Predictors of recurrence after paclitaxel drug-coated balloon use for treating femoropopliteal in-stent restenosis

• Published in: Vascular 2024-08, Vol.32 (4), p.834-841
• Main Authors: Taha, Ashraf Gamal, Saleh, Mahmoud Ismael, Ali, Haitham, Gamal, Walid M
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Chronic Limb-Threatening Ischemia - therapy; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery - diagnostic imaging; Femoral Artery - physiopathology; Humans; Male; Middle Aged; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Peripheral Arterial Disease - diagnostic imaging; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - therapy; Popliteal Artery - diagnostic imaging; Popliteal Artery - physiopathology; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
• ISSN: 1708-5381; 1708-539X; 1708-539X
• DOI: 10.1177/17085381231162123

Objective Paclitaxel drug-coated balloon (PDCB) angioplasty has been shown to be an effective treatment of in-stent restenosis (ISR) at the femoropopliteal (FP) arteries. Long-term studies, however, have shown a progressive decrease in the patency rates following PDCB. The aim of this study was to determine the predictors of stenosis recurrence after PDCB treatment of FP-ISR, and its immediate and mid-term outcomes. Methods This prospective, non-randomized study included all chronic lower extremity ischemia patients of Rutherford class 3–6 who underwent PDCB angioplasty to treat >50% FP-ISR between June 2017 and December 2019. The primary endpoint was primary patency, defined as freedom from binary restenosis and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints included 12-months freedom from CD-TLR and major adverse events (MAEs). Results A total of 73 symptomatic chronic limb ischemia patients (73 limbs including 63 with limb threatening ischemia) underwent PDCB angioplasty of FP-ISR lesions (13.7% Tosaka class I, 54.8% class II, and 31.5% class III). The mean ISR lesion length was 121.8 ± 52.7 mm. Technical success was achieved in 70 (95.9%) patients. Kaplan–Meier estimate of the 12-months rates of primary patency and freedom from CD-TLR was 76.1% and 87.4%, respectively. At one year, MAEs occurred in eight patients (11.0%) including two deaths (2.7%), one major amputation (1.4%), and six (8.2%) surgical revascularizations. Multivariable analysis showed that Tosaka class III ISR (HR 4.51, CI: 1.31–15.53, p < 0.001) and reference vessel diameter (HR 0.38, 95% CI: 0.18–080, p = 0.01) were independently associated with recurrent ISR. Conclusions PDCB is safe and effective treatment of FP-ISR lesions. Occlusive ISR lesions and reference vessel diameter were independently associated with recurrent ISR stenosis after PDCB treatment.