Table 1.
Hazard Ratios for the Primary End Point for Individual Cox Models*
| Warfarin |
Aspirin |
Hazard Ratio (95% CI) for Warfarin vs Aspirin |
P Value |
||||
|---|---|---|---|---|---|---|---|
| Events/Patients | Rate† | Events/Patients | Rate† | For HR‡ | For Interaction§ | ||
| Age group, y | |||||||
| <60 | 93/508 | 4.81 | 130/522 | 6.76 | 0.65 (0.49–0.86) | 0.002 | 0.001 |
| ≥60 | 209/634 | 9.91 | 190/641 | 9.01 | 1.16 (0.94–1.43) | 0.16 | |
| Country | |||||||
| Poland | 34/129 | 7.70 | 50/134 | 12.38 | 0.61 (0.40–0.95) | 0.03 | |
| Ukraine | 20/57 | 9.68 | 28/58 | 13.75 | 0.78 (0.43–1.43) | 0.43 | |
| United States | 115/463 | 6.06 | 130/440 | 7.55 | 0.79 (0.61–1.02) | 0.07 | 0.02 |
| Argentina and other European | 68/308 | 7.75 | 67/348 | 6.57 | 1.18 (0.84–1.67) | 0.34 | |
| Hungary | 30/75 | 13.06 | 22/77 | 9.34 | 1.29 (0.73–2.28) | 0.38 | |
| Canada | 35/110 | 8.90 | 23/106 | 5.12 | 1.69 (0.98–2.90) | 0.06 | |
| Sex | |||||||
| Men | 240/906 | 7.55 | 281/939 | 8.71 | 0.88 (0.73–1.05) | 0.16 | 0.07 |
| Women | 62/236 | 7.17 | 39/224 | 4.83 | 1.34 (0.88–2.03) | 0.17 | |
| Smoking | |||||||
| Current | 46/213 | 5.96 | 63/195 | 9.30 | 0.62 (0.41–0.92) | 0.02 | |
| Former | 173/585 | 8.29 | 178/604 | 8.50 | 0.98 (0.78–1.22) | 0.84 | 0.08 |
| Never | 83/344 | 6.99 | 79/364 | 6.26 | 1.10 (0.80–1.53) | 0.55 | |
| NYHA class | |||||||
| NYHA 3 or 4 | 116/368 | 9.12 | 131/347 | 11.72 | 0.78 (0.60–1.01) | 0.06 | 0.11 |
| NYHA 1 or 2 | 186/774 | 6.71 | 189/816 | 6.48 | 1.03 (0.83–1.26) | 0.82 | |
| Prior stroke or TIA | 45/155 | 8.39 | 56/139 | 12.56 | 0.72 (0.47–1.11) | 0.14 | 0.21 |
| No prior stroke or TIA | 257/987 | 7.33 | 264/1024 | 7.36 | 0.98 (0.82–1.17) | 0.79 | |
| Statin | |||||||
| No | 21/137 | 6.80 | 29/147 | 9.42 | 0.77 (0.42–1.39) | 0.39 | |
| Unknown | 92/315 | 6.79 | 112/312 | 8.58 | 0.78 (0.59–1.04) | 0.09 | 0.22 |
| Yes | 189/690 | 7.94 | 179/704 | 7.40 | 1.06 (0.85–1.31) | 0.61 | |
| Hemoglobin | |||||||
| Low | 180/613 | 8.31 | 184/586 | 9.25 | 0.84 (0.67–1.04) | 0.11 | 0.23 |
| High | 122/529 | 6.50 | 136/577 | 6.65 | 1.03 (0.80–1.33) | 0.81 | |
| 6-minute walk, m | |||||||
| High | 97/499 | 5.49 | 126/550 | 6.60 | 0.81 (0.61–1.06) | 0.12 | 0.24 |
| Low | 205/643 | 9.00 | 194/613 | 9.14 | 0.99 (0.81–1.22) | 0.94 | |
| Diabetes mellitus | |||||||
| No | 177/771 | 6.37 | 201/812 | 7.06 | 0.86 (0.70–1.06) | 0.16 | 0.25 |
| Yes | 125/371 | 9.86 | 119/351 | 10.05 | 1.06 (0.81–1.39) | 0.67 | |
| Aspirin or other antiplatelet, prior use | |||||||
