Archive

Archive for April, 2012

ESC Taskforce on New Anticaogulants for Atrial Fibrillation and Acute Coronary Syndromes

A very useful review paper from the European Society of Cardiology Working Group on Thrombosis is available here.

Journal Club 18 April 2012

Article:

Low-Molecular-Weight Heparin and Mortality in Acutely Ill Medical Patients

Presenter

NS

PICO

Double blinded placebo controlled randomized clinical trial (8307 patients)

Population

hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia,Mexico, the Philippines, and Tunisia

Intervention

subcutaneous enoxaparin (40 mg daily) on top of standard care (including elastic stockings with graduated compression)

Comparator

Placebo on top of standard care (including elastic stockings with graduated compression)
There was significant discussion regarding thromboembolism prophylaxis in medical patients using enoxaparin.

Outcome

The primary efficacy outcome was the rate of death from any cause at 30 days
after randomization. The primary safety outcome was the rate of major bleeding
during and up to 48 hours after the treatment period.
Findings (from paper)

Results

A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic
stockings with graduated compression (4171 patients) or placebo plus elastic stockings
with graduated compression (4136 patients) and were included in the intentionto-
treat population. The rate of death from any cause at day 30 was 4.9% in the
enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95%
confidence interval [CI], 0.8 to 1.2; P = 0.83). The rate of major bleeding was 0.4%
in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7
to 3.1; P = 0.35).

Conclusions

The use of enoxaparin plus elastic stockings with graduated compression, as compared
with elastic stockings with graduated compression alone, was not associated with
a reduction in the rate of death from any cause among hospitalized, acutely ill medical
patients.

Discussion Summary 

  • what is the evidence for compression stockings?: note Cochrane reviews and meta-analyses
  • is there a difference in outcome between below knee and above knee stockings?
  • The MEDENOX trial primary end-point was venographic or ultrasound  deep venous thrombosis. There was a lower mortality (11 vs 14% , p=NS, low event rate) but only 3 fatal pulmonary embolism. Case for reducing mortality or fatal or massive pulmonary embolism for enoxaparin 40 mg per day not made. Note some of the event differences may have been reduction of other cardiovascular events such as myocardial infarction
  • current paper shows no difference in mortality in medical patient group between compression stockings and compression stockings and enoxaparin 40 mg subcutaneously. Unadjudicated bleeding was higher but not adjudicated bleeding events
  • how strong is the evidence of thromboembolism prohylaxis with enoxaparin in the surgical literature for: mortality, pulmonary embolism
  • rivaroxaban trials with enoxaparin as comparator: no advantage in medical patients but increased bleeding
  • apparently policy with incentives for routine prescribing of enoxaparin in medical patients is in place: on the  basis of the evidence presented the rationale for this was questioned

The presenter also provided this relevant link from theheart.org.

Journal club 11 April 2012

Article:


Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale

Presenter

SP

PICO

Population:

patients between 18 and
60 years of age who presented with a cryptogenic stroke or transient ischemic attack
(TIA) and had a patent foramen ovale

Intervention

StarFlex PFO closure device

Comparator

Medical therapy: aspirin alone, warfarin alone, aspirin and warfarin (at discretion of investigator)

Outcome

The primary end point was a composite of
stroke or transient ischemic attack during 2 years of follow-up, death from any
cause during the first 30 days, or death from neurologic causes between 31 days
and 2 years
Findings
A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan–
Meier estimate) of the primary end point was 5.5% in the closure group (447 patients)
as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard
ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P = 0.37). The respective rates were
2.9% and 3.1% for stroke (P = 0.79) and 3.1% and 4.1% for TIA (P = 0.44). No deaths
occurred by 30 days in either group, and there were no deaths from neurologic
causes during the 2-year follow-up period. A cause other than paradoxical embolism
was usually apparent in patients with recurrent neurologic events.

Discussion Summary 

  • This was a negative trial.
  • The issues of being under-powered.
  • The high frequency of alternative explanations for stroke were noted/
  • The increased frequency of atrial fibrillation in the device group compared with medical therapy and the transesophageal echocardiographic’device associated thrombus’ are concerning and suggest that medical therapy is in general the preferred initial strategy.

 

 

See also previous post.

Giant cell myocarditis references

The education session 10 April 2012 involved presentation of a patient with giant cell myocarditis.

A small collection of references is linked as follows:

 

Any other papers or materials are welcome.

Journal Club 4 April 2012

Article:


CT Angiography for Safe Discharge of Patients with Possible Acute Coronary Syndromes

Presenter

JFY

PICO

Multicentre US randomised clinical trial

Population:

Low to intermediate risk patients with possible acute coronary syndrome (age>30 and TIMI score 0 to 2)

Intervention

CT Coronary Angiography

Comparator

Traditional care

Outcome

The primary outcome
was safety, assessed in the subgroup of patients with a negative CCTA examination,
with safety defined as the absence of myocardial infarction and cardiac death
during the first 30 days after presentation.

Findings

1370 subjects: 908 in the CCTA group and 462 in the group receiving traditional
care. The baseline characteristics were similar in the two groups. Of 640 patients
with a negative CCTA examination, none died or had a myocardial infarction
within 30 days (0%; 95% confidence interval [CI], 0 to 0.57). As compared with patients
receiving traditional care, patients in the CCTA group had a higher rate of discharge
from the emergency department (49.6% vs. 22.7%; difference, 26.8 percentage
points; 95% CI, 21.4 to 32.2), a shorter length of stay (median, 18.0 hours vs.
24.8 hours; P<0.001), and a higher rate of detection of coronary disease (9.0% vs.
3.5%; difference, 5.6 percentage points; 95% CI, 0 to 11.2). There was one serious
adverse event in each group.

Conclusions

A CCTA-based strategy for low-to-intermediate-risk patients presenting with a possible
acute coronary syndrome appears to allow the safe, expedited discharge from the
emergency department of many patients who would otherwise be admitted.