Rates Of Systemic Embolism Research Articles

Efficacy of direct oral anticoagulants vs. warfarin in left ventricular thrombus in myocardial infarction: systematic review and meta-analysis.

Current recommendations for antithrombotic strategies in left ventricular (LV) thrombus following myocardial infarction (MI) remain uncertain. This study aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) compared to warfarin in LV thrombus following MI. A systematic search using four databases, including PubMed, Embase, Web of Science, and Cochrane CENTRAL, was conducted from inception to 8 July 2024, without language restrictions. The inclusion criteria were studies that included patients with LV thrombus following MI and compared the efficacy or safety of DOACs and warfarin. There were 11 studies (3 randomized and 8 nonrandomized) included in this meta-analysis, involving 14 927 participants. We used a random-effects model for this meta-analysis. DOACs were associated with higher thrombus resolution than warfarin, with a risk ratio (RR) of 1.07 [95% confidence interval (CI) 1.00-1.15], P = 0.04. Similarly, DOACs were associated with a lower rate of stroke and systemic embolism, with an RR of 0.84 (95% CI 0.78-0.90), P < 0.01. DOACs also marginally reduced the rate of major bleeding compared with warfarin, with an RR of 0.87 (95% CI 0.75-1.00), P = 0.05. DOACs were associated with higher rates of LV thrombus resolution, lower rates of stroke/systemic embolism, and marginally reduced major and bleeding events compared with warfarin in patients with LV thrombus following acute MI. Therefore, DOACs may be a reasonable alternative to warfarin in this setting.

Comparison of Direct Oral Anticoagulants and Vitamin K Antagonists for Left Ventricular Thrombus: A Global Retrospective Study

IntroductionGuidelines for managing left ventricular thrombus remain limited, particularly when incorporating oral anticoagulants into dual antiplatelet therapy for acute myocardial infarction. This study aims to assess the safety and efficacy of direct oral anticoagulants (DOAC) versus vitamin K antagonist (VKA) in managing left ventricular thrombus among patients with and without recent myocardial infarction. MethodsThis retrospective observational study used data from the TriNetX research network. Patients with left ventricular thrombus treated with either DOACs or VKAs between December 1, 2013, to December 1, 2023, were included. Subgroup analyses were conducted for patients with or without recent acute coronary syndrome (<1 month). Risk and Kaplan-Meier survival analysis were conducted at 90 days since the indexed event. ResultsA total of 39,770 patients were included. DOACs treatment had lower rates of stroke (11.8% vs. 13.7%, RR=0.859, 95% CI 0.816-0.905, p<0.001), major bleeding (4.8% vs. 5.3%, RR=0.902, 95% CI 0.829-0.982, p=0.018), and systemic embolism (3.5% vs. 4.2%, RR=0.841, 95% CI 0.762-0.928, p=0.001) compared to VKAs in overall cohort. Within acute coronary syndrome group (N=14,302), DOACs had lower stroke (12.3% vs. 14.4%, RR=0.860, 95% CI 0.791-0.935, p<0.0001) and systemic embolism (3.1% vs. 4%, RR=0.774, 95% CI 0.651-0.919, p=0.003) risks. For non-acute coronary syndrome group (N=24,162), DOACs had lower stroke (11.4% vs. 13.1%, RR=0.868, 95% CI 0.811-0.929, p<0.001) and major bleeding (4.8% vs. 5.5%, RR=0.877, 95% CI 0.787-0.977, p=0.017) risks. No significant differences in all-cause mortality were observed across groups. ConclusionDOACs demonstrated better safety and efficacy outcomes when compared to VKAs in left ventricular thrombus treatment, with or without recent acute coronary syndrome.

Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives.

Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC.

Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation

In older patients with atrial fibrillation who take anticoagulants for stroke prevention, bleeding is increased compared with younger patients, thus, clinicians frequently prescribe lower than recommended doses in older patients despite limited randomized data. To evaluate ischemic and bleeding outcomes in patients 80 years and older with atrial fibrillation receiving edoxaban, 60 mg vs 30 mg, and edoxaban, 30 mg vs warfarin. The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a parallel-design, double-blind, global clinical trial that randomized patients with atrial fibrillation to either one of 2 edoxaban dosing regimens or warfarin. This secondary analysis focused on patients 80 years or older without dose-reduction criteria receiving edoxaban, 60 mg vs 30 mg, as well as patients with or without dose-reduction criteria receiving edoxaban, 30 mg, vs warfarin. Study data were analyzed between October 2022 and December 2023. Oral edoxaban, 30 mg once daily; edoxaban, 60 mg once daily; or warfarin. Primary net clinical outcome of death, stroke or systemic embolism, and major bleeding and each individual component. The current analysis included 2966 patients 80 years and older (mean [SD] age, 83 [2.7] years; 1671 male [56%]). Among 1138 patients 80 years and older without dose-reduction criteria, those receiving edoxaban, 60 mg vs 30 mg, had more major bleeding events (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03), particularly gastrointestinal hemorrhage (HR, 2.24; 95% CI, 1.29-3.90; P = .004), with no significant difference in efficacy end points. Findings were supported by analyses of endogenous factor Xa inhibition, a marker of anticoagulant effect, which was comparable between younger patients receiving edoxaban, 60 mg, and older patients receiving edoxaban, 30 mg. In 2406 patients 80 years and older with or without dose-reduction criteria, patients receiving edoxaban, 30 mg, vs warfarin had lower rates of the primary net clinical outcome (HR, 0.78; 95% CI, 0.68-0.91; P = .001), major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001), and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046), whereas rates of stroke or systemic embolism were comparable. In this post hoc analysis of the ENGAGE AF-TIMI 48 randomized clinical trial, in patients 80 years and older with atrial fibrillation, major bleeding events were lower in patients randomized to receive edoxaban, 30 mg per day, compared with either edoxaban, 60 mg per day (in patients without dose-reduction criteria), or warfarin (irrespective of dose-reduction status), without an offsetting increase in ischemic events. These data support the concept that lower-dose anticoagulants, such as edoxaban, 30 mg, may be considered in older patients with atrial fibrillation even in the absence of dose-reduction criteria. ClinicalTrials.gov Identifier: NCT00781391.

Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: Rationale and Design of the ENBALV Trial.

Anticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement. The ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes. The ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice. Japan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .

Percutaneous left atrial appendage closure for stroke prevention in hypertrophic cardiomyopathy patients with atrial fibrillation

BackgroundPercutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain. ObjectiveThe study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC. MethodsBy use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders. ResultsOf 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC. ConclusionThese real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk.

SAFETY AND EFFICACY OF A LIGHT ANTITHROMBOTIC REGIMEN AFTER LEFT ATRIAL APPENDAGE OCCLUSION: INSIGHTS FROM THE LOGIC (LEFT ATRIAL APPENDAGE OCCLUSION IN PATIENTS WITH GASTROINTESTINAL OR INTRACRANIAL BLEEDING) INTERNATIONAL MULTICENTER REGISTRY

Abstract Background Antithrombotic therapy (AT) after left atrial appendage occlusion (LAAO) in patients with non–valvular atrial fibrillation (NVAF) has the purpose of preventing device related thrombosis (DRT), avoiding embolic events; nevertheless, the correct antithrombotic regimen after LAAO is still under debate. Aims Aim of this substudy of the observational LOGIC registry was to describe the efficacy and safety of a light antithrombotic regimen, comprising single antiplatelet therapy or none, compared to a standard antithrombotic regimen, after a successful LAAO. Methods Patients with NVAF that underwent LAAO were previously included in the LOGIC registry. Patients receiving single or no AT were considered as light therapy group, while other regimen were considered as standard regimen group. Outcomes of interest were: death from any causes and cardiovascular death, ischemic stroke, transient ischemic attack and systemic embolization, any bleeding and major bleeding at 12 months. Results. Six hundred and twenty–eight patients were considered in the analysis, 31.4% received a light antithrombotic regimen. There were no differences in overall and cardiovascular mortality (5.1% Vs 6.7%, p=0.426 and 2.0% Vs 1.4%, p=0.553 respectively). Cerebrovascular stroke and transient ischemic attack were similar between the two groups (1.5% Vs 1.4%, p=0.898 and 1.5% Vs 1.3%, p=0.847). Light regimen was not associated with an increased rate of systemic embolism (1.0% Vs 0.7%, p=0.447 and HR 0.88 [95% CI: 0.34 – 2.27; p=0.79]). Conclusions An AT regimen based on single or no antithrombotic therapy after LAAO seems to be safe in patients with high–bleeding risk, without increasing cerebrovascular or peripheral ischemic events.

