Pub Date : 2024-08-01Epub Date: 2024-06-14DOI: 10.1161/CIRCOUTCOMES.123.010595
Ga Young Heo, Jung Tak Park, Hyo Jeong Kim, Kyung Won Kim, Yong Uk Kwon, Soo Hyun Kim, Gui Ok Kim, Seung Hyeok Han, Tae-Hyun Yoo, Shin-Wook Kang, Hyung Woo Kim
Background: Atrial fibrillation (AF) can lead to stroke, heart failure, and mortality and has a greater prevalence in dialysis patients than in the general population. Several studies have suggested that uremic toxins may contribute to the development of AF. However, the association between dialysis adequacy and incident AF has not been well established.
Methods: In this retrospective nationwide cohort study, we analyzed data from the Korean National Periodic Hemodialysis Quality Assessment from 2013 to 2015 of patients who received outpatient maintenance hemodialysis 3× a week. The main exposure was single pooled Kt/V (spKt/V), which is the dialysis adequacy index, and the primary outcome was the development of AF. For the primary analysis, patients were categorized into quartiles according to baseline spKt/V. The lowest quartile, representing the lowest adequacy, was used as the reference group. Fine-Gray subdistribution hazard models were used, treating all-cause mortality as a competing risk.
Results: Of 25 173 patients, the mean age was 60 (51-69) years, and 14 772 (58.7%) were men. During a median follow-up of 5.7 years, incident AF occurred in a total of 3883 (15.4%) patients. Participants with a higher spKt/V tended to have lower AF incidence. In survival analysis, a graded association was observed between the risk of incident AF and spKt/V quartiles: subdistribution hazard ratios and 95% CIs for the second, third, and the highest quartile compared with the lowest quartile were 0.90 (95% CI, 0.82-0.98), 0.84 (95% CI, 0.77-0.93), and 0.79 (95% CI, 0.72-0.88), respectively.
Conclusions: This nationwide cohort study showed that a higher spKt/V is associated with a reduced risk of incident AF. These findings suggests that reducing uremic toxin burden through enhanced dialysis clearance may be associated with a lower risk of AF development in patients undergoing maintenance hemodialysis.
{"title":"Adequacy of Dialysis and Incidence of Atrial Fibrillation in Patients Undergoing Hemodialysis.","authors":"Ga Young Heo, Jung Tak Park, Hyo Jeong Kim, Kyung Won Kim, Yong Uk Kwon, Soo Hyun Kim, Gui Ok Kim, Seung Hyeok Han, Tae-Hyun Yoo, Shin-Wook Kang, Hyung Woo Kim","doi":"10.1161/CIRCOUTCOMES.123.010595","DOIUrl":"10.1161/CIRCOUTCOMES.123.010595","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) can lead to stroke, heart failure, and mortality and has a greater prevalence in dialysis patients than in the general population. Several studies have suggested that uremic toxins may contribute to the development of AF. However, the association between dialysis adequacy and incident AF has not been well established.</p><p><strong>Methods: </strong>In this retrospective nationwide cohort study, we analyzed data from the Korean National Periodic Hemodialysis Quality Assessment from 2013 to 2015 of patients who received outpatient maintenance hemodialysis 3× a week. The main exposure was single pooled Kt/V (spKt/V), which is the dialysis adequacy index, and the primary outcome was the development of AF. For the primary analysis, patients were categorized into quartiles according to baseline spKt/V. The lowest quartile, representing the lowest adequacy, was used as the reference group. Fine-Gray subdistribution hazard models were used, treating all-cause mortality as a competing risk.