BALLOON ANGIOPLASTY COMBINED WITH PRIMARY STENTING VERSUS BALLOON ANGIOPLASTY ALONE IN FEMOROPOPLITEAL OBSTRUCTIONS - A COMPARATIVE RANDOMIZED STUDY

Purpose: To evaluate whether balloon angioplasty combined with stentin g (ST) of symptomatic femoropopliteal disease would provide better res ults compared with balloon angioplasty alone (BA), Methods: Fifty-one patients were randomized between ST (24 patients) and BA (27 patients) . Follow-up comprised clinical and hemodynamic assessment and color-fl ow duplex ultrasound examinations. Results: Residual stenosis (greater than or equal to 30% diameter reduction) occurred in three BA patient s, but not in the ST patients. By life-table analysis the cumulative r ate 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 paten cy 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). Oc clusion occurred in five ST patients (21%) compared with two BA patien ts (7%). Conclusion: ST does not improve clinical and hemodynamic outc ome compared with BA. Moreover, the occlusion rate in ST-treated patie nts is higher.