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Early switch to dabigatran safe for patients with intermediate-risk pulmonary embolism: PEITHO-2 trial
![Early switch to dabigatran safe for patients with intermediate-risk pulmonary embolism: PEITHO-2 trial Early switch to dabigatran safe for patients with intermediate-risk pulmonary embolism: PEITHO-2 trial](https://medicaldialogues.in/h-upload/2020/09/08/750x450_134266-acute-pulmonary-embolism.webp)
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."
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
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751