Stroke in Patients With Peripheral Artery Disease.

Abstract

Background and Purpose- Predictors of stroke and transient ischemic attack (TIA) in patients with peripheral artery disease (PAD) are poorly understood. The primary aims of this analysis were to (1) determine the incidence of ischemic/hemorrhagic stroke and TIA in patients with symptomatic PAD, (2) identify predictors of stroke in patients with PAD, and (3) compare the rate of stroke in ticagrelor- and clopidogrel-treated patients. Methods- EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) randomized 13 885 patients with symptomatic PAD to receive monotherapy with ticagrelor or clopidogrel for the prevention of major adverse cardiovascular events (cardiovascular death, myocardial infarction, or ischemic stroke). Ischemic/hemorrhagic stroke and TIA were adjudicated and measured as incidence rates postrandomization and cumulative incidence (per patient-years). Post hoc multivariable competing risk hazards analyses were performed using baseline characteristics to determine factors associated with all-cause stroke in patients with PAD. Results- A total of 458 cerebrovascular events in 424 patients (317 ischemic strokes, 39 hemorrhagic strokes, and 102 TIAs) occurred over a median follow-up of 30 months, for a cumulative incidence of 0.87, 0.11, and 0.27 per 100 patient-years, respectively. Age, prior stroke, prior atrial fibrillation/flutter, diabetes mellitus, geographic region, ankle-brachial index <0.60, prior amputation, and systolic blood pressure were independent baseline factors associated with the occurrence of all-cause stroke. After adjustment for baseline factors, the rates of ischemic stroke and all-cause stroke remained lower in patients treated with ticagrelor as compared with those receiving clopidogrel. There was no significant difference in the incidence of hemorrhagic stroke or TIA between the 2 treatment groups. Conclusions- In patients with symptomatic PAD, ischemic stroke and TIA occur frequently over time. Comorbidities such as age, prior stroke, prior atrial fibrillation/flutter, diabetes mellitus, higher blood pressure, prior amputation, lower ankle-brachial index, and geographic region were each independently associated with the occurrence of all-cause stroke. Use of ticagrelor, as compared with clopidogrel, was associated with a lower adjusted rate of ischemic and all-cause stroke. Further study is needed to optimize medical management and risk reduction of all-cause stroke in patients with PAD. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01732822.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1161/strokeaha.118.023534

Publication Info

Kolls, Brad J, Shelly Sapp, Frank W Rockhold, J Dedrick Jordan, Keith E Dombrowski, F Gerry R Fowkes, Kenneth W Mahaffey, Jeffrey S Berger, et al. (2019). Stroke in Patients With Peripheral Artery Disease. Stroke. p. STROKEAHA118023534. 10.1161/strokeaha.118.023534 Retrieved from https://hdl.handle.net/10161/18590.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Kolls

Bradley Jason Kolls

Associate Professor of Neurology

As a neurointensivist, I am interested in improving our ability to monitor brain function and impact of therapy on our patients in the critical care setting. To this end I am developing new approaches to patient monitoring that will integrate patient physiologic monitoring with brain activity recorded by electroencephalography (EEG). On the basic science side I am interested in the central nervous system's response to injury. Although much attention has been focused on closed head injury as of late, stroke and brain hemorrhage are just as common in the civilian population and pose many of the same clinical challenges as traumatic brain injury. Using mouse models of clinically relevant brain injury, including models of stroke, subarachnoid hemorrhage, lobar hemorrhage, closed head injury and penetrating brain injury, we can explore the key molecular events that lead to edema, secondary brain injury, hyperexcitability and epilepsy, and other sequelae which contribute to poor patient recovery, and significant morbidity following brain injury. By investigating the underlying mechanisms that contribute to these adaptive changes using electrophysiology and molecular biology approaches we can then find ways to prevent them from becoming maladaptive and develop new therapies for our patients with head injuries.

Rockhold

Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics

Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has held faculty appointments at six different universities.    Dr. Rockhold served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently Chair of the Board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.    Frank is widely published in major scientific journals across a wide variety of research topics.

Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.  

Jones

William Schuyler Jones

Professor of Medicine

I am an interventional cardiologist with a specific focus on the diagnosis and treatment of patients with cardiovascular disease. As a clinician, I see patients in the office and do coronary and peripheral vascular procedures (angiography and interventions) in the Duke Cardiac Catheterization Laboratory. I have served as the Medical Director of the cath lab at Duke since 2016. Alongside my partners in the cath lab, we collaborate with our cardiothoracic surgeons to hold Heart Team meetings each week, and we frequently are asked to address complex cardiovascular issues as a multidisciplinary team.

I also have a broad background in cardiovascular site-based research, multicenter clinical trials, clinical event classification, and observational analyses. I have helped to lead clinical trial efforts at the Duke Clinical Research Institute (DCRI) by designing and conducting studies evaluating new and existing treatments for patients with coronary artery disease and peripheral artery disease. My specific research interests include examining access to care and disparities in care for patients with peripheral artery disease and the design and conduct of pragmatic clinical trials in cardiovascular disease.

Patel

Manesh Raman Patel

Richard Sean Stack, M.D. Distinguished Professor

Manesh Patel is the Chief of the Division of Cardiology and the Division of Clinical Pharmacology.  His clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and endovascular intervention.  His is involved in several clinical trials involving patients with cardiovascular disease and in cardiac imaging.  He is also the Chair of the American College of Cardiology Task Force for Appropriate Use Criteria for Cardiovascular Procedures and is Chair of the American Heart Association Diagnostic and Interventional Cath Committee.

Patel's interest in cardiac imaging, quality of care, cardiac devices is also evident in his research.  His integration of these efforts into his roles at Duke was recognized in 2010 when he received the prestigious Duke Cardiology Fellowship Mentor Award.   In 2011, Dr. Patel was named the endowed John Bush Simpson Assistant Professor of Cardiology.  In 2013, Dr. Patel received the Robert M. Califf Faculty clinical research Award.

Currently, Dr. Patel is leading an effort to redesign the delivery of care to patients undergoing invasive catheterization procedures in the health system with a specific aim of measure and providing individualized, patient centered, innovative, and efficient care.


Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.