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Risks for Major Bleeding from Thrombolytic Therapy in Patients with Acute Pulmonary Embolism: Consideration of Noninvasive Management

Paul D. Stein; Russell D. Hull; and Gary Raskob
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From the Henry Ford Heart and Vascular Institute, Detroit, Michigan. Requests for Reprints: Paul D. Stein, MD, Henry Ford Hospital, New Center Pavilion—Room 1105, 2921 West Grand Boulevard, Detroit, MI 48202-2691.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1994;121(5):313-317. doi:10.7326/0003-4819-121-5-199409010-00001
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Objective: To assess the relative risks for bleeding with thrombolytic therapy in patients who are managed using pulmonary angiograms compared with those managed using noninvasive tests, primarily the ventilation-perfusion lung scan.

Design: A decision analysis based on data from other studies.

Methods: The risk for major bleeding in patients with pulmonary embolism who receive thrombolytic therapy after a noninvasive diagnosis was assessed from complications of thrombolytic therapy in patients with myocardial infarction, assuming that the same risk ratio for major bleeding when comparing an invasive with a noninvasive approach applied to patients with pulmonary embolism. The risk ratio was 3.3 (95% CI, 1.5 to 9.8) for major bleeding in patients with myocardial infarction. One or more major complications of pulmonary angiography occurred in 1.3% of patients (CI, 0.6% to 1.9%).

Results: The average reported risk was 14% (18 of 129 patients) (CI, 7.9% to 20.1%) for major bleeding in patients who had pulmonary angiography before receiving tissue plasminogen activator (tPA). The estimated risk was 4.2% (estimated CI, 1.4% to 9.3%) for major bleeding with tPA after a noninvasive diagnosis of pulmonary embolism. Assuming a risk of 1.3% for major complications from pulmonary angiography, a risk for major hemorrhage of 14.0% for an invasive diagnosis, and a risk of 4.2% for a noninvasive diagnosis, fewer complications would occur with noninvasive management if the prevalence of pulmonary embolism exceeded 21%.

Conclusion: Among patients with suspected pulmonary embolism who are candidates for thrombolytic therapy, it is safer to use noninvasive diagnostic tests in many patients.


Grahic Jump Location
Figure 1.
Predicted major complications from pulmonary angiography plus major bleeding from thrombolytic therapy shown as a function of the prevalence of pulmonary embolism.

Total major complications were major complications from angiography plus major bleeding from thrombolytic therapy. Predicted complications assume a rate of 1.3% for major complications from angiography and rates of 14.0% (observed value); 7.9%, and 20.1% (lower and upper ends of the 95% CI, respectively) for major bleeding among patients treated with thrombolytic therapy after an angiographic diagnosis. The total predicted complications describe a straight line with the slope = rate of major bleeding after angiography and the intercept = percentage of major complications of angiography. Major bleeding from thrombolytic therapy after a noninvasive diagnosis is shown by horizontal lines at assumed rates of 4.2% (observed value), 1.4%, and 9.3% (lower and upper ends of the 95% CI, respectively). PE = pulmonary embolism.

Grahic Jump Location




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