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

Contemporary Clinical Trials

Volumn 33, Issue 2, 2012, Pages 410-416

  Luijendijk, Paul ^a,b   Bouma, Berto J ^a   Vriend, Joris W J ^c   Groenink, Maarten ^a   Vliegen, Hubert W ^d   De Groot, Eric ^a   Pieper, Petronella G ^e   Van Dijk, Arie P J ^f   Sieswerda, Gertjan T ^g   Veen, Gerrit ^h   Zwinderman, Aeilko H ^a   Mulder, Barbara J M ^a,b  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b ROYAL NETHERLANDS ACADEMY OF ARTS AND SCIENCES   (Netherlands)

^c HAGA HOSPITAL   (Netherlands)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^g UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^h VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Aortic coarctation; Carotid intima media thickness (CIMT); HMG coA reductase inhibitors (statins); Premature atherosclerosis

Indexed keywords

ATORVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PLACEBO;

ADULT; AORTA COARCTATION; AORTA SURGERY; ARTERIAL WALL THICKNESS; ARTICLE; ATHEROSCLEROSIS; B SCAN; CARDIOVASCULAR RISK; CAROTID ARTERY; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFECT; DRUG MEGADOSE; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

ADULT; AORTIC COARCTATION; ATHEROSCLEROSIS; CARDIAC SURGICAL PROCEDURES; CAROTID ARTERIES; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HEPTANOIC ACIDS; HISTORY, ANCIENT; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; POSTOPERATIVE CARE; PROSPECTIVE STUDIES; PYRROLES; TREATMENT OUTCOME;

EID: 84856228760     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2011.11.011     Document Type: Article

References (39)

