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}
Pub Date : 2024-11-15DOI: 10.1016/j.ahj.2024.11.004
Navid Noory MD , Oscar Westin MD, PhD , Mathew S. Maurer MD , Emil Fosbøl MD, PhD , Finn Gustafsson MD, PhD, DMSc
Amyloidosis is a systemic disease affecting multiple organs, and often presents with cardiac involvement, with 2 primary underlying pathologies: amyloid light chain- and transthyretin cardiac amyloidosis. Chest pain can occur in both types with variable clinical presentations. This narrative review describes the relationship between cardiac amyloidosis (CA) and chest pain. A PubMed search (June 03. 2024) identified 393 articles related to chest pain in CA. Twenty-eight studies, in English and with full text, were selected. Articles included were case reports, reviews, perfusion- and autopsy studies. In CA patients 10%-20% report chest pain as the initial symptom preceding the diagnosis, and the overall prevalence of chest pain is 38% of patients with CA and it is related to an increased risk of heart failure hospitalization. The mechanisms leading to chest pain in CA patients include increased left ventricular diastolic pressure, infiltration of amyloid fibrils inside and around coronary arteries, and amyloid compression of the microvasculature. The mechanisms commonly lead to elevations of plasma troponin levels, which are higher in amyloid patients with chest pain compared to amyloid patients without chest pain. Symptomatic treatment of chest pain can be challenging due to the low tolerability of medical therapy and poor outcomes of coronary interventions in alleviating the pain and with a higher rate of complications. Our review underscores the importance of recognizing chest pain as a CA symptom, particularly in the elderly. Persistent troponin elevation without coronary artery disease could indicate CA. Screening-based and longitudinal studies are crucial for understanding the relationship between chest pain and CA. Acknowledging the significance of chest pain in CA may facilitate early intervention and improve patient outcomes.
淀粉样变性是一种影响多个器官的全身性疾病，通常表现为心脏受累，有两种主要的潜在病理：淀粉样轻链和转淀粉样蛋白心脏淀粉样变性。两种类型均可出现胸痛，临床表现各不相同。本综述描述了 CA 与胸痛之间的关系。通过 PubMed 搜索（2024 年 6 月 3 日）发现了 393 篇与 CA 胸痛相关的文章。其中 28 篇为英文全文。文章包括病例报告、综述、灌注研究和尸检研究。在 CA 患者中，10%-20% 的患者在确诊前将胸痛作为最初的症状，CA 患者胸痛的总体发病率为 38%，并且与心力衰竭住院风险的增加有关。导致 CA 患者胸痛的机制包括左心室舒张压升高、淀粉样蛋白纤维浸润冠状动脉内部和周围以及淀粉样蛋白压迫微血管。这些机制通常会导致血浆肌钙蛋白水平升高，与无胸痛的淀粉样变性患者相比，有胸痛的淀粉样变性患者的肌钙蛋白水平更高。由于药物治疗的耐受性低，冠状动脉介入治疗在缓解疼痛方面效果不佳，且并发症发生率较高，因此胸痛的对症治疗具有挑战性。我们的综述强调了将胸痛视为 CA 症状的重要性，尤其是在老年人中。在没有冠状动脉疾病的情况下，肌钙蛋白持续升高可能预示着冠心病。以筛查为基础的纵向研究对于了解胸痛与 CA 之间的关系至关重要。认识到胸痛在 CA 中的重要性可促进早期干预并改善患者预后。
{"title":"Chest pain and coronary artery disease in cardiac amyloidosis: Prevalence, mechanisms, and clinical implications","authors":"Navid Noory MD , Oscar Westin MD, PhD , Mathew S. Maurer MD , Emil Fosbøl MD, PhD , Finn Gustafsson MD, PhD, DMSc","doi":"10.1016/j.ahj.2024.11.004","DOIUrl":"10.1016/j.ahj.2024.11.004","url":null,"abstract":"<div><div>Amyloidosis is a systemic disease affecting multiple organs, and often presents with cardiac involvement, with 2 primary underlying pathologies: amyloid light chain- and transthyretin cardiac amyloidosis. Chest pain can occur in both types with variable clinical presentations. This narrative review describes the relationship between cardiac amyloidosis (CA) and chest pain. A PubMed search (June 03. 2024) identified 393 articles related to chest pain in CA. Twenty-eight studies, in English and with full text, were selected. Articles included were case reports, reviews, perfusion- and autopsy studies. In CA patients 10%-20% report chest pain as the initial symptom preceding the diagnosis, and the overall prevalence of chest pain is 38% of patients with CA and it is related to an increased risk of heart failure hospitalization. The mechanisms leading to chest pain in CA patients include increased left ventricular diastolic pressure, infiltration of amyloid fibrils inside and around coronary arteries, and amyloid compression of the microvasculature. The mechanisms commonly lead to elevations