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Scientific article
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Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism: Rationale and design of the PEITHO-3 trial

Publication date2021-09-24
First online date2021-09-24
Abstract

Intermediate high-risk pulmonary embolism (PE) is characterised by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent haemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of haemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International Trial (PEITHO)-3 study (EudraCT 2018-000816-96) is a randomised, placebo-controlled, double-blind, multicentre, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate high-risk PE will also fulfil at least one clinical criterion of severity: systolic blood pressure ≤ 110 mmHg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, haemodynamic decompensation or PE recurrence within 30 days of randomisation. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, haemodynamic decompensation, or stroke within 30 days; dyspnoea, functional limitation or RV dysfunction at 6 months and 2 years; and utilisation of healthcare resources within 30 days and 2 years. The study is planned to enrol 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.

eng
Keywords
  • Pulmonary embolism
  • Intermediate–high
  • Risk
  • Reduced
  • Dose thrombolysis
  • Prognosis
  • Randomized trial
Funding
  • KO 1939/3-1 - [Deutsche Forschnungsgemeinschaft]
  • PHRCN-16-0580 - [Programme hospitalier de recherche clinique]
Citation (ISO format)
SANCHEZ, Olivier et al. Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism: Rationale and design of the PEITHO-3 trial. In: Thrombosis and haemostasis, 2021. doi: 10.1055/a-1653-4699
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Article (Published version)
Identifiers
ISSN of the journal0340-6245
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Technical informations

Creation10/04/2021 1:07:00 PM
First validation10/04/2021 1:07:00 PM
Update time03/16/2023 2:40:31 AM
Status update03/16/2023 2:40:28 AM
Last indexation05/06/2024 9:56:53 AM
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