title: 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.
abstract: 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.
  
  
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00562016.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Leonard M Miller School of Medicine, 1600 NW 10th Ave, Miami, FL 33156, USA. WONEILL1@hfhs.org
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Moses
authors.forename: Jose P S
authors.initials: JP
authors.lastname: Henriques
authors.forename: Simon
authors.initials: S
authors.lastname: Dixon
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.forename: Igor
authors.initials: I
authors.lastname: Palacios
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.forename: Suresh
authors.initials: S
authors.lastname: Mulukutla
authors.forename: Vladimír
authors.initials: V
authors.lastname: Dzavík
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.forename: Magnus
authors.initials: M
authors.lastname: Ohman
mesh_terms: D000368:Aged; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends