Table 1. Randomized clinical trials assessing DAT including a DOAC versus TAT including VKA in patients with atrial fibrillation undergoing PCI.

Trial name	PIONEER AF-PCI	RE-DUAL PCI	AUGUSTUS	ENTRUST AF-PCI
Trial type	Randomized, open label	Randomized, open label	Randomized, open label	Randomized, open label
Study enrollment	May 2013-July 2015	July 2014-May 2017	Sep 2015-April 2018	Feb 2017-May 2018
Major inclusion criteria	Age ≥ 18 years with non-valvular AF within last 1 year and who had just undergone PCI with stent placement (bare metal or drug eluting) for stable angina or acute coronary syndrome	Age ≥ 18 years with non-valvular AF within last 1 year and who had just undergone PCI with stent placement for stable angina or acute coronary syndrome	Age ≥ 18 years with previous, persistent, permanent or paroxysmal non-valvular AF; recent acute coronary syndrome or PCI, planned use of P2Y12 inhibitor for at least 6 months	Age ≥ 18 years, atrial fibrillation requiring oral anticoagulation, successful PCI for stable CAD or ACS
Major exclusion criteria	History of stroke/TIA, significant gastrointestinal bleeding within 12 months before randomization, eGFR<30 ml/min, Hgb<10 g/dl	Mechanical or biological heart valves, cardiogenic shock, prior stroke, surgery, gastrointestinal bleeding, major bleeding within 1 month prior to randomization, Hgb<10 g/dl, eGFR<30 ml/min, active liver disease	History of intracranial haemorrhage, recent or planned CABG, coagulopathy, ongoing bleeding, contraindication to either VKA, apixaban, P2Y12 inhibitors or aspirin; severe renal insufficiency	Mechanical heart valves, moderate-to-severe mitral stenosis, end-stage renal disease, other major comorbidities
Treatment arm	Rivaroxaban + single antiplatelet therapy with clopidogrel/ prasugrel/ticagrelor for 12 months duration	Dabigatran 110 mg twice daily or 150 mg twice daily + clopidogrel/ticagrelor	Two-by-two factorial design: Apixaban vs VKA (target INR = 2.0–3.0); ASA 81 mg/die vs placebo	Edoxaban 60 mg once daily + clopidogrel 75 mg for 12 months by default: alternatively prasugrel 5/10 mg once daily or ticagrelor 90 mg twice daily at the investigator’s discretion
Control arm	ASA + clopidogrel/prasugrel/ ticagrelor + warfarin, duration 1, 6, or 12 months pre-specified per treating physician	Aspirin + clopidogrel/ ticagrelor + warfarin	See cell above for randomized treatments. In addition clopidogrel/prasugrel/ticagrelor for 6 months	VKA + clopidogrel 75 mg for 12 months by default: alternatively prasugrel 5/10 mg once daily or ticagrelor 90 mg twice daily at the investigator’s discretion + ASA 100 daily for 1–12 months
Follow up, months (mean)	12 months	14months	6 months	12 months
Primary outcome (primary safety endpoint)	Clinically significant bleeding (a composite of TIMI major and minor bleeding, or bleeding requiring medical attention)	ISTH major bleeding or clinically relevant non-major bleeding event	ISTH major or clinically relevant nonmajor bleeding	Composite of major or clinically relevant non-major (CRNM) bleeding (according ISTH)
Secondary outcome (secondary efficacy endpoint)	MACE (a composite of death, MI or stroke), each component of MACE and stent thrombosis	Composite of death, MI, stroke, systemic embolism or unplanned revascularization	A composite of death or hospitalization; a composite of death or ischemic events; each component of the composite endpoints; Acute Myocardial Infarction, Urgent revascularization and stent thrombosis	Stroke, ischemic stroke, haemorrhagic stroke, systemic embolic events, MI, all-cause death, cardiovascular or unexplained death