NEJM:新冠重症病人,需要肝素抗凝治疗吗?

2021-08-08 MedSci原创 MedSci原创

背景

背景

血栓形成和炎症可能会导致新冠病毒感染(Covid-19) 患者的发病率和死亡率。我们假设治疗剂量的抗凝治疗会改善 Covid-19 危重患者的预后。

在去年一些研究表明,使用肝素进行抗凝治疗,对患者有益。在国内的《新型冠状病毒肺炎(重症)标准治疗专家共识》中也提到采用肝素治疗新冠肺炎的重症。但是,一直没有高水平临床证据。

方法

在一项开放标签、适应性、多平台、随机临床试验中,患有严重 Covid-19 的危重患者被随机分配到符合当地常规护理的实用定义的肝素治疗剂量抗凝治疗或常规药物血栓预防方案。主要终点为无器官支持天数,包括住院死亡(指定值为 -1)和存活至第 21 天的无血管或呼吸器官支持天数相结合

这项研究设计之初,即统一了治疗方案和统计方案,但是三个研究各自独立进行。在设计方面也略有差异。严重 Covid-19 被定义为Covid-19导致接受 ICU 级别,需要呼吸或心血管器官支持(通过高流量鼻导管吸氧、无创或有创机械通气、体外生命支持、血管加压药或正性肌力药)。在 ACTIV-4a 中,ICU 的定义被认为在大流行期间难以实施,因此无论医院环境如何,都使用 ICU 级别的器官支持来定义 ICU 级别的护理。如果患者在随机分组前因 Covid-19 入住 ICU 48 小时或更长时间(在 REMAP-CAP 中)或住院 72 小时或更长时间(在 ACTIV-4a 和 ATTACC 中),则不符合资格。如果他们面临死亡的迫在眉睫的风险并且没有持续承诺提供完整的器官支持,或者如果他们处于高出血风险中,正在接受双重抗血小板治疗,有单独的治疗剂量抗凝治疗的临床适应症,他们也不符合资格,或有肝素敏感性病史,包括肝素诱导的血小板减少症。

治疗剂量的抗凝治疗根据当地治疗急性静脉血栓栓塞的方案进行长达 14 天或直至康复(定义为出院或停止补充氧气至少 24 小时)。 常规护理血栓预防治疗的给药剂量和持续时间由治疗临床医生根据当地实践确定,包括标准低剂量血栓预防或增强的中剂量血栓预防。

结果

当治疗剂量抗凝治疗达到预设的无效标准时,试验停止。获得了 1098 名患者的主要结局数据(534 名被分配到治疗剂量抗凝治疗,564 名被分配到常规护理血栓预防)。在分配到治疗剂量抗凝治疗的患者中,无器官支持天数的中位数为 1(四分位距,-1 到 16),而在分配到常规治疗血栓预防的患者中,该天数的中值为 4(四分位距,-1 到 16) (调整后的比例优势比,0.83;95% 可信区间,0.67 至 1.03;无效的后验概率 [定义为优势比 <1.2],99.9%)。两组患者存活出院的百分比相似(分别为 62.7% 和 64.5%;调整后的比值比为 0.84;95% 可信区间为 0.64 至 1.11)。

在治疗组共335例(62.7%) 病人接受了治疗剂量的抗凝治疗,而在对照组,即接受常规血栓预防治疗中,有364例 (64.5%)接受常规血栓预防治疗直至了院。两组相比,患者存活直至出院相比,OR为0.84(95%CI为0.64-1.11)

Primary and Secondary Outcomes.