Prophylactic Anticoagulation to Prevent Left Ventricular Thrombus Following Acute Myocardial Infarction: A Systematic Review and Meta-Analysis

Clinical practice guidelines from the American Heart Association recommend consideration of prophylactic anticoagulation to prevent left ventricular thrombus (LVT) formation in anterior ST-elevation myocardial infarction (STEMI) patients. These guidelines were given a low certainty of evidence (Class IIb, Level C), relying primarily on case studies and expert consensus to inform practice. Our objective was to compare the safety and efficacy of prophylactic anticoagulation, in addition to dual antiplatelet therapy (DAPT), in the current era of timely primary percutaneous coronary intervention (pPCI). EMBASE, MEDLINE and Cochrane Library were systematically searched from January 2012 through June 2022. A total of 7,378 publications were screened, and 5 publications were eventually included in this review: 1 randomized control trial and 4 retrospective studies involving 1,461 patients. Data were pooled using a fixed effects model and reported as odds ratios (OR) with 95% confidence intervals (CI). The primary outcome of interest was the rate of LVT formation, and the secondary outcomes were the rate of major bleeding and systemic embolism. Pooled analysis showed a significantly lower rate of LVT formation (OR: 0.28 [95% CI: 0.11–0.73; p < 0.01]) and significantly higher rates of bleeding (OR: 2.85 [95% CI: 1.13–7.24; p= 0.03]) in the triple therapy (TT) group compared to DAPT. No significant difference was observed in the rate of systemic embolism between the groups (OR: 0.37 [95% CI: 0.12–1.13; p = 0.08]). In this meta-analysis, there is no conclusive evidence to either support or oppose the use of TT for LVT prevention in anterior STEMI patients treated with pPCI. Appropriately powered randomized controlled trials are warranted to further evaluate the benefits of LVT prevention against the risks of major bleeding in this population.

One-year clinical outcomes and the impact of procedural configurations in patients with left atrial appendage occlusion

Abstract Background To evaluate the long-term clinical performance, the impact of procedural configurations and post-procedure medications in atrial fibrillation patients with percutaneous left atrial appendage occlusion (LAAO). Methods The RECORD study was a prospective, all-comers registry conducted in 39 Chinese centers that consecutively enrolling patients who received LAAO between 1st April 2019 and 31st October 2020 with minimum inclusion and exclusion criteria. Events including any death, any stroke, systemic embolism and bleeding event were collected at 1 year and adjudicated by an independent clinical event committee. Cox proportional hazard models with multivariable adjustments were applied to estimate hazard ratios (HRs) for each outcome. Results Of the 3,096 participants, 3,082 successfully received an LAAO implant and 3,013 (97.8%) completed the 1-year follow-up. Participants had a high risk of stroke (mean CHA2DS2-VASc score of 4.0) and a moderate-to-high risk of bleeding (mean HAS-BLED score of 2.4). Local anesthetic was performed in 1,287 (41.6%) patients and fluoroscopy guidance in 492 (16.0%) patients. In 1295 (42.0%) cases, one-stage combination procedures of LAAO and radiofrequency ablation or cryoablation (CA) were performed. At 1 year, the composite ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients. Any life-threatening, disabling or major bleeding events occurred in 71 (2.36%) patients. There was no significant association between the type of anesthesia (general versus local), modality of image guidance (TEE, ICE, or fluoroscopy) with the ischemic or bleeding events. Combination procedures of LAAO plus CA was associated with a significantly lower rate of death, stroke, or systemic embolism than performing LAAO only (3.5% versus 5.2%, HRadjusted:0.69, 95%CI:0.48-0.98, P=0.041). The commonest antithrombotic strategy was OAC | APT | APT (38.1%; corresponded to medication prescribed at discharge | 45 days | 6 months), followed by OAC | OAC | APT (27.0%). Compared with OAC | APT | APT, the OAC | OAC | APT group was associated with a higher risk of life-threatening, disabling or major bleeding (1.2% versus 2.5%, HRadjusted:0.50, 95%CI: 0.25-0.99, P=0.47); whereas the risk of death, stroke and SE was numerically similar (2.9% versus 3.0%, HRadjusted:1.05, 95%CI: 0.61-1.78, P=0.867). There was no significant difference between OAC | APT | APT and OAC+APT | APT | APT groups regarding ischemic events; however, in patients with HAS-BLED ≥ 3, OAC | APT | APT was associated with lower rates of life-threatening, disabling or major bleeding events (1.1% versus 4.8%, HRadjusted:4.55, 95%CI: 1.31-15.81, P=0.017). Conclusion In Chinese centers, patients with a WATCHMAN LAAO device had low rates of ischemic and bleeding events at 1 year. One-stage combination procedures of LAAO and catheter ablation was associated with a significantly lower rate of ischemic events than performing LAAO only.Procedural configurations to outcomesPost-LAAO antithrombotic medications

