Safety and Efficacy of Low Molecular Weight Heparin followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism: an international multicentre management study (PEITHO-2)

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Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. In a multinational, multicentre, single-arm, phase 4 trial, adult patients with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis, received parenteral low-molecular-weight or unfractionated heparin for 72 h after diagnosis before switching to oral dabigatran 150 mg twice per day following a standard clinical assessment. The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months. The study was terminated early, following sample size adaptation after the predefined interim analysis. Between Jan 1, 2016, and July 31, 2019, 1418 patients with pulmonary embolism were screened, of whom 402 were enrolled and included in the intention-to-treat analysis (median age of 69.5 years). Median follow-up was 217 days and median duration of hospitalization was 6 days. The primary outcome occurred in seven (2% [upper bound of right-sided 95% CI 3]; p<0.0001 for rejecting the null hypothesis) patients, with all events occurring in the intermediate-high-risk group. At 6 months, 11 (3% [95% CI 1–5]) patients had at least one major bleeding. Our results can help to refine guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, optimising the use of resources and avoiding extended hospitalisation.