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Microalbuminuria in Patients with Type 2 Diabetes Mellitus Treated with a Phytoformula as Adjuvant.
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-12-01 DOI: 10.1016/j.ahj.2024.09.019
Nidia Angélica García Espinoza DACM , Hugo Morales Tello DACM , Ricardo Sacchi Córdova BS , Nicasio Morales Sarabia BS , Jair Isaí Ortega Gaxiola PhD , José Alfredo Primelles Gingele BS , María Magdalena Valencia Gutiérrez MD, MPH , Erick Ayala Calvillo PhD , Cesar Ochoa Martinez MD, PhD
Introduction: Diabetic nephropathy develops in 40% of patients 10 years after the diagnosis of diabetes, with albuminuria >300mg/dl (>200µg/min) more than twice in 3-6 months. (1) Strict glycemic control reduces mortality by 48% (2) and macroalbuminuria by 50%. The Terrabrio SAPI de CV group developed the Elevaté® Body Balance phytoformula made with Shilajit (Asphaltum punjabianum), Chaga (Inonotus obliquus), Moringa (Moringa oleifera), Berberine (Berberina vulgaris, Coptis chinensis French) and Bayetilla (Hamelia patens) used in traditional herbal medicine.
Objective: To evaluate changes in albuminuria in patients with DM2 treated with a phytoformula as adjuvant therapy.
Methods: A controlled clinical trial was conducted in 269 patients with DM2 treated with oral hypoglycemic agents plus 1.5 g/day of the phytoformulation under treatment for 90 days; a sub analysis of 20 patients with albuminuria was performed.
Results: In the 20 patients with albuminuria, age was 53.20 (49.25-58) years, 12(60%) women and 8(40%) men; time of diagnosis of DM2 was 7.41±4.36 years, treated with metformin 16(80%), sulfonylureas 19(95%) and insulin 3(15%); 3-month changes in waist from 95.85±9. 82 to 93.80±10.34 with p 0.044; HbA1c from 9.82±1.24 to 7.28±1.70 with p 0.0001; BUN from 10.44±3.43 to 12.30±5.53 with p 0.023; Albuminuria from 43.50±36.45 to 30±35.39 with p 0.0001; GFR from 93.57±14.54 to 93.85±18.56 with p 0.908, with no differences in BMI, blood pressure, urea, and creatinine. Correlation was 0.795 between HbAc1 and albuminuria.
Conclusions: Phytoformula reduced waist, HbA1c and albuminuria at 3 months; no changes in BMI and GFR were present.
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引用次数: 0
A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia 急性冠状动脉综合征和冠状动脉扩张患者抗血栓治疗的随机试验。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-29 DOI: 10.1016/j.ahj.2024.11.012
Diego Araiza-Garaygordobil MD, MSc , Rodrigo Gopar-Nieto MD, MSc , Jorge Daniel Sierra-Lara Martínez MD , Ajit S Mullasari MBBS, MD, DM , Nallely Belderrain-Morales MD , Nitzha Andrea Nájera-Rojas MD , Braiana Angeles Diaz-Herrera MD , Vianney Sarabia-Chao MD , Diana Laura Alfaro-Ponce MD , Jose Luis Briseño-De la Cruz MD , Maximiliano Ruiz-Beltrán MD , Marco Antonio Martínez-Ríos MD , Yigal Piña-Reyna MD , Ximena Latapi-Ruiz Esparza MD , Flavio Adrian Grimaldo-Gomez MD , Evelyn Cortina-De la Rosa QFB , María Oliva Romero-Arroyo QFB , Alejandro Sierra-Gonzalez de Cossio MD , Héctor González-Pacheco MD , Alexandra Arias-Mendoza MD, MBA

Background

Coronary artery ectasia (CAE) of the culprit infarct artery is a rare finding in patients with acute coronary syndrome (ACS). While anticoagulants have been suggested to reduce recurrent events, the optimal antithrombotic therapy remains unclear.

Methods

OVER-TIME was an open label, exploratory, randomized controlled trial comparing dual antiplatelet therapy (DAPT; acetyl-salicylic-acid 100mg plus clopidogrel 75mg daily) versus single antiplatelet (SAPT, clopidogrel 75mg) plus DOAC (rivaroxaban 15mg) in patients with ACS and CAE. The study primary objectives were 1) the composite of cardiovascular death, recurrent MI and repeat revascularization and 2) total bleeding events (BARC 1-5) at 12 months. The secondary objective was fibrin clot lysis time (using turbidimetry).

Results

A total of 62 patients were randomized, 32 (51.6%) to receive DAPT and 30 (48.3%) to receive SAPT+DOAC. Patients were aged 55.5 years (±10.6) and mostly male (86.9%); STEMI was the most common presentation (83.8%). No statistically significant differences (HR 0.24, 95% CI 0.02-2.16, P = .20) in the risk of the primary endpoint were found; however, a numerically lower rate of recurrent MI (4 events – 12.5% - in the DAPT arm vs. 1 event – 3.3% in the SAPT+DOAC arm) was observed. The risk of bleeding events was not different HR 0.75 (95% CI 0.26-2.16, P = .59). A statistically significant reduction in fibrin clot lysis time (-24.7% reduction, P = .038) was observed in those randomized to SAPT+DOAC, but not in DAPT (-14.7% reduction, P = .25).

Conclusions

In this exploratory study including patients with ACS and CAE of the culprit artery, the use of rivaroxaban 15mg in addition to clopidogrel was not associated with a statistically lower risk of major adverse cardiovascular events; however, a lower rate of recurrent MI and a reduction in fibrin clot lysis time were observed. Future studies to address antithrombotic therapy in CAE are needed.

