Pub Date : 2024-05-30DOI: 10.1016/j.ahj.2024.05.013
Carla Richardson BSc, MSc , Tom Gilbert BSc(Hons) , Saadia Aslam MB , Cassandra L. Brookes BSc, MSc , Anvesha Singh BM, PhD , David E. Newby BA, BSc, PhD, BM, DM, DSc , Marc R. Dweck BSc, MBChB, MRCP , Ralph A. H. Stewart MBChB, MD , Paul S. Myles MBBS, MPH, MD, DSc , Tom Briffa PhD , Joseph Selvanayagam MBBS(Hons) DPhil , Clara K. Chow MBBS, PhD , Gavin J. Murphy BSc, MBChB, MD , Enoch F. Akowuah MBChB(Hons), MD, MRCS , Joanne Lord BSc, MSc, PhD , Shaun Barber BSc, PhD , Ana Suazo Di Paola BSc, MSc , Gerry P. McCann BSc, MBChB, MD , Graham S. Hillis BMedBiol, MBChB, PhD
Background
Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’.
Methods
In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life.
Results
Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up.
Conclusions
The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.
{"title":"Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial","authors":"Carla Richardson BSc, MSc , Tom Gilbert BSc(Hons) , Saadia Aslam MB , Cassandra L. Brookes BSc, MSc , Anvesha Singh BM, PhD , David E. Newby BA, BSc, PhD, BM, DM, DSc , Marc R. Dweck BSc, MBChB, MRCP , Ralph A. H. Stewart MBChB, MD , Paul S. Myles MBBS, MPH, MD, DSc , Tom Briffa PhD , Joseph Selvanayagam MBBS(Hons) DPhil , Clara K. Chow MBBS, PhD , Gavin J. Murphy BSc, MBChB, MD , Enoch F. Akowuah MBChB(Hons), MD, MRCS , Joanne Lord BSc, MSc, PhD , Shaun Barber BSc, PhD , Ana Suazo Di Paola BSc, MSc , Gerry P. McCann BSc, MBChB, MD , Graham S. Hillis BMedBiol, MBChB, PhD","doi":"10.1016/j.ahj.2024.05.013","DOIUrl":"10.1016/j.ahj.2024.05.013","url":null,"abstract":"<div><h3>Background</h3><p>Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The <u>E</u>arly valve replacement in severe <u>ASY</u>mptomatic <u>A</u>ortic <u>S</u>tenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’.</p></div><div><h3>Methods</h3><p>In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life.</p></div><div><h3>Results</h3><p>Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up.</p></div><div><h3>Conclusions</h3><p>The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001285/pdfft?md5=dfce1202fcab2521c060ba9c3c7fc07b&pid=1-s2.0-S0002870324001285-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141183642","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 : 2024-05-29DOI: 10.1016/j.ahj.2024.05.011
Lior Lupu MD, MBA, Dan Haberman MD, Kalyan R. Chitturi DO, Jason P. Wermers MS, Itsik Ben-Dor MD, Ron Waksman MD
Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.
{"title":"Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system","authors":"Lior Lupu MD, MBA, Dan Haberman MD, Kalyan R. Chitturi DO, Jason P. Wermers MS, Itsik Ben-Dor MD, Ron Waksman MD","doi":"10.1016/j.ahj.2024.05.011","DOIUrl":"10.1016/j.ahj.2024.05.011","url":null,"abstract":"<div><p>Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178970","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 : 2024-05-24DOI: 10.1016/j.ahj.2024.05.012
Joselyn Rwebembera MMed , Emma Ndagire MMed , Natalie Carvalho PhD , Allison R. Webel PhD , Craig Sable MD , Emmy Okello PhD , Rachel Sarnacki MBA , Alison M. Spaziani MPH , Atukunda Mucunguzi Msc , Daniel Engelman PhD , Anneke Grobler PhD , Andrew Steer PhD , Andrea Beaton MD
Background
Rheumatic Heart Disease (RHD) persists as a major cardiovascular driver of mortality and morbidity among young people in low-and middle-income countries. Secondary antibiotic prophylaxis (SAP) with penicillin remains the cornerstone of RHD control, however, suboptimal treatment adherence undermines most secondary prevention programs. Many of the barriers to optimal SAP adherence are specific to the intramuscular form of penicillin and may potentially be overcome by use of oral penicillin. This noninferiority trial is comparing the efficacy of intramuscular to oral penicillin SAP to prevent progression of mild RHD at 2 years.
