Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions

PURPOSE: The purpose of this study was to evaluate whether percutaneous transluminal angioplasty (PTA) combined with Palmaz stent placement provides long-term advantages compared to PTA alone after 34 months of follow-up in the femoropopliteal region. MATERIALS AND METHODS: Thirty patients randomized to undergo PTA in combination with stent placement and 23 patients randomized to undergo PTA alone were evaluated. RESULTS: Mean follow-up ( SD) for the PTA group was 33.8 months (+/- 8.7) and for the Palmaz group 29.1 months (+/- 6.2), with a maximum follow-up period of 39 months for both groups. No significant differences in primary or secondary patency rates could be observed at 12 or 39 months. After 39 months, the primary patency rate for PTA alone was 68.4% and the secondary patency rate was 89.5%; the primary patency rate for PTA with stent placement was 62% and the secondary patency rate was 90%. CONCLUSIONS: The results of this study show that even after a long-term follow up of more than 3 years, PTA with stent placement in the femoropopliteal artery does not produce better results than PTA alone, although it does provide better initial luminal gain after the procedure.