WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.
Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.
The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.
The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.