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.