MULTICENTER STUDIES OF ULTRA-HIGH-DOSE, SHORT-DURATION STREPTOKINASE TREATMENT OF DEEP VEIN THROMBOSIS

Abstract Eighty-six patients with phlebographically verified deep vein thrombosis (DVT) of the femoral, iliac, and/or popliteal veins who had symptoms of up to 10 days' duration were enrolled in one of two prospective, multicenter, randomized, double-blind studies. In study A, each of the 47 patients received streptokinase therapy according to one of the following three dose schedules—3.0 million (M) IU of streptokinase over 2 hours (group 1), 6.0 M IU of streptokinase over 4 hours (group 2), or 9.0 M IU of streptokinase over 6 hours (group 3). In study B, each of the 39 enrolled patients received streptokinase according to one of the three dose schedules just described or according to a fourth schedule—4.5 M IU of streptokinase over 3 hours (group 4). Each patient received two infusions of the same dose on two successive days. Heparin was given between and after the infusions, followed by warfarin alone when the prothrombin time reached the therapeutic range. In the 76 patients evaluable for efficacy, phlebographically similar improvement in thrombus extension was observed in all groups without evidence of dose dependency. Group 2 had the highest success rate, while group 4 had the lowest. Eleven patients experienced streptokinase-related allergic reactions, which led to discontinuation of therapy in five patients, two of whom experienced serious adverse reactions. The frequency and severity of adverse events were not significantly different between groups. We conclude that the ultra-high-dose, short-term infusion regimen of streptokinase is more convenient than the conventional 3 to 5 days of continuous therapy in the treatment of DVT. Further studies are needed to establish an optimal dosage schedule.