of plasma troponin levels, which are higher in amyloid patients with chest pain compared to amyloid patients without chest pain. Symptomatic treatment of chest pain can be challenging due to the low tolerability of medical therapy and poor outcomes of coronary interventions in alleviating the pain and with a higher rate of complications. Our review underscores the importance of recognizing chest pain as a CA symptom, particularly in the elderly. Persistent troponin elevation without coronary artery disease could indicate CA. Screening-based and longitudinal studies are crucial for understanding the relationship between chest pain and CA. Acknowledging the significance of chest pain in CA may facilitate early intervention and improve patient outcomes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 52-59"},"PeriodicalIF":3.7,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643263","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 : 2024-11-13DOI: 10.1016/j.ahj.2024.11.003
Bishoy Abraham MD , Mustafa Suppah MD , Juan Farina MD , Michael Botros MD , Ayman Fath MD , Sara Kaldas MD , Michael Megaly MD , Chieh-Ju Chao MD , Reza Arsanjani MD , Chadi Ayoub MD , F. David Fortuin MD , John Sweeney MD , Patricia Pellikka MD , Vuyisile Nkomo MD , Mohamad Alkhouli MD , David Holmes Jr MD , Amr Badr MD , Said Alsidawi MD
<div><h3>Background</h3><div>Tricuspid regurgitation (TR) and mitral regurgitation (MR) are common valvular conditions encountered in patients undergoing transcatheter aortic valve replacement (TAVR). This retrospective study investigates the impact of moderate or severe TR and MR on all-cause mortality in 1-year post-TAVR patients.</div></div><div><h3>Methods</h3><div>Consecutive patients who underwent TAVR at the 3 academic tertiary care centers in our health system between 2012 and 2018 were identified. Patients were stratified into 2 groups based on valvular regurgitation severity: moderate/severe MR vs no/mild MR, and moderate/severe TR vs no/mild TR. Primary outcome was all-cause mortality at 1-year and 5-year follow up, and secondary outcome was in-hospital death. Logistic regression analysis was conducted to assess the relationship between moderate/severe MR or TR and all-cause mortality at 1-year and 5-year follow-up.</div></div><div><h3>Results</h3><div>We included a total of 1,071 patients who underwent TAVR with mean age 80.9 ± 8.6 years, 97% white, and 58.3% males. Moderate or severe MR group included 52 (4.88%) patients while mild or no MR group included 1,015 (95.12%) patients. There was no significant difference between both groups in TAVR procedure success rate (100% vs 97.83%, <em>P</em> = .283), in-hospital mortality (0 vs 1.08%, <em>P</em> = .450), or mortality at 1-year follow up (15.38% vs 14.09%, <em>P</em> = .794). At 5-year follow up, moderate/severe MR group had higher mortality (61.4% vs 49.5%, <em>P</em> = .046). In multivariable logistic regression analysis, moderate or severe MR did not show significant correlation with all-cause mortality at 1-year and 5-year follow up. Moderate or severe TR group included 86 (8.03%) patients while mild or no TR group included 985 (91.97%) patients. There was no difference between both groups in TAVR procedure success (98.8% vs 97.9%, <em>P</em> = .54) or in-hospital mortality (0% vs 1.1%, <em>P</em> = .33). At 1-year follow up, patients with moderate or severe TR had higher mortality (26.7% vs 13.2%, <em>P</em> = .001) compared to patients with mild or no TR. Same finding was noted with extended follow up at 5-years (68.3% vs 48.7%, <em>P</em> < .001). In multivariable cox regression analysis, moderate/severe TR was associated with higher all-cause mortality at 1-year (OR 1.94, 95% CI [01.09, 3.44], <em>P</em> = .023) and at 5-year (OR 1.46, 95% CI [1.092, 1.952], <em>P</em> = .011) follow up. Patients with combined moderate/severe MR and TR have even higher mortality compared to either moderate/severe valve regurgitation alone or mild/no valve regurgitation at 5-year follow up.</div></div><div><h3>Conclusion</h3><div>At long term follow up, moderate/severe TR, but not MR, is associated with higher mortality in patients underwent TAVR. Combined moderate/severe TR and MR had even worse mortality. Careful assessment of multivalvular heart disease prior to the procedure is warrante
