Table 1.
Rivaroxaban (N = 73) | Apixaban (N = 105) | P value | |
---|---|---|---|
Age, year | 74.9 ± 7.5 | 77.3 ± 9.1 | 0.067 |
Male | 37 (50.7) | 60 (57.1) | 0.445 |
Body weight, kg | 61.8 ± 11.6 | 64.9 ± 10.3 | 0.061 |
CRE, mg/dL | 1.0 ± 0.3 | 1.2 ± 0.5 | 0.020* |
CrCL, mL/minutes | 52.4 ± 19.5 | 50.0 ± 20.0 | 0.438 |
ALT < 35 U/La | 62 (93.9) | 77 (87.5) | 0.272 |
CHA2DS2VAScb | 3.9 ± 1.5 | 4.3 ± 1.4 | 0.070 |
HAS‐BLEDc | 2.2 ± 0.8 | 2.5 ± 0.8 | 0.075 |
Comorbidities | |||
IS or TIA | 29 (39.7) | 52 (49.5) | 0.223 |
CHF | 15 (20.5) | 18 (17.1) | 0.564 |
Hypertension | 55 (75.3) | 84 (80.0) | 0.468 |
Diabetes | 20 (27.4) | 26 (24.8) | 0.730 |
MI or PAOD | 5 (6.8) | 16 (15.2) | 0.102 |
Malignancy | 10 (13.7) | 17 (16.2) | 0.678 |
Bleeding history | 10 (13.7) | 20 (19.0) | 0.418 |
ICH | 1 (1.4) | 6 (5.7) | 0.243 |
GI bleeding | 5 (6.8) | 7 (6.7) | 1.000 |
Other bleeding | 6 (8.2) | 8 (7.6) | 1.000 |
NOAC levels | |||
Fasted status while monitoring | 28 (38.4) | 34 (32.4) | 0.428 |
Trough, ng/mL | 39.2 ± 60.8 | 105.9 ± 57.2 | Not applicable |
Lower than ranged | 23 (31.5) | 11 (10.5) | 0.001* |
Within ranged | 47 (64.4) | 89 (84.8) | 0.002* |
Higher than ranged | 3 (4.1) | 5 (4.8) | 1.000 |
Peak, ng/mLe | 186.4 ± 100.8 | 221.3 ± 116.5 | Not applicable |
Lower than ranged | 38 (55.9) | 2 (1.9) | < 0.001* |
Within ranged | 23 (33.8) | 80 (76.9) | < 0.001* |
Higher than ranged | 7 (10.3) | 22 (21.2) | 0.094 |
NOAC use | |||
Good adherencef | 62 (84.9) | 78 (74.3) | 0.097 |
Low‐dose regimeng | 39 (53.4) | 61 (58.1) | 0.169 |
Appropriate doseh | 55 (77.5) | 65 (62.5) | 0.046* |
Lower than recommended | 10 | 37 | 0.002* |
Concurrent medications | |||
Amiodarone | 16 (21.9) | 33 (31.4) | 0.176 |
Dronedarone | 4 (5.5) | 2 (1.9) | 0.229 |
NSAID | 1 (1.4) | 1 (1.0) | 1.000 |
Aspirin | 1 (1.4) | 1 (1.0) | 1.000 |
Clopidogrel | 0 (0) | 3 (2.9) | 0.270 |
Data are expressed as mean ± SD or number (percentage). For characteristics significantly different between two groups, the P‐value is marked by label "*."
ALT, alanine transaminase; CHF, congestive heart failure; CrCL, creatinine clearance (estimated by Cockcorfot‐Gault Formula); CRE, serum creatinine; GI, gastrointestinal; ICH, intracranial hemorrhage; IS, ischemic stroke; MI, myocardial infarction; NOAC, nonvitamin K antagonist oral anticoagulants; NSAID, nonsteroidal anti‐inflammatory drugs; PAOD, peripheral arterial vascular disease; TIA, transient ischemic attack; U/L, upper limit.
aALT data was missing in 7 patients in the rivaroxaban group and 17 patients in the apixaban group. bCHA2DS2VASc score: To evaluate the risk for ischemic stroke among patients with atrial fibrillation. Higher score indicates higher risk of ischemic stroke. One point was assigned to congestive heart failure, hypertension, age 65–74 years, diabetes, female sex, or vascular disease, and two points were assigned to age ≥ 75 years and previous stroke or transient ischemic attack history. cHASBLED score: To evaluate the risk for bleeding. Higher score indicates higher risk. One point is assigned to hypertension, abnormal liver function, abnormal renal function, stroke history, bleeding history, labile international normalized ratio (INR) during warfarin therapy, age over 65 years, antiplatelet agent, nonsteroidal anti‐inflammatory drug, or ethanol use. The item labile INR was not calculated in the present study. dThe data was compared with the expected rivaroxaban level reported in pharmacokinetic studies, and the expected apixaban level showed in the product monograph. eFive patients in the rivaroxaban group and one patient in the apixaban group did not monitor the peak levels. fGood adherence was defined as no self‐reported missed NOAC dose in the past 1 week, during NOAC treatment, and no reasons other than forgetting to take the NOAC dose. This was evaluated by providing participants a three‐item questionnaire. gLow‐dose regimen was defined as 10 mg o.d. for rivaroxaban and 2.5 mg b.i.d. for apixaban. hAppropriate dose was defined as ordering the NOAC according to the product labeling, including correct dose and frequency per indication, and appropriately adjusted renal dose. iConcurrent medications: None of our patients concomitantly used verapamil, azole antifungal agents, protease inhibitors (P‐glycoprotein (P‐gp) inhibitors), and rifampin, enzyme‐inducing antiepileptic drugs, such as phenytoin and phenobarbital (P‐gp inducers).