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.
Key findings include:
- The primary outcome occurred in seven (2% patients, with all events occurring in those with intermediate-high-risk pulmonary embolism (seven [3%]).
- At 6 months, 11 (3%) of 402 patients had at least one major bleeding event and 16 (4%) had at least one clinically relevant non-major bleeding event; the only fatal hemorrhage occurred in one (<1%) patient before the switch to dabigatran.
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."
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.