Thrombolytic therapy compared with mechanical recanalization in nonacute peripheral arterial occlusions: A randomized trial

PURPOSE: To evaluate whether thrombolytic therapy followed by angioplasty has any added benefit compared with angioplasty alone for the treatment 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 occlusions were randomized either to thrombolytic therapy with recombinant tissue-type plasminogen activator for up to 4 hours (n = 11) followed by angioplasty or to angioplasty alone (n = 9). Clinical follow-up was obtained 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 angioplasty (n = 7; 86% at 6 months; 51% at 1 year) compared with angioplasty alone 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 complication in the thrombolysis group was peripheral embolization; three of these four patients were among those who had limb-threatening ischemia as the indication for entry into this study. There was no increased incidence of bleeding with thrombolytic therapy. CONCLUSIONS: A short course of thrombolytic therapy prior to angioplasty appears to improve the 1-year patency rate for claudication due to iliac or femoropopliteal occlusions. However, patients with limb-threatening ischemia have a high prevalence of peripheral embolization and dismal patency rates with this form of therapy. A larger scale study is necessary to confirm these findings.