Pub Date : 2025-01-25DOI: 10.1016/j.ahj.2025.01.011
Thanat Chaikijurajai MD , Horng H. Chen MBBCh , W.H. Wilson Tang MD
Background
We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction.
Methods
Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels.
Results
Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP nonresponse score was 0.72 (95% CI, 0.67-0.77). After adjusting for covariates, only NNRS (P = .044) and KCCQ-OSS (P = .002) remained predictive for NT-proBNP nonresponse at 12 months.
Conclusion
NT-proBNP nonresponse score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.
{"title":"Baseline NT-proBNP nonresponse score and health status measures in assessing treatment responses in heart failure with reduced ejection fraction","authors":"Thanat Chaikijurajai MD , Horng H. Chen MBBCh , W.H. Wilson Tang MD","doi":"10.1016/j.ahj.2025.01.011","DOIUrl":"10.1016/j.ahj.2025.01.011","url":null,"abstract":"<div><h3>Background</h3><div>We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction.</div></div><div><h3>Methods</h3><div>Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels.</div></div><div><h3>Results</h3><div>Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP nonresponse score was 0.72 (95% CI, 0.67-0.77). After adjusting for covariates, only NNRS (<em>P</em> = .044) and KCCQ-OSS (<em>P</em> = .002) remained predictive for NT-proBNP nonresponse at 12 months.</div></div><div><h3>Conclusion</h3><div>NT-proBNP nonresponse score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 17-25"},"PeriodicalIF":3.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051375","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 : 2025-01-23DOI: 10.1016/j.ahj.2025.01.010
David E. Kandzari MD , Azeem Latib MD , Darren Mylotte MD, PhD , Ziad A. Ali MD, DPhil , Azfar Zaman MD , Sandeep Brar MD , Maria Parke MS , Bruno Scheller MD
Background and Rationale
In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels.
Trial Design
Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (AgentTM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.
Conclusions
The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.
Trial Registration
Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.
{"title":"Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease","authors":"David E. Kandzari MD , Azeem Latib MD , Darren Mylotte MD, PhD , Ziad A. Ali MD, DPhil , Azfar Zaman MD , Sandeep Brar MD , Maria Parke MS , Bruno Scheller MD","doi":"10.1016/j.ahj.2025.01.010","DOIUrl":"10.1016/j.ahj.2025.01.010","url":null,"abstract":"<div><h3>Background and Rationale</h3><div>In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) <em>de novo</em> lesions in small vessels.</div></div><div><h3>Trial Design</h3><div>Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (Agent<sup>TM</sup>, Boston Scientific Corporation, Natick MA), and (2) patients with <em>de novo</em> small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.</div></div><div><h3>Conclusions</h3><div>The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and <em>de novo</em> small vessel lesions.</div></div><div><h3>Trial Registration</h3><div>Prevail Global, NCT06535854, is registered at <span><span>https://clinicaltrials.gov/study/NCT06535854</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 26-36"},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035976","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 : 2025-01-23DOI: 10.1016/j.ahj.2025.01.008
Moein Ebrahimi MD , Gregg C. Fonarow MD
{"title":"Higher levels of glucose within the normal range and cardiovascular risk: A landscape beyond diabetes and prediabetes","authors":"Moein Ebrahimi MD , Gregg C. Fonarow MD","doi":"10.1016/j.ahj.2025.01.008","DOIUrl":"10.1016/j.ahj.2025.01.008","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 1-4"},"PeriodicalIF":3.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035975","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 : 2025-01-18DOI: 10.1016/j.ahj.2025.01.007
Stephen Balter PhD , Jeffrey Moses MD , Kais Hyasat MBBS , Michael Collins MD , Ajay Kirtane MD , Margaret McEntegart MD, PhD , Leroy E Rabbani MD , Gasmelseed Y Ahmed MD, PhD
Background
This retrospective study addresses the role of operator and fluoroscopy equipment in reducing patient radiation exposure in the Cath lab.
Methods
Data from 99,400 procedures performed in our institution between 2007 and 2019 were reviewed. Dosimetric parameters included reference point air kerma (Ka,r), Kerma Area Product (PKA), fluoroscopic time, and contrast volume. Results are characterized by their 50th and 99th percentiles. Data from a subset of fluoroscopes that were in continuous use and a subset of operators who used the same “continuous” fluoroscope in every year of the study were also analyzed.
Results
For all procedures, median Ka,r declined by 63%, from 1.5 to 0.5Gy; 99th percentiles declined by 44%, from 8.6 to 4.8Gy. For the 3 “continuous fluoroscopes” median Ka,r declined by 60% from 1.6 to 0.6Gy; 99th percentile by 52% from 9.1 to 4.4Gy. The all-procedure median contrast volume declined by 53%, from 150 to 70ml; 99th percentile by 42% from 600 to 350ml. The all-procedure median fluoroscopy time declined by 2%; the 99th percentile increased by 32%. In the continuous subset, median fluoroscopy time declined by 20%; 99th percentile increased by 5%. For the operator's subset, the median Ka,r declined by 43% (P = .0362); the 99th percentile decreased by 22% (P = .0481). Substantial radiation dose procedures decreased from 7% to 0.8% of the procedure volume.
Conclusions
There was a significant reduction in patient radiation (Ka,r and PKA) and contrast volume during the study period driven by systematic and operator practice changes.
