Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.
Abstract
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.
Type
Journal articleSubject
EUCLID Steering Committee and InvestigatorsLower Extremity
Humans
Hypertension
Ischemia
Ticlopidine
Adenosine
Treatment Outcome
Hospitalization
Vascular Surgical Procedures
Limb Salvage
Incidence
Proportional Hazards Models
Risk Factors
Prospective Studies
Aged
Middle Aged
Female
Male
Stroke
Kaplan-Meier Estimate
Peripheral Arterial Disease
Purinergic P2Y Receptor Antagonists
Clopidogrel
Ticagrelor
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https://hdl.handle.net/10161/19423Published Version (Please cite this version)
10.1016/j.ejvs.2017.11.006Publication Info
Norgren, 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.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.
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Show full item recordScholars@Duke
William Schuyler Jones
Associate 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
Manesh Raman Patel
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
Frank Wesley Rockhold
Professor of Biostatistics & Bioinformatics
Frank is a fulltime 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 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
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