Drug Coated Balloon Angioplasty after Plain or Scoring Balloon for Vessel Preparation for Femoropopliteal Arterial Disease (DASBAD): A Randomised Controlled Trial.
Source: PubMed, NCBI / U.S. National Library of Medicine
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 procedural costs. Patients with FP disease and Rutherford category 4 or 5 were randomised to PBA (control) or SB as vessel preparation. 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 residual stenosis > 30% 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 procedural 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. Bailout stenting was requ
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 procedural costs. Patients with FP disease and Rutherford category 4 or 5 were randomised to PBA (control) or SB as vessel preparation. 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 residual stenosis > 30% 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 procedural 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. 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). Procedural costs were €108 lower per patient in the SB cohort (p = .003). In this study, the use of a SB for vessel preparation prior to DCB angioplasty in CLTI patients with FP lesions significantly reduced the need for bailout stenting and was associated with improved primary patency and lower procedural costs compared with PBA. (ClinicalTrials registration ID: NCT07136883).