Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial.

Abstract

BACKGROUND:Lower extremity revascularization (LER) is a common treatment in patients with peripheral artery disease (PAD), but long-term outcomes are poorly defined. OBJECTIVES:The aim was to analyze LER in the EUCLID (Examining Use of tiCagreLor In paD) trial to determine predictors and cardiovascular outcomes. METHODS:Patients were grouped according to whether they received a post-randomization LER (n = 1,738) or not (n = 12,147). All variables were assessed for significance in univariable and parsimonious multivariable models. The primary endpoint was myocardial infarction, ischemic stroke, or cardiovascular death; major adverse limb events (MALE) included acute limb ischemia or major amputation. RESULTS:A post-randomization LER occurred in 12.5% of patients and was an endovascular LER in 74.7%. Endovascular LERs were performed more often in North America, whereas surgical procedures occurred more frequently in Europe. Independent factors predicting LER were prior and type of prior LER, geographic region, limb symptoms, diabetes, and smoking. A post-randomization LER was associated with an increased risk for the primary endpoint (hazard ratio: 1.60; 95% confidence interval: 1.35 to 1.90; p < 0.0001) and MALE (hazard ratio: 12.0; 95% confidence interval: 9.47 to 15.30; p < 0.0001). Event rates for the primary endpoint after LER were numerically higher in the surgical subgroup, but MALE were similar between surgical and endovascular LER. CONCLUSIONS:In the EUCLID trial, LER was most often endovascular. Following LER, there was an increased hazard for the primary endpoint (with higher event rates in the surgical group) and a markedly increased risk for MALE events (with similar event rates between surgical and endovascular LER procedures). (A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease [EUCLID]; NCT01732822).

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Citation

Published Version (Please cite this version)

10.1016/j.jacc.2018.07.046

Publication Info

Baumgartner, Iris, Lars Norgren, F Gerry R Fowkes, Hillary Mulder, Manesh R Patel, Jeffrey S Berger, W Schuyler Jones, Frank W Rockhold, et al. (2018). Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial. Journal of the American College of Cardiology, 72(14). pp. 1563–1572. 10.1016/j.jacc.2018.07.046 Retrieved from https://hdl.handle.net/10161/19419.

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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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