Kidney Week

Abstract: PO2547

Vitamin K1 Retards Progression of Cardiovascular Calcifications in Hemodialysis Patients: The VitaVasK Trial

Session Information

• Late-Breaking Clinical Trials Posters
  November 04, 2021 | Location: On-Demand, Virtual Only
  Abstract Time: 10:00 AM - 12:00 PM

Category: Hypertension and CVD

• 1402 Hypertension and CVD: Clinical, Outcomes, and Trials

Authors

• Saritas, Turgay, University Hospital RWTH Aachen, Aachen, Germany

Turgay Saritas,

• Reinartz, Sebastian Daniel, University Hospital RWTH Aachen, Aachen, Germany

Sebastian Daniel Reinartz,

• Krueger, Thilo, DaVita, Geilenkirchen, Germany

Thilo Krueger,

• Evenepoel, Pieter, University Hospitals Leuven, Leuven, Belgium

Pieter Evenepoel,

• Jadoul, Michel Y., Cliniques Saint-Luc, University of Louvain Medical School, Brussels, Belgium

Michel Y. Jadoul,

• Kopp, Christoph, Universitatsklinikum Erlangen, Erlangen, Bayern, Germany

Christoph Kopp,

• Ketteler, Markus, Robert-Bosch-Krankenhaus GmbH, Stuttgart, Baden-Württemberg, Germany

Markus Ketteler,

• Stenvinkel, Peter, Karolinska Universitetsjukhuset i Huddinge, Huddinge, Sweden

Peter Stenvinkel,

• Westenfeld, Ralf, Heinrich-Heine-Universitat Dusseldorf, Dusseldorf, Nordrhein-Westfalen, Germany

Ralf Westenfeld,

• Wied, Stephanie, University Hospital RWTH Aachen, Aachen, Germany

Stephanie Wied,

• Siepmann, Robert, University Hospital RWTH Aachen, Aachen, Germany

Robert Siepmann,

• Hilgers, Ralf-dieter, University Hospital RWTH Aachen, Aachen, Germany

Ralf-dieter Hilgers,

• Schurgers, Leon J., Universiteit Maastricht, Maastricht, Limburg, Netherlands

Leon J. Schurgers,

• Floege, Jürgen, University Hospital RWTH Aachen, Aachen, Germany

Jürgen Floege,

Background

Cardiovascular calcifications are prevented by matrix Gla protein (MGP), a protein activated by vitamin K. As HD patients exhibit marked vitamin K deficiency, the VitaVasK trial (EudraCT No.: 2010-021264-14) analysed whether vitamin K1 supplementation affects progression of coronary artery calcifications (CAC) and thoracic aortic calcifications (TAC) in these patients.

Methods

This prospective, open-label, multicenter trial randomized patients with preexisting CAC to continue on standard care or to additionally receive 5 mg vit K1 orally thrice weekly. Primary end points were progression of TAC and CAC volume scores in CT scans during 18 months. Repeated linear mixed effects models assessed the treatment effect after adjusting for study site.

Results

Of 60 randomized patients, 20 dropped out for reasons unrelated to vit K1, resulting in 23 control and 17 vit K1 patients. The trial was stopped early due to low recruitment rate. TAC progressed significantly between baseline and 18 months but its progression was reduced by a mean of 56% in the vit K1 compared to the control group at 18 months (p=0.039) (Table). CAC significantly progressed within the control group, but not within the vit K1 group. Progression at 18 months was lower by an average of 68% in the vit K1 group compared to the control group (p=0.072). Inactive dp-ucMGP in plasma was elevated at baseline, confirming vit K deficiency. Levels at 18 months were 110±40% of baseline in controls but rapidly dropped in the vit K1 group to 27±12% at 18 months. No treatment-related adverse events were noted.

Conclusion

Despite early termination, this randomized trial identifies a highly effective mode of correcting the vit K deficiency in chronic HD patients. Our intervention is potent, safe and cost-effective to reduce progression of cardiovascular calcification in this high-risk population.

: Changes in volume score versus baseline within groups

Data are means (SE), adjusted for study site, and p-value. * p<0.05 versus vitamin K1

Funding

• Private Foundation Support