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July 2, 2014
Risks, Benefits Found for Thrombolytic Therapy in
Pulmonary Embolism Philadelphia—Using thrombolytic therapy to dissolve the blood clots in pulmonary embolism can lower death rates but at the high cost of increasing risks of major bleeding and intracranial hemorrhage, according to a recent study. The report, published recent in the Journal of the American Medical Association, was based on analysis of data from 16 trials performed over the last 45 years, among patients with pulmonary embolism (PE). The authors caution that the results may not apply to patients with low-risk pulmonary embolism. The study involved a meta-analysis of 16 randomized clinical trials of thrombolytic therapy for PE involving 2,115 patients. Of the study group, 210, or 9.9%, had low-risk PE, 71% had intermediate-risk PE, 1.5% had high-risk PE; risk was unable to be classified in 18%. “We discovered that thrombolysis was associated with a clear reduction in deaths in grey-area, intermediate-risk, pulmonary embolism patients,” said the study's senior author, Jay Giri, MD, MPH, assistant professor of clinical medicine at the University of Pennsylvania in Philadelphia. “Of course, this potential benefit must be balanced against potential bleeding risks, which we also attempted to clarify. With this knowledge, future research can help identify subgroups of patients who are most likely to obtain this mortality benefit and least likely to be harmed by bleeding, particularly intracranial hemorrhage.” While researchers found that thrombolytic therapy for PE was associated with a 47% lower odds of death—2.2% of patients in the thrombolytic therapy group and 3.9% of patients in the anticoagulant group died during an average follow-up of 82 days—thrombolytic therapy also was associated with a 2.7 times greater risk of major bleeding compared with anticoagulant therapy. The rate of major bleeding in the anticoagulation group was only 3.4% compared to 9.2% in the thrombolytic therapy group. Major bleeding was not significantly increased, however, in patients 65 years and younger, according to the authors. In addition, thrombolysis was associated with a greater intracranial hemorrhage rate (1.5% vs. 0.2%) but also lower risk of recurrent PE (1.2% vs 3.0%). “Risk stratification models for bleeding in all patients, but especially the elderly, are warranted to identify the individuals at the highest risk of hemorrhagic complications with thrombolytic therapy,” the authors write. “Future research should also be directed toward concomitant [accompanying] use of other medications, especially the ‘novel oral anticoagulants’ in conjunction with thrombolytics in patients with hemodynamically stable PE.” In an accompanying editorial, Joshua A. Beckman, MD, of Brigham and Women’s Hospital in Boston, writes that the study “raises new questions” and calls for more research. “For example, should thrombolytic therapy in intermediate-risk patients older than 65 years be avoided?” Beckman asks. “While the risk of bleeding is increased in older patients, the point estimate for mortality is similar to that in younger patients. Risk stratification for bleeding may favor use of thrombolysis in patients older than 65 years. Second, would the net clinical benefit be better with consistent use of catheter-based thrombolysis using lower doses of fibrinolytic agents for significant pulmonary artery thrombus [blood clot] reduction? Additional clinical trials are needed to guide optimal use of thrombolytic therapy in patients with PE.” Giri suggested that additional research “should focus on standardization of dosages of medication in thrombolysis as well as explore the optimal method of administration, namely intravenous versus catheter-directed therapy into the pulmonary arteries, to determine maximal clinical benefits with minimization of bleeding risk.”
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