Table 1. Trials of combined... | American Society of Hematology

Table 1.

Trials of combined antithrombotic therapy for AF and CAD

Name	WOEST⁸	PIONEER AF-PCI¹¹	RE-DUAL PCI⁹	AUGUSTUS¹²	ENTRUST-AF PCI¹³
Total patients	573	2124	2725	4614	1506
Population	Patients taking OAC undergoing PCI	Patients with AF undergoing PCI	Patients with AF undergoing PCI	Patients with AF and recent ACS or PCI	Patients with AF and recent ACS or PCI
ACS	155 (27.1%)	1096 (51.6%)	1744 (64.0%)	2811 (60.9%)	777 (51.6%)
Treatments	• OAC + clopidogrel (double therapy) • OAC + DAPT with clopidogrel (triple therapy)	• Group 1: Rivaroxaban 15 mg daily + clopidogrel • Group 2: Rivaroxaban 2.5 mg twice daily + DAPT (1, 6, or 12 mo) • Group 3: VKA + DAPT (1, 6, or 12 mo)	• Dabigatran 110 mg twice daily + clopidogrel or ticagrelor • Dabigatran 150 mg twice daily + clopidogrel or ticagrelor • VKA + DAPT with clopidogrel or ticagrelor	• Apixaban 5 mg twice daily + DAPT • Apixaban 5 mg twice daily + P2Y12 only • VKA + DAPT • VKA + P2Y12 only	• Edoxaban 30-60 mg daily + P2Y12 • VKA + DAPT
Notable exclusion criteria	Prior intracranial bleed, cardiogenic shock, recent peptic ulcer or major bleeding, or thrombocytopenia	Prior stroke, recent GI bleeding event, CrCl <30 mL/min, or anemia (Hg <10 g/dL)	Cardiac valve replacement (mechanical or bioprosthetic) or CrCl <30 mL/min	Anticoagulant use for indications other than AF, severe renal insufficiency, prior intracranial bleed, recent or planned coronary artery bypass graft surgery, or ongoing bleeding	Mechanical heart valve, moderate to severe mitral stenosis, and end-stage renal disease
Bleeding outcome: rate and definition	Double therapy, 19.4% Triple therapy, 44.4% Double vs triple, HR 0.36 (95% CI, 0.26-0.50)	Group 1, 16.8% Group 2, 18.0% Group 3, 26.7% 1 vs 3, HR 0.59 (95% CI, 0.47-0.76) 2 vs 3, HR 0.63 (95% CI, 0.50-0.80)	D110 + P2Y12, 15.4% D150 + P2Y12, 20.2% VKA + DAPT, 26.9% D110 vs TT, HR 0.52 (95% CI, 0.42-0.63) D150 vs TT, HR 0.72 (95% CI, 0.58-0.88)	Apixaban, 10.5% VKA, 14.7% DAPT, 16.1% P2Y12 only, 9.0% Apixaban vs VKA, HR 0.69 (95% CI, 0.58-0.81) DAPT vs P2Y12, HR 1.89 (95% CI, 1.59-2.24)	Edoxaban, 17% VKA, 20% Edoxaban vs VKA, HR 0.83 (95% CI, 0.65-1.05)
Bleeding outcome definition	Any bleeding	TIMI major + minor bleeding	ISTH major + CRNM bleeding	ISTH major + CRNM bleeding	ISTH major + CRNM bleeding

Name	WOEST⁸	PIONEER AF-PCI¹¹	RE-DUAL PCI⁹	AUGUSTUS¹²	ENTRUST-AF PCI¹³
Total patients	573	2124	2725	4614	1506
Population	Patients taking OAC undergoing PCI	Patients with AF undergoing PCI	Patients with AF undergoing PCI	Patients with AF and recent ACS or PCI	Patients with AF and recent ACS or PCI
ACS	155 (27.1%)	1096 (51.6%)	1744 (64.0%)	2811 (60.9%)	777 (51.6%)
Treatments	• OAC + clopidogrel (double therapy) • OAC + DAPT with clopidogrel (triple therapy)	• Group 1: Rivaroxaban 15 mg daily + clopidogrel • Group 2: Rivaroxaban 2.5 mg twice daily + DAPT (1, 6, or 12 mo) • Group 3: VKA + DAPT (1, 6, or 12 mo)	• Dabigatran 110 mg twice daily + clopidogrel or ticagrelor • Dabigatran 150 mg twice daily + clopidogrel or ticagrelor • VKA + DAPT with clopidogrel or ticagrelor	• Apixaban 5 mg twice daily + DAPT • Apixaban 5 mg twice daily + P2Y12 only • VKA + DAPT • VKA + P2Y12 only	• Edoxaban 30-60 mg daily + P2Y12 • VKA + DAPT
Notable exclusion criteria	Prior intracranial bleed, cardiogenic shock, recent peptic ulcer or major bleeding, or thrombocytopenia	Prior stroke, recent GI bleeding event, CrCl <30 mL/min, or anemia (Hg <10 g/dL)	Cardiac valve replacement (mechanical or bioprosthetic) or CrCl <30 mL/min	Anticoagulant use for indications other than AF, severe renal insufficiency, prior intracranial bleed, recent or planned coronary artery bypass graft surgery, or ongoing bleeding	Mechanical heart valve, moderate to severe mitral stenosis, and end-stage renal disease
Bleeding outcome: rate and definition	Double therapy, 19.4% Triple therapy, 44.4% Double vs triple, HR 0.36 (95% CI, 0.26-0.50)	Group 1, 16.8% Group 2, 18.0% Group 3, 26.7% 1 vs 3, HR 0.59 (95% CI, 0.47-0.76) 2 vs 3, HR 0.63 (95% CI, 0.50-0.80)	D110 + P2Y12, 15.4% D150 + P2Y12, 20.2% VKA + DAPT, 26.9% D110 vs TT, HR 0.52 (95% CI, 0.42-0.63) D150 vs TT, HR 0.72 (95% CI, 0.58-0.88)	Apixaban, 10.5% VKA, 14.7% DAPT, 16.1% P2Y12 only, 9.0% Apixaban vs VKA, HR 0.69 (95% CI, 0.58-0.81) DAPT vs P2Y12, HR 1.89 (95% CI, 1.59-2.24)	Edoxaban, 17% VKA, 20% Edoxaban vs VKA, HR 0.83 (95% CI, 0.65-1.05)
Bleeding outcome definition	Any bleeding	TIMI major + minor bleeding	ISTH major + CRNM bleeding	ISTH major + CRNM bleeding	ISTH major + CRNM bleeding

CrCl, creatinine clearance; CRNM, clinically relevant nonmajor; Hg, hemoglobin; ISTH, International Society on Thrombosis and Haemostasis; OAC, oral anticoagulant; TIMI, Thrombolysis in Myocardial Infarction; TT, triple therapy; VKA, vitamin K antagonist.

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