{"title":"Evolving operator practices reduced patient radiation dose in interventional cardiology: Trends in a single center","authors":"Stephen Balter PhD , Jeffrey Moses MD , Kais Hyasat MBBS , Michael Collins MD , Ajay Kirtane MD , Margaret McEntegart MD, PhD , Leroy E Rabbani MD , Gasmelseed Y Ahmed MD, PhD","doi":"10.1016/j.ahj.2025.01.007","DOIUrl":"10.1016/j.ahj.2025.01.007","url":null,"abstract":"<div><h3>Background</h3><div>This retrospective study addresses the role of operator and fluoroscopy equipment in reducing patient radiation exposure in the Cath lab.</div></div><div><h3>Methods</h3><div>Data from 99,400 procedures performed in our institution between 2007 and 2019 were reviewed. Dosimetric parameters included reference point air kerma (K<sub>a,r</sub>), Kerma Area Product (P<sub>KA</sub>), fluoroscopic time, and contrast volume. Results are characterized by their 50th and 99th percentiles. Data from a subset of fluoroscopes that were in continuous use and a subset of operators who used the same “continuous” fluoroscope in every year of the study were also analyzed.</div></div><div><h3>Results</h3><div>For all procedures, median K<sub>a,r</sub> declined by 63%, from 1.5 to 0.5Gy; 99th percentiles declined by 44%, from 8.6 to 4.8Gy. For the 3 “continuous fluoroscopes” median K<sub>a,r</sub> declined by 60% from 1.6 to 0.6Gy; 99th percentile by 52% from 9.1 to 4.4Gy. The all-procedure median contrast volume declined by 53%, from 150 to 70ml; 99th percentile by 42% from 600 to 350ml. The all-procedure median fluoroscopy time declined by 2%; the 99th percentile increased by 32%. In the continuous subset, median fluoroscopy time declined by 20%; 99th percentile increased by 5%. For the operator's subset, the median K<sub>a,r</sub> declined by 43% (<em>P</em> = .0362); the 99th percentile decreased by 22% (<em>P</em> = .0481). Substantial radiation dose procedures decreased from 7% to 0.8% of the procedure volume.</div></div><div><h3>Conclusions</h3><div>There was a significant reduction in patient radiation (K<sub>a,r</sub> and P<sub>KA</sub>) and contrast volume during the study period driven by systematic and operator practice changes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"283 ","pages":"Pages 5-16"},"PeriodicalIF":3.7,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998798","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 : 2025-01-17DOI: 10.1016/j.ahj.2025.01.005
Andrea R. Hsu BS , Snigdha Karnakoti MBBS , Ahmed T. Abdelhalim MBBS , William R. Miranda MD , Heidi M. Connolly MD , Joseph A. Dearani MD , Daniel C. DeSimone MD , Alexander C. Egbe MD, MPH
Background
Patients with congenital heart disease (CHD) often require prosthetic valve implantation, increasing their lifetime risk of developing prosthetic valve endocarditis (PVE). The purpose of this study was to determine the incidence, risk factors, and outcomes of PVE in adults with CHD.
Method
Retrospective cohort study of adults with CHD and prior prosthetic valve implantation (2003-2023). Patients diagnosed with PVE were designated as the PVE group, while the patients without PVE were designated as the reference group.
Results
Of 9161 patients, 3150 (34%) had prosthetic valves. Among the patients with prosthetic valve, 86 (2.7%) developed PVE, yielding an incidence of 5.2 (95% confidence interval [CI] 4.8-1-5.6) events per 1000 patient-years. Of the 86 patients with PVE, the average age at the time of PVE diagnosis was 35 ± 9 years, the average interval between prosthetic valve implantation and PVE was 91 ± 27 months, and mean duration of follow-up with11.6 ± 4.9 years. The risk factors for PVE were male sex, younger age, type 2 diabetes, multiple prosthetic valves, and Melody bioprosthetic valve implantation. PVE was associated with more than a 2-fold increase in all-cause mortality (adjusted hazard ratio 2.21, 95% CI 1.33-3.68, P = .002), after adjustment for demographic/anatomic indices, and comorbidities. Of 86 patients with PVE, 21 (24%) died during follow-up. The 30-day, 1-year, and 5-year mortality after diagnosis of PVE was 1.6%, 12% and 15%, respectively. Of 86 patients, 39 (45%) developed 47 PVE-related complications (perivalvular abscess[(n = 21], and septic emboli [n = 26]). PVE-related complications were associated with all-cause mortality.
Conclusions
PVE was common in CHD patients with prosthetic valves and was associated with all-cause mortality. These findings highlight the prognostic implications of prosthetic valve implantation in patients with CHD, and the need for new criteria for risk stratification in order to improve outcomes.
