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. Author manuscript; available in PMC: 2019 Aug 21.
Published in final edited form as: N Engl J Med. 2018 Nov 10;380(8):752–762. doi: 10.1056/NEJMoa1809798

Table 2.

Cardiovascular Clinical End Points.

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.