Methods/Design
The Intramuscular vs Enteral Penicillin Prophylaxis to Prevent Progression of Rheumatic Heart Disease (GOALIE) trial is randomizing Ugandan children aged 5 to 17 years identified by echocardiographic screening with mild RHD (Stage A or B as defined by 2023 World Heart Federation criteria) to Benzathine Benzyl Penicillin G (BPG arm, every-28-day intramuscular penicillin) or Phenoxymethyl Penicillin (Pen V arm, twice daily oral penicillin) for a period of 2 years. A blinded echocardiography adjudication panel of 3 RHD experts and 2 cardiologists is determining the echocardiographic stage of RHD at enrollment and will do the same at study completion by consensus review. Treatment adherence and study retention are supported through peer support groups and case management strategies. The primary outcome is the proportion of children in the Pen V arm who progress to more advanced RHD compared to those in the BPG arm. Secondary outcomes are patient-reported outcomes (treatment acceptance, satisfaction, and health related quality of life), costs, and cost-effectiveness of oral compared to intramuscular penicillin prophylaxis for RHD. A total sample size of 1,004 participants will provide 90% power to demonstrate noninferiority using a margin of 4% with allowance for 7% loss to follow-up. Participant enrollment commenced in October 2023 and final participant follow-up is expected in December 2026. The graphical abstract (Fig. 1) summarizes the flow of echocardiographic screening, participant enrollment and follow-up.
Discussion
The GOALIE trial is critical in global efforts to refine a pragmatic approach to secondary prevention for RHD control. GOALIE insists that the inferiority of oral penicillin be proven contemporarily and against the most important near-term clinical outcome of progression of RHD severity. This work also considers other factors that could influence the adoption of oral prophylaxis and change the calculus for acceptable efficacy including patient-reported outcomes and costs.
{"title":"Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial)","authors":"Joselyn Rwebembera MMed , Emma Ndagire MMed , Natalie Carvalho PhD , Allison R. Webel PhD , Craig Sable MD , Emmy Okello PhD , Rachel Sarnacki MBA , Alison M. Spaziani MPH , Atukunda Mucunguzi Msc , Daniel Engelman PhD , Anneke Grobler PhD , Andrew Steer PhD , Andrea Beaton MD","doi":"10.1016/j.ahj.2024.05.012","DOIUrl":"10.1016/j.ahj.2024.05.012","url":null,"abstract":"<div><h3>Background</h3><p>Rheumatic Heart Disease (RHD) persists as a major cardiovascular driver of mortality and morbidity among young people in low-and middle-income countries. Secondary antibiotic prophylaxis (SAP) with penicillin remains the cornerstone of RHD control, however, suboptimal treatment adherence undermines most secondary prevention programs. Many of the barriers to optimal SAP adherence are specific to the intramuscular form of penicillin and may potentially be overcome by use of oral penicillin. This noninferiority trial is comparing the efficacy of intramuscular to oral penicillin SAP to prevent progression of mild RHD at 2 years.</p></div><div><h3>Methods/Design</h3><p>The Intramuscular vs Enteral Penicillin Prophylaxis to Prevent Progression of Rheumatic Heart Disease (GOALIE) trial is randomizing Ugandan children aged 5 to 17 years identified by echocardiographic screening with mild RHD (Stage A or B as defined by 2023 World Heart Federation criteria) to Benzathine Benzyl Penicillin G (BPG arm, every-28-day intramuscular penicillin) or Phenoxymethyl Penicillin (Pen V arm, twice daily oral penicillin) for a period of 2 years. A blinded echocardiography adjudication panel of 3 RHD experts and 2 cardiologists is determining the echocardiographic stage of RHD at enrollment and will do the same at study completion by consensus review. Treatment adherence and study retention are supported through peer support groups and case management strategies. The primary outcome is the proportion of children in the Pen V arm who progress to more advanced RHD compared to those in the BPG arm. Secondary outcomes are patient-reported outcomes (treatment acceptance, satisfaction, and health related quality of life), costs, and cost-effectiveness of oral compared to intramuscular penicillin prophylaxis for RHD. A total sample size of 1,004 participants will provide 90% power to demonstrate noninferiority using a margin of 4% with allowance for 7% loss to follow-up. Participant enrollment commenced in October 2023 and final participant follow-up is expected in December 2026. The graphical abstract (Fig. 1) summarizes the flow of echocardiographic screening, participant enrollment and follow-up.