Reteplase in the treatment of peripheral arterial and venous occlusions: Apilot study

PURPOSE: Reteplase, a truncated mutant of tissue plasminogen activator, has been used successfully in the treatment of acute coronary occlusion, but, heretofore, it has not been investigated in the setting of peripheral vascu lar occlusion, Reteplase is a potential recombinant thrombolytic agent that may offer an appropriate alternative to currently employed plasminogen act ivators, MATERIALS AND METHODS: Over a 6-month period reteplase was used to treat pe ripheral vascular occlusions at five centers in the United States, The agen t was used in peripheral arterial occlusion (n = 26, 70.3%) or venous occlu sion (n = 11, 29,7%), in doses ranging from 0.5 to 2.0 U/h, infused directl y into the thrombus, A lacing dose (4.3 +/- 0.9 U) was employed in 17 patie nts (45.9%), and 25 patients (67.6%) received concurrent heparin therapy in a subtherapeutic dose (n = 14, 37.8%) or as full therapeutic anticoagulati on (n = 11, 29.7%). RESULTS: The 26 patients with arterial occlusions received a total dose of reteplase that averaged 20.5 U +/- 5.3 (mean +/- SEM), ranging from 3.5 to 82 U, The duration of infusion was 19.3 hours +/- 2.4 with a range of 0.2-3 6 hours, Complete dissolution of the occluding thrombus was achieved in 23 patients (88.5%). Hemorrhagic complications developed in eight patients (30 .8%) and were major in five patients (19.2%), No patient experienced intrac ranial bleeding, Although there was no association between the dose regimen and thrombolytic efficacy, bleeding complications appeared to be more freq uent as the dose was increased from 0.5 to 2.0 U/h, The 11 patients treated for deep venous thrombi received an average of 32.6 U +/- 7.4 of reteplase , ranging from 6 to 75 U over a mean length of time of 31.1 hours +/- 7.3 ( range, 4-84 hours), Complete dissolution of thrombus occurred in eight pati ents (72.7%), Hemorrhagic complications developed in three patients (27.3%) and one of the episodes was major (9.1%). No patient experienced intracran ial hemorrhage, CONCLUSIONS: Reteplase appears to be an acceptable alternative thrombolytic agent with a satisfactory safety and efficacy profile in the setting of pe ripheral arterial and venous occlusion, As such, it may provide an attracti ve alternative for the treatment of peripheral arterial and venous thrombot ic occlusions. However, definitive conclusions must await the results of co ntrolled comparisons of reteplase to other thrombolytic agents.