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 tra nsluminal angioplasty (PTA) combined with Palmaz stent placement provides l ong-term advantages compared to PTA alone after 34 months of follow-up in t he femoropopliteal region. MATERIALS AND METHODS: Thirty patients randomized to undergo PTA in combina tion with stent placement and 23 patients randomized to undergo PTA alone w ere evaluated. RESULTS: Mean follow-up ( SD) for the PTA group was 33.8 months (+/- 8.7) a nd for the Palmaz group 29.1 months (+/- 6.2), with a maximum follow-up per iod 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 mont hs, the primary patency rate for PTA alone was 68.4% and the secondary pate ncy rate was 89.5%; the primary patency rate for PTA with stent placement w as 62% and the secondary patency rate was 90%. CONCLUSIONS: The results of this study show that even after a long-term fol low up of more than 3 years, PTA with stent placement in the femoropoplitea l artery does not produce better results than PTA alone, although it does p rovide better initial luminal gain after the procedure.