4:12 PM Abstract No. 50 Quality of life outcomes from a randomized controlled trial comparing drug-eluting balloon to conventional balloon angioplasty for below-the-knee arteries in patients with critical limb ischemia

Abstract

To report the quality of life (QOL) results of a randomized controlled trial comparing drug-eluting balloon (DEB) to conventional balloon (CB) angioplasty for below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI). In this investigator-initiated, dual center, blinded, randomized controlled trial (NCT02129634), 138 patients (93 males) with mean age of 62.6 years (std = 9.9), were randomized to either DEB (n = 70) or CB angioplasty (n = 68). 94.2% of the patients had diabetes and 52.9% had end-stage renal failure (ESRF). QOL measured with the EQ-5D over the follow-up period of 12 months were compared between the 2 groups after adjustment for baseline utility scores. Baseline QOL were similar in both groups. There was no significant difference in adjusted QALY gained at 12 months in both groups. The 6-month target lesion angiographic primary patency (primary endpoint) (DEB 41.9% vs. CB 37.8%, P = 0.479) and 12-month limb salvage rate (DEB 75.0% vs. CB 84.6%, P = 0.097.) were not statistically significant. The 12-month amputation-free survival (AFS) was however better in the CB group (DEB 54.1% vs. CB 77.3%, log rank test P = 0.016). The use of DEB angioplasty for BTK interventions for CLI did not show superiority in the QALY gained at 12 months compared with CB angioplasty. The 6-month angiographic patency of target lesion and 12-month limb salvage rate were also similar. AFS was however significantly different at 12 months, in favor of the CB group.