Abstract
BACKGROUND AND OBJECTIVES: Patients receiving hemodialysis are at risk of cardiovascular events. A novel blood test (T(50) test) determines the individual calcification propensity of blood. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: T(50) was determined in 2785 baseline serum samples of patients receiving hemodialysis enrolled in the Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) trial and the T(50) results were related to patient outcomes. RESULTS: Serum albumin, bicarbonate, HDL cholesterol, and creatinine were the main factors positively/directly and phosphate was the main factor negatively/inversely associated with T(50). The primary composite end point (all-cause mortality, myocardial infarction [MI], hospitalization for unstable angina, heart failure, or peripheral vascular event [PVE]) was reached in 1350 patients after a median follow-up time of 619 days. After adjustments for confounding, a lower T(50) was independently associated with a higher risk of the primary composite end point as a continuous measure (hazard ratio [HR] per 1 SD lower T(50), 1.15; 95% confidence interval [95% CI], 1.08 to 1.22; P<0.001). Furthermore, lower T(50) was associated with a higher risk in all-cause mortality (HR per 1 SD lower T(50), 1.10; 95% CI, 1.02 to 1.17; P=0.001), MI (HR per 1 SD lower T(50), 1.38; 95% CI, 1.19 to 1.60; P<0.001), and PVE (HR per 1 SD lower T(50), 1.22; 95% CI, 1.05 to 1.42; P=0.01). T(50) improved risk prediction (integrated discrimination improvement and net reclassification improvement, P<0.001 and P=0.001) of the primary composite end point. CONCLUSIONS: Blood calcification propensity was independently associated with the primary composite end point, all-cause mortality, MI, and PVE in the EVOLVE study and improved risk prediction. Prospective trials should clarify whether T(50)-guided therapies improve outcomes.