Atrial Fibrillation Patients with Immune Thrombocytopenia: A Review of Management Options and Bleeding Risks

Aim : The objective of this research is to review the bleeding risks in patients with atrial fibrillation (Afib) and immune thrombocytopenia (ITP) and explore various management strategies to formulate an optimal therapeutic approach that improves the prognosis of these patients. Methods: In this study, we devised our search approach by utilizing PubMed's Medical Subject Headings (MeSH) terms and incorporating pertinent keywords extracted from article titles and abstracts. To ensure a comprehensive scope, we integrated terms associated with immune thrombocytopenia purpura, such as “Immune Thrombocytopenia,” and similar expressions. Additionally, terms related to atrial fibrillation, including “atrial fibrillation,” were included to identify articles discussing atrial fibrillation in the context of immune thrombocytopenia. To adapt the initial search strategy for Embase, Web of Science, and Scopus databases, we employed a polyglot translator. All identified studies resulting from the search strategy were imported into EndNote, where duplicate articles were meticulously removed. The remaining studies were then transferred to Rayyan for further duplicate elimination and to initiate the screening process. The study incorporates full-text articles, submitted abstracts, and conference abstracts. Excluded from this analysis were studies falling into the following categories: (1) animal studies, (2) reviews or non-original articles, and (3) non-English articles. Results: A total of 1891 articles were retrieved from four databases, and after careful selection, 14 relevant full-text articles were analyzed. Among these, 12 studies investigated the efficacy of anticoagulants in managing cases of concurrent Afib and ITP as well as their bleeding risks. Comparing bleeding risk between groups was usually done through measuring by CHA 2DS 2 VASc or HAS BLED scoring systems and survival was also compared by using Kaplan-Meier curves A few of them also compared the efficacy and safety of warfarin against Non-Vitamin K Antagonists which has shown that Non-Vitamin K Antagonists have a lower event rate of major bleeding, lower hazard ration of systemic embolism and higher survival rate compared to warfarin The remaining two papers explored the efficacy and safety of surgical interventions, specifically left atrial appendage closure. Many studies reported that anticoagulant therapies were associated with reduced bleeding risk and have shown promising outcomes in managing patients with Afib and ITP. Additionally, percutaneous left atrial appendage closure has been reported to be a potentially safe management option for atrial fibrillation in patients with primary hemostatic disorders, including thrombocytopenia. Conclusion: In essence, this review focused on investigating the bleeding risk associated with atrial fibrillation (Afib) in patients with immune thrombocytopenia (ITP) and examining available management strategies. While the precise pathophysiological mechanisms linking atrial fibrillation and ITP remain incompletely understood, the review emphasized the intricate interplay between thromboembolic risk and bleeding complications in this specific patient group. The findings suggest that certain anticoagulation regimens and also left atrial appendage closure have shown promising safety and effectiveness in Afib patients with thrombocytopenia. Nevertheless, further research with larger sample sizes and diverse populations is needed to enhance our understanding of the Afib-ITP relationship. Such studies will yield more definitive conclusions and valuable insights into optimal anticoagulation approaches and alternative therapies for patients with both Afib and ITP.

