Early switch to dabigatran safe for patients with intermediate-risk pulmonary embolism: PEITHO-2 trial

Germany: An early switch from heparin to dabigatran in patients with intermediate-risk pulmonary embolism is safe and effective, show results from the phase 4 PEITHO-2 trial.

The study results were published in The Lancet Haematology on August 04, 2021. 

For the management of acute pulmonary embolism, the current guidelines recommend a risk-adjusted treatment strategy. However, in this specific patient category, optimal treatment (reperfusion strategies, (anticoagulant treatment, and duration of hospitalization) is currently unknown. Considering this, Frederikus A Klok, Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands, and colleagues aimed to investigate the safety and effectiveness of the treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran). 

The phase 4 PEITHO-2 trial was a single-arm, multinational trial occurring at 42 hospitals across Europe. It enrolled adult 402 patients (aged ≥18 years) with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis. Patients received parenteral low-molecular-weight or unfractionated heparin for 72 h after diagnosis of pulmonary embolism before switching to oral dabigatran 150 mg twice per day following a standard clinical assessment. Median follow-up was 217 days and 370 (92%) patients adhered to the protocol. 

The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months. The primary and safety outcomes were assessed in the intention-to-treat population. Following the advice of the data safety and monitoring board, the study was terminated early after a change in sample size based on the predefined interim analysis.

The researchers concluded, "Our results can help to refine guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, optimizing the use of resources and avoiding extended hospitalization." 

Reference:

The study titled, "Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial," is published in The Lancet Haematology.

DOI: https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(21)00203-9/fulltext