Clinical Outcomes of low-voltage area-guided left atrial linear ablation for non-paroxysmal atrial fibrillation patients.

BACKGROUND: The therapeutic effect of low-voltage area (LVA)-guided left atrial (LA) linear ablation for non-paroxysmal atrial fibrillation (non-PAF) is uncertain. We aimed to investigate the efficacy of LA linear ablation based on the preexisting LVA and its effects on LA reverse remodeling in non-PAF patients. METHODS: We retrospectively evaluated 145 consecutive patients who underwent radiofrequency catheter ablation for drug-refractory non-PAF. CARTO-guided bipolar voltage mapping was performed in atrial fibrillation (AF). LVA was defined as sites with voltage ≤ 0.5 mV. If circumferential pulmonary vein isolation couldn't convert AF into sinus rhythm, additional LA linear ablation was performed preferentially at sites within LVA. RESULTS: After a mean follow-up duration of 48 ± 33 months, 29 of 145 patients had drugs-refractory AF/LA tachycardia recurrence. Low LA emptying fraction, large LA size and high extent of LVA were associated with AF recurrence. There were 136 patients undergoing LA linear ablation. The rate of linear block at the mitral isthmus was significantly higher via LVA-guided than non-LVA-guided linear ablation. Patients undergoing LVA-guided linear ablation had larger LA size and higher extent of LVA, but the long-term AF/LA tachycardia-free survival rate was higher than the non-LVA-guided group. The LA reverse remodeling effects by resuming sinus rhythm were noted even in patients with a diseased left atrium undergoing extensive LA linear ablation. CONCLUSIONS: LVA-guided linear ablation through targeting the arrhythmogenic LVA and reducing LA mass provides a better clinical outcome than non-LVA guided linear ablation, and outweighs the harmful effects of iatrogenic scaring in non-PAF patients.

[Effect of anticoagulant therapy on the course of COVID-19 in comorbid patients].

INTRODUCTION: Analysis of the pathogenesis of coronavirus infection caused SARS-CoV-2 indicates a significant impact of hemorheological disorders on its course and outcomes. It is known that chronic cardiovascular diseases are associated with the risk of severe course and lethal outcomes both in COVID-19 and other infectious diseases. Therefore, in each case it is necessary to study the interaction and mutual influence of different components of the treatment program prescribed to such patients.The purpose of this work was to evaluate the effect of coagulation activity on the course of a novel coronavirus infection (COVID-19) and to justify the management of comorbid patients having been received novel oral anticoagulants (NOACs) in previously selected doses according to indications in concomitant somatic diseases. MATERIAL AND METHODS: Total 76 cases of confirmed coronavirus infection in patients who had been received initial therapy on an outpatient basis were analyzed. 26 patients who received NOACs (rivaroxaban, apixaban, dabigatran) made up the main group and 50 - the comparison (control) group in which patients had not been administered any drugs that affect blood clotting until the episode of COVID-19. All patients have been prescribed therapy following the Provisional guidelines «Prevention, diagnosis and treatment of coronavirus infection (COVID-19)¼ (https://static-0.minzdrav.gov.ru/system/attachments/attaches/). RESULTS AND DISCUSSION: The number of hospitalizations was significantly fewer in the group of patients who had been received NOACs (19 vs. 66% in the control group). No deaths or cases of severe respiratory and/or renal failure were observed in the main group, while adverse outcomes were noted in 14% of patients who had not been administered these drugs. CONCLUSION: Taking NOACs reduces the probability of severe course and adverse outcomes in the development of coronavirus infection caused by SARS-CoV-2, which indicates a significant contribution of coagulation mechanisms to the pathogenesis in COVID-19. There were no indications for drug replacement and correction of anticoagulant therapy regimens in patients who received adequate therapy with oral anticoagulants for treating a non-severe form of coronavirus infection in ambulatory patient settings.

Thromboembolism, bleeding and vascular death in nonvalvular atrial fibrillation patients with type 2 diabetes receiving rivaroxaban or warfarin.

