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Atrial fibrillation outcomes in patients from Asia and non-Asia countries: insights from GARFIELD-AF.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-06 DOI: 10.1136/openhrt-2024-003109
Chun-Yan Cheng, Tian-Yu Lian, Xi-Jie Zhu, Saverio Virdone, Kai Sun, John Camm, Xian-Mei Li, Shinya Goto, Karen Pieper, Gloria Kayani, Xian-Hong Fang, Zhi-Cheng Jing, Ajay K Kakkar

Background: Differences in the clinical outcomes and level of risk among Asian versus non-Asian patients with atrial fibrillation (AF) have been sparsely investigated.

Objective: To provide a contemporary prospective comparison of outcomes for newly diagnosed patients with AF, between Asian and non-Asian regions.

Methods: Six Asian countries (China, Japan, India, Singapore, South Korea and Thailand) and 29 countries outside Asia participated in the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) study. Newly diagnosed patients with AF, enrolled between 2010 and 2016, were followed up for≥2 years. The outcome studies were all-cause, cardiovascular and non-cardiovascular mortality, non-haemorrhagic stroke/systemic embolism (SE), major bleeding. The association of geographical region with clinical outcomes (event rates per 100 person-years) were estimated using multivariable Cox models.

Results: 13 841/52 057 (26.6%) GARFIELD-AF participants were enrolled in Asia. Average age and prevalence of cardiovascular comorbidities were lower than in non-Asian countries and patients at high risk of stroke (ie, CHA2DS2-VASc≥2 excl. sex) were less frequently anticoagulated (60.1% vs 73.2%). Non-vitamin K oral anticoagulant (NOAC) was similar in both regions (∼28%), though Asian patients were more frequently underdosed. Both Asian and non-Asian patients who received NOAC at enrolment experienced lower all-cause mortality and non-haemorrhagic stroke/SE compared with patients on other treatments or none.All-cause mortality, non-cardiovascular mortality and major bleeding were less frequent in patients from Asia versus non-Asia (HR (95% CI): 0.62 (0.39 to 0.99), 0.52 (0.28 to 0.97), 0.58 (0.36 to 0.96), respectively). Associations of moderate-to-severe chronic kidney disease and vascular disease with increased risk of all-cause mortality were stronger in Asian versus non-Asian patients (interaction p values: 0.0250 and 0.0076, respectively). There was notable heterogeneity in oral anticoagulant (OAC) usage within the Asian countries.

Conclusions: Patients in Asian countries had a lower risk of all-cause mortality and major bleeding compared to the rest of the world. NOAC had evident benefits for reducing mortality and stroke across populations. Further studies on sociocultural impacts on OAC outcomes are needed.

Trial registration number: ClinicalTrials.gov NCT01090362.

{"title":"Atrial fibrillation outcomes in patients from Asia and non-Asia countries: insights from GARFIELD-AF.","authors":"Chun-Yan Cheng, Tian-Yu Lian, Xi-Jie Zhu, Saverio Virdone, Kai Sun, John Camm, Xian-Mei Li, Shinya Goto, Karen Pieper, Gloria Kayani, Xian-Hong Fang, Zhi-Cheng Jing, Ajay K Kakkar","doi":"10.1136/openhrt-2024-003109","DOIUrl":"10.1136/openhrt-2024-003109","url":null,"abstract":"<p><strong>Background: </strong>Differences in the clinical outcomes and level of risk among Asian versus non-Asian patients with atrial fibrillation (AF) have been sparsely investigated.</p><p><strong>Objective: </strong>To provide a contemporary prospective comparison of outcomes for newly diagnosed patients with AF, between Asian and non-Asian regions.</p><p><strong>Methods: </strong>Six Asian countries (China, Japan, India, Singapore, South Korea and Thailand) and 29 countries outside Asia participated in the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) study. Newly diagnosed patients with AF, enrolled between 2010 and 2016, were followed up for≥2 years. The outcome studies were all-cause, cardiovascular and non-cardiovascular mortality, non-haemorrhagic stroke/systemic embolism (SE), major bleeding. The association of geographical region with clinical outcomes (event rates per 100 person-years) were estimated using multivariable Cox models.</p><p><strong>Results: </strong>13 841/52 057 (26.6%) GARFIELD-AF participants were enrolled in Asia. Average age and prevalence of cardiovascular comorbidities were lower than in non-Asian countries and patients at high risk of stroke (ie, CHA<sub>2</sub>DS<sub>2</sub>-VASc≥2 excl. sex) were less frequently anticoagulated (60.1% vs 73.2%). Non-vitamin K oral anticoagulant (NOAC) was similar in both regions (∼28%), though Asian patients were more frequently underdosed. Both Asian and non-Asian patients who received NOAC at enrolment experienced lower all-cause mortality and non-haemorrhagic stroke/SE compared with patients on other treatments or none.All-cause mortality, non-cardiovascular mortality and major bleeding were less frequent in patients from Asia versus non-Asia (HR (95% CI): 0.62 (0.39 to 0.99), 0.52 (0.28 to 0.97), 0.58 (0.36 to 0.96), respectively). Associations of moderate-to-severe chronic kidney disease and vascular disease with increased risk of all-cause mortality were stronger in Asian versus non-Asian patients (interaction p values: 0.0250 and 0.0076, respectively). There was notable heterogeneity in oral anticoagulant (OAC) usage within the Asian countries.</p><p><strong>Conclusions: </strong>Patients in Asian countries had a lower risk of all-cause mortality and major bleeding compared to the rest of the world. NOAC had evident benefits for reducing mortality and stroke across populations. Further studies on sociocultural impacts on OAC outcomes are needed.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov NCT01090362.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11804197/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Revealing the limitations of 10-year MACE observations: 20-year observed total cardiovascular burden in the EPIC-Norfolk study.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-04 DOI: 10.1136/openhrt-2024-002981
Tinka J van Trier, Marjolein Snaterse, Jannick An Dorresteijn, Manon van den Bogaart, Wilma Jm Scholte Op Reimer, Frank Lj Visseren, Ron Jg Peters, Harald T Jørstad, S Matthijs Boekholdt

