Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.
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OBJECTIVES:Critical limb ischaemia (CLI) implies an increased risk of cardiovascular morbidity and mortality, and the optimal antithrombotic treatment is not established. DESIGN, MATERIALS, METHODS:The EUCLID trial investigated the effect of monotherapy with ticagrelor versus clopidogrel in 13,885 patients with peripheral artery disease (PAD); the primary endpoint was cardiovascular death, myocardial infarction, or ischaemic stroke. Patients planned for revascularisation or amputation within 3 months, were excluded. This analysis focuses on the subgroup with CLI, defined by rest pain (58.8%), major (9.0%) or minor (32.2%) tissue loss. RESULTS:In EUCLID, 643 patients (4.6%) had CLI at baseline. Diabetes mellitus was more common in the CLI group, while coronary disease, carotid disease, and hypertension were more common in the non-CLI group. A majority of CLI patients (62.1%) had only lower extremity PAD. In patients enrolled on the ankle brachial index (ABI) criteria, ABI was 0.55 ± 0.21 (mean ± SD) for those with CLI versus 0.63 ± 0.15 for those without CLI. The primary efficacy endpoint significantly increased among patients with CLI compared with those without CLI with a rate of 8.85 versus 4.28/100 patient years (adjusted for baseline characteristics hazard ratio [HR] 1.43 [95% CI 1.16-1.76]; p = 0.0009). When acute limb ischaemia requiring hospitalisation was added to the model, significant differences remained (adjusted HR 1.38, [95% CI 1.13-1.69]; p = 0.0016). The 1 year mortality was 8.9%. A trend towards increased lower limb revascularisation among those with CLI was observed. Bleeding (TIMI major, fatal, intracranial) did not differ between those with and without CLI. CONCLUSIONS:Nearly 5% of patients enrolled in EUCLID had CLI at baseline. Milder forms of CLI dominated, a result of the trial design. Patients with CLI had a significantly higher rate of cardiovascular mortality and morbidity versus those without CLI. Further efforts are required to reduce the risk of cardiovascular events in PAD, especially in patients with CLI. CLINICALTRIALS.GOV: NCT01732822.
SubjectEUCLID Steering Committee and Investigators
Vascular Surgical Procedures
Proportional Hazards Models
Peripheral Arterial Disease
Purinergic P2Y Receptor Antagonists
Published Version (Please cite this version)10.1016/j.ejvs.2017.11.006
Publication InfoNorgren, Lars; Patel, Manesh R; Hiatt, William R; Wojdyla, Daniel M; Fowkes, F Gerry R; Baumgartner, Iris; ... EUCLID Steering Committee and Investigators (2018). Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery, 55(1). pp. 109-117. 10.1016/j.ejvs.2017.11.006. Retrieved from https://hdl.handle.net/10161/19423.
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Associate Professor of Medicine
I am an interventional cardiologist with a specific focus on the diagnosis and treatment of patients with vascular disease, and I perform coronary and peripheral angiography and interventions. I have a broad background in cardiovascular site-based research, multicenter clinical trials, clinical event classification, and observational analyses. Currently, I am helping to lead a Duke Clinical Research Institute (DCRI) effort to coordinate a multinational, multicenter randomized clinical tria
Professor of Medicine
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
Professor of Biostatistics & Bioinformatics
Frank is a fulltime Professor of Biostatistics and Bioinformatics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, 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
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