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Background: There has been an increasing uptake of transcatheter left atrial appendage occlusion (LAAO) for stroke reduction in atrial fibrillation., Objectives: To investigate the perceptions and approaches among a nationally representative sample of physicians., Methods: Using the American Medical Association Physician Masterfile, we selected a random sample of 500 physicians from each of the specialties: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists. The participants received the survey by mail up to three times from November 9, 2021 to January 14, 2022. In addition to the questions about experiences, perceptions, and approaches, physicians were randomly assigned to 1 of the 4 versions of a patient vignette: white man, white woman, black man, and black woman, to investigate potential bias in decision-making., Results: The top three reasons for considering LAAO were: a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%), whereas the top three reasons for withholding LAAO were: other indications for long-term oral anticoagulation (87.7%), a low bleeding risk (77.0%), and a low stroke risk (65.6%). For the reasons limiting recommendations for LAAO, 59.8% mentioned procedural risks, 42.6% mentioned "limiting efficacy data comparing LAAO to NOAC" and 32.8% mentioned "limited safety data comparing LAAO to NOAC." There was no difference in physicians' decision-making by patients' race, gender, or the concordance between patients' and physicians' race or gender., Conclusions: In the first U.S. national physician survey of LAAO, individual physicians' perspectives varied greatly, which provided information that will help customize future educational activities for different audiences., Condensed Abstract: Although diverse practice patterns of LAAO have been documented, little is known about the reasoning or perceptions that drive these variations. Unlike prior surveys that were directed to Centers that performed LAAO, the current survey obtained insights from individual physicians, not only those who perform the procedures (interventional cardiologists and electrophysiologists) but also those who are closely involved in the decision-making and referral process (general cardiologists and vascular neurologists). The findings identify key evidence gaps and help prioritize future studies to establish a consistent and evidence-based best practice for AF stroke prevention., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Lifelong oral anticoagulation is recommended in patients with atrial fibrillation (AF) to prevent stroke. Over the last decade, multiple new oral anticoagulants (OACs) have expanded the number of treatment options for these patients. While population-level effectiveness of OACs has been compared, it is unclear if there is variability in benefit and risk across patient subgroups., Methods: We analyzed claims and medical data for 34,569 patients who initiated a nonvitamin K antagonist oral anticoagulant (non-vitamin K antagonist oral anticoagulant (NOAC); apixaban, dabigatran, and rivaroxaban) or warfarin for nonvalvular AF between 08/01/2010 and 11/29/2017 from the OptumLabs Data Warehouse. A machine learning (ML) method was applied to match different OAC groups on several baseline variables including, age, sex, race, renal function, and CHA 2 DS 2 -VASC score. A causal ML method was then used to discover patient subgroups characterizing the head-to-head treatment effects of the OACs on a primary composite outcome of ischemic stroke, intracranial hemorrhage, and all-cause mortality., Results: The mean age, number of females and white race in the entire cohort of 34,569 patients were 71.2 (SD, 10.7) years, 14,916 (43.1%), and 25,051 (72.5%) respectively. During a mean follow-up of 8.3 (SD, 9.0) months, 2,110 (6.1%) of patients experienced the composite outcome, of whom 1,675 (4.8%) died. The causal ML method identified 5 subgroups with variables favoring apixaban over dabigatran; 2 subgroups favoring apixaban over rivaroxaban; 1 subgroup favoring dabigatran over rivaroxaban; and 1 subgroup favoring rivaroxaban over dabigatran in terms of risk reduction of the primary endpoint. No subgroup favored warfarin and most dabigatran vs warfarin users favored neither drug. The variables that most influenced favoring one subgroup over another included Age, history of ischemic stroke, thromboembolism, estimated glomerular filtration rate, Race, and myocardial infarction., Conclusions: Among patients with AF treated with a NOAC or warfarin, a causal ML method identified patient subgroups with differences in outcomes associated with OAC use. The findings suggest that the effects of OACs are heterogeneous across subgroups of AF patients, which could help personalize the choice of OAC. Future prospective studies are needed to better understand the clinical impact of the subgroups with respect to OAC selection., Competing Interests: Disclosures None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background This study aimed to compare percutaneous left atrial appendage occlusion (LAAO) with non-vitamin K antagonist oral anticoagulants among