JAMA Neurol:药物洗脱支架能明显降低高级别ICAS患者支架内狭窄和卒中复发风险!(NOVA研究)

2022-01-05 MedSci原创 MedSci原创

与BMS相比,DES可降低有症状的高等级ICAS患者的ISR和缺血性卒中复发的风险。

支架内再狭窄(ISR)是使用标准裸金属支架(BMS)治疗的患者在颅内支架术后复发中风的主要原因。目前,有关药物洗脱支架(DES)是否能降低颅内动脉粥样硬化性狭窄(ICAS)的ISR风险仍不清楚。

为了研究DES是否能降低有症状的高等级ICAS患者的ISR和卒中复发的风险,来自我国首都医科大学天坛医院神经内科的专家开展了相关研究,结果发表在JAMA Neurology杂志上。

2015年4月27日至2018年11月16日,在中国16个颅内支架手术量大的医疗中心进行了一项前瞻性、多中心、开放标签的随机临床试验,并对结果进行盲法评估。有症状的高级别ICAS患者被随机纳入并随访1年。

患者被随机分配接受DES(NOVA颅内西罗莫司洗脱支架系统)或BMS(Apollo颅内支架系统)治疗,比例为1:1。主要疗效终点是手术后1年内的ISR,定义为植入支架内或紧邻支架(5mm内)的管腔直径大于50%的狭窄。主要安全终点是手术后30天内的任何中风或死亡。

结果共有263名参与者(194名男性[73.8%];中位[IQR]年龄,58[52-65]岁)被纳入分析,其中132人被随机分配到DES组,131人被分配到BMS组。总的来说,DES组的1年ISR率低于BMS组,总体风险降低76%(10 [9.5%] vs 32 [30.2%];OR=0.24;95% CI,0.11-0.52;P < .001)。

DES组和BMS组随访1年内支架内在狭窄风险差异

其中,DES组从第31天到1年的缺血性中风复发率也明显较低,风险降低90%(1 [0.8%] vs 9 [6.9%];HR=0.10;95%CI,0.01-0.80;P = .03)。但在DES组和BMS组之间,30天内任何中风或死亡的比率没有明显差异(10[7.6%] vs 7[5.3%];OR=1.45;95%CI,0.54-3.94;P=.46)。

综上,本试验发现,与BMS相比,DES可降低有症状的高等级ICAS患者的ISR和缺血性卒中复发的风险。

参考文献:

Jia B, Zhang X, Ma N, et al. Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial. JAMA Neurol. Published online January 04, 2022. doi:10.1001/jamaneurol.2021.4804

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    2022-07-21 yinhl1978
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GetPortalCommentsPageByObjectIdResponse(id=1181014, encodeId=0eef1181014ea, content=已学, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d75d5428239, createdName=ms9000001014338978, createdTime=Wed Jan 05 20:19:52 CST 2022, time=2022-01-05, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1905597, encodeId=a327190559e51, content=<a href='/topic/show?id=0eb34259ea1' target=_blank style='color:#2F92EE;'>#复发风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42597, encryptionId=0eb34259ea1, topicName=复发风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Fri Sep 02 09:13:28 CST 2022, time=2022-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2001668, encodeId=633720016682c, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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GetPortalCommentsPageByObjectIdResponse(id=1181014, encodeId=0eef1181014ea, content=已学, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d75d5428239, createdName=ms9000001014338978, createdTime=Wed Jan 05 20:19:52 CST 2022, time=2022-01-05, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1905597, encodeId=a327190559e51, content=<a href='/topic/show?id=0eb34259ea1' target=_blank style='color:#2F92EE;'>#复发风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42597, encryptionId=0eb34259ea1, topicName=复发风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Fri Sep 02 09:13:28 CST 2022, time=2022-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2001668, encodeId=633720016682c, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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encodeId=262e1500990e0, content=<a href='/topic/show?id=7218933363' target=_blank style='color:#2F92EE;'>#ICAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9333, encryptionId=7218933363, topicName=ICAS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=23a69492679, createdName=手留余香, createdTime=Fri Jan 07 04:13:28 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1624981, encodeId=1591162498116, content=<a href='/topic/show?id=0333412062' target=_blank style='color:#2F92EE;'>#Cas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4120, encryptionId=0333412062, topicName=Cas)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=411420689333, createdName=yaanren, createdTime=Fri Jan 07 04:13:28 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181438, encodeId=2d44118143851, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211111/81c0b64745c644319545ec26d7ef0b34/9ddb2864d5df4dd9bf4305e380bffc96.jpg, createdBy=c7835705079, createdName=屋顶瞄爱赏月, createdTime=Thu Jan 06 19:18:37 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181437, encodeId=564c118143eaf, content=心血管新福利, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a6316446470, createdName=ms6000002088801177, createdTime=Thu Jan 06 19:16:26 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181014, encodeId=0eef1181014ea, content=已学, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d75d5428239, createdName=ms9000001014338978, createdTime=Wed Jan 05 20:19:52 CST 2022, time=2022-01-05, status=1, ipAttribution=)]
    2022-01-07 手留余香
  7. 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GetPortalCommentsPageByObjectIdResponse(id=1181014, encodeId=0eef1181014ea, content=已学, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d75d5428239, createdName=ms9000001014338978, createdTime=Wed Jan 05 20:19:52 CST 2022, time=2022-01-05, status=1, ipAttribution=)]
    2022-01-07 yaanren
  8. [GetPortalCommentsPageByObjectIdResponse(id=1905597, encodeId=a327190559e51, content=<a href='/topic/show?id=0eb34259ea1' target=_blank style='color:#2F92EE;'>#复发风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42597, encryptionId=0eb34259ea1, topicName=复发风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Fri Sep 02 09:13:28 CST 2022, time=2022-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2001668, encodeId=633720016682c, content=<a href='/topic/show?id=d5df12695e6' target=_blank style='color:#2F92EE;'>#Neurol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12695, encryptionId=d5df12695e6, topicName=Neurol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, 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CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181438, encodeId=2d44118143851, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211111/81c0b64745c644319545ec26d7ef0b34/9ddb2864d5df4dd9bf4305e380bffc96.jpg, createdBy=c7835705079, createdName=屋顶瞄爱赏月, createdTime=Thu Jan 06 19:18:37 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181437, encodeId=564c118143eaf, content=心血管新福利, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a6316446470, createdName=ms6000002088801177, createdTime=Thu Jan 06 19:16:26 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181014, encodeId=0eef1181014ea, content=已学, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d75d5428239, createdName=ms9000001014338978, createdTime=Wed Jan 05 20:19:52 CST 2022, time=2022-01-05, status=1, ipAttribution=)]
    2022-01-06 屋顶瞄爱赏月

