SYMPLICITY HTN-3 results to be announced:a mystery or a story foretold?

• 来源期刊: 生物医学研究杂志（英文版）
• 年，卷（期）: 2014,（2）
• 页码范围: 73-74
• 页数: 2页
• 语种: 英文
• DOI: 10.7555/JBR.28.20140026

摘要

The SYMPLICITY HTN-1[1] and HTN-2 studies[2] showed that renal denervation (RDN) is feasible as a novel treatment for resistant hypertension.Despite great enthusiasm toward this new treatment modality[3],until now the current evidence rests on only one randomized controlled trial[2].SYMPLICITY HTN-3[4] is a pivotal study started for regulatory purposes in the United States with the goal to evaluate the efficacy and safety of RDN in treatment of resistant hypertension.It is a randomized trial including 535 resistant hypertensive patients randomized to RDN or control (sham) in a ratio of 2∶1.On 9 January 2014,Medtronic announced that SYMPLICITY HTN-3 failed to meet its primary endpoint of efficacy (http://newsroom.medtronic.com/phoenix.zhtml?c =251324&p =irolnewsArticle&ID=1889335&highlight) and that the final scientific results will be reported at the 63th Scientific Meeting of the American Cardiology College,to be held in Washington DC on 29-31 March 2014.In the wake of this announcement,Medtronic suspended SYMPLICITY HTN-4 in the United States,HTN-Japan and HTN-India.Other manufacturers halted on-going studies (Covidien) or put their research programs on hold (St Jude Medical and Boston Scientific),because of the uncertainty about what SYMPLICITY HTN-3 will report.