Pub Date : 2024-12-01DOI: 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.
{"title":"Microalbuminuria in Patients with Type 2 Diabetes Mellitus Treated with a Phytoformula as Adjuvant.","authors":"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","doi":"10.1016/j.ahj.2024.09.019","DOIUrl":"10.1016/j.ahj.2024.09.019","url":null,"abstract":"<div><div><strong>Introduction:</strong> 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.</div><div><strong>Objective:</strong> To evaluate changes in albuminuria in patients with DM2 treated with a phytoformula as adjuvant therapy.</div><div><strong>Methods:</strong> 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.</div><div><strong>Results:</strong> 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.</div><div><strong>Conclusions:</strong> Phytoformula reduced waist, HbA1c and albuminuria at 3 months; no changes in BMI and GFR were present.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 6-7"},"PeriodicalIF":3.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143156693","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}
Pub Date : 2024-11-29DOI: 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。
{"title":"A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia","authors":"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","doi":"10.1016/j.ahj.2024.11.012","DOIUrl":"10.1016/j.ahj.2024.11.012","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov ID NCT05233124, URL: <span><span>https://clinicaltrials.gov/study/NCT05233124</span><svg><path></path></svg></span></div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 103-111"},"PeriodicalIF":3.7,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765559","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}
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.
{"title":"Implementing guideline-directed medical therapy: Stakeholder-identified barriers and facilitators","authors":"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","doi":"10.1016/j.ahj.2024.11.011","DOIUrl":"10.1016/j.ahj.2024.11.011","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 23-31"},"PeriodicalIF":3.7,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754428","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}
Pub Date : 2024-11-27DOI: 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.
{"title":"Contribution margins and utilization of transcatheter aortic valve replacement versus surgical aortic valve replacement in the Medicare population","authors":"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","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 < 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}
Pub Date : 2024-11-26DOI: 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.
{"title":"Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study","authors":"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","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 <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.</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}
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.
{"title":"All-cause mortality and death by aortic dissection in women with Turner syndrome: A national clinical cohort study","authors":"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","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}
Pub Date : 2024-11-24DOI: 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.
{"title":"The Federal Trade Commission investigation of pharmaceutical benefit managers","authors":"Dina Sheira BA , Kevin Schulman MD","doi":"10.1016/j.ahj.2024.11.009","DOIUrl":"10.1016/j.ahj.2024.11.009","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"281 ","pages":"Pages 20-22"},"PeriodicalIF":3.7,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715280","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}
Pub Date : 2024-11-21DOI: 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.
{"title":"Prognosis of patients with nonspecific electrocardiogram findings in a Tanzanian emergency department","authors":"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","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}
Pub Date : 2024-11-18DOI: 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.
{"title":"Changes in coverage, access, and health status among adults with cardiovascular disease after medicaid work requirements","authors":"Eden Engel-Rebitzer MD , Lucas Marinacci MD , ZhaoNian Zheng MSc , Rishi K. Wadhera MD, MPP, MPhil","doi":"10.1016/j.ahj.2024.10.014","DOIUrl":"10.1016/j.ahj.2024.10.014","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"279 ","pages":"Pages 104-106"},"PeriodicalIF":3.7,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674924","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}
Pub Date : 2024-11-17DOI: 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.
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 , 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","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}