Efficacy of drug-coated balloons in treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis / 中华全科医师杂志

ABSTRACT

Objective:To evaluate the mid-term clinical efficacy of drug-coated balloons (DCB)in the treatment of femoro-popliteal artery TASC Ⅱ C/D de novo stenosis and in-stent restenosis.Methods:A total of 126 patients with TASC Ⅱ C/D femoro-popliteal artery stenosis treated with DCB in Renji Hospital and Pudong New Area People's Hospital from December 2016 to August 2020 were retrospectively enrolled, including 74 cases of de novo stenosis (de novo group) and 52 cases of in-stent restenosis (ISR group). The clinical data and lesion characteristics were analyzed; the primary patency rate, primary-assisted patency rate, secondary patency rate, and the freedom from target lesion revascularization (f-TLR)rate were evaluated; the perioperative complications, mortality and amputation rate were compared between two groups. Kaplan-Meier method was used to evaluate the patency rate of target vessel lesions, and Cox regression analysis was used to evaluate the relative risk factors.Results:There were 6 patients died in each group during the followup period. The lesion length of the de novo and ISR groups were (21.25±12.64) cm and (34.71±12.02) cm, respectively( t=33.74, P<0.001). The popliteal artery involvement was 33.8% (25/74) in the de novo group and 15.4% (8/52) in the ISR group (χ 2=5.35, P=0.021). The operational success rate was 100.0% in both groups, and the perioperative complication rate was 6.8% (5/74) in the de novo group and 1.9% (1/52) in ISR group. The median follow-up time was 22 month and 17 months; the mean follow-up time were(19.78 ± 11.02) months and (20.02 ± 11.32) months in the de novo group and ISR group, respectively. The primary patency rates at 6, 12 and 24 months after intervention were 89.1%, 73.4%, 50.8% in the Denovo group, and 87.8%, 68.8%, 42.0% in the ISR group, respectively; the primary assisted patency rate was 90.7%, 78.4%, 62.8% in the de novo group, and 89.3%,77.1%, 62.8% in the ISR group, respectively; the secondary patency rate was 95.1%,95.1%, 88.7% in de novo group, and 94.9%, 88.9%, 84.3% in ISR group, respectively; the f-TLR rate was 97.3%, 88.6%, 79.2% in de novo group, and 90.0%, 77.7%, 74.7% in ISR group, respectively (all P>0.05). Cox regression analysis showed that P2 and P3 segment involvement of the popliteal artery were independent factors affecting the patency rate of target lesion. Conclusions:The mid-term clinical efficacy of DCB in the treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis is satisfactory.