Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study

Background. To investigate the-one year outcome of PTA and stenting and PTA alone for femoropopliteal occlusions. Design: Randomized prospective study . Methods. 32 patients with femoropopliteal occlusions were randomized into t wo treatment groups: PTA and Strecker-stent (n=15) and PTA alone (n=17). Th e median age of the patients was 71 years. All patients had chronic limb is chaemia, 66% had tissue loss, 19% had rest pain and 15% had disabling claud ication. The median ABPI was 0.45. The occlusion was confined to the superf icial femoral artery in 30 cases and to the popliteal artery in 2 cases. Th e median length of the occlusions was 7.3 cm. Aspirin (ASA), 160 mg daily, was administrated postoperatively but no anticoagulation was used. The foll ow-up included: clinical examination, measurement of ABPI and control angio graphy at 12 months or earlier when necessary (20 patients). Results. There was no mortality or limb loss as a consequence of the treatm ent. There were six (16%) immediate major complications in five patients. I n the PTA group, one patient had a myocardial infarction and three patients needed arteriography due to bleeding. In the stent group, one patient requ ired arteriography and embolectomy. The one-year mortality was 6% and there were no amputations. Four patients (two in each group) were operated on wi th a femorodistal bypass. The rate of clinical improvement was 71% after PT A and stent and 60% after PTA alone (p=0.17). An increased ABPI (>0.10) was shown in 50% of the stent group and 61% in the PTA group (p=0.17). Angiogr aphic re-occlusions were seen in 33% and 75% in the stent and PTA groups re spectively (p=0.17), while the rate of restenosis was significantly higher in the stent group (50% vs 25%) (p=0.033). Conclusions. Stenting following PTA for femoropopliteal occlusions does not significantly improve neither the clinical state nor the clinical/angiogra phic patency. The results do not justify any routine placement of stent fol lowing PTA in the successfully recanalized femoropopliteal arteries. The lo w rate of acceptance of a follow-up angiography indicates that this kind of study should preferably use duplex scanning instead of angiography for fol low-up.