背景：三尖瓣反流（TR）和二尖瓣反流（MR）是经导管主动脉瓣置换术（TAVR）患者常见的瓣膜疾病。这项回顾性研究调查了中度或重度TR和MR对TAVR术后一年患者全因死亡率的影响：确定了 2012 年至 2018 年期间在我们医疗系统的 3 个学术三级护理中心接受 TAVR 的连续患者。根据瓣膜返流严重程度将患者分为两组：中度/重度 MR 与无/轻度 MR，以及中度/重度 TR 与无/轻度 TR。主要结果是随访1年和5年时的全因死亡率，次要结果是院内死亡。我们进行了逻辑回归分析，以评估中度/重度MR或TR与随访1年和5年的全因死亡率之间的关系：我们共纳入了 1071 名接受 TAVR 的患者，他们的平均年龄为 80.9 ± 8.6 岁，97% 为白人，58.3% 为男性。中度或重度 MR 组包括 52 名患者（4.88%），而轻度或无 MR 组包括 1,015 名患者（95.12%）。两组患者在TAVR手术成功率（100% vs. 97.83%，P=0.283）、院内死亡率（0 vs. 1.08%，P=0.450）或1年随访死亡率（15.38% vs. 14.09%，P=0.794）方面无明显差异。在 5 年随访中，中度/重度 MR 组死亡率更高（61.4% 对 49.5%，P=0.046）。在多变量逻辑回归分析中，中度或重度MR与随访1年和5年的全因死亡率无显著相关性。中度或重度TR组包括86名患者（8.03%），而轻度或无TR组包括985名患者（91.97%）。两组在TAVR手术成功率（98.8% vs. 97.9%，P=0.54）和院内死亡率（0% vs. 1.1%，P=0.33）方面没有差异。在1年的随访中，中度或重度TR患者的死亡率（26.7% vs. 13.2%，p=0.001）高于轻度或无TR患者。在延长随访 5 年后也发现了同样的情况（68.3% 对 48.7%，P=0.001）：在长期随访中，中度/重度TR与接受TAVR的患者死亡率升高有关，但与MR无关。合并中度/重度TR和MR的死亡率更低。手术前应仔细评估多瓣膜心脏病。
{"title":"Impact of moderate or severe mitral and tricuspid valves regurgitation after transcatheter aortic valve replacement","authors":"Bishoy Abraham MD , Mustafa Suppah MD , Juan Farina MD , Michael Botros MD , Ayman Fath MD , Sara Kaldas MD , Michael Megaly MD , Chieh-Ju Chao MD , Reza Arsanjani MD , Chadi Ayoub MD , F. David Fortuin MD , John Sweeney MD , Patricia Pellikka MD , Vuyisile Nkomo MD , Mohamad Alkhouli MD , David Holmes Jr MD , Amr Badr MD , Said Alsidawi MD","doi":"10.1016/j.ahj.2024.11.003","DOIUrl":"10.1016/j.ahj.2024.11.003","url":null,"abstract":"<div><h3>Background</h3><div>Tricuspid regurgitation (TR) and mitral regurgitation (MR) are common valvular conditions encountered in patients undergoing transcatheter aortic valve replacement (TAVR). This retrospective study investigates the impact of moderate or severe TR and MR on all-cause mortality in 1-year post-TAVR patients.</div></div><div><h3>Methods</h3><div>Consecutive patients who underwent TAVR at the 3 academic tertiary care centers in our health system between 2012 and 2018 were identified. Patients were stratified into 2 groups based on valvular regurgitation severity: moderate/severe MR vs no/mild MR, and moderate/severe TR vs no/mild TR. Primary outcome was all-cause mortality at 1-year and 5-year follow up, and secondary outcome was in-hospital death. Logistic regression analysis was conducted to assess the relationship between moderate/severe MR or TR and all-cause mortality at 1-year and 5-year follow-up.</div></div><div><h3>Results</h3><div>We included a total of 1,071 patients who underwent TAVR with mean age 80.9 ± 8.6 years, 97% white, and 58.3% males. Moderate or severe MR group included 52 (4.88%) patients while mild or no MR group included 1,015 (95.12%) patients. There was no significant difference between both groups in TAVR procedure success rate (100% vs 97.83%, <em>P</em> = .283), in-hospital mortality (0 vs 1.08%, <em>P</em> = .450), or mortality at 1-year follow up (15.38% vs 14.09%, <em>P</em> = .794). At 5-year follow up, moderate/severe MR group had higher mortality (61.4% vs 49.5%, <em>P</em> = .046). In multivariable logistic regression analysis, moderate or severe MR did not show significant correlation with all-cause mortality at 1-year and 5-year follow up. Moderate or severe TR group included 86 (8.03%) patients while mild or no TR group included 985 (91.97%) patients. There was no difference between both groups in TAVR procedure success (98.8% vs 97.9%, <em>P</em> = .54) or in-hospital mortality (0% vs 1.1%, <em>P</em> = .33). At 1-year follow up, patients with moderate or severe TR had higher mortality (26.7% vs 13.2%, <em>P</em> = .001) compared to patients with mild or no TR. Same finding was noted with extended follow up at 5-years (68.3% vs 48.7%, <em>P</em> < .001). In multivariable cox regression analysis, moderate/severe TR was associated with higher all-cause mortality at 1-year (OR 1.94, 95% CI [01.09, 3.44], <em>P</em> = .023) and at 5-year (OR 1.46, 95% CI [1.092, 1.952], <em>P</em> = .011) follow up. Patients with combined moderate/severe MR and TR have even higher mortality compared to either moderate/severe valve regurgitation alone or mild/no valve regurgitation at 5-year follow up.