Pub Date : 2026-01-03DOI: 10.1016/j.ahj.2026.107339
Roberto Diletti MD, PhD , Joost Daemen MD, PhD , Benjamin Faurie MD , Marco Barbierato MD , Didier Tchetche MD , Thomas Hovasse MD , Koen Teeuwen MD, PhD , Rohit M. Oemrawsingh MD, PhD , Abdelhakim Allali MD, PhD , Gianluca Campo MD, PhD , Johan Bennett MD, PhD , Fernando Alfonso MD , Kambis Mashayekhi MD, PhD , Raul Moreno MD, PhD , Youssef S. Abdelwahed MD, PhD , Admir Dedic MD, PhD , Jose M. de la Torre Hernandez MD, PhD , John C. Murphy MB, BCH, MD, MRCP , Ignacio Amat-Santos MD, PhD , Joseph Dens MD, PhD , Nicolas M. Van Mieghem MD, PhD
Background
Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low.
Methods
The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites.
Conclusions
The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure.
Trial Registration
The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.
{"title":"Intravascular ultrasound guidance for complex high-risk indicated procedures: The IVUS CHIP trial study design","authors":"Roberto Diletti MD, PhD , Joost Daemen MD, PhD , Benjamin Faurie MD , Marco Barbierato MD , Didier Tchetche MD , Thomas Hovasse MD , Koen Teeuwen MD, PhD , Rohit M. Oemrawsingh MD, PhD , Abdelhakim Allali MD, PhD , Gianluca Campo MD, PhD , Johan Bennett MD, PhD , Fernando Alfonso MD , Kambis Mashayekhi MD, PhD , Raul Moreno MD, PhD , Youssef S. Abdelwahed MD, PhD , Admir Dedic MD, PhD , Jose M. de la Torre Hernandez MD, PhD , John C. Murphy MB, BCH, MD, MRCP , Ignacio Amat-Santos MD, PhD , Joseph Dens MD, PhD , Nicolas M. Van Mieghem MD, PhD","doi":"10.1016/j.ahj.2026.107339","DOIUrl":"10.1016/j.ahj.2026.107339","url":null,"abstract":"<div><h3>Background</h3><div>Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low.</div></div><div><h3>Methods</h3><div>The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites.</div></div><div><h3>Conclusions</h3><div>The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure.</div></div><div><h3>Trial Registration</h3><div>The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107339"},"PeriodicalIF":3.5,"publicationDate":"2026-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905456","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 : 2026-01-02DOI: 10.1016/j.ahj.2026.107340
Balaji Tamarappoo MD, PhD , Rafal Wolny MD, PhD , Guadalupe Flores Tomasino MD , Daniel Berman MD , Eileen Handberg PhD , Carl J. Pepine MD , Margaret C. Lo MD , Matthew Budoff MD , Leslee Shaw PhD , Chrisandra Shufelt MD , Janet Wei MD , Martha Gulati MD, MS , C. Noel Bairey Merz MD , Damini Dey PhD
Background
Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective in intermediate outcome trials; however, impact on coronary plaque has not been well characterized.
Objectives
The Women’s IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR NCT03417388) trial testing intensive medical therapy (IMT) (high intensity statin, ACEI or ARB and low dose aspirin) vs usual care (UC) in women with suspected INOCA offers the opportunity to evaluate the impact of IMT vs UC on plaque composition, and chest pain symptoms by coronary CT angiography (CCTA). We hypothesize that IMT provides beneficial data on plaque composition impacting flow reserve and trial outcomes.
Methods
This WARRIOR ancillary study will consecutively enroll 200 eligible participants randomized to IMT vs UC by baseline and exit CCTA. Changes in plaque and peri‑coronary artery adipose tissue attenuation (PCAT) characteristics will be quantified.
Results
Results will address: (1) Changes in coronary plaque characteristics and their hemodynamic significance using AI-enabled quantification of CCTA; (2) Changes in plaque inflammatory characteristics through pericoronary adipose tissue (PCAT) density analysis; (3) Plaque burden, composition and PCAT density changes related to angina score (Seattle Angina Questionnaire [SAQ]), (4) Derive a quantitative machine learning risk score (MLRS) using CCTA-derived variables for prediction of change in angina.
Conclusions
The ancillary study will be the first to quantify the impact of IMT vs UC on plaque composition, and outcomes in women with suspected INOCA.