Background: Primary prevention strategies for cardiovascular disease (CVD) conventionally rely on 10-year risk estimates of major adverse cardiovascular events (MACE). However, communicating longer-term total CVD risk may better facilitate informed preventive decisions. Therefore, we aimed to quantify how well 10-year observed incidence reflects 20-year observed incidence and how MACE reflects total CVD events across demographic groups, using observations in long-term prospective data.

Methods: In individuals aged 40-79 without CVD or diabetes from the population-based EPIC-Norfolk cohort, we compared the first occurrence of 10 and 20 years (1) 3-point MACE events (non-fatal myocardial infarction+non-fatal stroke+fatal CVD) and (2) total CVD events (all non-fatal and fatal CVD events leading to hospitalisation), stratified by sex and age.

Results: Among 22 569 participants (57% women), incident 10-year and 20-year 3-point MACE was 5.3% and 15.5%, respectively, yielding 20/10 year ratios from 2.2 (in older men) to 4.5 (in younger women). Total CVD increased from 10.5% at 10 years to 26.9% at 20 years, with ratios ranging from 1.9 (older men) to 3.9 (younger women). Ratios between 10-year MACE and 20-year total CVD varied substantially, ranging from 3-fold in (older men) to 10-fold (younger women).

Conclusions: The observed incidence of CVD roughly triples from 10 to 20 years of follow-up, with 10-year MACE observations underestimating 20-year total CVD burden by a factor ranging from 3 (older men) to 10 (younger women). These findings highlight the limitations of communicating 10-year MACE risk assessments to facilitate informed decisions in longer-term CVD prevention-particularly in younger women.

{"title":"Revealing the limitations of 10-year MACE observations: 20-year observed total cardiovascular burden in the EPIC-Norfolk study.","authors":"Tinka J van Trier, Marjolein Snaterse, Jannick An Dorresteijn, Manon van den Bogaart, Wilma Jm Scholte Op Reimer, Frank Lj Visseren, Ron Jg Peters, Harald T Jørstad, S Matthijs Boekholdt","doi":"10.1136/openhrt-2024-002981","DOIUrl":"10.1136/openhrt-2024-002981","url":null,"abstract":"<p><strong>Background: </strong>Primary prevention strategies for cardiovascular disease (CVD) conventionally rely on 10-year risk estimates of major adverse cardiovascular events (MACE). However, communicating longer-term total CVD risk may better facilitate informed preventive decisions. Therefore, we aimed to quantify how well 10-year observed incidence reflects 20-year observed incidence and how MACE reflects total CVD events across demographic groups, using observations in long-term prospective data.</p><p><strong>Methods: </strong>In individuals aged 40-79 without CVD or diabetes from the population-based EPIC-Norfolk cohort, we compared the first occurrence of 10 and 20 years (1) 3-point MACE events (non-fatal myocardial infarction+non-fatal stroke+fatal CVD) and (2) total CVD events (all non-fatal and fatal CVD events leading to hospitalisation), stratified by sex and age.</p><p><strong>Results: </strong>Among 22 569 participants (57% women), incident 10-year and 20-year 3-point MACE was 5.3% and 15.5%, respectively, yielding 20/10 year ratios from 2.2 (in older men) to 4.5 (in younger women). Total CVD increased from 10.5% at 10 years to 26.9% at 20 years, with ratios ranging from 1.9 (older men) to 3.9 (younger women). Ratios between 10-year MACE and 20-year total CVD varied substantially, ranging from 3-fold in (older men) to 10-fold (younger women).</p><p><strong>Conclusions: </strong>The observed incidence of CVD roughly triples from 10 to 20 years of follow-up, with 10-year MACE observations underestimating 20-year total CVD burden by a factor ranging from 3 (older men) to 10 (younger women). These findings highlight the limitations of communicating 10-year MACE risk assessments to facilitate informed decisions in longer-term CVD prevention-particularly in younger women.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tissue Doppler echocardiography predicts long-term cardiovascular mortality: the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) legacy 20-year follow-up study.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-04 DOI: 10.1136/openhrt-2024-002795
Anenta Ratneswaren, Tong Wu, Amit Kaura, Devan Wasan, Somayeh Rostamian, Andrew Sharp, Neil R Poulter, P S Sever, Alice Stanton, Simon Thom, Darrel Francis, Alun D Hughes, Anoop Sv Shah, Jamil Mayet

Background: Left ventricular diastolic function as assessed by tissue Doppler echocardiography predicts cardiovascular event rates at 4 years of follow-up in patients with hypertension. Our aim was to evaluate whether this extends to predicting cardiovascular mortality after 20 years of follow-up.