</p><p><strong>Results: </strong>Of 25 173 patients, the mean age was 60 (51-69) years, and 14 772 (58.7%) were men. During a median follow-up of 5.7 years, incident AF occurred in a total of 3883 (15.4%) patients. Participants with a higher spKt/V tended to have lower AF incidence. In survival analysis, a graded association was observed between the risk of incident AF and spKt/V quartiles: subdistribution hazard ratios and 95% CIs for the second, third, and the highest quartile compared with the lowest quartile were 0.90 (95% CI, 0.82-0.98), 0.84 (95% CI, 0.77-0.93), and 0.79 (95% CI, 0.72-0.88), respectively.</p><p><strong>Conclusions: </strong>This nationwide cohort study showed that a higher spKt/V is associated with a reduced risk of incident AF. These findings suggests that reducing uremic toxin burden through enhanced dialysis clearance may be associated with a lower risk of AF development in patients undergoing maintenance hemodialysis.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e010595"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-08DOI: 10.1161/CIRCOUTCOMES.124.011189
Patrick Highton, Kamlesh Khunti
{"title":"Letter by Highton and Khunti Regarding Article, \"Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID): A Randomized Clinical Trial\".","authors":"Patrick Highton, Kamlesh Khunti","doi":"10.1161/CIRCOUTCOMES.124.011189","DOIUrl":"10.1161/CIRCOUTCOMES.124.011189","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011189"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555801","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}
Background: The increasing prevalence of frailty has gained considerable attention due to its profound influence on clinical outcomes. However, our understanding of the progression of frailty and long-term clinical outcomes in older individuals with atrial fibrillation remains scarce.
Methods: Using data from 2012 to 2018 from a comprehensive claims database incorporating primary and hospital care records in Shizuoka, Japan, we selected patients aged ≥65 years with atrial fibrillation who initiated oral anticoagulant therapy. The trajectory of frailty was plotted using Sankey plots, illustrating the annual changes in their frailty according to the electronic frailty index during a 3-year follow-up after oral anticoagulant initiation, along with the incidence of clinical adverse outcomes. For deceased patients, we assessed their frailty status in the year preceding their death.
Results: Of 6247 eligible patients (45.1% women; mean age, 79.3±8.0 years) at oral anticoagulant initiation, 7.7% were categorized as fit (electronic frailty index, 0-0.12), 30.1% as mildly frail (>0.12-0.24), 35.4% as moderately frail (>0.24-0.36), and 25.9% as severely frail (>0.36). Over the 3-year follow-up, 10.4% of initially fit patients transitioned to moderately frail or severely frail. Conversely, 12.5% of severely frail patients improved to fit or mildly frail. Death, stroke, and major bleeding occurred in 23.4%, 4.1%, and 2.2% of patients, respectively. Among the mortality cases, 74.8% (N=1183) and 3.5% (N=55) had experienced moderately or severely frail and either a stroke or major bleeding in the year preceding their death, respectively.
Conclusions: In a contemporary era of atrial fibrillation management, a minor fraction of older patients on oral anticoagulants died following a stroke or major bleeding. However, their frailty demonstrated a dynamic trajectory, and a substantial proportion of death was observed after transitioning to a moderately or severely frail state.