patients with atrial fibrillation. Methods and Results Using a US administrative database, 562 850 patients with atrial fibrillation were identified, among whom 8397 were treated with LAAO and 554 453 were treated with non-vitamin K antagonist oral anticoagulants between March 13, 2015 and December 31, 2018. Propensity score overlap weighting was used to balance baseline characteristics. The primary outcome was a composite end point of ischemic stroke or systemic embolism, major bleeding, and all-cause mortality. The mean age was 76.4±7.6 years; 280 097 (49.8%) were female. Mean follow-up was 1.5±1.0 years. LAAO was associated with no significant difference in the risk of the primary composite end point (hazard ratio [HR], 0.93 [0.84-1.03]), or the secondary outcomes including ischemic stroke/systemic embolism (HR, 1.07 [0.81-1.41]), and intracranial bleeding (HR, 1.08 [0.72-1.61]). LAAO was associated with a higher risk of major bleeding (HR, 1.22 [1.05-1.42], P =0.01) and a lower risk of mortality (HR, 0.73 [0.64-0.84], P <0.001). The lower risk of mortality associated with LAAO was most pronounced in patients with a prior history of intracranial bleeding. Conclusions In comparison to non-vitamin K antagonist oral anticoagulants, LAAO was associated with no significant difference in the risk of the composite outcome and a lower risk of mortality, which suggests LAAO might be a reasonable option in select patients with atrial fibrillation. The observation of higher bleeding risk associated with LAAO highlights the need to optimize postprocedural antithrombotic regimens as well as systematic efforts to assess and address bleeding predispositions.

Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Importance: Surgical occlusion of the left atrial appendage (LAAO) may be performed during concurrent cardiac surgery. However, few data exist on the association of LAAO with long-term risk of stroke, and some evidence suggests that this procedure may be associated with subsequent development of atrial fibrillation (AF)., Objective: To evaluate the association of surgical LAAO performed during cardiac surgery with risk of stroke, mortality, and development of subsequent AF., Design, Setting, and Participants: Retrospective cohort study using a large US administrative database that contains data from adult patients (≥18 years) with private insurance or Medicare Advantage who underwent coronary artery bypass graft (CABG) or valve surgery between January 1, 2009, and March 30, 2017, with final follow-up on March 31, 2017. One-to-one propensity score matching was used to balance patients on 76 dimensions to compare those with vs without LAAO, stratified by history of prior AF at the time of surgery., Exposures: Surgical LAAO vs no surgical LAAO during cardiac surgery., Main Outcomes and Measures: The primary outcomes were stroke (ie, ischemic stroke or systemic embolism) and all-cause mortality. The secondary outcomes were postoperative AF (AF within 30 days after surgery among patients without prior AF) and long-term AF-related health utilization (event rates of outpatient visits and hospitalizations)., Results: Among 75 782 patients who underwent cardiac surgery (mean age, 66.0 [SD, 11.2] years; 2 2091 [29.2%] women, 25 721 [33.9%] with preexisting AF), 4374 (5.8%) underwent concurrent LAAO, and mean follow-up was 2.1 (SD, 1.9) years. In the 8590 propensity score-matched patients, LAAO was associated with a reduced risk of stroke (1.14 vs 1.59 events per 100 person-years; hazard ratio [HR], 0.73 [95% CI, 0.56-0.96]; P = .03) and mortality (3.01 vs 4.30 events per 100 person-years; HR, 0.71 [95% CI, 0.60-0.84]; P < .001). LAAO was associated with higher rates of AF-related outpatient visits (11.96 vs 10.26 events per person-year; absolute difference, 1.70 [95% CI, 1.60-1.80] events per person-year; rate ratio, 1.17 [95% CI, 1.10-1.24]; P < .001) and hospitalizations (0.36 vs 0.32 event per person-year; absolute difference, 0.04 [95% CI, 0.02-0.06] event per person-year; rate ratio, 1.13 [95% CI, 1.05-1.21]; P = .002). In patients with prior AF (6438/8590 [74.9%]) with vs without LAAO, risk of stroke was 1.11 vs 1.71 events per 100 person-years (HR, 0.68 [95% CI, 0.50-0.92]; P = .01) and risk of mortality was 3.22 vs 4.93 events per 100 person-years (HR, 0.67 [95% CI, 0.56-0.80]; P < .001), respectively. In patients without prior AF (2152/8590 [25.1%]) with vs without LAAO, risk of stroke was 1.23 vs 1.26 events per 100 person-years (HR, 0.95 [95% CI, 0.54-1.68]), risk of mortality was 2.30 vs 2.49 events per 100 person-years (HR, 0.92 [95% CI, 0.61-1.37]), and risk of postoperative AF was 27.7% vs 20.2% events per 100 person-years (HR, 1.46 [95% CI, 1.22-1.73]; P < .001). The interaction term between prior AF and LAAO was not significant (P = .29 for stroke and P = .16 for mortality)., Conclusions and Relevance: Among patients undergoing cardiac surgery, concurrent surgical LAAO, compared with no surgical LAAO, was associated with reduced risk of subsequent stroke and all-cause mortality. Further research, including from randomized clinical trials, is needed to more definitively determine the role of surgical LAAO.