Trial Registration
WARRIOR Ancillary Study for CCTA Analysis, NCT05035056
{"title":"Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis","authors":"Balaji Tamarappoo MD, PhD , Rafal Wolny MD, PhD , Guadalupe Flores Tomasino MD , Daniel Berman MD , Eileen Handberg PhD , Carl J. Pepine MD , Margaret C. Lo MD , Matthew Budoff MD , Leslee Shaw PhD , Chrisandra Shufelt MD , Janet Wei MD , Martha Gulati MD, MS , C. Noel Bairey Merz MD , Damini Dey PhD","doi":"10.1016/j.ahj.2026.107340","DOIUrl":"10.1016/j.ahj.2026.107340","url":null,"abstract":"<div><h3>Background</h3><div>Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective in intermediate outcome trials; however, impact on coronary plaque has not been well characterized.</div></div><div><h3>Objectives</h3><div>The Women’s IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR NCT03417388) trial testing intensive medical therapy (IMT) (high intensity statin, ACEI or ARB and low dose aspirin) vs usual care (UC) in women with suspected INOCA offers the opportunity to evaluate the impact of IMT vs UC on plaque composition, and chest pain symptoms by coronary CT angiography (CCTA). We hypothesize that IMT provides beneficial data on plaque composition impacting flow reserve and trial outcomes.</div></div><div><h3>Methods</h3><div>This WARRIOR ancillary study will consecutively enroll 200 eligible participants randomized to IMT vs UC by baseline and exit CCTA. Changes in plaque and peri‑coronary artery adipose tissue attenuation (PCAT) characteristics will be quantified.</div></div><div><h3>Results</h3><div>Results will address: (1) Changes in coronary plaque characteristics and their hemodynamic significance using AI-enabled quantification of CCTA; (2) Changes in plaque inflammatory characteristics through pericoronary adipose tissue (PCAT) density analysis; (3) Plaque burden, composition and PCAT density changes related to angina score (Seattle Angina Questionnaire [SAQ]), (4) Derive a quantitative machine learning risk score (MLRS) using CCTA-derived variables for prediction of change in angina.</div></div><div><h3>Conclusions</h3><div>The ancillary study will be the first to quantify the impact of IMT vs UC on plaque composition, and outcomes in women with suspected INOCA.</div></div><div><h3>Trial Registration</h3><div>WARRIOR Ancillary Study for CCTA Analysis, NCT05035056</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107340"},"PeriodicalIF":3.5,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899098","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 : 2025-12-31DOI: 10.1016/j.ahj.2025.107337
Francisco B. Alexandrino MD , Reid Schlesinger MD , Jared Bird MD , Eunjung Lee PhD , Abhishek J. Deshmukh MBBS , Vuyisile T. Nkomo MD, MPH , Jae K. Oh , Peter A. Noseworthy MD , Patricia A. Pellikka MD , Zachi Attia PhD , Francisco Lopez-Jimenez MD , Paul A. Friedman , Garvan C. Kane MD, PhD , Sorin V. Pislaru MD, PhD , Gal Tsaban MD, PhD
Background
Early structural heart disease (SHD) detection is crucial for improving prognostic outcomes, but widely accessible screening methods are lacking. The advent of artificial intelligence-enabled electrocardiograms (AI-ECG) and point-of-care cardiac-ultrasonography (POCCUS) offers promising new approaches for patient screening. We explored the feasibility and potential of integrating these innovative technologies into a practical SHD screening framework.
Methods
Outpatients undergoing ECG at the Mayo Clinic ECG laboratory between November 2023 and February 2024 were pragmatically offered POCCUS, performed by novice operators and reviewed by expert echocardiographers. AI-ECG and POCCUS findings were integrated to assess SHD, including reduced left ventricular systolic function (ejection-fraction<50%), aortic stenosis, and increased left ventricular wall thickness suggestive of cardiac amyloidosis or hypertrophic cardiomyopathy. Operators were blinded to patients’ comorbidities and formal echocardiogram results.
Results
Of 486 patients (median-age 64 years; 49% women), 286 had available formal echocardiography, with 17.5% having SHD. AI-ECG had a 32% positive predictive value (PPV) and a 94% negative predictive value (NPV) to detect any SHD. Adding POCCUS increased the overall PPV to 64% with an NPV of 93%, with an increase in diagnostic accuracy from 67% to 88%. Notably, 89.5% (17/19) of the “false positives” by AI-ECG + POCCUS had less-than-moderate-SHD. Applying the AI-ECG + POCCUS screening workflow on the entire cohort resulted in a number-needed-to-screen of 8 to identify 1 patient requiring formal echocardiography.