Methods: Conventional (E) and tissue Doppler (e') echocardiography was performed on hypertensive participants in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) with long-term follow-up ascertained via linkage to the Office of National Statistics. Cardiovascular mortality was defined as death from coronary heart disease, stroke and other cardiovascular aetiology such as heart failure or peripheral vascular disease. Unadjusted and adjusted Cox regression survival models were constructed to investigate the association between tissue Doppler echocardiography measurements and long-term cardiovascular mortality.

Results: Among 506 hypertensive patients (median age 64, interquartile range (58, 69), 87% male), there were 200 (40%) deaths over a 20-year follow-up period. 60 deaths (12%) were cardiovascular-related.A reduction in e' was independently associated with increased cardiovascular mortality, after adjusting for the ACC/AHA Atherosclerotic Cardiovascular Disease (ASCVD) risk score, with an inverse HR of 1.22 per 1 cm/s decrease (95% CI 1.04-1.43). A higher E/e' ratio was independently associated with increased cardiovascular mortality, after adjusting for the ASCVD risk score, with an HR of 1.12 per 1-unit increase (95% CI, 1.02 to 1.23).

Conclusions: Impaired left ventricular diastolic function, measured using tissue Doppler echocardiography through e' and E/e', independently predicts increased cardiovascular mortality over 20 years in hypertensive patients, highlighting its long-term prognostic significance.

{"title":"Tissue Doppler echocardiography predicts long-term cardiovascular mortality: the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) legacy 20-year follow-up study.","authors":"Anenta Ratneswaren, Tong Wu, Amit Kaura, Devan Wasan, Somayeh Rostamian, Andrew Sharp, Neil R Poulter, P S Sever, Alice Stanton, Simon Thom, Darrel Francis, Alun D Hughes, Anoop Sv Shah, Jamil Mayet","doi":"10.1136/openhrt-2024-002795","DOIUrl":"10.1136/openhrt-2024-002795","url":null,"abstract":"<p><strong>Background: </strong>Left ventricular diastolic function as assessed by tissue Doppler echocardiography predicts cardiovascular event rates at 4 years of follow-up in patients with hypertension. Our aim was to evaluate whether this extends to predicting cardiovascular mortality after 20 years of follow-up.</p><p><strong>Methods: </strong>Conventional (E) and tissue Doppler (e') echocardiography was performed on hypertensive participants in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) with long-term follow-up ascertained via linkage to the Office of National Statistics. Cardiovascular mortality was defined as death from coronary heart disease, stroke and other cardiovascular aetiology such as heart failure or peripheral vascular disease. Unadjusted and adjusted Cox regression survival models were constructed to investigate the association between tissue Doppler echocardiography measurements and long-term cardiovascular mortality.</p><p><strong>Results: </strong>Among 506 hypertensive patients (median age 64, interquartile range (58, 69), 87% male), there were 200 (40%) deaths over a 20-year follow-up period. 60 deaths (12%) were cardiovascular-related.A reduction in e' was independently associated with increased cardiovascular mortality, after adjusting for the ACC/AHA Atherosclerotic Cardiovascular Disease (ASCVD) risk score, with an inverse HR of 1.22 per 1 cm/s decrease (95% CI 1.04-1.43). A higher E/e' ratio was independently associated with increased cardiovascular mortality, after adjusting for the ASCVD risk score, with an HR of 1.12 per 1-unit increase (95% CI, 1.02 to 1.23).</p><p><strong>Conclusions: </strong>Impaired left ventricular diastolic function, measured using tissue Doppler echocardiography through e' and E/e', independently predicts increased cardiovascular mortality over 20 years in hypertensive patients, highlighting its long-term prognostic significance.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cardiac events and procedures following COVID-19 compared with other pneumonias: a national register study.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-04 DOI: 10.1136/openhrt-2024-002914
Tarjei Øvrebotten, Birgitte Tholin, Kristian Berge, Peder Langeland Myhre, Knut Stavem

Background: Studies have shown an increased risk of cardiac disease following COVID-19, but how it compares to pneumonia of other etiologies is unclear.

Aims: To determine the incidence and HRs of cardiac disease in patients hospitalised with COVID-19 compared with other viral or bacterial pneumonias.

Methods: Using nationwide registry data, we estimated the incidence of cardiac events after hospitalisation with COVID-19 (n=2082) in February to November 2020 vs hospitalisation with viral (n=9018) or bacterial (n=29 339) pneumonia in 2018-2019. We defined outcomes using ICD-10 codes for incident myocarditis, acute myocardial infarction, atrial fibrillation/flutter, heart failure, ischaemic heart disease, other cardiac disease and total cardiac disease (any heart condition). We used Cox regression and logistic regression for analysis.

Results: Patients with COVID-19 had a mean (SD) age of 60 (18) years, compared with 69 (19) years for viral and 72 (17) years for bacterial pneumonia. Those with COVID-19 were more often male and had fewer comorbidities and fewer prior hospitalisations. Patients with COVID-19 had a lower hazard of new-onset cardiac disease compared with viral (HR 0.79 [95%CI 0.66 to 0.93]) and bacterial pneumonia (HR 0.66 [95%CI 0.57 to 0.78]), adjusted for age, sex, comorbidity, hospital admission prior year and respiratory support. Results were similar when including recurrent events.

Conclusion: Patients hospitalised with COVID-19 had a lower hazard of new-onset cardiac disease during the first 9 months after hospitalisation compared with patients with other viral or bacterial pneumonias after adjusting for multiple possible confounders. However, there may still be residual confounding from other or unknown factors.

