title: Comparison of the use of hemodynamic support in patients ≥80 years versus patients <80 years during high-risk percutaneous coronary interventions (from the Multicenter PROTECT II Randomized Study).
abstract: The outcomes of hemodynamic support during high-risk percutaneous coronary intervention in the very elderly are unknown. We sought to compare outcomes between the patients ≥80 years versus patients <80 years enrolled in the PROTECT II (Prospective Randomized Clinical Trial of Hemodynamic Support with the Impella 2.5 versus Intra-Aortic Balloon Pump in Patients undergoing High Risk Percutaneous Coronary Intervention) randomized trial. Patients who underwent high-risk percutaneous coronary intervention with an unprotected left main or last patent conduit and a left ventricular ejection fraction ≤35% or with 3-vessel disease and a left ventricular ejection fraction ≤30% were randomized to receive an intra-aortic balloon pump or the Impella 2.5; 90-day (or the longest follow-up) outcomes were compared between patients ≥80 years (n = 59) and patients <80 years (n = 368). At 90 days, the composite end point of major adverse events and major adverse cerebral and cardiac events were similar between patients ≥80 and <80 years (45.6% vs 44.1%, p = 0.823, and 23.7% vs 26.8%, p = 0.622, respectively). There were no differences in death, stroke, or myocardial infarction rates between the 2 groups, but fewer repeat revascularization procedures were required in patients ≥80 years (1.7% vs 10.4%, p = 0.032). Bleeding and vascular complication rates were low and comparable between the 2 age groups (3.4% vs 2.4%, p = 0.671, and 6.8% vs 5.4%, p = 0.677, respectively). Multivariate analysis confirmed that age was not an independent predictor of major adverse events (odds ratio = 1.031, 95% confidence interval 0.459-2.315, p = 0.941), whereas Impella 2.5 was an independent predictor for improved outcomes irrespective of age (odds ratio = 0.601, 95% confidence interval 0.391-0.923, p = 0.020). In conclusion, the use of percutaneous circulatory support is reasonable and feasible in a selected octogenarian population with similar outcomes as those of younger selected patients. Irrespective of age, the use of Impella 2.5 was an independent predictor of favorable outcomes.
authors.affiliation: Cavanagh Heart Center, Banner Good Samaritan Medical Center, Phoenix, Arizona. Electronic address: ashish.pershad@bannerhealth.com.
authors.forename: Ashish
authors.initials: A
authors.lastname: Pershad
authors.affiliation: Cavanagh Heart Center, Banner Good Samaritan Medical Center, Phoenix, Arizona.
authors.forename: Ghassan
authors.initials: G
authors.lastname: Fraij
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.affiliation: Providence Hospital and Medical Center, Southfield, Michigan.
authors.forename: Shukri W
authors.initials: SW
authors.lastname: David
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: University of Texas Memorial Hermann Health Science Center, Houston, Texas.
authors.forename: Ali E
authors.initials: AE
authors.lastname: Denktas
authors.affiliation: Carolina Medical Center, Charlotte, North Carolina.
authors.forename: B Hadley
authors.initials: BH
authors.lastname: Wilson
authors.affiliation: Beaumont Hospital, Royal Oak, Michigan.
authors.forename: Simon R
authors.initials: SR
authors.lastname: Dixon
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Columbia University Medical Center New York Presbyterian Hospital, New York, New York.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: Henry Ford Medical Center, Detroit, Michigan.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada / Q000453:epidemiology; D003324:Coronary Artery Disease / Q000503:physiopathology / Q000601:surgery*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D015994:Incidence; D007423:Intra-Aortic Balloon Pumping / Q000379:methods*; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D012086:Reoperation / Q000706:statistics & numerical data; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016277:Ventricular Function, Left / Q000502:physiology*