THROMBOLYTIC THERAPY COMPARED WITH MECHANICAL RECANALIZATION IN NONACUTE PERIPHERAL ARTERIAL OCCLUSIONS - A RANDOMIZED TRIAL

PURPOSE: To evaluate whether thrombolytic therapy followed by angiopla sty has any added benefit compared with angioplasty alone for the trea tment of chronic peripheral arterial occlusions. PATIENTS AND METHODS: Twenty patients with claudication or limb-threatening ischemia of at least 3 weeks duration due to iliac or femoropopliteal artery occlusio ns were randomized either to thrombolytic therapy with recombinant tis sue-type plasminogen activator for up to 4 hours (n = 11) followed by angioplasty or to angioplasty alone (n = 9). Clinical follow-up was ob tained for 1 year. RESULTS: Life-table analysis revealed a significant improvement in the cumulative primary patency rate for patients with claudication treated initially with thrombolysis followed by angioplas ty (n = 7; 86% at 6 months; 51% at 1 year) compared with angioplasty a lone In = 9; 11% at 6 months and 1 year) (P < .02). All four patients with limb-threatening ischemia were randomized to thrombolytic therapy , and none exhibited continued patency at 1 year. The most common comp lication in the thrombolysis group was peripheral embolization; three of these four patients were among those who had limb-threatening ische mia as the indication for entry into this study. There was no increase d incidence of bleeding with thrombolytic therapy. CONCLUSIONS: A shor t course of thrombolytic therapy prior to angioplasty appears to impro ve the 1-year patency rate for claudication due to iliac or femoropopl iteal occlusions. However, patients with limb-threatening ischemia hav e a high prevalence of peripheral embolization and dismal patency rate s with this form of therapy. A larger scale study is necessary to conf irm these findings.