Table 1.
RE-LY trial | Medicare | ||
---|---|---|---|
Baseline characteristics | dabigatran 150mg + warfarin (n=12,098) |
Early post-market target population (n=20,552) |
Extended time window target population (n=30,626) |
Demographics | |||
Age; mean (sd) | 71.4 (8.6) | 78.6 (6.4) | 77.6 (6.23) |
<65 | 1983 (16.4) | 0 (0.0) | 0 (0.0) |
>=65-<75 | 5226 (43.2) | 4,874 (23.7) | 8,366 (27.3) |
>=75 | 4889 (40.4) | 15678 (76.3) | 22260 (72.7) |
Sex (Female) | 4449 (36.8) | 9948 (48.4) | 13772 (45.0) |
Race (White) | 8471 (70.0) | 19526 (95.0) | 29013 (94.7) |
Risk stratification score for AF | |||
CHADS2 score; mean (sd) | 2.15 (1.13) | 2.15 (0.91) | 2.11 (0.91) |
0 or 1 | 3823 (31.6) | 4282 (20.8) | 6809 (22.2) |
2 | 4365 (36.1) | 10465 (50.9) | 15667 (51.2) |
3 | 2420 (20.0) | 4298 (20.9) | 5964 (19.5) |
4 | 1071 (8.9) | 1201 (5.8) | 1769 (5.8) |
5 or 6 | 419 (3.5) | 306 (1.5) | 417 (1.4) |
Comorbidities | |||
Stroke or TIA | 2428 (20.1) | 999 (4.9) | 1949 (6.4) |
Myocardial infarction | 1997 (16.5) | 898 (4.4) | 1824 (6.0) |
Heart failure | 3856 (31.9) | 2587 (12.6) | 3466 (11.3) |
Diabetes | 2812 (23.2) | 5587 (27.2) | 8190 (26.7) |
Coronary artery disease | 3373 (27.9) | 6174 (30.0) | 9254 (30.2) |
Hypertension | 9545 (78.9) | 17062 (83.0) | 25529 (83.4) |
Cancer | 1272 (10.5) | 5169 (25.2) | 7468 (24.4) |
Medications in use at baseline | |||
ACE Inhibitor | 5424 (44.8) | 7787 (37.9) | 11184 (36.5) |
ARB | 2888 (23.9) | 4193 (20.4) | 6962 (22.7) |
Amiodarone | 1329 (11.0) | 1521 (7.4) | 2399 (7.8) |
Beta blocker | 7609 (62.9) | 13352 (65.0) | 20428 (66.7) |
Clopidogrel | 682 (5.6) | 2047 (10.0) | 3430 (11.2) |
Digoxin | 3509 (29.0) | 3564 (17.3) | 3218 (10.5) |
Diltiazem | 1120 (9.3) | 3356 (16.3) | 5060 (16.5) |
Diuretic | 6189 (51.2) | 5230 (25.4) | 6317 (20.6) |
H2-receptor antagonist | 519 (4.3) | 719 (3.5) | 1234 (4.0) |
Oral Hypoglycemic | 2004 (16.6) | 4195 (20.4) | 6332 (20.7) |
Other NSAID | 613 (5.1) | 2116 (10.3) | 3866 (12.6) |
Other antiarrhythmic | 981 (8.1) | 3105 (15.1) | 4619 (15.1) |
Parenteral anticoagulant | 642 (5.3) | 456 (2.2) | 676 (2.2) |
Proton-pump inhibitors | 1720 (14.2) | 3329 (16.2) | 5544 (18.1) |
Statin | 5355 (44.3) | 11159 (54.3) | 17049 (55.7) |
Any antithromobotic treatment | 5378 (44.5) | 2595 (12.6) | 4219 (13.8) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; COX, cyclooxygenase; H2-receptor: histamine type-2 receptor; NSAID, nonsteroidal anti-inflammatory drug; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy; sd, standard deviation; TIA, transient ischemic attack; VKA, vitamin K antagonist.