Safety and Effectiveness of Debulking for the Treatment of Infrainguinal Peripheral Artery Disease. Data From the Recording Courses of vascular Diseases Registry in 2910 Patients.

ABSTRACT

We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up. The secondary endpoint included the need for bail-out stenting. Overall, 2910 patients were analyzed; 2552 without and 358 with debulking-assisted EVR. Patients were 72 (interquartile range (IQR) = 15) years old and 1027 (35.3%) had diabetes. Overall complication rates were similarly low in the debulking vs the non-debulking group (4.7 vs 3.2%, P = .18). However, peripheral embolizations rates were low but more frequent with debulking vs. non-debulking procedures (3.9 vs 1.1%, P < .001). After adjustment for clinical and lesion-specific parameters, including LCS, no differences were noted for the primary endpoint (odds ration (OR) = 0.99, 95%CI = 0.69-1.41, P = .94). Bail-out stenting was less frequently performed in patients with debulking-assisted EVR (OR = 0.5, 95%CI = 0.38-0.65, P < .0001). Debulking-assisted EVR is currently used in ∼12% of EVR with infrainguinal lesions and is associated with lower bail-out stent rates but higher peripheral embolization rates; no differences were found regarding index limb re-intervention and amputation rates.