Pub Date : 2025-02-15DOI: 10.1016/j.acvd.2025.01.006
Romain Didier, Gilles Lemesle, Gilles Montalescot, P H Gabriel Steg, Eric Vicaut, Dominique Mottier, Christophe Bauters, Philippe Mabo, Tabassome Simon, Claire Bouleti, Stephane Andrieu, Denis Angoulvant, Gerald Vanzetto, Mathieu Kerneis, Guillaume Cayla, Martine Gilard
Background: Antithrombotic management in patients with chronic coronary syndrome and previous stent implantation who require long-term oral anticoagulation is highly challenging in daily practice, especially in those at high residual risk of coronary and vascular events. Dual therapy with oral anticoagulation and aspirin may lead to a higher risk of bleeding, whereas stopping aspirin in high-risk patients with coronary artery disease after percutaneous coronary intervention may lead to recurrent ischaemic events.
Aim: To assess the optimal antithrombotic regimen that should be pursued long term (often lifelong) in these patients.
Methods: The AQUATIC study is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentre study conducted in patients with chronic coronary syndrome at high risk of ischaemic events (i.e., stent implantation [> 6 months before inclusion] in a context of previous acute coronary syndrome and/or with high-risk features of ischaemic event recurrences) and requiring long-term oral anticoagulation. For superiority, we ensure 80% power at level α=0.05 to detect a 25% reduction in hazard in the experimental group relative to the control group. Overall, 2000 patients will be randomized in a 1:1 ratio to receive either oral anticoagulation and aspirin or oral anticoagulation and placebo. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization and acute limb ischaemia. Major bleeding according to the International Society on Thrombosis and Haemostasis definition is a secondary safety endpoint that will be assessed as a priority.
Conclusion: The AQUATIC trial will test the efficacy and safety of adding aspirin to long-term oral anticoagulation in patients with chronic coronary syndrome and previous coronary stenting who are at high residual risk of recurrent ischaemic events and require oral anticoagulation.
{"title":"Assessment of quitting versus using aspirin therapy in patients with stabilized coronary artery disease after stenting who require long-term oral anticoagulation: Rationale for and design of the AQUATIC double-blind randomized trial.","authors":"Romain Didier, Gilles Lemesle, Gilles Montalescot, P H Gabriel Steg, Eric Vicaut, Dominique Mottier, Christophe Bauters, Philippe Mabo, Tabassome Simon, Claire Bouleti, Stephane Andrieu, Denis Angoulvant, Gerald Vanzetto, Mathieu Kerneis, Guillaume Cayla, Martine Gilard","doi":"10.1016/j.acvd.2025.01.006","DOIUrl":"https://doi.org/10.1016/j.acvd.2025.01.006","url":null,"abstract":"<p><strong>Background: </strong>Antithrombotic management in patients with chronic coronary syndrome and previous stent implantation who require long-term oral anticoagulation is highly challenging in daily practice, especially in those at high residual risk of coronary and vascular events. Dual therapy with oral anticoagulation and aspirin may lead to a higher risk of bleeding, whereas stopping aspirin in high-risk patients with coronary artery disease after percutaneous coronary intervention may lead to recurrent ischaemic events.</p><p><strong>Aim: </strong>To assess the optimal antithrombotic regimen that should be pursued long term (often lifelong) in these patients.</p><p><strong>Methods: </strong>The AQUATIC study is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentre study conducted in patients with chronic coronary syndrome at high risk of ischaemic events (i.e., stent implantation [> 6 months before inclusion] in a context of previous acute coronary syndrome and/or with high-risk features of ischaemic event recurrences) and requiring long-term oral anticoagulation. For superiority, we ensure 80% power at level α=0.05 to detect a 25% reduction in hazard in the experimental group relative to the control group. Overall, 2000 patients will be randomized in a 1:1 ratio to receive either oral anticoagulation and aspirin or oral anticoagulation and placebo. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization and acute limb ischaemia. Major bleeding according to the International Society on Thrombosis and Haemostasis definition is a secondary safety endpoint that will be assessed as a priority.</p><p><strong>Conclusion: </strong>The AQUATIC trial will test the efficacy and safety of adding aspirin to long-term oral anticoagulation in patients with chronic coronary syndrome and previous coronary stenting who are at high residual risk of recurrent ischaemic events and require oral anticoagulation.</p>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-15DOI: 10.1016/j.acvd.2024.11.004
Clément Boiteux, Simon Viscogliosi, Sinan Boissiere, Astrid Monier, Geoffroy Ditac, Roland Henaine, Olivier Metton, Antoine Deliniere, Rémi Thevenard, Nawel Babouri, Kévin Gardey, Francis Bessière
Background: Three-dimensional electroanatomical mapping has become an essential tool in paediatric electrophysiology to precisely identify areas involved in arrhythmias. Anatomical variations in Koch's triangle, especially fluoroscopic enlargement of the coronary sinus ostium, have been found more frequently in patients with atrioventricular nodal reentrant tachycardia (AVNRT) than in those with atrioventricular reentrant tachycardia (AVRT). This finding is consistent with easier coronary sinus cannulation during electrophysiology procedures in patients with AVNRT.