Trial Registration

ClinicalTrials.gov ID NCT05233124, URL: https://clinicaltrials.gov/study/NCT05233124
背景:在急性冠脉综合征(ACS)患者中,罪魁祸首梗死动脉的冠状动脉扩张(CAE)是一种罕见的发现。虽然抗凝剂已被建议减少复发事件,但最佳的抗血栓治疗仍不清楚。方法:OVER-TIME是一项开放标签、探索性、随机对照试验,比较双重抗血小板治疗(DAPT;在ACS和CAE患者中,乙酰水杨酸100mg +氯吡格雷75mg /天)与单一抗血小板药物(SAPT,氯吡格雷75mg) + DOAC(利伐沙班15mg)比较。研究的主要目标是:1)心血管死亡、复发性心肌梗死和重复血运重建的综合情况;2)12个月的总出血事件(barc1 -5)。次要目的是纤维蛋白凝块溶解时间(使用浊度法)。结果:共62例患者随机化,32例(51.6%)患者接受DAPT, 30例(48.3%)患者接受SAPT+DOAC。患者年龄55.5岁(±10.6岁),以男性为主(86.9%);STEMI是最常见的表现(83.8%)。主要终点的风险无统计学差异(HR 0.24, 95% CI 0.02-2.16, p = 0.20);然而,观察到数值上较低的心肌梗死复发率(DAPT组为4例,12.5%,SAPT+DOAC组为1例,3.3%)。出血事件的风险无差异,HR 0.75 (95% CI 0.26-2.16, p = 0.59)。随机分配到SAPT+DOAC组的患者纤维蛋白凝块溶解时间有统计学意义的减少(减少-24.7%,p = 0.038),但DAPT组没有(减少-14.7%,p = 0.25)。结论:在这项包括ACS和CAE患者的探索性研究中,在氯吡格雷的基础上使用利伐沙班15mg与主要不良心血管事件的风险降低没有统计学意义上的相关性;然而,观察到心肌梗死复发率较低,纤维蛋白凝块溶解时间缩短。需要进一步研究CAE的抗血栓治疗。
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引用次数: 0
Implementing guideline-directed medical therapy: Stakeholder-identified barriers and facilitators 实施指南指导的医疗治疗:利益相关者确定的障碍和促进因素。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-28 DOI: 10.1016/j.ahj.2024.11.011
Josephine Harrington MD , Monica Leyva MHA , Vishal N Rao MD MPH , Megan Oakes , Nkiru Osude MD , Hayden B Bosworth PhD , Neha J Pagidipati MD MPH

Background

Despite strong evidence and Class I recommendations to support the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), use of these medications remain suboptimal. There is a great need to understand 1) what barriers to implementation of these therapies exist and 2) effective ways to support implementation of these therapies.

Methods

Using the Consolidated Framework for Implementation Research framework, we conducted a broad array of interviews with stakeholders in the care of patients with HFrEF across 26 health systems to determine the barriers to GDMT implementation that health systems face, and to identify any factors that facilitated GDMT implementation and titration. We conducted interviews across a variety of health system phenotypes, including academic, private, fee-for-service, and bundled payment health systems to understand whether barriers and facilitators to GDMT implementation existed across system types.

Results

Barriers to GDMT implementation appeared to be consistent across phenotypes and included a lack of time, difficulty in maintaining GDMT across the inpatient to outpatient transition and, among non-HF specialists, a lack of knowledge of guidelines. However, differences emerged when stakeholders described whether tools (facilitators) were available to overcome these barriers to help facilitate GDMT implementation, particularly when comparing institutions with fee-for-service vs bundled payment models. Health systems using bundled payment models were more likely than fee-for-service systems to report that they had support staff such as care managers and pharmacist technicians to improve GDMT use, institutional support for improving GDMT implementation, and champions for GDMT. In contrast, systems using a fee-for-service model rarely reported that these tools were available.

Conclusion

In this analysis of stakeholder-reported barriers and facilitators to GDMT implementation and titration, we find health systems face similar barriers to GDMT implementation. However, we note that systems using bundled payment models are more likely to report the availability of tools to help overcome these barriers. Future work is needed to understand whether similar facilitators would be effective in fee-for-service systems, or whether alternative facilitators might be more appropriate.
背景:尽管有强有力的证据和一级推荐支持使用指南导向药物治疗(GDMT)治疗心力衰竭伴射血分数降低(HFrEF)患者,但这些药物的使用仍然不是最佳的。我们非常需要了解:1)实施这些疗法存在哪些障碍;2)支持实施这些疗法的有效方法。方法:使用实施研究框架的综合框架,我们对26个卫生系统中HFrEF患者护理的利益相关者进行了广泛的访谈,以确定卫生系统面临的GDMT实施障碍,并确定促进GDMT实施和滴定的任何因素。我们在各种卫生系统表型中进行了访谈,包括学术、私人、按服务收费和捆绑支付卫生系统,以了解在不同系统类型中是否存在GDMT实施的障碍和促进因素。结果:GDMT实施的障碍似乎在各种表型中是一致的,包括缺乏时间,在住院到门诊过渡期间维持GDMT的困难,以及在非hf专家中缺乏指南知识。然而,当利益相关者描述是否有工具(促进者)来克服这些障碍以帮助促进GDMT的实施时,特别是在比较服务收费与捆绑支付模式的机构时,差异就出现了。使用捆绑支付模式的卫生系统比按服务收费的系统更有可能报告说,他们有支持人员,如护理经理和药剂师技术人员来改善GDMT的使用,为改善GDMT的实施提供机构支持,以及GDMT的拥护者。相比之下,使用按服务收费模式的系统很少报告这些工具可用。结论:在对利益相关者报告的GDMT实施和滴定的障碍和促进因素的分析中,我们发现卫生系统面临类似的GDMT实施障碍。然而,我们注意到,使用捆绑支付模式的系统更有可能报告帮助克服这些障碍的工具的可用性。今后的工作需要了解类似的促进器是否在按服务收费的系统中有效,或者替代的促进器是否可能更合适。
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引用次数: 0
Contribution margins and utilization of transcatheter aortic valve replacement versus surgical aortic valve replacement in the Medicare population 经导管主动脉瓣置换术与外科主动脉瓣置换术在医疗保险人群中的应用。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-27 DOI: 10.1016/j.ahj.2024.11.010
Kriyana P. Reddy BS , Kaitlyn Shultz MS , Lauren A. Eberly MD, MPH , Sameed Ahmed M. Khatana MD, MPH , Alexander C. Fanaroff MD, MHS , Dharam J. Kumbhani MD, SM , Sammy Elmariah MD, MPH , Paul Fiorilli MD , Howard Herrmann MD , Nimesh D. Desai MD, PhD , Pavan Atluri MD , Wilson Y. Szeto MD , Fenton McCarthy MD , David J. Cohen MD, MS , Peter W. Groeneveld MD, MS , Jay Giri MD, MPH , Ashwin S. Nathan MD, MS

Background

Hospitals and health systems must balance the demand for transcatheter aortic valve replacement (TAVR) against financial sustainability. Patients may be eligible for both TAVR and surgical aortic valve replacement (SAVR), but financial realities for hospitals may affect differential access to those therapies. We sought to understand the landscape of costs and reimbursement for TAVR and SAVR in the US and to understand the association of procedural reimbursement with receipt of either.