背景:先天性心脏病(CHD)患者经常需要人工瓣膜植入术,这增加了他们一生中发生人工瓣膜心内膜炎(PVE)的风险。本研究的目的是确定成人冠心病患者PVE的发病率、危险因素和结局。方法:回顾性队列研究2003-2023年成人冠心病患者人工心脏瓣膜置换术。诊断为PVE的患者为PVE组,未诊断为PVE的患者为参照组。结果:9161例患者中,3150例(34%)采用人工瓣膜。在植入人工瓣膜的患者中,86例(2.7%)发生PVE,发生率为5.2(95%可信区间[CI] 4.8-1-5.6) / 1000患者年。86例PVE患者诊断时平均年龄为35±9岁,人工瓣膜置入术至PVE的平均间隔为91±27个月,平均随访时间为11.6±4.9年。发生PVE的危险因素为男性、低龄、2型糖尿病、多瓣膜置换术和Melody生物瓣膜置换术。经人口统计学/解剖学指标和合并症校正后,PVE与全因死亡率增加2倍以上相关(校正风险比2.21,95% CI 1.33-3.68, p=0.002)。86例PVE患者中,21例(24%)在随访期间死亡。PVE诊断后30天、1年和5年死亡率分别为1.6%、12%和15%。86例患者中,39例(45%)出现47例pve相关并发症(瓣膜周围脓肿[n= 21],脓毒性栓塞[n=26])。pve相关并发症与全因死亡率相关。结论:PVE在植入人工瓣膜的冠心病患者中很常见,并与全因死亡率相关。这些发现强调了人工瓣膜置入术对冠心病患者预后的影响,以及需要新的风险分层标准以改善预后。
{"title":"Incidence and outcomes of prosthetic valve endocarditis in adults with congenital heart disease","authors":"Andrea R. Hsu BS , Snigdha Karnakoti MBBS , Ahmed T. Abdelhalim MBBS , William R. Miranda MD , Heidi M. Connolly MD , Joseph A. Dearani MD , Daniel C. DeSimone MD , Alexander C. Egbe MD, MPH","doi":"10.1016/j.ahj.2025.01.005","DOIUrl":"10.1016/j.ahj.2025.01.005","url":null,"abstract":"<div><h3>Background</h3><div>Patients with congenital heart disease (CHD) often require prosthetic valve implantation, increasing their lifetime risk of developing prosthetic valve endocarditis (PVE). The purpose of this study was to determine the incidence, risk factors, and outcomes of PVE in adults with CHD.</div></div><div><h3>Method</h3><div>Retrospective cohort study of adults with CHD and prior prosthetic valve implantation (2003-2023). Patients diagnosed with PVE were designated as the PVE group, while the patients without PVE were designated as the reference group.</div></div><div><h3>Results</h3><div>Of 9161 patients, 3150 (34%) had prosthetic valves. Among the patients with prosthetic valve, 86 (2.7%) developed PVE, yielding an incidence of 5.2 (95% confidence interval [CI] 4.8-1-5.6) events per 1000 patient-years. Of the 86 patients with PVE, the average age at the time of PVE diagnosis was 35 ± 9 years, the average interval between prosthetic valve implantation and PVE was 91 ± 27 months, and mean duration of follow-up with11.6 ± 4.9 years. The risk factors for PVE were male sex, younger age, type 2 diabetes, multiple prosthetic valves, and Melody bioprosthetic valve implantation. PVE was associated with more than a 2-fold increase in all-cause mortality (adjusted hazard ratio 2.21, 95% CI 1.33-3.68, <em>P</em> = .002), after adjustment for demographic/anatomic indices, and comorbidities. Of 86 patients with PVE, 21 (24%) died during follow-up. The 30-day, 1-year, and 5-year mortality after diagnosis of PVE was 1.6%, 12% and 15%, respectively. Of 86 patients, 39 (45%) developed 47 PVE-related complications (perivalvular abscess[(<em>n</em> = 21], and septic emboli [<em>n</em> = 26]). PVE-related complications were associated with all-cause mortality.</div></div><div><h3>Conclusions</h3><div>PVE was common in CHD patients with prosthetic valves and was associated with all-cause mortality. These findings highlight the prognostic implications of prosthetic valve implantation in patients with CHD, and the need for new criteria for risk stratification in order to improve outcomes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 125-133"},"PeriodicalIF":3.7,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998799","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 : 2025-01-17DOI: 10.1016/j.ahj.2025.01.009
Gerard T. Portela PhD , Gregory Ducrocq MD , Marnie Bertolet PhD , John H. Alexander MD, MHS , Shaun G. Goodman MD , Simone Glynn MD, MPH, MSc , Jordan B. Strom MD, MSc , Sonja A. Swanson ScD , Gilles Lemesle MD , Sunil V. Rao MD , Meechai Tessalee MD , Tamar S. Polonsky MD, MSCI , Michael Goldfarb MD, MSc , Jay H. Traverse MD, ME , Lynne Uhl MD , Brandon M. Herbert MPH, PhD , Johanne Silvain MD, PhD , Jeffrey L. Carson MD , Maria M. Brooks PhD , MINT Trial Investigators
Background
Risk-benefit tradeoffs between restrictive versus liberal red blood cell transfusion strategies may vary across individuals. This exploratory analysis aimed to derive and evaluate individualized treatment effects of defined transfusion strategies in patients with acute MI and anemia with the goal of minimizing adverse cardiovascular outcomes.
Methods
This study analyzed 3,447 (98.4%) patients randomized in the MINT (Myocardial Ischemia and Transfusion) trial between April 2017 to April 2023. Outcomes for this analysis included 30-day death or recurrent MI, death, and major adverse cardiovascular events (MACE, a composite of death, MI, stroke, and ischemia-driven unscheduled revascularization). Machine learning methods were used to identify baseline patient characteristics that informed the individualized treatment effect of a restrictive versus liberal transfusion strategy for each patient. The expected population risk of an outcome under a scenario in which patients received their optimal treatment, as indicated by the individualized treatment effect, was contrasted with expected risks for universally applying a restrictive strategy or a liberal strategy to all patients.
Results
Baseline characteristics did not inform individualized treatment effects on 30-day death and death or MI, suggesting minimal heterogeneity in treatment effect on these outcomes. An algorithm for estimating the individualized treatment effect on 30-day MACE included 12 baseline factors. If all patients received the optimal treatment as indicated by their estimated individualized treatment effect, the predicted risk of 30-day MACE in the sample population was 15.2% (95% CI 14.2%-16.2%). This corresponded to 4.0 (difference: −4.0%, 95% CI −5.8, −2.1) and 2.3 (difference: −2.3%, 95% CI −3.7, −0.9) percentage point risk reductions compared to applying a restrictive or liberal strategy to everyone respectively.
