Table 2.
Event rates for outcomes in study cohorts, overall and within hemoglobin strata
| Baseline ESA Nonusers | Baseline ESA Users | ESA Naives | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hb 8–10 g/dL | Hb 10.1–10.5 g/dL | Hb >10.5 g/dL | All | Hb 8–11 g/dL | Hb 11.1–12.5 g/dL | All | Hb 8–10 g/dL | Hb >10 g/dL | All | |
| (N = 761) | (N = 780) | (N = 30,658) | (N = 32,199) | (N = 79) | (N = 30) | (N = 109) | (N = 193) | (N = 73) | (N = 266) | |
| eGFR, mL/min/1.73m2, mean ± SD | 40.3 ± 12.6 | 40.5 ± 11.8 | 48.3 ± 9.1 | 47.9 ± 9.4 | 27.0 ± 11.6 | 32.8 ± 12.0 | 28.6 ± 11.9 | 26.9 ± 11.6 | 29.5 ± 11.5 | 27.6 ± 11.6 |
| MACE | ||||||||||
| Event n | 283 | 226 | 5788 | 6297 | 28 | 8 | 36 | 55 | 22 | 77 |
| Pt-year | 1345 | 1552 | 68,321 | 71,218 | 125 | 59 | 183 | 209 | 89 | 298 |
| Mean follow-up, years | 1.77 | 1.99 | 2.23 | 2.21 | 1.58 | 1.95 | 1.68 | 1.08 | 1.22 | 1.12 |
| Rate per 100 pt-year (95% CI) | 21.04 (18.73, 23.64) | 14.56 (12.78, 16.59) | 8.47 (8.26, 8.69) | 8.84 (8.63, 9.06) | 22.45 (15.50, 32.51) | 13.66 (6.83, 27.31) | 19.64 (14.17, 27.23) | 26.32 (20.20, 34.28) | 24.67 (16.24, 37.46) | 25.82 (20.65, 32.28) |
| MACE+ | ||||||||||
| Event n | 369 | 301 | 7515 | 8185 | 40 | 15 | 55 | 80 | 32 | 112 |
| Pt-year | 1203 | 1428 | 65,674 | 68,305 | 106 | 48 | 154 | 178 | 78 | 257 |
| Mean follow-up, years | 1.58 | 1.83 | 2.14 | 2.12 | 1.34 | 1.61 | 1.42 | 0.92 | 1.07 | 0.97 |
| Rate per 100 pt-year (95% CI) | 30.66 (27.69, 33.95) | 21.08 (18.83, 23.60) | 11.44 (11.19, 11.70) | 11.98 (11.73, 12.25) | 37.78 (27.71, 51.51) | 30.98 (18.68, 51.38) | 35.65 (27.37, 46.43) | 44.84 (36.02, 55.83) | 40.85 (28.89, 57.77) | 43.62 (36.25, 52.50) |
| Death | ||||||||||
| Event n | 190 | 136 | 2573 | 2899 | 20 | 6 | 26 | 32 | 10 | 42 |
| Pt-year | 1533 | 1734 | 73,529 | 76,796 | 142 | 61 | 202 | 235 | 102 | 337 |
| Mean follow-up, years | 2.01 | 2.22 | 2.40 | 2.39 | 1.79 | 2.03 | 1.86 | 1.22 | 1.40 | 1.27 |
| Rate per 100 pt-year (95% CI) | 12.39 (10.75, 14.28) | 7.84 (6.63, 9.28) | 3.50 (3.37, 3.64) | 3.77 (3.64, 3.91) | 14.12 (9.11, 21.88) | 9.87 (4.43, 21.97) | 12.84 (8.74, 18.86) | 13.63 (9.64, 19.27) | 9.82 (5.28, 18.24) | 12.48 (9.22, 16.88) |
| MI | ||||||||||
| Event n | 109 | 107 | 2587 | 2803 | 15 | 2 | 17 | 32 | 7 | 39 |
| Pt-year | 1441 | 1629 | 70,796 | 73,866 | 128 | 59 | 187 | 216 | 96 | 312 |
| Mean follow-up, years | 1.89 | 2.09 | 2.31 | 2.29 | 1.62 | 1.96 | 1.71 | 1.12 | 1.31 | 1.17 |
| Rate per 100 pt-year (95% CI) | 7.57 (6.27, 9.13) | 6.57 (5.43, 7.94) | 3.65 (3.52, 3.80) | 3.79 (3.66, 3.94) | 11.72 (7.06, 19.44) | 3.41 (0.85, 13.63) | 9.11 (5.66, 14.65) | 14.78 (10.45, 20.90) | 7.31 (3.48, 15.33) | 12.49 (9.13, 17.09) |
| Stroke | ||||||||||
| Event n | 123 | 90 | 2840 | 3053 | 5 | 2 | 7 | 16 | 11 | 27 |
| Pt-year | 1409 | 1632 | 70,395 | 73,436 | 138 | 61 | 199 | 224 | 94 | 319 |
| Mean follow-up, years | 1.85 | 2.09 | 2.30 | 2.28 | 1.75 | 2.02 | 1.82 | 1.16 | 1.29 | 1.20 |
| Rate per 100 pt-year (95% CI) | 8.73 (7.32, 10.42) | 5.51 (4.49, 6.78) | 4.03 (3.89, 4.19) | 4.16 (4.01, 4.31) | 3.62 (1.51, 8.70) | 3.29 (0.82, 13.17) | 3.52 (1.68, 7.38) | 7.14 (4.37, 11.65) | 11.65 (6.45, 21.03) | 8.47 (5.81, 12.36) |
| CHF hospitalization | ||||||||||
| Event n | 261 | 224 | 4443 | 4928 | 31 | 14 | 45 | 66 | 23 | 89 |
| Pt-year | 1291 | 1497 | 68,827 | 71,614 | 112 | 48 | 161 | 188 | 84 | 272 |
| Mean follow-up, years | 1.70 | 1.92 | 2.24 | 2.22 | 1.42 | 1.62 | 1.47 | 0.98 | 1.15 | 1.02 |
| Rate per 100 pt-year (95% CI) | 20.22 (17.91, 22.83) | 14.97 (13.13, 17.06) | 6.46 (6.27, 6.65) | 6.88 (6.69, 7.08) | 27.67 (19.46, 39.34) | 28.88 (17.11, 48.77) | 28.03 (20.93, 37.55) | 35.05 (27.53, 44.61) | 27.50 (18.27, 41.38) | 32.73 (26.59, 40.28) |
Abbreviations: CHF congestive heart failure, CI confidence interval, CKD chronic kidney disease, ESA erythropoiesis-stimulating agent, Hb hemoglobin; hosp hospitalization, MI myocardial infarction, MACE major adverse cardiovascular events, n event count, pt patient, PVD peripheral vascular disease, SD standard deviation, yr year. Event rates 95% confidence intervals are based on exact Poisson estimates. In the case that an exact Poisson regression failed, normal approximation was used. Primary analysis, intent-to-treat