{"title":"Cardiac events and procedures following COVID-19 compared with other pneumonias: a national register study.","authors":"Tarjei Øvrebotten, Birgitte Tholin, Kristian Berge, Peder Langeland Myhre, Knut Stavem","doi":"10.1136/openhrt-2024-002914","DOIUrl":"10.1136/openhrt-2024-002914","url":null,"abstract":"<p><strong>Background: </strong>Studies have shown an increased risk of cardiac disease following COVID-19, but how it compares to pneumonia of other etiologies is unclear.</p><p><strong>Aims: </strong>To determine the incidence and HRs of cardiac disease in patients hospitalised with COVID-19 compared with other viral or bacterial pneumonias.</p><p><strong>Methods: </strong>Using nationwide registry data, we estimated the incidence of cardiac events after hospitalisation with COVID-19 (n=2082) in February to November 2020 vs hospitalisation with viral (n=9018) or bacterial (n=29 339) pneumonia in 2018-2019. We defined outcomes using ICD-10 codes for incident myocarditis, acute myocardial infarction, atrial fibrillation/flutter, heart failure, ischaemic heart disease, other cardiac disease and total cardiac disease (any heart condition). We used Cox regression and logistic regression for analysis.</p><p><strong>Results: </strong>Patients with COVID-19 had a mean (SD) age of 60 (18) years, compared with 69 (19) years for viral and 72 (17) years for bacterial pneumonia. Those with COVID-19 were more often male and had fewer comorbidities and fewer prior hospitalisations. Patients with COVID-19 had a lower hazard of new-onset cardiac disease compared with viral (HR 0.79 [95%CI 0.66 to 0.93]) and bacterial pneumonia (HR 0.66 [95%CI 0.57 to 0.78]), adjusted for age, sex, comorbidity, hospital admission prior year and respiratory support. Results were similar when including recurrent events.</p><p><strong>Conclusion: </strong>Patients hospitalised with COVID-19 had a lower hazard of new-onset cardiac disease during the first 9 months after hospitalisation compared with patients with other viral or bacterial pneumonias after adjusting for multiple possible confounders. However, there may still be residual confounding from other or unknown factors.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Embolic risk management in infective endocarditis: predicting the 'embolic roulette'.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1136/openhrt-2024-003060
Adela Mihaela Serban, Diana Pepine, Andreea Inceu, Alexandra Dadarlat, Alexandru Achim

Life-threatening complications of infective endocarditis (IE,) are heart failure, uncontrolled infection and embolic events (EE), which pose significant morbidity and mortality risks. EE from vegetation rupture are frequent, occurring in more than 50% of patients and can lead to ischaemic stroke and systemic organ infarctions, contributing to poor patient outcomes. Early identification and characterisation of embolic risk factors, including vegetation size, mobility and echogenicity assessed through transthoracic and transoesophageal echocardiography, but also certain pathogens and biomarkers are important for guiding clinical decisions. The latest European Guidelines recommendations emphasise the role of imaging modalities like CT and MRI in detecting silent emboli and guiding therapeutic interventions, including the timely consideration of surgical options to mitigate embolic risks. In this regard, embolic vascular dissemination-including asymptomatic cases detected through multimodality imaging-has been introduced as a new minor criterion for the diagnosis of IE.Depending on the location and severity of the embolism, the embolic risk can either escalate or alternatively, complicate and delay cardiac surgery. The decision to proceed with surgery should not hinge solely on the occurrence of an embolic event, although current guidelines often emphasise this criterion. Therefore, future perspectives should focus on identifying high-risk profiles for EE and investigating whether early surgical intervention benefits these patients, even if they respond favourably to antibiotic therapy. This review explores current literature on echocardiographic and biomarker predictors of EE in IE, aiming to enhance clinical strategies for mitigating embolic complications and improving patient outcomes.

危及生命的感染性心内膜炎(IE)并发症包括心力衰竭、感染失控和栓塞事件(EE),这些并发症都会带来严重的发病率和死亡率风险。植被破裂引起的栓塞事件很常见,50% 以上的患者都会发生,并可能导致缺血性中风和全身器官梗塞,造成不良的患者预后。早期识别和确定栓塞风险因素,包括通过经胸和经食道超声心动图评估的植被大小、移动性和回声性,以及某些病原体和生物标志物,对于指导临床决策非常重要。最新的《欧洲指南》建议强调 CT 和 MRI 等成像模式在检测无声栓塞和指导治疗干预方面的作用,包括及时考虑手术方案以降低栓塞风险。在这方面,栓塞血管播散(包括通过多模态成像发现的无症状病例)已被作为诊断 IE 的一个新的次要标准。根据栓塞的位置和严重程度,栓塞风险可能会增加,也可能会使心脏手术复杂化或延迟。尽管目前的指南经常强调栓塞事件这一标准,但是否继续手术的决定不应仅取决于栓塞事件的发生。因此,未来的研究重点应放在识别 EE 的高危人群,并研究早期手术干预是否对这些患者有益,即使他们对抗生素治疗反应良好。本综述探讨了目前有关 IE 中 EE 的超声心动图和生物标志物预测指标的文献,旨在加强临床策略,以减轻栓塞并发症并改善患者预后。
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引用次数: 0
Efficacy and safety of anti-thrombotic therapy after surgical mitral valve repair: a scoping review.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-30 DOI: 10.1136/openhrt-2024-003158
Hazal Ece Babadagli, Jian Ye, Jenny Chen, Ricky Turgeon, Erica Hz Wang

Background: Mitral valve repair (MVr) is the gold standard treatment for degenerative mitral regurgitation, yet there is ongoing controversy regarding optimal anti-thrombotic therapy post-MVr. This scoping review aimed to summarise current evidence on the safety and efficacy of anti-thrombotic therapy after MVr, identify knowledge gaps and propose a future study design.

