[PTA versus Palmaz stent placement in femoropopliteal artery stenoses: results of a multicenter prospective randomized study (REFSA)]

Abstract

Purpose: To evaluate whether stent placement is superior to percutaneous transluminal angioplasty (PTA) in the treatment of chronic symptoms in short femoropopliteal arterial stenoses.

Materials and methods: One hundred twenty-four limbs in 116 patients, who ranged in age from 39 to 87 years (mean age, 67 years), were randomized to PTA (n = 53) versus PTA followed by implantation of long-medium Palmaz-Stents (n = 71). Inclusion criteria were intermittent claudication or chronic critical limb ischemia, short stenosis or occlusion (lesion length < or = 5 cm), and at least one patent run-off vessel at angiography. The follow-up included clinical assessment, measurement of ankle/brachial index (ABI), color duplex ultrasound, and/or angiography at 6, 12 and 24 months. Angiographic follow-up between 12 and 36 months was available in 54 limbs (45 %).

Results: Initial technical success was achieved in 50 of 53 limbs (94.4 %) in the PTA group versus 70 of 71 limbs (98.6 %) in the stent group. Overall, major complications occurred in 9.5 % (n = 11), with n = 4 in the PTA group compared to n = 7 in the stent group. No difference was found between the groups of treatment: clinical success at 1 and 2 years was 80.5 and 77.1 % in the PTA group versus 78.1 and 71.0 % in the stent group. The cumulative 1-year and 2-year angiographic primary patency rates were 66.1 and 49.1 % in the stent group versus 76.1 and 66.1 % in the PTA group. The secondary 1-year and 2-year angiographic patency rates were 88.5 and 53.3 % in the stent group versus 82.7 % and 76.2 % in the PTA group.

Conclusion: The primary success rate was slightly higher after stent placement than after PTA. However, the angiographic, clinical and hemodynamic success after 1 and 2 years tends to be slightly better for PTA.