6/29/23, 1:37 AM PEITHO Pathway Feedback Search Clinical Topics Home Studies PEITHO PEITHO DiseaseDeep vein thrombosis DiseasePulmonary embolism Trial question What is the role of tenecteplase in normotensive patients with intermediate-risk PE? Study design Multi-center Double blinded RCT Population Characteristics of study participants 53.0% female N = 1006 47.0% male 1006 patients (532 female, 473 male) Inclusion criteria: normotensive patients with intermediate-risk PE Key exclusion criteria: significant bleeding risk, coagulation disorder, administration of thrombolytic agents within the previous 4 days, uncontrolled hypertension, hypersensitivity to tenecteplase, alteplase, UFH, or pregnancy, lactation or parturition within the previous 30 days Interventions N=506 tenecteplase (fibrinolysis received as a single weight-based intravenous bolus of 30-50 mg tenecteplase given over a period of 5-10 seconds) N=500 placebo (a single intravenous bolus of the same volume and appearance as the bolus of tenecteplase) https://web.pathway.md/studies/rec7JTIz3bAhJ6odR 1/2 6/29/23, 1:37 AM PEITHO Pathway Primary outcome Death or hemodynamic decompensation at 7 days 5.6 % 5.6 4.2 % 2.8 % 2.6 Significant decrease 1.4 % NNT = 33 0.0 % Tenecteplase Placebo Significant decrease in death or hemodynamic decompensation at 7 days (2.6% vs. 5.6%; OR 0.44, 95% CI 0.23 to 0.87) Secondary outcomes No significant difference in death at 7 days (1.2% vs. 1.8%; OR 0.65, 95% CI 0.23 to 1.85) Significant decrease in the rate of hemodynamic compensation within 7 days (1.6% vs. 5%; OR 0.3, 95% CI 0.14 to 0.68) No significant difference in death at 30 days (2.4% vs. 3.2%; OR 0.73, 95% CI 0.34 to 1.57) Safety outcomes Significant differences in extracranial bleeding (6.3% vs. 1.2%, p < 0.001) and stroke (2.4% vs. 0.2%, p = 0.003). Conclusion In normotensive patients with intermediate-risk PE, tenecteplase was superior to placebo with respect to death or hemodynamic decompensation at 7 days. Reference Meyer G, Vicaut E, Danays T et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. Open reference URL https://web.pathway.md/studies/rec7JTIz3bAhJ6odR 2/2