Methods

We included fee-for-service Medicare beneficiaries undergoing isolated TAVR or SAVR in 2016-2019. For each TAVR and SAVR, inpatient revenues and direct costs were calculated at the claim level. The contribution margin (CM) for each TAVR or SAVR was then calculated as total revenues minus total direct costs, which defines the net profit for the procedure for the hospital. Multivariate logistic regressions were used to identify hospital characteristics associated with positive TAVR CMs. Multivariate linear regression was used to assess the relationship between relative volume of TAVR cases and relative differences in TAVR versus SAVR CMs at the hospital level.

Results

Of 542 sites, 377 (69.6%) had positive CMs, and 165 (30.4%) had negative CMs for TAVR; 505 (93.2%) had positive CMs for SAVR. Median revenues, costs, and CMs for TAVR decreased between 2016 and 2019. The median (IQR) total CM per hospital for TAVR decreased from $10,574 ($1,331-$22,259) in 2016 to $6,744 ($6,099-$17,511) in 2019 (P < 0.001). Teaching hospital status (aOR 1.77, 95% CI 1.07-2.93) and for-profit status (aOR 3.7, 95% CI 1.8-7.6) were associated with increased odds of positive TAVR CMs relative to nonteaching hospital status and nonprofit status, respectively, in multivariate logistic regression models. The median (IQR) proportion of TAVR of total AVR was 76.67% (69.6%-82.5%) compared with 74.6% (66.9%-80.4%) at hospitals with negative TAVR CMs (P = .04). There was no significant linear relationship between hospital-level difference in median TAVR and SAVR CMs and hospital-level proportion of TAVR of total AVR in multivariate models.

Conclusions

Most hospitals had positive CMs for TAVR and nearly all had positive CMs for SAVR. Positive CMs for TAVR for individual hospitals were associated with a significant increase in the utilization of TAVR. However, the magnitude of difference in TAVR versus SAVR CM was not associated with differential procedural use.
背景:医院和卫生系统必须平衡经导管主动脉瓣置换术(TAVR)的需求和财务可持续性。患者可能同时符合TAVR和外科主动脉瓣置换术(SAVR)的条件,但医院的财务状况可能会影响这些治疗方法的差异。我们试图了解美国TAVR和SAVR的成本和报销情况,并了解程序报销与收到两者的关系。方法:我们纳入了2016-2019年接受孤立TAVR或SAVR的按服务收费的医疗保险受益人。对于每个TAVR和SAVR,住院收入和直接成本在索赔水平上计算。然后计算每个TAVR或SAVR的贡献边际(CM)为总收入减去总直接成本,这定义了医院的手术净利润。采用多变量logistic回归来确定与TAVR阳性CMs相关的医院特征。采用多元线性回归评估TAVR病例的相对数量与TAVR与SAVR CMs在医院水平上的相对差异之间的关系。结果:542个站点中CMs阳性377个(69.6%),TAVR阴性165个(30.4%);505例(93.2%)为SAVR阳性。2016年至2019年期间,TAVR的收入、成本和CMs中位数均有所下降。每家医院TAVR的总CM中位数(IQR)从2016年的10,574美元(1,331美元至22259美元)下降到2019年的6,744美元(6,099美元至17,511美元)(p结论:大多数医院TAVR CM阳性,几乎所有医院SAVR CM阳性。个别医院TAVR阳性CMs与TAVR使用率显著增加相关。然而,TAVR与SAVR CM的差异大小与手术使用的差异无关。
{"title":"Contribution margins and utilization of transcatheter aortic valve replacement versus surgical aortic valve replacement in the Medicare population","authors":"Kriyana P. Reddy BS ,&nbsp;Kaitlyn Shultz MS ,&nbsp;Lauren A. Eberly MD, MPH ,&nbsp;Sameed Ahmed M. Khatana MD, MPH ,&nbsp;Alexander C. Fanaroff MD, MHS ,&nbsp;Dharam J. Kumbhani MD, SM ,&nbsp;Sammy Elmariah MD, MPH ,&nbsp;Paul Fiorilli MD ,&nbsp;Howard Herrmann MD ,&nbsp;Nimesh D. Desai MD, PhD ,&nbsp;Pavan Atluri MD ,&nbsp;Wilson Y. Szeto MD ,&nbsp;Fenton McCarthy MD ,&nbsp;David J. Cohen MD, MS ,&nbsp;Peter W. Groeneveld MD, MS ,&nbsp;Jay Giri MD, MPH ,&nbsp;Ashwin S. Nathan MD, MS","doi":"10.1016/j.ahj.2024.11.010","DOIUrl":"10.1016/j.ahj.2024.11.010","url":null,"abstract":"<div><h3>Background</h3><div>Hospitals and health systems must balance the demand for transcatheter aortic valve replacement (TAVR) against financial sustainability. Patients may be eligible for both TAVR and surgical aortic valve replacement (SAVR), but financial realities for hospitals may affect differential access to those therapies. We sought to understand the landscape of costs and reimbursement for TAVR and SAVR in the US and to understand the association of procedural reimbursement with receipt of either.</div></div><div><h3>Methods</h3><div>We included fee-for-service Medicare beneficiaries undergoing isolated TAVR or SAVR in 2016-2019. For each TAVR and SAVR, inpatient revenues and direct costs were calculated at the claim level. The contribution margin (CM) for each TAVR or SAVR was then calculated as total revenues minus total direct costs, which defines the net profit for the procedure for the hospital. Multivariate logistic regressions were used to identify hospital characteristics associated with positive TAVR CMs. Multivariate linear regression was used to assess the relationship between relative volume of TAVR cases and relative differences in TAVR versus SAVR CMs at the hospital level.</div></div><div><h3>Results</h3><div>Of 542 sites, 377 (69.6%) had positive CMs, and 165 (30.4%) had negative CMs for TAVR; 505 (93.2%) had positive CMs for SAVR. Median revenues, costs, and CMs for TAVR decreased between 2016 and 2019. The median (IQR) total CM per hospital for TAVR decreased from $10,574 ($1,331-$22,259) in 2016 to $6,744 ($6,099-$17,511) in 2019 (P &lt; 0.001). Teaching hospital status (aOR 1.77, 95% CI 1.07-2.93) and for-profit status (aOR 3.7, 95% CI 1.8-7.6) were associated with increased odds of positive TAVR CMs relative to nonteaching hospital status and nonprofit status, respectively, in multivariate logistic regression models. The median (IQR) proportion of TAVR of total AVR was 76.67% (69.6%-82.5%) compared with 74.6% (66.9%-80.4%) at hospitals with negative TAVR CMs (<em>P</em> = .04). There was no significant linear relationship between hospital-level difference in median TAVR and SAVR CMs and hospital-level proportion of TAVR of total AVR in multivariate models.</div></div><div><h3>Conclusions</h3><div>Most hospitals had positive CMs for TAVR and nearly all had positive CMs for SAVR. Positive CMs for TAVR for individual hospitals were associated with a significant increase in the utilization of TAVR. However, the magnitude of difference in TAVR versus SAVR CM was not associated with differential procedural use.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 59-70"},"PeriodicalIF":3.7,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study COVID疫苗相关心肌炎/心包炎(CAMP)研究的设计和基本原理:简短标题:CAMP研究的设计和基本原理。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-26 DOI: 10.1016/j.ahj.2024.11.008
Dongngan T. Truong MD, MSCI , Brian J. Harty MA , Jessica Bainton RN, MSc , Annette Baker MSN, CPNP , Tamara T. Bradford MD , Bing Cai PhD , Julia Coleman BA , Cynthia de Luise PhD , Audrey Dionne MD , Kevin Friedman MD , Juleen Gayed MBBS , Emily Graham MS , Pei-Ni Jone MD , Stephan Lanes PhD , Gail D. Pearson MD, ScD , Michael A. Portman MD , Andrew J. Powell MD , Mark W. Russell MD , Arash A. Sabati MD , Michael D. Taylor MD , Jane W. Newburger MD, MPH