{"title":"Trajectories of Frailty and Clinical Outcomes in Older Adults With Atrial Fibrillation: Insights From the Shizuoka Kokuho Database.","authors":"Ryo Nakamaru, Shiori Nishimura, Hiraku Kumamaru, Satoshi Shoji, Eiji Nakatani, Hiroyuki Yamamoto, Yoshiki Miyachi, Hiroaki Miyata, Shun Kohsaka","doi":"10.1161/CIRCOUTCOMES.123.010642","DOIUrl":"https://doi.org/10.1161/CIRCOUTCOMES.123.010642","url":null,"abstract":"<p><strong>Background: </strong>The increasing prevalence of frailty has gained considerable attention due to its profound influence on clinical outcomes. However, our understanding of the progression of frailty and long-term clinical outcomes in older individuals with atrial fibrillation remains scarce.</p><p><strong>Methods: </strong>Using data from 2012 to 2018 from a comprehensive claims database incorporating primary and hospital care records in Shizuoka, Japan, we selected patients aged ≥65 years with atrial fibrillation who initiated oral anticoagulant therapy. The trajectory of frailty was plotted using Sankey plots, illustrating the annual changes in their frailty according to the electronic frailty index during a 3-year follow-up after oral anticoagulant initiation, along with the incidence of clinical adverse outcomes. For deceased patients, we assessed their frailty status in the year preceding their death.</p><p><strong>Results: </strong>Of 6247 eligible patients (45.1% women; mean age, 79.3±8.0 years) at oral anticoagulant initiation, 7.7% were categorized as fit (electronic frailty index, 0-0.12), 30.1% as mildly frail (>0.12-0.24), 35.4% as moderately frail (>0.24-0.36), and 25.9% as severely frail (>0.36). Over the 3-year follow-up, 10.4% of initially fit patients transitioned to moderately frail or severely frail. Conversely, 12.5% of severely frail patients improved to fit or mildly frail. Death, stroke, and major bleeding occurred in 23.4%, 4.1%, and 2.2% of patients, respectively. Among the mortality cases, 74.8% (N=1183) and 3.5% (N=55) had experienced moderately or severely frail and either a stroke or major bleeding in the year preceding their death, respectively.</p><p><strong>Conclusions: </strong>In a contemporary era of atrial fibrillation management, a minor fraction of older patients on oral anticoagulants died following a stroke or major bleeding. However, their frailty demonstrated a dynamic trajectory, and a substantial proportion of death was observed after transitioning to a moderately or severely frail state.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":"17 8","pages":"e010642"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-01DOI: 10.1161/HCQ.0000000000000131
Katherine E Di Palo, Shelli Feder, Yleana T Baggenstos, Cyrille K Cornelio, Daniel E Forman, Parag Goyal, Min Ji Kwak, Colleen K McIlvennan
Cardiovascular disease exacts a heavy toll on health and quality of life and is the leading cause of death among people ≥65 years of age. Although medical, surgical, and device therapies can certainly prolong a life span, disease progression from chronic to advanced to end stage is temporally unpredictable, uncertain, and marked by worsening symptoms that result in recurrent hospitalizations and excessive health care use. Compared with other serious illnesses, medication management that incorporates a palliative approach is underused among individuals with cardiovascular disease. This scientific statement describes palliative pharmacotherapy inclusive of cardiovascular drugs and essential palliative medicines that work synergistically to control symptoms and enhance quality of life. We also summarize and clarify available evidence on the utility of guideline-directed and evidence-based medical therapies in individuals with end-stage heart failure, pulmonary arterial hypertension, coronary heart disease, and other cardiomyopathies while providing clinical considerations for de-escalating or deprescribing. Shared decision-making and goal-oriented care are emphasized and considered quintessential to the iterative process of patient-centered medication management across the spectrum of cardiovascular disease.
