In this episode, I’ll discuss catheter-directed thrombolytics for patients with intermediate-high-risk pulmonary embolism.
How to use catheter-directed thrombolytics to benefit patients with intermediate-high-risk pulmonary embolism has been the subject of considerable research over the last decade. Researchers recently published a major study in this area in the New England Journal of Medicine.
The trial in question was an open-label randomized trial where the authors randomly assigned over 500 patients with intermediate-high–risk acute pulmonary embolism (defined by hemodynamic stability, a simplified Pulmonary Embolism Severity Index score of 1 or higher, and right ventricular dysfunction plus an elevated level of cardiac troponin or natriuretic peptide) in a 1:1 ratio to receive catheter-directed thrombolysis with alteplase plus anticoagulation therapy (thrombolysis group) or anticoagulation therapy alone (standard-care group).
The primary outcome was a composite of death from any cause, recurrence of pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days after randomization. Secondary outcomes included clinically relevant bleeding, major bleeding, and intracranial hemorrhage.
A primary-outcome event occurred in just 0.7% of patients in the thrombolysis group and in 6.8% of patients in the standard-care group. This represents a statistically significant relative risk of 0.1 in favor of thrombolytics.
The authors determined this difference was driven mainly by the lower incidence of cardiorespiratory decompensation or collapse in the thrombolysis group.
By day 7, clinically relevant bleeding had occurred in 4.6% of patients in the thrombolytics group and in 5.0% of patients in the standard-care group. Major bleeding had occurred in 1.4% and 2.2% of patients in the thrombolytics and standard-care groups. The thrombolytic group did have a 0.7% rate of intracranial hemorrhage vs. none for standard care. Only one patient in the thrombolysis group died within 30 days, while 4 patients in the standard-care group died within 7 days.
The authors concluded:
Among patients with intermediate-high–risk acute pulmonary embolism, catheter-directed thrombolysis with alteplase plus anticoagulation therapy led to a lower risk of death from any cause, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days after randomization than anticoagulation therapy alone.
This study is the best and highest-quality trial on catheter-directed thrombolytics and is very likely to generate much more interest in this procedure among providers.
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