Randomized trials comparing OAC monotherapy vs. OAC plus SAPT in AF patients with CCS
| . | OAC-ALONE6 . | AFIRE7 . | EPIC-CAD8 . |
|---|---|---|---|
| Study design | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, superiority |
| No. of pts. | 696 | 2236 | 1040 |
| Definition of CCS | PCI >1 year earlier | PCI/CABG >1 year earlier or angiographically confirmed CAD not requiring revascularization | PCI/CABG >6 months earlier or acute coronary syndrome treated with PCI/CABG >12 months earlier or significant coronary artery stenosis at coronary angiography/CT scan treated medically |
| Type of OAC | VKA (75%) DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) (25%) | DOAC (rivaroxaban) (100%) | DOAC (edoxaban) (100%) |
| Type of SAPT | Aspirin (86%), clopidogrel (24%) | Aspirin (70%), clopidogrel (24%), other P2Y12-inhibitors (4%) | Aspirin (62%), clopidogrel (38%) |
| Follow-up duration | 2.5 years (median) | 2 years (median) | 1 year |
| Risk of main clinical outcomes [HR (95% CI)] | |||
| Efficacy | 1.16 (0.79–1.72)a | 0.72 (0.55–0.95)b,* | 1.23 (0.48–3.10)c,g |
| Safety | 0.73 (0.44–1.20)d | 0.59 (0.39–0.89)d,** | 0.32 (0.14–0.73)d,g |
| Net clinical benefit | 0.99 (0.71–1.39)e,*** | 0.62 (0.47–0.82)e,g | 0.44 (0.30–0.65)f,**** |
| . | OAC-ALONE6 . | AFIRE7 . | EPIC-CAD8 . |
|---|---|---|---|
| Study design | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, superiority |
| No. of pts. | 696 | 2236 | 1040 |
| Definition of CCS | PCI >1 year earlier | PCI/CABG >1 year earlier or angiographically confirmed CAD not requiring revascularization | PCI/CABG >6 months earlier or acute coronary syndrome treated with PCI/CABG >12 months earlier or significant coronary artery stenosis at coronary angiography/CT scan treated medically |
| Type of OAC | VKA (75%) DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) (25%) | DOAC (rivaroxaban) (100%) | DOAC (edoxaban) (100%) |
| Type of SAPT | Aspirin (86%), clopidogrel (24%) | Aspirin (70%), clopidogrel (24%), other P2Y12-inhibitors (4%) | Aspirin (62%), clopidogrel (38%) |
| Follow-up duration | 2.5 years (median) | 2 years (median) | 1 year |
| Risk of main clinical outcomes [HR (95% CI)] | |||
| Efficacy | 1.16 (0.79–1.72)a | 0.72 (0.55–0.95)b,* | 1.23 (0.48–3.10)c,g |
| Safety | 0.73 (0.44–1.20)d | 0.59 (0.39–0.89)d,** | 0.32 (0.14–0.73)d,g |
| Net clinical benefit | 0.99 (0.71–1.39)e,*** | 0.62 (0.47–0.82)e,g | 0.44 (0.30–0.65)f,**** |
OAC, oral anticoagulation; AF, atrial fibrillation; CCS, chronic coronary syndrome; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; CAD, coronary artery disease; VKA, vitamin K-antagonist; SAPT, single antiplatelet therapy; HR, hazard ratio; CI, confidence intervals; CV, cardiovascular; MI, myocardial infarction; SE, systemic embolism; ISTH, International Society of Thrombosis and Haemostasis; CRNM, clinically relevant nonmajor.
*P < 0.001 (noninferiority); **P = 0.01 (superiority); ***P = 0.016 (noninferiority); ****P < 0.001 (superiority).
Composite of all-cause death, MI, stroke, or SE.
Composite of stroke, SE, MI, unstable angina requiring revascularization or all-cause death.
Composite of all-cause death, MI, ischaemic stroke, or SE.
ISTH major bleeding.
Composite of all-cause death, MI, stroke, SE, or ISTH major bleeding.
Composite of all-cause death, MI, stroke, SE, unplanned urgent revascularization, or ISTH major bleeding or CRNM bleeding.
Secondary endpoint not undergoing statistical analysis for evaluation of treatment effect.
