TY - JOUR
T1 - 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)
AU - Pershad, Ashish
AU - Fraij, Ghassan
AU - Massaro, Joseph M.
AU - David, Shukri W.
AU - Kleiman, Neal S.
AU - Denktas, Ali E.
AU - Wilson, B. Hadley
AU - Dixon, Simon R.
AU - Ohman, E. Magnus
AU - Douglas, Pamela S.
AU - Moses, Jeffrey W.
AU - O'Neill, William W.
N1 - Funding Information:
Drs Pershad, Fraij, David, Denktas, Kleiman, Dixon, and O'Neill have no conflict of interest to report for this study. Dr Massaro reported receiving funding for the study from the Harvard Clinical Research Institute for Biostatistics, Trial Design, and Analyses . Dr Moses reported receiving modest funding for participation in some advisory board meetings and speaking engagement. Dr Douglas reported her institution, the Duke Clinical Research Institute , has received funding for the Echocardiographic Core Laboratory analysis for the PROTECT II study. Dr Ohman reported receiving grants from Daiichi Sankyo , Maquet (formerly Datascope), Abiomed , and Eli Lilly .
Copyright:
Copyright 2017 Medline is the source for the citation and abstract of this record.
PY - 2014/9/1
Y1 - 2014/9/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.amjcard.2014.05.055
DO - 10.1016/j.amjcard.2014.05.055
M3 - Article
C2 - 25037676
AN - SCOPUS:84908386911
VL - 114
SP - 657
EP - 664
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 5
ER -