Background

Minimal data are available on mid- and long-term outcomes following COVID-19 vaccine-associated myocarditis/pericarditis. The COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) study aims to characterize the mid- and long-term sequelae of myocarditis/pericarditis following administration of any Pfizer-BioNTech COVID-19 vaccine (herein referred to as COMIRNATY®). Herein we describe the rationale and design of CAMP.

Methods

This ongoing and actively enrolling multicenter observational cohort study across 32 North American pediatric cardiac centers will include at least 200 patients <21 years-old who presented ≤21 days from COMIRNATY® vaccination and meet the Centers for Disease Control and Prevention (CDC) case definition of probable or confirmed myocarditis/pericarditis or isolated pericarditis. The comparison cohort will consist of 100 patients <21 years-old with COVID-19 associated myocarditis/pericarditis, including those who meet the contemporaneous CDC case definition of multisystem inflammatory syndrome (MIS-C). The study will collect detailed hospital and follow-up data for up to 5 years following illness onset. Electrocardiograms, echocardiograms, and cardiac magnetic resonance (CMR) examinations will be interpreted in core laboratories. The primary outcomes are 1) composite of left ventricular ejection fraction <55% by echocardiogram, findings of myocarditis by original or revised Lake Louise criteria on CMR, and/or the presence of high-grade arrhythmias or conduction system disturbances at 6 months after myocarditis/pericarditis onset; 2) complications, such as death, and non-cardiac morbidities; and 3) patient-reported outcomes of global health, functional status, and quality of life. Analyses will include descriptive statistics and regression modeling.

Current Status

Still enrolling, with 273 participants currently enrolled as of 10/16/2024 (173 vaccine-associated myocarditis/pericarditis, 100 COVID-19-associated myocarditis/pericarditis)

