Table 3.
Paroxysmal AF |
Persistent AF |
Interaction P-value | |||||
---|---|---|---|---|---|---|---|
Rivaroxaban events/100 Pt-Yrs (total events) | Warfarin events/ 100 Pt-Yrs (total events) | Rivaroxaban vs. Warfarin adjusted HR (95% CI) | Rivaroxaban Events/100 Pt-Yrs (total events) | Warfarin events/100 Pt-Yrs (total events) | Rivaroxaban vs. Warfarin adjusted HR (95% CI) | ||
Efficacy outcomes | |||||||
Stroke or SE | 1.73 (42) | 1.74 (43) | 1.00 (0.65, 1.53) | 2.03 (225) | 2.32 (255) | 0.88 (0.74, 1.06) | 0.60 |
All-cause death | 3.77 (90) | 3.28 (80) | 1.13 (0.83, 1.52) | 4.53 (490) | 5.02 (539) | 0.91 (0.80, 1.02) | 0.19 |
Stroke/SE/death | 5.19 (122) | 4.63 (111) | 1.11 (0.86, 1.43) | 6.05 (643) | 6.62 (698) | 0.92 (0.82, 1.02) | 0.18 |
Stroke or TIA | 2.19 (53) | 2.32 (57) | 0.95 (0.66, 1.39) | 2.47 (272) | 2.63 (288) | 0.94 (0.80, 1.11) | 0.96 |
Stroke | 1.60 (39) | 1.58 (39) | 1.03 (0.66, 1.60) | 1.91 (212) | 2.13 (234) | 0.91 (0.75, 1.09) | 0.61 |
TIA | 0.57 (14) | 0.76 (19) | 0.75 (0.37, 1.49) | 0.57 (64) | 0.54 (61) | 1.05 (0.74, 1.49) | 0.40 |
Safety outcomes | |||||||
Major bleeding | 3.43 (66) | 3.19 (65) | 1.06 (0.75, 1.49) | 3.61 (323) | 3.49 (315) | 1.08 (0.92, 1.26) | 0.94 |
Efficacy end-point models were adjusted for the following: age, sex, body mass index, region, diabetes, prior stroke/TIA, vascular disease (myocardial infarction, peripheral artery disease, carotid occlusive disease), congestive heart failure, hypertension, chronic obstructive pulmonary disease, diastolic blood pressure, creatinine clearance (calculated using the Cockcroft–Gault equation), heart rate, and abstinence from alcohol. Safety end-point models were adjusted for the following: age; sex; region; prior stroke/TIA; anaemia; prior gastrointestinal bleed; chronic obstructive pulmonary disease; diastolic blood pressure; creatinine clearance (Cockcroft–Gault equation); platelets; albumin; and prior aspirin, vitamin K antagonist, or thienopyridine use.
AF, atrial fibrillation; CI, confidence interval; HR, hazard ratio; SE, systemic embolism; TIA, transient ischaemic attack.