心肌梗死后猝死率--来自 VALIANT 和 PARADISE-MI 试验的启示。

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JAMA cardiology Pub Date : 2024-10-01 DOI:10.1001/jamacardio.2024.2356
James P Curtain, Marc A Pfeffer, Eugene Braunwald, Brian L Claggett, Christopher B Granger, Lars Køber, Eldrin F Lewis, Aldo P Maggioni, Doug L Mann, Jean L Rouleau, Scott D Solomon, Philippe Gabriel Steg, Peter V Finn, Alberto Fernandez, Karola S Jering, John J V McMurray
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引用次数: 0

摘要

重要性:猝死是急性心肌梗死(AMI)后的主要死因。确定减少心肌梗死后心力衰竭事件优越性的前瞻性 ARNi 与 ACE 抑制剂对比试验(PARADISE-MI)和缬沙坦治疗急性心肌梗死试验(VALIANT)招募了急性心肌梗死后肺充血和/或左心室功能障碍的患者。尚未研究此类患者的预后是否随时间推移而改变:比较 PARADISE-MI 和 VALIANT 试验中 AMI 后猝死/心脏骤停(RCA)的发生率:这是对纳入AMI患者的多中心随机临床试验的二次分析。在主要分析中,VALIANT队列仅限于具有 "PARADISE-MI-like "特征的患者(例如,至少有一个增高的危险因素且无心力衰竭病史)。对两项试验中患者的基线特征进行了比较。VALIANT试验的入组时间为1998年12月至2001年6月,PARADISE-MI试验的入组时间为2016年12月至2020年3月。VALIANT试验和PARADISE-MI试验的中位随访时间分别为24.7个月和22个月。分析对象包括合并肺充血和/或左心室功能障碍的急性心肌梗死患者:结果:共有 5661 名患者被纳入 PARADISE-MI 队列(平均 [SD] 年龄为 63.7 [11.5] 岁;4298 名男性 [75.9%]),9617 名患者被纳入 VALIANT(PARADISE-MI-like)队列(平均 [SD] 年龄为 66.1[11.5]岁;男性 6504 名[67.6%]),VALIANT(总)队列中有 14 703 名患者(平均 [SD] 年龄 64.8 [11.8]岁;男性 10 133 名[68.9%])。在 VALIANT 试验的 PARADISE-MI-like 队列中,9617 名参与者中有 707 人(7.4%)经历了猝死/RCA。在 PARADISE-MI 试验的 5661 名参与者中,共有 148 人(2.6%)经历了猝死/RCA。在这两项试验中,梗死后第一个月的猝死率最高:VALIANT试验的猝死率为19.3(95% CI,16.4-22.6)/100人年,PARADISE-MI试验的猝死率为9.5(95% CI,7.0-12.7)/100人年,此后猝死率稳步下降。与VALIANT队列相比,PARADISE-MI试验中的患者更常接受经皮冠状动脉介入治疗,并更常服用β受体阻滞剂、他汀类药物和矿化皮质激素受体拮抗剂:急性心肌梗死后,猝死/冠心病发作的风险在第一个月最高,之后迅速下降。结果显示,与20年前的患者相比,接受现代治疗的左心室射血分数降低和/或肺充血患者的猝死/RCA发生率降低了2至3倍。需要采取干预措施,进一步保护心梗后第一个月的高危人群:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT02924727。
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Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials.

Importance: Sudden death is a leading cause of death after acute myocardial infarction (AMI). The Prospective ARNi vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI (PARADISE-MI) and Valsartan in Acute Myocardial Infarction (VALIANT) trials enrolled patients with pulmonary congestion and/or left ventricular dysfunction after AMI. Whether the prognosis in such patients has changed over time has not been examined.

Objective: To compare the rate of sudden death/resuscitated cardiac arrest (RCA) after AMI in the PARADISE-MI and VALIANT trials.

Design, setting, and participants: This was a secondary analysis of multicenter randomized clinical trials enrolling patients after AMI. In the primary analysis, the VALIANT cohort was restricted to patients with "PARADISE-MI-like" characteristics (eg, at least 1 augmenting risk factor and no history of heart failure). The baseline characteristics of people in both trials were compared. The VALIANT trial enrolled from December 1998 to June 2001, and the PARADISE-MI trial enrolled between December 2016, and March 2020. The median follow-up in the VALIANT and PARADISE-MI trials was 24.7 and 22 months, respectively. People with AMI, complicated by pulmonary congestion and/or left ventricular dysfunction, were included in the analysis.

Exposure: Sudden death after AMI.

Results: A total of 5661 patients were included in the PARADISE-MI cohort (mean [SD] age, 63.7 [11.5] years; 4298 male [75.9%]), 9617 were included in the VALIANT (PARADISE-MI-like) cohort (mean [SD] age, 66.1 [11.5] years; 6504 male [67.6%]), and 14 703 patients were included in the VALIANT (total) cohort (mean [SD] age, 64.8 [11.8] years; 10 133 male [68.9%]). In the PARADISE-MI-like cohort of the VALIANT trial, 707 of 9617 participants (7.4%) experienced sudden death/RCA. A total of 148 of 5661 people (2.6%) in the PARADISE-MI trial experienced sudden death/RCA. Sudden death rates were highest in the first month after infarction in both trials: 19.3 (95% CI, 16.4-22.6) per 100 person-years in the VALIANT trial and 9.5 (95% CI, 7.0-12.7) per 100 person-years in the PARADISE-MI trial, and these rates declined steadily thereafter. Compared with the VALIANT cohort, people in the PARADISE-MI trial were more often treated with percutaneous coronary intervention for their qualifying AMI and received a β-blocker, statin, and mineralocorticoid receptor antagonist more frequently.

Conclusions and relevance: After AMI, the risk of sudden death/RCA was highest in the first month, declining rapidly thereafter. Results revealed that compared with counterparts from 20 years ago, the rate of sudden death/RCA in patients with a reduced left ventricular ejection fraction and/or pulmonary congestion was 2- to 3-fold lower in people receiving contemporary management. Interventions to further protect people in the highest risk first month after infarction are needed.

Trial registration: ClinicalTrials.gov Identifier: NCT02924727.

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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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