{"title":"Palliative Pharmacotherapy for Cardiovascular Disease: A Scientific Statement From the American Heart Association.","authors":"Katherine E Di Palo, Shelli Feder, Yleana T Baggenstos, Cyrille K Cornelio, Daniel E Forman, Parag Goyal, Min Ji Kwak, Colleen K McIlvennan","doi":"10.1161/HCQ.0000000000000131","DOIUrl":"10.1161/HCQ.0000000000000131","url":null,"abstract":"<p><p>Cardiovascular disease exacts a heavy toll on health and quality of life and is the leading cause of death among people ≥65 years of age. Although medical, surgical, and device therapies can certainly prolong a life span, disease progression from chronic to advanced to end stage is temporally unpredictable, uncertain, and marked by worsening symptoms that result in recurrent hospitalizations and excessive health care use. Compared with other serious illnesses, medication management that incorporates a palliative approach is underused among individuals with cardiovascular disease. This scientific statement describes palliative pharmacotherapy inclusive of cardiovascular drugs and essential palliative medicines that work synergistically to control symptoms and enhance quality of life. We also summarize and clarify available evidence on the utility of guideline-directed and evidence-based medical therapies in individuals with end-stage heart failure, pulmonary arterial hypertension, coronary heart disease, and other cardiomyopathies while providing clinical considerations for de-escalating or deprescribing. Shared decision-making and goal-oriented care are emphasized and considered quintessential to the iterative process of patient-centered medication management across the spectrum of cardiovascular disease.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e000131"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-14DOI: 10.1161/CIRCOUTCOMES.124.011063
Puja Mehta, Jeffrey M Turner
{"title":"More Is Better!!","authors":"Puja Mehta, Jeffrey M Turner","doi":"10.1161/CIRCOUTCOMES.124.011063","DOIUrl":"10.1161/CIRCOUTCOMES.124.011063","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011063"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-08-21DOI: 10.1161/CIRCOUTCOMES.124.010601
Chris T Longenecker, Luisa Brant, Emmy Okello, Andrea Beaton
{"title":"More With Less: Diffusing Innovations in Cardiovascular Service Delivery.","authors":"Chris T Longenecker, Luisa Brant, Emmy Okello, Andrea Beaton","doi":"10.1161/CIRCOUTCOMES.124.010601","DOIUrl":"https://doi.org/10.1161/CIRCOUTCOMES.124.010601","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":"17 8","pages":"e010601"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-29DOI: 10.1161/CIRCOUTCOMES.124.011275
Yasser M Sammour, John A Spertus
{"title":"Par for the Course: The Interplay Between Telehealth Parity Laws and Hypertension Medication Adherence.","authors":"Yasser M Sammour, John A Spertus","doi":"10.1161/CIRCOUTCOMES.124.011275","DOIUrl":"10.1161/CIRCOUTCOMES.124.011275","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011275"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-19DOI: 10.1161/CIRCOUTCOMES.123.010396
Katherine T Mills, Samantha S O'Connell, Meng Pan, Katherine M Obst, Hua He, Jiang He
Background: Globally, only 13.8% of patients with hypertension have their blood pressure (BP) controlled. Trials testing interventions to overcome barriers to BP control have produced mixed results. Type of health care professional delivering the intervention may play an important role in intervention success. The goal of this meta-analysis is to determine which health care professionals are most effective at delivering BP reduction interventions.
Methods: We searched Medline and Embase (until December 2023) for randomized controlled trials of interventions targeting barriers to hypertension control reporting who led intervention delivery. One hundred articles worldwide with 116 comparisons and 90 474 participants with hypertension were included. Trials were grouped by health care professional, and the effects of the intervention on systolic and diastolic BP were combined using random effects models and generalized estimating equations.
Results: Pharmacist-led interventions , community health worker-led interventions, and health educator-led interventions resulted in the greatest systolic BP reductions of -7.3 (95% CI, -9.1 to -5.6), -7.1 (95% CI, -10.8 to -3.4), and -5.2 (95% CI, -7.8 to -2.6) mm Hg, respectively. Interventions led by multiple health care professionals, nurses, and physicians also resulted in significant systolic BP reductions of -4.2 (95% CI, -6.1 to -2.4), -3.0 (95% CI, -4.2 to -1.9), and -2.4 (95% CI, -3.4 to -1.5) mm Hg, respectively. Similarly, the greatest diastolic BP reductions were -3.9 (95% CI, -5.2 to -2.5) mm Hg for pharmacist-led and -3.7 (95% CI, -6.6 to -0.8) mm Hg for community health worker-led interventions. In pairwise comparisons, pharmacist were significantly more effective than multiple health care professionals, nurses, and physicians at delivering interventions.
Conclusions: Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.