Aim: To explore anatomical differences in the coronary sinus and Koch's triangle between children with AVNRT and AVRT using three-dimensional system acquisitions.
Methods: We conducted a single-centre retrospective study of paediatric patients undergoing a catheter ablation procedure for AVNRT or AVRT. Detailed anatomy of the coronary sinus ostium, global morphology and Koch's triangle properties was assessed via catheter-based intracardiac three-dimensional electroanatomical mapping, and compared.
Results: Forty-four children were enrolled (22 in each group). The median age was 14.6 (interquartile range [IQR] 10.9-16.2) years. The coronary sinus ostium area and diameter were similar in the AVNRT and AVRT groups: area, 1.0 (IQR 0.7-1.2) vs. 1.2 (IQR 0.5-1.6) cm/m2, respectively (P=0.71; 95% confidence interval of median difference -0.3 to 0.3); diameter, 1.0 (IQR 0.8-1.5) vs. 1.1 (IQR 0.9-1.4) cm/m2, respectively (P=0.56; 95% confidence interval of median difference -0.2 to 0.2). Five patients (22.7%) in each group had a coronary sinus with a windsock morphology. There was no difference in the Koch's triangle area between the AVNRT and AVRT groups: 1.4 (IQR 1.1-2.0) vs. 1.6 (IQR 1.3-1.9) cm2/m2, respectively (P=0.37; 95% CI of median difference -0.2 to 0.5).
Conclusions: Our findings suggest no difference in coronary sinus anatomy between these two junctional tachycardias. A potential explanation is the limited ability of three-dimensional mapping technologies to accurately define complex intracardiac structures.
{"title":"Koch's triangle and coronary sinus anatomy assessed by three-dimensional electroanatomical mapping in paediatric patients with junctional tachycardia.","authors":"Clément Boiteux, Simon Viscogliosi, Sinan Boissiere, Astrid Monier, Geoffroy Ditac, Roland Henaine, Olivier Metton, Antoine Deliniere, Rémi Thevenard, Nawel Babouri, Kévin Gardey, Francis Bessière","doi":"10.1016/j.acvd.2024.11.004","DOIUrl":"https://doi.org/10.1016/j.acvd.2024.11.004","url":null,"abstract":"<p><strong>Background: </strong>Three-dimensional electroanatomical mapping has become an essential tool in paediatric electrophysiology to precisely identify areas involved in arrhythmias. Anatomical variations in Koch's triangle, especially fluoroscopic enlargement of the coronary sinus ostium, have been found more frequently in patients with atrioventricular nodal reentrant tachycardia (AVNRT) than in those with atrioventricular reentrant tachycardia (AVRT). This finding is consistent with easier coronary sinus cannulation during electrophysiology procedures in patients with AVNRT.</p><p><strong>Aim: </strong>To explore anatomical differences in the coronary sinus and Koch's triangle between children with AVNRT and AVRT using three-dimensional system acquisitions.</p><p><strong>Methods: </strong>We conducted a single-centre retrospective study of paediatric patients undergoing a catheter ablation procedure for AVNRT or AVRT. Detailed anatomy of the coronary sinus ostium, global morphology and Koch's triangle properties was assessed via catheter-based intracardiac three-dimensional electroanatomical mapping, and compared.