Table 2.
Details of the randomized clinical studies.
| Trial | Time from MI to study entry | Follow-up | Patient characteristics
|
Outcomes
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MI (%) | CHF (%) | DM (%) | Statin/lipid lowering drugs (%) | BB (%) | Antiplatelet agents (%) | Revascularization (%) | Death (%) in treatment arm | SCD (%) in treatment arm | MCE (%) in treatment arm | |||
| Positive studies | ||||||||||||
| DART3 | Mean 41 days | 2 yrs | 100 | N/A | 0 | N/A | 26 | 5 | N/A | 9.3 | N/A | 12.5 |
| GISSI-Prevenzione4 | w/in 3 months, median 16 days | 3.5 yrs | 100 | 14 | 14 | 5 (46% at 3.5 yrs) | 44 | 92 | 5 | 8.3 | 1.9 | 9.2 |
| JELIS5 | N/A | 4.6 yrs | 5 | N/A | 16 | 97 | 9 | 13 | 5 | 3.1 | 0.2 | 2.8 |
| GISSI-HF6 | N/A | 3.9 yrs | 42 | 100 (90% EF ≤ 40) | 28 | 22 | 65 | 58 (+29% oral anticoagulation) | N/A | 27 | 8.8 | N/A |
| Negative studies | ||||||||||||
| DART-211 | N/A | 6 months | 50 | N/A | 11 | N/A | 43 | N/A | N/A | 18.5 | 5.5 | N/A |
| Alpha-Omega12 | w/in 10 yrs, median 3.7 yrs | 40 months | 100 | N/A | 20 | 85 | N/A | 98 | N/A | 7.7 | 2.8 (ventricular arrhythmia events) | 14 |
| OMEGA13 | 3–14 days | 1 yr | 100 | 25 | 28 | 81 | 86 | 94 | 78 | 4.6 | 1.5 | 10.4 |
| SU.FOL.OM314 | w/in 12 months, median 101 days | 4.7 yrs | 47 | N/A | N/A | 86 | 68 | 94 | N/A | 4.7 | N/A | 6.5 |
| ORIGIN15 | N/A | 6.2 yrs | 59% (MI, CVA, or revascularization) | N/A (severe CHF excluded) | N/A | 53 | 53 | 70 | N/A | 15.1 | 4.6 (death from arrhythmia) | 16.5 |
Abbreviations: BB, beta blocker; CHF, congestive heart failure; CVA, cerebrovascular accident; DM, diabetes mellitus; MACCE, major adverse cardio-cerebrovascular event; MCE, major cardiovascular event; MI, myocardial infarction; N/A, not available; SCD, sudden cardiac death.