Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.
- Norgren L Faculty of Medicine and Health, Örebro University, Örebro, Sweden. Electronic address: Lars.Norgren@regionorebrolan.se.
- Patel MR Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
- Hiatt WR University of Colorado School of Medicine and CPC Clinical Research, Aurora, CO, USA.
- Wojdyla DM Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
- Fowkes FGR Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
- Baumgartner I Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland.
- Mahaffey KW Stanford Centre for Clinical Research, Stanford University School of Medicine, Stanford, CA, USA.
- Berger JS Department of Medicine, Department of Surgery, New York University School of Medicine, New York, NY, USA.
- Jones WS Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
- Katona BG AstraZeneca Gaithersburg, Gaithersburg, MD, USA.
- Held P AstraZeneca Gothenburg, Mölndal, Sweden.
- Blomster JI AstraZeneca Gothenburg, Mölndal, Sweden.
- Rockhold FW Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
- Björck M Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University, Uppsala, Sweden.
- 2017-12-24
Published in:
- European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - 2018
Antithrombotic treatment
Critical limb ischaemia
Demographics
Medical history
Trial data
Adenosine
Aged
Clopidogrel
Female
Hospitalization
Humans
Hypertension
Incidence
Ischemia
Kaplan-Meier Estimate
Limb Salvage
Lower Extremity
Male
Middle Aged
Peripheral Arterial Disease
Proportional Hazards Models
Prospective Studies
Purinergic P2Y Receptor Antagonists
Risk Factors
Stroke
Ticagrelor
Ticlopidine
Treatment Outcome
Vascular Surgical Procedures
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.ejvs.2017.11.006
- PMID 29273390
- Persistent URL
- https://sonar.ch/global/documents/58197
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