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Patients with peripheral artery disease (PAD) in the lower extremities experienced more adverse events if they required revascularization, according to researchers.

A post hoc analysis of the EUCLID trial showed that 12.5% of participants got a lower-extremity surgical or endovascular revascularization over a 2-year period, reported William Hiatt, MD, of the University of Colorado School of Medicine in Aurora, and collaborators in the Oct. 2 issue of the .

This group also had greater combined risk of MI, ischemic stroke, and cardiovascular death (HR 1.60, 95% CI 1.35-1.90) as well as major adverse limb events (MALEs) in the form of acute limb ischemia or major amputation (HR 12.0, 95% CI 9.47-15.30) in that 2-year period.

"Whether these increased risks are directly related to the intervention, reflect a high-risk group, or both remains to be determined," they said, noting the possibility of unmeasured confounding of this post-hoc analysis.

The main finding from EUCLID -- primarily designed to compare ticagrelor (Brilinta) and clopidogrel (Plavix) in PAD patients (n=13,885) -- was that ticagrelor was no better than clopidogrel at preventing events. The sole perceivable advantage to the more potent antiplatelet was that it brought ischemic strokes down.

Three-quarters of post-randomization revascularizations were performed as endovascular procedures, which compared to surgery were associated with numerically fewer primary endpoint events (but no fewer MALEs).

Those who entered the EUCLID trial based on a history of prior lower-extremity revascularization were more likely to get the minimally invasive procedure, whereas those enrolled based on ankle-brachial index/toe-brachial index criteria tended to undergo surgery instead.

The predictors of revascularization after randomization to ticagrelor or clopidogrel were classical risk factors such as smoking (HR 1.26, 95% CI 1.09-1.45) and diabetes (HR 1.28, 95% CI 1.16-1.41) -- factors that paled in comparison to prior lower-extremity revascularization:

• Surgical and endovascular: HR 3.99, 95% CI 3.42-4.66
• Endovascular only: HR 2.56, 95% CI 2.25-2.92
• Surgical only: HR 1.65, 95% CI 1.40-1.94

"Now, the EUCLID trial shows that LER [lower-extremity revascularization] will perhaps also increase risk of future LER," wrote Gregory Moneta, MD, of Oregon Health & Science University in Portland, in an accompanying editorial.

He noted that the initial revascularization may have been elective for claudication or required for limb salvage in chronic limb-threatening ischemia. In any case, he critiqued the study for not analyzing indications for revascularizations at baseline or following randomization.

The message for patients who need lower-extremity revascularization for limb salvage, Moneta suggested, was stop smoking, control diabetes, take statin and antiplatelet medications, and realize that surgical or endovascular revascularization procedures for limb salvage means that possible future interventions may be needed.

As for those with intermittent claudication, he said, the message is similar: stop smoking, control diabetes, take statin and antiplatelet medications, walk, and maybe stay out of the operating room or catheterization laboratory. "Patients with asymptomatic PAD and intermittent claudication must understand that their PAD does not pose a significant risk of amputation, making intervention not needed to save their limb."

Hiatt and colleagues found regional differences in the choice of lower-extremity revascularization, namely a preference for endovascular procedures in North America compared with surgery in Europe and Central/South America.

It is a sign of "a problem of our moral and societal responsibility with respect to intervention for PAD," Moneta said, suggesting that these regional differences "potentially indicat[e] reimbursement as a consideration in PAD management."