Table 2.

Hazard ratios (HR) and 95% confidence intervals (CI) of cardiovascular outcomes by randomized assignment to n−3 fatty acids (n−3 FAs)^a

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 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
Ischaemic 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
Ancillary outcomes
First hospitalization for heart failure	244	255	0.96	0.80–1.14
Recurrent hospitalization for heart failure	326	379	0.86	0.74–0.998
Atrial fibrillation	469	431	1.09	0.96–1.24
Excluding the first two years of follow-up:
Major CVD event	269	301	0.89	0.76–1.05
Total MI	94	131	0.72	0.55–0.93
Total stroke	103	112	0.92	0.70–1.20

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.

Adapted from Manson et al.¹⁶