Methods: We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, the WHO International Clinical Trials Registry Platform and bibliographies of included trials, guidelines and other reviews from inception to 17 September 2024. Randomised controlled trials (RCT) and cohort and case-control studies assessing any anti-thrombotic therapy with any outcomes after MVr were included. Using a predefined collection form, two authors independently extracted data on study characteristics and results were summarised narratively into themes based on the PICO elements.

Results: Of 1296 screened references, we included 11 studies (10 cohort and one non-inferiority RCT). All studies compared vitamin K antagonist (VKA) to an anti-platelet, direct oral anti-coagulant or no anti-thrombotic therapy for median duration of 90 days. Thromboembolic and bleeding event incidences ranged from 0% to 14.3% and 0% to 9.1%, respectively. Seven studies reported no difference in thromboembolic events, and three reported reduced rates with VKA compared with control, while results for bleeding events varied widely. The RCT found edoxaban was non-inferior to warfarin for thromboembolic outcomes, but not for bleeding. Substantial methodological and clinical heterogeneity, high risk of bias and insufficient mitigation of confounders, such as concomitant atrial fibrillation, were prevalent across studies.

Conclusion: Based on this scoping review, existing literature on anti-thrombotic therapy after MVr is inconclusive due to design limitations. We proposed a study design for a pragmatic RCT that addresses prior study limitations and that could provide definitive evidence to guide anti-thrombotic management in MVr patients.

{"title":"Efficacy and safety of anti-thrombotic therapy after surgical mitral valve repair: a scoping review.","authors":"Hazal Ece Babadagli, Jian Ye, Jenny Chen, Ricky Turgeon, Erica Hz Wang","doi":"10.1136/openhrt-2024-003158","DOIUrl":"10.1136/openhrt-2024-003158","url":null,"abstract":"<p><strong>Background: </strong>Mitral valve repair (MVr) is the gold standard treatment for degenerative mitral regurgitation, yet there is ongoing controversy regarding optimal anti-thrombotic therapy post-MVr. This scoping review aimed to summarise current evidence on the safety and efficacy of anti-thrombotic therapy after MVr, identify knowledge gaps and propose a future study design.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, the WHO International Clinical Trials Registry Platform and bibliographies of included trials, guidelines and other reviews from inception to 17 September 2024. Randomised controlled trials (RCT) and cohort and case-control studies assessing any anti-thrombotic therapy with any outcomes after MVr were included. Using a predefined collection form, two authors independently extracted data on study characteristics and results were summarised narratively into themes based on the PICO elements.</p><p><strong>Results: </strong>Of 1296 screened references, we included 11 studies (10 cohort and one non-inferiority RCT). All studies compared vitamin K antagonist (VKA) to an anti-platelet, direct oral anti-coagulant or no anti-thrombotic therapy for median duration of 90 days. Thromboembolic and bleeding event incidences ranged from 0% to 14.3% and 0% to 9.1%, respectively. Seven studies reported no difference in thromboembolic events, and three reported reduced rates with VKA compared with control, while results for bleeding events varied widely. The RCT found edoxaban was non-inferior to warfarin for thromboembolic outcomes, but not for bleeding. Substantial methodological and clinical heterogeneity, high risk of bias and insufficient mitigation of confounders, such as concomitant atrial fibrillation, were prevalent across studies.</p><p><strong>Conclusion: </strong>Based on this scoping review, existing literature on anti-thrombotic therapy after MVr is inconclusive due to design limitations. We proposed a study design for a pragmatic RCT that addresses prior study limitations and that could provide definitive evidence to guide anti-thrombotic management in MVr patients.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of porcelain aorta on outcomes in transfemoral aortic valve implantation (TAVI) with balloon-expandable valves.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-30 DOI: 10.1136/openhrt-2024-003069
Philipp Lauten, Julian Kreutz, Lisa C Costello-Boerrigter, Mathias Schreiber, Guido Boerrigter, Christian Albert, Mohammad El Garhy, Björn Göbel, Bernhard Schieffer, Harald Lapp, Tamer Owais, Thomas Kuntze, Birgit Markus

Background: Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis and porcelain aorta (PA). Neurological outcomes of patients with PA undergoing TAVI with modern valves require clarification as most trials examined balloon-expandable valves (BEV) and self-expandable valves in intermediate or high-risk patients, but not specifically in patients with PA. Our aim was to compare outcomes, including stroke and mortality, in well-matched patients with and without PA who received BEV during transfemoral TAVI procedures.

Methods: Consecutive patients undergoing TAVI were entered into a registry. For this single-centre (Zentralklinik Bad Berka, Germany), retrospective analysis, we only selected patients who received BEV. PA diagnosis was made when non-contrast axial CT images fulfilled Valve Academic Research Consortium-2 criteria for PA. There was 2:1 nearest neighbour matching of patients without and with PA. The primary outcome measure was 30-day mortality or stroke within 72 hours. Secondary outcome measures were 30-day mortality, stroke within 72 hours, technical success and 30-day device success.

