Table 2.

Efficacy and safety findings from the PLATO trial at 12 months [40]

Outcome (%)	Ticagrelor	Clopidogrel	HR (95% CI)	P-value
Efficacy
Cardiovascular death, MI, or stroke	9.8	11.7	0.84 (0.77–0.92)	<0.001
Cardiovascular death	4.0	5.1	0.79 (0.69–0.91)	0.001
MI	5.8	6.9	0.84 (0.75–0.95)	0.005
Stroke	1.5	1.3	1.17 (0.91–1.52)	0.22
Death from any cause	4.5	5.9	0.78 (0.69–0.89)	<0.001
Stent thrombosis—definite	1.3	1.9	0.67 (0.50–0.91)	0.009
Stent thrombosis—definite or probable	2.2	2.9	0.75 (0.59–0.95)	0.02
Primary end point—invasive approach	8.9	10.6	0.84 (0.75–0.94)	0.003
Primary end point—ischemia-driven approach
Safety
PLATO total major bleeding	11.6	11.2	1.04 (0.95–1.13)	0.43
TIMI total major bleeding	7.9	7.7	1.03 (0.93–1.15)	0.57
PLATO non-CABG major bleeding	4.5	3.8	1.19 (1.02–1.38)	0.03
TIMI non-CABG major bleeding	2.8	2.2	1.25 (1.03–1.53)	0.03
Need for transfusion	8.9	8.9	1.00 (0.91–1.11)	0.96
Life-threatening bleeding	5.8	5.8	1.03 (0.90–1.16)	0.70
Intracranial bleeding	0.3	0.2	1.87 (0.98–3.58)	0.06
Fatal bleeding	0.3	0.3	0.87 (0.48–1.59)	0.66
PLATO major or minor bleeding	16.1	14.6	1.11 (1.03–1.20)	0.008
TIMI major or minor bleeding	11.4	10.9	1.05 (0.96–1.15)	0.33
Dyspnea—any	13.8	7.8	1.84 (1.68–2.02)	<0.001
Dyspnea—requiring stopping study drug	0.9	0.1	6.12 (3.41–11.01)	<0.001
Holter identified ventricular pauses ≥ 3 s at 7 days	5.8	3.6	NR	0.01
Holter identified ventricular pauses ≥ 3 s at 30 days	2.1	1.7	NR	0.52

CAGB coronary artery bypass graft, CI confidence interval, HR hazard ratio, MI myocardial infarction; NR not reported; PLATO platelet inhibition and patient outcomes, TIMI thrombolysis in myocardial infarction