Jamie W Bellinge1,2, Roslyn J Francis1,3, Sing Ching Lee1,2, Alistair Vickery1,4, William Macdonald5, Seng Khee Gan1,6, Gerard T Chew1,6, Michael Phillips7, Joshua R Lewis1,8,9, Gerald F Watts1,10, Carl J Schultz11,12. 1. School of Medicine, Faculty of Health and Biomedical Science, University of Western Australia, Royal Perth Hospital Campus, M570, Po Box X2213, Perth, Western Australia, Australia. 2. Department of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia. 3. Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia. 4. Black Swan Health, Perth, Western Australia, Australia. 5. Department of Nuclear Medicine, Royal Perth Hospital, Perth, Western Australia, Australia. 6. Department of Endocrinology and Diabetes, Royal Perth Hospital, Perth, Western Australia, Australia. 7. Harry Perkins Institute for Medical Research, and Centre for Medical Research, University of Western Australia and, Nedlands, Western Australia, Australia. 8. School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia. 9. Centre for Kidney Research, Children's Hospital Westmead, School of Public Health, University of Sydney, Westmead, New South Wales, Australia. 10. Cardiometabolic service, Department of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia. 11. School of Medicine, Faculty of Health and Biomedical Science, University of Western Australia, Royal Perth Hospital Campus, M570, Po Box X2213, Perth, Western Australia, Australia. carl.schultz@uwa.edu.au. 12. Department of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia. carl.schultz@uwa.edu.au.
Abstract
BACKGROUND: There is currently no treatment for attenuating progression of arterial calcification. 18F-sodium fluoride positron emission tomography (18F-NaF PET) locates regions of calcification activity. We tested whether vitamin-K1 or colchicine affected arterial calcification activity. METHODS: 154 patients with diabetes mellitus and coronary calcification, as detected using computed tomography (CT), were randomized to one of four treatment groups (placebo/placebo, vitamin-K1 [10 mg/day]/placebo, colchicine [0.5 mg/day]/placebo, vitamin-K1 [10 mg/day]/ colchicine [0.5 mg/day]) in a double-blind, placebo-controlled 2x2 factorial trial of three months duration. Change in coronary calcification activity was estimated as a change in coronary maximum tissue-to-background ratio (TBRmax) on 18F-NaF PET. RESULTS: 149 subjects completed follow-up (vitamin-K1: placebo = 73:76 and colchicine: placebo = 73:76). Neither vitamin-K1 nor colchicine had a statistically significant effect on the coronary TBRmax compared with placebo (mean difference for treatment groups 0·00 ± 0·16 and 0·01 ± 0·17, respectively, p > 0.05). There were no serious adverse effects reported with colchicine or vitamin-K1. CONCLUSIONS: In patients with type 2 diabetes, neither vitamin-K1 nor colchicine significantly decreases coronary calcification activity, as estimated by 18F-NaF PET, over a period of 3 months. CLINICAL TRIAL REGISTRATION: ACTRN12616000024448.
BACKGROUND: There is currently no treatment for attenuating progression of arterial calcification. 18F-sodium fluoride positron emission tomography (18F-NaF PET) locates regions of calcification activity. We tested whether vitamin-K1 or colchicine affected arterial calcification activity. METHODS: 154 patients with diabetes mellitus and coronary calcification, as detected using computed tomography (CT), were randomized to one of four treatment groups (placebo/placebo, vitamin-K1 [10 mg/day]/placebo, colchicine [0.5 mg/day]/placebo, vitamin-K1 [10 mg/day]/ colchicine [0.5 mg/day]) in a double-blind, placebo-controlled 2x2 factorial trial of three months duration. Change in coronary calcification activity was estimated as a change in coronary maximum tissue-to-background ratio (TBRmax) on 18F-NaF PET. RESULTS: 149 subjects completed follow-up (vitamin-K1: placebo = 73:76 and colchicine: placebo = 73:76). Neither vitamin-K1 nor colchicine had a statistically significant effect on the coronary TBRmax compared with placebo (mean difference for treatment groups 0·00 ± 0·16 and 0·01 ± 0·17, respectively, p > 0.05). There were no serious adverse effects reported with colchicine or vitamin-K1. CONCLUSIONS: In patients with type 2 diabetes, neither vitamin-K1 nor colchicine significantly decreases coronary calcification activity, as estimated by 18F-NaF PET, over a period of 3 months. CLINICAL TRIAL REGISTRATION: ACTRN12616000024448.
