Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial

Abstract

<jats:p> In patients with symptomatic peripheral artery disease (PAD), the impact of chronic kidney disease (CKD) on major adverse cardiovascular events has not been fully evaluated. The Examining Use of Ticagrelor In PAD (EUCLID) trial randomized 13,885 patients with PAD to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. This post hoc analysis compared the incidence of the primary composite endpoint (cardiovascular death, myocardial infarction (MI), or ischemic stroke) in patients with CKD (eGFR < 60 mL/min/1.73 m<jats:sup>2</jats:sup>) with those without CKD (eGFR ⩾ 60 mL/min/1.73 m<jats:sup>2</jats:sup>). The primary safety endpoint was thrombolysis in MI (TIMI) major bleeding. A total of 13,483 patients were included; 3332 (25%) had CKD, of whom 237 had stage 4/5 disease. Median follow-up was approximately 30 months. After statistical adjustment, patients with CKD had a higher rate of the primary endpoint compared with those without CKD (6.75 vs 3.72 events/100 patient-years; adjusted hazard ratio (HR) 1.45, 95% CI 1.30–1.63). CKD was not associated with increased risk of hospitalization for acute limb ischemia (ALI) (adjusted HR 0.96, 95% CI 0.69–1.34) or major amputation (adjusted HR 0.92, 95% CI 0.66–1.28). CKD was not associated with a significantly increased risk of major bleeding (adjusted HR 1.21, 95% CI 0.89–1.64), but minor bleeding was significantly increased (adjusted HR 1.51, 95% CI 1.07–2.15). In conclusion, patients with PAD and CKD had higher rates of cardiovascular death, MI, and ischemic stroke, but similar rates of ALI, major amputation, and TIMI major bleeding when compared with patients without CKD. ClinicalTrials.gov Identifier: NCT01732822 </jats:p>

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Published Version (Please cite this version)

10.1177/1358863x19864172

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Hopley, Charles W, Sarah Kavanagh, Manesh R Patel, Cara Ostrom, Iris Baumgartner, Jeffrey S Berger, Juuso I Blomster, F Gerry R Fowkes, et al. (n.d.). Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vascular Medicine. pp. 1358863X1986417–1358863X1986417. 10.1177/1358863x19864172 Retrieved from https://hdl.handle.net/10161/19116.

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Scholars@Duke

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.

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.  


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