| Unknown | 88/304 | 6.77 | 99/288 | 8.34 | 0.75 (0.55–1.02) | 0.06 | |
| No | 38/221 | 7.67 | 36/233 | 6.97 | 1.01 (0.63–1.62) | 0.96 | 0.25 |
| Yes | 176/617 | 7.83 | 185/642 | 7.94 | 1.03 (0.83–1.27) | 0.82 | |
| BUN | |||||||
| Low | 126/555 | 6.03 | 151/598 | 6.95 | 0.83 (0.65–1.07) | 0.15 | 0.26 |
| High | 176/587 | 9.00 | 169/565 | 9.08 | 1.01 (0.81–1.26) | 0.93 | |
| BMI category | |||||||
| >30 | 89/415 | 5.75 | 106/428 | 6.95 | 0.82 (0.61–1.10) | 0.18 | |
| <25 | 91/294 | 9.08 | 92/265 | 10.52 | 0.84 (0.61–1.14) | 0.26 | 0.27 |
| 25–30 | 122/433 | 8.17 | 122/470 | 7.47 | 1.10 (0.84–1.44) | 0.47 | |
| Warfarin, prior use | |||||||
| Yes | 26/90 | 7.72 | 27/89 | 8.62 | 0.69 (0.38–1.23) | 0.21 | 0.29 |
| No | 276/1052 | 7.44 | 293/1074 | 7.88 | 0.96 (0.81–1.13) | 0.60 | |
| Device | |||||||
| No | 236/870 | 7.61 | 268/911 | 8.35 | 0.89 (0.75–1.07) | 0.23 | 0.32 |
| Yes | 66/272 | 7.00 | 52/252 | 6.33 | 1.11 (0.76, 1.63) | 0.59 | |
| eGFR | |||||||
| High | 115/549 | 5.71 | 141/591 | 6.62 | 0.83 (0.65–1.08) | 0.17 | 0.36 |
| Low | 187/593 | 9.22 | 179/572 | 9.41 | 0.98 (0.79–1.22) | 0.84 | |
| WBC | |||||||
| High | 144/590 | 6.76 | 166/596 | 8.28 | 0.87 (0.69–1.10) | 0.23 | 0.40 |
| Low | 158/552 | 8.25 | 154/567 | 7.59 | 1.00 (0.79–1.27) | 0.98 | |
| Myocardial infarction | |||||||
| No | 144/593 | 6.73 | 155/600 | 7.30 | 0.87 (0.69–1.11) | 0.26 | 0.43 |
| Yes | 158/549 | 8.30 | 165/563 | 8.64 | 1.00 (0.79–1.26) | 0.998 | |
| Education | |||||||
| College grad | 32/163 | 4.96 | 52/193 | 6.99 | 0.72 (0.45–1.14) | 0.16 | |
| High School grad | 134/487 | 7.36 | 130/460 | 8.04 | 0.92 (0.71–1.19) | 0.52 | 0.45 |
| Less than High School | 136/492 | 8.62 | 138/510 | 8.25 | 1.01 (0.79–1.29) | 0.96 | |
| Alcohol use | |||||||
| Current | 63/279 | 6.23 | 67/293 | 6.73 | 0.80 (0.56–1.15) | 0.23 | |
| Former | 73/250 | 7.85 | 87/256 | 9.31 | 0.87 (0.62–1.22) | 0.42 | 0.49 |
| Never | 166/613 | 7.89 | 166/614 | 7.89 | 1.02 (0.82–1.28) | 0.85 | |
| Sodium | |||||||
| High | 160/611 | 7.30 | 167/608 | 7.82 | 0.89 (0.71–1.12) | 0.32 | 0.55 |
| Low | 142/531 | 7.66 | 153/555 | 8.06 | 0.99 (0.78–1.25) | 0.92 | |
| Mini-mental status examination | |||||||
| Low | 121/397 | 8.91 | 127/415 | 8.93 | 0.88 (0.67–1.14) | 0.33 | 0.58 |
| High | 181/745 | 6.74 | 193/748 | 7.40 | 0.97 (0.78–1.19) | 0.75 | |
| Coronary artery disease | |||||||
| No | 109/491 | 5.96 | 112/480 | 6.39 | 0.88 (0.67–1.18) | 0.41 | 0.62 |
| Yes | 193/651 | 8.71 | 208/683 | 9.13 | 0.97 (0.79–1.20) | 0.80 | |
| Atrial fibrillation | |||||||