Results: After matching patients with (n=141) and without PA (n=282), the primary outcome of mortality at <30 days or stroke within 72 hours was higher in PA versus non-PA (7.8% vs 2.5%; OR 3.32 (95% CI 1.25 to 8.85); p=0.019). With regard to secondary outcomes, PA was not associated with mortality at 30 days (4.3% vs 2.1%; OR 2.04 (95% CI 0.65 to 6.48); p=0.23); however, stroke within 72 hours was significantly higher in PA versus non-PA (3.5% vs 0.4%; OR 10.33 (95% CI 1.17 to 91.12); p=0.017). Technical and device success were uninfluenced by PA.

Conclusions: Transfemoral TAVI with BEV in patients with PA was associated with a higher risk of the primary combined endpoint of mortality at 30 days or stroke within 72 hours, which was primarily driven by stroke within 72 hours. These findings might influence cerebral embolic protection device use in patients with PA.

{"title":"Impact of porcelain aorta on outcomes in transfemoral aortic valve implantation (TAVI) with balloon-expandable valves.","authors":"Philipp Lauten, Julian Kreutz, Lisa C Costello-Boerrigter, Mathias Schreiber, Guido Boerrigter, Christian Albert, Mohammad El Garhy, Björn Göbel, Bernhard Schieffer, Harald Lapp, Tamer Owais, Thomas Kuntze, Birgit Markus","doi":"10.1136/openhrt-2024-003069","DOIUrl":"10.1136/openhrt-2024-003069","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis and porcelain aorta (PA). Neurological outcomes of patients with PA undergoing TAVI with modern valves require clarification as most trials examined balloon-expandable valves (BEV) and self-expandable valves in intermediate or high-risk patients, but not specifically in patients with PA. Our aim was to compare outcomes, including stroke and mortality, in well-matched patients with and without PA who received BEV during transfemoral TAVI procedures.</p><p><strong>Methods: </strong>Consecutive patients undergoing TAVI were entered into a registry. For this single-centre (Zentralklinik Bad Berka, Germany), retrospective analysis, we only selected patients who received BEV. PA diagnosis was made when non-contrast axial CT images fulfilled Valve Academic Research Consortium-2 criteria for PA. There was 2:1 nearest neighbour matching of patients without and with PA. The primary outcome measure was 30-day mortality or stroke within 72 hours. Secondary outcome measures were 30-day mortality, stroke within 72 hours, technical success and 30-day device success.</p><p><strong>Results: </strong>After matching patients with (n=141) and without PA (n=282), the primary outcome of mortality at <30 days or stroke within 72 hours was higher in PA versus non-PA (7.8% vs 2.5%; OR 3.32 (95% CI 1.25 to 8.85); p=0.019). With regard to secondary outcomes, PA was not associated with mortality at 30 days (4.3% vs 2.1%; OR 2.04 (95% CI 0.65 to 6.48); p=0.23); however, stroke within 72 hours was significantly higher in PA versus non-PA (3.5% vs 0.4%; OR 10.33 (95% CI 1.17 to 91.12); p=0.017). Technical and device success were uninfluenced by PA.</p><p><strong>Conclusions: </strong>Transfemoral TAVI with BEV in patients with PA was associated with a higher risk of the primary combined endpoint of mortality at 30 days or stroke within 72 hours, which was primarily driven by stroke within 72 hours. These findings might influence cerebral embolic protection device use in patients with PA.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sacubitril/valsartan is associated with improvements in quality of life in adult congenital heart disease patients with systemic right ventricular failure.
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-30 DOI: 10.1136/openhrt-2024-003009
Ralph M L Neijenhuis, Marieke Nederend, Anna E van Groningen, Monique R M Jongbloed, Hubert W Vliegen, J Wouter Jukema, Philippine Kiès, Anastasia D Egorova

Background: Short-term improvements in quality of life (QOL) have been reported in adult congenital heart disease patients with systemic right ventricle (sRV) failure after treatment with sacubitril/valsartan. This study aimed to evaluate the medium-term QOL changes in sRV failure patients treated with sacubitril/valsartan.

Methods: In this single-centre, prospective cohort study, patients with symptomatic sRV failure completed the Netherlands Organisation for Applied Scientific Research/Academic Hospital Leiden Questionnaire for Adult's Health-Related Quality of Life (TAAQOL) at baseline and after starting treatment with sacubitril/valsartan. The TAAQOL was taken at structured outpatient follow-up moments after 6, 12, 24 and 36 months of treatment. Linear mixed effects models were used to evaluate the medium-term changes in 12 QOL domains.

Results: Of 40 sRV failure patients initiated on sacubitril/valsartan, 35 completed the titration phase, and 31 filled in a total of 98 TAAQOL questionnaires (response rate 77.5%). Significant improvements in gross motoric functioning (p=0.008), cognitive function (p=0.002), sleep (p=0.041), social functioning (p<0.001) and daily activities (p=0.001) were observed during follow-up. No significant changes were observed in fine motoric functioning, pain, sexuality, vitality, positive, depressive or aggressive emotions. Of interest, periods with restrictions relating to the COVID-19 pandemic did not significantly influence changes over time in any of the 12 QOL domains.

Conclusions: Sacubitril/valsartan treatment was associated with persistent medium-term QOL improvements in gross motoric functioning, cognitive function, sleep, social functioning and daily activities domains in sRV failure patients. Self-perceived QOL of sRV failure patients may be amenable to improvement with sacubitril/valsartan.

