Rationale and design of a trial on the effect of high dose statins on cardiovascular risk in adults after successful coarctation repair

• Published in: Contemporary clinical trials 2012-03, Vol.33 (2), p.410-416
• Main Authors: Luijendijk, Paul, Bouma, Berto J, Vriend, Joris W.J, Groenink, Maarten, Vliegen, Hubert W, de Groot, Eric, Pieper, Petronella G, van Dijk, Arie P.J, Sieswerda, Gertjan T, Veen, Gerrit, Zwinderman, Aeilko H, Mulder, Barbara J.M
• Format: Article
• Language: English
• Subjects: Adult; Aortic coarctation; Aortic Coarctation - complications; Aortic Coarctation - surgery; Atherosclerosis - complications; Atherosclerosis - diagnostic imaging; Atherosclerosis - drug therapy; Atorvastatin Calcium; Cardiac Surgical Procedures; Cardiovascular; Carotid Arteries - diagnostic imaging; Carotid intima-media thickness (CIMT); Disease Progression; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Hematology, Oncology and Palliative Medicine; Heptanoic Acids - administration & dosage; History, Ancient; HMG-coA-reductase-inhibitors (statins); Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Male; Postoperative Care - methods; Premature atherosclerosis; Prospective Studies; Pyrroles - administration & dosage; Treatment Outcome; Ultrasonography
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2011.11.011

Abstract Background HMG-coA-reductase-inhibitors (statins) have been proven to reduce atherosclerosis progression as observed by carotid intima-media thickness in patients with known coronary heart disease, independent of lipid lowering. Cardiovascular complications are common in patients after successful coarctation repair. The effect of statins on cardiovascular risk in adults after successful coarctation repair has not yet been established. Methods We designed a multicentre, prospective, randomised, open label trial to evaluate the effect of the HMGcoA-reductase-inhibitor (Atorvastatin) on atherosclerotic progression in adult post-coarctectomy patients. The primary endpoint in this study is the carotid intima-media thickness as measured by Bmode ultrasonography of the carotid arteries. Conclusion This large prospective, randomised, open label trial will establish the effect of HMG-coA-reductase inhibitors (Atorvastatin) on cardiovascular risk in adult patients after successful coarctation repair.