</p><p><strong>Results: </strong>Forty-four children were enrolled (22 in each group). The median age was 14.6 (interquartile range [IQR] 10.9-16.2) years. The coronary sinus ostium area and diameter were similar in the AVNRT and AVRT groups: area, 1.0 (IQR 0.7-1.2) vs. 1.2 (IQR 0.5-1.6) cm/m<sup>2</sup>, respectively (P=0.71; 95% confidence interval of median difference -0.3 to 0.3); diameter, 1.0 (IQR 0.8-1.5) vs. 1.1 (IQR 0.9-1.4) cm/m<sup>2</sup>, respectively (P=0.56; 95% confidence interval of median difference -0.2 to 0.2). Five patients (22.7%) in each group had a coronary sinus with a windsock morphology. There was no difference in the Koch's triangle area between the AVNRT and AVRT groups: 1.4 (IQR 1.1-2.0) vs. 1.6 (IQR 1.3-1.9) cm<sup>2</sup>/m<sup>2</sup>, respectively (P=0.37; 95% CI of median difference -0.2 to 0.5).</p><p><strong>Conclusions: </strong>Our findings suggest no difference in coronary sinus anatomy between these two junctional tachycardias. A potential explanation is the limited ability of three-dimensional mapping technologies to accurately define complex intracardiac structures.</p>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143477249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-13DOI: 10.1016/j.acvd.2025.01.005
Yang Zhang, Yongchen Hao, Jun Liu, Na Yang, Sidney C Smith, Yong Huo, Gregg C Fonarow, Junbo Ge, Louise Morgan, Zhaoqing Sun, Danqing Hu, Yiqian Yang, Chang-Sheng Ma, Dong Zhao, Yaling Han, Jing Liu, Yong Zeng
Background: In patients with acute coronary syndromes (ACS) requiring percutaneous coronary intervention (PCI), abnormally elevated platelet counts are often associated with an increased risk of stent thrombosis and bleeding.
Aims: To explore the associations between clinical benefits and PCI in patients with ACS and elevated platelet counts.
Methods: Between July 2017 and December 2019, 50,009 patients with ACS were enrolled in the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome Project. This study included patients with platelet count≥300×109/L. The primary outcome was net adverse clinical events (NACE), including major adverse cardiovascular or cerebrovascular events (MACCE; all-cause death, myocardial infarction, ischaemic stroke and stent thrombosis) and major bleeding during the index hospitalization. The difference in the risk of NACE between PCI and non-PCI groups was analysed using multivariable analysis and inverse probability of treatment weighting.
Results: Among 4501 patients, PCI rates decreased as platelet count increased, with 3029 patients ultimately undergoing PCI. These patients exhibited a lower rate of NACE (adjusted odds ratio [OR]: 0.53, 95% confidence interval [95% CI]: 0.37-0.77; P=0.001) and a reduced risk of MACCE (OR: 0.44, 95% CI: 0.29-0.67; P<0.001). No significant differences in major bleeding were observed (adjusted OR: 1.40, 95% CI: 0.62-3.16; P=0.417). Inverse probability of treatment weighting confirmed these findings.
Conclusion: In patients with ACS and increased platelet counts who have more complex thrombohaemorrhagic profiles, PCI can effectively reduce the risk of ischaemic events without increasing the risk of bleeding.