{"title":"Sacubitril/valsartan is associated with improvements in quality of life in adult congenital heart disease patients with systemic right ventricular failure.","authors":"Ralph M L Neijenhuis, Marieke Nederend, Anna E van Groningen, Monique R M Jongbloed, Hubert W Vliegen, J Wouter Jukema, Philippine Kiès, Anastasia D Egorova","doi":"10.1136/openhrt-2024-003009","DOIUrl":"10.1136/openhrt-2024-003009","url":null,"abstract":"<p><strong>Background: </strong>Short-term improvements in quality of life (QOL) have been reported in adult congenital heart disease patients with systemic right ventricle (sRV) failure after treatment with sacubitril/valsartan. This study aimed to evaluate the medium-term QOL changes in sRV failure patients treated with sacubitril/valsartan.</p><p><strong>Methods: </strong>In this single-centre, prospective cohort study, patients with symptomatic sRV failure completed the Netherlands Organisation for Applied Scientific Research/Academic Hospital Leiden Questionnaire for Adult's Health-Related Quality of Life (TAAQOL) at baseline and after starting treatment with sacubitril/valsartan. The TAAQOL was taken at structured outpatient follow-up moments after 6, 12, 24 and 36 months of treatment. Linear mixed effects models were used to evaluate the medium-term changes in 12 QOL domains.</p><p><strong>Results: </strong>Of 40 sRV failure patients initiated on sacubitril/valsartan, 35 completed the titration phase, and 31 filled in a total of 98 TAAQOL questionnaires (response rate 77.5%). Significant improvements in gross motoric functioning (p=0.008), cognitive function (p=0.002), sleep (p=0.041), social functioning (p<0.001) and daily activities (p=0.001) were observed during follow-up. No significant changes were observed in fine motoric functioning, pain, sexuality, vitality, positive, depressive or aggressive emotions. Of interest, periods with restrictions relating to the COVID-19 pandemic did not significantly influence changes over time in any of the 12 QOL domains.</p><p><strong>Conclusions: </strong>Sacubitril/valsartan treatment was associated with persistent medium-term QOL improvements in gross motoric functioning, cognitive function, sleep, social functioning and daily activities domains in sRV failure patients. Self-perceived QOL of sRV failure patients may be amenable to improvement with sacubitril/valsartan.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Complex high-risk indicated PCI (CHIP-PCI): is it safe to let fellows-in-training perform it as primary operators?
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-30 DOI: 10.1136/openhrt-2024-003131
Majd B Protty, Saad Hasan, Diluka Premawardhana, Mohammed Shugaa Addin, Holly Morgan, Shantu Bundhoo, Hussain Hussain, Zia Ul-Haq, Alexander Chase, David Hildick-Smith, Anirban Choudhury, Tim Kinnaird, Ahmed Hailan

Background: Training in complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) has frequently been reserved for established operators (consultants/attending) with trainees (fellows-in-training or FIT) being often discouraged from carrying out such procedures as a primary operator due to their high-risk nature. Whether the outcomes of these cases differ if the primary operator is a supervised FIT compared with a consultant is unknown.

Methods: Using multicentre PCI data from three cardiac centres in South Wales, UK (2018-2022), we identified 2295 CHIP-PCI cases with a UK-BCIS CHIP Score of 3 or more. These were then divided by primary operator status (supervised FIT vs consultant); the primary outcome was in-hospital major adverse cardiac events (IH-MACCE). Multivariate logistic models were developed to adjust for differences in baseline and procedural characteristics.

Results: The primary operator in 838 (36%) of the PCIs was a supervised FIT. Baseline and procedural characteristics had lower complexity in CHIP-PCI cases carried out by supervised FIT vs consultant. In a multivariate-adjusted model, supervised FIT procedures were associated with lower odds of concurrent valve disease (OR 0.45, 95% CI: 0.29 to 0.69), dual access (OR 0.58, 95% CI: 0.41 to 0.83), cutting/scoring balloons (OR 0.59, 95% CI: 0.44 to 0.79) and rotational atherectomy (OR 0.60, 95% CI: 0.42 to 0.87). After adjusting for all variables, however, there was no difference in the primary outcome (OR 0.72, 95% 0.34 to 1.51) or any secondary outcomes. Sensitivity analyses restricted to patients with higher CHIP Scores (4+ and 5+) showed comparable IH-MACCE.

Conclusions: Training FIT as primary operators in CHIP-PCI appears to be feasible and safe and can be delivered within the standard training programme. The comparable outcomes are likely driven by the two-operator 'buddy' effect that a FIT supervised by a consultant benefits from.