Conclusions
The integration of AI-ECG and POCCUS holds promise as a potentially effective screening method for SHD, facilitating improved patient selection for formal echocardiography.
{"title":"Integrating AI-ECG and point-of-care cardiac ultrasound for screening structural heart disease: A proof-of-concept study","authors":"Francisco B. Alexandrino MD , Reid Schlesinger MD , Jared Bird MD , Eunjung Lee PhD , Abhishek J. Deshmukh MBBS , Vuyisile T. Nkomo MD, MPH , Jae K. Oh , Peter A. Noseworthy MD , Patricia A. Pellikka MD , Zachi Attia PhD , Francisco Lopez-Jimenez MD , Paul A. Friedman , Garvan C. Kane MD, PhD , Sorin V. Pislaru MD, PhD , Gal Tsaban MD, PhD","doi":"10.1016/j.ahj.2025.107337","DOIUrl":"10.1016/j.ahj.2025.107337","url":null,"abstract":"<div><h3>Background</h3><div>Early structural heart disease (SHD) detection is crucial for improving prognostic outcomes, but widely accessible screening methods are lacking. The advent of artificial intelligence-enabled electrocardiograms (AI-ECG) and point-of-care cardiac-ultrasonography (POCCUS) offers promising new approaches for patient screening. We explored the feasibility and potential of integrating these innovative technologies into a practical SHD screening framework.</div></div><div><h3>Methods</h3><div>Outpatients undergoing ECG at the Mayo Clinic ECG laboratory between November 2023 and February 2024 were pragmatically offered POCCUS, performed by novice operators and reviewed by expert echocardiographers. AI-ECG and POCCUS findings were integrated to assess SHD, including reduced left ventricular systolic function (ejection-fraction<50%), aortic stenosis, and increased left ventricular wall thickness suggestive of cardiac amyloidosis or hypertrophic cardiomyopathy. Operators were blinded to patients’ comorbidities and formal echocardiogram results.</div></div><div><h3>Results</h3><div>Of 486 patients (median-age 64 years; 49% women), 286 had available formal echocardiography, with 17.5% having SHD. AI-ECG had a 32% positive predictive value (PPV) and a 94% negative predictive value (NPV) to detect any SHD. Adding POCCUS increased the overall PPV to 64% with an NPV of 93%, with an increase in diagnostic accuracy from 67% to 88%. Notably, 89.5% (17/19) of the “false positives” by AI-ECG + POCCUS had less-than-moderate-SHD. Applying the AI-ECG + POCCUS screening workflow on the entire cohort resulted in a number-needed-to-screen of 8 to identify 1 patient requiring formal echocardiography.</div></div><div><h3>Conclusions</h3><div>The integration of AI-ECG and POCCUS holds promise as a potentially effective screening method for SHD, facilitating improved patient selection for formal echocardiography.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107337"},"PeriodicalIF":3.5,"publicationDate":"2025-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145892136","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 : 2025-12-30DOI: 10.1016/j.ahj.2025.107335
P M Kistler, R Crowley
{"title":"Response to comment on: Yoga vs regular exercise for atrial fibrillation - design considerations for the yoga-AF randomized trial.","authors":"P M Kistler, R Crowley","doi":"10.1016/j.ahj.2025.107335","DOIUrl":"10.1016/j.ahj.2025.107335","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107335"},"PeriodicalIF":3.5,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145888211","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 : 2025-12-29DOI: 10.1016/j.ahj.2025.107334
Alan Cohen
{"title":"Another perspective on democracy, healthcare and the public good.","authors":"Alan Cohen","doi":"10.1016/j.ahj.2025.107334","DOIUrl":"10.1016/j.ahj.2025.107334","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107334"},"PeriodicalIF":3.5,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145877472","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 : 2025-12-26DOI: 10.1016/j.ahj.2025.107332
Deborah J. Wexler MD, MSc , Lindsay S. Mayberry PhD , Lyndsay A. Nelson PhD , Jeremy Lema-Driscoll BA , Ligia C. Flores MS , Maureen Malloy BS , Jean G. MacFadyen BA , Joseph Shen BS , Elaine Zaharris BA , Harsha Karanchi MD , Ranee Chatterjee MD, MPH , Catherine P. Benziger MD, MPH , Jake E. Decker MD , Rita Kalyani MD, MHS , Camila Manrique-Acevedo MD, MHS , Jacqueline Lonier MD , Edward Simeone MA , Kathleen Mieras BSAH , Amanda R.O. Siqueira MD , Russell L. Rothman MD, MPP , Brendan M. Everett MD, MPH
Background
Dual therapy with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is frequently recommended. We compared rates of medication initiation and discontinuation between participants assigned to treatment with a single medication class or dual therapy in the feasibility phase of the PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) pragmatic trial.
