Table 3.
Patient characteristics across all included studies for atrial fibrillation plus remote (> 1 year) ACS and/or PCI
| AFIRE (n = 2236) | OAC-ALONE (n = 696) | ||
|---|---|---|---|
| Country | Japan | Japan | |
| Age, mean, y | 74.4 | 75.1 | |
| Female sex, % | 21.0 | 14.8 | |
| CHADS2, mean | 2 | 2.5 | |
| CHA2DS2-VASc, mean | 4 | 4.6 | |
| HAS-BLED, mean | 2 | 2 | |
| ACS, % | 35.1 | 38.6 | |
| PCI, % | 70.7 | 100 | |
| DES, % | 67.7 | 70.4 | |
| Time from index event, y | > 1 | > 1 (median 4.5) | |
| Baseline antiplatelet, % | |||
| ASA | 56.7 | 85.9 | |
| Clopidogrel | 23.3 | 14.5 | |
| Other | 7.8 | - | |
| Baseline anticoagulant, % | |||
| Apixaban | 10.6 | 10 | |
| Dabigatran | 5.7 | 5.9 | |
| Edoxaban | 2.8 | 2.9 | |
| Rivaroxaban | 60.9 | 5.9 | |
| Warfarin | 13 | 75.2 | |
| Study OAC in both groups | Rivaroxaban 15 mg | Warfarin or DOAC | |
| Antiplatelet in comparator group | ASA or P2Y12 inhibitor | ASA or clopidogrel | |
| Post-randomization antiplatelet | |||
| OAC monotherapy | Dual-pathway therapy | ||
| ASA | 0.7 | 70.2 | — |
| Clopidogrel | 0.1 | 25.4 | — |
| Prasugrel | 0.1 | 1.5 | — |
| MACE definition | Death, MI, stroke, systemic embolism, unstable angina requiring revascularization | Death, MI, stroke, systemic embolism | |
| Major bleeding definition | ISTH | ISTH | |
| Non-major clinically-relevant bleeding definition | ISTH | TIMI | |
| Follow-up duration, mo | 24.1 | 30 | |
ACS, acute coronary syndrome; AFIRE, Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease; ASA, acetylsalicylic acid; CHADS2, Congestive Heart Failure, Hypertension, Age ≥ 75, Diabetes, and Prior Stroke/Transient Ischemic Attack (doubled); CHA2DS2-VASc, Congestive Heart Failure, Hypertension, Age [≥ 75 years] [doubled], Diabetes Mellitus, Stroke/Transient Ischemic Attack [doubled], Vascular Disease, Age [65-74] Years, Sex Category [female]); DES, drug-eluting stent; HAS-BLED, Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly (> 65 Years), Drugs/Alcohol Concomitantly; ISTH, International Society on Thrombosis and Haemostasis; MACE, major adverse cardiovascular events; MI, myocardial infarction; OAC, oral anticoagulant; OAC-ALONE, Optimizing Antithrombotic Care in Patients With Atrial Fibrillation and Coronary Stent; PCI, percutaneous coronary intervention; TIMI; thrombolysis in myocardial infarction.