Table 3

Summary of randomised controlled trials included in the review by length of follow-up, bleeding definition used and in-hospital management strategy

Primary author	Location	Trial	Study design	Length of follow-up	Bleeding criteria	In-hospital management strategy	N	Participants with bleed	Crude incidence of bleeding per 100 persons and 95% CI	Quality score
Yusuf et al 56	Multicentre	OASIS-5	RCT	6 months	OASIS-5 major	NR	20 078	357	1.84 (1.66 to 2.03)*	High
Jolly et al 4	Multicentre	CURE	Post hoc analysis of RCT	8 months	CURE major	PCI	2658	28	1.07 (0.74 to 1.54)*	6†
Khan et al 34	Multicentre	APPRAISE-2	Post hoc analysis of RCT	240 days (median)	Any bleeding event	NR	7392	506	7.32 (6.73 to 7.96)*	7†
Carrabba et al 63	Italy	BLESS	RCT	12 months	BARC 1–3	PCI	193	76	39.4 (32.8 to 46.4)*	Acceptable
Cuisset et al 49	France	TOPIC	RCT	12 months	BARC≥2	PCI	634	106	16.7 (14.0 to 19.8)*	Low
Han et al 32	China	BRIGHT	RCT	12 months	BARC 1–5	PCI	2194	47	2.33 (1.76 to 3.08)*	Acceptable
Savonitto et al 42	Italy	Italian Elderly ACS	RCT	12 months	BARC 2, 3a and 3b	NR	313	3	0.96 (0.33 to 2.78)*	Acceptable
Mrdovic et al 38	Serbia	RISK-PCI	Post hoc analysis of RCT	12 months	TIMI major/minor	PCI	2045	25	1.29 (0.87 to 1.89)*	5†
Atar et al 60	Multicentre	OPUS-TIMI 16	Post hoc analysis of RCT	12 months	Gastrointestinal bleed	NR	10 288	104	1.02 (0.84 to 1.24)*	5†
Kohli et al 35	Multicentre	TRITON-TIMI 38	Post hoc analysis of RCT	15 months	TIMI major/minor	PCI	12 674	407	3.23 (2.94 to 3.56) *	7†
Mahaffey et al 37	Multicentre	TRACER	Post hoc analysis of RCT	502 days (median)	TIMI major/minor	NR	11 368	236	2.12 (1.87 to 2.41)*	6†
Yeh et al 3	USA	DAPT	RCT	18 months	BARC 2–5	PCI	3576	111	3.10 (2.58 to 3.72)*	Acceptable
Costa et al 66	Italy	PRODIGY	Post hoc analysis of RCT	24 months	BARC 2–5	PCI	1465	82	5.60 (4.53 to 6.89)*	5†
Bonaca et al 67	Multicentre	PEGASUS-TIMI 54	RCT	33 months	TIMI major	NR	21 162	435	2.08 (1.89 to 2.28)*	High
Nikolsky et al 58	Multicentre	HORIZON-AMI	Post hoc analysis of RCT	3 years	HORIZON major	PCI	3602	63	2.15 (1.68 to 2.74)*	5†
Bergen et al 24	The Netherlands	ASPECT	RCT	37 months	Major bleed	NR	3404	99	2.91 (2.39 to 3.53)*	Low

*Incidence and associated 95% CI calculated from data within study.
†Quality assessed by Newcastle Ottawa Scale.
APPRAISE-2, apixaban for prevention of acute ischaemic events; ASPECT, anticoagulants in the secondary prevention of events in coronary thrombosis; BARC, Bleeding Academic Research Consortium; BLESS, bleeding events and maintenance dose of prasugrel; BRIGHT, bivalirudin in acute myocardial infarction vs heparin and glycoprotein inhibitor plus heparin; CURE, clopidogrel in unstable angina to prevent recurrent events; DAPT, dual antiplatelet therapy study; HORIZON, harmonising otcomes with revascularisation and stents; HORIZON-AMI, harmonising outcomes with revascularisation and stents in acute myocardial infarction; GI, gastrointestinal; NR, not reported; OASIS-5, the fifth organisation to assess strategies in acute ischaemic syndromes; OPUS-TIMI 16, orbofiban in patients with unstable coronary syndrome-thrombolysis in myocardial infarction 16; PCI, percutaneous coronary intervention; PRODIGY, prolonging dual antiplatelet treatment after grading stent-induced intimal hyperplasia; PEGASUS-TIMI 54, prevention of cardiovascular events in patients with prior heart attack using ticagrelor compared with placebo on a background of aspirin thrombolysis in myocardial infarction 54; RCT, randomised controlled trial; RISK-PCI, risk scoring model to predict net adverse cardiovascular outcomes after primary percutaneous coronary intervention; TIMI, thrombolysis in myocardial infarction; TOPIC, timing of platelet inhibition after acute coronary syndrome; TRACER, thrombin receptor antagonist for clinical event reduction in acute coronary syndrome; TRITON-TIMI 38, trial to assess improvement in therapeutic outcomes by optimising platelet inhibition with prasugrel-thrombolysis in myocardial infarction 38.