    学习了

    0

  9. 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    2022-01-06 ms6000002088801177

    心血管新福利

    0

  10. 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    2022-01-05 ms9000001014338978

    已学

    0

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支架在更新换代。以佐他莫司洗脱支架和钴铬依维莫司洗脱支架的第二代药物洗脱支架,由于在很多研究中显示出了优越的益处,而在临床实践中广泛应用,在很多大型医院,其应用率远超过第一代药物洗脱支架。

欧洲血运重建指南:**经桡动脉路径,所有介入都应使用药物支架,新型口服抗凝药地位提升,比伐卢定地位下降

ESC2018上,欧洲心脏协会联合欧洲心胸外科协会发布了2018年心肌血运重建治疗指南,包括经皮冠状动脉介入(PCI)和搭桥手术相关的药物、入路、术式、器械、影像学检查和适应证选择等。

拓展阅读

欧洲血运重建指南:**经桡动脉路径,所有介入都应使用药物支架,新型口服抗凝药地位提升,比伐卢定地位下降

ESC2018上,欧洲心脏协会联合欧洲心胸外科协会发布了2018年心肌血运重建治疗指南,包括经皮冠状动脉介入(PCI)和搭桥手术相关的药物、入路、术式、器械、影像学检查和适应证选择等。

科学家研发“功成即退”的人体“补丁”

衣服破了可以修补,人体器官出了问题也需要打“补丁”。我国每年需骨钉骨板“补丁”近1000万枚,因心血管疾病使用近100万只支架“补丁”。钛合金和不锈钢等骨钉骨板需要二次手术取出,而血管支架术后再狭窄率高达20%~30%,即使是药物支架再狭窄率也高达5-10%,而且一旦发生再狭窄危及生命,给患者带来了巨大的经济以及心理负担。

EuroInterventionInt J Cardiovasc Imaging:阜外医院研究称,新生动脉粥样硬化在药物支架再狭窄中起重要作用

近日,阜外医院宋雷等发表了两篇文章,提示在药物支架再狭窄发生发展过程中,尤其是晚期支架再狭窄,新生动脉粥样硬化(Neoatherosclerosis)起了重要作用,尤其是对于第一代药物支架作用更为明显。

Int J Cardiovas Imag:新生动脉粥样硬化在药物支架再狭窄中起重要作用

近日,阜外医院宋雷等发表了两篇文章,提示在药物支架再狭窄发生发展过程中,尤其是晚期支架再狭窄,新生动脉粥样硬化(Neoatherosclerosis)起了重要作用,尤其是对于第一代药物支架作用更为明显。

Chin Med J:阜外袁晋青等发现,第一代和第二代药物支架疗效和安全性相似

支架在更新换代。以佐他莫司洗脱支架和钴铬依维莫司洗脱支架的第二代药物洗脱支架,由于在很多研究中显示出了优越的益处,而在临床实践中广泛应用,在很多大型医院,其应用率远超过第一代药物洗脱支架。

JACC:冠心病植入药物洗脱支架后即刻FFR对临床事件的预测作用及其阈值

DES后FFR与TVF率密切相关。未来研究应更加关注支架置入术后FFR受损的机制和治疗。