Table 2.
CV outcomes in the WHI hormone therapy trials during the intervention and extended follow‐up phase according to age at randomization
| CEE + MPA Arm | CEE‐Only Arm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of Events (annualized %) | No. of Events, (annualized %) | |||||||||
| CEE + MPA, n = 8506 | Placebo, n = 8102 | Difference/10 000 PY | HR (95% CI) | P Value | CEE, n = 5310 | Placebo, n = 5429 | Difference/10 000 PY | HR (95% CI) | P Value | |
| Intervention | ||||||||||
| CHD | 0.81 | 0.08 | ||||||||
| 50–59 y | 38 (0.23) | 27 (0.17) | 5 | 1.34 (0.82‐2.19) | 21 (0.17) | 35 (0.28) | –11 | 0.60 (0.35‐1.04) | ||
| 60–69 y | 79 (0.37) | 73 (0.37) | 0 | 1.01 (0.73‐1.39) | 100 (0.61) | 108 (0.63) | –3 | 0.95 (0.72‐1.24) | ||
| 70–79 y | 79 (0.82) | 59 (0.63) | 19 | 1.31 (0.93‐1.84) | 83 (0.97) | 79 (0.90) | 7 | 1.09 (0.80‐1.49) | ||
| Total MI | 0.55 | 0.02 | ||||||||
| 50–59 y | 32 (0.19) | 23 (0.15) | 4 | 1.32 (0.77‐2.25) | 17 (0.14) | 31 (0.25) | –11 | 0.55 (0.31‐1.00) | ||
| 60–69 y | 70 (0.33) | 62 (0.31) | 2 | 1.05 (0.74‐1.47) | 76 (0.46) | 82 (0.48) | –2 | 0.95 (0.69‐1.30) | ||
| 70–79 y | 66 (0.69) | 44 (0.47) | 21 | 1.46 (1.00‐2.15) | 71 (0.83) | 60 (0.69) | 14 | 1.24 (0.88‐1.75) | ||
| CABG or PCI | 0.67 | 0.06 | ||||||||
| 50–59 y | 34 (0.20) | 32 (0.20) | 0 | 1.03 (0.63‐1.68) | 29 (0.24) | 51 (0.41) | –17 | 0.56 (0.35‐0.88) | ||
| 60–69 y | 92 (0.43) | 103 (0.52) | –9 | 0.85 (0.64‐1.13) | 129 (0.79) | 116 (0.69) | 11 | 1.13 (0.88‐1.46) | ||
| 70–79 y | 72 (0.75) | 65 (0.70) | 5 | 1.08 (0.77‐1.51) | 91 (1.07) | 88 (1.02) | 5 | 1.07 (0.79‐1.43) | ||
| All‐cause mortality | 0.20 | 0.04 | ||||||||
| 50–59 y | 35 (0.21) | 48 (0.31) | –10 | 0.67 (0.43‐1.04) | 35 (0.29) | 50 (0.40) | –11 | 0.70 (0.46‐1.09) | ||
| 60–69 y | 111 (0.51) | 94 (0.47) | 5 | 1.07 (0.81‐1.41) | 130 (0.78) | 134 (0.77) | 0 | 1.01 (0.79‐1.29) | ||
| 70–79 y | 104 (1.06) | 96 (1.02) | 4 | 1.03 (0.78‐1.36) | 136 (1.55) | 115 (1.29) | 26 | 1.21 (0.95‐1.56) | ||
| Extended follow‐up | ||||||||||
| CHD | 0.99 | 0.12 | ||||||||
| 50–59 y | 93 (0.26) | 69 (0.21) | 5 | 1.27 (0.93‐1.74) | 42 (0.21) | 64 (0.32) | –11 | 0.65 (0.44‐0.96) | ||
| 60–69 y | 201 (0.44) | 199 (0.46) | –2 | 0.97 (0.79‐1.18) | 183 (0.67) | 188 (0.67) | 0 | 1.00 (0.82‐1.23) | ||
| 70–79 y | 193 (0.98) | 162 (0.84) | 14 | 1.17 (0.95‐1.44) | 138 (1.03) | 141 (1.03) | 0 | 1.01 (0.80‐1.28) | ||
| Total MI | 0.46 | 0.007 | ||||||||
| 50–59 y | 75 (0.21) | 57 (0.17) | 4 | 1.25 (0.88‐1.76) | 35 (0.17) | 58 (0.29) | –11 | 0.60 (0.39‐0.91) | ||
| 60–69 y | 165 (0.36) | 158 (0.36) | 0 | 0.99 (0.8‐1.24) | 140 (0.52) | 139 (0.49) | 2 | 1.03 (0.82‐1.31) | ||
| 70–79 y | 149 (0.76) | 109 (0.57) | 19 | 1.34 (1.05‐1.72) | 110 (0.82) | 91 (0.67) | 16 | 1.25 (0.95‐1.65) | ||
| CABG or PCI | 0.34 | 0.40 | ||||||||
| 50–59 y | 102 (0.29) | 96 (0.29) | 0 | 1.01 (0.76‐1.34) | 71 (0.36) | 83 (0.42) | –6 | 0.83 (0.60‐1.14) | ||
| 60–69 y | 246 (0.54) | 244 (0.57) | –3 | 0.98 (0.82‐1.18) | 212 (0.80) | 192 (0.69) | 10 | 1.12 (0.92‐1.37) | ||
| 70–79 y | 158 (0.81) | 131 (0.69) | 12 | 1.18 (0.94‐1.49) | 122 (0.93) | 121 (0.90) | 2 | 1.03 (0.80‐1.33) | ||
| All‐cause mortality | 0.23 | 0.10 | ||||||||
| 50–59 y | 141 (0.39) | 149 (0.44) | –5 | 0.88 (0.70‐1.11) | 90 (0.45) | 115 (0.56) | –12 | 0.78 (0.59‐1.03) | ||
| 60–69 y | 452 (0.97) | 429 (0.97) | –1 | 0.99 (0.87‐1.13) | 301 (1.08) | 308 (1.07) | 1 | 1.02 (0.87‐1.19) | ||
| 70–79 y | 418 (2.07) | 388 (1.97) | 9 | 1.04 (0.91‐1.20) | 313 (2.26) | 302 (2.15) | 11 | 1.06 (0.90‐1.24) | ||
Abbreviations: CABG, coronary artery bypass grafting; CEE, conjugated equine estrogens; CHD, coronary heart disease (defined as nonfatal MI and CHD death); CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; MPA, medroxyprogesterone acetate; PCI, percutaneous coronary intervention; PY, person‐years; WHI, Women's Health Initiative. P values for trend by age.