2. Fibrinolysis for Patients with
Intermediate Risk Pulmonary
Embolism
PEITHO Trial
Published in N Engl J Med 2014; 370:1402-1411
April 10 2014
by Meyer et al
3. Background
Acute right ventricular pressure overload –
determinant of severity and clinical outcome for
PE
Submassive PE/Intermediate risk -
controversial
4. Clinical Question
Among patients with submassive PE being
treated with unfractionated heparin, does
administration of tenecteplase reduce all-cause
mortality or hemodynamic decompensation at
7 days when compared to placebo?
5. Design
Multicenter, randomised, double-blind, placebo
controlled trial
N = 1,005
Tenecteplase (n=506)
Placebo (n=499)
Setting : 76 centers in 13 countries
Enrollment : 2007 – 2012
Follow up : 30 days
Analysis : Intention to treat
6. Population
Inclusion Criteria
≥ 18 yr old
Confirmed PE with
symptoms ≤ 15 days
RV dysfunction as
defined by
(RVID/LVID >0.9)
ECHO
CT Angio
Elevated Trop
Exclusion Criteria
Hemodynamic
collapse
Coagulopathy
Use of
thrombolytics/IVC
filters/p.
thrombectomy in
prior 4 days
Uncontrolled HTN
7. Intervention
Tenecteplase 30mg-50 mg IV – by weight
Control
Placebo
Both group initiated on UFH immediately after
randomisation with goal aPTT 2.0-2.5X
8. Results
Primary Outcome
All cause mortality or hemodynamic
decompesation at 7 days
Thrombolysis 2.6% vs Placebo 5.6% (p=0.02,
NNT=33)
9. Results
Secondary Outcome
All cause mortality at 7 days
Thrombolysis 1.2% vs Placebo 1.8% (p=0.42)
All cause mortality at 30 days
Thrombolysis 2.4% vs Placebo 3.2% (p=0.42)
Hemodynamic decompensation at 7 days
Thrombolysis 1.6% vs Placebo 5.0% (p=0.002,
N=29)
Recurrent PE at 7 days
Thrombolysis 0.2% vs Placebo 1.0% (p=0.12)
10. Results
Adverse Events
Bleeding at 7 days
Major Extracranial
Thrombolysis 6.3% vs Placebo 1.3 % (p<0.001, NNH
= 20)
Stroke at 7 days
Thrombolysis 2.4% vs Placebo 0.2 % (p=0.003,
NNH = 45)
12. Conclusion
Those intermediate risk PE, primary outcome of
early death or hemodynamic decompensation
was reduced after treatment with thrombolysis
but associated with significant increase in risk
of intracranial and other major bleeding
13. Questions
What is the primary outcome of this study? Do
you think this is appropriate?
What is intention to treat analysis? Give two
advantages and two disadvantages of this
method of analysis.
At the end of this journal club, Dr Jo Mower asks
you whether it should be introduced in your
department. Give reasons to support your
stand.
14. THANK YOU
Next Journal Club on 26 August 2015
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