Table 1:
Study Characteristics
| Trials | Sample Size | AF at baseline included in the analysis | Mean age, years | Female Patients, (%) | White Patients, (%) | Intervention Arm | Control Arm | Median follow-up, years | Total AF events (% per year) | Type of AF Event |
|---|---|---|---|---|---|---|---|---|---|---|
| VITAL8 | 25119 | No | 67 | 12757 (51) | 17425 (71) | 1g per day of omega-3 fatty acids (460 mg EPA and 380 mg of DHA) | Olive oil | 5.3 | 900 (0.7%) | New-onset AF |
| ASCEND * 22, 23 | 15480* | Yes | 63 | 5796 (37) | 14935 (96) | 1g per day of omega-3 fatty acids (460 mg EPA and 380 mg of DHA) | Olive oil | 7.4 | 301 (0.3%) | Main paper: patient-reported AF (without excluding preexisting AF). Research letter: New-onset AF |
| STRENGTH 6 | 13078 | Yes | 62.5 | 4568 (35) | 10723 (82) | 4g per day of omega-3 fatty acids (EPA and DHA) | Corn oil | 3.5 | 230 (0.5%) | New-onset AF |
| RP 25 | 12505 | Yes | 64 | 4818 (39) | NA | 1g per day of omega-3 fatty acids (EPA and DHA < 85% in ratio from 0.9:1 to 1.5:1) | Olive oil | 5 | 205 (0.3%) | Hospitalization for AF (without excluding preexisting AF). |
| REDUCE-IT 2 | 8179 | Yes | 64 | 2357 (29) | 7379 (90) | 4g per day of icosapent ethyl (ethyl ester of EPA) | Mineral oil | 4.9 | 374 (0.9%) | New-onset or worsening AF events (without excluding preexisting AF). |
| GISSI-HF 24 | 5835 | No | 66 | 1252 (21) | NA | 1g per day of omega-3 fatty acids (850– 882 mg of EPA DHA esters at an average ratio of 1.2:1. | Olive oil | 3.9 | 852 (3.7%) | New-onset AF |
| OMEMI 7 | 1014** | No | 75 | 294 (29) | 1012 (100) | 1.8g per day of omega-3 fatty acids (930 mg EPA and 660 mg DHA) | Corn oil | 2*** | 43 (2.1%) | New-onset AF |
| Total | 81210 | 65 | 31842 (39) | 4.9 | 2905 (1.3%) |
Patient-reported AF adverse events were extracted from the original publication of ASCEND trial. The post-hoc research letter reporting a more comprehensive assessment of AF (N=1177) based on electronic health records was used as sensitivity analysis.
The total sample size of the trial was 1014, but 759 were included in the AF analysis after excluding those with prevalent AF.
Only total duration of the trial was reported.Abbreviations: AF, atrial fibrillation; ASCEND, A Study of Cardiovascular Events in Diabetes; DHA, docosahexaenoic acid; GISSI-HF, Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca; NA, not available, OMEMI, Omega-3 fatty acids in Elderly with Myocardial Infarction; REDUCE-IT, Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial; RP, The Risk and Prevention Study; STRENGTH, Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia; VITAL, The Vitamin D and Omega-3 Trial.