1. Ing F.F., Starc T.J., Griffiths S.P., Gersony W.M. Early diagnosis of coarctation of the aorta in children: a continuing dilemma. Pediatrics 1996, 98:378-382.
2. Ward K.E., Pryor R.W., Matson J.R., Razook J.D., Thompson W.M., Elkins R.C. Delayed detection of coarctation in infancy: implications for timing of newborn follow-up. Pediatrics 1990, 86:972-976.
3. Campbell M. Natural history of coarctation of the aorta. Br Heart J 1970, 32:633-640.
4. Crafoord C., Nylin G. Congenital coarctation of the aorta and its surgical treatment. J Thorac Surg 1945, 14:347-361.
5. Cohen M., Fuster V., Steele P.M., Driscoll D., McGoon D.C. Coarctation of the aorta. Long-term follow-up and prediction of outcome after surgical correction. Circulation 1989, 80:840-845.
6. Vriend J.W., Engelfriet P.M., de Groot E., Elsen B.M., Kastelein J.J., Mulder B.J. Age at repair and left ventricular mass in patients after repair of aortic coarctation. J Thorac Cardiovasc Surg 2005, 130:896-897.
7. Brili S., Dernellis J., Aggeli C., Pitsavos C., Hatzos C., Stefanadis C., et al. Aortic elastic properties in patients with repaired coarctation of aorta. Am J Cardiol 1998, 82:1140-1143. A10.
8. Brili S., Tousoulis D., Antoniades C., Aggeli C., Roubelakis A., S.Papathanasiu, et al. Evidence of vascular dysfunction in young patients with successfully repaired coarctation of aorta. Atherosclerosis 2005, 182:97-103.
9. de Divitiis D.M., Pilla C., Kattenhorn M., Donald A., Zadinello M., Wallace S., et al. Ambulatory blood pressure, left ventricular mass, and conduit artery function late after successful repair of coarctation of the aorta. J Am Coll Cardiol 2003, 41:2259-2265.
10. Meyer A.A., Joharchi M.S., Kundt G., Schuff-Werner P., Steinhoff G., Kienast W. Predicting the risk of early atherosclerotic disease development in children after repair of aortic coarctation. Eur Heart J 2005, 26:617-622.
11. Sehested J., Baandrup U., Mikkelsen E. Different reactivity and structure of the prestenotic and poststenotic aorta in human coarctation. Implications for baroreceptor function. Circulation 1982, 65:1060-1065.
12. Vriend J.W., de Groot E., de Waal T.T., Zijta F.M., Kastelein J.J., Mulder B.J. Increased carotid and femoral intima-media thickness in patients after repair of aortic coarctation: influence of early repair. Am Heart J 2006, 151:242-247.
13. Daniels S.R. Repair of coarctation of the aorta and hypertension: does age matter?. Lancet 2001, 358:89.
14. Toro-Salazar O.H., Steinberger J., Thomas W., Rocchini A.P., Carpenter B., Moller J.H. Long-term follow-up of patients after coarctation of the aorta repair. Am J Cardiol 2002, 89:541-547.
15. Vriend J.W., Mulder B.J. Late complications in patients after repair of aortic coarctation: implications for management. Int J Cardiol 2005, 101:399-406.
16. Vriend J.W., Mulder B.J. Exercise-induced hypertension in patients after repair of aortic coarctation. Eur J Appl Physiol 2005, 93:733-734.
17. Vriend J.W., van Montfrans G.A., Romkes H.H., Vliegen H.W., Veen G., Tijssen J.G., et al. Relation between exercise-induced hypertension and sustained hypertension in adult patients after successful repair of aortic coarctation. J Hypertens 2004, 22:501-509.
18. Shukla A., Sharma M.K., Jain A., Goel P.K. Prevention of atherosclerosis progression using atorvastatin in normolipidemic coronary artery disease patients-a controlled randomized trial. Indian Heart J 2005, 57:675-680.
19. Davignon J. Beneficial cardiovascular pleiotropic effects of statins. Circulation 2004, 109:III39-III43.
20. Makris G.C., Lavida A., Nicolaides A.N., Geroulakos G. The effect of statins on carotid plaque morphology: a LDL-associated action or one more pleiotropic effect of statins?. Atherosclerosis 2010, 213:8-20.
21. Vriend J.W., van der Velde E., Mulder B.J. National registry and DNA-bank of patients with congenital heart disease: the CONCOR-project. Ned Tijdschr Geneeskd 2004, 148:1646-1647.
22. Cuddy M.L. Treatment of hypertension: guidelines from JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure 1). J Pract Nurs 2005, 55:17-21.
23. Roman M.J., Devereux R.B., Kramer-Fox R., O'Loughlin J. Two-dimensional echocardiographic aortic root dimensions in normal children and adults. Am J Cardiol 1989, 64:507-512.
24. Vasan R.S., Larson M.G., Benjamin E.J., Levy D. Echocardiographic reference values for aortic root size: the Framingham Heart Study. J Am Soc Echocardiogr 1995, 8:793-800.
25. Roberts W.C. The congenitally bicuspid aortic valve. A study of 85 autopsy cases. Am J Cardiol 1970, 26:72-83.
26. Warnes C.A., Williams R.G., Bashore T.M., Child J.S., Connolly H.M., Dearani J.A., et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease). Developed in Collaboration with the American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008, 52:e1-e121.
27. Baumgartner H., Hung J., Bermejo J., Chambers J.B., Evangelista A., Griffin B.P., et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr 2009, 22:1-23.
28. Ou P., Celermajer D.S., Mousseaux E., Giron A., Aggoun Y., Szezepanski L., et al. Vascular remodeling after "successful" repair of coarctation: impact of aortic arch geometry. J Am Coll Cardiol 2007, 49:883-890.
29. Bots M.L., Evans G.W., Riley W.A., Grobbee D.E. Carotid intima-media thickness measurements in intervention studies: design options, progression rates, and sample size considerations: a point of view. Stroke 2003, 34:2985-2994.
30. Krogmann O.N., Rammos S., Jakob M., Corin W.J., Hess O.M., Bourgeois M. Left ventricular diastolic dysfunction late after coarctation repair in childhood: influence of left ventricular hypertrophy. J Am Coll Cardiol 1993, 21:1454-1460.
31. Leandro J., Smallhorn J.F., Benson L., Musewe N., Balfe J.W., Dyck J.D., et al. Ambulatory blood pressure monitoring and left ventricular mass and function after successful surgical repair of coarctation of the aorta. J Am Coll Cardiol 1992, 20:197-204.
32. Ong C.M., Canter C.E., Gutierrez F.R., Sekarski D.R., Goldring D.R. Increased stiffness and persistent narrowing of the aorta after successful repair of coarctation of the aorta: relationship to left ventricular mass and blood pressure at rest and with exercise. Am Heart J 1992, 123:1594-1600.
33. Chambless L.E., Heiss G., Folsom A.R., Rosamond W., Szklo M., Sharrett A.R., et al. Association of coronary heart disease incidence with carotid arterial wall thickness and major risk factors: the Atherosclerosis Risk in Communities (ARIC) study, 1987-1993. Am J Epidemiol 1997, 146:483-494.
34. Lorenz M.W., Markus H.S., Bots M.L., Rosvall M., Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation 2007, 115:459-467.
35. O'Leary D.H., Bots M.L. Imaging of atherosclerosis: carotid intima-media thickness. Eur Heart J 2010, 31:1682-1689.
36. Espeland M.A., O'Leary D.H., Terry J.G., Morgan T., Evans G., Mudra H. Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Curr Control Trials Cardiovasc Med 2005, 6:3.
37. Vriend J.W., de Groot E., Bouma B.J., Hrudova J., Kastelein J.J., Tijssen J.G., et al. Carotid intima-media thickness in post-coarctectomy patients with exercise induced hypertension. Heart 2005, 91:962-963.
38. Vriend J.W., Zwinderman A.H., de Groot E., Kastelein J.J., Bouma B.J., Mulder B.J. Predictive value of mild, residual descending aortic narrowing for blood pressure and vascular damage in patients after repair of aortic coarctation. Eur Heart J 2005, 26:84-90.
39. Masoura C., Pitsavos C., Aznaouridis K., Skoumas I., Vlachopoulos C., Stefanadis C. Arterial endothelial function and wall thickness in familial hypercholesterolemia and familial combined hyperlipidemia and the effect of statins. A systematic review and meta-analysis. Atherosclerosis 2011, 214:129-138.