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Pulmonary EmbolIsm THrOmbolysis (PEITHO)-1 Trial

First International Trial: Fibrinolysis for patients with intermediate-risk pulmonary embolism

The Pulmonary Embolism International Thrombolysis Study (PEITHO) 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

Two-year follow-up of randomized patients has also been completed; the results will be available shortly.