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葛均波院士:2021年心血管治疗领域重大研究盘点

2021-12-18 心血管健康联盟信息平台 心血管健康联盟信息平台

在即将过去的2021年里,心血管领域陆续公布和发表了多项重磅研究,一睹为快!

在即将过去的2021年里,心血管领域陆续公布和发表了多项重磅研究。12月18日,中国心血管健康大会(CCHC)“院士讲坛”上,复旦大学附属中山医院葛均波院士心衰药物治疗、冠状动脉疾病治疗、左心耳封堵、经导管主动脉瓣置换术(TAVR)后抗栓、高血压这五个方面,对2021年心血管治疗领域发表的重要研究进行盘点和总结。
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图1:葛均波院士
心衰药物治疗进展

 

 

EMPEROR-Preserved研究:为HFpEF治疗“雪中送炭”
相比于射血分数降低的心力衰竭(HFrEF),射血分数保留的心衰(HFpEF)的治疗一直缺乏有效的治疗手段。欧洲心脏病学会(ESC)2021公布的EMPEROR-Preserved研究,首次证实了SGTL2抑制剂恩格列净在HFpEF患者中的疗效与安全性。
 
研究在23个国家和地区622个中心纳入5988例NYHA Ⅱ~Ⅳ级且LVEF>40%的心力衰竭患者,随机分为两组,分别在标准治疗基础上接受恩格列净或安慰剂治疗。主要终点为心血管死亡或心衰住院组成的复合终点。
 
中位随访26.2个月,恩格列净主要终点事件发生率降低21%,主要终点的改善主要得益于心力衰竭住院风险明显降低27%。此外,恩格列净组肾功能的下降速度也较慢。恩格列净成为首个治疗全阶段心衰的药物。同时,我们也期待正在进行的DELIVER研究,看达格列净能否复制恩格列净在LVE≥40%的HFpEF治疗上取得的效果。
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图2:EMPEROR-Preserved研究结果
GALACTIC-HF研究:为HFrEF治疗“锦上添花”
近年来,针对HFrEF的药物治疗靶点日益丰富。既往研究显示,正性肌力药物可改善血流动力学,但不能改善HFrEF临床预后。GALACTIC-HF研究是迄今为止在心衰治疗领域开展的最大规模Ⅲ期全球性心血管结局研究之一,首次证实增加心肌收缩力的药物可以改善HFrEF患者临床预后。
 
研究纳入8256例左室射血分数(LVEF)≤35%的有症状慢性心衰患者,分别在心衰标准疗法的基础上加用Omecamtiv Mecarbil(简称OM)或安慰剂。中位随访21.8个月,OM组发生心衰或心血管死亡的风险显著降低,OM在减少心血管死亡方面并无明显获益。
 
亚组分析显示,基线LVEF<28%,OM组主要终点事件的改善更为明显,较安慰剂下降了16%,这提示OM对LVEF较低的患者效果更显著。
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图3:GALACTIC-HF研究主要结果
冠状动脉疾病治疗进展

 

 

FAME 3研究:三支病变,FFR指导PCI vs. CABG
对于合并左主干和/或三支血管病变,SYNTAX评分较高的患者,目前欧美指南推荐冠状动脉旁路移植术(CABG)优于经皮冠状动脉介入治疗术(PCI)。那么,在三支病变患者中,冠状动脉血流储备分数(FFR)联用第二代药物涂层支架(DES)行PCI的治疗策略是否会优于/非劣于CABG?FAME 3研究对此进行了探索。
 
研究将48个中心1500例患者按照1∶1的比例随机分配至接受FFR指导PCI治疗或CABG治疗。随访1年发现,FFR指导的PCI治疗与CABG组相比,除了再次血运重建外,在其它终点事件方面(如死亡、心肌梗死卒中)未见明显差异。
 
在FAME 3研究中,不论FFR指导的PCI组(10.6%)还是CABG组(6.9%),事件发生率均低于之前的SYNTAX研究的CABG组(12.4%)。对于SYNTAX积分较低的三支血管病变患者,可以优选PCI治疗;而对于SYNTAX积分较高的三支血管病变患者,CABG可能仍是首选。
 
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图4:FAME 3研究主要结果
FAVOR Ⅲ China研究:QFR指导PCI改善预后
对于定量血流分数(QFR)指导PCI能否改善临床预后,中国医学科学院阜外医院徐波教授美国经导管心血管治疗研讨会(TCT)2021公布的FAVOR Ⅲ China研究给出了肯定的答案。
 
研究由全国26家中心参与,受试者按1∶1随机分配到QFR指导组和造影指导组。QFR指导组中,仅对QFR≤0.80的病变进行介入干预,如果所有测量血管QFR均>0.80,则仅单纯药物治疗;造影指导组则按标准造影指导方法,基于术者目测,进行介入干预。
 
结果显示,与造影指导PCI相比,QFR指导PCI的1年主要心血管不良事件(MACE)发生相对风险下降35%,主要获益源于QFR指导组具有更低的心肌梗死和缺血驱动的血运重建发生率。
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图5:FAVOR Ⅲ China研究主要结果
MASTER-DAPT研究:出血高危人群PCI后DAPT时程
随着DES的不断发展,支架内血栓事件的发生率逐渐降低,为缩短高出血风险(HBR)患者双重小板治疗(DAPT)时程带来希望。那么,HBR患者在DES植入术后最优的DAPT时程是多久?
 