Conclusions
The MINT trial average treatment effect, favoring a liberal strategy, may be optimal to minimize risk of 30-day death and death or MI for acute MI patients with anemia represented in the MINT sample as no individualized treatment effects were estimated on these outcomes. However, individualized transfusion strategy decisions have potential to reduce risk of 30-day MACE. External validation of the MACE algorithm is required before clinical use.
背景:限制与自由红细胞输血策略之间的风险-收益权衡可能因个体而异。本探索性分析旨在得出并评估明确的输血策略对急性心肌梗死和贫血患者的个体化治疗效果,以最大限度地减少不良心血管结局。方法:本研究分析了2017年4月至2023年4月在MINT(心肌缺血和输血)试验中随机分配的3447例(98.4%)患者。该分析的结果包括30天死亡或复发性心肌梗死、死亡和主要不良心血管事件(MACE,死亡、心肌梗死、中风和缺血驱动的非计划性血运重建的复合)。使用机器学习方法来确定基线患者特征,这些特征为每位患者提供了限制性和自由输血策略的个性化治疗效果。个体治疗效果表明,在患者接受最佳治疗的情况下,结果的预期人群风险与对所有患者普遍应用限制性策略或自由策略的预期风险进行对比。结果:基线特征并没有告诉个体化治疗对30天死亡和死亡或心肌梗死的影响,表明治疗对这些结果的影响具有最小的异质性。估计30天MACE个体化治疗效果的算法包括12个基线因素。如果所有患者都接受了根据其估计的个体化治疗效果所指示的最佳治疗,则样本人群中30天MACE的预测风险为15.2% (95% CI 14.2%至16.2%)。与对每个人分别应用限制性或自由策略相比,这对应于4.0(差异:-4.0%,95% CI -5.8, -2.1)和2.3(差异:-2.3%,95% CI -3.7, -0.9)个百分点的风险降低。结论:MINT试验的平均治疗效果倾向于自由策略,对于MINT样本中伴有贫血的急性心肌梗死患者的30天死亡和死亡或心肌梗死的风险可能是最佳的,因为没有估计个体化治疗效果对这些结果的影响。然而,个性化的输血策略决策有可能降低30天MACE的风险。MACE算法在临床使用前需要进行外部验证。试验注册:ClinicalTrials.gov, NCT02981407, https://clinicaltrials.gov/study/NCT02981407。
{"title":"Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia","authors":"Gerard T. Portela PhD , Gregory Ducrocq MD , Marnie Bertolet PhD , John H. Alexander MD, MHS , Shaun G. Goodman MD , Simone Glynn MD, MPH, MSc , Jordan B. Strom MD, MSc , Sonja A. Swanson ScD , Gilles Lemesle MD , Sunil V. Rao MD , Meechai Tessalee MD , Tamar S. Polonsky MD, MSCI , Michael Goldfarb MD, MSc , Jay H. Traverse MD, ME , Lynne Uhl MD , Brandon M. Herbert MPH, PhD , Johanne Silvain MD, PhD , Jeffrey L. Carson MD , Maria M. Brooks PhD , MINT Trial Investigators","doi":"10.1016/j.ahj.2025.01.009","DOIUrl":"10.1016/j.ahj.2025.01.009","url":null,"abstract":"<div><h3>Background</h3><div>Risk-benefit tradeoffs between restrictive versus liberal red blood cell transfusion strategies may vary across individuals. This exploratory analysis aimed to derive and evaluate individualized treatment effects of defined transfusion strategies in patients with acute MI and anemia with the goal of minimizing adverse cardiovascular outcomes.</div></div><div><h3>Methods</h3><div>This study analyzed 3,447 (98.4%) patients randomized in the MINT (Myocardial Ischemia and Transfusion) trial between April 2017 to April 2023. Outcomes for this analysis included 30-day death or recurrent MI, death, and major adverse cardiovascular events (MACE, a composite of death, MI, stroke, and ischemia-driven unscheduled revascularization). Machine learning methods were used to identify baseline patient characteristics that informed the individualized treatment effect of a restrictive versus liberal transfusion strategy for each patient. The expected population risk of an outcome under a scenario in which patients received their optimal treatment, as indicated by the individualized treatment effect, was contrasted with expected risks for universally applying a restrictive strategy or a liberal strategy to all patients.</div></div><div><h3>Results</h3><div>Baseline characteristics did not inform individualized treatment effects on 30-day death and death or MI, suggesting minimal heterogeneity in treatment effect on these outcomes. An algorithm for estimating the individualized treatment effect on 30-day MACE included 12 baseline factors. If all patients received the optimal treatment as indicated by their estimated individualized treatment effect, the predicted risk of 30-day MACE in the sample population was 15.2% (95% CI 14.2%-16.2%). This corresponded to 4.0 (difference: −4.0%, 95% CI −5.8, −2.1) and 2.3 (difference: −2.3%, 95% CI −3.7, −0.9) percentage point risk reductions compared to applying a restrictive or liberal strategy to everyone respectively.</div></div><div><h3>Conclusions</h3><div>The MINT trial average treatment effect, favoring a liberal strategy, may be optimal to minimize risk of 30-day death and death or MI for acute MI patients with anemia represented in the MINT sample as no individualized treatment effects were estimated on these outcomes. However, individualized transfusion strategy decisions have potential to reduce risk of 30-day MACE. External validation of the MACE algorithm is required before clinical use.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov, NCT02981407, <span><span>https://clinicaltrials.gov/study/NCT02981407</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 146-155"},"PeriodicalIF":3.7,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998800","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 : 2025-01-17DOI: 10.1016/j.ahj.2025.01.006
Nicole Horn MSc , Laura Gärtner PhD , Ardawan J. Rastan MD , Térezia B. Andrási MD , Juliane Lenz , Andreas Böning MD , Miriam Salzmann-Djufri MD , Ulrike Puvogel MD , Bernd Niemann MD , Maria Genovese MSc , Sibel Habash MSc , Frank Euteneuer PhD , Winfried Rief PhD , Stefan Salzmann PhD
Background
Many patients experience a reduced quality of life for months after heart surgery. Besides medical factors, psychological factors such as preoperative expectations influence the recovery process. The ValvEx study investigated whether an expectation-focused preoperative intervention before heart valve surgery would (i) improve the postoperative recovery process by reducing illness-related disability and ii) impact secondary outcomes such as increased positive realistic expectations, and reduce preoperative anxiety.
