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

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Abstract

PURPOSE: The risk factors for bleeding in patients receiving recombinant tissue-type plasminogen activator for massive pulmonary embolism are not known.

PATIENTS AND METHODS: The hospital records of 132 consecutive patients who received recombinant tissue-type plasminogen activator for massive pulmonary embolism were retrospectively reviewed. Bleeding was estimated by using the bleeding severity index, a method previously validated in patients receiving 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, and the agreement among these criteria was assessed.

RESULTS: According to the bleeding severity index, 33 patients (25%) had one or more major bleeding complications. Hemorrhage at the venous puncture site for angiography was the most frequent complication (15 patients, 11%). Major bleeding at the catheterization site was more common at the femoral site (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 resulted in a variation in the major bleeding rate from 3% to 43%. The kappa coefficient 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 only variable significantly associated with major bleeding. Most of the differences observed in the pulmonary embolism thrombolytic trials are likely related to the differences in the definition of bleeding rather than to the thrombolytic regimen.

Section snippets

Patients

We retrospectively analyzed the hospital records of all patients who received recombinant tissue-type plasminogen activator for massive pulmonary embolism in our hospital between November 1988 and March 1994. All but four patients had pulmonary embolism objectively diagnosed by selective bilateral pulmonary angiography. Massive pulmonary embolism was defined by a pulmonary vascular obstruction score >20/34 (ie, >60%) according to the criteria of Miller et al (15). The four remaining patients

Results

Between 1988 and 1994, 132 consecutive adult patients received intravenous alteplase for massive pulmonary embolism. There were 57 men (43%) and 75 women with a mean age of 66 years (range: 19 to 88 years). Nineteen patients (14%) received 100 mg alteplase over 2 hours, 61 (46%) received 1 mg/kg over 10 minutes, and 52 (39%) received 0.6 mg/kg over 10 minutes.

Ten patients (8%) died during the hospital stay, including two from bleeding (one patient with intracranial bleeding, another with

Discussion

Bleeding, particularly when pulmonary angiography was performed via femoral access site, was a frequent complication of thrombolytic treatment in patients with pulmonary embolism. The 25% rate of major bleeding that we observed is somewhat greater than those reported in trials of thrombolytic treatment of patients with pulmonary embolism (12), though the 1.5% incidence of intracranial hemorrhage was similar to that recently reported (11). However, the use of different definitions of major

Conclusion

In patients with massive pulmonary embolism diagnosed invasively, the use of a superficial arm vein for performing angiography may reduce thrombolysis-induced bleeding complications. The comparability of clinical trials on thrombolysis in pulmonary embolism would benefit from the use of more reproducible methods for estimating the bleeding rate.

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