</p></div><div><h3>Discussion</h3><p>The GOALIE trial is critical in global efforts to refine a pragmatic approach to secondary prevention for RHD control. GOALIE insists that the inferiority of oral penicillin be proven contemporarily and against the most important near-term clinical outcome of progression of RHD severity. This work also considers other factors that could influence the adoption of oral prophylaxis and change the calculus for acceptable efficacy including patient-reported outcomes and costs.</p></div><div><h3>Trial Registration</h3><p>ClinicalTrials.gov: NCT05693545</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001273/pdfft?md5=82e9678fae7f1411d6728a94ffbcde20&pid=1-s2.0-S0002870324001273-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141136736","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 : 2024-05-23DOI: 10.1016/j.ahj.2024.05.009
Anthony E. Peters MD , W. Schuyler Jones MD , Brian Anderson MD , Carolyn T. Bramante MD, MPH , Uli Broedl MD , Christoph P. Hornik MD, PhD, MPH , Lindsay Kehoe MS , Kirk U. Knowlton MD , Esther Krofah MPP , Martin Landray PhD, FRCP , Trevan Locke PhD , Manesh R. Patel MD , Mitchell Psotka MD, PhD , Frank W. Rockhold PhD , Lothar Roessig MD , Russell L. Rothman MD, MPP , Lesley Schofield BS , Norman Stockbridge MD, PhD , Anne Trontell MD, MPH , Lesley H. Curtis PhD , Adrian F. Hernandez MD, MHS
The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert “Think Tank” panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.
{"title":"Framework of the strengths and challenges of clinically integrated trials: An expert panel report","authors":"Anthony E. Peters MD , W. Schuyler Jones MD , Brian Anderson MD , Carolyn T. Bramante MD, MPH , Uli Broedl MD , Christoph P. Hornik MD, PhD, MPH , Lindsay Kehoe MS , Kirk U. Knowlton MD , Esther Krofah MPP , Martin Landray PhD, FRCP , Trevan Locke PhD , Manesh R. Patel MD , Mitchell Psotka MD, PhD , Frank W. Rockhold PhD , Lothar Roessig MD , Russell L. Rothman MD, MPP , Lesley Schofield BS , Norman Stockbridge MD, PhD , Anne Trontell MD, MPH , Lesley H. Curtis PhD , Adrian F. Hernandez MD, MHS","doi":"10.1016/j.ahj.2024.05.009","DOIUrl":"10.1016/j.ahj.2024.05.009","url":null,"abstract":"<div><p>The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert “Think Tank” panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141132744","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 : 2024-05-21DOI: 10.1016/j.ahj.2024.05.010
Jonathan Kusner MD , Ravi B. Patel MD , Mo Hu MS , Alain G. Bertoni MD , Erin D. Michos MD , Ambarish Pandey MD , Lisa B. VanWagner MD , Sanjiv Shah MD , Marat Fudim MD
Background
Metabolic dysfunction associated steatotic liver disease (MASLD) has been linked to heart failure with preserved ejection fraction (HFpEF). We sought to understand association between individuals with amounts of liver adiposity greater than would be predicted by their body mass index (BMI) in order to understand whether this disproportionate liver fat (DLF) represents a proxy of metabolic risk shared between liver and heart disease.
Methods
We studied 2,932 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) who received computed tomography (CT) measurements of hepatic attenuation. Quartiles of DLF were compared and multivariable linear regression was performed to evaluate the association of DLF with clinical, echocardiographic, and quality of life metrics.
Results
Compared to the lowest quartile of DLF, individuals in the highest quartile of DLF were more likely to be male (52.0% vs 47.1%, P < .001), less likely to be Black or African American (14.8 % vs 38.1% P < .001), have higher rates of dysglycemia (31.9% vs 16.6%, P < .001) and triglycerides (140 [98.0, 199.0] vs 99.0 [72.0, 144.0] mg/dL, P > .001). These individuals had lower global longitudinal strain (−0.13 [−0.25, −0.02], P = .02), stroke volumes (−1.05 [−1.76, −0.33], P < .01), lateral e' velocity (−0.10 [−0.18, −0.02], P = .02), and 6-minute walk distances (−4.25 [−7.62 to −0.88], P = .01).
