Clinical Outcomes after Endovascular Treatment Failure in Patients with Femoropopliteal Occlusive Disease.

Background: To analyze the clinical impact derived from endovascular treatment failure on patients with femoropopliteal occlusive disease (FPOD) regarding their preoperative clinical stage.

Methods: Retrospective review for primary endovascular procedures for FPOD from 2008 to 2013. Primary end point included clinical deterioration defined as acute limb ischemia (ALI) or clinical worsening by, at least, one Rutherford's classification category, related to procedure's failure (restenosis >70% or occlusion).

Results: Ninety procedures were analyzed in 85 patients, 87.8% operated due to critical limb ischemia. The lesion treated was classified as Trans-Atlantic Inter-Society Consensus (TASC)-A/B in 76.7%, with a mean length of 98.5 ± 54 mm. Covered stent graft (SG) was used in 31.1% of the cases. Median follow-up was 14.5 months and treatment failure occurred in 33.3% of cases (n = 30, 9 restenosis and 21 occlusions). Clinical worsening was assessed in 40% of treatment failures and 6 of 21 (28.6%) presented as ALI. Twenty-two major adverse limb events (MALEs) were recorded and 8 major amputations. Regarding the type of stent, more occlusions were recorded on patients treated with SG compared with bare metal stent (39.3% vs. 16%; P = 0.02). However, no differences were found between groups regarding clinical worsening attributable to treatment failure (HR, 1.33; CI 95%, 0.5-3.5; P = 0.5). On multivariate analysis, TASC-C/D lesions (HR, 5.5; CI 95%, 2.3-13.3; P < 0.001) and female sex (HR, 4.9; CI 95%, 1.9-12.5; P = 0.001) behaved as significant predictors for failure and dual-antiplatelet therapy as a protective factor (HR, 0.3; CI 95%, 0.3-0.13; P = 0.03). No predictors were obtained regarding clinical worsening and occurrence of MALEs in our series.

Conclusions: Patients with failure of endovascular procedures on FPOD appeared with clinical worsening in a no negligible number of cases in our sample regarding their preoperative clinical situation. Thus, we believe that endovascular treatment should be carefully deliberated.