{"title":"Role of Health Care Professionals in the Success of Blood Pressure Control Interventions in Patients With Hypertension: A Meta-Analysis.","authors":"Katherine T Mills, Samantha S O'Connell, Meng Pan, Katherine M Obst, Hua He, Jiang He","doi":"10.1161/CIRCOUTCOMES.123.010396","DOIUrl":"10.1161/CIRCOUTCOMES.123.010396","url":null,"abstract":"<p><strong>Background: </strong>Globally, only 13.8% of patients with hypertension have their blood pressure (BP) controlled. Trials testing interventions to overcome barriers to BP control have produced mixed results. Type of health care professional delivering the intervention may play an important role in intervention success. The goal of this meta-analysis is to determine which health care professionals are most effective at delivering BP reduction interventions.</p><p><strong>Methods: </strong>We searched Medline and Embase (until December 2023) for randomized controlled trials of interventions targeting barriers to hypertension control reporting who led intervention delivery. One hundred articles worldwide with 116 comparisons and 90 474 participants with hypertension were included. Trials were grouped by health care professional, and the effects of the intervention on systolic and diastolic BP were combined using random effects models and generalized estimating equations.</p><p><strong>Results: </strong>Pharmacist-led interventions , community health worker-led interventions, and health educator-led interventions resulted in the greatest systolic BP reductions of -7.3 (95% CI, -9.1 to -5.6), -7.1 (95% CI, -10.8 to -3.4), and -5.2 (95% CI, -7.8 to -2.6) mm Hg, respectively. Interventions led by multiple health care professionals, nurses, and physicians also resulted in significant systolic BP reductions of -4.2 (95% CI, -6.1 to -2.4), -3.0 (95% CI, -4.2 to -1.9), and -2.4 (95% CI, -3.4 to -1.5) mm Hg, respectively. Similarly, the greatest diastolic BP reductions were -3.9 (95% CI, -5.2 to -2.5) mm Hg for pharmacist-led and -3.7 (95% CI, -6.6 to -0.8) mm Hg for community health worker-led interventions. In pairwise comparisons, pharmacist were significantly more effective than multiple health care professionals, nurses, and physicians at delivering interventions.</p><p><strong>Conclusions: </strong>Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e010396"},"PeriodicalIF":6.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11338746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01Epub Date: 2024-06-03DOI: 10.1161/CIRCOUTCOMES.123.010561
Brian A Bergmark, Jeong-Gun Park, Rose A Hamershock, Giorgio E M Melloni, Raffaele De Caterina, Elliott M Antman, Christian T Ruff, Howard Rutman, Michele F Mercuri, Hans-Joachim Lanz, Eugene Braunwald, Robert P Giugliano
Background: Cardiovascular trials often use a composite end point and a time-to-first event model. We sought to compare edoxaban versus warfarin using the win ratio, which offers data complementary to time-to-first event analysis, emphasizing the most severe clinical events.
Methods: ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind, randomized trial in which patients with atrial fibrillation were assigned 1:1:1 to a higher dose edoxaban regimen (60/30 mg daily), a lower dose edoxaban regimen (30/15 mg daily), or warfarin. In an exploratory analysis, we analyzed the trial outcomes using an unmatched win ratio approach. The win ratio for each edoxaban regimen was the total number of edoxaban wins divided by the number of warfarin wins for the following ranked clinical outcomes: 1: death; 2: hemorrhagic stroke; 3: ischemic stroke/systemic embolic event/epidural or subdural bleeding; 4: noncerebral International Society on Thrombosis and Haemostasis major bleeding; and 5: cardiovascular hospitalization.
Results: 21 105 patients were randomized to higher dose edoxaban regimen (N=7035), lower dose edoxaban regimen (N=7034), or warfarin (N=7046), yielding >49 million pairs for each treatment comparison. The median age was 72 years, 38% were women, and 59% had prior vitamin K antagonist use. The win ratio was 1.11 (95% CI, 1.05-1.18) for higher dose edoxaban regimen versus warfarin and 1.11 (95% CI, 1.05-1.18) for lower dose edoxaban regimen versus warfarin. The favorable impacts of edoxaban on death (34% of wins) and cardiovascular hospitalization (41% of wins) were the major contributors to the win ratio. Results consistently favored edoxaban in subgroups based on creatine clearance and dose reduction at baseline, with heightened benefit among those without prior vitamin K antagonist use.
