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Triton timi 38
1. TRITON - TIMI 38
AHA 2007
Orlando, Florida
TRIAL TO ASSESS IMPROVEMENT IN THERAPEUTIC
OUTCOMES BY OPTIMIZING PLATELET INHIBITION
WITH PRASUGREL – THROMBOLYSIS IN MYOCARDIAL
INFARCTION 38
DR. SBAM. MUJAHITH
MEDICAL REGISTRAR
NHSL
7. Major Exclusion Criteria
Severe comorbidity
Increased bleeding risk
Prior hemorrhagic stroke or any stroke < 3 months
Any thienopyridine within 5 days
No exclusion for advanced age or renal function
8. Enrollment: Nov 2004 - Jan 2007
Argentina (195) Finland (116) New Zealand (49)
Australia (217) France (146) Poland (1938)
Austria (182) Germany (999) Portugal (67)
Belgium (287) Hungary (695) Slovakia (140)
Brazil (225) Iceland (10) South Africa (404)
Canada (251) Israel (1219) Spain (178)
Chile (114) Italy (782) Sweden (154)
Czech Rep (340) Latvia (21) Switzerland (136)
Denmark (33) Lithuania (54) United Kingdom (73)
Estonia (134) Netherlands (390) United States (4059)
30 Countries 707 Sites
9. Median duration of therapy – 14.5 months
Double-blind
ACS (STEMI or UA/NSTEMI) & Planned PCI
ASA
PRASUGREL
60 mg LD/ 10 mg MD
CLOPIDOGREL
300 mg LD/ 75 mg MD
N= 13,608
Study Design
10. End Points
Primary efficacy end points: CV death/MI/stroke
Secondary efficacy end points: CV death, MI, Stroke,
Rehospitalization due to cardiac ischaemic event, UTVR
Key safety end point: TIMI major bleeding not related to CABG
14. Results of the study
1. Prasugrel compared with clopidogrel significantly reduced
the incidence of the primary endpoint, the composite of the rate
of cardiovascular death, myocardial infarction, or stroke from
12.1 to 9.9% (hazard ratio: 0.81; P < 0.001)
15. 2. Significant benefit of prasugrel was found during the first 3
days (hazard ratio: 0.82; P = 0.01) and from day 4 to the end of
the study (hazard ratio: 0.8; P = 0.003)
16. 3. Of the patients treated with prasugrel, 2.4% experienced
at least one TIMI major haemorrhage unrelated to coronary
artery bypass graft, compared with 1.8% treated with
clopidogrel (hazard ratio: 1.32; P = 0.03)
17. 4. Thus, in the entire study group, the balance of efficacy
and safety was in favour of prasugrel with an absolute
2.2% reduction in the primary efficacy endpoint by
prasugrel when compared with clopidogrel that was
opposed by an only 0.6% increase in major haemorrhage.
24. Bleeding events over 15 months
Major
non-CABG
Life
threatening
Intra-cranial
haemorrhage
Minor
non-CABG
Major or minor
non-CABG
Major or minor
CABG/non-CABG
Proportionofpopulation(%)
2.1
1.1
0.3
2.7
4.7 4.8
2.4
1.3
0.2
2.8
5.1
5.9
0
1
2
3
4
5
6
7
Clopidogrel
Prasugrel
p=NS
p=NS
p=NS
p=NS
p=NS
p=NS
25. Net clinical benefit at 15 months
14.6 14.7
12.2 12.5
0
2
4
6
8
10
12
14
16
18
p=0.02
NNT=42
Death / non-fatal MI /
non-fatal stroke or
major non-CABG bleeding
Death / MI /stroke/
major bleeding
(CABG and non-CABG)
p=0.04
NNT=45
Clopidogrel
Prasugrel
Proportionofpopulation(%)
26. In post hoc subgroup analyses, following major
subgroups showed less clinical benefit or clinical
harm:
1. Patients with a history of stroke or transient
ischemic attack before enrollment
2. The elderly (age ≥75 years)
3. Those with a body weight of less than 60 kg
29. Conclusion
In conclusion, in patients with acute coronary syndromes undergoing
PCI, prasugrel significantly reduced the incidence of ischaemic
events, both in the acute and long term. Prasugrel was associated
with an increased risk of bleeding. In the entire cohort, the
superior efficacy of prasugrel outweighed the increased risk
of bleeding.
30. "Prasugrel appears to be particularly potent, with the danger of
serious bleeding in patients who undergo CABG or who have
cerebrovascular disease. It will also be interesting to see how well
this drug is tolerated in the real treatment world."
Dr Eric Topol
31. "The holy grail of antithrombotic drug development is
balancing improved efficacy against the risk of increased
bleeding. It appears that prasugrel has fallen short in this
regard."
Dr Sanjay Kaul