Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.

Norgren, Lars

Patel, Manesh R

Hiatt, William R

Wojdyla, Daniel M

Fowkes, F Gerry R

Baumgartner, Iris

Mahaffey, Kenneth W

Berger, Jeffrey S

Jones, W Schuyler

Katona, Brian G

Held, Peter

Blomster, Juuso I

Rockhold, Frank W

Björck, Martin

EUCLID Steering Committee and Investigators

2019-10-14T21:15:38Z

2019-10-14T21:15:38Z

2018-01

2019-10-14T21:15:38Z

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.

S1078-5884(17)30673-1

1078-5884

1532-2165

https://hdl.handle.net/10161/19423

eng

Elsevier BV

European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

10.1016/j.ejvs.2017.11.006

EUCLID Steering Committee and Investigators

Lower 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

Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.

Journal article

Patel, Manesh R|0000-0001-6477-9728

Wojdyla, Daniel M|0009-0009-3431-2014

Jones, W Schuyler|0000-0002-7288-9596

Rockhold, Frank W|0000-0003-3732-4765

109

117

1

School of Medicine

Duke

Duke Clinical Research Institute

Institutes and Centers

Population Health Sciences

Basic Science Departments

Medicine, Cardiology

Medicine

Clinical Science Departments

Duke Innovation & Entrepreneurship

Initiatives

Institutes and Provost's Academic Units

Biostatistics & Bioinformatics

Published

55