Conclusions: In a win ratio analysis of the ENGAGE AF-TIMI 48 trial, both dose regimens of edoxaban were superior to warfarin for the net clinical outcome incorporating ischemic and bleeding events. As the win ratio emphasizes the most severe clinical events, this analysis supports the superiority of edoxaban over warfarin in patients with atrial fibrillation.
{"title":"Application of the Win Ratio Method in the ENGAGE AF-TIMI 48 Trial Comparing Edoxaban With Warfarin in Patients With Atrial Fibrillation.","authors":"Brian A Bergmark, Jeong-Gun Park, Rose A Hamershock, Giorgio E M Melloni, Raffaele De Caterina, Elliott M Antman, Christian T Ruff, Howard Rutman, Michele F Mercuri, Hans-Joachim Lanz, Eugene Braunwald, Robert P Giugliano","doi":"10.1161/CIRCOUTCOMES.123.010561","DOIUrl":"10.1161/CIRCOUTCOMES.123.010561","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular trials often use a composite end point and a time-to-first event model. We sought to compare edoxaban versus warfarin using the win ratio, which offers data complementary to time-to-first event analysis, emphasizing the most severe clinical events.</p><p><strong>Methods: </strong>ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind, randomized trial in which patients with atrial fibrillation were assigned 1:1:1 to a higher dose edoxaban regimen (60/30 mg daily), a lower dose edoxaban regimen (30/15 mg daily), or warfarin. In an exploratory analysis, we analyzed the trial outcomes using an unmatched win ratio approach. The win ratio for each edoxaban regimen was the total number of edoxaban wins divided by the number of warfarin wins for the following ranked clinical outcomes: 1: death; 2: hemorrhagic stroke; 3: ischemic stroke/systemic embolic event/epidural or subdural bleeding; 4: noncerebral International Society on Thrombosis and Haemostasis major bleeding; and 5: cardiovascular hospitalization.</p><p><strong>Results: </strong>21 105 patients were randomized to higher dose edoxaban regimen (N=7035), lower dose edoxaban regimen (N=7034), or warfarin (N=7046), yielding >49 million pairs for each treatment comparison. The median age was 72 years, 38% were women, and 59% had prior vitamin K antagonist use. The win ratio was 1.11 (95% CI, 1.05-1.18) for higher dose edoxaban regimen versus warfarin and 1.11 (95% CI, 1.05-1.18) for lower dose edoxaban regimen versus warfarin. The favorable impacts of edoxaban on death (34% of wins) and cardiovascular hospitalization (41% of wins) were the major contributors to the win ratio. Results consistently favored edoxaban in subgroups based on creatine clearance and dose reduction at baseline, with heightened benefit among those without prior vitamin K antagonist use.</p><p><strong>Conclusions: </strong>In a win ratio analysis of the ENGAGE AF-TIMI 48 trial, both dose regimens of edoxaban were superior to warfarin for the net clinical outcome incorporating ischemic and bleeding events. As the win ratio emphasizes the most severe clinical events, this analysis supports the superiority of edoxaban over warfarin in patients with atrial fibrillation.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781391.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e010561"},"PeriodicalIF":6.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01Epub Date: 2024-05-21DOI: 10.1161/CIRCOUTCOMES.123.010459
Michael P Thompson, Hechuan Hou, Donald S Likosky, Francis D Pagani, Jason R Falvey, Kathryn H Bowles, Rishi K Wadhera, Madeline R Sterling
Background: Home health care (HHC) has been increasingly used to improve care transitions and avoid poor outcomes, but there is limited data on its use and efficacy following coronary artery bypass grafting. The purpose of this study was to describe HHC use and its association with outcomes among Medicare beneficiaries undergoing coronary artery bypass grafting.