Clinical Profiles and One-Year Outcome in Middle Eastern Patients With Atrial Fibrillation and Hypertension: Analysis From the Jordan Atrial Fibrillation Study.

Studies on the impact of hypertension (HTN) on the outcome of patients with atrial fibrillation (AF) in the Middle East are scarce. The aim of this contemporary multicenter study is to evaluate the effect of the coexisting HTN on the baseline clinical profiles and 1-year prognosis in a cohort of Middle Eastern patients with AF. Consecutive AF patients in 29 hospitals and cardiology clinics were enrolled in the Jordan AF study (May 2019-December 2020). Patients were prospectively followed up for 1year, and the study had no influence on their treatment, which was at the discretion of the treating physician. We compared clinical features, use of medications, and 1-year prognosis in patients with AF/HTN compared with AF/no HTN. Among 1849 non-valvular AF patients, 76.4% had HTN, with higher prevalence of diabetes, dyslipidemia, coronary heart disease, stroke, and left ventricular hypertrophy in HTN patients. There was a higher thromboembolic and bleeding risk among HTN patients. At 1year, HTN patients had significantly higher rates of stroke and systemic embolism (SSE) (4.5%), acute coronary syndrome (ACS) (2.4%), rehospitalization (27.9%), and major bleeding events (3.0%) compared with non-HTN patients. In this cohort, the coexistence of HTN was associated with worse baseline clinical profile and 1-year outcomes.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™legacy and FLX devices, there has been no reported long-term data for this approach. We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CTA-basedpreprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Unintended Consequences of Increased Out-of-Pocket Costs During Medicare Coverage Gap on Anticoagulant Discontinuation and Stroke.

This study aims to assess the risk of direct oral anticoagulant (DOAC) discontinuation among Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) who reach the Medicare coverage gap stratified by low-income subsidy (LIS) status and the impact of DOAC discontinuation on rates of stroke and systemic embolism (SE) among beneficiaries with increased out-of-pocket (OOP) costs due to not receiving LIS. In this retrospective cohort study, Medicare claims data (2015-2020) were used to identify beneficiaries with NVAF who initiated rivaroxaban or apixaban and entered the coverage gap during ≥ 1year. DOAC discontinuation rates during the coverage gap were stratified by receipt of Medicare Part D Low-Income Subsidy (LIS), a proxy for not experiencing increased OOP costs. Among non-LIS beneficiaries, incidence rates of stroke and SE during the subsequent 12months were compared between beneficiaries who did and did not discontinue DOAC in the coverage gap. Among 303,695 beneficiaries, mean age was 77.3years, and 28% received LIS. After adjusting for baseline differences, non-LIS beneficiaries (N = 218,838) had 78% higher risk of discontinuing DOAC during the coverage gap vs. LIS recipients (adjusted hazard ratio [aHR], 1.78; 95% CI [1.73, 1.82]). Among non-LIS beneficiaries, DOAC discontinuation during coverage gap (N = 91,397; 34%) was associated with 14% higher risk of experiencing stroke and SE during the subsequent 12months (aHR, 1.14; 95% CI [1.08, 1.20]). Increased OOP costs during Medicare coverage gap were associated with higher risk of DOAC discontinuation, which in turn was associated with higher risk of stroke and SE among beneficiaries with NVAF.

