Table 2.
End Point | Low-Dose Methotrexate (N = 2391) | Placebo (N = 2395) | Hazard Ratio (95% CI)* | P Value | ||
---|---|---|---|---|---|---|
no. of patients | incidence rate/100 person-yr | no. of patients | incidence rate/100 person-yr | |||
Primary end points† | ||||||
Final primary end point: major adverse cardio- vascular event or hospitalization for unstable angina that led to urgent revascularization | 201 | 4.13 | 207 | 4.31 | 0.96 (0.79–1.16) | 0.67 |
Original primary end point: major adverse cardiovascular event | 170 | 3.46 | 167 | 3.43 | 1.01 (0.82–1.25) | 0.91 |
Secondary end points† | ||||||
Death from any cause | 96 | 1.80 | 83 | 1.55 | 1.16 (0.87–1.56) | |
Major adverse cardiovascular event or any coronary revascularization | 278 | 5.86 | 288 | 6.15 | 0.95 (0.81–1.12) | |
Hospitalization for congestive heart failure | 48 | 0.95 | 53 | 1.06 | 0.89 (0.60–1.31) | |
Major adverse cardiovascular event, coronary revascularization, hospitalization for congestive heart failure, or death from any cause | 344 | 7.30 | 345 | 7.42 | 0.98 (0.84–1.14) | |
Tertiary end points | ||||||
Nonfatal myocardial infarction | 113 | 2.29 | 114 | 2.32 | 0.99 (0.76–1.29) | |
Nonfatal stroke | 28 | 0.55 | 30 | 0.60 | 0.91 (0.54–1.52) | |
Cardiovascular death | 49 | 0.92 | 43 | 0.80 | 1.14 (0.76–1.72) | |
Hospitalization for unstable angina that led to urgent revascularization | 41 | 0.81 | 50 | 1.01 | 0.81 (0.53–1.22) | |
Coronary revascularization | 190 | 3.95 | 205 | 4.30 | 0.92 (0.75–1.12) | |
Arterial revascularization | 195 | 4.05 | 185 | 3.84 | 1.05 (0.86–1.28) |
Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.
Major adverse cardiovascular events included nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death.