Online Table 1. Baseline demographics and patient characteristics of patients enrolled in the worldwide XANTUS program by region Western Europe, Canada and Israel (n = 5,287) Eastern Europe (n = 2,577) Middle East and Africa (n = 690) East Asia (n = 2,233) Latin America (n = 334) Age, years, mean ± SD <65, n (%) 65–75, n (%) >75, n (%) 72.0±9.9 1,041 (19.7) 2,189 (41.4) 2,057 (38.9) 68.2±10.5 900 (34.9) 991 (38.5) 686 (26.6) 66.0±11.9 286 (41.4) 257 (37.2) 147 (21.3) 70.5±10.6 590 (26.4) 825 (36.9) 818 (36.9) 72.9±10.1 67 (20.1) 110 (32.9) 157 (47.0) Gender, male, n (%) 3209 (60.7) 1317 (51.1) 358 (51.9) 1303 (58.4) 167 (50.0) First available weight, kg, mean ± SD 82.5±17.4 84.7±16.8 82.7±17.3 66.1±12.8 76.9±17.0 BMI, kg/m2, mean ± SD BMI ≤18.5, n (%) 28.0±5.0 29 (0.5) 29.5±5.0 6 (0.2) 29.8±6.1 3 (0.4) 24.9±3.9 44 (2.0) 28.4±5.1 2 (0.6)
BMI 18.5–30, n (%) BMI >30, n (%) Missing, n (%) 2,911 (55.1) 1,224 (23.2) 1,123 (21.2) 1,386 (53.8) 864 (33.5) 321 (12.5) 253 (36.7) 196 (28.4) 238 (34.5) 1,229 (55.0) 141 (6.3) 819 (36.7) 189 (56.6) 98 (29.3) 45 (13.5) First available creatinine clearance (mL/min), n (%) <15 15–29 30–49 50–80 >80 Missing 7 (0.1) 60 (1.1) 447 (8.5) 1,905 (36.0) 1,090 (20.6) 1,778 (33.6) 24 (0.9) 33 (1.3) 241 (9.4) 801 (31.1) 749 (29.1) 729 (28.3) 0 (0) 9 (1.3) 43 (6.2) 151 (21.9) 171 (24.8) 316 (45.8) 15 (0.7) 55 (2.5) 296 (13.3) 535 (24.0) 256 (11.5) 1,076 (48.2) 1 (0.3) 9 (2.7) 34 (10.2) 86 (25.7) 54 (16.2) 150 (44.9) Preexisting comorbidities, n (%) Hypertension Diabetes mellitus stroke/TIA/non-CNS SE 3,733 (70.6) 1,015 (19.2) 867 (16.4) 2,288 (88.8) 524 (20.3) 627 (24.3) 532 (77.1) 288 (41.7) 90 (13.0) 1,639 (73.4) 589 (26.4) 734 (32.9) 284 (85.0) 68 (20.4) 54 (16.2)
Prior antithrombotic therapy, n (%) Yes No 3,789 (71.7) 1,498 (28.3) 1838 (71.3)739 (28.7) 389 (56.4) 301 (43.6) 1,426 (63.9) 807 (36.1) 141 (42.2) 193 (57.8) Type of prior antithrombotic therapy, n (%) VKA DTI Factor Xa inhibitor (excluding rivaroxaban) ASA (excluding DAPT) DAPT Heparin Other antithrombotics Multiple 2,035 (38.5) 158 (3.0) 7 (0.1) 967 (18.3) 53 (1.0) 174 (3.3) 55 (1.0) 340 (6.4) 996 (38.6) 66 (2.6) 5 (0.2) 540 (21.0) 26 (1.0) 73 (2.8) 6 (0.2) 126 (4.9) 221 (30.6) 44 (6.4) 0 (0.0) 96 (13.9) 14 (2.0) 4 (0.6) 1 (0.1) 19 (2.8) 803 (36.0) 149 (6.7) 1 (<0.05) 356 (15.9) 20 (0.9) 10 (0.4) 18 (0.8) 69 (3.1) 74 (22.2) 10 (3.0) 4 (1.2) 45 (13.5) 2 (0.6) 3 (0.9) 0 (0.0) 3 (0.9)
Online Table 3. Treatment-emergent outcomes in the worldwide XANTUS program by region and prior antithrombotic therapy (yes versus no) Outcome All regions Western Europe/ Canada/Israel Eastern Europe Middle East/ Africa East Asia Latin America Yes n=7583 No n=3538 Yes n=3789 No n=1498 Yes n=1838 No n=739 Yes n=389 No n=301 Yes n=1426 No n=807 Yes n=141 No n=193 Major bleeding 1.9 1.3 2.4 1.9 1.3 0.6 1.9 1.1 1.6 1.2 0.8 0.6 All-cause death 1.9 1.8 2.0 2.0 1.6 1.1 3.3 1.8 1.7 2.0 3.1 2.3 SE 1.0 0.9 1.1 0.8 0.3 0.9 0.8 0.7 2.1 1.4 N/A N/A Incidence rates (events/100 patient-years [95% CI]). CI = confidence interval; CNS = central nervous system; N/A = not applicable; SE = systemic embolism.
Concomitant antiplatelets/NSAIDs, % 20.9 Antiplatelets: 7.6 NSAIDs: 10.2 NR Non-ASA antiplatelets:* 10.3 ASA:* 40.2 NSAIDs:14.2 Antiplatelets: 23.7 NSAIDs: 36.9 Impaired renal function, % CrCl <50 mL/min: 11.5 Abnormal renal function: 6.9† CrCl <50 mL/min: 12.5 Renal disease: >15 Renal disease: 4.1 Renal insufficiency: 17.1 Patient risk scores CHADS2 mean 2.0 2.4 NR NR NR CHA2DS2-VASc score, mean 3.5 NR NR 3.0 3.7 CHA2DS2-VASc ≥2, % 87.9 92.6 90.7 81.7 NR