Drug Coated Balloon Angioplasty after Plain or Scoring Balloon for Vessel Preparation for Femoropopliteal Arterial Disease (DASBAD): A Randomised Controlled Trial.

Abstract

Plain balloon angioplasty (PBA) remains the standard technique for vessel preparation in peripheral artery disease. This prospective, single centre, single blind, parallel group, superiority randomised trial enrolled chronic limb threatening ischaemia (CLTI) patients with femoropopliteal (FP) lesions. It evaluated whether AngioSculpt scoring balloon (SB) use, compared with PBA, before Luminor drug coated balloon (DCB) angioplasty in FP lesions and CLTI reduces the need for bailout stenting and improves patency without increasing procedure costs. Patients with FP disease and Rutherford category four or five were randomised to PBA (control) or SB as vessel preparation. The sample size was calculated based on expected bailout stenting rates from previous studies, requiring 39 patients per arm. The primary endpoint was bailout stenting, defined as stent implantation during the index procedure for > 30% residual stenosis or type C dissection (Kobayashi classification). Secondary endpoints included primary patency, defined as duplex ultrasound peak systolic velocity ratio < 2.5 without clinically driven target lesion revascularisation, and procedure cost, defined as the total cost of all balloons and stents used during the index procedure. Eighty-three subjects were enrolled between September 2020 and November 2022 (43 SB, 40 PBA). Mean follow up was 517 ± 272 days. Mean lesion length was 235 ± 134 mm in the SB group and 219 ± 130 mm in the control group. Bailout stenting was required in 33% of PBA vs. 5% of SB (p = .003). Overall primary patency was higher in the SB group (91% vs. 70%; p = .035). Procedure costs were €108 lower per patient in the SB cohort (p = .003). In this study, the use of an SB for vessel preparation before DCB angioplasty in CLTI patients with FP lesions significantly reduced the need for bailout stenting and was associated with improved primary patency and lower procedure costs compared with PBA. (ClinicalTrials registration ID: NCT07136883).