Methods
N = 89 patients undergoing heart valve surgery were randomized into 1 of 2 groups after a baseline assessment: Standard medical care (SOC) vs SOC plus psychological expectation-focused intervention (EXPECT) on the day of hospital admission. Further assessments were conducted on the evening before surgery, 4 to 6 days and 3 months after surgery. The primary outcome was illness-related disability. Constrained longitudinal data analyses were conducted to analyze the intervention effects, while the need for information was considered as a potential moderator.
Results
No general effects were observed for the EXPECT intervention over time regarding the primary outcome illness-related disability (Pain Disability Index, PDI) and the secondary outcomes (P ≥ .167). The intervention effects were moderated by the individual need for information: Patients with a higher need for information who received the EXPECT intervention were less anxious on the evening before surgery (P = .020, d = 0.314) and less restricted in their quality of life 4 to 6 days after surgery compared to patients who received SOC (P = .005, d = 0.464).
Conclusions
The ValvEx study is the first multicentre study investigating the expectation-optimizing preoperative intervention in heart valve patients. The implementation of the EXPECT intervention seemed to optimize outcomes after heart valve surgery for certain patients, such as patients with a high need for information. It is possible that there were no direct effects of the EXPECT intervention because the intervention dose was too low. These preliminary findings need to be corroborated by larger multicenter trials.
Trial registration The study was preregistered at ClinicalTrials (identifier: NCT04502121, https://clinicaltrials.gov/study/NCT04502121).
{"title":"Effects of a preoperative psychological expectation-focused intervention in patients undergoing valvular surgery - the randomized controlled ValvEx (valve patients’ expectations) study","authors":"Nicole Horn MSc , Laura Gärtner PhD , Ardawan J. Rastan MD , Térezia B. Andrási MD , Juliane Lenz , Andreas Böning MD , Miriam Salzmann-Djufri MD , Ulrike Puvogel MD , Bernd Niemann MD , Maria Genovese MSc , Sibel Habash MSc , Frank Euteneuer PhD , Winfried Rief PhD , Stefan Salzmann PhD","doi":"10.1016/j.ahj.2025.01.006","DOIUrl":"10.1016/j.ahj.2025.01.006","url":null,"abstract":"<div><h3>Background</h3><div>Many patients experience a reduced quality of life for months after heart surgery. Besides medical factors, psychological factors such as preoperative expectations influence the recovery process. The ValvEx study investigated whether an expectation-focused preoperative intervention before heart valve surgery would (i) improve the postoperative recovery process by reducing illness-related disability and ii) impact secondary outcomes such as increased positive realistic expectations, and reduce preoperative anxiety.</div></div><div><h3>Methods</h3><div>N = 89 patients undergoing heart valve surgery were randomized into 1 of 2 groups after a baseline assessment: Standard medical care (SOC) vs SOC plus psychological expectation-focused intervention (EXPECT) on the day of hospital admission. Further assessments were conducted on the evening before surgery, 4 to 6 days and 3 months after surgery. The primary outcome was illness-related disability. Constrained longitudinal data analyses were conducted to analyze the intervention effects, while the need for information was considered as a potential moderator.</div></div><div><h3>Results</h3><div>No general effects were observed for the EXPECT intervention over time regarding the primary outcome illness-related disability (Pain Disability Index, PDI) and the secondary outcomes (<em>P</em> ≥ .167). The intervention effects were moderated by the individual need for information: Patients with a higher need for information who received the EXPECT intervention were less anxious on the evening before surgery (<em>P</em> = .020, d = 0.314) and less restricted in their quality of life 4 to 6 days after surgery compared to patients who received SOC (<em>P</em> = .005, d = 0.464).</div></div><div><h3>Conclusions</h3><div>The ValvEx study is the first multicentre study investigating the expectation-optimizing preoperative intervention in heart valve patients. The implementation of the EXPECT intervention seemed to optimize outcomes after heart valve surgery for certain patients, such as patients with a high need for information. It is possible that there were no direct effects of the EXPECT intervention because the intervention dose was too low. These preliminary findings need to be corroborated by larger multicenter trials.</div><div><strong>Trial registration</strong> The study was preregistered at ClinicalTrials (identifier: NCT04502121, <span><span>https://clinicaltrials.gov/study/NCT04502121</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 156-169"},"PeriodicalIF":3.7,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998797","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 : 2025-01-09DOI: 10.1016/j.ahj.2025.01.004
Elissa A.S. Polomski MD , Julius C. Heemelaar MD, PhD , Mian E.S. de Ronde MD , Ahmed A.M. Al Jaff BSc , B.J.A. Mertens PhD , Paul R.M. van Dijkman MD, PhD , J. Wouter Jukema MD, PhD , M. Louisa Antoni MD, PhD
Background
Cancer and cancer treatment may accelerate the development of cardiovascular disease. With the improved prognosis of cancer survivors, cardiovascular events are increasing in this patient group. However, it is unknown whether the prevalence of coronary atherosclerosis is increased in patients with a history of cancer. This study aims to evaluate the prevalence and severity of coronary atherosclerosis in different age groups of cancer survivors compared to matched controls.