{"title":"Percutaneous coronary intervention in patients with acute coronary syndromes and increased platelet count.","authors":"Yang Zhang, Yongchen Hao, Jun Liu, Na Yang, Sidney C Smith, Yong Huo, Gregg C Fonarow, Junbo Ge, Louise Morgan, Zhaoqing Sun, Danqing Hu, Yiqian Yang, Chang-Sheng Ma, Dong Zhao, Yaling Han, Jing Liu, Yong Zeng","doi":"10.1016/j.acvd.2025.01.005","DOIUrl":"https://doi.org/10.1016/j.acvd.2025.01.005","url":null,"abstract":"<p><strong>Background: </strong>In patients with acute coronary syndromes (ACS) requiring percutaneous coronary intervention (PCI), abnormally elevated platelet counts are often associated with an increased risk of stent thrombosis and bleeding.</p><p><strong>Aims: </strong>To explore the associations between clinical benefits and PCI in patients with ACS and elevated platelet counts.</p><p><strong>Methods: </strong>Between July 2017 and December 2019, 50,009 patients with ACS were enrolled in the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome Project. This study included patients with platelet count≥300×10<sup>9</sup>/L. The primary outcome was net adverse clinical events (NACE), including major adverse cardiovascular or cerebrovascular events (MACCE; all-cause death, myocardial infarction, ischaemic stroke and stent thrombosis) and major bleeding during the index hospitalization. The difference in the risk of NACE between PCI and non-PCI groups was analysed using multivariable analysis and inverse probability of treatment weighting.</p><p><strong>Results: </strong>Among 4501 patients, PCI rates decreased as platelet count increased, with 3029 patients ultimately undergoing PCI. These patients exhibited a lower rate of NACE (adjusted odds ratio [OR]: 0.53, 95% confidence interval [95% CI]: 0.37-0.77; P=0.001) and a reduced risk of MACCE (OR: 0.44, 95% CI: 0.29-0.67; P<0.001). No significant differences in major bleeding were observed (adjusted OR: 1.40, 95% CI: 0.62-3.16; P=0.417). Inverse probability of treatment weighting confirmed these findings.</p><p><strong>Conclusion: </strong>In patients with ACS and increased platelet counts who have more complex thrombohaemorrhagic profiles, PCI can effectively reduce the risk of ischaemic events without increasing the risk of bleeding.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/study/NCT02306616.</p>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143473253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-12DOI: 10.1016/j.acvd.2025.01.004
Gilles Lemesle, Hubert Dromas, Nicolas Danchin, Hakim Benamer, Bernard Iung
{"title":"What's new in the recent updated ESC guidelines on chronic coronary syndrome management?","authors":"Gilles Lemesle, Hubert Dromas, Nicolas Danchin, Hakim Benamer, Bernard Iung","doi":"10.1016/j.acvd.2025.01.004","DOIUrl":"https://doi.org/10.1016/j.acvd.2025.01.004","url":null,"abstract":"","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143477254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.acvd.2024.10.320
Raoul Bacquelin , Pascal Defaye
Background
On the one hand, climate change affects health and healthcare systems worldwide. On the other hand, the healthcare system contributes to environmental pollution. These environmental issues concern rhythmology, particularly because of the use of complex, often plastic, single-use devices.
Aims
To assess current practices, as well as the training received by rhythmologists and their willingness to implement the necessary changes.
Methods
A four-part questionnaire with 15 questions was designed, and was distributed online to rhythmologists, via the French Society of Cardiology.
Results
Eighty-seven responses were received from 42 French departments. Most rhythmologists (98.9%) had never attended courses on climate change and its impact on human health during their medical studies; they thought it would be relevant to offer courses on these issues as part of initial medical training (59.5% of answers), continuing medical education (62.3% of answers) and training in interventional rhythmology (55.9% of answers). The participants had already been able to implement actions in their healthcare establishments, in the following categories: transport; food; waste management; scientific studies; and political work. One hundred percent of rhythmologists were willing to change some of their interventional practices if the changes did not alter the risk for the patient or diminish the clinical benefit. However, there were numerous obstacles to overcome: “I don’t know where to start”; “I’m not helped by my healthcare institution”; “regulatory constraints are too important”; “I don’t have the time” and “I don’t know what's relevant”.
Conclusions
These responses reinforce the importance of supporting these doctors so that their interventional practices can evolve. This evolution in interventional practices, based on scientific studies, and within a legislative and regulatory framework adapted to environmental issues, will enable the development of a more sustainable rhythmology practice.