Conclusion
DLF is associated with abnormal metabolic profiles and ventricular functional changes known to be associated with HFpEF and may serve as an early metric to assess for those that may progress to clinical HFpEF.
背景:代谢功能障碍相关性脂肪性肝病(MASLD)与射血分数保留型心力衰竭(HFpEF)有关。我们试图了解肝脏脂肪含量高于体重指数(BMI)预测值的个体之间的关联,以了解这种不成比例的肝脏脂肪(DLF)是否代表肝脏和心脏病之间共同的代谢风险:我们研究了多种族动脉粥样硬化研究(MESA)中的 2932 名参与者,他们接受了肝衰减的计算机断层扫描(CT)测量。对DLF的四分位数进行了比较,并进行了多变量线性回归,以评估DLF与临床、超声心动图和生活质量指标的关系:与 DLF 最低四分位数的人相比,DLF 最高四分位数的人更可能是男性(52.0% vs 47.1%,p < 0.001),更不可能是黑人或非裔美国人(14.8% vs 38.1% p 0.001)。这些人的总体纵向应变(-0.13 [-0.25, -0.02],P = 0.02)、卒中量(-1.05 [-1.76, -0.33],P <0.01)、侧向e'速度(-0.10 [-0.18, -0.02],P = 0.02)和6分钟步行距离(-4.25 [-7.62 to -0.88],P = 0.01)均较低:DLF与HFpEF已知的代谢异常和心室功能变化有关,可作为评估可能发展为临床HFpEF的早期指标。
{"title":"Association of disproportionate liver fat with markers of heart failure: The multi-ethnic study of atherosclerosis","authors":"Jonathan Kusner MD , Ravi B. Patel MD , Mo Hu MS , Alain G. Bertoni MD , Erin D. Michos MD , Ambarish Pandey MD , Lisa B. VanWagner MD , Sanjiv Shah MD , Marat Fudim MD","doi":"10.1016/j.ahj.2024.05.010","DOIUrl":"10.1016/j.ahj.2024.05.010","url":null,"abstract":"<div><h3>Background</h3><p>Metabolic dysfunction associated steatotic liver disease (MASLD) has been linked to heart failure with preserved ejection fraction (HFpEF). We sought to understand association between individuals with amounts of liver adiposity greater than would be predicted by their body mass index (BMI) in order to understand whether this disproportionate liver fat (DLF) represents a proxy of metabolic risk shared between liver and heart disease.</p></div><div><h3>Methods</h3><p>We studied 2,932 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) who received computed tomography (CT) measurements of hepatic attenuation. Quartiles of DLF were compared and multivariable linear regression was performed to evaluate the association of DLF with clinical, echocardiographic, and quality of life metrics.</p></div><div><h3>Results</h3><p>Compared to the lowest quartile of DLF, individuals in the highest quartile of DLF were more likely to be male (52.0% vs 47.1%, <em>P</em> < .001), less likely to be Black or African American (14.8 % vs 38.1% <em>P</em> < .001), have higher rates of dysglycemia (31.9% vs 16.6%, <em>P</em> < .001) and triglycerides (140 [98.0, 199.0] vs 99.0 [72.0, 144.0] mg/dL, <em>P</em> > .001). These individuals had lower global longitudinal strain (−0.13 [−0.25, −0.02], <em>P</em> = .02), stroke volumes (−1.05 [−1.76, −0.33], <em>P</em> < .01), lateral e' velocity (−0.10 [−0.18, −0.02], <em>P</em> = .02), and 6-minute walk distances (−4.25 [−7.62 to −0.88], <em>P</em> = .01).</p></div><div><h3>Conclusion</h3><p>DLF is associated with abnormal metabolic profiles and ventricular functional changes known to be associated with HFpEF and may serve as an early metric to assess for those that may progress to clinical HFpEF.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080462","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 : 2024-05-17DOI: 10.1016/j.ahj.2024.04.021
Background
As a mega-biobank linked to a national healthcare system, the Million Veteran Program (MVP) can directly improve the health care of participants. To determine the feasibility and outcomes of returning medically actionable genetic results to MVP participants, the program launched the MVP Return of Actionable Results (MVP-ROAR) Study, with familial hypercholesterolemia (FH) as an exemplar actionable condition.