Methods
PRECIDENTD randomly assigned participants with type 2 diabetes (T2D) and ASCVD or high ASCVD risk to fill prescriptions for SGLT2i, GLP-1RA, or dual therapy (1:1:1) using their own insurance. Analyses compared medication fill and discontinuation rates of assigned medication(s), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical and Mental Health Scores, and Modified Kansas City Cardiomyopathy Questionnaire (mKCCQ)-12 between the combined monotherapy (SGLT2i or GLP-1RA) and dual therapy (SGLT2i and GLP-1RA) groups.
Results
This report includes 173 insured participants [median age 67 years (IQR 62, 72), 46% female, 35% non-White, 67% with ASCVD]; 113 assigned to monotherapy and 60 to dual therapy. Monotherapy vs dual therapy fill rates were 84% vs 53% (P < .001) 4 months after randomization and 87% vs 68% overall (P = .004) during 10-month median follow-up. Of those who filled medication, 22% in monotherapy and 49% in dual therapy discontinued a study medication (P = .002), mostly due to side effects. PROMIS and mKCCQ-12 scores showed no change.
Conclusions
Despite efforts to facilitate medication uptake in the feasibility phase of the PRECIDENTD pragmatic trial, barriers to initiation and ongoing use challenge the use of combination SGLT2i and GLP-1RA in T2D.
{"title":"Dual versus monotherapy with SGLT2 inhibitor and GLP-1 receptor agonist: PRECIDENTD pragmatic randomized trial","authors":"Deborah J. Wexler MD, MSc , Lindsay S. Mayberry PhD , Lyndsay A. Nelson PhD , Jeremy Lema-Driscoll BA , Ligia C. Flores MS , Maureen Malloy BS , Jean G. MacFadyen BA , Joseph Shen BS , Elaine Zaharris BA , Harsha Karanchi MD , Ranee Chatterjee MD, MPH , Catherine P. Benziger MD, MPH , Jake E. Decker MD , Rita Kalyani MD, MHS , Camila Manrique-Acevedo MD, MHS , Jacqueline Lonier MD , Edward Simeone MA , Kathleen Mieras BSAH , Amanda R.O. Siqueira MD , Russell L. Rothman MD, MPP , Brendan M. Everett MD, MPH","doi":"10.1016/j.ahj.2025.107332","DOIUrl":"10.1016/j.ahj.2025.107332","url":null,"abstract":"<div><h3>Background</h3><div>Dual therapy with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is frequently recommended. We compared rates of medication initiation and discontinuation between participants assigned to treatment with a single medication class or dual therapy in the feasibility phase of the PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) pragmatic trial.</div></div><div><h3>Methods</h3><div>PRECIDENTD randomly assigned participants with type 2 diabetes (T2D) and ASCVD or high ASCVD risk to fill prescriptions for SGLT2i, GLP-1RA, or dual therapy (1:1:1) using their own insurance. Analyses compared medication fill and discontinuation rates of assigned medication(s), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical and Mental Health Scores, and Modified Kansas City Cardiomyopathy Questionnaire (mKCCQ)-12 between the combined monotherapy (SGLT2i or GLP-1RA) and dual therapy (SGLT2i and GLP-1RA) groups.</div></div><div><h3>Results</h3><div>This report includes 173 insured participants [median age 67 years (IQR 62, 72), 46% female, 35% non-White, 67% with ASCVD]; 113 assigned to monotherapy and 60 to dual therapy. Monotherapy vs dual therapy fill rates were 84% vs 53% (<em>P</em> < .001) 4 months after randomization and 87% vs 68% overall (<em>P</em> = .004) during 10-month median follow-up. Of those who filled medication, 22% in monotherapy and 49% in dual therapy discontinued a study medication (<em>P</em> = .002), mostly due to side effects. PROMIS and mKCCQ-12 scores showed no change.</div></div><div><h3>Conclusions</h3><div>Despite efforts to facilitate medication uptake in the feasibility phase of the PRECIDENTD pragmatic trial, barriers to initiation and ongoing use challenge the use of combination SGLT2i and GLP-1RA in T2D.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT05390892, <span><span>https://clinicaltrials.gov/study/NCT05390892</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107332"},"PeriodicalIF":3.5,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145848819","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 : 2025-12-25DOI: 10.1016/j.ahj.2025.107336
