Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study

Abstract

Background: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO.Materials and methods: We retrospectively analyzed 359 limbs of 318 patients who underwent EVT with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model.Results: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P=0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P=0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P=0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P=0.003).Conclusion: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.

Retrospective multicenter registry for endovascular treatment with newer devices in over 25‐cm femoropopliteal artery disease: A retrospective observational study

“…The main findings in the present study are as follows: (1) the 1‐year primary patency rate and freedom from CD‐TLR were 79.3% and 82.4%, respectively; (2) the predictors of 1‐year restenosis were the lack of cilostazol, P3 segment involvement, and small RVD; (3) all‐cause mortality, major amputation, and CD‐TLR were observed in 9.7%, 1.8%, and 13.3%, respectively, of the whole population at 1 year. The previous registries demonstrated that poor primary patency was associated with conservative antiplatelet therapies, involvement of popliteal segments and small vessel disease 7,8,17,18 ; however, these studies included patients with relatively short FP lesions (mean length ranged from 8.4 to 21.9 cm). Our study highlighted that the importance of the classical risk factors was consistent in extremely diffuse FP lesions.…”

“…The aim of this study was to evaluate the safety and efficacy of the contemporary EVT using the latest devices in patients with symptomatic PAD having FP lesions longer than 25 cm in clinical practice. In addition, several studies indicated that medical treatment might be helpful to keep patency after revascularization such as antiplatelet therapy, cilostazol and oral anti‐coagulation; therefore, anti‐thrombotic therapies can play an important role in the current EVT era 7–9 . We investigated the associated factors to improve the vessel patency, which included patent and lesion background, EVT devices and medical treatment.…”

“…In addition, several studies indicated that medical treatment might be helpful to keep patency after revascularization such as antiplatelet therapy, cilostazol and oral anti-coagulation; therefore, anti-thrombotic therapies can play an important role in the current EVT era. [7][8][9] We investigated the associated factors to improve the vessel patency, which included patent and lesion background, EVT devices and medical treatment. From the database of seven cardiovascular centers including consecutive 3635 patients with FP lesions, a total of 504 patients with 614 lesions undergoing EVT for diffuse FP lesions at each hospital were retrospectively reviewed (Figure 1).…”