Methods
The MVP-ROAR Study consists of a completed single-arm pilot phase and an ongoing randomized clinical trial (RCT), in which MVP participants are recontacted and invited to receive clinical confirmatory gene sequencing testing and a telegenetic counseling intervention. The primary outcome of the RCT is 6-month change in low-density lipoprotein cholesterol (LDL-C) between participants receiving results at baseline and those receiving results after 6 months.
Results
The pilot developed processes to identify and recontact participants nationally with probable pathogenic variants in low-density lipoprotein receptor (LDLR) on the MVP genotype array, invite them to clinical confirmatory gene sequencing, and deliver a telegenetic counseling intervention. Among participants in the pilot phase, 8 (100%) had active statin prescriptions after 6 months. Results were shared with 16 first-degree family members. Six-month ΔLDL-C (low-density lipoprotein cholesterol) after the genetic counseling intervention was −37 mg/dL (95% CI: −12 to −61; P = .03). The ongoing RCT will determine between-arm differences in this primary outcome.
Conclusion
While underscoring the importance of clinical confirmation of research results, the pilot phase of the MVP-ROAR Study marks a turning point in MVP and demonstrates the feasibility of returning genetic results to participants and their providers. The ongoing RCT will contribute to understanding how such a program might improve patient health care and outcomes.
Clinical Trial Registration: ClinicalTrials.gov ID NCT04178122.
{"title":"Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study","authors":"","doi":"10.1016/j.ahj.2024.04.021","DOIUrl":"10.1016/j.ahj.2024.04.021","url":null,"abstract":"<div><h3>Background</h3><p>As a mega-biobank linked to a national healthcare system, the Million Veteran Program (MVP) can directly improve the health care of participants. To determine the feasibility and outcomes of returning medically actionable genetic results to MVP participants, the program launched the MVP Return of Actionable Results (MVP-ROAR) Study, with familial hypercholesterolemia (FH) as an exemplar actionable condition.</p></div><div><h3>Methods</h3><p>The MVP-ROAR Study consists of a completed single-arm pilot phase and an ongoing randomized clinical trial (RCT), in which MVP participants are recontacted and invited to receive clinical confirmatory gene sequencing testing and a telegenetic counseling intervention. The primary outcome of the RCT is 6-month change in low-density lipoprotein cholesterol (LDL-C) between participants receiving results at baseline and those receiving results after 6 months.</p></div><div><h3>Results</h3><p>The pilot developed processes to identify and recontact participants nationally with probable pathogenic variants in <em>low-density lipoprotein receptor (LDLR)</em> on the MVP genotype array, invite them to clinical confirmatory gene sequencing, and deliver a telegenetic counseling intervention. Among participants in the pilot phase, 8 (100%) had active statin prescriptions after 6 months. Results were shared with 16 first-degree family members. Six-month ΔLDL-C (low-density lipoprotein cholesterol) after the genetic counseling intervention was −37 mg/dL (95% CI: −12 to −61; <em>P</em> = .03). The ongoing RCT will determine between-arm differences in this primary outcome.</p></div><div><h3>Conclusion</h3><p>While underscoring the importance of clinical confirmation of research results, the pilot phase of the MVP-ROAR Study marks a turning point in MVP and demonstrates the feasibility of returning genetic results to participants and their providers. The ongoing RCT will contribute to understanding how such a program might improve patient health care and outcomes.</p><p>Clinical Trial Registration: ClinicalTrials.gov ID NCT04178122.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955736","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 : 2024-05-15DOI: 10.1016/j.ahj.2024.05.008
Yvonne Commodore-Mensah PhD, MHS, RN , Yuling Chen PhD, RN , Oluwabunmi Ogungbe PhD, MPH, RN , Xiaoyue Liu PhD, RN , Faith E. Metlock PhDc , Kathryn A. Carson ScM , Justin B. Echouffo-Tcheugui MD, PhD, MPhil , Chidinma Ibe PhD, MPH , Deidra Crews MD, ScM , Lisa A. Cooper MD, MPH , Cheryl Dennison Himmelfarb PhD, RN
Background
Hypertension and diabetes are major risk factors for cardiovascular diseases, stroke, and chronic kidney disease (CKD). Disparities in hypertension control persist among Black and Hispanic adults and persons living in poverty in the United States. The “LINKED-HEARTS Program” (a Cardiometabolic Health Program LINKED with Community Health WorkErs and Mobile HeAlth TelemonitoRing To reduce Health DisparitieS”), is a multi-level intervention that includes home blood pressure (BP) monitoring (HBPM), blood glucose telemonitoring, and team-based care. This study aims to examine the effect of the LINKED-HEARTS Program intervention in improving BP control compared to enhanced usual care (EUC) and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the program.
