Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2) : a multinational, multicentre, single-arm, phase 4 trial
| Autor: | Frederikus A Klok, Gerrit Toenges, Anna C Mavromanoli, Stefano Barco, Walter Ageno, Hélène Bouvaist, Marianne Brodmann, Claudio Cuccia, Francis Couturaud, Claudia Dellas, Konstantinos Dimopoulos, Daniel Duerschmied, Klaus Empen, Pompilio Faggiano, Emile Ferrari, Nazzareno Galiè, Marcello Galvani, Alexandre Ghuysen, George Giannakoulas, Menno V Huisman, David Jiménez, Matija Kozak, Irene Marthe Lang, Mareike Lankeit, Nicolas Meneveau, Thomas Münzel, Massimiliano Palazzini, Antoniu Octavian Petris, Giancarlo Piovaccari, Aldo Salvi, Sebastian Schellong, Kai-Helge Schmidt, Franck Verschuren, Irene Schmidtmann, Guy Meyer, Stavros V Konstantinides, Jaime Antonio, Abelaira Freire, Ibrahim Akin, Toni Anusic, Dorothea Becker, Laurent Bertoletti, Giuseppe Bettoni, Harald Binder, Regina Carels, Giuseppe Di Pasquale, Daniel Dürschmied, Iolanda Enea, Joachim Ficker, Sabine Genth-Zotz, Philippe Girard, Stanislav Gorbulev, Matthias Held, Lukas Hobohm, Menno V. Huisman, Frederikus A. Klok, Stavros V. Konstantinides, Kai Kronfeld, Walter Lehmacher, Concepcion Patricia Lopez Miguel, Nadine Martin, Anna Mavromanoli, Roman Pareznik, Kurt Quitzau, Irinel Raluca Parepa, Purificacion Ramirez Martin, Marc Righini, Silviu Bogdan Todea, Adam Torbicki, Luca Valerio, Thomas Vanassche, Luminita Animarie Vida-Simiti, Anamaria Wolf-Pütz |
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| Přispěvatelé: | Klok, Frederikus A., Toenges, Gerrit, Mavromanoli, Anna C., Barco, Stefano, Ageno, Walter, Bouvaist, Hélène, Brodmann, Marianne, Cuccia, Claudio, Couturaud, Franci, Dellas, Claudia, Dimopoulos, Konstantino, Duerschmied, Daniel, Empen, Klau, Faggiano, Pompilio, Ferrari, Emile, Galiè, Nazzareno, Galvani, Marcello, Ghuysen, Alexandre, Giannakoulas, George, Huisman, Menno V., Jiménez, David, Kozak, Matija, Lang, Irene Marthe, Lankeit, Mareike, Meneveau, Nicola, Münzel, Thoma, Palazzini, Massimiliano, Petris, Antoniu Octavian, Piovaccari, Giancarlo, Salvi, Aldo, Schellong, Sebastian, Schmidt, Kai-Helge, Verschuren, Franck, Schmidtmann, Irene, Meyer, Guy, Konstantinides, Stavros V. |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Population Administration Oral Hemorrhage 030204 cardiovascular system & hematology Drug Administration Schedule Dabigatran 03 medical and health sciences 0302 clinical medicine Risk Factors Internal medicine medicine Humans 030212 general & internal medicine education Aged Aged 80 and over education.field_of_study RIGHT-VENTRICULAR DYSFUNCTION VENOUS THROMBOEMBOLISM DABIGATRAN MANAGEMENT WARFARIN HOSPITALIZATION RATIONALE HEPARIN DESIGN Heparin business.industry Anticoagulants Venous Thromboembolism Hematology Guideline Middle Aged Interim analysis medicine.disease Thrombosis 3. Good health Pulmonary embolism Clinical trial Treatment Outcome Female Pulmonary Embolism business Follow-Up Studies medicine.drug |
| Zdroj: | Lancet Haematology, 8(9), E627-E636. ELSEVIER SCI LTD |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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