Table 4.
Event rates by region, and by CV risk and ESA hyporesponsive status
| N patients | All-cause mortality |
MACE |
MACE+ |
||||
|---|---|---|---|---|---|---|---|
| N events | Rate (95% CI) | N events | Rate (95% CI) | N events | Rate (95% CI) | ||
| North America | |||||||
| All patients | 3893 | 705 | 14.0 (13.0–15.0) | 843 | 17.2 (16.1–18.4) | 932 | 19.4 (18.2–20.7) |
| Low CV risk | 1507 | 139 | 6.9 (5.8–8.1) | 170 | 8.5 (7.3–9.9) | 189 | 9.6 (8.3–11.0) |
| High CV risk | 2386 | 566 | 18.7 (17.2–20.3) | 673 | 23.1 (21.4–24.9) | 743 | 26.3 (24.4–28.2) |
| Nonhyporesponder | 2816 | 492 | 12.7 (11.7–13.9) | 601 | 16.0 (14.8–17.3) | 664 | 18.0 (16.7–19.5) |
| Hyporesponder | 164 | 42 | 19.1 (14.1–25.8) | 47 | 22.0 (16.6–29.3) | 53 | 25.9 (19.8–33.9) |
| Europe | |||||||
| All patients | 8746 | 1676 | 13.2 (12.6–13.8) | 1938 | 15.6 (14.9–16.3) | 2113 | 17.4 (16.6–18.1) |
| Low CV risk | 4185 | 402 | 6.6 (6.0–7.3) | 483 | 8.0 (7.3–8.8) | 542 | 9.1 (8.4–9.9) |
| High CV risk | 4561 | 1274 | 19.3 (18.3–20.4) | 1455 | 22.8 (21.7–24.0) | 1571 | 25.3 (24.1–26.6) |
| Nonhyporesponder | 4997 | 927 | 11.6 (10.9–12.4) | 1080 | 13.8 (13.0–14.7) | 1182 | 15.4 (14.6–16.3) |
| Hyporesponder | 257 | 74 | 18.7 (14.9–23.5) | 86 | 22.3 (18.0–27.5) | 95 | 25.4 (20.8–31.1) |
| Japan | |||||||
| All patients | 3921 | 412 | 5.4 (4.9–5.9) | 511 | 6.8 (6.2–7.4) | 556 | 7.5 (6.9–8.1) |
| Low CV risk | 2208 | 126 | 2.7 (2.3–3.3) | 162 | 3.6 (3.0–4.1) | 178 | 3.9 (3.4–4.5) |
| High CV risk | 1713 | 286 | 9.4 (8.4–10.5) | 349 | 11.7 (10.6–13.0) | 378 | 12.9 (11.7–14.3) |
| Nonhyporesponder | 2617 | 216 | 4.0 (3.5–4.6) | 281 | 5.3 (4.8–6.0) | 313 | 6.0 (5.4–6.7) |
| Hyporesponder | 463 | 66 | 7.4 (5.8–9.4) | 79 | 8.9 (7.1–11.1) | 83 | 9.4 (7.6–11.7) |
CI, confidence interval; CV, cardiovascular; ESA, erythropoiesis-stimulating agent; MACE, major adverse cardiovascular events; MACE+, MACE plus heart failure and thromboembolic events.
MACE includes all-cause mortality plus hospitalization due to MI or stroke; MACE+ includes MACE plus HF and thromboembolic events (non-VA); rates expressed per 100 patient-years.
High CV risk patients are those meeting criteria for at least 2 of 6 factors: (1) age >65 years, (2) history of myocardial infarction, (3) history of stroke or transient ischemic attack, (4) History of congestive heart failure, (5) History of diabetes, (6) History of peripheral vascular disease.
Hyporesponder definition detailed in Methods (note: because of dose differences across countries, a different definition of hyporesponder was used in Japan (>5000 units/wk instead of >10,000 units/wk). Note that the number of patients in the Hyporesponder + Nonhyporesponder groups do not sum to the total because of missing data, deaths, and losses to follow-up during the 3-month run-in period. DOPPS phase 4 and 5 data combined.