Table 1 Open in new tab Major randomized...

Design

Patients (n)

Treatment groups

AF (%)

Maximum time in TAT in DTA group (days)

ACS (%)

Follow-up (months)

Primary outcome

WOEST

RCT, open-label, 1:1

573

VKA + P₂Y₁₂i for 1 or 12 months
vs.
VKA + aspirin + P₂Y₁₂i
for 1 or 12 months

Haemorrhagic events of any kind (according to the TIMI and GUSTO criteria)

ISAR-TRIPLE

RCT open-label, 1:1

614

6 weeks of VKA + clopidogrel + aspirin
vs.
6 months of VKA + clopidogrel + aspirin

Composite endpoint of death, myocardial infarction, stent thrombosis, stroke or major bleeding

PIONEER-AF

RCT open-label, 1:1:1

2124

Rivaroxaban (15 mg/od) + P₂Y₁₂i
vs. rivaroxaban (2.5 mg/b.i.d.) + aspirin + P₂Y₁₂i
vs.
VKA + aspirin + P₂Y₁₂i

100

Clinically relevant bleeding (major bleeding according to TIMI criteria, minor bleeding or bleeding that required medical intervention)

RE-DUAL PCI

RCT open-label, 1:1:1

2725

Dabigatran (110 mg/b.i.d.) + P₂Y₁₂i
vs.
dabigatran (150 mg/b.i.d.) + P₂Y₁₂i
vs.
VKA + aspirin (1–3 mesi) + P₂Y₁₂i

100

Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)

AUGUSTUS

RCT open-label, 2 × 2

4614

apixaban (5 mg/b.i.d.) + P₂Y₁₂i
vs.
apixaban (5 mg/b.i.d.) + aspirin + P₂Y₁₂i
vs.
VKA + P₂Y₁₂i
vs.
VKA + aspirin + P₂Y₁₂

100

Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)

ENTRUST-AF PCI

RCT open-label, 1:1

1506

Edoxaban (60 mg/od) + P₂Y₁₂i
vs.
VKA + aspirin (1–12 mesi) + P₂Y₁₂i

100

Clinically relevant major or non-major bleeding (according to ISTH criteria)

Table 1

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Major randomized trials comparing TAT and DAT

	Design	Patients (n)	Treatment groups	AF (%)	Maximum time in TAT in DTA group (days)	ACS (%)	Follow-up (months)	Primary outcome
WOEST	RCT, open-label, 1:1	573	VKA + P₂Y₁₂i for 1 or 12 months vs. VKA + aspirin + P₂Y₁₂i for 1 or 12 months	69	<1	28	12	Haemorrhagic events of any kind (according to the TIMI and GUSTO criteria)
ISAR-TRIPLE	RCT open-label, 1:1	614	6 weeks of VKA + clopidogrel + aspirin vs. 6 months of VKA + clopidogrel + aspirin	84	/	32	9	Composite endpoint of death, myocardial infarction, stent thrombosis, stroke or major bleeding
PIONEER-AF	RCT open-label, 1:1:1	2124	Rivaroxaban (15 mg/od) + P₂Y₁₂i vs. rivaroxaban (2.5 mg/b.i.d.) + aspirin + P₂Y₁₂i vs. VKA + aspirin + P₂Y₁₂i	100	3	52	12	Clinically relevant bleeding (major bleeding according to TIMI criteria, minor bleeding or bleeding that required medical intervention)
RE-DUAL PCI	RCT open-label, 1:1:1	2725	Dabigatran (110 mg/b.i.d.) + P₂Y₁₂i vs. dabigatran (150 mg/b.i.d.) + P₂Y₁₂i vs. VKA + aspirin (1–3 mesi) + P₂Y₁₂i	100	5	51	14	Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)
AUGUSTUS	RCT open-label, 2 × 2	4614	apixaban (5 mg/b.i.d.) + P₂Y₁₂i vs. apixaban (5 mg/b.i.d.) + aspirin + P₂Y₁₂i vs. VKA + P₂Y₁₂i vs. VKA + aspirin + P₂Y₁₂	100	14	60	6	Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)
ENTRUST-AF PCI	RCT open-label, 1:1	1506	Edoxaban (60 mg/od) + P₂Y₁₂i vs. VKA + aspirin (1–12 mesi) + P₂Y₁₂i	100	5	52	12	Clinically relevant major or non-major bleeding (according to ISTH criteria)

	Design	Patients (n)	Treatment groups	AF (%)	Maximum time in TAT in DTA group (days)	ACS (%)	Follow-up (months)	Primary outcome
WOEST	RCT, open-label, 1:1	573	VKA + P₂Y₁₂i for 1 or 12 months vs. VKA + aspirin + P₂Y₁₂i for 1 or 12 months	69	<1	28	12	Haemorrhagic events of any kind (according to the TIMI and GUSTO criteria)
ISAR-TRIPLE	RCT open-label, 1:1	614	6 weeks of VKA + clopidogrel + aspirin vs. 6 months of VKA + clopidogrel + aspirin	84	/	32	9	Composite endpoint of death, myocardial infarction, stent thrombosis, stroke or major bleeding
PIONEER-AF	RCT open-label, 1:1:1	2124	Rivaroxaban (15 mg/od) + P₂Y₁₂i vs. rivaroxaban (2.5 mg/b.i.d.) + aspirin + P₂Y₁₂i vs. VKA + aspirin + P₂Y₁₂i	100	3	52	12	Clinically relevant bleeding (major bleeding according to TIMI criteria, minor bleeding or bleeding that required medical intervention)
RE-DUAL PCI	RCT open-label, 1:1:1	2725	Dabigatran (110 mg/b.i.d.) + P₂Y₁₂i vs. dabigatran (150 mg/b.i.d.) + P₂Y₁₂i vs. VKA + aspirin (1–3 mesi) + P₂Y₁₂i	100	5	51	14	Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)
AUGUSTUS	RCT open-label, 2 × 2	4614	apixaban (5 mg/b.i.d.) + P₂Y₁₂i vs. apixaban (5 mg/b.i.d.) + aspirin + P₂Y₁₂i vs. VKA + P₂Y₁₂i vs. VKA + aspirin + P₂Y₁₂	100	14	60	6	Clinically relevant bleeding (major bleeding according to ISTH definition or clinically relevant non-major bleeding events)
ENTRUST-AF PCI	RCT open-label, 1:1	1506	Edoxaban (60 mg/od) + P₂Y₁₂i vs. VKA + aspirin (1–12 mesi) + P₂Y₁₂i	100	5	52	12	Clinically relevant major or non-major bleeding (according to ISTH criteria)

ACS, acute coronoary syndrome; AF, atrial fibrillation; bd, bis in die; GUSTO, Global Use of Streptokinase and t-PA for Occluded Coronary Arteries; ISTH, International Society on Thrombosis and Haemostasis; od, omni die; P₂Y₁₂i, P₂Y₁₂ platelet receptor inhibitors; RCT, randomized controlled trial; VKA, vitamin K antagonists.

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