BACKGROUND: Diabetes increases a patient's risk of developing atrial fibrillation by 49%. Patients with nonvalvular atrial fibrillation are at a fivefold increased risk of stroke and die more frequently from vascular causes. We sought to evaluate the effectiveness and safety of rivaroxaban versus warfarin in nonvalvular atrial fibrillation patients with type 2 diabetes. METHODS: This was an analysis of Optum® De-Identified electronic health record data from 11/2010 to 12/2019. We included adults with nonvalvular atrial fibrillation and type 2 diabetes, newly started on rivaroxaban or warfarin and with ≥ 12-months of prior electronic health record activity. Patients who were pregnant, had alternative indications for oral anticoagulation or valvular heart disease were excluded. We evaluated the incidence rate (%/year) of developing the composite outcome of stroke/systemic embolism or vascular death and major or clinically relevant nonmajor bleeding as well as each endpoint individually. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted proportional hazards regression. RESULTS: We included 32,078 rivaroxaban (31% initiated on 15 mg dose) and 83,971warfarin users (time-in-therapeutic range = 47 ± 28%). Rivaroxaban was associated with a reduced risk of stroke/systemic embolism or vascular death (3.79 vs. 4.19; hazard ratio = 0.91, 95% confdience interval = 0.88-0.95), driven mostly by reductions in vascular death (2.81 vs 3.18, hazard ratio = 0.90, 95% confidence interval = 0.86-0.95) and systemic embolism (0.13 vs. 0.16; hazard ratio = 0.82, 95% confidence interval = 0.66-1.02). Major/clinically relevant nonmajor bleeding was less frequent with rivaroxaban versus warfarin (2.17 vs. 2.31; hazard ratio = 0.94, 95% confidence interval = 0.89-0.99) due to decreased critical organ bleeding (including intracranial hemorrhage) (0.35 vs. 0.54; hazard ratio = 0.63, 95% confidence interval = 0.55-0.72). CONCLUSIONS: In nonvalvular atrial fibrillation patients with type 2 diabetes, rivaroxaban was associated with an ~ 10% relative reduction in vascular mortality and fewer bleeding-related hospitalizations versus warfarin.

Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.

AIM: To investigate the differences in the characteristics and clinical outcomes of recently diagnosed patients with atrial fibrillation (AF) receiving different types of anticoagulants in a real-life setting. METHODS: We retrospectively analyzed the charts of 1000 consecutive patients with non-valvular AF diagnosed at our institution or referred it to from 2013 to 2018. RESULTS: Over the observed period, the frequency of direct oral anticoagulation (DOAC) therapy use significantly increased (P = 0.002). Patients receiving warfarin had more unfavorable thromboembolic and bleeding risk factors than patients receiving DOAC. Predetermined stroke and major bleeding risks were similarly distributed among the dabigatran, rivaroxaban, and apixaban groups. Patients receiving warfarin had shorter time-to-major bleeding (TTB), time to thrombosis (TTT), and overall survival (OS) than patients receiving DOACs. After adjustment for factors unbalanced at baseline, the warfarin group showed significantly shorter OS (hazard ratio 2.27, 95% confidence interval 1.44-3.57, P<0.001], while TTB and TTT did not significantly differ between the groups. Only 37% of patients on warfarin had optimal dosing control, and they did not differ significantly in TTB, TTT, and OS from patients on DOACs. CONCLUSION: Warfarin and DOACs are administered to different target populations, possibly due to socio-economic reasons. Patients receiving warfarin rarely obtain optimal dosing control, and experience significantly shorter survival compared with patients receiving DOACs.

Comparative Effectiveness of Rivaroxaban, Apixaban, and Warfarin in Atrial Fibrillation Patients With Polypharmacy.

