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 (2018). Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial. European journal of vascular and endovascular surgery EJVES, 55(1), pp. 109-117. Elsevier 10.1016/j.ejvs.2017.11.006

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Baumgartner, Iris

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1078-5884

Publisher:

Elsevier

Language:

English

Submitter:

Catherine Gut

Date Deposited:

06 Apr 2018 13:30

Last Modified:

26 Oct 2019 22:22

Publisher DOI:

10.1016/j.ejvs.2017.11.006

PubMed ID:

29273390

Uncontrolled Keywords:

Antithrombotic treatment Critical limb ischaemia Demographics Medical history Trial data

BORIS DOI:

10.7892/boris.108854

URI:

https://boris.unibe.ch/id/eprint/108854

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