Efficacy of Bosentan in Patients after Fontan Procedures:a Double-blind, Randomized Controlled Trial

Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease(CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure(m PAP) a...

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Published inJournal of Huazhong University of Science and Technology. Medical sciences Vol. 36; no. 4; pp. 534 - 540
Main Author 尚小珂 卢蓉 张喜 张长东 肖书娜 柳梅 王斌 董念国
Format Journal Article
LanguageEnglish
Published Wuhan Huazhong University of Science and Technology 01.08.2016
Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China%SinoScript LLC, Vernon, Connecticut 06066, USA%Department of Intervention, Wuhan Asia Heart Hospital, Wuhan 430022, China%Department of Radiology, The Keck School of Medicine, University of Southern California, California 90033, USA
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ISSN1672-0733
1993-1352
DOI10.1007/s11596-016-1621-8

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Summary:Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease(CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure(m PAP) and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists(Bosentan) has been demonstrated to improve the patients' prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group(P=0.018 and P=0.027). Bosentan could improve New York Heart Association(NYHA) functional status and improve the results of the 6-min walking test(6MWT) in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments.
Bibliography:Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease(CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure(m PAP) and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists(Bosentan) has been demonstrated to improve the patients' prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group(P=0.018 and P=0.027). Bosentan could improve New York Heart Association(NYHA) functional status and improve the results of the 6-min walking test(6MWT) in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments.
Fontan procedure; Bosentan; prognosis; pulmonary hypertension; pulmonary vascular resistance
42-1679/R
Xiao-ke SHANG, Rong LU, Xi ZHANG, Chang-dong ZHANG , Shu-na XIAO, Mei LIU, Bin WANG, Nian-guo DONG (1 Cardiac Surgery, Union Hospital, Tongfi Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; 2SinoScript LLC, Vernon, Connecticut 06066, USA; 3Department of Intervention, Wuhan Asia Heart Hospital, Wuhan 430022, China; 4Department of Radiology, The Keck School of Medicine, University of Southern California, California 90033, USA)
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ISSN:1672-0733
1993-1352
DOI:10.1007/s11596-016-1621-8