{"title":"Complex high-risk indicated PCI (CHIP-PCI): is it safe to let fellows-in-training perform it as primary operators?","authors":"Majd B Protty, Saad Hasan, Diluka Premawardhana, Mohammed Shugaa Addin, Holly Morgan, Shantu Bundhoo, Hussain Hussain, Zia Ul-Haq, Alexander Chase, David Hildick-Smith, Anirban Choudhury, Tim Kinnaird, Ahmed Hailan","doi":"10.1136/openhrt-2024-003131","DOIUrl":"10.1136/openhrt-2024-003131","url":null,"abstract":"<p><strong>Background: </strong>Training in complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) has frequently been reserved for established operators (consultants/attending) with trainees (fellows-in-training or FIT) being often discouraged from carrying out such procedures as a primary operator due to their high-risk nature. Whether the outcomes of these cases differ if the primary operator is a supervised FIT compared with a consultant is unknown.</p><p><strong>Methods: </strong>Using multicentre PCI data from three cardiac centres in South Wales, UK (2018-2022), we identified 2295 CHIP-PCI cases with a UK-BCIS CHIP Score of 3 or more. These were then divided by primary operator status (supervised FIT vs consultant); the primary outcome was in-hospital major adverse cardiac events (IH-MACCE). Multivariate logistic models were developed to adjust for differences in baseline and procedural characteristics.</p><p><strong>Results: </strong>The primary operator in 838 (36%) of the PCIs was a supervised FIT. Baseline and procedural characteristics had lower complexity in CHIP-PCI cases carried out by supervised FIT vs consultant. In a multivariate-adjusted model, supervised FIT procedures were associated with lower odds of concurrent valve disease (OR 0.45, 95% CI: 0.29 to 0.69), dual access (OR 0.58, 95% CI: 0.41 to 0.83), cutting/scoring balloons (OR 0.59, 95% CI: 0.44 to 0.79) and rotational atherectomy (OR 0.60, 95% CI: 0.42 to 0.87). After adjusting for all variables, however, there was no difference in the primary outcome (OR 0.72, 95% 0.34 to 1.51) or any secondary outcomes. Sensitivity analyses restricted to patients with higher CHIP Scores (4+ and 5+) showed comparable IH-MACCE.</p><p><strong>Conclusions: </strong>Training FIT as primary operators in CHIP-PCI appears to be feasible and safe and can be delivered within the standard training programme. The comparable outcomes are likely driven by the two-operator 'buddy' effect that a FIT supervised by a consultant benefits from.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy?
IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-28 DOI: 10.1136/openhrt-2024-003083
Eva Christine Ida Woelders, Yoshinobu Onuma, Kai Ninomiya, Neil O'Leary, Peter Damman, Denise Adriana Maria Peeters, Arnoud Willem Johannes van 't Hof, Marco Valgimigli, Pascal Vranckx, Stephan Windecker, Patrick Washington J C Serruys, Robert-Jan Matthijs van Geuns

Background and aims: Due to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).

Methods: A post hoc analysis of the GLOBAL LEADERS trial was performed to compare the predictive value of the ZON-HR classification with the PRECISE-DAPT score. Also, the outcomes stratified by either method were compared and the interaction of HBR on the treatment effect was determined.

Results: The required parameters for the ZON-HR classification (3.7% HBR) and PRECISE-DAPT score (16.6% HBR) were available in 99.9% and 93% of the patients, respectively. The ZON-HR classification had a lower sensitivity (0.09 vs 0.26) and a higher specificity (0.97 vs 0.84), positive predictive value (0.13 vs 0.08) and accuracy (0.92 vs 0.82). Regression analysis showed that both methods predicted hazard for bleeding risk with HRs of 1.87 (95% CI: 1.59 to 2.18) and 2.67 (95% CI: 2.10 to 3.41) for the PRECISE-DAPT score and ZON-HR classification, respectively. The omission of aspirin reduced bleeding events only in acute coronary syndrome (ACS) patients without HBR (HR: 0.74, 95% CI: 0.61 to 0.90, p value for interaction of HBR: 0.04).

Conclusions: Stratification for bleeding risk according to the ZON-HR classification was feasible in almost all patients and showed to be more conservative than the PRECISE-DAPT score with a consistent prognostic accuracy. The benefit of aspirin omission was the largest in ACS patients without HBR.

Trial registration number: NCT01813435.

{"title":"Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy?","authors":"Eva Christine Ida Woelders, Yoshinobu Onuma, Kai Ninomiya, Neil O'Leary, Peter Damman, Denise Adriana Maria Peeters, Arnoud Willem Johannes van 't Hof, Marco Valgimigli, Pascal Vranckx, Stephan Windecker, Patrick Washington J C Serruys, Robert-Jan Matthijs van Geuns","doi":"10.1136/openhrt-2024-003083","DOIUrl":"10.1136/openhrt-2024-003083","url":null,"abstract":"<p><strong>Background and aims: </strong>Due to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).</p><p><strong>Methods: </strong>A post hoc analysis of the GLOBAL LEADERS trial was performed to compare the predictive value of the ZON-HR classification with the PRECISE-DAPT score. Also, the outcomes stratified by either method were compared and the interaction of HBR on the treatment effect was determined.</p><p><strong>Results: </strong>The required parameters for the ZON-HR classification (3.7% HBR) and PRECISE-DAPT score (16.6% HBR) were available in 99.9% and 93% of the patients, respectively. The ZON-HR classification had a lower sensitivity (0.09 vs 0.26) and a higher specificity (0.97 vs 0.84), positive predictive value (0.13 vs 0.08) and accuracy (0.92 vs 0.82). Regression analysis showed that both methods predicted hazard for bleeding risk with HRs of 1.87 (95% CI: 1.59 to 2.18) and 2.67 (95% CI: 2.10 to 3.41) for the PRECISE-DAPT score and ZON-HR classification, respectively. The omission of aspirin reduced bleeding events only in acute coronary syndrome (ACS) patients without HBR (HR: 0.74, 95% CI: 0.61 to 0.90, p value for interaction of HBR: 0.04).</p><p><strong>Conclusions: </strong>Stratification for bleeding risk according to the ZON-HR classification was feasible in almost all patients and showed to be more conservative than the PRECISE-DAPT score with a consistent prognostic accuracy. The benefit of aspirin omission was the largest in ACS patients without HBR.</p><p><strong>Trial registration number: </strong>NCT01813435.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"12 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11781092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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