"Tenecteplase in Normotensive Patients with Pulmonary Embolism". The New England Journal of Medicine. 2014. 370(15):1402-1411. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
In normotensive patients with intermediate-risk pulmonary embolism, does treatment with tenecteplase in addition to anticoagulation improve clinical outcomes?
In normotensive patients with intermediate-risk pulmonary embolism, tenecteplase treatment reduced the primary composite outcome of death or hemodynamic decompensation compared to placebo, but increased the risk of major hemorrhage and stroke.
Fibrinolytic therapy for pulmonary embolism (PE) is debated, particularly for patients with intermediate-risk PE who are normotensive but have right ventricular dysfunction or myocardial injury. The Pulmonary Embolism Thrombolysis (PEITHO) trial assessed the role of the fibrinolytic agent tenecteplase in this patient population.
As of the last knowledge update, specific guidelines reflecting the results of this trial were not referenced.
- Multicenter, double-blind, placebo-controlled randomized trial - N=1,005 participants with intermediate-risk PE - Tenecteplase + heparin (n=506) - Placebo + heparin (n=499) - Setting: 76 sites in 13 countries - Enrollment: November 2007 to July 2012 - Follow-up: 30 days - Analysis: Intention-to-treat - Primary outcome: Death or hemodynamic decompensation within 7 days
Inclusion Criteria: - Age ≥18 years - Confirmed acute PE with symptom onset within 15 days - Echocardiography or CT showing right ventricular dysfunction - Positive cardiac troponin I or T test
Exclusion Criteria: - Systolic blood pressure <90 mm Hg or drop ≥40 mm Hg for >15 minutes - Active internal bleeding - Ischemic stroke within preceding 2 months
Baseline Characteristics: - Median age: 70 years - Female: 44.5% - Normotensive at randomization
- Tenecteplase: single weight-based intravenous bolus (30-50 mg) - Placebo: intravenous bolus of the same volume and appearance as tenecteplase - Both groups received unfractionated heparin according to protocol
Primary Outcomes: - Death or hemodynamic decompensation within 7 days: 2.6% (tenecteplase) vs. 5.6% (placebo); OR 0.44 [95% CI, 0.23 to 0.87]; P=0.02
Secondary Outcome: - Death within 7 days: 1.2% vs. 1.8%; P=0.42 - Death within 30 days: 2.4% vs. 3.2%; P=0.42
- Study not powered to detect differences in death rates, which were infrequent. - Hemodynamic decompensation had a broad definition, including persistent hypotension without overt clinical compromise. - Intracranial and major bleeding rates may limit the practical use of fibrinolytic therapy in intermediate-risk PE.
Supported by Programme Hospitalier de Recherche Clinique in France, the Federal Ministry of Education and Research in Germany, and a grant from Boehringer Ingelheim.
- Konstantinides, Stavros V., et al. "Fibrinolysis for patients with intermediate-risk pulmonary embolism." New England Journal of Medicine 370.15 (2014): 1402-1411.