Purpose: To evaluate whether primary stenting is superior to balloon angioplasty (PTA) alone in the treatment of femoropopliteal obstructive disease.
Materials and methods: Sixty-two patients, 24 female and 38 male, mean age 67 years (39-87) years, were randomized to PTA alone (n = 37) or balloon angioplasty followed by implantation of Palmaz stents (n = 33). Follow-up included clinical assessment, ankle-brachial index (ABI), color duplex ultrasound at 1, 3, 6 and 12 months after intervention and intravenous angiography at 6 or 12 months.
Results: We had four cases of primary PTA failures (10.8%) and no early (< 30 days) thrombosis compared to one primary stent failure (3.0%) and three early thromboses (9.0%) in the stent group. Cumulative primary angiographic patency rates (life-table analysis) for PTA alone were 82% and 72% (6 and 12 months, respectively) compared to 81% and 60% for primary stent placement. The secondary angiographic patency were 97% and 88% for PTA and 88% and 72% for stent implantation, respectively. However, there was no significant difference in patency rates.
Conclusions: Despite fewer primary technical failures, mid-term angiographic and clinical patency were not improved by primary stent placement compared to PTA alone.