postoperative Complications
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Intra-Aortic Balloon Pumping
  • Humans
  • Hemodynamics