Outcome Therapeutic-Dose Anticoagulation
(N=536)
Usual-Care Thromboprophylaxis
(N=567)
Adjusted Difference in Risk (95% Credible Interval) Adjusted Odds Ratio (95% Credible Interval)* Probability of Superiority Probability of Futility Probability of Inferiority
  median no. (IQR) percentage points   % % %
Organ support–free days up to day 21 1 (–1 to 16) 4 (–1 to 16) 0.83 (0.67 to 1.03) 5.0 99.9 95.0
  no. of patients/total no. (%)          
Survival to hospital discharge 335/534 (62.7) 364/564 (64.5) –4.1 (–10.7 to 2.4) 0.84 (0.64 to 1.11) 10.8 99.6 89.2
Major thrombotic events or death§ 213/531 (40.1) 230/560 (41.1) 1.0 (–5.6 to 7.4) 1.04 (0.79 to 1.35) 40.3 59.7
Major thrombotic events 34/530 (6.4) 58/559 (10.4)
Death in hospital 199/534 (37.3) 200/564 (35.5)
Any thrombotic events or death§ 217/531 (40.9) 232/560 (41.4) 1.5 (–4.9 to 8.0) 1.06 (0.81 to 1.38) 33.4 66.6
Any thrombotic events 38/530 (7.2) 62/559 (11.1)
Death in hospital 199/534 (37.3) 200/564 (35.5)
Major bleeding§ 20/529 (3.8) 13/562 (2.3) 1.1 (–0.6 to 4.4) 1.48 (0.75 to 3.04) 12.8 87.2

Odds ratios were adjusted for age, sex, trial site, and enrollment time interval.

Days free of cardiovascular or respiratory organ support was evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of organ support up to day 21 among patients who survived to hospital discharge. Outcomes were known for 534 patients assigned to therapeutic-dose anticoagulation and for 564 patients assigned to usual-care pharmacologic thromboprophylaxis. The odds ratio is an adjusted proportional odds ratio.

The probabilities of superiority (odds ratio, >1), inferiority (odds ratio, <1), and futility (odds ratio, <1.2) of therapeutic-dose anticoagulation were computed from the posterior distribution.

The probabilities of superiority (odds ratio, <1) and inferiority (odds ratio, >1) of therapeutic-dose anticoagulation were computed from the posterior distribution.

Major thrombotic events include pulmonary embolism, myocardial infarction, ischemic cerebrovascular event, and systemic arterial thromboembolism.

Any thrombotic events include major thrombotic events or deep-vein thrombosis.

在第21天时,无器官支持天数比较

尽管接受治疗剂量抗凝治疗的组中发生主要血栓形成事件的患者少于接受常规治疗药物血栓预防治疗的组(6.4% vs. 10.4%),但主要血栓形成事件或 两组的死亡率相似(分别为 40.1% 和 41.1%;调整后比值比中位数为 1.04;95% 可信区间为 0.79 至 1.35)(表 2)。 一项纳入深静脉血栓形成的分析显示了类似的结果。 表 S4 中提供了血栓形成事件的细目分类。 在治疗期间,接受治疗剂量抗凝治疗的患者中有 3.8% 发生了大出血事件,而接受常规血栓预防治疗的患者中有 2.3% 发生了大出血事件

结论:

在 Covid-19 危重患者中,使用普通肝素或低分子量肝素进行治疗剂量抗凝治疗的初始策略与更大的出院存活率或更多的心血管或呼吸器官无病天数无关,也不支持比常规治疗药物血栓预防更有效。 就这些结果而言,治疗剂量抗凝治疗不如常规治疗血栓预防的可靠性很高。(REMAP-CAP、ACTIV-4a 和 ATTACC 试验)

在本期《新英格兰杂志》上还配发了评论。

该评论认为这三项试验中ACTIV-4a是常规的RCT,而REMAP-CAP 和ATTACC是适应症随机试验设计,其中一篇文章关注重病患者,另一篇文章关注中度疾病患者。在这两篇文章中,针对标准血栓预防措施评估了治疗剂量肝素或 LMWH(后者用于两组中 >90% 的患者)的潜在益处和风险。主要发现是,治疗剂量的肝素或 LMWH 并没有改善危重患者在没有器官支持的情况下的主要结局,并且与常规护理预防相比,与更多的严重出血并发症相关(3.8% 对 2.3%)。相比之下,在中度患者中,治疗剂量的肝素或 LMWH 似乎增加了出院前的生存概率,同时减少了对器官支持的需求。然而,在中度疾病患者中,肝素或 LMWH 发生的大出血多于血栓预防(1.9% 对 0.9%)。