Methods
Using a hybrid type I effectiveness-implementation design, 428 adults with uncontrolled hypertension (systolic BP ≥ 140 mm Hg) and diabetes or CKD will be recruited from 18 primary care practices, including community health centers, in Maryland. Using a cluster-randomized trial design, practices are randomly assigned to the LINKED-HEARTS intervention arm or EUC arm. Participants in the LINKED-HEARTS intervention arm receive training on HBPM, BP and glucose telemonitoring, and community health worker and pharmacist telehealth visits on lifestyle modification and medication management over 12 months. The primary outcome is the proportion of participants with controlled BP (<140/90 mm Hg) at 12 months.
Conclusions
The study tests a multi-level intervention to control multiple chronic diseases. Findings from the study may be leveraged to reduce disparities in the management and control of chronic diseases and make primary care more responsive to the needs of underserved populations.
{"title":"Design and rationale of the cardiometabolic health program linked with community health workers and mobile health telemonitoring to reduce health disparities (LINKED-HEARTS) program","authors":"Yvonne Commodore-Mensah PhD, MHS, RN , Yuling Chen PhD, RN , Oluwabunmi Ogungbe PhD, MPH, RN , Xiaoyue Liu PhD, RN , Faith E. Metlock PhDc , Kathryn A. Carson ScM , Justin B. Echouffo-Tcheugui MD, PhD, MPhil , Chidinma Ibe PhD, MPH , Deidra Crews MD, ScM , Lisa A. Cooper MD, MPH , Cheryl Dennison Himmelfarb PhD, RN","doi":"10.1016/j.ahj.2024.05.008","DOIUrl":"10.1016/j.ahj.2024.05.008","url":null,"abstract":"<div><h3>Background</h3><p>Hypertension and diabetes are major risk factors for cardiovascular diseases, stroke, and chronic kidney disease (CKD). Disparities in hypertension control persist among Black and Hispanic adults and persons living in poverty in the United States. The “LINKED-HEARTS Program” (a Cardiometabolic Health Program LINKED with Community Health WorkErs and Mobile HeAlth TelemonitoRing To reduce Health DisparitieS”), is a multi-level intervention that includes home blood pressure (BP) monitoring (HBPM), blood glucose telemonitoring, and team-based care. This study aims to examine the effect of the LINKED-HEARTS Program intervention in improving BP control compared to enhanced usual care (EUC) and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the program.</p></div><div><h3>Methods</h3><p>Using a hybrid type I effectiveness-implementation design, 428 adults with uncontrolled hypertension (systolic BP ≥ 140 mm Hg) and diabetes or CKD will be recruited from 18 primary care practices, including community health centers, in Maryland. Using a cluster-randomized trial design, practices are randomly assigned to the LINKED-HEARTS intervention arm or EUC arm. Participants in the LINKED-HEARTS intervention arm receive training on HBPM, BP and glucose telemonitoring, and community health worker and pharmacist telehealth visits on lifestyle modification and medication management over 12 months. The primary outcome is the proportion of participants with controlled BP (<140/90 mm Hg) at 12 months.</p></div><div><h3>Conclusions</h3><p>The study tests a multi-level intervention to control multiple chronic diseases. Findings from the study may be leveraged to reduce disparities in the management and control of chronic diseases and make primary care more responsive to the needs of underserved populations.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov. Identifier: NCT05321368.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001236/pdfft?md5=283b87d839324030bfba0c6c324d092d&pid=1-s2.0-S0002870324001236-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955780","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 : 2024-05-12DOI: 10.1016/j.ahj.2024.04.019
Mattia Arrigo MD , Beth Davison PhD , Christopher Edwards BS , Marianna Adamo MD , Andrew P. Ambrosy MD , Marianela Barros MD , Jan Biegus MD , Jelena Celutkiene MD , Kamilė Čerlinskaitė-Bajorė MD , Ovidiu Chioncel MD , Alain Cohen-Solal MD PhD , Albertino Damasceno MD PhD , Rafael Diaz MD , Gerasimos Filippatos MD , Etienne Gayat MD PhD , Antoine Kimmoun MD PhD , Carolyn S.P. Lam MD PhD , Marco Metra MD , Maria Novosadova MD , Matteo Pagnesi MD , Alexandre Mebazaa MD PhD
Background
The STRONG-HF trial showed that high-intensity care (HIC) consisting of rapid up-titration of guideline-directed medical therapy (GDMT) and close follow-up reduced all-cause death or heart failure (HF) readmission at 180 days compared to usual care (UC). We hypothesized that significant differences in patient characteristics, management, and outcomes over the enrolment period may exist.
