The Pulmonary Embolism International Thrombolysis Study (PEITHO)-1 was a large multinational, randomized, investigator initiated and academically sponsored trial which set out to determine whether normotensive, intermediate-risk patients with confirmed pulmonary embolism (PE) and right ventricular dysfunction, detected by echocardiography or CT, plus evidence of myocardial injury indicated by a positive troponin test, may benefit from early thrombolytic treatment (tenecteplase).
The primary efficacy end point was a clinical composite end point of all-cause mortality or haemodynamic collapse within the first 7 days. Safety end points were total strokes (intracranial haemorrhage or ischaemic stroke) within 7 days, and major bleeds (other than intracranial haemorrhage) within 7 days.
PEITHO was conducted at 76 sites in 13 countries and enrolled a total of 1006 patients. The study was funded through grants from the German government (Federal Ministry of Education and Research) and from the French Ministry of Health, and supported by Boehringer Ingelheim. It was published in the New England Journal of Medicine in 2014
The Pulmonary Embolism International Study (PEITHO)-2 is a prospective, multicenter, phase IV, single-armed (management) trial that has been designed to address clinically relevant unresolved issues in the management of patients with intermediate-risk pulmonary embolism (PE). Risk stratification of PE is based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations, as recommended by the 2014 ESC guidelines. The primary objective of the study is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months, is effective and safe. The secondary objective is to assess the recovery of right ventricular function over the first days of treatment, and to evaluate its importance for the 6-month prognosis of patients with intermediate-risk PE. Approximately 700 patients with acute symptomatic intermediate-risk PE will be included in 40 hospitals across Europe. The study is planned to enrol its first patient in the fourth quarter of 2015.
PEITHO-2 Steering Committee and National Coordinators: Stavros Konstantinides, Germany (PI); Guy Meyer, France (Co-PI); Jan Beyer-Westendorf, Germany; Michael Christ, Germany; Daniel Dürschmied, Germany; Klaus Empen, Germany; Nazzareno Galiè, Italy; Matthias Held, Germany; Menno Huisman, The Netherlands; David Jiménez, Spain; Frederikus Klok, The Netherlands; Matija Kozak, Slovenia; Irene Lang, Austria; Nicolas Meneveau, France; Piotr Pruszczyk, Poland; Sebastian Schellong, Germany; Branislav Stefanovic, Serbia; Adam Torbicki, Poland; Franck Verschuren, Belgium