Abstract
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.
Keywords
In-stent restenosis, paclitaxel drug-coated balloon, peripheral arterial disease, drug-eluting balloon, femoropopliteal
arteries