Clinical profile and prognosis of elderly patients with left ventricular thrombus after anticoagulation

BackgroundContemporary data regarding the clinical characteristics and prognosis of left ventricular thrombus (LVT) in older adults (aged ≥ 65 years old) are lacking. In this study, we characterized elderly patients with LVT (aged ≥ 65 years old) and investigated the long-term prognosis in this highly vulnerable patient population.MethodsThis single-center, retrospective study was conducted from January 2017 to December 2022. Patients with a reported LVT were assessed primarily by transthoracic echocardiography (TEE) and classified into two groups: elderly LVT groups and younger LVT groups. All patients were treated with anticoagulant treatment. Major adverse cardiovascular event (MACE) was defined as the composite of all-cause mortality, systemic embolism, and rehospitalization for cardiovascular events. Survival analyses were performed with the Kaplan-Meier method and Cox proportional-hazard model.ResultsA total of 315 eligible patients were included. Compared to the younger LVT group (n = 171), the elderly LVT group (n = 144) had a lower proportion of males and lower serum creatinine clearance, as well as a higher level of NT-proBNP, and a higher rate of history of systemic embolism. LVT resolution occurred in 59.7% and 69.0% of patients in the elderly LVT group and younger LVT group, respectively, with no significant difference (adjusted HR, 0.97; 95% CI, 0.74–1.28; P = 0.836). Yet, elderly patients with LVT, had higher prevalence rates of MACE (adjusted HR, 1.52; 95% CI, 1.10–2.11; P = 0.012), systemic embolism (adjusted HR, 2.81; 95% CI, 1.20–6.59; P = 0.017) and all-cause mortality (adjusted HR, 2.20; 95% CI, 1.29–3.74; P = 0.004) compared with younger patients with LVT. After adjusting for mortality in the Fine–Gray model, similar results were observed. Additionally, patients treated with different anticoagulation therapies (DOACs vs. warfarin) achieved a similar improvement in prognosis (P > 0.05) or LVT resolution (P > 0.05) in elderly patients with LVT.ConclusionsOur results found that elderly patients experiencing LVT have a poor prognosis compared with the younger ones. Clinical prognosis in elderly patients did not significantly differ with the type of anticoagulant used. With aging societies worldwide, further evidence of antithrombotic therapy in elderly individuals with LVT is necessary.

Predictors of stroke or systemic embolism in patients with non-valvular atrial fibrillation with CHA2DS2-VASc score of 0

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Anticoagulant therapy has been important for stroke prevention in patients with atrial fibrillation (AF). However, it was not recommended due to its relatively higher risk of bleeding than its lower risk of stroke in patients with a CHA2DS2-VASc score of 0. Purpose This study aimed to evaluate the predictors of stroke in AF patients with very low risk of stroke. Methods Between 1990 and 2020, 542 patients with non-valvular AF (NVAF) with a CHA2DS2-VASc score of 0 followed up for at least 6 months were enrolled. Patients whose only risk factor was female were included as a CHA2DS2-VASc score of 0 in this study. The primary outcome was stroke or systemic embolism. Results The mean age at AF diagnosis was 49.9 years, and 398 (73.4%) were men. During the mean follow-up of 4.7 years, the primary outcome rate was 0.78%/year (stroke, 0.70%/year; systemic embolism, 0.08%/year), and major bleeding and all-cause death occurred in 0.31%/year and 1.02%/year, respectively. The proportions of age ≥50 years at diagnosis, left ventricular end-diastolic dimension (LVEDD) of ≥46 mm, and non-paroxysmal AF in patients with stroke or systemic embolism were significantly higher than in those without. Cox proportional hazard model, age of ≥50 years at diagnosis (hazard ratio [HR] 6.710, 95% confidence interval [CI] 1.811–24.860, P-value=0.004), LVEDD of ≥46 mm (HR 4.513, 95% CI 1.038–19.626, P-value=0.045), and non-paroxysmal AF (HR 5.575, 95% CI 1.621–19.175, P-value=0.006) were identified as independent predictors of stroke or systemic embolism. Patients with all three independent predictors had a higher risk of stroke or systemic embolism (4.21%/year), whereas those without did not have stroke or systemic embolism. Conclusion The annual stroke or systemic embolism rate in NVAF patients with CHA2DS2-VASc score of 0 was 0.78%/year. Age at AF diagnosis, LVEDD, and non-paroxysmal AF were independent predictors of stroke or systemic embolism in patients considered to be at very low risk of stroke.