Conclusions

With long-term follow-up and core laboratories for standardized assessments of cardiac testing, the CAMP study will make important contributions to our understanding of the mid- and long-term cardiac and non-cardiac sequelae of COVID-19 vaccine-associated myocarditis/pericarditis.
背景:关于COVID-19疫苗相关心肌炎/心包炎的中期和长期结局的数据很少。COVID疫苗相关心肌炎/心包炎(CAMP)研究旨在描述任何辉瑞- biontech COVID-19疫苗(以下简称COMIRNATY®)接种后心肌炎/心包炎的中长期后遗症。本文描述了CAMP的基本原理和设计。方法:这项正在进行并积极纳入的多中心观察队列研究将在32个北美儿童心脏中心纳入至少200名患者。目前状态:仍在纳入,截至2024年10月16日,目前有273名参与者入组(173名疫苗相关心肌炎/心包炎,100名covid -19相关心肌炎/心包炎)。通过长期随访和核心实验室对心脏检查进行标准化评估,CAMP研究将为我们了解COVID-19疫苗相关心肌炎/心包炎的中长期心脏和非心脏后遗症做出重要贡献。
{"title":"Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study","authors":"Dongngan T. Truong MD, MSCI ,&nbsp;Brian J. Harty MA ,&nbsp;Jessica Bainton RN, MSc ,&nbsp;Annette Baker MSN, CPNP ,&nbsp;Tamara T. Bradford MD ,&nbsp;Bing Cai PhD ,&nbsp;Julia Coleman BA ,&nbsp;Cynthia de Luise PhD ,&nbsp;Audrey Dionne MD ,&nbsp;Kevin Friedman MD ,&nbsp;Juleen Gayed MBBS ,&nbsp;Emily Graham MS ,&nbsp;Pei-Ni Jone MD ,&nbsp;Stephan Lanes PhD ,&nbsp;Gail D. Pearson MD, ScD ,&nbsp;Michael A. Portman MD ,&nbsp;Andrew J. Powell MD ,&nbsp;Mark W. Russell MD ,&nbsp;Arash A. Sabati MD ,&nbsp;Michael D. Taylor MD ,&nbsp;Jane W. Newburger MD, MPH","doi":"10.1016/j.ahj.2024.11.008","DOIUrl":"10.1016/j.ahj.2024.11.008","url":null,"abstract":"<div><h3>Background</h3><div>Minimal data are available on mid- and long-term outcomes following COVID-19 vaccine-associated myocarditis/pericarditis. The <strong><u>C</u></strong>OVID Vaccine-<strong><u>A</u></strong>ssociated <strong><u>M</u></strong>yocarditis<strong>/<u>P</u></strong>ericarditis (CAMP) study aims to characterize the mid- and long-term sequelae of myocarditis/pericarditis following administration of any Pfizer-BioNTech COVID-19 vaccine (herein referred to as COMIRNATY®). Herein we describe the rationale and design of CAMP.</div></div><div><h3>Methods</h3><div>This ongoing and actively enrolling multicenter observational cohort study across 32 North American pediatric cardiac centers will include at least 200 patients &lt;21 years-old who presented ≤21 days from COMIRNATY® vaccination and meet the Centers for Disease Control and Prevention (CDC) case definition of probable or confirmed myocarditis/pericarditis or isolated pericarditis. The comparison cohort will consist of 100 patients &lt;21 years-old with COVID-19 associated myocarditis/pericarditis, including those who meet the contemporaneous CDC case definition of multisystem inflammatory syndrome (MIS-C). The study will collect detailed hospital and follow-up data for up to 5 years following illness onset. Electrocardiograms, echocardiograms, and cardiac magnetic resonance (CMR) examinations will be interpreted in core laboratories. The primary outcomes are 1) composite of left ventricular ejection fraction &lt;55% by echocardiogram, findings of myocarditis by original or revised Lake Louise criteria on CMR, and/or the presence of high-grade arrhythmias or conduction system disturbances at 6 months after myocarditis/pericarditis onset; 2) complications, such as death, and non-cardiac morbidities; and 3) patient-reported outcomes of global health, functional status, and quality of life. Analyses will include descriptive statistics and regression modeling.</div></div><div><h3>Current Status</h3><div>Still enrolling, with 273 participants currently enrolled as of 10/16/2024 (173 vaccine-associated myocarditis/pericarditis, 100 COVID-19-associated myocarditis/pericarditis)</div></div><div><h3>Conclusions</h3><div>With long-term follow-up and core laboratories for standardized assessments of cardiac testing, the CAMP study will make important contributions to our understanding of the mid- and long-term cardiac and non-cardiac sequelae of COVID-19 vaccine-associated myocarditis/pericarditis.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 32-42"},"PeriodicalIF":3.7,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
All-cause mortality and death by aortic dissection in women with Turner syndrome: A national clinical cohort study 特纳综合征女性的全因死亡率和主动脉夹层导致的死亡:一项全国临床队列研究。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-26 DOI: 10.1016/j.ahj.2024.11.007
Sofia Thunström MD , Erik Thunström MD, PhD, FESC , Sabine Naessén MD, PhD , Kerstin Berntorp MD, PhD , Margareta Laczna Kitlinski MD, PhD , Bertil Ekman MD, PhD , Jeanette Wahlberg MD, PhD , Ingrid Bergström MD, PhD , Magnus Isaksson MD, PhD , Carmen Basic MD, PhD , Teresia Svanvik MD, PhD , Inger Bryman MD, PhD , Kerstin Landin-Wilhelmsen MD, PhD

Background

Turner syndrome (TS) is a complex genetic disorder with raised mortality. Our objective was to investigate mortality and causes of death in TS.

Methods

A matched retrospective observational study of women with TS recruited from the Turner centers in Sweden were conducted. A total of 472 women with TS, ≥16 years old with a cytogenetically verified diagnosis and 2357 controls, matched for birthyear and sex, were examined and followed since 1995 for up to 26 years. Survival analyses were performed with Cox proportional hazard models. Kaplan-Meier curves were generated. Cumulative incidence rates were evaluated by competing risks analysis, using cumulative incidence function.

Results

During a mean follow-up of 17 years, 35 (7.4%) women with TS and 70 (3.0%) controls died. All-cause mortality was elevated in TS, hazard ratio (HR) 2.90 (95% CI 1.92-4.37), mainly due to circulatory diseases and notably aortic dissection, with HR of 9.11 (95% CI 4.54-18.25) and 21.79 (95% CI 4.62-102.82), respectively. Aortic dissection was the single largest cause of death in TS, accounting for 23% (8/35) of total deaths. Death by cancer or external causes were not raised in TS. In individuals below 45 years of age death, aortic dissections were greatly increased compared to controls, HR 55.59 (95% CI 2.33-1325.69). From the ages 46 to 80 years a notably higher risk of dying by heart diseases, aortic dissection excluded, was shown in TS compared to controls HR, 7.7 (2.65-22.36). The median survival time was 8 years shorter in TS compared to controls.

