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Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial
Lars Norgren1, Manesh R Patel2, William R Hiatt3
1Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Insights
Critical limb ischaemia (CLI) patients in the EUCLID trial faced higher cardiovascular risks. Further research is needed to improve outcomes for these peripheral artery disease (PAD) patients.
Area of Science:
- Cardiovascular Medicine
- Vascular Surgery
- Clinical Trials
Background:
- Critical limb ischaemia (CLI) is associated with increased cardiovascular morbidity and mortality.
- Optimal antithrombotic treatment strategies for CLI remain undefined.
- Peripheral artery disease (PAD) affects millions globally, with CLI representing its most severe manifestation.
Purpose of the Study:
- To analyze cardiovascular outcomes in patients with CLI within the EUCLID trial.
- To compare the incidence of major adverse cardiovascular events (MACE) in CLI versus non-CLI patients with PAD.
- To evaluate the impact of CLI on mortality and revascularization rates.
Main Methods:
- Analysis of the EUCLID trial subgroup with CLI (n=643) versus non-CLI patients (n=13,242).
- CLI defined by rest pain, major or minor tissue loss.
- Primary endpoint: cardiovascular death, myocardial infarction, or ischaemic stroke. Secondary analysis included acute limb ischaemia and bleeding events.
Main Results:
- CLI patients experienced significantly higher rates of the primary efficacy endpoint (8.85 vs. 4.28 per 100 patient-years; adjusted HR 1.43).
- One-year mortality in the CLI subgroup was 8.9%.
- No significant difference in major bleeding events was observed between CLI and non-CLI groups.
Conclusions:
- Patients with CLI in the EUCLID trial had a substantially higher risk of cardiovascular events and mortality.
- The findings underscore the need for targeted strategies to mitigate cardiovascular risk in PAD patients with CLI.
- Further research is warranted to establish optimal antithrombotic therapies for this high-risk population.
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.
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