Author + information
- Received April 2, 2020
- Revision received May 19, 2020
- Accepted June 23, 2020
- Published online October 5, 2020.
- Francesco Liistro, MD∗ (, )
- Paolo Angioli, MD,
- Giorgio Ventoruzzo, MD,
- Kenneth Ducci, MD,
- Matteo Rocco Reccia, MD,
- Lucia Ricci, MD,
- Giovanni Falsini, MD,
- Alessia Scatena, MD,
- Maurizio Pieroni, MD and
- Leonardo Bolognese, MD
- ↵∗Address for correspondence:
Dr. Francesco Liistro, San Donato Hospital, Cardiovascular Department, via Pietro Nenni 20, 52100 Arezzo, Italy.
Objectives The aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention.
Background Restenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results.
Methods ACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints.
Results From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred.
Conclusions Litos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.
Dr. Liistro is principal investigator of the In.Pact BTK study for Medtronic; and is a consultant for Medtronic, Boston Scientific, and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received April 2, 2020.
- Revision received May 19, 2020.
- Accepted June 23, 2020.
- 2020 American College of Cardiology Foundation
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