Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study.
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.
                Thirty patients randomized to undergo PTA in combination with stent placement and 23 patients randomized to undergo PTA alone were evaluated.
                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%.
                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. To evaluate whether balloon angioplasty combined with stenting (ST) of symptomatic femoropopliteal disease would provide better results compared with balloon angioplasty alone (BA).
                Fifty-one patients were randomized between ST (24 patients) and BA (27 patients). Follow-up comprised clinical and hemodynamic assessment and color-flow duplex ultrasound examinations.
                Residual stenosis (> or = 30% diameter reduction) occurred in three BA patients, but not in the ST patients. By life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year with ST was 74% (SE 9%) and for those with BA 85% (SE 7%) (p = 0.25). The primary patency at 1 year assessed by color-flow duplex ultrasound was 62% (SE 9%) for ST-treated patients and 74% (SE 8%) for BA patients (p = 0.22). Occlusion occurred in five ST patients (21%) compared with two BA patients (7%).
                ST does not improve clinical and hemodynamic outcome compared with BA. Moreover, the occlusion rate in ST-treated patients is higher.
The small number of relevant studies identified together with the small sample sizes and methodological weaknesses severely limit the usefulness of this review in guiding practice. The results from larger multicentre trials are needed.