When physicians are free to individualize therapy for patients with critical limb ischemia (CLI), the “endovascular-first approach” achieved a noninferior amputation-free survival (AFS) rate compared with bypass surgery, according to an interim analysis of the CRITISCH Registry published in JACC: Cardiovascular Interventions.

The study of 1,200 CLI patients from 27 vascular centers between January 2013 and September 2014 left first-line treatment selection up to the discretion of the responsible physician. Overall, endovascular therapy was applied to 642 patients (54 percent) and bypass surgery to 284 patients (24 percent). Median follow-up time was one year in both groups. The primary composite endpoint was AFS and/or death from any cause. Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted.

Results found one-year AFS was 75 percent in the endovascular group and 72 percent in the bypass surgery group. Researchers noted that the patients receiving endovascular treatment were older and frailer, had greater frequency of chronic kidney disease and usually presented with ischemic lesions of the digits. Bypass surgery was applied more commonly in patients having already had one or more previous vascular interventions. Nonetheless, the noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed, while any impact of the treatment strategy on time until death, major amputation and reintervention and/or above-ankle amputation was not observed.

“This study highlights that when physicians are free to individualize therapy for their CLI patients, they achieved encouraging outcomes with both therapies,” the authors say. “Despite the fact that sicker and higher risk patients were included in the endovascular group, a low early mortality rate as well as a statistically noticeable shorter in-hospital stay compared with bypass surgery were observed.”

Moving forward, the authors suggest further investigation into the most effective treatment for patients with chronic kidney disease – the “most striking risk factor” for both amputation and death, according to the study.

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JACC Cardiovasc Interv 2016;9:2557-65.

Keywords: ACC Publications, Cardiology Interventions, Amputation, Ankle, Ankle Joint, Registries, Survival Rate

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