</div></div><div><h3>Conclusion</h3><div>At long term follow up, moderate/severe TR, but not MR, is associated with higher mortality in patients underwent TAVR. Combined moderate/severe TR and MR had even worse mortality. Careful assessment of multivalvular heart disease prior to the procedure is warrante","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 79-88"},"PeriodicalIF":3.7,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612449","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 : 2024-11-12DOI: 10.1016/j.ahj.2024.10.018
Masaaki Nakase MD , Daijiro Tomii MD , Annette Maznyczka MD, PhD, MSc, BSc , Dik Heg PhD , Taishi Okuno MD , Daryoush Samim MD , Stefan Stortecky MD, MPH , Jonas Lanz MD, MSc , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc
Background
The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown.
Objectives
We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable vs. self-expanding THVs.
Methods
In a retrospective analysis from the Bern TAVI registry, patients with LVEF <50% who underwent TAVI with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups.
Results
A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P < .001) and a higher incidence of ≥mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P < .001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, HRadjusted: 1.44; 95% CI: 1.02-2.03; P = .037). There were no significant differences in other clinical outcomes up to 5 years between groups.
Conclusions
In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.
{"title":"Five‐year outcomes with self‐expanding versus balloon‐expandable TAVI in patients with left ventricular systolic dysfunction","authors":"Masaaki Nakase MD , Daijiro Tomii MD , Annette Maznyczka MD, PhD, MSc, BSc , Dik Heg PhD , Taishi Okuno MD , Daryoush Samim MD , Stefan Stortecky MD, MPH , Jonas Lanz MD, MSc , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc","doi":"10.1016/j.ahj.2024.10.018","DOIUrl":"10.1016/j.ahj.2024.10.018","url":null,"abstract":"<div><h3>Background</h3><div>The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown.</div></div><div><h3>Objectives</h3><div>We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable vs. self-expanding THVs.</div></div><div><h3>Methods</h3><div>In a retrospective analysis from the Bern TAVI registry, patients with LVEF <50% who underwent TAVI with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups.</div></div><div><h3>Results</h3><div>A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; <em>P</em> < .001) and a higher incidence of ≥mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; <em>P</em> < .001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, HR<sub>adjusted</sub>: 1.44; 95% CI: 1.02-2.03; <em>P</em> = .037). There were no significant differences in other clinical outcomes up to 5 years between groups.</div></div><div><h3>Conclusions</h3><div>In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>https://www.clinicaltrials.gov</span><svg><path></path></svg></span>. NCT01368250.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 18-29"},"PeriodicalIF":3.7,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612447","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 : 2024-11-12DOI: 10.1016/j.ahj.2024.10.017
Ming Yang MD, PhD , Jie Xu MD, PhD , Jing Xue MD , Yuesong Pan PhD , Aichun Cheng MD , Feng Gao MD , Xia Meng MD , Zhongrong Miao MD , Yilong Wang MD , Yongjun Wang MD , CHANCE Investigators
Background
Both high-sensitive C-reactive protein (hsCRP) and CYP2C19 genotypes are independent predictors of clinical outcomes after ischemic stroke. We aim to evaluate the association of CYP2C19 loss-of-function alleles (LoFA) carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels using the CHANCE trial.