Randomized trials comparing OAC monotherapy vs. OAC plus SAPT in AF patients with CCS
| . | OAC-ALONE6 . | AFIRE7 . | EPIC-CAD8 . |
|---|---|---|---|
| Study design | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, superiority |
| No. of pts. | 696 | 2236 | 1040 |
| Definition of CCS | PCI >1 year earlier | PCI/CABG >1 year earlier or angiographically confirmed CAD not requiring revascularization | PCI/CABG >6 months earlier or acute coronary syndrome treated with PCI/CABG >12 months earlier or significant coronary artery stenosis at coronary angiography/CT scan treated medically |
| Type of OAC | VKA (75%) DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) (25%) | DOAC (rivaroxaban) (100%) | DOAC (edoxaban) (100%) |
| Type of SAPT | Aspirin (86%), clopidogrel (24%) | Aspirin (70%), clopidogrel (24%), other P2Y12-inhibitors (4%) | Aspirin (62%), clopidogrel (38%) |
| Follow-up duration | 2.5 years (median) | 2 years (median) | 1 year |
| Risk of main clinical outcomes [HR (95% CI)] | |||
| Efficacy | 1.16 (0.79–1.72)a | 0.72 (0.55–0.95)b,* | 1.23 (0.48–3.10)c,g |
| Safety | 0.73 (0.44–1.20)d | 0.59 (0.39–0.89)d,** | 0.32 (0.14–0.73)d,g |
| Net clinical benefit | 0.99 (0.71–1.39)e,*** | 0.62 (0.47–0.82)e,g | 0.44 (0.30–0.65)f,**** |
| . | OAC-ALONE6 . | AFIRE7 . | EPIC-CAD8 . |
|---|---|---|---|
| Study design | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, noninferiority | Prospective, multicentre, open-label, superiority |
| No. of pts. | 696 | 2236 | 1040 |
| Definition of CCS | PCI >1 year earlier | PCI/CABG >1 year earlier or angiographically confirmed CAD not requiring revascularization | PCI/CABG >6 months earlier or acute coronary syndrome treated with PCI/CABG >12 months earlier or significant coronary artery stenosis at coronary angiography/CT scan treated medically |
| Type of OAC | VKA (75%) DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) (25%) | DOAC (rivaroxaban) (100%) | DOAC (edoxaban) (100%) |
| Type of SAPT | Aspirin (86%), clopidogrel (24%) | Aspirin (70%), clopidogrel (24%), other P2Y12-inhibitors (4%) | Aspirin (62%), clopidogrel (38%) |
| Follow-up duration | 2.5 years (median) | 2 years (median) | 1 year |
| Risk of main clinical outcomes [HR (95% CI)] | |||
| Efficacy | 1.16 (0.79–1.72)a | 0.72 (0.55–0.95)b,* | 1.23 (0.48–3.10)c,g |
| Safety | 0.73 (0.44–1.20)d | 0.59 (0.39–0.89)d,** | 0.32 (0.14–0.73)d,g |
| Net clinical benefit | 0.99 (0.71–1.39)e,*** | 0.62 (0.47–0.82)e,g | 0.44 (0.30–0.65)f,**** |
OAC, oral anticoagulation; AF, atrial fibrillation; CCS, chronic coronary syndrome; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; CAD, coronary artery disease; VKA, vitamin K-antagonist; SAPT, single antiplatelet therapy; HR, hazard ratio; CI, confidence intervals; CV, cardiovascular; MI, myocardial infarction; SE, systemic embolism; ISTH, International Society of Thrombosis and Haemostasis; CRNM, clinically relevant nonmajor.
*P < 0.001 (noninferiority); **P = 0.01 (superiority); ***P = 0.016 (noninferiority); ****P < 0.001 (superiority).
Composite of all-cause death, MI, stroke, or SE.
Composite of stroke, SE, MI, unstable angina requiring revascularization or all-cause death.
Composite of all-cause death, MI, ischaemic stroke, or SE.
ISTH major bleeding.
Composite of all-cause death, MI, stroke, SE, or ISTH major bleeding.
Composite of all-cause death, MI, stroke, SE, unplanned urgent revascularization, or ISTH major bleeding or CRNM bleeding.
Secondary endpoint not undergoing statistical analysis for evaluation of treatment effect.
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