为什么在不同人群中结果可能不一样?一个因素可能是,在危重患者中,潜在的血栓形成和炎症损伤可能已经太严重,无法受到更高剂量肝素的影响。在严重的 Covid-19 中,血栓形成是由一系列细胞因子、活化补体、血小板、内皮细胞和炎症细胞以及微泡驱动的,这些细胞为凝血反应提供有效的催化表面。 这些表面结合的复合物和纤维蛋白结合的凝血酶是抗凝血酶是肝素和低分子肝素中的关键辅因子,对抑制作用具有很强的抵抗力。如果我们假设这种机制在中度疾病患者中不太活跃,它可能有助于解释在非危重患者中观察到的血栓预防益处。 导致不同发现的其他原因可能与人群差异有关。

尽管绝大多数危重患者是在英国进行 REMAP-CAP 试验的中心招募的,但中度患者主要是从美国和巴西的 ATTACC 和 ACTIV-4a 试验中招募的。这些人口不仅在地域上而且在种族上也不同。接下来,有一些与平台试验中对照组的非并发性质相关的警告,其中实验组在不同时间进入和退出试验。

尽管作者在在他们的模型中,这种调整可能没有完全纠正传统随机对照试验中未观察到的差异。此外,标准预防方法由医生自行决定,导致治疗组内混合使用常规预防剂量和中间剂量。因此,在涉及危重患者的试验中,22.4% 的患者接受治疗。

有了前面的警告,从这些混合数据中可以得出什么结论? 首先,现有证据不支持使用治疗剂量的肝素或低分子肝素来预防危重患者的血栓形成。 可能需要其他抗血栓形成或什至原纤维蛋白溶解策略。 其次,中等剂量或治疗剂量的血栓预防药物对 Covid-19 中度患者是否有效和安全仍然是一个重要问题。 尽管存在抗凝治疗对 Covid-19 非危重患者有益的信号,但医生必须解决以下关键问题:缺乏对肝素或低分子肝素确实(或不)提供保护的机制的了解以及 个体患者的出血风险是否大于获益。 正如已故的 Ed Salzman 在 LMWH 临床研究的早期总结的那样:“抗血栓治疗领域的一项有前途的创新,但尚无定论。”

原始出处:

The REMAP-CAP, ACTIV-4a, and ATTACC Investigators. Therapeutic anticoagulation with heparin in critically ill patients with Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2103417.

Sholzberg MTang GHRahhal H, et al. Heparin for moderately ill patients with Covid-19. July 92021 (https://www.medrxiv.org/content/10.1101/2021.07.08.21259351v2. opens in new tab). preprint.

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    2021-10-23 芳芳要加油呀

    谢谢

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1063256, encodeId=ca201063256f3, content=谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ae6c5608723, createdName=芳芳要加油呀, createdTime=Sat Oct 23 21:53:27 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1006230, encodeId=6acd1006230ce, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160531/IMG574DA473DF46C6923.jpg, createdBy=e39768313, createdName=xzmynya, createdTime=Mon Aug 09 08:45:30 CST 2021, time=2021-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029840, encodeId=9d7e102984023, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sun Aug 08 23:52:46 CST 2021, time=2021-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035719, encodeId=3d611035e1975, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sun Aug 08 23:52:46 CST 2021, time=2021-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1006146, encodeId=b35b100614611, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201107/0e992c9cbb7e4bfc82d642ba0e9fe718/6fa4c63468cc49febcc91dba2fb4201a.jpg, createdBy=fa625399541, createdName=DIfh, createdTime=Sun Aug 08 21:23:41 CST 2021, time=2021-08-08, status=1, ipAttribution=)]
    2021-08-09 xzmynya

    学习了

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    2021-08-08 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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    2021-08-08 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

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    2021-08-08 DIfh

    学习

    0

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