Methods
Two groups of the 1,078 patients enrolled in STRONG-HF were created according to the order of enrolment within center. The early group consisted of the first 10 patients enrolled at each center (N = 342) and the late group consisted of the following patients (N = 736).
Results
Late enrollees were younger, had more frequently reduced ejection fraction, slightly lower NT-proBNP and creatinine levels compared with early enrollees. The primary outcome occurred less frequently in early compared to late enrollees (15% vs. 21%, aHR 0.65, 95% CI 0.42-0.99, P = .044). No treatment-by-enrolment interaction was seen in respect to the average percentage of optimal dose of GDMT after randomization, which was consistently higher in early and late patients randomized to HIC compared to UC. The higher use of renin-angiotensin-inhibitors in the HIC arm was more pronounced in the late enrollees both after randomization (interaction-P = .013) and at 90 days (interaction-P < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, P = .10), but the efficacy of HIC showed no interaction with the enrolment group (aHR 0.77, 95% CI 0.35-1.67 in early and 0.58, 95% CI 0.40-0.83 in late enrollees, adjusted interaction-P = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, P = .73).
Conclusions
Late enrollees have different clinical characteristics and higher event rates compared to early enrollees. GDMT implementation in the HIC arm robustly achieved similar doses with consistent efficacy in early and late enrollees, mitigating the higher risk of adverse outcome in late enrollees.
{"title":"Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial","authors":"Mattia Arrigo MD , Beth Davison PhD , Christopher Edwards BS , Marianna Adamo MD , Andrew P. Ambrosy MD , Marianela Barros MD , Jan Biegus MD , Jelena Celutkiene MD , Kamilė Čerlinskaitė-Bajorė MD , Ovidiu Chioncel MD , Alain Cohen-Solal MD PhD , Albertino Damasceno MD PhD , Rafael Diaz MD , Gerasimos Filippatos MD , Etienne Gayat MD PhD , Antoine Kimmoun MD PhD , Carolyn S.P. Lam MD PhD , Marco Metra MD , Maria Novosadova MD , Matteo Pagnesi MD , Alexandre Mebazaa MD PhD","doi":"10.1016/j.ahj.2024.04.019","DOIUrl":"10.1016/j.ahj.2024.04.019","url":null,"abstract":"<div><h3>Background</h3><p>The STRONG-HF trial showed that high-intensity care (HIC) consisting of rapid up-titration of guideline-directed medical therapy (GDMT) and close follow-up reduced all-cause death or heart failure (HF) readmission at 180 days compared to usual care (UC). We hypothesized that significant differences in patient characteristics, management, and outcomes over the enrolment period may exist.</p></div><div><h3>Methods</h3><p>Two groups of the 1,078 patients enrolled in STRONG-HF were created according to the order of enrolment within center. The early group consisted of the first 10 patients enrolled at each center (N = 342) and the late group consisted of the following patients (N = 736).</p></div><div><h3>Results</h3><p>Late enrollees were younger, had more frequently reduced ejection fraction, slightly lower NT-proBNP and creatinine levels compared with early enrollees. The primary outcome occurred less frequently in early compared to late enrollees (15% vs. 21%, aHR 0.65, 95% CI 0.42-0.99, <em>P</em> = .044). No treatment-by-enrolment interaction was seen in respect to the average percentage of optimal dose of GDMT after randomization, which was consistently higher in early and late patients randomized to HIC compared to UC. The higher use of renin-angiotensin-inhibitors in the HIC arm was more pronounced in the late enrollees both after randomization (interaction-<em>P</em> = .013) and at 90 days (interaction-<em>P</em> < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, <em>P</em> = .10), but the efficacy of HIC showed no interaction with the enrolment group (aHR 0.77, 95% CI 0.35-1.67 in early and 0.58, 95% CI 0.40-0.83 in late enrollees, adjusted interaction-<em>P</em> = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, <em>P</em> = .73).</p></div><div><h3>Conclusions</h3><p>Late enrollees have different clinical characteristics and higher event rates compared to early enrollees. GDMT implementation in the HIC arm robustly achieved similar doses with consistent efficacy in early and late enrollees, mitigating the higher risk of adverse outcome in late enrollees.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov Identifier: NCT03412201.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001066/pdfft?md5=b31c009e863a0c10f74ef6385298c412&pid=1-s2.0-S0002870324001066-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140915603","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 : 2024-05-09DOI: 10.1016/j.ahj.2024.05.003
Christian Juhl Terkelsen MD, DmSc, PhD , Troels Thim MD, PhD , Philip Freeman BSc, MBBS, MRCP, PhD , Jordi Sanchez Dahl MD, DmSc, PhD , Bjarne Linde Nørgaard MD, DmSc, PhD , Won-Yong Kim MD, DmSc, PhD , Mariann Tang MD, PhD , Henrik Toft Sørensen MD, PhD, DMSc, DSc , Evald Høj Christiansen MD, PhD , Henrik Nissen MD, PhD
Introduction
Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves.