Methods
Consecutive cancer survivors aged > 30 years who underwent evaluation for stable coronary artery disease with coronary computed tomography angiography (CCTA) were included in this retrospective study. Propensity score matching was performed and cancer survivors were matched 1:2 to a control population without oncological history. The presence of coronary atherosclerosis was assessed in both groups.
Results
The study population consisted of 312 cancer survivors and 624 matched controls. Median age at CCTA scan was 59.2 [50.3-67.5] years and 66.0% was female. Coronary atherosclerosis was observed in 257 (82.4%) cancer survivors compared to 459 (73.6%) control patients with an Odds Ratio (OR) of 1.68 [95% CI: 1.19-2.36], P = .003. Mainly younger cancer survivors aged between 30 and 59 years had an increased prevalence of coronary atherosclerosis with an OR of 2.21 [95% CI: 1.40-3.49] compared to control patients (P = .001). In addition, thoracic radiotherapy showed a significant association with increased prevalence of atherosclerosis in the younger population with an OR of 3.29 ([95% CI: 1.70-6.38], P < .001).
Conclusions
Patients with a history cancer have an increased prevalence of coronary atherosclerosis on CCTA compared to matched patients without cancer. This effect was most pronounced in younger patients aged 30 to 59 years.
{"title":"Increased prevalence of coronary atherosclerosis in cancer survivors: A retrospective matched cross-sectional study with coronary CT angiography","authors":"Elissa A.S. Polomski MD , Julius C. Heemelaar MD, PhD , Mian E.S. de Ronde MD , Ahmed A.M. Al Jaff BSc , B.J.A. Mertens PhD , Paul R.M. van Dijkman MD, PhD , J. Wouter Jukema MD, PhD , M. Louisa Antoni MD, PhD","doi":"10.1016/j.ahj.2025.01.004","DOIUrl":"10.1016/j.ahj.2025.01.004","url":null,"abstract":"<div><h3>Background</h3><div>Cancer and cancer treatment may accelerate the development of cardiovascular disease. With the improved prognosis of cancer survivors, cardiovascular events are increasing in this patient group. However, it is unknown whether the prevalence of coronary atherosclerosis is increased in patients with a history of cancer. This study aims to evaluate the prevalence and severity of coronary atherosclerosis in different age groups of cancer survivors compared to matched controls.</div></div><div><h3>Methods</h3><div>Consecutive cancer survivors aged > 30 years who underwent evaluation for stable coronary artery disease with coronary computed tomography angiography (CCTA) were included in this retrospective study. Propensity score matching was performed and cancer survivors were matched 1:2 to a control population without oncological history. The presence of coronary atherosclerosis was assessed in both groups.</div></div><div><h3>Results</h3><div>The study population consisted of 312 cancer survivors and 624 matched controls. Median age at CCTA scan was 59.2 [50.3-67.5] years and 66.0% was female. Coronary atherosclerosis was observed in 257 (82.4%) cancer survivors compared to 459 (73.6%) control patients with an Odds Ratio (OR) of 1.68 [95% CI: 1.19-2.36], <em>P = .</em>003. Mainly younger cancer survivors aged between 30 and 59 years had an increased prevalence of coronary atherosclerosis with an OR of 2.21 [95% CI: 1.40-3.49] compared to control patients (<em>P = .</em>001). In addition, thoracic radiotherapy showed a significant association with increased prevalence of atherosclerosis in the younger population with an OR of 3.29 ([95% CI: 1.70-6.38], <em>P < .</em>001).</div></div><div><h3>Conclusions</h3><div>Patients with a history cancer have an increased prevalence of coronary atherosclerosis on CCTA compared to matched patients without cancer. This effect was most pronounced in younger patients aged 30 to 59 years.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 134-145"},"PeriodicalIF":3.7,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963556","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}
The role of lipoprotein(a) (Lp(a)) in the risk-assessment of patients with de-novo stable chest pain is sparsely investigated. We assessed the association between Lp(a) concentration and the presence of coronary stenosis on coronary computed tomography (CT) angiography in a broad population of patients referred with stable chest pain.
Methods
Lp(a) measurements and coronary CT angiography were performed in 4,346 patients with stable chest pain and no previous history of coronary artery disease. The patients were included in the trial program, the Danish study of Non-Invasive testing in Coronary artery disease, Dan-NICAD. The prevalence and odds ratios for stenosis were calculated comparing normal Lp(a) (< 20 nmol/l) with moderately elevated (20 to <125 nmol/l), high (125 to <200 nmol/l), and very high (≥200 nmol/l) Lp(a) concentrations in both univariate and multivariate analyses.
Results
In total, 2,418 (55.6%), 1,276 (29.4%), 425 (9.8%), and 227 (5.2%) patients had normal, moderately elevated, high, and very high Lp(a) levels, respectively. The prevalences of coronary stenosis increased with increasing Lp(a) concentration (n = 569 (23.5%), n = 328 (25.7%), n = 129 (30.4%), and n = 77 (33.9%) in patients with normal, moderately elevated, high, and very high Lp(a), respectively). Likewise, the prevalence of patients with multivessel disease increased with increasing Lp(a) concentration (n = 252 (10.4%), n = 149 (11.7%), n = 61 (14.4%), and n = 41 (18.1%) in patients with normal, moderately elevated, high, and very high Lp(a), respectively). In an unadjusted model, odds ratios for stenosis increased with increasing Lp(a) concentrations odds ratio 95% CI: 1.12 (0.96-1.31), 1.42 (1.13-1.77), and 1.67 (1.24-2.22) for moderately elevated, high, and very high Lp(a) versus normal Lp(a), respectively). Adjustment for age, sex, and cardiovascular risk factors did not affect the association.
