Table 1.

TRA-CER and TRA 2P-TIMI50: efficacy, bleeding, and net clinical outcome

Endpoint	Vorapaxar	Placebo	Hazard ratio (95% CI)	P value
TRA-CER [37]
n	6,473	6,471
Cardiovascular death, myocardial infarction, stroke, recurrent ischemia with hospitalization or urgent coronary revascularization	18.5	19.9	0.92 (0.85–1.01)	0.07
Cardiovascular death, myocardial infarction or stroke	14.7	16.4	0.89 (0.81–0.98)	0.02
Myocardial infarction	11.1	12.5	0.88 (0.79–0.98)	0.02
Death from any cause	6.5	6.1	1.05 (0.90–1.23)	0.52
GUSTO moderate or severe bleeding	7.2	5.2	1.35 (1.16–1.58)	<0.001
TIMI major or minor bleeding	6.5	4.0	1.56 (1.32–1.85)	<0.001
Intracranial hemorrhage	1.1	0.2	3.39 (1.78–6.45)	<0.001
TRA 2P-TIMI50 [38]
n	13,225	13,224
Cardiovascular death, myocardial infarction or stroke	9.3	10.5	0.87 (0.80–0.94)	<0.001
Cardiovascular death, myocardial infarction, stroke or urgent coronary revascularization	11.2	12.4	0.88 (0.82–0.95)	0.001
Myocardial infarction	5.2	6.1	0.83 (0.74–0.93)	0.001
Death from any cause	5.0	5.3	0.95 (0.85–1.07)	0.41
GUSTO moderate or severe bleeding	4.2	2.5	1.66 (1.43–1.93)	<0.001
Intracranial hemorrhage	1.0	0.5	1.94 (1.39–2.70)	<0.001
Cardiovascular death, myocardial infarction, stroke or GUSTO moderate or severe bleeding	11.7	12.1	0.97 (0.90–1.04)	0.40

Cumulative Kaplan–Meier event rates at 3 years

GUSTO Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries, n number of patients, TIMI thrombolysis in myocardial infarction, TRA 2P-TIMI50 Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events, TRA-CER Thrombin Receptor Antagonist for Clinical Event Reduction in ACS Trial