Table 2.
Endpoint | n-3 FAs (N =12,933) | Placebo (N =12,938) | HR | 95% CI |
---|---|---|---|---|
# of participants w/event | ||||
Cardiovascular disease (CVD), primary and secondary outcomes |
||||
Major CVD eventb,c | 386 | 419 | 0.92 | 0.80–1.06 |
Expanded CVD eventd | 527 | 567 | 0.93 | 0.82–1.04 |
Total myocardial infarction (MI) | 145 | 200 | 0.72 | 0.59–0.90 |
Total stroke | 148 | 142 | 1.04 | 0.83–1.31 |
Cardiovascular mortality | 142 | 148 | 0.96 | 0.76–1.21 |
Other vascular outcomese | ||||
Percutaneous coronary intervention (PCI) | 162 | 208 | 0.78 | 0.63–0.95 |
Coronary artery bypass graft (CABG) | 85 | 86 | 0.99 | 0.73–1.33 |
Fatal MI | 13 | 26 | 0.50 | 0.26–0.97 |
Coronary heart disease (CHD) mortality | 37 | 49 | 0.76 | 0.49–1.16 |
Total CHDf | 308 | 370 | 0.83 | 0.71–0.97 |
Ischemic stroke | 111 | 116 | 0.96 | 0.74–1.24 |
Hemorrhagic stroke | 25 | 19 | 1.32 | 0.72–2.39 |
Fatal stroke | 22 | 20 | 1.10 | 0.60–2.01 |
Total invasive cancerb | 820 | 797 | 1.03 | 0.93–1.13 |
Cancer mortality | 168 | 173 | 0.97 | 0.79–1.20 |
All-cause mortality | 493 | 485 | 1.02 | 0.90–1.15 |
Excluding the first two years of follow-up: | ||||
Cardiovascular outcomes | ||||
Major CVD event | 269 | 301 | 0.89 | 0.76–1.05 |
Total myocardial infarction | 94 | 131 | 0.72 | 0.55–0.93 |
Total stroke | 103 | 112 | 0.92 | 0.70–1.20 |
Total invasive cancer | 536 | 476 | 1.13 | 1.00–1.28 |
Cancer mortality | 126 | 135 | 0.93 | 0.73–1.19 |
All-cause mortality | 371 | 381 | 0.97 | 0.84–1.12 |
Analyses were from Cox regression models that were controlled for age, sex, and randomization group in the vitamin D portion of the trial. Analyses were not adjusted for multiple comparisons.
Primary outcomes
A composite of MI, stroke, and cardiovascular mortality
A composite of MI, stroke, cardiovascular mortality, and coronary revascularization (CABG, PCI)
Not prespecified as primary or secondary outcomes.
A composite of MI, coronary revascularization (CABG, PCI), and CHD death