Table 3.

Clinical End Points by Infusion Arms for Patients With Diabetes Mellitus

End PointEDTA Chelation (n=322)Placebo (n=311)Hazard Ratio (95% CI)P ValueAdjusted*
CIP Value
Primary end point80 (25%)117 (38%)0.59 (0.44–0.79)<0.0010.39–0.880.002
Death32 (10%)50 (16%)0.57 (0.36–0.88)0.0110.30–1.060.099
MI16 (5%)30 (10%)0.48 (0.26–0.88)0.0150.20–1.130.135
Stroke4 (1%)3 (1%)1.19 (0.27–5.30)0.8290.14–9.88
Coronary revascularization48 (15%)62 (20%)0.68 (0.48–0.99)0.0420.40–1.160.378
Hospitalization for angina5 (2%)6 (2%)0.72 (0.22–2.36)0.5880.13–3.87
Secondary end point35 (11%)52 (17%)0.60 (0.39–0.91)0.0170.32–1.090.153
Cardiovascular death19 (6%)27 (9%)0.63 (0.35–1.13)0.1180.27–1.44
  • CI indicates confidence interval; and MI, myocardial infarction.

  • * Bonferroni adjustment for 9 subgroup factors. CIs are adjusted to a level of 99.4%, and P value is 9× the nominal P value.