| Yes | 14/44 | 8.91 | 13/42 | 9.93 | 0.78 (0.33–1.80) | 0.55 | 0.67 |
| No | 288/1098 | 7.41 | 307/1121 | 7.87 | 0.94 (0.79–1.11) | 0.45 | |
| Diastolic blood pressure | |||||||
| High | 133/577 | 6.38 | 142/587 | 6.92 | 0.89 (0.70–1.14) | 0.38 | 0.67 |
| Low | 169/565 | 8.62 | 178/576 | 8.98 | 0.96 (0.77–1.20) | 0.74 | |
| PVD | |||||||
| No | 158/560 | 7.87 | 171/575 | 8.54 | 0.92 (0.76–1.09) | 0.33 | 0.68 |
| Yes | 144/582 | 7.07 | 149/588 | 7.34 | 1.01 (0.67–1.52) | 0.97 | |
| Ischemic cardiomyopathy | |||||||
| No | 147/654 | 6.01 | 155/660 | 6.39 | 0.91 (0.72–1.15) | 0.43 | 0.70 |
| Yes | 155/488 | 9.68 | 165/503 | 10.28 | 0.97 (0.77–1.23) | 0.82 | |
| Race/ethnicity | |||||||
| Hispanic | 17/85 | 6.62 | 18/81 | 8.42 | 0.67 (0.33–1.33) | 0.25 | |
| Black | 48/166 | 7.37 | 47/166 | 7.63 | 0.92 (0.59–1.41) | 0.69 | 0.79 |
| White | 229/859 | 7.56 | 245/879 | 7.98 | 0.96 (0.80–1.16) | 0.67 | |
| Other | 8/32 | 7.51 | 10/37 | 7.44 | 0.98 (0.37–2.61) | 0.97 | |
| Hypertension | |||||||
| Unknown | 12/38 | 7.75 | 13/35 | 9.52 | 0.82 (0.34–1.95) | 0.65 | |
| Yes | 167/671 | 7.15 | 190/696 | 8.06 | 0.90 (0.72–1.12) | 0.33 | 0.83 |
| No | 123/433 | 7.91 | 117/432 | 7.60 | 0.99 (0.76–1.29) | 0.93 | |
| Hematocrit | |||||||
| High | 128/552 | 6.6 | 143/577 | 7.07 | 0.87 (0.52–1.47) | 0.61 | 0.83 |
| Low | 174/590 | 8.27 | 177/586 | 8.80 | 0.91 (0.73–1.13) | 0.38 | |
| Systolic blood pressure | |||||||
| Low | 158/560 | 7.87 | 171/575 | 8.54 | 0.92 (0.73–1.16) | 0.48 | 0.88 |
| High | 144/582 | 7.07 | 149/588 | 7.34 | 0.94 (0.74–1.20) | 0.64 | |
| Ejection fraction | |||||||
| Middle | 83/283 | 8.04 | 76/269 | 8.00 | 0.90 (0.71–1.15) | 0.41 | |
| High | 59/261 | 6.09 | 81/272 | 8.26 | 0.93 (0.65–1.33) | 0.70 | 0.97 |
| Low | 100/305 | 9.48 | 89/298 | 8.80 | 0.95 (0.70–1.28) | 0.72 | |
BMI indicates body mass index; BUN, blood urea nitrogen; CI, confidence interval; eGFR, estimated glomerular filtration rate; HR, hazard ratio; NYHA, New York Heart Association; PVD, peripheral vascular disease; TIA, transient ischemic attack; and WBC, white blood cell.
Each model includes terms for treatment, baseline variable, and treatment×baseline variable interaction. Variables are presented in increasing order of P value for the interaction term. Within variables, subgroups are in increasing order of the HR.
Rates are per 100 patient-years.
P value for the HR.
P value for the test for treatment×baseline variable interaction in a Cox model stratified by site, prior stroke status, and NYHA classification.