{"title":"Questionnaire on sustainability practices in French rhythmology departments","authors":"Raoul Bacquelin , Pascal Defaye","doi":"10.1016/j.acvd.2024.10.320","DOIUrl":"10.1016/j.acvd.2024.10.320","url":null,"abstract":"<div><h3>Background</h3><div>On the one hand, climate change affects health and healthcare systems worldwide. On the other hand, the healthcare system contributes to environmental pollution. These environmental issues concern rhythmology, particularly because of the use of complex, often plastic, single-use devices.</div></div><div><h3>Aims</h3><div>To assess current practices, as well as the training received by rhythmologists and their willingness to implement the necessary changes.</div></div><div><h3>Methods</h3><div>A four-part questionnaire with 15 questions was designed, and was distributed online to rhythmologists, via the French Society of Cardiology.</div></div><div><h3>Results</h3><div>Eighty-seven responses were received from 42 French departments. Most rhythmologists (98.9%) had never attended courses on climate change and its impact on human health during their medical studies; they thought it would be relevant to offer courses on these issues as part of initial medical training (59.5% of answers), continuing medical education (62.3% of answers) and training in interventional rhythmology (55.9% of answers). The participants had already been able to implement actions in their healthcare establishments, in the following categories: transport; food; waste management; scientific studies; and political work. One hundred percent of rhythmologists were willing to change some of their interventional practices if the changes did not alter the risk for the patient or diminish the clinical benefit. However, there were numerous obstacles to overcome: “I don’t know where to start”; “I’m not helped by my healthcare institution”; “regulatory constraints are too important”; “I don’t have the time” and “I don’t know what's relevant”.</div></div><div><h3>Conclusions</h3><div>These responses reinforce the importance of supporting these doctors so that their interventional practices can evolve. This evolution in interventional practices, based on scientific studies, and within a legislative and regulatory framework adapted to environmental issues, will enable the development of a more sustainable rhythmology practice.</div></div>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":"118 2","pages":"Pages 93-100"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Early access experience in France with tafamidis meglumine, a selective transthyretin stabilizer for transthyretin-related amyloidosis cardiomyopathy (ATTR-CM), following transthyretin-related amyloidosis (ATTR) polyneuropathy approval and positive ATTR-ACT study results.
Aim
To describe the characteristics and clinical outcomes for patients in the French ATTR-CM tafamidis meglumine early access programme (28 Nov 2018 to 01 Jun 2021).
Methods
Patients with confirmed ATTR-CM received tafamidis meglumine 20 mg/day or 80 mg/day. Demographic and clinical data were collected prospectively until patients discontinued treatment or died, or the programme ended.
Results
Overall, 222 physicians from 126 centres enrolled 2788 patients. The median age was 82 years, 81.6% were male and New York Heart Association severity was class I for 12.8%, class II for 60.1% and class III for 27.0%. Overall, 1943 (74.6%) had genetic testing, and the results were available at tafamidis start for 1208 (62.2%) patients: 995 (82.4%) had wild-type ATTR and 213 (17.6%) had hereditary ATTR. Most patients started treatment ≤ 12 months after diagnosis (88.3%): 2268 (81.3%) at 20 mg/day, with 401 (17.7%) increasing to 80 mg/day. Median follow-up duration was 11.8 months. New York Heart Association class improved or remained stable for 1299 (77.6%), whereas 376 (22.4%) worsened between inclusion and last follow-up. Among patients initiated at 80 mg, 297 (81.1%) improved or remained stable and 69 (18.9%) worsened. New York Heart Association class progression did not vary with age. The 18-month survival rates were 89.8% (95% confidence interval: 87.0–92.0) among patients aged < 80 years, and 86.5% (95% confidence interval: 83.9–88.7) among those aged ≥ 80 years.
Conclusions
Early tafamidis meglumine access was given to 2788 patients with ATTR-CM. New York Heart Association class progression and survival were consistent with previously published data.
