Risk factors for clinical failure after stent graft treatment for femoropopliteal occlusive disease.

Objective: Optimal selection of a revascularization strategy in femoropopliteal occlusive disease (FPOD) remains controversial. Among endovascular treatment options for FPOD, covered stent placement has become increasingly used. We sought to examine the influence of clinical, anatomic, and device-related characteristics on the clinical performance of these devices.
Methods: This was a retrospective, single-center study of consecutively treated limbs that underwent Viabahn (W. L. Gore, Flagstaff, Ariz) stent graft placement for FPOD from 2005 to 2010. Clinical, anatomic, and device-related characteristics were obtained from review of medical records and angiograms. End points were occurrence of any reintervention, major adverse limb event (eg, major amputation, thrombolysis/thrombectomy, or open bypass surgery), or thrombolysis/thrombectomy treatment alone. Univariate predictors were calculated and multivariate models constructed for each clinical end point using Cox proportional hazards models.
Results: The study cohort included 87 limbs in 77 unique patients, with a median follow-up time of 382 days. The indication for intervention was claudication in 56%. In 25 cases (29%), the index procedure was a secondary intervention for FPOD, including treatment of in-stent restenosis in 22 cases (25%). Lesions treated included 45% TransAtlantic Inter-Society Consensus (TASC) II D and 58% chronic total occlusions. The observed Kaplan-Meier 1-year event rates for reintervention, major adverse limb event (MALE), and thrombolysis were 43%, 28%, and 17%, respectively. MALE occurred in 18 patients, nine of whom presented with acute limb ischemia; no patient underwent major amputation. Univariate predictors of negative outcomes included lack of dual-antiplatelet usage, advanced TASC II classification, smaller implant diameter, increased number of devices used, longer total implant length, and coverage of a patent distal collateral vessel. Multivariate analysis demonstrated that the presence of dual-antiplatelet usage was protective against all three outcomes, 5-mm device diameter was a risk factor for both reintervention and MALE, and the use of multiple devices and distal collateral coverage were significant risk factors for thrombolysis events.
Conclusions: Reintervention is common in the first year after Viabahn placement for FPOD, with more than half of the events being a MALE. Procedural factors such as antiplatelet therapy, stent graft diameter, implant length/number, and distal collateral coverage are strongly associated with adverse clinical outcomes. These factors should be carefully considered to optimize patient selection and intraoperative decision making for this procedure.
(Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)