Table 4.

Hazard Ratios (HR) and 95% Confidence Intervals (CIs) of Primary, Secondary, and Other Outcomes by Randomized Assignment to n-3 Fatty Acids (n-3 FAs)^a,b.

Endpoint	n-3 FAs (N = 12 933)	Placebo (N = 12 938)	HR	95% CI
	No. of participants w/event
Cardiovascular disease (CVD), primary and secondary outcomes
Major CVD eventc,d	386	419	0.92	0.80-1.06
Expanded CVD event e	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 outcomes f
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 CHD g	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 cancer c	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 2 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

^aAdapted from Manson et al. ¹⁸ with permission. Copyright ©2019, Massachusetts Medical Society.

^bAnalyses 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.

^cPrimary outcomes.

^dA composite of MI, stroke, and cardiovascular mortality.

^eA composite of MI, stroke, cardiovascular mortality, and coronary revascularization (CABG, PCI).

^fNot prespecified as primary or secondary outcomes.

^gA composite of MI, coronary revascularization (CABG, PCI), and CHD death.