PEITHO
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
47.0% male
N = 1005
1005 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=499 placebo (a single intravenous bolus of the same volume and appearance as the bolus of tenecteplase).
Primary outcome
Death or hemodynamic decompensation at 7 days
2.6%
5.6%
5.6 %
4.2 %
2.8 %
1.4 %
0.0 %
Tenecteplase
Placebo
Significant
decrease ▼
NNT = 33
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.
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