Background: There is growing interest in the role for non-vitamin K antagonist oral anticoagulants (NOACs) in patients without atrial fibrillation (AF). We aimed to provide a comprehensive assessment of the risks of ischemic stroke, myocardial infarction (MI), AF, and major bleeding in patients without previously diagnosed AF., Methods: Using a large US administrative database, we identified 6,495,875 patients ≥50 years between January 1, 2011, and September 30, 2016, who were not diagnosed with AF and were not treated with oral anticoagulants or nonaspirin antiplatelet agents. We assessed the risks by age, sex, the number of risk factors, and the combination of risk factors. We also calculated the number needed to treat or harm based on the untreated risks in our data set and relative risks of NOAC treatment derived from a recent clinical trial., Results: The event rates were 0.67%/y for ischemic stroke or MI, 0.96%/y for AF, and 0.52%/y for major bleeding. Among patients who had a stroke during follow-up, 84% were not diagnosed with AF at any time, and only 5% were diagnosed with AF before the stroke. Patients who had low number needed to treat for cardiovascular risk reduction (ie, potentially benefiting the most from the addition of NOACs) also had low number needed to harm for major bleeding (ie, facing serious harm)., Conclusions: Patients without diagnosed AF but with certain risk factors were at a particularly high cardiovascular risk and may require new prevention approaches. In addition to the ongoing trials, future trials in other high-risk populations, for example, diabetes and chronic kidney disease, may be warranted., (Copyright © 2018. Published by Elsevier Inc.)

The increasing adoption of non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation (AF) necessitates a reassessment of bleeding risk scores. Because known risk factors for bleeding are largely the same as for stroke, we hypothesize that stroke risk scores could also be used to identify patients with high bleeding risks. We aimed to compare the performance of 2 stroke risk scores (Congestive Heart failure, hypertension, Age ≥75 [doubled], Diabetes, Stroke [doubled], Vascular disease, Age 65-74, and Sex [female] [CHA 2 DS 2 -VASc] and Cardiac failure, Hypertension, Age, Diabetes, Stroke [Doubled] [CHADS 2 ]) and 3 bleeding risk scores (hypertension, abnormal renal/liver function [1 point each], stroke, bleeding history or predisposition, labile INR, elderly [.65 years], drugs/alcohol concomitantly [1 point each] [HAS-BLED], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT], and AnTicoagulation and Risk factors In Atrial fibrillation [ATRIA]) in predicting major and intracranial bleeding. Using a large US commercial insurance database, we identified 39,539 patients with nonvalvular AF who started NOACs between October 1, 2010 and June 30, 2015. The performance of risk scores was compared using C-statistic and net reclassification improvement (NRI). Over a total of 22,583 person-years, 665 patients (2.94% per year) had major bleeding, including 74 intracranial hemorrhages (0.33% per year). For the prediction of major bleeding, CHA 2 DS 2 -VASc had the highest C-statistic both as a continuous score (C-statistic 0.68) and as a categorical score (C-statistic 0.65). For the prediction of intracranial bleeding, CHADS 2 had the highest C-statistic both as a continuous score (C-statistic 0.66) and as a categorical score (C-statistic 0.66). There were no statistically significant differences between scores based on NRI. In conclusion, CHA 2 DS 2 -VASc, CHADS 2 , HAS-BLED, ORBIT, and ATRIA had similar, albeit modest, performance in predicting NOAC-associated bleeding in patients with AF. Careful assessment and active management of bleeding risk factors may be warranted in all patients on NOACs who have high stroke risk scores., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Oral anticoagulation is recommended as a lifelong therapy for most patients with atrial fibrillation (AF). However, data on long-term outcomes in clinical practice on these drugs are scarce, particularly for the recently approved agents. We aimed to describe differences in characteristics between patients in everyday practice and those enrolled in the pivotal trials, and to report