Conclusions
In stable, symptomatic patients without established coronary artery disease, Lp(a) levels are positively associated with the presence of coronary stenosis on coronary CT angiography. These findings may warrant using Lp(a) in the diagnostic management of patient with suspected coronary artery disease.
Trial Registration
The 3 studies within the Dan-NICAD program are registered on ClinicalTrials.gov: Dan-NICAD, NCT02264717, https://clinicaltrials.gov/study/NCT02264717?term=dan-nicad&rank=1. Dan-NICAD 2, NCT03481712, https://clinicaltrials.gov/study/NCT03481712?term=dan-nicad&rank=3. Dan-NICAD 3, NCT04707859, https://clinicaltrials.gov/study/NCT04707859?term=dan-nicad&rank=2.
{"title":"Elevated lipoprotein(a) levels are independently associated with the presence of significant coronary stenosis in de-novo patients with stable chest pain","authors":"Gitte Stokvad Brix MD , Laust Dupont Rasmussen MD, PhD , Palle Duun Rohde PhD , Louise Nissen MD, PhD , Mette Nyegaard PhD , Michelle Louise O'Donoghue MD, MPH , Morten Bøttcher MD, PhD , Simon Winther MD, PhD, DmSci","doi":"10.1016/j.ahj.2025.01.001","DOIUrl":"10.1016/j.ahj.2025.01.001","url":null,"abstract":"<div><h3>Background</h3><div>The role of lipoprotein(a) (Lp(a)) in the risk-assessment of patients with de-novo stable chest pain is sparsely investigated. We assessed the association between Lp(a) concentration and the presence of coronary stenosis on coronary computed tomography (CT) angiography in a broad population of patients referred with stable chest pain.</div></div><div><h3>Methods</h3><div>Lp(a) measurements and coronary CT angiography were performed in 4,346 patients with stable chest pain and no previous history of coronary artery disease. The patients were included in the trial program, the Danish study of Non-Invasive testing in Coronary artery disease, Dan-NICAD. The prevalence and odds ratios for stenosis were calculated comparing normal Lp(a) (< 20 nmol/l) with moderately elevated (20 to <125 nmol/l), high (125 to <200 nmol/l), and very high (≥200 nmol/l) Lp(a) concentrations in both univariate and multivariate analyses.</div></div><div><h3>Results</h3><div>In total, 2,418 (55.6%), 1,276 (29.4%), 425 (9.8%), and 227 (5.2%) patients had normal, moderately elevated, high, and very high Lp(a) levels, respectively. The prevalences of coronary stenosis increased with increasing Lp(a) concentration (n = 569 (23.5%), n = 328 (25.7%), n = 129 (30.4%), and n = 77 (33.9%) in patients with normal, moderately elevated, high, and very high Lp(a), respectively). Likewise, the prevalence of patients with multivessel disease increased with increasing Lp(a) concentration (n = 252 (10.4%), n = 149 (11.7%), n = 61 (14.4%), and n = 41 (18.1%) in patients with normal, moderately elevated, high, and very high Lp(a), respectively). In an unadjusted model, odds ratios for stenosis increased with increasing Lp(a) concentrations odds ratio 95% CI: 1.12 (0.96-1.31), 1.42 (1.13-1.77), and 1.67 (1.24-2.22) for moderately elevated, high, and very high Lp(a) versus normal Lp(a), respectively). Adjustment for age, sex, and cardiovascular risk factors did not affect the association.</div></div><div><h3>Conclusions</h3><div>In stable, symptomatic patients without established coronary artery disease, Lp(a) levels are positively associated with the presence of coronary stenosis on coronary CT angiography. These findings may warrant using Lp(a) in the diagnostic management of patient with suspected coronary artery disease.</div></div><div><h3>Trial Registration</h3><div>The 3 studies within the Dan-NICAD program are registered on ClinicalTrials.gov: Dan-NICAD, NCT02264717, <span><span>https://clinicaltrials.gov/study/NCT02264717?term=dan-nicad&rank=1</span><svg><path></path></svg></span>. Dan-NICAD 2, NCT03481712, <span><span>https://clinicaltrials.gov/study/NCT03481712?term=dan-nicad&rank=3</span><svg><path></path></svg></span>. Dan-NICAD 3, NCT04707859, <span><span>https://clinicaltrials.gov/study/NCT04707859?term=dan-nicad&rank=2</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 103-113"},"PeriodicalIF":3.7,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942857","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 : 2025-01-06DOI: 10.1016/j.ahj.2025.01.003
Alexander J. Blood MD, MSc , Lee-Shing Chang MD , Caitlin Colling MD , Gretchen Stern PharmD , Daniel Gabovitch MBA , David Zelle , Emily Zacherle MS, MBA , Joshua Noone PhD , Carey Robar MD , Samuel J. Aronson ALM, MA , Thomas A. Gaziano MD, MSc , Lina S. Matta PharmD, MPH , Jorge Plutzky MD , Christopher P. Cannon MD , Deborah J. Wexler MD , Benjamin M. Scirica MD, MPH
Background
The prevalence, chronicity and clinical impact of type 2 diabetes (T2D) defines this disease state as a critical determinant in morbidity and mortality, as encountered by individuals, health care systems, and public health in general. The need to understand and optimize T2D identification and management is now further heightened by the advent of medications with established cardiovascular (CV) and kidney benefits in such patients, namely sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA). Prescription rates for these agents have remained low despite guidelines incorporating and emphasizing their use. Better understanding T2D disease and management patterns, including percentage of patients meeting guideline indications, is necessary to address undertreatment, improve patient management, and enable better strategies. We evaluated such issues, including eligibility for and utilization of SGLT2i and GLP-1 RA, in a large health system caring for over 1.5 million patients annually.