Methods
Subjects with both of CYP2C19 major alleles information (*2, *3, and *17) and hsCRP measurements were enrolled from the prespecified subgroup. CYP2C19 LoFA carriers were defined as patients with either*2 or *3 allele. Cox proportional hazards models were used to assess the interaction of CYP2C19 LoFA carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels. The primary outcome was recurrent stroke within 90 days.
Results
Among 2,801 patients, 1,646 (58.8%) were LoFA carriers, and 922 (32.9%) had elevated hsCRP. In patients with nonelevated hsCRP, there was a significant interaction effect between CYP2C19 LoFA carrying status and dual/single antiplatelet regimens for prevention of recurrent stroke and combined vascular events (P = .048, .048, respectively), but, not in patients with elevated hsCRP (P = .502, .472, respectively). Only among patients with nonelevated hsCRP and noncarrier of CYP2C19 LoFA, dual antiplatelets significantly reduced the risk of recurrent stroke compared with aspirin alone (hazard ratio = 0.44 [0.26-0.74], P = .003). No significant differences in bleeding were found.
Conclusions
Nonelevated hsCRP and noncarrier of CYP2C19 LoFA may predict a better response to dual antiplatelet therapy in reducing stroke recurrence and composite vascular events for patients with minor stroke and high-risk TIA.
{"title":"Efficacy of dual antiplatelet therapy after ischemic stroke according to hsCRP levels and CYP2C19 genotype","authors":"Ming Yang MD, PhD , Jie Xu MD, PhD , Jing Xue MD , Yuesong Pan PhD , Aichun Cheng MD , Feng Gao MD , Xia Meng MD , Zhongrong Miao MD , Yilong Wang MD , Yongjun Wang MD , CHANCE Investigators","doi":"10.1016/j.ahj.2024.10.017","DOIUrl":"10.1016/j.ahj.2024.10.017","url":null,"abstract":"<div><h3>Background</h3><div>Both high-sensitive C-reactive protein (hsCRP) and <em>CYP2C19</em> genotypes are independent predictors of clinical outcomes after ischemic stroke. We aim to evaluate the association of <em>CYP2C19</em> loss-of-function alleles (LoFA) carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels using the CHANCE trial.</div></div><div><h3>Methods</h3><div>Subjects with both of <em>CYP2C19</em> major alleles information (<em>*2, *3</em>, and <em>*17</em>) and hsCRP measurements were enrolled from the prespecified subgroup. <em>CYP2C19</em> LoFA carriers were defined as patients with either<em>*2</em> or <em>*3</em> allele. Cox proportional hazards models were used to assess the interaction of <em>CYP2C19</em> LoFA carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels. The primary outcome was recurrent stroke within 90 days.</div></div><div><h3>Results</h3><div>Among 2,801 patients, 1,646 (58.8%) were LoFA carriers, and 922 (32.9%) had elevated hsCRP. In patients with nonelevated hsCRP, there was a significant interaction effect between <em>CYP2C19</em> LoFA carrying status and dual/single antiplatelet regimens for prevention of recurrent stroke and combined vascular events (<em>P</em> = .048, .048, respectively), but, not in patients with elevated hsCRP (<em>P</em> = .502, .472, respectively). Only among patients with nonelevated hsCRP and noncarrier of <em>CYP2C19</em> LoFA, dual antiplatelets significantly reduced the risk of recurrent stroke compared with aspirin alone (hazard ratio = 0.44 [0.26-0.74], <em>P</em> = .003). No significant differences in bleeding were found.</div></div><div><h3>Conclusions</h3><div>Nonelevated hsCRP and noncarrier of <em>CYP2C19</em> LoFA may predict a better response to dual antiplatelet therapy in reducing stroke recurrence and composite vascular events for patients with minor stroke and high-risk TIA.</div></div><div><h3>Trial Registration</h3><div>clinicaltrials.gov Identifier: NCT00979589</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"280 ","pages":"Pages 89-97"},"PeriodicalIF":3.7,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612446","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}
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