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JOURNAL CLUBBy Nicholas Ngua
Emergency UnitUHW
Fibrinolysis for Patients with Intermediate Risk Pulmonary EmbolismPEITHO Trial
Published in N Engl J Med 2014; 370:1402-1411 April 10 2014
by Meyer et al
Background Acute right ventricular pressure overload –
determinant of severity and clinical outcome for PE
Submassive PE/Intermediate risk - controversial
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?
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
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
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
Results Primary Outcome
All cause mortality or hemodynamic decompesation at 7 days
Thrombolysis 2.6% vs Placebo 5.6% (p=0.02, NNT=33)
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)
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)
Results Subgroup Analysis (Death & Hemodynamic
Decompensation) ≤ 75 yrs : Thrombolysis 1.7% vs Placebo 5.1% > 75 yrs : Thrombolysis 4.3% vs Placebo 6.7%
p=0.36 Subgroup Analysis (Major Extracranial Bleeding)
≤ 75 yrs : Thrombolysis 4.1% vs Placebo 1.5% > 75 yrs : Thrombolysis 11.1% vs Placebo 0.6%
p=0.09
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
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.
THE HEART PATHWAYRANDOMISED TRIALIdentifying Emergency Department Patients With Acute Chest Pain for Early Discharge
Circ Cardiovasc Qual Outcomes. 2015;8:195-203, published online before print March 3 2015
by Mahler et al
Background US trial AHA guideline - objective cardiac testing for low
risk - resource, low pick up rate Observational study using HEART pathway able
to early discharge >20% patients with acute chest pain
with negative predictive value (NPV) for a MACE >99% at 30 days
Clinical Question Can HEART Pathway meaningfully reduce
objective cardiac testing, increase early discharges and reduce index hospital length of stay compared with usual care while maintaining high sensitivity & NPV (99%) for MACE ?
Design Randomised Controlled, Single-center N = 282
HEART Pathway (n=141) Usual Care (n=141)
Setting : Tertiary academic center in US (104,000 patients per year with 24hr consultant cover)
Convenience Sampling (6 days excluding Saturday, 80 hours per week)
Stratified Randomisation (presence of known coronary disease including previous revascularisation)
Enrollement : Sept 2012 – Feb 2014
Population
Inclusion Criteria ≥ 21 yr old ACS symptoms ECG Troponin (ADVIA Centaur
platorm TnI-Ultra assay)
Exclusion Criteria New STE Hypotension Life expectancy < 1 yr Non cardiac Previous enrollment Non English speaking Incapacity/unwilling
to consent
Test Under Investigation The HEART Pathway
Gold Standard Usual Care No protocol Encouraged to follow ACC/AHA Guideline
Results Primary Outcome
Rate of objective cardiac testing within 30 days HEART Pathway 56.7% vs Usual Care 68.8%
(p=0.048)
Results Secondary Outcome
Early discharge rate HEART Pathway 39.7% vs Usual Care 18.4%
(p=0.0001) Index LOS
HEART Pathway 9.9 hours vs Usual Care 21.9 hours (p=0.013)
Safety Events MACE within 30 days
0 in all low risk HEART Pathway (n=66)
Conclusion Use of HEART Pathway significantly decreased
objective testing, early discharge rate of ~40 %, cut median LOS by 12 hours.
No MACE at 30 days
Questions Comment on the trial randomisation What is allocation concealment? Was this
present in this study? Give three strengths & three limitations of this
trial At the end of this journal club, Dr Jo Mower asks
you whether it should be introduced in your department. Give four reasons why you might want to institute in your department
THANK YOU Next Journal Club on 26 August 2015 Feedback on how to improve journal club