nifedipine in acute myocardial infarction (trent trial) (9292 patients admitted with ami)
DESCRIPTION
Weaknesses of major randomized trials: they are cleverly designed against coronary surgery. They are not representative of the daily practice (highly selected patient population), but their results are generalized for the whole population with CAD. - PowerPoint PPT PresentationTRANSCRIPT
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Weaknesses of major randomized trials: they are cleverly designed
against coronary surgery. They are not representative of the daily
practice (highly selected patient population), but their results are
generalized for the whole population with CAD.
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RANDOMIZATION IN ARTS TRIAL(Arterial Revascularization Therapy Study) University Hospital Zürich, April-December 1997 5/986 (0.5 %) patients
PTCA61.9%
CABG37.6%
Randomized0.5%
PTCA61.9%
CABG37.6%
Randomized0.5%
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STUDY ENROLLMENT IN MAJOR RANDOMIZED STUDIES COMPARING PTCA
TO CABG (91 730 patients) RITA, ERACI, GABI, EAST, CABRI AND BARI trials
Screened95.1%
Enrolled4.9%
Screened95.1%
Enrolled4.9%
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It is a well-known fact that patients recruited for trial have better survival
and better results than those eliminated from the trial because of some
exclusion criteria.
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NIFEDIPINE IN ACUTE MYOCARDIAL INFARCTION (TRENT TRIAL)
(9292 patients admitted with AMI)
18.2
26.8
6.3
9.36.7
10.2
0
5
10
15
20
25
30
Excluded Placebo Nifedipine
Mortality
Mortalitywith AMI
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When analyzing a trial, look carefully at “Material and Methods” section: crucial information explaining the
results might be found there.
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Serruys P et al. N Engl J Med 2009;360:961-972
Enrollment and Randomization of Patients with Previously Untreated Three-Vessel or Left Main Coronary Artery Disease in the SYNTAX Trial
2 years, 85 centres:10.6 patients/year
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Average number of patients seen by centres in Syntax trial is less than 11 patients/year!
If we accept the fact that “all comers” entered the trial, these centres should have been closed long ago, according to present
standard of PCI and CABG practice.
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Serruys P et al. N Engl J Med 2009;360:961-972
Cardiac-Related Medications Given after the Study Procedure
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A study with a radically different drug treatment protocols in the two analyzed groups is statistically
invalid.
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Difference in outcome in trials funded by for-profit and not-for-profit sources
JAMA 2006; 295(19):2270-4
49
3540
5057 55 54
6967 67 66
82
0
20
40
60
80
100
% p
ositi
ve
Not for profitMixedFor profit
p for trend < o.oo5
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Beware of industry sponsored trials! Results very often meet the
sponsor’s expectations!
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CABG MORTALITY RATES AMONG DIFFERENT SURGEONS: A PROSPECTIVE STUDY
JAMA 1991;266:803-809
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There is a major difference between swallowing a pill and performing a complex operation; this fact is not
appreciated by statisticians.
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Survival with CABG @ 3 years is 28.4 % higher!
Hannan E et al. N Engl J Med 2005;352:2174-2183
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Non-randomized observational trials can reach very important results, which are
presently ignored by the academia schooled in conventional statistics