Methods: Retrospective analysis of 100% of Medicare fee-for-service files identified 77 331 beneficiaries undergoing coronary artery bypass grafting and discharged to home between July 2016 and December 2018. The primary exposure of HHC use was defined as the presence of paid HHC claims within 30 days of discharge. Hierarchical logistic regression identified predictors of HHC use and the percentage of variation in HHC use attributed to the hospital. Propensity-matched logistic regression compared mortality, readmissions, emergency department visits, and cardiac rehabilitation enrollment at 30 and 90 days after discharge between HHC users and nonusers.
Results: A total of 26 751 (34.6%) of beneficiaries used HHC within 30 days of discharge, which was more common among beneficiaries who were older (72.9 versus 72.5 years), male (79.4% versus 77.4%), White (90.2% versus 89.2%), and not Medicare-Medicaid dual eligible (6.7% versus 8.8%). The median hospital-level rate of HHC use was 31.0% (interquartile range, 13.7%-54.5%) and ranged from 0% to 94.2%. Nearly 30% of the interhospital variation in HHC use was attributed to the discharging hospital (intraclass correlation coefficient, 0.296 [95% CI, 0.275-0.318]). Compared with non-HHC users, those using HHC were less likely to have a readmission or emergency department visit, were more likely to enroll in cardiac rehabilitation, and had modestly higher mortality within 30 or 90 days of discharge.
Conclusions: A third of Medicare beneficiaries undergoing coronary artery bypass grafting used HHC within 30 days of discharge, with wide interhospital variation in use and mixed associations with clinical outcomes and health care utilization.
{"title":"Home Health Care Use and Outcomes After Coronary Artery Bypass Grafting Among Medicare Beneficiaries.","authors":"Michael P Thompson, Hechuan Hou, Donald S Likosky, Francis D Pagani, Jason R Falvey, Kathryn H Bowles, Rishi K Wadhera, Madeline R Sterling","doi":"10.1161/CIRCOUTCOMES.123.010459","DOIUrl":"10.1161/CIRCOUTCOMES.123.010459","url":null,"abstract":"<p><strong>Background: </strong>Home health care (HHC) has been increasingly used to improve care transitions and avoid poor outcomes, but there is limited data on its use and efficacy following coronary artery bypass grafting. The purpose of this study was to describe HHC use and its association with outcomes among Medicare beneficiaries undergoing coronary artery bypass grafting.</p><p><strong>Methods: </strong>Retrospective analysis of 100% of Medicare fee-for-service files identified 77 331 beneficiaries undergoing coronary artery bypass grafting and discharged to home between July 2016 and December 2018. The primary exposure of HHC use was defined as the presence of paid HHC claims within 30 days of discharge. Hierarchical logistic regression identified predictors of HHC use and the percentage of variation in HHC use attributed to the hospital. Propensity-matched logistic regression compared mortality, readmissions, emergency department visits, and cardiac rehabilitation enrollment at 30 and 90 days after discharge between HHC users and nonusers.</p><p><strong>Results: </strong>A total of 26 751 (34.6%) of beneficiaries used HHC within 30 days of discharge, which was more common among beneficiaries who were older (72.9 versus 72.5 years), male (79.4% versus 77.4%), White (90.2% versus 89.2%), and not Medicare-Medicaid dual eligible (6.7% versus 8.8%). The median hospital-level rate of HHC use was 31.0% (interquartile range, 13.7%-54.5%) and ranged from 0% to 94.2%. Nearly 30% of the interhospital variation in HHC use was attributed to the discharging hospital (intraclass correlation coefficient, 0.296 [95% CI, 0.275-0.318]). Compared with non-HHC users, those using HHC were less likely to have a readmission or emergency department visit, were more likely to enroll in cardiac rehabilitation, and had modestly higher mortality within 30 or 90 days of discharge.</p><p><strong>Conclusions: </strong>A third of Medicare beneficiaries undergoing coronary artery bypass grafting used HHC within 30 days of discharge, with wide interhospital variation in use and mixed associations with clinical outcomes and health care utilization.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e010459"},"PeriodicalIF":6.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141071711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}