Sodium thiosulphate and progression of vascular calcification in end-stage renal disease patients: a double-blind, randomized, placebo-controlled study

Abstract

Background. Sodium thiosulphate (NaTS) is mostly used in haemodialysis (HD) patients with calcific uraemic arteriolopathy. This double-blind, randomized, placebo-controlled study assessed the effect of NaTS on progression of cardiovascular calcifications in HD patients. Methods. From 65 screened patients, we recruited 60 patients with an abdominal aorta Agatston calcification score >= 100. Thirty patients were randomized to receive NaTS 25 g/1.73m(2) and 30 patients to receive 100mL of 0.9% sodium chloride intravenously during the last 15 min of HD over a period of 6 months. The primary endpoint was the absolute change of the abdominal aortic calcification score. Results. The abdominal aortic calcification score and calcification volume of the abdominal aorta increased similarly in both treatment groups during the trial. As compared with the saline group, patients receiving NaTS exhibited a reduction of their iliac artery calcification score (-137 +/- 641 versus 245 +/- 755; P = 0.049), reduced pulse wave velocity (9.6 +/- 2.7 versus 11.4 +/- 3.6; P = 0.000) and a lower carotid intima-media thickness (0.77 +/- 0.1 versus 0.83 +/- 00.17; P = .033) and had better preservation of echocardiographic parameters of left ventricular hypertrophy. No patient of the NaTS group developed new cardiac valve calcifications during the trial as compared with 8 of 29 patients in the saline group. By univariate analysis, NaTS therapy was the only predictor of not developing new valvular calcifications. No adverse events possibly related to NaTS infusion were noted. Conclusions. While NaTS failed to retard abdominal aortic calcification progress, it positively affected calcification progress in iliac arteries and heart valves as well as several other cardiovascular functional parameters.