Richard C. Becker MD
{"title":"Response to the letter: Another perspective on democracy, healthcare and the public good","authors":"Richard C. Becker MD","doi":"10.1016/j.ahj.2025.107336","DOIUrl":"10.1016/j.ahj.2025.107336","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107336"},"PeriodicalIF":3.5,"publicationDate":"2025-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846506","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 : 2025-12-24DOI: 10.1016/j.ahj.2025.107331
Romain Chopard MD, PhD , Lukas Hobohm MD, PhD , Stefano Barco MD, PhD , Sripal Bangalore MD, MHA , Jay Giri MD, MPH , Felix Mahfoud MD , John Moriarty MD , Stephan Rosenkranz MD , Andrew Sharp MD , Holger Thiele MD , Catalin Toma MD , Victor F. Tapson MD , Craig D. Markovitz PhD , Stuart P. Rosenberg MS , Stavros Konstantinides MD, PhD , Nicolas Meneveau MD, PhD
Background
Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking.
Methods
PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari.
Conclusion
The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.
{"title":"Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial","authors":"Romain Chopard MD, PhD , Lukas Hobohm MD, PhD , Stefano Barco MD, PhD , Sripal Bangalore MD, MHA , Jay Giri MD, MPH , Felix Mahfoud MD , John Moriarty MD , Stephan Rosenkranz MD , Andrew Sharp MD , Holger Thiele MD , Catalin Toma MD , Victor F. Tapson MD , Craig D. Markovitz PhD , Stuart P. Rosenberg MS , Stavros Konstantinides MD, PhD , Nicolas Meneveau MD, PhD","doi":"10.1016/j.ahj.2025.107331","DOIUrl":"10.1016/j.ahj.2025.107331","url":null,"abstract":"<div><h3>Background</h3><div>Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking.</div></div><div><h3>Methods</h3><div>PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari.</div></div><div><h3>Conclusion</h3><div>The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> Identifier: NCT06588634.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107331"},"PeriodicalIF":3.5,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843255","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 : 2025-12-22DOI: 10.1016/j.ahj.2025.107330
Marc-André d’Entremont MD, MPH , Shun Fu Lee PhD , Harindra C. Wijeysundera MD, PhD , Michael B. Tsang MD, MSc , Shy Amlani MD , Anthony Wassef MD, MSc , Shahar Lavi MD , Derek Y.F. So MD, MSc , Jackie Betz BA , Jessica Tyrwhitt BSc , John Graham MD , Warren J. Cantor MD , Alireza Bagherli MD , Ram Vijayaraghavan MD , Sanjit S. Jolly MD MSc
Background
Balancing ischemic versus bleeding complications following percutaneous coronary intervention (PCI) remains challenging. However, the optimal dose of unfractionated heparin (UFH) for elective PCI is currently unclear.
Methods
A Randomized Trial of Higher versus Lower Dose Heparin for PCI (HD-PCI) is a multicenter, randomized, controlled, registry-based, open-label, cluster crossover trial of a lower-dose (70 units/kg) versus higher-dose (100 units/kg) UFH dosing hospital-level policy for elective PCI conducted in 11 centres in Ontario, Canada. The primary efficacy outcome was defined as a composite of all-cause death, myocardial infarction or target vessel revascularization; the key safety outcome was defined as major bleeding; and the key net benefit outcome was defined as the composite of all-cause death, myocardial infarction, target vessel revascularization or major bleeding. All outcomes were evaluated within 30 days of the index PCI.
Conclusions
HD-PCI is a large cluster randomized crossover trial that will inform the ischemic and bleeding effects of lower-dose (70 units/kg) versus higher-dose (100 units/kg) in patients undergoing elective PCI.
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