Author + information
- Received March 15, 2018
- Revision received May 24, 2018
- Accepted June 13, 2018
- Published online August 20, 2018.
- Connie N. Hess, MD, MHSa,b,∗ (, )@CUMedicalSchool,
- R. Kevin Rogers, MD, MSca,
- Tracy Y. Wang, MD, MHS, MScc,d,
- Rao Fu, PhD, MPHe,
- Jacob Gundrum, MSe,
- Nancy M. Allen LaPointe, PharmD, MHSd,e 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
- cDivision of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina
- dDuke Clinical Research Institute, Durham, North Carolina
- ePremier, Charlotte, North Carolina
- ↵∗Address for correspondence:
Dr. Connie N. Hess, 13199 East Montview Boulevard, Suite 200, Aurora, Colorado 80045.
Background Revascularization is important for symptom treatment and limb salvage in peripheral artery disease, yet little data exist on the incidence of post-procedure major adverse limb events (MALE) and longer-term outcomes.
Objectives This study sought to characterize hospitalizations and outpatient endovascular revascularizations after peripheral artery revascularization, assess temporal trends for outcomes, and identify factors associated with subsequent MALE hospitalization.
Methods Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2014, in the Premier Healthcare Database were examined for the primary outcome of 1-year MALE hospitalization. Secondary outcomes included 1-year outpatient endovascular revascularization and limb-related, cardiovascular, and all-cause inpatient hospitalizations. Multivariable logistic regression was used to identify factors associated with 1-year MALE hospitalization.
Results Among 381,415 revascularized patients, within 1 year post-index revascularization, 10.3% (n = 10,182) had a hospitalization for MALE, 11.0% (n = 42,056) had an outpatient endovascular revascularization, 18.8% (n = 71,663) had a limb-related hospitalization, 12.8% (n = 48,875) had a cardiovascular hospitalization, and 38.9% (n = 148,457) had any inpatient hospitalization. Over the study period, limb-related, cardiovascular, and all-cause hospitalizations decreased, whereas rates of outpatient endovascular revascularizations increased. Male sex, black race, Medicare and Medicaid insurance, diabetes, renal insufficiency, heart failure, smoking, baseline critical or acute limb ischemia, surgical revascularization, and noncardiology operator specialty were significantly associated with increased risk of MALE hospitalization.
Conclusions In contemporary practice, hospitalization for MALE occurs in 1 in 10 patients within 1 year after peripheral revascularization and is associated with patient and procedural factors. These data may inform efforts to improve post-procedure outcomes and limb-related clinical trial design.
Funding for this analysis was provided by a research grant from Merck (to Dr. Hess). The sponsor 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 Bayer and Merck. Dr. Rogers has served on the clinical events adjudication committee for the VOYAGER trial, sponsored by Bayer and run through CPC Clinical Research; and on the steering committee of the LIBERTY study, sponsored by CSI. Dr. Wang has received research grants to the Duke Clinical Research Institute from AstraZeneca, Boston Scientific, Bristol-Myers Squibb, CryoLife, Daiichi-Sankyo, Eli Lilly, Gilead Sciences, Novartis, Pfizer, and Regeneron; and has served as a consultant to or received honoraria from Merck, Gilead Sciences, and Pfizer. Dr. Hiatt has received grant support to CPC Clinical Research from the National Institutes of Health, Bayer, Janssen, and Pluristem. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 15, 2018.
- Revision received May 24, 2018.
- Accepted June 13, 2018.
- 2018 American College of Cardiology Foundation