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Randomized Controlled Trial
. 2025 May 6;14(9):e038509.
doi: 10.1161/JAHA.124.038509. Epub 2025 Apr 16.

Characteristics and Outcomes of Older Patients Undergoing Protected Percutaneous Coronary Intervention With Impella

Philipp Jakob  1 , Alexandra J Lansky  2 , Mir B Basir  3 , Michael J Schonning  4 , Batla Falah  4 , Zhipeng Zhou  4 , Wayne B Batchelor  5 , Arsalan Abu-Much  4 , Cindy L Grines  6 , William W O'Neill  3 , Barbara E Stähli  1
Affiliations
Randomized Controlled Trial

Characteristics and Outcomes of Older Patients Undergoing Protected Percutaneous Coronary Intervention With Impella

Philipp Jakob et al. J Am Heart Assoc. .

Abstract

Background: In patients undergoing high-risk percutaneous coronary intervention, Impella has become an important adjunctive tool to support revascularization. The impact of age on the outcomes of patients undergoing high-risk percutaneous coronary intervention is limited. The aim of this study is to describe the characteristics and outcomes of patients ≥75 years of age undergoing Impella-supported high-risk percutaneous coronary intervention.

Methods and results: Baseline characteristics and outcomes of patients ≥75 years of age versus those of patients <75 years of age in patients enrolled in the cVAD PROTECT III (Catheter-Based Ventricular Assist Device Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump in Patients Undergoing Non Emergent High Risk Percutaneous Coronary Intervention) study (NCT04136392). Major adverse cardiovascular and cerebral events (composite of all-cause death, nonfatal myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) were assessed at 30 and 90 days and all-cause death at 1 year. Out of 1237 patients, 493 (39.9%) patients were ≥75 years of age. Patients ≥75 years of age had less diabetes and prior myocardial infarction, more hypertension and dyslipidemia, worse renal function, more severe valvular heart disease, but higher left ventricular ejection fraction (P<0.05 for all comparisons). Baseline Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores were similar between groups. Older patients underwent more left main percutaneous coronary intervention (58% versus 39%; P<0.0001), atherectomy (32% versus 22%; P<0.0001), and femoral access (87% versus 79%, P=0.0003) as compared with younger patients. In-hospital vascular complications did not differ, but rates of respiratory failure, pericardial tamponade, and cardiogenic shock were higher in older patients. Rates of all-cause death and major adverse cardiovascular and cerebral events did not differ between groups at 30 and 90 days. Rates of all-cause death at 1 year were higher in patients ≥75 years (adjusted hazard ratio, 1.99 [95% CI, 1.24-3.18], P=0.004).

Conclusions: Impella-supported high-risk percutaneous coronary intervention in older patients is feasible with an acceptable safety profile. However, age ≥75 years remained a statistically significant predictor for all-cause death at 1 year.

Registration: URL: https://clinicaltrials.gov; Unique Identifier: NCT04136392.

Keywords: PROTECT III; age differences; all‐cause mortality; high‐risk percutaneous coronary intervention; major adverse cardiovascular and cerebrovascular events.

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Conflict of interest statement

Dr Lansky has received speaker fees from Abiomed. Dr Basir reports consultant/speaker fees from Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Dr Batchelor has received speaker honoraria from Boston Scientific, Abbott Medical, and Medtronic. Dr Grines reports participation on the advisory boards for Philips and Abiomed. Dr O'Neill reports grant/research support from St Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitralign. Dr Stähli and her research has been supported by a donation of H.H. Sheikh Khalifa bin Hamad Al‐Thani to the University of Zurich, Switzerland; investigator sponsored research received at the University of Zurich from Boston Scientific and Edwards Lifesciences; research grant support received at the University of Zurich from the OPO Foundation, the Iten‐Kohaut Foundation, the German Center for Cardiovascular Research, the German Heart Research Foundation, and the B. Braun Foundation; speaker fees from Boston Scientific, Abbott Vascular, and MedAlliance; and is a Steering Committee Member of the Cruz Senior study (SMT). All other coauthors have no relevant disclosures.

Figures

Figure 1
Figure 1. Kaplan–Meier event rates at 30 da stratified by age (
MACCE is the composite of all‐cause death, myocardial infarction, stroke/TIA, and repeat revascularization. MACCE indicates major adverse cardiac and cerebrovascular events; and TIA, transient ischemic attack.
Figure 2
Figure 2. Kaplan–Meier event rates at 90 days stratified by age (
MACCE is the composite of all‐cause death, myocardial infarction, stroke/TIA, and repeat revascularization. MACCE indicates major adverse cardiac and cerebrovascular events; and TIA, transient ischemic attack.
Figure 3
Figure 3. Kaplan–Meier event rates through 1 year stratified by age (
*Multivariable adjustment for estimated glomerular filtration rate, left ventricular ejection fraction, left main percutaneous coronary intervention, and pre‐percutaneous coronary intervention SYNTAX score. HR indicates hazard ratio.
See this image and copyright information in PMC

Comment in

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