Methods and analysis
The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years.
Summary
The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves.
{"title":"Randomized comparison of TAVI valves: The Compare-TAVI trial","authors":"Christian Juhl Terkelsen MD, DmSc, PhD , Troels Thim MD, PhD , Philip Freeman BSc, MBBS, MRCP, PhD , Jordi Sanchez Dahl MD, DmSc, PhD , Bjarne Linde Nørgaard MD, DmSc, PhD , Won-Yong Kim MD, DmSc, PhD , Mariann Tang MD, PhD , Henrik Toft Sørensen MD, PhD, DMSc, DSc , Evald Høj Christiansen MD, PhD , Henrik Nissen MD, PhD","doi":"10.1016/j.ahj.2024.05.003","DOIUrl":"10.1016/j.ahj.2024.05.003","url":null,"abstract":"<div><h3>Introduction</h3><p>Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves.</p></div><div><h3>Methods and analysis</h3><p>The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years.</p></div><div><h3>Summary</h3><p>The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140903970","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 : 2024-05-07DOI: 10.1016/j.ahj.2024.05.004
Yongcheol Kim MD, PhD , Hanbit Park MD , Hyuck-Jun Yoon , Jon Suh MD , Si-Hyuck Kang MD , Young-Hyo Lim MD , Duck Hyun Jang MD , Jae Hyoung Park MD , Eun-Seok Shin MD , Jang-Whan Bae MD , Jang Hoon Lee MD , Jun-Hyok Oh MD , Do-Yoon Kang MD , Jihoon Kweon MD , Min-Woo Jo MD , Duk-Woo Park MD, PhD , Young-Hak Kim MD, PhD , Jung-Min Ahn MD, PhD , The FLASH Trial Investigators
Background
Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories.
Methods
The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study.
Results
Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024.
Conclusion
The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention.
{"title":"Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial","authors":"Yongcheol Kim MD, PhD , Hanbit Park MD , Hyuck-Jun Yoon , Jon Suh MD , Si-Hyuck Kang MD , Young-Hyo Lim MD , Duck Hyun Jang MD , Jae Hyoung Park MD , Eun-Seok Shin MD , Jang-Whan Bae MD , Jang Hoon Lee MD , Jun-Hyok Oh MD , Do-Yoon Kang MD , Jihoon Kweon MD , Min-Woo Jo MD , Duk-Woo Park MD, PhD , Young-Hak Kim MD, PhD , Jung-Min Ahn MD, PhD , The FLASH Trial Investigators","doi":"10.1016/j.ahj.2024.05.004","DOIUrl":"10.1016/j.ahj.2024.05.004","url":null,"abstract":"<div><h3>Background</h3><p>Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories.</p></div><div><h3>Methods</h3><p>The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm<sup>2</sup>), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study.</p></div><div><h3>Results</h3><p>Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024.</p></div><div><h3>Conclusion</h3><p>The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention.</p></div><div><h3>Clinical trial registration</h3><p>URL: https://www.clinicaltrials.gov. Unique identifier: NCT05388357.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140896643","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}