New Trial to Assess Dabigatran in Intermediate-Risk Pulmonary Embolism
Primary outcomes of PEITHO-2 include recurrent symptoms of VTE or death within 6 months of initiating therapy for pulmonary embolism.
Patients diagnosed with an intermediate-risk pulmonary embolism (PE) may be able to start oral anticoagulation therapy after completing 72 hours of heparin therapy during hospitalization, according to a study published in Thrombosis and Haemostasis.
Researchers are currently recruiting patients to participate in a prospective, multicenter, multinational, single group clinical trial (Pulmonary Embolism International Trial 2 [PEITHO-2]; ClinicalTrials.gov identifier: NCT02596555) to determine the safety and efficacy of initiating oral thrombin inhibitor dabigatran for 6 months after receiving parenteral heparin anticoagulation therapy for the first 72 hours of treatment for an acute intermediate-risk PE.
Patients recruited must be 18 years of age or older, hemodynamically stable, and diagnosed with an acute intermediate-risk PE (N-terminal pro B-type natriuretic peptide levels >600 pg/mL). Dosage will start at 150 mg twice daily, with a dose of 110 mg twice daily for patients aged 80 years or older or who are also currently taking verapamil.
Primary outcomes include the occurrence of recurrent symptoms of venous thromboembolism or death within 6 months of therapy initiation related to a PE. All-cause mortality, duration of hospital stay, and the recovery of right ventricular function during 6 months of follow-up have been designated as secondary outcomes. Major bleeding, as defined by the International Society on Thrombosis and Haemostasis, is the primary safety outcome.
Enrollment is currently underway and is expected to be completed during the second quarter of 2019.
Clinicians should be aware of these findings, as they have the potential to "provide a deeper insight into [right ventricular] recovery after acute PE, and its implications for the long-term prognosis of the patients."
Klok FA, Ageno W, Barco S, et al; for the PEITHO-2 Investigators. Dabigatran after short heparin anticoagulation for acute intermediate-risk pulmonary embolism: rationale and design of the single-arm PEITHO-2 study. Thromb Haemost. 2017;117(12):2425-2434.