Conclusions

The increased mortality in TS was mainly driven by aortic dissections in the young and by heart diseases in the older. Healthcare professionals should prioritize detection and monitoring, with emphasis on cardiovascular diseases.
背景:特纳综合征(TS)是一种复杂的遗传性疾病,死亡率较高。我们的目标是调查 TS 患者的死亡率和死亡原因:我们对瑞典特纳中心招募的 TS 女性患者进行了一项匹配的回顾性观察研究。自 1995 年以来,共对 472 名年龄≥ 16 岁、经细胞遗传学确诊的 TS 女性患者和 2357 名出生年份和性别匹配的对照组患者进行了长达 26 年的随访。生存分析采用 Cox 比例危险模型进行。生成了卡普兰-梅耶曲线。使用累积发病率函数,通过竞争风险分析评估累积发病率:在平均 17 年的随访期间,35 名(7.4%)患有 TS 的妇女和 70 名(3.0%)对照组妇女死亡。TS患者的全因死亡率较高,危险比(HR)为2.90(95% CI 1.92-4.37),主要原因是循环系统疾病,尤其是主动脉夹层,其危险比分别为9.11(95% CI 4.54-18.25)和21.79(95% CI 4.62-102.82)。主动脉夹层是TS的最大死因,占总死亡人数的23%(8/35)。癌症或外部原因导致的死亡在TS中并不常见。与对照组相比,45岁以下人群的主动脉夹层死亡率大大增加,HR为55.59(95% CI为2.33-1325.69)。与对照组相比,TS 患者在 46 至 80 岁期间死于心脏病(不包括主动脉夹层)的风险明显更高,HR 为 7.7(2.65-22.36)。与对照组相比,TS患者的中位生存时间缩短了8年:结论:TS患者死亡率升高的主要原因是年轻人的主动脉夹层和老年人的心脏病。医护人员应优先进行检测和监测,重点是心血管疾病。
{"title":"All-cause mortality and death by aortic dissection in women with Turner syndrome: A national clinical cohort study","authors":"Sofia Thunström MD ,&nbsp;Erik Thunström MD, PhD, FESC ,&nbsp;Sabine Naessén MD, PhD ,&nbsp;Kerstin Berntorp MD, PhD ,&nbsp;Margareta Laczna Kitlinski MD, PhD ,&nbsp;Bertil Ekman MD, PhD ,&nbsp;Jeanette Wahlberg MD, PhD ,&nbsp;Ingrid Bergström MD, PhD ,&nbsp;Magnus Isaksson MD, PhD ,&nbsp;Carmen Basic MD, PhD ,&nbsp;Teresia Svanvik MD, PhD ,&nbsp;Inger Bryman MD, PhD ,&nbsp;Kerstin Landin-Wilhelmsen MD, PhD","doi":"10.1016/j.ahj.2024.11.007","DOIUrl":"10.1016/j.ahj.2024.11.007","url":null,"abstract":"<div><h3>Background</h3><div>Turner syndrome (TS) is a complex genetic disorder with raised mortality. Our objective was to investigate mortality and causes of death in TS.</div></div><div><h3>Methods</h3><div>A matched retrospective observational study of women with TS recruited from the Turner centers in Sweden were conducted. A total of 472 women with TS, ≥16 years old with a cytogenetically verified diagnosis and 2357 controls, matched for birthyear and sex, were examined and followed since 1995 for up to 26 years. Survival analyses were performed with Cox proportional hazard models. Kaplan-Meier curves were generated. Cumulative incidence rates were evaluated by competing risks analysis, using cumulative incidence function.</div></div><div><h3>Results</h3><div>During a mean follow-up of 17 years, 35 (7.4%) women with TS and 70 (3.0%) controls died. All-cause mortality was elevated in TS, hazard ratio (HR) 2.90 (95% CI 1.92-4.37), mainly due to circulatory diseases and notably aortic dissection, with HR of 9.11 (95% CI 4.54-18.25) and 21.79 (95% CI 4.62-102.82), respectively. Aortic dissection was the single largest cause of death in TS, accounting for 23% (8/35) of total deaths. Death by cancer or external causes were not raised in TS. In individuals below 45 years of age death, aortic dissections were greatly increased compared to controls, HR 55.59 (95% CI 2.33-1325.69). From the ages 46 to 80 years a notably higher risk of dying by heart diseases, aortic dissection excluded, was shown in TS compared to controls HR, 7.7 (2.65-22.36). The median survival time was 8 years shorter in TS compared to controls.</div></div><div><h3>Conclusions</h3><div>The increased mortality in TS was mainly driven by aortic dissections in the young and by heart diseases in the older. Healthcare professionals should prioritize detection and monitoring, with emphasis on cardiovascular diseases.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 1-9"},"PeriodicalIF":3.7,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Federal Trade Commission investigation of pharmaceutical benefit managers 联邦贸易委员会对药品福利管理公司的调查。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-24 DOI: 10.1016/j.ahj.2024.11.009
Dina Sheira BA , Kevin Schulman MD
The role of Pharmaceutical Business Managers remains a mystery to most physicians, and to most policy makers. Many of the business practices of a Pharmaceutical Business Manager are confidential and are beyond the purview of researchers. A recent Federal Trade Commission report raises many important questions about the role of these entities in the market. We review what the Federal Trade Commission found during their investigation and why physicians should be concerned.
对于大多数医生和政策制定者来说,药品业务经理的角色仍然是个谜。药品业务经理的许多商业行为都是保密的,不属于政策研究人员的研究范围。联邦贸易委员会最近的一份报告对这些实体在市场中的作用提出了许多重要问题。我们回顾了联邦贸易委员会在调查中发现的问题,以及医生应该关注的原因。
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引用次数: 0
Prognosis of patients with nonspecific electrocardiogram findings in a Tanzanian emergency department 坦桑尼亚急诊科非特异性心电图检查结果患者的预后。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-21 DOI: 10.1016/j.ahj.2024.11.006
Joshua T. Sarafian MScGH , Francis M. Sakita MD , Jerome J. Mlangi BS , Godfrey L. Kweka BS , Tumsifu G. Tarimo BS , Monica S. Kessy MD , Kajiru G. Kilonzo MD , Gerald S. Bloomfield MD, MPH , Julian T. Hertz MD, MScGH

Background

Nonspecific electrocardiogram (ECG) findings are associated with increased morbidity and mortality in high-income settings. ECGs are increasingly available in emergency departments (EDs) in low- and middle-income countries (LMICs), however the prognostic value of nonspecific ECG findings in resource-limited settings, particularly in sub-Saharan Africa, remains unclear.

Objective

To assess the association between nonspecific ECG findings and 30-day mortality among patients presenting with chest pain and shortness of breath to a Tanzanian ED.

Methods

Patient demographics and initial ECGs were collected from patients presenting with chest pain or shortness of breath to an ED in Moshi, Tanzania from January 2019 through January 2023. Two independent adjudicators interpreted ECGs using standardized criteria. Unadjusted and adjusted (adjusting for age and gender) odds ratios were calculated, and Pearson's chi-squared test was used to assess the association of each ECG finding with 30-day mortality.

Results

Among 1,111 participants, 231 (20.8%) died within 30 days of ED presentation. T-wave inversions (aOR 1.60, 95% CI 1.19-2.15, P = .002), resting tachycardia (aOR 1.57, 95% CI 1.16-2.13, P = .003), non-sinus rhythms (aOR 1.93, 95% CI 1.26-2.96, P = .003), and ST depressions (aOR 1.73, 95% CI 1.17-2.56, P = .006) were significantly associated with increased mortality. There was no significant association between 30-day mortality and left ventricular hypertrophy, bundle branch blocks, or Q waves. Patients with any abnormal ECG finding had higher mortality compared to those with normal ECGs (OR 1.53, 95% CI, 1.08-2.21, P = .019).