{"title":"Clinical outcomes for 2788 patients with transthyretin amyloidosis: Tafamidis meglumine early access program in France","authors":"Olivier Lairez , Patricia Réant , Jocelyn Inamo , Julien Jeanneteau , Fabrice Bauer , Gilbert Habib , Jean-Christophe Eicher , Benoit Lequeux , Damien Legallois , Constant Josse , Aurelie Hippocrate , Mathilde Bartoli , Margaux Dubois , Charlotte Noirot Cosson , Pierre-Alexandre Squara , Stephane Fievez , Aurore Quinault , Jeremie Rudant , Mounira Kharoubi , Thibaud Damy","doi":"10.1016/j.acvd.2024.08.006","DOIUrl":"10.1016/j.acvd.2024.08.006","url":null,"abstract":"<div><h3>Background</h3><div>Early access experience in France with tafamidis meglumine, a selective transthyretin stabilizer for transthyretin-related amyloidosis cardiomyopathy (ATTR-CM), following transthyretin-related amyloidosis (ATTR) polyneuropathy approval and positive ATTR-ACT study results.</div></div><div><h3>Aim</h3><div>To describe the characteristics and clinical outcomes for patients in the French ATTR-CM tafamidis meglumine early access programme (28 Nov 2018 to 01 Jun 2021).</div></div><div><h3>Methods</h3><div>Patients with confirmed ATTR-CM received tafamidis meglumine 20<!--> <!-->mg/day or 80<!--> <!-->mg/day. Demographic and clinical data were collected prospectively until patients discontinued treatment or died, or the programme ended.</div></div><div><h3>Results</h3><div>Overall, 222 physicians from 126 centres enrolled 2788 patients. The median age was 82<!--> <!-->years, 81.6% were male and New York Heart Association severity was class I for 12.8%, class II for 60.1% and class III for 27.0%. Overall, 1943 (74.6%) had genetic testing, and the results were available at tafamidis start for 1208 (62.2%) patients: 995 (82.4%) had wild-type ATTR and 213 (17.6%) had hereditary ATTR. Most patients started treatment<!--> <!-->≤<!--> <!-->12<!--> <!-->months after diagnosis (88.3%): 2268 (81.3%) at 20<!--> <!-->mg/day, with 401 (17.7%) increasing to 80<!--> <!-->mg/day. Median follow-up duration was 11.8<!--> <!-->months. New York Heart Association class improved or remained stable for 1299 (77.6%), whereas 376 (22.4%) worsened between inclusion and last follow-up. Among patients initiated at 80<!--> <!-->mg, 297 (81.1%) improved or remained stable and 69 (18.9%) worsened. New York Heart Association class progression did not vary with age. The 18-month survival rates were 89.8% (95% confidence interval: 87.0–92.0) among patients aged<!--> <!--><<!--> <!-->80<!--> <!-->years, and 86.5% (95% confidence interval: 83.9–88.7) among those aged<!--> <!-->≥<!--> <!-->80<!--> <!-->years.</div></div><div><h3>Conclusions</h3><div>Early tafamidis meglumine access was given to 2788 patients with ATTR-CM. New York Heart Association class progression and survival were consistent with previously published data.</div></div>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":"118 2","pages":"Pages 123-132"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142481646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.acvd.2024.09.005
Miloud Cherbi , Hamid Merdji , Clément Delmas
{"title":"Response to a letter from Modumudi et al. commenting on the article “Cardiogenic shock and infection: A lethal combination”","authors":"Miloud Cherbi , Hamid Merdji , Clément Delmas","doi":"10.1016/j.acvd.2024.09.005","DOIUrl":"10.1016/j.acvd.2024.09.005","url":null,"abstract":"","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":"118 2","pages":"Pages 138-139"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.acvd.2024.10.332
Morgane Brobst , Nicolas Chapet , Daylale Benchalkha , Elise Bourgeois , Fanchon Herman , Nicolas Molinari , Florence Leclercq , Jean-Luc Pasquié , Cyril Breuker , Ariane Sultan , François Roubille
Background
Recommended treatment after acute coronary syndrome (ACS) involves high-intensity statin therapy to achieve the low-density lipoprotein (LDL-C) target of < 1.4 mmol/L (European guidelines), but many patients discontinue statins because of real or perceived side-effects. Whether body mass index (BMI) influences statin intolerance remains unclear.
Aim
To assess statin tolerance 3 months after initiation, and to identify factors determining tolerance and persistence.
Methods
STATIC was a single-centre cohort study (November 2021 to April 2023) of patients admitted to cardiac intensive care units for ACS. The study had three stages: T0 (admission); W6 (6 weeks after ACS: statin efficiency); and M3 (3 months after ACS: statin tolerance and persistence). SAMS score was used to evaluate imputability in patients reporting muscular side-effects. Multivariable analysis identified factors influencing tolerance; statin persistence was assessed using pharmacy dispensing data.