long-term outcomes on oral anticoagulation in practice., Methods: We performed a retrospective cohort analysis using a large U.S. administrative database to identify patients with AF initiating oral anticoagulation and examine incident stroke (effectiveness endpoint, including ischemic stroke and systemic embolism) and major bleeding (safety endpoint)., Results: We identified 107,373 patients with AF initiating anticoagulants 7/1/2006-6/30/2016. These patients were more likely to be elderly, female, or to have advanced kidney disease in comparison to those enrolled in the trials. The event rates for major bleeding (3.1%, 2.8%, 4.0% and 4.9%/year for in apixaban-, dabigatran-, rivaroxaban- and warfarin-treated patients, respectively) were higher than those observed in trials. The event rates for stroke 0.9%, 1.0%, 0.9% and 1.4%/year the four drug cohorts), were similar to the trials. The three-year risk of stroke was 2.3%, 2.1%, 2.3% and 3.5%, and the three year risk of major bleeding was 5.4%, 7.0%, 8.2%, and 11.7% in the four drug cohorts., Conclusions: Clinical trials represent a narrow spectrum of the general AF population. The trials may underestimate the bleeding risk observed in practice. This study provides important data to help clinicians communicate expected outcomes to patient during shared decision-making., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes., Methods: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA 2 DS 2 -VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records., Discussion: This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke., Trial Registration: ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Background: Dose reduction of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in patients with atrial fibrillation (AF) with renal impairment. Failure to reduce the dose in patients with severe kidney disease may increase bleeding risk, whereas dose reductions without a firm indication may decrease the effectiveness of stroke prevention., Objectives: The goal of this study was to investigate NOAC dosing patterns and associated outcomes, i.e., stroke (ischemic stroke and systemic embolism) and major bleeding in patients treated in routine clinical practice., Methods: Using a large U.S. administrative database, 14,865 patients with AF were identified who initiated apixaban, dabigatran, or rivaroxaban between October 1, 2010, and September 30, 2015. We examined use of a standard dose in patients with a renal indication for dose reduction (potential overdosing) and use of a reduced dose when the renal indication is not present (potential underdosing). Cox proportional hazards regression was performed in propensity score-matched cohorts to investigate the outcomes., Results: Among the 1,473 patients with a renal indication for dose reduction, 43.0% were potentially overdosed, which was associated with a higher risk of major bleeding (hazard ratio: 2.19; 95% confidence interval: 1.07 to 4.46) but no statistically significant difference in stroke (3 NOACs pooled). Among the 13,392 patients with no renal indication for dose reduction, 13.3% were potentially underdosed. This underdosing was associated with a higher risk of stroke (hazard ratio: 4.87; 95% confidence interval: 1.30 to 18.26) but no statistically significant difference in major bleeding in apixaban-treated patients. There were no statistically significant relationships in dabigatran- or rivaroxaban-treated patients without a renal indication., Conclusions: In routine clinical practice, prescribed NOAC doses are often inconsistent with drug labeling. These prescribing patterns may be associated with worse safety with no benefit in effectiveness in patients with severe kidney disease and worse effectiveness with no benefit in safety in apixaban-treated patients with normal or mildly impaired renal function., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Oral anticoagulation (OAC) with warfarin is underused for atrial fibrillation (AF). The availability of direct oral anticoagulants (DOACs) may improve overall OAC rates in AF patients, but a large-scale evaluation of their effects has not been conducted., Objectives: This study assessed the effect of DOAC availability on overall OAC rates for nonvalvular AF., Methods: Between April 1, 2008 and September 30, 2014, we identified 655,000 patients with nonvalvular AF and a CHA 2 DS 2 -VASc score of >1 in the National Cardiovascular Data Registry PINNACLE registry. Temporal trends in overall OAC and individual warfarin and DOAC use were analyzed. Multivariable hierarchical logistic regression identified patient factors associated with OAC and DOAC use. Practice variation of OAC and DOAC use was also assessed., Results: Overall OAC rates increased from 52.4% to 60.7% among eligible AF patients (p for trend <0.01). Warfarin use decreased from 52.4% to 34.8% (p for trend <0.01), and DOAC use increased from 0% to 25.8% (p for trend <0.01). An increasing CHA 2 DS 2 -VASc score was associated with higher OAC use (odds ratio [OR]: 1.06; 95% confidence interval [CI]: 1.05 to 1.07), but with lower DOAC use (OR: 0.97; 95% CI: 0.96 to 0.98). Significant practice variation was present in OAC use (median odds ratio [MOR]: 1.52; 95% CI: 1.45 to 1.57) and in DOAC use (MOR: 3.58; 95% CI: 3.05 to 4.13)., Conclusions: Introduction of DOACs in routine practice was associated with improved rates of overall OAC use for AF, but significant gaps remain. In addition, there is significant practice-level variation in OAC and DOAC use., (Copyright © 2017 American College of Cardiology Foundation. All rights reserved.)

Background & Aims: Direct oral anticoagulant (DOAC) agents increase the risk of gastrointestinal (GI) bleeding. We investigated which DOAC had the most favorable GI safety profile and compared differences among these drugs in age-related risk of GI bleeding., Methods: We conducted a retrospective, propensity-matched study using administrative claims data from the OptumLabs Data Warehouse of privately insured individuals and Medicare Advantage enrollees. We created 3 propensity-matched cohorts of patients with non-valvular atrial fibrillation with incident exposure to dabigatran, rivaroxaban, or apixaban from October 1, 2010 through February 28, 2015. We compared data on rivaroxaban vs dabigatran for 31,574 patients, data on apixaban vs dabigatran for 13,084 patients, and data on apixaban vs rivaroxaban for 13,130 patients. Cox proportional hazards models, stratified by age, were used to estimate rates of total GI bleeding., Results: Baseline characteristics were well balanced among sub-cohorts. GI bleeding occurred more frequently in patients given rivaroxaban than dabigatran (hazard ratio [HR], 1.20; 95% confidence interval [CI], 1.00-1.45). Apixaban was associated with a lower risk of GI bleeding than dabigatran (HR, 0.39; 95% CI, 0.27-0.58; P < .001) or rivaroxaban (HR, 0.33; 95% CI, 0.22-0.49; P < .001). Rates of events for all DOACs increased among patients 75 years or older. Apixaban had a lower risk of association with GI bleeding in the very elderly than dabigatran (HR, 0.45; 95% CI, 0.29-0.71) or rivaroxaban (HR, 0.39; 95% CI, 0.25-0.61). Median times to GI bleeding were <90 days for apixaban and rivaroxaban and <120 days for dabigatran., Conclusions: In a population-based study of patients receiving DOAC agents, we found apixaban had the most favorable GI safety profile and rivaroxaban the least favorable profile. GI bleeding events among patient aged 75 years or older taking DOACs increased with age; the risk was greatest among persons 75 years. Apixaban had the most favorable GI safety profile among all age groups., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: The introduction of non-vitamin K antagonist oral anticoagulants (NOACs) has been a major advance for stroke prevention in atrial fibrillation (AF). Patients and clinicians now have a choice between different NOACs, but there is no direct comparative effectiveness evidence to guide decision-making. We aimed to compare the effectiveness and safety of dabigatran, rivaroxaban, and apixaban in clinical practice., Methods: Using a large US administrative claims database, we created three one-to-one propensity-score-matched cohorts of patients with nonvalvular AF who were users of dabigatran, rivaroxaban, or apixaban between October 1, 2010 and February 28, 2015 (rivaroxaban vs dabigatran, n = 31,574; apixaban vs dabigatran, n = 13,084; and apixaban vs rivaroxaban, n = 13,130). The primary outcomes were stroke and systemic embolism (effectiveness) and major bleeding (safety) that occurred during treatment. Cox proportional hazards models were used to compare outcomes in propensity-score-matched cohorts., Results: We found no differences between the three NOACs in the risk of stroke or systemic embolism (hazard ratio [HR], 1.00; 95% CI, 0.75-1.32 for rivaroxaban vs dabigatran; HR, 0.82; 95% CI, 0.51-1.31 for apixaban vs dabigatran; and HR, 1.05; 95% CI, 0.64-1.72 for apixaban vs rivaroxaban). Apixaban was associated with a lower risk of major bleeding (HR, 0.50; 95% CI, 0.36-0.70; P < .001 vs dabigatran and HR, 0.39; 95% CI, 0.28-0.54; P < .001 vs rivaroxaban). Rivaroxaban was associated with an increased risk of major bleeding (HR, 1.30; 95% CI, 1.10-1.53; P < .01) and intracranial bleeding (HR, 1.79; 95% CI, 1.12-2.86; P < .05) compared with dabigatran., Conclusions: Dabigatran, rivaroxaban, and apixaban appear to have similar effectiveness, although apixaban may be associated with a lower bleeding risk and rivaroxaban may be associated with an elevated bleeding risk., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: In comparison to warfarin, non-vitamin K antagonist oral anticoagulants (NOACs) have the advantages of ease of dosing, fewer drug interactions, and lack of need for ongoing monitoring. We sought to evaluate whether these advantages translate to improved adherence and whether adherence is associated with improved outcomes in patients with atrial fibrillation., Methods and Results: We performed a retrospective cohort analysis by using a large US commercial insurance database to identify 64 661 patients with atrial fibrillation who initiated warfarin, dabigatran, rivaroxaban, or apixaban treatment between November 1, 2010, and December 31, 2014. During a median of 1.1 y of follow-up, 47.5% of NOAC patients had a proportion of days covered of ≥80%, compared with 40.2% in warfarin patients (P<0.001). Patients with CHA2DS2-VASc (risk based on the presence of congestive heart failure, hypertension age 65-74 y, age ≥75 y, diabetes mellitus, prior stroke or transient ischemic attack, vascular disease, sex category) score ≥4 were at increased risk of stroke when they were not taking anticoagulation ≥1 month versus <1 week (1-3 months: hazard ratio [HR] 1.96, 3-6 months: HR 2.64, ≥6 months: HR 3.66; all P<0.001). Patients with CHA2DS2-VASc score 2 or 3 were at increased risk of stroke when they were not taking anticoagulation ≥6 months (HR 2.73, P<0.001). In these patients with CHA2DS2-VASc score ≥2, nonadherence was not associated with intracranial hemorrhage. Among patients with CHA2DS2-VASc score 0 or 1, time not taking anticoagulation was not associated with stroke, but not taking anticoagulation ≥3 months was associated with a significant reduction of bleeding., Conclusions: Adherence to anticoagulation is poor in practice and may be modestly improved with NOACs. Adherence to therapy appears to be most important in patients with CHA2DS2-VASc score ≥2, whereas the benefits of anticoagulation may not outweigh the harms in patients with CHA2DS2-VASc score 0 or 1., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: There is significant practice variation in oral anticoagulation (OAC) use following catheter ablation for atrial fibrillation. It is not clear whether the risk of cardioembolism increases after discontinuation of OAC following catheter ablation., Methods and Results: We identified 6886 patients within a large national administrative claims database who underwent catheter ablation for atrial fibrillation between January 1, 2005, and September 30, 2014. We assessed the effect of time off of OAC by CHA2DS2-VASc score (after adjusting for other comorbidities) on risk of cardioembolism, using Cox proportional hazards models. There was an increase in the use of non-vitamin K OAC after ablation from 0% in 2005 to 69.8% in 2014. OAC discontinuation was high, with only 60.5% and 31.3% of patients remaining on OAC at 3 and 12 months, respectively. The rate of discontinuation was higher in low-risk patients (82% versus 62.5% at 12 months for CHA2DS2-VASc 0-1 versus ≥2, respectively; P<0.001). Stroke occurred in 1.4% of patients with CHA2DS2-VASc ≥2 and 0.3% of those with CHA2DS2-VASc 0 or 1 over the study follow-up. The risk of cardioembolism