Conclusion

Certain nonspecific ECG findings are associated with increased risk of 30-day mortality. Locally tailored risk stratification tools and increased attention to nonspecific ECG changes may enhance ED care in LMICs.
背景:在高收入地区,非特异性心电图(ECG)结果与发病率和死亡率的增加有关。中低收入国家(LMIC)的急诊科越来越多地采用心电图,但在资源有限的环境中,尤其是在撒哈拉以南非洲地区,非特异性心电图结果的预后价值仍不明确:评估坦桑尼亚急诊室胸痛和气短患者的非特异性心电图结果与 30 天死亡率之间的关系:从 2019 年 1 月到 2023 年 1 月,在坦桑尼亚莫希的一家急诊室收集了因胸痛或呼吸急促而就诊的患者的人口统计数据和初始心电图。两名独立评审员使用标准化标准解释心电图。计算未调整和调整后(调整年龄和性别)的几率比,并使用皮尔逊卡方检验评估每项心电图结果与 30 天死亡率的关系:在 1 111 名参与者中,有 231 人(20.8%)在急诊室就诊后 30 天内死亡。T波倒置(aOR 1.60,95% CI 1.19-2.15,p = 0.002)、静息性心动过速(aOR 1.57,95% CI 1.16-2.13,p = 0.003)、非窦性心律(aOR 1.93,95% CI 1.26-2.96,p = 0.003)和ST段压低(aOR 1.73,95% CI 1.17-2.56,p = 0.006)与死亡率增加显著相关。30 天死亡率与左心室肥厚、束支传导阻滞或 Q 波无明显关系。与心电图正常的患者相比,有任何异常心电图发现的患者死亡率更高(OR 1.53,95% CI 1.08 - 2.21,p = 0.019):结论:某些非特异性心电图结果与30天死亡风险增加有关。结论:某些非特异性心电图结果与 30 天内死亡风险增加有关。根据当地情况定制的风险分层工具和对非特异性心电图变化的更多关注可加强低收入国家的急诊室护理。
{"title":"Prognosis of patients with nonspecific electrocardiogram findings in a Tanzanian emergency department","authors":"Joshua T. Sarafian MScGH ,&nbsp;Francis M. Sakita MD ,&nbsp;Jerome J. Mlangi BS ,&nbsp;Godfrey L. Kweka BS ,&nbsp;Tumsifu G. Tarimo BS ,&nbsp;Monica S. Kessy MD ,&nbsp;Kajiru G. Kilonzo MD ,&nbsp;Gerald S. Bloomfield MD, MPH ,&nbsp;Julian T. Hertz MD, MScGH","doi":"10.1016/j.ahj.2024.11.006","DOIUrl":"10.1016/j.ahj.2024.11.006","url":null,"abstract":"<div><h3>Background</h3><div>Nonspecific electrocardiogram (ECG) findings are associated with increased morbidity and mortality in high-income settings. ECGs are increasingly available in emergency departments (EDs) in low- and middle-income countries (LMICs), however the prognostic value of nonspecific ECG findings in resource-limited settings, particularly in sub-Saharan Africa, remains unclear.</div></div><div><h3>Objective</h3><div>To assess the association between nonspecific ECG findings and 30-day mortality among patients presenting with chest pain and shortness of breath to a Tanzanian ED.</div></div><div><h3>Methods</h3><div>Patient demographics and initial ECGs were collected from patients presenting with chest pain or shortness of breath to an ED in Moshi, Tanzania from January 2019 through January 2023. Two independent adjudicators interpreted ECGs using standardized criteria. Unadjusted and adjusted (adjusting for age and gender) odds ratios were calculated, and Pearson's chi-squared test was used to assess the association of each ECG finding with 30-day mortality.</div></div><div><h3>Results</h3><div>Among 1,111 participants, 231 (20.8%) died within 30 days of ED presentation. T-wave inversions (aOR 1.60, 95% CI 1.19-2.15, <em>P</em> = .002), resting tachycardia (aOR 1.57, 95% CI 1.16-2.13, <em>P</em> = .003), non-sinus rhythms (aOR 1.93, 95% CI 1.26-2.96, <em>P</em> = .003), and ST depressions (aOR 1.73, 95% CI 1.17-2.56, <em>P</em> = .006) were significantly associated with increased mortality. There was no significant association between 30-day mortality and left ventricular hypertrophy, bundle branch blocks, or Q waves. Patients with any abnormal ECG finding had higher mortality compared to those with normal ECGs (OR 1.53, 95% CI, 1.08-2.21, <em>P</em> = .019).</div></div><div><h3>Conclusion</h3><div>Certain nonspecific ECG findings are associated with increased risk of 30-day mortality. Locally tailored risk stratification tools and increased attention to nonspecific ECG changes may enhance ED care in LMICs.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 10-19"},"PeriodicalIF":3.7,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Changes in coverage, access, and health status among adults with cardiovascular disease after medicaid work requirements 医疗补助工作要求之后,患有心血管疾病的成年人在保险范围、使用机会和健康状况方面的变化。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-18 DOI: 10.1016/j.ahj.2024.10.014
Eden Engel-Rebitzer MD , Lucas Marinacci MD , ZhaoNian Zheng MSc , Rishi K. Wadhera MD, MPP, MPhil
Policymakers have intensified calls to expand work requirements in Medicaid across the United States, which could have implications for low-income adults who experience a high burden of cardiometabolic risk factors and disease. In this difference-in-differences analysis, we found that the implementation of Medicaid work requirements was associated with decreased health insurance coverage, no change in employment status, and a trend towards worse access to care. Our findings suggest that the expansion of work requirements could have major implications for the cardiovascular health of working-age adults in the US.
政策制定者强烈呼吁在全美范围内扩大医疗补助计划中的工作要求,这可能会对因心脏代谢风险因素和疾病而负担沉重的低收入成年人产生影响。在这项差异分析中,我们发现,医疗补助计划工作要求的实施与医疗保险覆盖面的减少、就业状况的不变以及获得医疗服务情况的恶化趋势有关。我们的研究结果表明,工作要求的扩大可能会对美国工作年龄成年人的心血管健康产生重大影响。
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引用次数: 0
Effect of apixaban versus vitamin K antagonist and aspirin versus placebo on days alive and out of hospital: An analysis from AUGUSTUS 阿哌沙班与维生素 K 拮抗剂相比,阿司匹林与安慰剂相比,对存活天数和出院天数的影响:AUGUSTUS 分析。
IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-17 DOI: 10.1016/j.ahj.2024.11.005
Alexander C. Fanaroff MD, MHS , Amit N. Vora MD, MPH , Daniel M. Wojdyla MS , Roxana Mehran MD , Christopher B. Granger MD , Shaun G. Goodman MD , Ronald Aronson MD , Stephan Windecker MD , John H. Alexander MD, MHS , Renato D. Lopes MD, PhD, MHS

Background

Clinical trials of antithrombotic agents typically use separate time-to-event analyses for bleeding and ischemic events, but this framework has limitations. Days alive and out of hospital (DAOH) is an alternative that may provide additional insight. We assessed the utility of DAOH as a clinical trial endpoint among patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention

Methods

AUGUSTUS, a randomized clinical trial, compared apixaban with warfarin and aspirin with placebo in 4614 patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention. We used Poisson regression with a robust variance estimate to compare DAOH by treatment group.

