Long-termclinical outcomes of valsartan in patientswith a systemic right ventricle: Follow-up of a multicenter randomized controlled trial

INTERNATIONAL JOURNAL OF CARDIOLOGY

卷:278

Article

van Dissel, Alexandra C.^1,2  Winter, Michiel M.¹  van der Bom, Teun¹  Vliegen, Hubert W.³  Van Dijk, Arie P. J.⁴  Pieper, Petronella G.⁵  Sieswerda, Gertjan T.⁶  Roos-Hesselink, Jolien W.⁷  Zwinderman, Aeilko H.⁸  Mulder, Barbara J. M.^1,2  Bouma, Berto J.¹ 

[1] Univ Amsterdam, Dept Cardiol, Amsterdam UMC, Heart Ctr, Amsterdam, Netherlands

[2] Netherlands Heart Inst, Utrecht, Netherlands

[3] Leiden Univ, Dept Cardiol, Med Ctr, Leiden, Netherlands

[4] Radboud Univ Nijmegen, Dept Cardiol, Med Ctr, Nijmegen, Netherlands

[5] Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[6] Univ Med Ctr Utrecht, Dept Cardiol, Utrecht, Netherlands

[7] Erasmus MC, Dept Cardiol, Rotterdam, Netherlands

[8] Univ Amsterdam, Dept Clin Epidemiol Biostat & Bioinformat, Amsterdam UMC, Amsterdam, Netherlands

关键词: Congenital heart disease;    Heart failure;    Transposition of the great arteries;    Systemic right ventricle;    Renin angiotensin aldosterone system;    Long-term follow-up;   

DOI  :  10.1016/j.ijcard.2018.11.027

来源: Elsevier

【 摘 要 】

Objectives: In the VAL-SERVE (Valsartan in Systemic Right Ventricle) trial, three-year valsartan treatment improved systemic ventricular function only in symptomatic patients with congenitally or with an atrial switch corrected transposition of the great arteries. The aim of the current study was to investigate the longer-term clinical outcomes after valsartan treatment. Methods: From 2006 to 2009, 88 adults were randomly allocated 1:1 to either valsartan or placebo for three consecutive years. Endpoints were defined as overall survival and freedom from clinical events (arrhythmia, heart failure, tricuspid valve surgery, death). Results: Cardiac drug use andmedian follow-up after trial close-out (8.3 years) was similar between the randomization groups. Six patients (valsartan n = 3, placebo n = 3) died in 364 and 365 person-years (P = 0.999). No difference in the composite or separate clinical endpoints was found between the randomization groups, with corresponding long-term event-free survival rates of 50% and 34%. Nevertheless, in symptomatic patients valsartan significantly reduced the risk for events compared to placebo (HR 0.37, 95% CI 0.17-0.92). Analysis for repeated events and on-treatment analysis with any renin-angiotensin-aldosterone-system-inhibitor did not alter these results. Conclusions: Valsartan treatment in systemic RV patients did not result in improved survival at longer-term follow-up, but was associated with decreased risk of events in symptomatic patients. (c) 2018 Elsevier B.V. All rights reserved.

【 授权许可】

Free