Gender Differences in Atrial Fibrillation: From the Thromboembolic Risk to the Anticoagulant Treatment Response

Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with an increased thromboembolic risk. The impact of the female sex as an independent risk factor for thromboembolic events in AF is still debated. Background and Objectives: The aim of this review is to evaluate the gender-related differences in cardioembolic risk and response to anticoagulants among AF patients. Materials and Methods: The PubMed database is used to review the reports about gender differences and thromboembolic risk in atrial fibrillation. Results: Non-vitamin K oral anticoagulants (NOACs) represent the gold standard for thromboembolic risk prevention in patients with non-valvular atrial fibrillation (NVAF). Despite a similar rate of stroke and systemic embolism (SE) among men and women in NOACs or vitamin K antagonists (VKAs) treatment, the use of NOACs in AF women is associated with a lower risk of intracranial bleeding, major bleeding, and all-cause mortality than in men. Conclusions: The female sex can be defined as a stroke risk modifier rather than a stroke risk factor since it mainly increases the thromboembolic risk in the presence of other risk factors. Further studies about the efficacy and safety profile of NOACs according to sex are needed to support clinicians in performing the most appropriate and tailored anticoagulant therapy, either in male or female AF patients.

Predictors of stroke or systemic embolism in patients with non-valvular atrial fibrillation with CHA2 DS2 -VASc score of 0.

Anticoagulant therapy has been important for stroke prevention in patients with atrial fibrillation (AF). However, it was not recommended due to its relatively higher risk of bleeding than its lower risk of stroke in patients with a CHA2 DS2 -VASc score of 0. This study aimed to evaluate the predictors of stroke in AF patients with very low risk of stroke. Between 1990 and 2020, 542 patients with non-valvular AF (NVAF) with a CHA2 DS2 -VASc score of 0 followed up for at least 6 months were enrolled. Patients with only being woman as a risk factor were included as a CHA2 DS2 -VASc score of 0 in this study. The primary outcome was stroke or systemic embolism. The primary outcome rate was 0.78%/year. In Cox hazard model, age of ≥50 years at diagnosis (hazard ratio [HR] 6.710, 95% confidence interval [CI] 1.811-24.860, p=.004), LVEDD of ≥46 mm (HR 4.513, 95% CI 1.038-19.626, p=.045), and non-paroxysmal AF (HR 5.575, 95% CI 1.621-19.175, p=.006) were identified as independent predictors of stroke or systemic embolism. Patients with all three independent predictors had a higher risk of stroke or systemic embolism (4.21%/year), whereas those without did not have a stroke or systemic embolism. The annual stroke or systemic embolism rate in NVAF patients with CHA2 DS2 -VASc score of 0 was 0.78%/year, and age at AF diagnosis, LVEDD, and non-paroxysmal AF were independent predictors of stroke or systemic embolism in patients considered to have a very low risk of stroke.

Comparison of primary and secondary stroke prevention in patients with nonvalvular atrial fibrillation: Results from the RAFFINE registry

ObjectivesClinical outcome data of primary and secondary prevention in patients with nonvalvular atrial fibrillation (NVAF) after the introduction of direct oral anticoagulant (DOAC) therapy are limited. Materials and MethodsA subgroup analysis of the RAFFINE registry, an observational, multicenter, prospective registry of Japanese patients with AF, was performed. Incidence rates of stroke or systemic embolism, all-cause death, major bleeding, and intracranial hemorrhage were compared between patients with and without a history of stroke or transient ischemic attack (TIA). ResultsOf 3,706 NVAF patients at baseline, 557 (15.0%) had a history of ischemic stroke or TIA (secondary prevention group), and 3,149 (85.0%) had no history of ischemic stroke or TIA (primary prevention group). The proportion of patients receiving oral anticoagulants was 87.2% (42.5% warfarin, 44.7% DOACs). The secondary prevention group had higher rates of stroke or systemic embolism (2.6% vs 1.0%/year, p<0.001), all-cause death (3.6% vs 2.4%/year, p<0.01), and major bleeding (2.0% vs 1.3%/year, p<0.01), and similar rates of intracranial hemorrhage (0.6% vs 0.5%/year, p=0.66) compared with the primary prevention group. A Cox proportional hazards model showed that a history of ischemic stroke or TIA was independently associated with an increased risk of stroke or systemic embolism (adjusted hazard ratio, 2.22; 95% confidence interval, 1.57 – 3.15; p<0.001). ConclusionsIn a contemporary cohort of NVAF patients, a history of ischemic stroke or TIA was still an independent predictor of stroke or systemic embolism, despite advances in anticoagulation therapy.

