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Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial. 心脏手术后补钾和预防心房颤动:TIGHT K 随机临床试验。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-24 DOI: 10.1001/jama.2024.17888
Benjamin O'Brien, Niall G Campbell, Elizabeth Allen, Zahra Jamal, Joanna Sturgess, Julie Sanders, Charles Opondo, Neil Roberts, Jonathan Aron, Maria Rita Maccaroni, Richard Gould, Bilal H Kirmani, Ben Gibbison, Gudrun Kunst, Alexander Zarbock, Maren Kleine-Brüggeney, Christian Stoppe, Keith Pearce, Mark Hughes, Laura Van Dyck, Richard Evans, Hugh E Montgomery, Diana Elbourne
<p><strong>Importance: </strong>Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly.</p><p><strong>Objective: </strong>To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger.</p><p><strong>Design, setting, and participants: </strong>This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023.</p><p><strong>Interventions: </strong>Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment.</p><p><strong>Main outcomes and measures: </strong>The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm-related events, clinical outcomes, and cost related to the intervention.</p><p><strong>Results: </strong>A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, -2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001).</p><p><strong>Conclusions and relevance: </strong>For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or advers
重要性:补充钾以维持高正常血清浓度是预防心脏手术后心房颤动(AFACS)的一种普遍策略,但这一策略缺乏循证医学证据、存在风险且成本高昂:目的:确定以较低的血清钾浓度作为补充钾的触发因素是否不劣于以较高的血清钾浓度作为补充钾的触发因素:这项开放标签、非劣效随机临床试验在英国和德国的 23 家心脏外科中心进行。2020 年 10 月 20 日至 2023 年 11 月 16 日期间,计划接受孤立冠状动脉旁路移植术(CABG)手术的无房性心律失常病史的患者被纳入研究范围。最后一名患者于 2023 年 12 月 11 日出院:患者被随机分配到严格或宽松的钾控制策略中(分别在血清钾浓度低于 4.5 mEq/L 或 3.6 mEq/L 时才补充钾)。患者佩戴动态心律监测仪,由核心实验室进行分析,该实验室对治疗分配进行了屏蔽:预设的主要终点是 CABG 术后 120 小时内或出院前(以先发生者为准)临床检测到并经心电图证实的新发 AFACS。所有主要结局事件均由一个事件验证委员会验证,该委员会对治疗任务进行了屏蔽。弛缓血钾控制的非劣效性定义为新发 AFACS 的风险差异,相关的单侧 97.5% CI 上限小于 10%。次要结果包括其他心律相关事件、临床结果以及与干预相关的成本:共有 1690 名患者(平均年龄 65 岁;女性 256 人 [15%])接受了随机治疗。主要终点发生在紧致组 26.2% 的患者(n = 219)和松弛组 27.8% 的患者(n = 231)身上,风险差异为 1.7% (95% CI, -2.6% to 5.9%)。在通过任何方法或仅通过动态心律监测仪检测到至少一次房颤的发生率、非房颤性心律失常、住院死亡率或住院时间方面,两组之间没有差异。宽松组患者购买和使用钾的人均成本明显降低(平均差异为 111.89 美元 [95% CI,103.60-120.19 美元];P 结论及意义:就 AFACS 预防而言,仅在血清钾浓度低于 3.6 mEq/L 时补充钾并不比目前普遍采用的补充钾以维持血清钾浓度大于或等于 4.5 mEq/L 的做法差。较低的补充阈值与心律失常或不良临床结果的增加无关:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT04053816。
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引用次数: 0
Service Animals. 服务动物。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-24 DOI: 10.1001/jama.2024.15017
Alan Jay Schwartz, Aditee P Ambardekar
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引用次数: 0
Statins for Primary Prevention of Cardiovascular Disease-With PREVENT, What's a Clinician to Do? 他汀类药物用于心血管疾病的一级预防--有了 PREVENT,临床医生该怎么办?
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-24 DOI: 10.1001/jama.2024.13887
Sadiya S Khan, Donald M Lloyd-Jones
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引用次数: 0
The US Preventive Services Task Force in Legal Jeopardy. 美国预防服务工作组陷入法律困境。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.17377
Christopher Robertson, Kirsten Bibbins-Domingo, Gregory Curfman
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引用次数: 0
Preventive Care Coverage Threatened by Federal Court Ruling. 联邦法院的裁决威胁到预防性保健的覆盖范围。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.16439
Carmel Shachar, Elizabeth Kaplan
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引用次数: 0
CT-Guided Thrombectomy for Large Core Stroke Up to 24 Hours-Another Piece in a Complex Puzzle. CT引导下的血栓切除术治疗大面积脑卒中长达24小时--复杂谜题中的又一谜团。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.15670
Jane Khalife, Daniel A Tonetti, Tudor G Jovin
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引用次数: 0
Tenth International Congress on Peer Review and Scientific Publication: Call for Abstracts. 第十届同行评审与科学出版国际大会:征集论文摘要。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.18311
John P A Ioannidis, Michael Berkwits, Annette Flanagin, Theodora Bloom
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引用次数: 0
Weight Loss-Induced Muscle Mass Loss. 减肥引起的肌肉质量下降。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.17212
William J Evans, Steven Cummings
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引用次数: 0
Weight Loss-Induced Muscle Mass Loss-Reply. 减肥导致肌肉量减少--回复。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-23 DOI: 10.1001/jama.2024.17215
Caterina Conte, Kevin D Hall, Samuel Klein
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引用次数: 0
Errors in Table 1. 表 1 中的误差。
IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-20 DOI: 10.1001/jama.2024.20028
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引用次数: 0
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Jama-Journal of the American Medical Association
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