Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial

医学 中期分析 达比加群 内科学 肺栓塞 临床试验 低分子肝素 人口 深静脉 华法林 肝素 拜瑞妥 血栓形成 外科 心房颤动 环境卫生
作者
Frederikus A. Klok,Gerrit Toenges,Anna C. Mavromanoli,Stefano Barco,Walter Ageno,Hélène Bouvaist,Marianne Brodmann,Claudio Cuccia,Françis Couturaud,Claudia Dellas,Konstantinos Dimopoulos,Daniel Duerschmied,Klaus Empen,Pompilio Faggiano,Émile Ferrari,Nazzareno Galiè,Marcello Galvani,Alexandre Ghuysen,George Giannakoulas,Menno V. Huisman,David Jiménez,Matija Kozak,Iréne Lang,Mareike Lankeit,Nicolas Méneveau,Thomas Münzel,Massimiliano Palazzini,Antoniu Octavian Petriş,Giancarlo Piovaccari,Aldo Salvi,Sebastian Schellong,Kai‐Helge Schmidt,Franck Verschuren,Irene Schmidtmann,Guy Meyer,Stavros Konstantinides,Jaime Antonio,Abelaira Freire,Walter Ageno,İbrahim Akın,Toni Anušić,Laurent Bertoletti,Dorothea Becker,Laurent Bertoletti,Giuseppe Bettoni,Harald Binder,Marianne Brodmann,Hélène Bouvaist,Joachim H. Ficker,Claudio Cuccia,Françis Couturaud,Claudia Dellas,Giuseppe Sangiorgi,Konstantinos Dimopoulos,Daniel Duerschmied,Klaus Empen,Iolanda Enea,Pompilio Faggiano,Émile Ferrari,Joachim H. Ficker,Nazzareno Galiè,Marcello Galvani,Sabine Genth‐Zotz,George Giannakoulas,Philippe Girard,Stanislav Gorbulev,Alexandre Ghuysen,Matthias Held,Lukas Hobohm,Nazzareno Galiè,David Jiménez,Frederikus A. Klok,Stavros Konstantinides,Matija Kozak,Kai Kronfeld,Iréne Lang,Mareike Lankeit,Walter Lehmacher,Concepcion Patricia Lopez Miguel,Nadine Martin,Anna C. Mavromanoli,Nicolas Méneveau,Guy Meyer,Thomas Münzel,Massimiliano Palazzini,Roman Parežnik,Antoniu Octavian Petriş,Giancarlo Piovaccari,Kurt Quitzau,Irinel Raluca Parepa,Purificación Ramírez Martín,Marc Righini,Aldo Salvi,Sebastian Schellong,Kai‐Helge Schmidt,Irene Schmidtmann,Gerrit Toenges,Silviu Bogdan Todea,Adam Torbicki,Luca Valerio,Thomas Vanassche,Franck Verschuren,L Vida-Simiti,Anamaria Wolf-Pütz
出处
期刊:The Lancet Haematology [Elsevier BV]
卷期号:8 (9): e627-e636 被引量:12
标识
DOI:10.1016/s2352-3026(21)00203-9
摘要

Background Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether 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), is effective and safe. Methods We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. Adult patients (aged ≥18 years) with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis, were enrolled. 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. 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. The study was terminated early, as advised by the data safety and monitoring board, following sample size adaptation after the predefined interim analysis on Dec 18, 2018. This trial is registered with the EU Clinical Trials Register (EudraCT 2015-001830-12) and ClinicalTrials.gov (NCT02596555). Findings Between Jan 1, 2016, and July 31, 2019, 1418 patients with pulmonary embolism were screened, of whom 402 were enrolled and were included in the intention-to-treat analysis (median age was 69·5 years [IQR 60·0–78·0); 192 [48%] were women and 210 [52%] were men). Median follow-up was 217 days (IQR 210–224) and 370 (92%) patients adhered to the protocol. 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 those with intermediate-high-risk pulmonary embolism (seven [3%; upper bound of right-sided 95% CI 5] of 283). At 6 months, 11 (3% [95% CI 1–5]) of 402 patients had at least one major bleeding event and 16 (4% [2–6]) had at least one clinically relevant non-major bleeding event; the only fatal haemorrhage occurred in one (<1%) patient before the switch to dabigatran. Interpretation A strategy of early switch from heparin to dabigatran following standard clinical assessment was effective and safe in patients with intermediate-risk pulmonary embolism. 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. Funding German Federal Ministry of Education and Research, University Medical Center Mainz, and Boehringer Ingelheim.
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