http://www.theheart.org/web_slides/1384319.do Trial on Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2ºP-TIMI 50) to assess the effects of vorapaxar in preventing heart attack and stroke in patients with atherosclesis

1. TRA 2ºP-TIMI 50 (Thrombin Receptor
Antagonist in Secondary Prevention of
Atherothrombotic Ischemic Events)

2. TRA 2ºP-TIMI 50 (Thrombin Receptor Antagonist in
Secondary Prevention of Atherothrombotic Ischemic Events)
D Morrow (Brigham and Women's Hospital, Boston, MA)
American College of Cardiology 2012 Scientific Sessions
• Trial to assess the effects of vorapaxar in preventing heart attack and stroke in
patients with atherosclerosis
• Population and treatment:
26 449 patients with a history of atherosclerotic disease
Randomized to vorapaxar 2.5 mg per day or placebo
• Primary outcome:
First occurrence of any component of the composite of CV death, MI, stroke,
and urgent coronary revascularization

3. TRA 2ºP-TIMI 50: Results (efficacy)
• After a median follow-up of 2.5 years, there was a significant 13% relative
reduction in the primary efficacy end point for the whole patient population
• The reduction was slightly larger in the patients without a history of stroke
Primary end point: CV death/MI/stroke
Group Vorapaxar (%) Placebo (%) HR (95%) p
All patients (n=26 449) 9.3 10.5 0.87 (0.80–094) <0.001
No prior stroke (n=20 699) 8.3 9.6 0.84 (0.76–0.93) <0.001

4. TRA 2ºP-TIMI 50: Results (safety)
• All measures of major bleeding, including ICH, increased with vorapaxar in the
total population but were less severe with vorapaxar in patients without prior stroke
Increase in bleeding with vorapaxar vs placebo
Outcome Absolute increase (%) HR p
In patients with history of stroke (n=5746)
TIMI non–CABG-related major bleeding 2.0 1.87 <0.001
ICH 1.5 2.55 <0.001
Fatal 0.2 1.48 0.46
In patients without history of stroke (n=20 699)
TIMI non–CABG-related major bleeding 0.7 1.35 0.005
ICH 0.2 1.55 0.049
Fatal 0.1 1.44 0.30

5. TRA 2ºP-TIMI 50: Commentary*
"This is the first time we have seen a definitive additional benefit on top of aspirin in
post-MI patients with stable atherosclerotic disease."
- Dr David Morrow
"It would not be in my personal medical chest. The number need to treat (to prevent
one event) is high and the risks are not minor."
- Dr Eduardo Marban
"I would rather think about individual patients than numbers needed to treat. This is
clearly a drug that needs individualized treatment."
- Dr David Holmes
*All comments from TRA 2°P-TIMI 50: Future possible for vorapaxar in patients with prior MI?
(http://www.theheart.org/article/1373903.do)

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