Percutaneous revascularization of femoropopliteal artery disease: PTA and PTA plus stent. Results after six years' follow-up.

PURPOSE: To compare the long-term patency after the treatment of mild-to-moderate femoropopliteal artery disease by percutaneous transluminal angioplasty (PTA) alone (PTA group) and PTA plus stenting (STENT group) in a non-randomised retrospective study. MATERIALS AND METHODS: Eighty-six limbs in 64 patients (mean age 67+/-8 years, 47 males and 17 females) with femoropopliteal artery disease and symptomatic for mild-to-moderate intermittent claudication (Rutherford's category 1-2) were treated by percutaneous revascularization. None of the patients had critical lower limb ischaemia. Of the 86 lesions, 63 (40 stenoses and 23 occlusions) were treated by PTA alone and 23 (12 stenoses and 11 occlusions) by PTA plus stent implantation. The success was defined as a maximal = or < 30% residual stenosis of vessel lumen diameter, as defined by biplane angiography. The angiography findings were confirmed by colour-Doppler sonography of the treated segment. A peak systolic velocity = or < 150 cm/sec in the treated segment and an improvement of the ankle/brachial index by gs; 0.15 were considered indications of haemodynamic success. Restenosis at follow-up (mean 21 months, range 1-72 months) was defined by colour-Doppler sonography as a peak systolic velocity gs; 230 cm/sec or a peak systolic velocity ratio gs; 2.5 in the treated area and a gs; 0.15 decrease in ankle/brachial index compared with post-procedure measurements. RESULTS: Treatment by PTA plus stenting enabled correction of residual stenosis in 15/23 limbs, relief of PTA complications in 7/23 limbs and correction of restenosis after a PTA in 1/23. In the PTA group the treatment was successful in 59/86 limbs (68%) versus 21/23 (91%) in the STENT group (chi squared value= 0,04). As a whole, major complications occurred in 5.8% of cases (n=5), 3 in the PTA group and 2 in the STENT group. The primary patency rates at 6, 12, and 24 months were 70%, 66% and 58% in the PTA group versus 74%, 67% and 46% in the STENT group (Gehan p value=0.96). The secondary patency rates at 6, 12, 24 months were 75%, 73%, 65% in the PTA group versus 84%, 76%, 64% in the STENT group (Gehan p value=0,59). DISCUSSION AND CONCLUSIONS: In this study, stenting and PTA for the treatment of mild-to-moderate femoropopliteal peripheral artery disease improved the primary technical success of PTA by correcting residual stenosis, elastic recoil and occlusive intimal flaps. Moreover, stenting can prevent delayed constrictive remodelling. However, stenting did not improve long-term outcomes in comparison with PTA alone given that stent implantation increases the risk of restenosis due to myointimal hyperplasia. Our findings regarding the complication rates and long-term outcome agree with those published by other authors. Colour-Doppler US monitoring enabled early detection of restenosis in the treated area and its differentiation from the development of new lesions in other areas