Midterm Results of a 4F Compatible Stent in Treatment of Femoropopliteal Atherosclerotic Disease

Objective: Percutaneous interventions are effective in treating peripheral arterial disease (PAD). Lower profile catheter systems can reduce peri-procedure access complications and permit early ambulation. While the Xpert nitinol self expanding stent is 4F compatible, its use in treating PAD remains unproven. The purpose of this study is to evaluate the efficacy and outcomes of treating femoropopliteal PAD with Xpert stents.
Methods: A retrospective review was undertaken for patients treated by a single physician in an 18-month period who underwent Xpert stent placement in the superficial femoral or above-knee popliteal artery. Demographics, indications, lesion characteristics, peri-procedural complications and outcomes were recorded.
Results: 34 limbs (29 patients) underwent placement of 47 Xpert stents after suboptimal balloon angioplasty (residual stenosis, flow-limiting dissection). Indication for intervention included claudication (74%) and critical limb ischemia (26%). TASC II classifications were: A (17 limbs, 50%), B (14, 41%), C (2, 6%) and D (1, 3%). 41% of limbs had occlusions. Mean target vessel diameter was 4.9 mm and lesion length was 7.1 cm. Technical success was 100% with no access site complications. All patients experienced initial clinical improvement. One patient was lost to follow-up and another died within 3 months (stroke). The remaining 32 limbs comprised the cohort for outcome analysis. 6 limbs had stent occlusion within one year. The remaining 26 limbs had a mean follow-up of 12.6 months. 2 limbs underwent secondary intervention to treat in-stent restenosis. Freedom from TLR for the cohort was 81.2%. Duplex ultrasound documented primary patency rate at 6 months for all limbs was 78.3% (18/23). Sustained clinical improvement was found in 96% (25/26) limbs with patent stents.
Conclusions: Treatment of femoropopliteal lesions with a 4F compatible stent is safe and associated with initial technical success. Midterm TLR and patency results are comparable to those reported for other available stents. Further studies are warranted to evaluate the long term outcomes of 4F based interventions for PAD.