Diabetes, CLI among factors connected to major amputation in PAD
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In an analysis of the EUCLID trial, factors associated with major amputation in peripheral artery disease included diabetes, prior amputation, critical limb ischemia and an ankle-brachial index of less than 0.8.
Healio previously reported on the findings of the EUCLID trial, which compared ticagrelor with clopidogrel for the prevention of atherothrombotic events in patients with PAD.
“EUCLID offers the rare opportunity to study a large global experience of major amputation in a PAD population with almost complete follow-up data and adequate amputation events,” Chandler A. Long, MD, vascular surgeon at Duke University Medical Center, and colleagues wrote. “As a worldwide medical therapy trial, the background surgical care over its course is not dictated by the study and represents the current global state of major amputation in PAD.”
For this analysis, published in Circulation: Cardiovascular Quality and Outcomes, researchers described the incidence of amputations among participants in the EUCLID trial, categorized amputations by the presence of CLI (defined as Rutherford category 4 to 6) and determined the events associated with major amputation.
During a mean follow-up of 30 months, 2.8% of the cohort underwent any type of post-randomization lower-extremity amputation. The rate of major amputation during the trial was 1.6% overall, 8.4% in those with CLI and 1.2% in those without CLI.
The annualized rate for major amputation was 0.6% in the coverall cohort, 3.9% in patients with CLI at and 0.5% in patients without CLI, according to the study.
Amputation factors in EUCLID
Variables associated with elevated risk for major amputation in PAD included prior major amputation (HR = 3.98; 95% CI, 2.62-6.03), prior minor amputation (HR = 2.39; 95% CI, 1.62-3.55), diabetes (HR = 1.92; 95% CI, 1.43-2.57), prior lower-extremity revascularization (HR = 1.78; 95% CI, 1.33-2.39), baseline Rutherford category 4 to 6 (HR = 3.5; 95% CI, 2.47-4.98) and ankle-brachial index (HR for every 0.1 reduction below 0.8 = 1.37; 95% CI, 1.26-1.49).
Amputation in CLI and PAD
Among patients with no CLI at baseline, factors most associated with major amputation included prior major amputation (HR = 6.55; 95% CI, 4.17-10.3), prior minor amputation (HR = 3.39; 95% CI, 2.21-5.22), prior lower-extremity revascularization (HR = 1.97; 95% CI, 1.41-2.76), ankle-brachial index (HR for every 0.1 reduction below 0.8 = 1.45; 95% CI, 1.31-1.59) and diabetes (HR = 1.91; 95% CI, 1.38-2.63).
Statin use was associated with lower risk for major amputation in PAD without CLI (HR = 0.47; 95% CI, 0.34-0.64).
In patients who had CLI at baseline ankle-brachial index (for every 0.1 reduction below 0.8, HR = 1.22; 95% CI, 1.06-1.41) was the only factor associated with increased risk for major amputation.
Mortality and amputation in PAD
After major amputation, the 30-day mortality rate was 6.5% overall, 5.6% among patients with CLI at baseline and 6.8% in patients without CLI.
The annualized rate of mortality after major amputation in PAD was 22.8% in patients with CLI at baseline and 16% in those with no CLI at baseline.
“Mortality over time following major amputation is lower in the EUCLID trial compared with registry data, and statin use appears protective,” the researchers wrote. “The former could be due to trial conduct or merely lower numbers of major amputees to follow than in the registries. The latter finding was not prespecified. The cohort enrolled with symptomatic claudication at baseline who eventually underwent a major amputation is worthy of further study.”
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