Incidence and predictors of major hemorrhagic complications from thrombolytic therapy in patients with massive pulmonary embolism

PURPOSE: The risk factors for bleeding in patients receiving recombinant ti ssue-type plasminogen activator for massive pulmonary embolism are not know n. PATIENTS AND METHODS: The hospital records of 132 consecutive patients who received recombinant tissue-type plasminogen activator for massive pulmonar y embolism were retrospectively reviewed. Bleeding tvas estimated by using the bleeding severity index, a method previously validated in patients rece iving anticoagulants. Multivariate stepwise logistic regression was used to identify independent risk factors for bleeding. Four other definitions of bleeding in large pulmonary embolism thrombolytic trials were also used, an d the agreement among these criteria was assessed. RESULTS: According to the bleeding severity index, 33 patients (25%) had on e or more major bleeding complications. Hemorrhage at the venous puncture s ite for angiography was the most frequent complication (15 patients, 11%). Major bleeding at the catheterization site was more common at the femoral s ite ( 14 of 63 patients = 22%) than at the brachial site ( 1 of 63 patients = 2%; P = 0.0004). The use of the five different bleeding definitions resu lted in a variation in the major bleeding rate from 3% to 43%. The kappa co efficient varied from 0.07 to 0.84, indicating poor agreement between most of the classifications. CONCLUSION: The use of the femoral vein for pulmonary angiography was the o nly variable significantly associated with major bleeding. Most of the diff erences observed in the pulmonary embolism thrombolytic trials are likely r elated to the differences in the definition of bleeding rather than to the thrombolytic regimen. Am J Med. 1998;105:472-477. (C) 1998 by Excerpta Medi ca, Inc.