title: Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial.
abstract: OBJECTIVE
  To evaluate the efficacy of hemodynamic support using Impella 2.5 (IR2.5) vs intra-aortic balloon pump (IABP) in patients with 3-vessel coronary artery disease (3VD).
  
  
  BACKGROUND
  PROTECT II demonstrated favorable 90-day outcomes in patients with impaired LVEF and left main or 3VD undergoing PCI with hemodynamic support with IR2.5 compared to IABP. It is unclear if this was due to a specific benefit in a patient sub-population and if certain patients may derive particular benefit from PCI with IR2.5 support.
  
  
  METHODS
  Patients in PROTECT II were stratified upon enrollment into the left main/last patent vessel or 3VD subgroups and randomized to IR2.5 or IABP within those groups. Patients in the 3VD substratum were required to have LVEF ≤30%.
  
  
  RESULTS
  Among the 3VD subgroup (n = 325 patients; IR2.5 167, IABP 158) patients were well matched, except for prior heart failure or CABG, which were more common in the IR2.5 group (both P ≤ 0.01). Mean number of lesions treated was 3.0 ± 1.5 vs. 2.9 ± 1.4 (P = 0.61). At 30 days after PCI, patients that received IR2.5 compared to IABP support trended toward a reduction in incidence of major adverse events (MAE): 32.9% vs. 42.4% (P = 0.078). At 90 days after PCI, there was a significant difference favoring IR2.5 for incidence of MAE: 39.5% vs. 51.0% (P = 0.039), with this effect being consistent across multiple clinical subgroups. Use of IR2.5 was an independent predictor of improved 90-day outcomes.
  
  
  CONCLUSIONS
  Patients with 3VD and reduced LVEF show improved outcomes when PCI is performed with IR2.5 hemodynamic support.
authors.affiliation: Mount Sinai Medical Centre, New York, New York, USA.
authors.forename: Jason C
authors.initials: JC
authors.lastname: Kovacic
authors.forename: Annapoorna
authors.initials: A
authors.lastname: Kini
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Samin K
authors.initials: SK
authors.lastname: Sharma
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000628:therapy*; D005260:Female; D006353:Heart-Assist Devices; D006801:Humans; D007423:Intra-Aortic Balloon Pumping; D008297:Male; D063868:Patient Outcome Assessment; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011446:Prospective Studies; D013318:Stroke Volume; D018487:Ventricular Dysfunction, Left / Q000628:therapy