对PARTNER 3数据的分析发现，在低危重度主动脉瓣狭窄（AS）患者中，与外科主动脉瓣置换术（SAVR）相比，经导管主动脉瓣置换术（TAVR）治疗后一年疾病特异的生活质量呈现中度但显著改善。

 

 

 

　　研究结果于第三十一届经导管心血管治疗（TCT）学术会议上公布。TCT是由心血管研究基金会（CRF）赞助的世界上最重要的心血管介入医学教育会议。

 

　　PARTNER 3随机试验表明，与SAVR相比，TAVR结合SAPIEN 3瓣膜可降低手术风险较低的重度AS患者1年内的死亡、卒中或再入院率。然而，治疗策略对该人群早期和晚期健康相关生活质量的影响尚不清楚。

 

　　研究人员在PARTNER 3试验中比较接受TAVR或SAVR治疗的低风险重症患者在1个月、6个月和12个月时的健康状况。分析发现，在一年的随访期内，尽管大多数患者在基线时只有NYHA一级或二级症状，但与基线相比，TAVR或SAVR治疗可显著改善疾病特异性和一般性健康状况。与以往关于经股动脉TAVR的研究一致，与以往的经股动脉TAVR研究一致，在所有尺度上，TAVR在一个月内的健康状况均显著优于SAVR（KCCQ-OS的平均差异为16.0分；P<0.001）。然而，与既往研究相比，研究人员观察到，在6个月和12个月时，TAVR在疾病特异性健康状况方面比SAVR有持续的获益，尽管减弱了（KCCQ-OS的平均差异为2.6分和1.8分；P＜0.04）。

 

　　在将生存率和健康状况变化结合在一起的分析中，TAVR在所有时间点都显示比SAVR显著的健康状况获益（P<0.05）。探索性分析表明，TAVR对晚期健康状况的获益是由KCCQ评分有较大改善（即≥20分）的患者比例差异所驱动。这些获益可部分地通过TAVR和SAVR术后并发症的差异率解释。

 

　　“这是第一个证明TAVR在6个月和12个月（患者从手术中完全康复的时间点）时具有持久的，尽管是适度的，疾病特异性健康状态优势的随机试验”马萨诸塞州伯灵顿的拉希医院和医疗中心的心脏病研究介入主任Suzanne J. Baron医学博士说。“在这个低风险人群中，需进一步的研究评估TAVR和SAVR在一年以上的健康状况获益的持久性。”

 

 

　　Background

　　In patients with severe aortic stenosis (AS) at low surgical risk， treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death， stroke， and rehospitalization at 1 year compared with surgical aortic valve replacement; however， the effect of treatment strategy on health status is unknown.

 

　　在手术风险较低的重度主动脉瓣狭窄（AS）患者中，经导管主动脉瓣置换术（TAVR）治疗与外科手术主动脉瓣置换术相比，1年内死亡率、卒中率和再住院率较低；然而，治疗策略对健康状况的影响尚不清楚。

 

　　Objectives

　　This study sought to compare health status outcomes of TAVR vs. surgery in lowrisk patients with severe AS.

 

　　本研究旨在比较TAVR与外科手术治疗重度AS的低风险患者的健康状况。

 

　　Methods

　　Between 3/2016 and 10/2017， 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline， 1， 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ)， SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time.

 

　　在2016年3月至2017年10月期间，1000名低风险AS患者被随机分配到PARTNER 3试验中，进行球囊扩式瓣膜的经股动脉TAVR术或外科手术进行。使用堪萨斯市心肌病问卷（KCCQ）、SF-36和EQ-5D评估基线、1个月、6个月和12个月的健康状况。主要终点是KCCQ总分（KCCQ-OS）评分随时间的变化。纵向生长曲线模型用于比较治疗组之间健康状况随时间的变化。

 

　　Results

　　At 1 month， TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points;P< 0.001). At 6 and 12 months， health status remained better with TAVR， although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; P< 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; P=0.03) and 12 months (87.3% vs. 82.8%;P=0.07).

 

　　1个月时，TAVR的健康状况优于外科手术（KCCQ-OS平均差16.0分；P＜0.001）。在6个月和12个月时，TAVR的健康状况仍较好，尽管效果有所降低（KCCQ-OS平均差2.6分和1.8分；P＜0.04)。在6个月（90.3% vs. 85.3%；P=0.03）和12个月（87.3% vs. 82.8%; P=0.07）时，用TAVR治疗结局良好的患者比例大于外科手术（KCCQ-OS≥75且未从基线显著下降）。

 

　　CONDENSED ABSTRACT

　　Whether transcatheter aortic valve replacement (TAVR) improves health-related quality of life compared with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at low surgical risk is unknown. Using data from the PARTNER 3 trial， we compared health status outcomes after TAVR vs. SAVR in low-risk patients at 1， 6 and 12 months. Consistent with previous studies of transfemoral TAVR， TAVR was associated with significantly better early health status compared with SAVR. However， in contrast to findings in higher risk populations， TAVR was also associated with late health status benefits compared with SAVR in this low-risk population.

 

　　在低手术风险的重度主动脉瓣狭窄患者中，经导管主动脉瓣置换术（TAVR）是否比外科主动脉瓣置换术（SAVR）改善健康相关的生活质量尚不清楚。利用PARTNER 3试验的数据，我们比较低风险患者1、6和12个月TAVR与SAVR治疗后的健康状况。与以往经股动脉TAVR的研究一致，TAVR与SAVR相比，早期健康状况明显改善。然而，与高危人群的研究结果相反，与低危人群的SAVR相比，TAVR也与晚期健康状况获益相关。

 

 

 

 

 

　　The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation， research， and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years， CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation， CRF Clinical Trials Center， CRF Center for Education， CRF Digital， TCTMD， and Structural Heart: The Journal of the Heart Team.Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 31st year， TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. TCT also includes interactive training pavilions where clinicians can gain vital skills to apply immediately to their practices.

 

　　For more information，

　　visit www.crf.org and www.tctconference.com.