Drug-eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial

Abstract

Introduction - Claudication and critical limb threatening ischemia (CLTI) are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DES) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both methods. Methods - Patients were randomized at 6 hospitals in Finland. Patients were included between 2011 and 2014, follow-up ended in 2016. Patients presented with rest pain or severe claudication (Rutherford class II-IV), patients with wounds or tissue loss were excluded. 5-25 cm SFA-lesions were eligible for inclusion. The lesions were diagnosed and measured using magnetic resonance angiography or computed tomography angiography. Concomitant inflow or outflow procedures were not allowed. All patients provided written informed consent. Inclusion and exclusion criteria are listed in table 1. Patients were randomized to BA+DES or prosthetic AK femoropopliteal bypass. 2:1 (DES:BSX) block randomization was performed at the ward or outpatient clinic following eligibility and signed informed consent. Bypass surgery was performed under general anesthesia or spinal blockade from incisions to the groin and proximal popliteal artery. A 6 mm heparin-bonded polytetrafluoroethylene (PTFE) graft was used. The graft was tunneled anatomically or subcutaneously depending on surgeon´s preference. Procedures were performed under systemic heparinization with an activated clotting time (ACT) between 200 and 300 seconds. In the stent group, access was obtained from the ipsilateral or contralateral common femoral artery. The occlusion was recanalized and crossed intraluminally or subintimally prior to predilatation and stent deployment. The stent was post-dilated according to instructions-for-use. Patients received 5000 IU systemic heparin during the procedure. Follow-up was 24 months and the primary outcome measure was overall stent or graft patency. Secondary outcome measures were primary and assisted patency as well as amputation-free survival. Follow-up was performed by clinical evaluation for symptoms and by duplex ultrasound to assess patency at 1, 6, 12, and 24 months postoperatively. Results - 41 patients were eventually analyzed. 6 month secondary patency was 91 % (DES) vs. 83 % (BSX) (P=.450). The corresponding numbers at 12-months in the DES and BSX groups were 74 % and 80 % (P= .750). At 24 months the respective numbers were 56 % and 71 % (P=.830) (fig1). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. 5 patients were excluded due to unsuccessful recanalization. There were no deaths or major amputations in either group during 12-month follow-up. The number of patients lost to follow-up at 6, 12, and 24 months was 0 (0.0 %), 6 (14.2 %) and 11 (26.2 %), respectively. Conclusion - This is the first randomized trial comparing the DES to prosthetic bypass in above knee femoropopliteal occlusion. At 12 and 24 months after the procedure there was no statistically significant difference in primary patency, assisted primary patency or secondary patency between the groups. Although underpowered, our study suggests non-inferiority of the DES compared to PTFE-bypass in this patient group. Larger studies are needed for more definitive conclusions.