In this episode, I’ll discuss new data on intermediate-risk PE treatment.
Intermediate-risk pulmonary embolism is usually defined as a patient with a PE and right ventricular heart strain but without hemodynamic instability. This patient population is considered under-studied and management strategies vary.
A group of researchers recently published in Lancet a multinational, multicentre, single-arm Phase 4 trial describing the use of early oral dabigatran therapy in patients with intermediate-risk PE. The objective of the authors was to determine whether treatment of acute intermediate-risk PE with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months, was effective and safe. The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months.
402 patients across 42 hospitals were analyzed. All patients were adults with symptomatic intermediate-risk pulmonary embolism. After receiving parenteral low-molecular-weight or unfractionated heparin for 72 hours, patients were switched to oral dabigatran 150 mg twice per day following a standard clinical assessment.
According to the study protocol, the switch to oral dabigatran at 72 hours was to proceed unless:
1. The patient is in shock (or hemodynamic collapse is considered imminent)
2. The patient has received thrombolytic, surgical or catheter-directed treatment, or underwent cava filter implantation within the past 48 hours
3. There is active bleeding
4. The patient is unable to take oral medication
Only 2% of the patients experienced the primary outcome. By 6 months, 3% of patients had at least one major bleeding event however the only fatal hemorrhage occurred in a patient before they were switched to dabigatran.
These results suggest that intermediate-risk PE patients may be switched at 72 hours to oral dabigatran and can be expected to experience satisfactory outcomes. While there is no control group, this study adds to the sparse literature available on how to manage these intermediate-risk PE patients.
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