June 17th, 2014
Mixed Results for Thrombolysis in Pulmonary Embolism
Larry Husten, PHD
The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation.
A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, there was a significant, 47% reduction in mortality with thrombolysis relative to standard anticoagulation, but this was accompanied by significant increases in major bleeding, including intracranial hemorrhage. The increased risk in bleeding was significant only in patients over 65 years of age.
- Mortality: 2.17% with thrombolysis versus 3.89% with standard anticoagulation (odds ratio, 0.53, CI 0.32-0.88)
- Major bleeding: 9.24% versus 3.42% (OR, 2.73, CI 1.91-3.91)
- Intracranial hemorrhage: 1.46% versus 0.19% (OR 4.63, CI 1.78-12.04)
A similar pattern was observed in the large subgroup (1775 patients) deemed to be at intermediate risk.
The mortality benefit, the authors write, “must be tempered by the finding of significantly increased risk of major bleeding and ICH associated with thrombolytic therapy, particularly for patients older than 65 years.” They advise that risk stratification for bleeding should be performed in all patients, especially the elderly, to identify those at high risk for bleeding complications.
In an accompanying editorial, Joshua Beckman writes that “the net clinical benefit of thrombolysis suggests evidence of modest efficacy for thrombolysis in intermediate-risk PE, rendering the need for decision making on a patient-by-patient basis.”
CardioExchange’s John Ryan interviews study authors Saurav Chatterjee and Jay Giri about their findings. Join the conversation.