Author + information
- Received May 2, 2019
- Revision received November 4, 2019
- Accepted November 19, 2019
- Published online February 3, 2020.
- Connie N. Hess, MD, MHSa,b,∗ (, )@CUMedicalSchool,
- Tracy Y. Wang, MD, MHS, MScc,d,
- Julia Weleski Fu, PhD, MPHe,
- Jacob Gundrum, MSe,
- Nancy M. Allen LaPointe, PharmD, MHSe,
- R. Kevin Rogers, MD, MSca and
- William R. Hiatt, MDa,b
- aDivision of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado
- bCPC Clinical Research, Aurora, Colorado
- cDuke Clinical Research Institute, Durham, North Carolina
- dDivision of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina
- ePremier, Inc., Charlotte, North Carolina
- ↵∗Address for correspondence:
Dr. Connie N. Hess, University of Colorado School of Medicine, 13199 E. Montview Boulevard, Suite 200, Aurora, Colorado 80045.
Background Long-term cardiovascular and limb outcomes after revascularization for peripheral artery disease and, in particular, prognosis after post-procedure major adverse limb events (MALE) are not well-studied.
Objectives This study sought to describe outcomes after peripheral revascularization and assess relationships between post-procedure MALE hospitalization and subsequent events.
Methods Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2015, in the Premier Healthcare Database were examined for the co-primary outcomes of interest, composite myocardial infarction (MI) or stroke and composite major amputation or peripheral revascularization. Multivariable adjusted Cox proportional hazards models with post-procedure MALE hospitalization included as a time-dependent covariate were developed to estimate hazard ratios for outcomes.
Results Among 393,017 revascularized patients followed for a median of 2.7 years (interquartile range: 1.3 to 4.4 years), the cumulative incidence of MI or stroke was 9.8% and that of major amputation or peripheral revascularization was 41.9%. A total of 50,750 patients (12.9%) had at least 1 post-procedure MALE hospitalization. In time-dependent covariate adjusted models, post-procedure MALE hospitalization was associated with greater risk of subsequent MI or stroke (hazard ratio: 1.34; 95% confidence interval: 1.28 to 1.40) and major amputation or peripheral revascularization (hazard ratio: 8.13; 95% confidence interval: 7.96 to 8.29). After peripheral revascularization with or without post-procedure MALE hospitalization, risk of limb events increased rapidly post-procedure and more slowly after the first year, whereas cardiac risk increased steadily during follow-up.
Conclusions Revascularized peripheral artery disease patients face earlier limb and later cardiovascular ischemic risk that is heightened among patients with post-procedure MALE hospitalization. Increased provider awareness of these long-term risks may guide efforts to improve post-procedural outcomes.
Support for this analysis was provided by a research grant from Merck, Kenilworth, New Jersey (to Dr. Hess). The grantor had no role in the conception or design of this analysis, interpretation of the data, or drafting of the manuscript. Dr. Hess has received research funding to CPC Clinical Research from Merck, Bayer, and Amgen. Dr. Wang has received grants to the Duke Clinical Research Institute from AstraZeneca, Bristol-Myers Squibb, Cryolife, Portola, Pfizer, and Regeneron; and has received consulting honoraria from AstraZeneca. Dr. Rogers has served on a clinical events adjudication committee for a Bayer-funded trial. Dr. Hiatt has received grants to CPC Clinical Research from the National Institutes of Health, Bayer, Janssen, Amgen, and Pluristem; and is an employee of the University of Colorado School of Medicine. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 2, 2019.
- Revision received November 4, 2019.
- Accepted November 19, 2019.
- 2020 American College of Cardiology Foundation
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