Dabigatran after Short Heparin Anticoagulation for Acute Intermediate-Risk Pulmonary Embolism: Rationale and Design of the Single-Arm PEITHO-2 Study
| Autor: | Joachim H. Ficker, Franck Verschuren, Irene M. Lang, Thomas Münzel, Guy Meyer, Matthias Held, Frederikus A. Klok, Antoniu Petris, Menno V. Huisman, Pompilio Faggiano, Stavros Konstantinides, David Jiménez, Matija Kozak, Anamaria Wolf-Puetz, Piotr Pruszczyk, Alexandre Ghuysen, Daniel Duerschmied, Kai-Helge Schmidt, Harald Binder, Mareike Lankeit, Peitho Investigators, Nazzareno Galiè, Sebastian Schellong, Kurt Quitzau, Stefano Barco, Klaus Empen, Branislav Stefanovic, Benjamin Brenner, Walter Ageno, Nadine Heydenreich |
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| Přispěvatelé: | Klok, Frederikus A, Ageno, Walter, Barco, Stefano, Binder, Harald, Brenner, Benjamin, Duerschmied, Daniel, Empen, Klau, Faggiano, Pompilio, Ficker, Joachim H, Galiè, Nazzareno, Ghuysen, Alexandre, Held, Matthia, Heydenreich, Nadine, Huisman, Menno V, Jiménez, David, Kozak, Matija, Lang, Irene M, Lankeit, Mareike, Münzel, Thoma, Petris, Antoniu, Pruszczyk, Piotr, Quitzau, Kurt, Schellong, Sebastian, Schmidt, Kai-Helge, Stefanovic, Branislav S, Verschuren, Franck, Wolf-Puetz, Anamaria, Meyer, Guy, Konstantinides, Stavros V |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
Risk medicine.medical_specialty pulmonary embolism Drug-Related Side Effects and Adverse Reactions medicine.medical_treatment Hemorrhage intermediate risk 030204 cardiovascular system & hematology Dabigatran 03 medical and health sciences Young Adult 0302 clinical medicine Recurrence Internal medicine Germany medicine Humans dabigatran 030212 general & internal medicine Prospective Studies Prospective cohort study Survival analysis venous thromboembolism recurrence business.industry Heparin Anticoagulants Hematology Thrombolysis Reference Standards medicine.disease Thrombosis Survival Analysis 3. Good health Pulmonary embolism right ventricular function Regimen Treatment Outcome Research Design major bleeding Acute Disease Female business medicine.drug Follow-Up Studies |
| Zdroj: | Thrombosis and Haemostasis, 117(12), 2425-2434 |
| Popis: | Patients with intermediate-risk pulmonary embolism (PE) may, depending on the method and cut-off values used for definition, account for up to 60% of all patients with PE and have an 8% or higher risk of short-term adverse outcome. Although four non-vitamin K-dependent direct oral anticoagulants (NOACs) have been approved for the treatment of venous thromboembolism, their safety and efficacy as well as the optimal anticoagulation regimen using these drugs have not been systematically investigated in intermediate-risk PE. Moreover, it remains unknown how many patients with intermediate-high-risk and intermediate-low-risk PE were included in most of the phase III NOAC trials. The ongoing Pulmonary Embolism International Thrombolysis 2 (PEITHO-2) study is a prospective, multicentre, multinational, single-arm trial investigating whether treatment of acute intermediate-risk PE with parenteral heparin anticoagulation over the first 72 hours, followed by the direct oral thrombin inhibitor dabigatran over 6 months, is effective and safe. The primary efficacy outcome is recurrent symptomatic venous thromboembolism or death related to PE within the first 6 months. The primary safety outcome is major bleeding as defined by the International Society on Thrombosis and Haemostasis. Secondary outcomes include all-cause mortality, the overall duration of hospital stay (index event and repeated hospitalizations) and the temporal pattern of recovery of right ventricular function over the 6-month follow-up period. By applying and evaluating a contemporary risk-tailored treatment strategy for acute PE, PEITHO-2 will implement the recommendations of current guidelines and contribute to their further evolution. |
| Databáze: | OpenAIRE |
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