Authors: Amr Abdelbaky; Erin Corsini; Amparo L Figueroa; Sara Fontanez; Sharath Subramanian; Maros Ferencik; Thomas J Brady; Udo Hoffmann; Ahmed Tawakol Journal: Circ Cardiovasc Imaging Date: 2013-07-05 Impact factor: 7.792
Authors: Jean-Claude Tardif; Simon Kouz; David D Waters; Olivier F Bertrand; Rafael Diaz; Aldo P Maggioni; Fausto J Pinto; Reda Ibrahim; Habib Gamra; Ghassan S Kiwan; Colin Berry; José López-Sendón; Petr Ostadal; Wolfgang Koenig; Denis Angoulvant; Jean C Grégoire; Marc-André Lavoie; Marie-Pierre Dubé; David Rhainds; Mylène Provencher; Lucie Blondeau; Andreas Orfanos; Philippe L L'Allier; Marie-Claude Guertin; François Roubille Journal: N Engl J Med Date: 2019-11-16 Impact factor: 91.245
Authors: M Kyla Shea; Christopher J O'Donnell; Udo Hoffmann; Gerard E Dallal; Bess Dawson-Hughes; José M Ordovas; Paul A Price; Matthew K Williamson; Sarah L Booth Journal: Am J Clin Nutr Date: 2009-04-22 Impact factor: 7.045
Authors: Robert Detrano; Alan D Guerci; J Jeffrey Carr; Diane E Bild; Gregory Burke; Aaron R Folsom; Kiang Liu; Steven Shea; Moyses Szklo; David A Bluemke; Daniel H O'Leary; Russell Tracy; Karol Watson; Nathan D Wong; Richard A Kronmal Journal: N Engl J Med Date: 2008-03-27 Impact factor: 91.245
Authors: Lavienja A J L M Braam; Arnold P G Hoeks; Fred Brouns; Karly Hamulyák; Monique J W Gerichhausen; Cees Vermeer Journal: Thromb Haemost Date: 2004-02 Impact factor: 5.249
Authors: Richard A Kronmal; Robyn L McClelland; Robert Detrano; Steven Shea; João A Lima; Mary Cushman; Diane E Bild; Gregory L Burke Journal: Circulation Date: 2007-05-14 Impact factor: 29.690
Authors: L J Schurgers; H M H Spronk; J N Skepper; T M Hackeng; C M Shanahan; C Vermeer; P L Weissberg; D Proudfoot Journal: J Thromb Haemost Date: 2007-09-10 Impact factor: 5.824
Authors: Marc R Dweck; William S A Jenkins; Alex T Vesey; Mark A H Pringle; Calvin W L Chin; Tamir S Malley; William J A Cowie; Vasiliki Tsampasian; Hamish Richardson; Alison Fletcher; William A Wallace; Renzo Pessotto; Edwin J R van Beek; Nicholas A Boon; James H F Rudd; David E Newby Journal: Circ Cardiovasc Imaging Date: 2014-02-07 Impact factor: 7.792
Authors: Nils Lehmann; Raimund Erbel; Amir A Mahabadi; Michael Rauwolf; Stefan Möhlenkamp; Susanne Moebus; Hagen Kälsch; Thomas Budde; Axel Schmermund; Andreas Stang; Dagmar Führer-Sakel; Christian Weimar; Ulla Roggenbuck; Nico Dragano; Karl-Heinz Jöckel Journal: Circulation Date: 2017-11-15 Impact factor: 29.690