MASTER-DAPT研究将4434名符合条件的患者按照1∶1比例随机分为短程DAPT治疗组(1个月)或标准DAPT治疗组(3个月或6个月)。两组在净临床不良事件、主要心脑血管不良事件方面相当,在大出血或临床相关非大出血方面,短程DAPT治疗组显著低于标准DAPT治疗组(6.5% vs. 9.4%)。
 
目前的指南对缩短HBR患者的DAPT时间给出的证据级别为C(专家意见),未来的指南可能会参考MASTER DAPT试验结果,提高证据级别并将HBR患者的DAPT时间由3~6个月缩短为1个月。
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图6:MASTER-DAPT研究-净临床不良事件
左心耳封堵治疗进展

 

LAAOS Ⅲ:外科LAAO预防房颤卒中新证据
PROTECT-AF、PREVAIL等随机对照试验(RCT)证实左心耳封堵预防房颤卒中的有效性;外科左心耳夹闭(LAAO)的证据缺乏,指南推荐等级较低。LAAOS Ⅲ研究旨在评价在其他心脏手术同期行LAAO是否可降低房颤患者卒中及系统性栓塞风险。
 
研究入组4811名因其他适应证接受心脏外科手术的房颤卒中高危患者,平均随访3.8年,相比未封堵患者,术中同期行LAAO的患者缺血性卒中和系统性栓塞事件的风险显著降低。两组患者围术期出血、心衰、死亡等发生率无显著差异。
 
然而,LAAO能否替代口服抗凝药;低危患者同期行LAAO的价值等问题还需进一步探索。
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图7:LAAOS Ⅲ研究主要结果
Amulet IDE:Amulet vs. Watchman头对头对比
临床上可供选择的左心耳封堵器械主要包括塞式和盖式。Amulet IDE研究是第一个头对头对比Amulet和Watchman两种最常用的左心耳封堵器的RCT。研究纳入来自全球150家中心的1878名卒中高危非瓣膜性房颤(NVAF)患者,1∶1随机分入Amulet或Watchman封堵器组。
结果显示,Amulet封堵器组基于设备的左心耳闭合率(98.9%)高于Watchman封堵器(96.8%),且在主要安全性终点和主要有效性终点方面均不劣于Watchman封堵器。该研究部进一步证实左心耳封堵对NVAF卒中预防的作用,但左心耳封堵术后抗栓策略值得思考。
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图8:Amulet IDE研究结果
TAVR术后抗栓,路在何方?

 

ATLANTIS:NOACs应用于TAVR术后抗栓
TAVR术后最优的抗栓方案尚未明确。ATLANTIS研究是近年来寻找TAVR术后最佳抗栓治疗方案道路上的又一重磅研究。研究纳入欧洲4个国家49个中心1510名成功行TAVR的患者,基于是否有口服抗凝治疗的指征分成:有抗凝治疗指征组(包括华法林治疗组、阿哌沙班治疗组)和无抗凝治疗指征组(包括抗血小板治疗组、阿哌沙班治疗组)。
 
结果显示,无论是否包括瓣膜血栓这一终点事件,阿哌沙班治疗比目前的标准治疗方案(无论抗凝或者抗血小板的群体)均没有显示出优效性。因此,有关TAVR术后最佳抗栓治疗方案的探索仍将继续。
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图9:ATLANTIS研究结果
ENVISAGE-TAVI AF:为TAVR房颤患者抗凝治疗提供重要证据
ENVISAGE-TAVI AF试验旨在探究TAVR术后复发或新发房颤患者中比较艾多沙班与维生素K拮抗剂(VKA)的疗效和安全性。研究纳入14个国家173个中心1426例在TAVR术后有口服抗凝治疗常规适应证的复发或新发房颤患者。
 
结果显示,TAVR治疗后艾多沙班预防卒中和其他血栓栓塞事件不劣于VKA,但大出血发生率更高。该研究结果仅适用于合并房颤、中等手术风险和症状性AS老年患者,而不适用于手术风险较低的年轻患者、无症状性主动脉瓣狭窄以及同时接受PCI的患者。
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图10:ENVISAGE-TAVI AF研究结果
 
高血压治疗目标值最新进展

 

 

STEP:为老年高血压强化降压新添佐证
老年高血压患者中进行的降压试验结果好坏参半,而且指南推荐了不同的降压目标水平。ESC 2021会上,中国医学科学院阜外医院的蔡军教授发布的STEP研究,探讨以收缩压(SBP)<130 mmHg为目标的强化治疗是否可以降低心血管疾病的风险。
 
研究纳入中国42个临床研究中心8511名老年原发性高血压患者,分为强化治疗组(SBP<130 mmHg但≥110 mmHg)、标准治疗组(SBP 130~150 mmHg)。中位随访3.34年,强化治疗组SBP的平均下降幅度为19.4 mmHg,主要复合终点的相对风险降低26%。
 
SPRINT研究证实,SBP目标<120 mmHg有心血管获益,但存在挑战性,因为这可能导致更高药物费用和更频繁就诊,且肾损伤发生率显著增加。然而,在STEP研究中,SBP目标<130 mmHg未观察到肾脏损伤发生率增加。
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图11:STEP研究主要结果
回顾2021年心血管领域涌现出的重磅研究,这些研究结果为未来的研究指引了方向,也为指南的更新提供了更多循证医学证据。
我们也看到,在盘点的十大临床研究中,有2个是中国原创性临床研究结果,这说明中国临床研究的质量和水平在不断提高,越来越受到国内外同行的认可和关注。当然,我们期待心血管领域未来能出现更多的进展!

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    2021-12-24 ms7000001791634956

    学习

    0

  5. 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    2021-12-22 ms4000000901131801

    学习到了!!!!

    0

  6. 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  7. 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    2021-12-19 12186752m54暂无昵称

    学习

    0

  8. 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    2021-12-19 weigq

    学习

    0

  9. 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    2021-12-19 1250495am25(暂无昵称)

    学习一下真不错

    0

  10. 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    2021-12-19 April6697

    学习了!

    0

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