Photo Credit: Mr. Suphachai Praserdumrongchai

The prospective registry study evaluating paclitaxel drug-coated balloon (DCB) for in-stent restenosis (ISR) in the superficial femoral artery (SFA) or popliteal artery demonstrated promising outcomes, achieving a 90% freedom from target lesion revascularization at 12 months and highlighting advancements compared to plain balloon angioplasty outcomes.

The following is a summary of “A Registry-based Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of In-stent Restenosis of the Femoral-popliteal Artery,” published in the January 2024 issue of Surgery by Bertges et al.

This study presents findings from a prospective, single-arm registry investigation aimed at evaluating the efficacy and safety of utilizing a paclitaxel drug-coated balloon (DCB) for managing in-stent restenosis (ISR) within the superficial femoral artery (SFA) or popliteal artery in a United States cohort.

Conducted between December 2016 and January 2020, this study engaged in a prospective, non-randomized, multi-center registry within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry. The investigation involved 300 patients from 43 sites, assessing clinical outcomes at 12, 24, and 36 months. The primary endpoint focused on target lesion revascularization (TLR) at 12 months, while secondary endpoints included technical success, target vessel revascularization (TVR), major limb amputation, and all-cause mortality. Survival probabilities were derived using Kaplan-Meier survival estimates.

The patient cohort comprised 58% males, with a mean age of 68 ± 10 years. Among them, 56% had diabetes, and 80% presented with claudication, while 20% exhibited rest pain. Lesions primarily included ISR of the SFA (68%), SFA-popliteal (26%), and popliteal arteries (7%), with a mean lesion length of 17.8 ± 11.8 cm. Occlusions were observed in 43% of cases, with a mean occluded length of 16 ± 10 cm. Technical success was achieved in 99% of cases, with 5% undergoing re-stenting and 0.6% undergoing thrombolysis. Kaplan-Meier estimates revealed freedom from TLR at 12, 24, and 36 months to be 90%, 72%, and 62%, respectively. Similarly, freedom from TVR and major limb amputation at the same intervals was 88%, 68%, 59%, and 99%, respectively. Survival rates stood at 95%, 89%, and 85% at 12, 24, and 36 months.

This post-market registry-based study showcases promising outcomes in treating femoral-popliteal ISR with paclitaxel DCB, displaying notable advancements compared to outcomes reported in the literature for plain balloon angioplasty. These results underscore the SVS VQI’s ability to conduct post-market evaluations of peripheral devices in collaboration with industry and federal regulators.

Source: sciencedirect.com/science/article/abs/pii/S0741521424000041