Table 3.

Major RCTs and bleeding criteria to assess best long-term secondary prevention strategy in chronic coronary syndrome.

RCTs	Study population	Primary endpoint	Main safety results	Bleeding criteria
DAPT [32]	Daily aspirin 75–162 mg + clopidogrel 75 mg or prasugrel 10 mg vs. daily aspirin 75–162 mg + placebo	Stent thrombosis 0.4% vs. 1.4%	Moderate or severe bleeds: 2.5% vs. 1.6%	GUSTO criteria and BARC criteria
		HR 0.29 [95% CI 0.17–0.48]	p = 0.001
		p 0.001
PEGASUS [30]	(A) Ticagrelor 90 mg b.i.d. plus aspirin vs. (A’) Ticagrelor 60 mg plus aspirin vs. (B) placebo + aspirin	Composite of CV death, MI, stroke:	TIMI major bleeds: 2.6% in A vs. 2.3% in A’ vs. 1.06% in B (p 0.001 for A or A’ vs. B)	TIMI bleeding classification
		A vs. B: HR 0.8 [95% CI 0.75–0.96]
		p = 0.008;
		A’ vs. B: HR 0.84 [95% CI 0.74–0.95]
		p = 0.004
COMPASS [33]	(A) Rivaroxaban 2.5 mg twice a day plus aspirin 100 mg once daily vs. (A’) Rivaroxaban 5 mg twice a day vs. (B) Aspirin 100 mg once daily	Composite of CV death, MI or stroke: 4.1% vs. 4.9% vs. 5.4% in A vs. A’ vs. B; p 0.001 for A vs. B; p = 0.12 for A’ vs. B	Major bleeds A vs. B: 3.1% vs. 1.9%, HR 1.70 [95% CI 1.4–2.05]	Modified ISTH major bleeding
			p 0.001
			Fatal bleeds A or A’ vs. B: non-significant
			Intracranial bleeds A vs. B: 0.3% vs. 0.3%, p = 0.60

DAPT, dual antiplatelet therapy; HR, hazard ratio; CI, confidence interval; CV, cardiovascular; MI, myocardial infarction; ISTH, International Society on Thrombosis and Haemostasis; GUSTO, Global use of Streptokinase and t-PA for Occluded Coronary Arteries; BARC, Bleeding Academic Research Consortium; TIMI, thrombolysis in myocardial infarction.