Results

Mean (SD) DAOH was 168 (31); median (IQR) was 177 (169-180); 75% of patients neither died nor were hospitalized. Mean (SD) DAOH was 169 (28) with apixaban + placebo, 168 (29) with apixaban + aspirin, 168 (33) with warfarin + placebo, and 167 (33) with warfarin + aspirin. There were no significant differences in the rate ratio for DAOH for apixaban vs. warfarin (RR 1.00, 95% CI 0.99-1.01) or aspirin vs. placebo (RR 1.00, 95% CI 1.00-1.01). Compared with warfarin, apixaban increased the proportion of patients who neither died nor were hospitalized during follow-up (76.8 vs. 73.3%; OR 0.83, 95% CI 0.73-0.95).

Conclusion

In this analysis of AUGUSTUS, there was no difference in DAOH by treatment arm. These findings contrast with time-to-event analyses, which showed lower rates of major bleeding and hospitalization with apixaban and placebo. DAOH may not be very a useful measure of effects of antithrombotic therapies in this population.

Trial Registration

clinicaltrials.gov; NCT02415400; https://clinicaltrials.gov/study/NCT02415400
背景:抗血栓药物临床试验通常对出血和缺血事件分别进行事件发生时间分析,但这一框架存在局限性。存活和出院天数(DAOH)是一种可提供更多见解的替代方法。方法:AUGUSTUS 是一项随机临床试验,在 4614 例心房颤动合并急性冠状动脉综合征或经皮冠状动脉介入治疗的患者中,比较了阿哌沙班与华法林以及阿司匹林与安慰剂。我们使用带有稳健方差估计的泊松回归来比较各治疗组的DAOH:平均(标清)DAOH为168(31);中位数(IQR)为177(169-180);75%的患者既未死亡也未住院。阿哌沙班+安慰剂的平均(标清)DAOH为169(28),阿哌沙班+阿司匹林为168(29),华法林+安慰剂为168(33),华法林+阿司匹林为167(33)。阿哌沙班与华法林(RR 1.00,95% CI 0.99-1.00)或阿司匹林与安慰剂(RR 1.00,95% CI 1.00-1.01)相比,DAOH比率无明显差异。阿哌沙班提高了随访期间既不死亡也不住院的患者比例(76.8% vs. 73.3%;OR 0.83,95% CI 0.73-0.95):结论:在这项 AUGUSTUS 分析中,不同治疗组的 DAOH 没有差异。这些结果与时间事件分析结果形成鲜明对比,后者显示阿哌沙班和安慰剂的大出血率和住院率更低。在这一人群中,DAOH 可能不是衡量抗血栓疗法效果的有用指标。
{"title":"Effect of apixaban versus vitamin K antagonist and aspirin versus placebo on days alive and out of hospital: An analysis from AUGUSTUS","authors":"Alexander C. Fanaroff MD, MHS ,&nbsp;Amit N. Vora MD, MPH ,&nbsp;Daniel M. Wojdyla MS ,&nbsp;Roxana Mehran MD ,&nbsp;Christopher B. Granger MD ,&nbsp;Shaun G. Goodman MD ,&nbsp;Ronald Aronson MD ,&nbsp;Stephan Windecker MD ,&nbsp;John H. Alexander MD, MHS ,&nbsp;Renato D. Lopes MD, PhD, MHS","doi":"10.1016/j.ahj.2024.11.005","DOIUrl":"10.1016/j.ahj.2024.11.005","url":null,"abstract":"<div><h3>Background</h3><div>Clinical trials of antithrombotic agents typically use separate time-to-event analyses for bleeding and ischemic events, but this framework has limitations. Days alive and out of hospital (DAOH) is an alternative that may provide additional insight. We assessed the utility of DAOH as a clinical trial endpoint among patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention</div></div><div><h3>Methods</h3><div>AUGUSTUS, a randomized clinical trial, compared apixaban with warfarin and aspirin with placebo in 4614 patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention. We used Poisson regression with a robust variance estimate to compare DAOH by treatment group.</div></div><div><h3>Results</h3><div>Mean (SD) DAOH was 168 (31); median (IQR) was 177 (169-180); 75% of patients neither died nor were hospitalized. Mean (SD) DAOH was 169 (28) with apixaban + placebo, 168 (29) with apixaban + aspirin, 168 (33) with warfarin + placebo, and 167 (33) with warfarin + aspirin. There were no significant differences in the rate ratio for DAOH for apixaban vs. warfarin (RR 1.00, 95% CI 0.99-1.01) or aspirin vs. placebo (RR 1.00, 95% CI 1.00-1.01). Compared with warfarin, apixaban increased the proportion of patients who neither died nor were hospitalized during follow-up (76.8 vs. 73.3%; OR 0.83, 95% CI 0.73-0.95).</div></div><div><h3>Conclusion</h3><div>In this analysis of AUGUSTUS, there was no difference in DAOH by treatment arm. These findings contrast with time-to-event analyses, which showed lower rates of major bleeding and hospitalization with apixaban and placebo. DAOH may not be very a useful measure of effects of antithrombotic therapies in this population.</div></div><div><h3>Trial Registration</h3><div>clinicaltrials.gov; NCT02415400; <span><span>https://clinicaltrials.gov/study/NCT02415400</span><svg><path></path></svg></span></div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 60-69"},"PeriodicalIF":3.7,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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American heart journal
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