Results
Overall, 289 patients were included (77.9% men; mean age 64.2 years; 22.7% with BMI ≥ 30 kg/m2). At T0, 38.1% had hypertension, 28.5% dyslipidaemia and 15.9% diabetes. At discharge, 269 patients received statins: 97.0% had a high-intensity statin; 43.5% had a statin/ezetimibe combination. At W6, mean LDL-C was 1.58 mmol/L, with 45.5% at the LDL-C target. At M3, 6.0% reported side-effects (3.6% muscular, 1.2% liver, 1.2% gastrointestinal). Mean SAMS score was 5.67. No significant differences in muscular or hepatic side-effects were found between patients with BMI ≥ 30 versus < 30 kg/m2. Persistence was 98.4% at M3 follow-up. The proportion of patients on a high-intensity statin or a statin/ezetimibe did not change from discharge to M3 (P = 0.45 and P = 1.00, respectively).
Conclusions
Statins are effective, but not always enough to reach LDL-C target. Tolerance and persistence were good, with muscular side-effects as expected, but without any guarantee of statin imputability. BMI did not influence statin tolerance in this study.
{"title":"Impact of obesity on tolerance and persistence of statins in patients within 3 months following an acute myocardial infarction: A real-world study","authors":"Morgane Brobst , Nicolas Chapet , Daylale Benchalkha , Elise Bourgeois , Fanchon Herman , Nicolas Molinari , Florence Leclercq , Jean-Luc Pasquié , Cyril Breuker , Ariane Sultan , François Roubille","doi":"10.1016/j.acvd.2024.10.332","DOIUrl":"10.1016/j.acvd.2024.10.332","url":null,"abstract":"<div><h3>Background</h3><div>Recommended treatment after acute coronary syndrome (ACS) involves high-intensity statin therapy to achieve the low-density lipoprotein (LDL-C) target of<!--> <!--><<!--> <!-->1.4<!--> <!-->mmol/L (European guidelines), but many patients discontinue statins because of real or perceived side-effects. Whether body mass index (BMI) influences statin intolerance remains unclear.</div></div><div><h3>Aim</h3><div>To assess statin tolerance 3<!--> <!-->months after initiation, and to identify factors determining tolerance and persistence.</div></div><div><h3>Methods</h3><div>STATIC was a single-centre cohort study (November 2021 to April 2023) of patients admitted to cardiac intensive care units for ACS. The study had three stages: T0 (admission); W6 (6 weeks after ACS: statin efficiency); and M3 (3<!--> <!-->months after ACS: statin tolerance and persistence). SAMS score was used to evaluate imputability in patients reporting muscular side-effects. Multivariable analysis identified factors influencing tolerance; statin persistence was assessed using pharmacy dispensing data.</div></div><div><h3>Results</h3><div>Overall, 289 patients were included (77.9% men; mean age 64.2<!--> <!-->years; 22.7% with BMI<!--> <!-->≥<!--> <!-->30<!--> <!-->kg/m<sup>2</sup>). At T0, 38.1% had hypertension, 28.5% dyslipidaemia and 15.9% diabetes. At discharge, 269 patients received statins: 97.0% had a high-intensity statin; 43.5% had a statin/ezetimibe combination. At W6, mean LDL-C was 1.58<!--> <!-->mmol/L, with 45.5% at the LDL-C target. At M3, 6.0% reported side-effects (3.6% muscular, 1.2% liver, 1.2% gastrointestinal). Mean SAMS score was 5.67. No significant differences in muscular or hepatic side-effects were found between patients with BMI<!--> <!-->≥<!--> <!-->30 versus<!--> <!--><<!--> <!-->30 kg/m<sup>2</sup>. Persistence was 98.4% at M3 follow-up. The proportion of patients on a high-intensity statin or a statin/ezetimibe did not change from discharge to M3 (<em>P</em> <!-->=<!--> <!-->0.45 and <em>P</em> <!-->=<!--> <!-->1.00, respectively).</div></div><div><h3>Conclusions</h3><div>Statins are effective, but not always enough to reach LDL-C target. Tolerance and persistence were good, with muscular side-effects as expected, but without any guarantee of statin imputability. BMI did not influence statin tolerance in this study.</div></div>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":"118 2","pages":"Pages 85-92"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142900674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}