in the first 3 months after ablation was increased among those with any time off OAC (hazard ratio 8.06 [95% CI 1.53-42.3], P<0.05). The risk of cardioembolism beyond 3 months was increased with OAC discontinuation among high-risk patients (hazard ratio 2.48 [95% CI 1.11-5.52], P<0.05) but not low-risk patients., Conclusion: The overall risk of stroke in postablation patients is low; however, OAC discontinuation after ablation is common and is associated with increased risk of cardioembolism for all patients within the first 3 months and for high-risk patients in the long term. Continuing OAC for at least 3 months in all patients and indefinitely in high-risk patients appears to be the safest strategy., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Stroke is the major cause of morbidity and mortality related to atrial fibrillation (AF). Catheter ablation for AF is effective in reducing AF burden, but its impact on long-term stroke risk is unknown., Objective: We sought to evaluate the periprocedural and long-term stroke risk after catheter ablation or cardioversion for AF., Methods: This retrospective, propensity-matched study using a national administrative claims database identified patients with AF who underwent catheter ablation and a comparison group (matched on age, sex, year of treatment, CHA2DS2-Vasc score, and Charlson index) who underwent cardioversion between 2005 and 2012. The primary end points were (1) time to first ischemic or hemorrhagic stroke or transient ischemic attack (TIA) and (2) time to first ischemic or hemorrhagic stroke excluding TIA. We compared periprocedural incident stroke (within 30 days of ablation or cardioversion) as well as total strokes between the 2 groups., Results: A total of 24,244 patients (12,122 patients undergoing ablation and 12,122 patients undergoing cardioversion) were included in the analysis. Incident periprocedural stroke or TIA occurred in 0.5% of the ablation group and 0.3% of the cardioversion group (P = .04). There was a significant initial risk of stroke/TIA with ablation within the first 30 days (rate ratio 1.53; P = .05). After 30 days, this risk was significantly lower in the ablation group (rate ratio 0.78; P = .03)., Conclusion: In patients with AF, there is a small periprocedural stroke risk with ablation in comparison to cardioversion. However, over longer-term follow-up, ablation is associated with a slightly lower rate of stroke., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Studies have suggested that patients with acute ischemic stroke who present to the hospital during off-hours (weekends and nights) may or may not have worse clinical outcomes compared to patients who present during regular hours., Methods: We searched Medline In-Process & Other Non-Indexed Citations, MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and Scopus through August 2013, and included any study that evaluated the association between time of patient presentation to a healthcare facility and mortality or modified Rankin Scale in acute ischemic stroke. Quality of studies was assessed with the Newcastle-Ottawa Scale. A random-effect meta-analysis model was applied. Heterogeneity was assessed using the Q statistic and I(2). A priori subgroup analyses were used to explain observed heterogeneity., Results: A total of 21 cohort studies (23 cohorts) with fair quality enrolling 1,421,914 patients were included. Off-hour presentation for patients with acute ischemic stroke was associated with significantly higher short-term mortality (OR, 1.11, 95% CI 1.06-1.17). Presenting at accredited stroke centers (OR 1.04, 95% CI 0.98-1.11) and countries in North America (OR 1.05, 95% CI 1.01-1.09) were associated with smaller increase in mortality during off-hours. The results were not significantly different between adjusted (OR, 1.11, 95% CI 1.05-1.16) and unadjusted (OR, 1.13, 95% CI 0.95-1.35) outcomes. The proportion of patients with modified Rankin Scale at discharge ≥ 2-3 was higher in patients presenting during off-hours (OR, 1.14, 95% CI 1.06-1.22)., Discussion: The evidence suggests that patients with acute ischemic stroke presenting during off-hours have higher short-term mortality and greater disability at discharge., (Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)