Comparative Effectiveness and Safety Between Apixaban, Dabigatran, Edoxaban, and Rivaroxaban Among Patients With Atrial Fibrillation : A Multinational Population-Based Cohort Study.

Current guidelines recommend using direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), but head-to-head trial data do not exist to guide the choice of DOAC. To do a large-scale comparison between all DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) in routine clinical practice. Multinational population-based cohort study. Five standardized electronic health care databases, which covered 221 million people in France, Germany, the United Kingdom, and the United States. Patients who were newly diagnosed with AF from 2010 through 2019 and received a new DOAC prescription. Database-specific hazard ratios (HRs) of ischemic stroke or systemic embolism, intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and all-cause mortality between DOACs were estimated using a Cox regression model stratified by propensity score and pooled using a random-effects model. A total of 527226 new DOAC users met the inclusion criteria (apixaban, n = 281320; dabigatran, n = 61008; edoxaban, n = 12722; and rivaroxaban, n = 172176). Apixaban use was associated with lower risk for GIB than use of dabigatran (HR, 0.81 [95% CI, 0.70 to 0.94]), edoxaban (HR, 0.77 [CI, 0.66 to 0.91]), or rivaroxaban (HR, 0.72 [CI, 0.66 to 0.79]). No substantial differences were observed for other outcomes or DOAC-DOAC comparisons. The results were consistent for patients aged 80 years or older. Consistent associations between lower GIB risk and apixaban versus rivaroxaban were observed among patients receiving the standard dose (HR, 0.72 [CI, 0.64 to 0.82]), those receiving a reduced dose (HR, 0.68 [CI, 0.61 to 0.77]), and those with chronic kidney disease (HR, 0.68 [CI, 0.59 to 0.77]). Residual confounding is possible. Among patients with AF, apixaban use was associated with lower risk for GIB and similar rates of ischemic stroke or systemic embolism, ICH, and all-cause mortality compared with dabigatran, edoxaban, and rivaroxaban. This finding was consistent for patients aged 80 years or older and those with chronic kidney disease, who are often underrepresented in clinical trials. None.

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial

BackgroundWomen have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited. ObjectivesThe aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer™ Amulet™ LAA Occluder) trial. MethodsThe following outcomes were compared between men and women: in-hospital complications, device-related outcomes (peridevice leak at 45 days and device-related thrombus at 18 months), and long-term clinical outcomes (death, thromboembolism, and bleeding). Subanalyses for the interaction between sex and device type were performed. ResultsA total of 1,833 patients underwent attempted device implantation (917 with the Amulet and 916 with the Watchman), of whom 734 were women (40%). Device success was 97.4% in men and 97.1% in women (P = 0.60). Rates of major in-hospital adverse events were higher in women (4.4% vs 1.9%; P < 0.01), driven by major bleeding (3.7% vs 1.0%; P < 0.01) and pericardial effusion requiring intervention (2.0% vs 0.5%; P < 0.01). Peridevice leak and device-related thrombus were similar in men and women (18.3% vs 18.9% [P = 0.78] and 3.3% vs 5.0% [P = 0.10], respectively). There were no differences between men and women in rates of ischemic stroke or systemic embolism (2.6% vs 2.6%; P = 0.98), transient ischemic attack (1.3% vs 1.6%; P = 0.69), hemorrhagic stroke (0.5% vs 0.4%; P = 0.88), major bleeding (10.1% vs 10.9%; P = 0.49), cardiovascular death (4.3% vs 3.5%; P = 0.45), or all-cause death (8.9% vs 6.9%; P = 0.16). ConclusionsIn the Amulet IDE trial, long-term clinical outcomes including effectiveness following LAAO were comparable in men and women despite the higher rates of in-hospital complications due to major bleeding and pericardial effusion in women. (Amplatzer™ Amulet™ LAA Occluder Trial [Amulet IDE]; NCT02879448)