Methods
The electronic health record (EHR) at a large health network in the Northeastern United States was queried to identify patients 18 years of age or older with T2D and at least 1 hemoglobin A1c (HbA1c) between January 1, 2020 and January 1, 2023, examining those with T2D and 1) atherosclerotic CV disease (ASCVD), 2) an estimated 10-year ASCVD risk score ≥ 10% without known ASCVD, 3) heart failure (HF), and/or 4) chronic kidney disease (CKD) based on EHR listed comorbidities. Demographics, medications, comorbidities, and indications for SGLT2i and/or GLP-1 RA therapy were assessed by 1 or more of the 4 indications above as outlined in society guidelines.
Results
Of the 147,338 patients who met inclusion criteria, 47% were female, 28% were non-white, and 14% with a non-English language preference. Of those, 121,508 (83%) had an indication for either SGLT2i or GLP-1 RA based on guideline recommendations: 17% were prescribed an SGLT2i, 22% were prescribed GLP-1 RA, and 6% of patients were prescribed both medications. Only 33% of all eligible patients were prescribed therapy. Of patients eligible for either an SGLT2i or GLP-1 RA therapy not currently receiving either therapy, 49% had 10-year ASCVD risk ≥ 10% without known ASCVD, 42% had ASCVD, 52% had CKD, and 14% had HF.
Conclusions
More than 4 out of 5 patients with T2D had a CV or kidney indication for either SGLT2i or GLP-1 RA. However, uptake of SGLT2i/GLP-1 RA in these high-risk populations remains low (just 32%) across this health network. Future studies are needed to identify better strategies to overcome provider, patient, and system-level barriers to the uptake and dissemination of guideline-concordant T2D therapies.
{"title":"Type 2 diabetes disease and management patterns across a large, diverse healthcare system: Issues and opportunities for guideline-directed therapies","authors":"Alexander J. Blood MD, MSc , Lee-Shing Chang MD , Caitlin Colling MD , Gretchen Stern PharmD , Daniel Gabovitch MBA , David Zelle , Emily Zacherle MS, MBA , Joshua Noone PhD , Carey Robar MD , Samuel J. Aronson ALM, MA , Thomas A. Gaziano MD, MSc , Lina S. Matta PharmD, MPH , Jorge Plutzky MD , Christopher P. Cannon MD , Deborah J. Wexler MD , Benjamin M. Scirica MD, MPH","doi":"10.1016/j.ahj.2025.01.003","DOIUrl":"10.1016/j.ahj.2025.01.003","url":null,"abstract":"<div><h3>Background</h3><div>The prevalence, chronicity and clinical impact of type 2 diabetes (T2D) defines this disease state as a critical determinant in morbidity and mortality, as encountered by individuals, health care systems, and public health in general. The need to understand and optimize T2D identification and management is now further heightened by the advent of medications with established cardiovascular (CV) and kidney benefits in such patients, namely sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA). Prescription rates for these agents have remained low despite guidelines incorporating and emphasizing their use. Better understanding T2D disease and management patterns, including percentage of patients meeting guideline indications, is necessary to address undertreatment, improve patient management, and enable better strategies. We evaluated such issues, including eligibility for and utilization of SGLT2i and GLP-1 RA, in a large health system caring for over 1.5 million patients annually.</div></div><div><h3>Methods</h3><div>The electronic health record (EHR) at a large health network in the Northeastern United States was queried to identify patients 18 years of age or older with T2D and at least 1 hemoglobin A1c (HbA1c) between January 1, 2020 and January 1, 2023, examining those with T2D and 1) atherosclerotic CV disease (ASCVD), 2) an estimated 10-year ASCVD risk score ≥ 10% without known ASCVD, 3) heart failure (HF), and/or 4) chronic kidney disease (CKD) based on EHR listed comorbidities. Demographics, medications, comorbidities, and indications for SGLT2i and/or GLP-1 RA therapy were assessed by 1 or more of the 4 indications above as outlined in society guidelines.</div></div><div><h3>Results</h3><div>Of the 147,338 patients who met inclusion criteria, 47% were female, 28% were non-white, and 14% with a non-English language preference. Of those, 121,508 (83%) had an indication for either SGLT2i or GLP-1 RA based on guideline recommendations: 17% were prescribed an SGLT2i, 22% were prescribed GLP-1 RA, and 6% of patients were prescribed both medications. Only 33% of all eligible patients were prescribed therapy. Of patients eligible for either an SGLT2i or GLP-1 RA therapy not currently receiving either therapy, 49% had 10-year ASCVD risk ≥ 10% without known ASCVD, 42% had ASCVD, 52% had CKD, and 14% had HF.</div></div><div><h3>Conclusions</h3><div>More than 4 out of 5 patients with T2D had a CV or kidney indication for either SGLT2i or GLP-1 RA. However, uptake of SGLT2i/GLP-1 RA in these high-risk populations remains low (just 32%) across this health network. Future studies are needed to identify better strategies to overcome provider, patient, and system-level barriers to the uptake and dissemination of guideline-concordant T2D therapies.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Pages 114-124"},"PeriodicalIF":3.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942858","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}