BACKGROUND AND PURPOSE: Comparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation and high polypharmacy are unknown. METHODS: We used Medicare administrative data to evaluate patients with new atrial fibrillation diagnosis from 2015 to 2017, who initiated an oral anticoagulant within 90 days of diagnosis. Patients taking ≤3, 4 to 8, or ≥9 other prescription medications were categorized as having low, moderate, or high polypharmacy, respectively. Within polypharmacy categories, patients receiving apixaban 5 mg twice daily, rivaroxaban 20 mg once daily, or warfarin were matched using a 3-way propensity score matching. Study outcomes included ischemic stroke, bleeding, and all-cause mortality. RESULTS: The study cohort included 6985 patients using apixaban, 3838 using rivaroxaban, and 6639 using warfarin. In the propensity-matched cohorts there was no difference in risk of ischemic stroke between the 3 drugs in patients with low and moderate polypharmacy. However, among patients with high polypharmacy, the risk of ischemic stroke was higher with apixaban compared with warfarin (adjusted hazard ratio 2.34 [95% CI, 1.01-5.42]; P=0.05) and similar to rivaroxaban (adjusted hazard ratio, 1.38 [95% CI, 0.67-2.84]; P=0.4). There was no difference in risk of death between the 3 drugs in patients with low and moderate polypharmacy, but apixaban was associated with a higher risk of death compared with rivaroxaban (adjusted hazard ratio, 2.03 [95% CI, 1.01-4.08]; P=0.05) in the high polypharmacy group. Apixaban had lower bleeding risk compared with warfarin in the low polypharmacy group (adjusted hazard ratio, 0.54 [95% CI, 0.32-0.90]; P=0.02), but there was no difference in bleeding between the 3 drugs in the moderate and high polypharmacy groups. CONCLUSIONS: Our study suggests that among patients with significant polypharmacy (>8 drugs), there may be a higher stroke and mortality risk with apixaban compared with warfarin and rivaroxaban. However, differences were of borderline significance.

Comprehensive Management With the ABC (Atrial Fibrillation Better Care) Pathway in Clinically Complex Patients With Atrial Fibrillation: A Post Hoc Ancillary Analysis From the AFFIRM Trial.

Background For patients with atrial fibrillation, a comprehensive care approach based on the Atrial fibrillation Better Care (ABC) pathway can reduce the occurrence of adverse outcomes. The aim of this paper was to investigate if an approach based on the ABC pathway is associated with a reduced risk of adverse events in "clinically complex" atrial fibrillation patients, including those with multiple comorbidities, polypharmacy, and prior hospitalizations. Methods and Results We performed a post hoc analysis of the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial. The principal outcome was the composite of all-cause hospitalization and all-cause death. An integrated care approach (ABC group) was used in 3.8% of the multimorbidity group, 4.0% of the polypharmacy group, and 4.8%, of the hospitalized groups. In all "clinically complex" groups, the cumulative risk of the composite outcome was significantly lower in patients managed consistent with the ABC pathway versus non-ABC pathway-adherent (all P<0.05). Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups. Secondary analyses showed that the higher number of ABC criteria fulfilled the larger associated reduction in relative risk, even for secondary outcomes considered. Conclusions Use of an ABC consistent pathway is associated with fewer major adverse events in patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization.

Catheter ablation for the management of atrial fibrillation: current technical perspectives.

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice, with a prevalence that increases alongside the ageing population worldwide. The management of AF involves restoration of sinus rhythm through antiarrhythmic drug therapy. Yet, these medications have only modest efficacy in achieving long-term success, have not shown to result in a mortality benefit, are frequently not tolerated and have associated adverse side effects. Therefore, catheter ablation has become a valuable treatment approach for AF and even a viable first-line strategy in select cases. Traditionally, the combination of radiofrequency energy and a three-dimensional electroanatomical mapping system has been used to guide catheter ablation for AF. However, single-procedural efficacy and long-term outcomes still remain suboptimal for many patients, particularly those with persistent or long-standing AF. Recent advances in ablation technology and strategy, therefore, provide new procedural approaches for catheter-based treatment with the aim of overcoming current challenges in procedural duration and overall success. The aim of this paper was to provide an updated review of the current practices and techniques relating to ablation for AF and to compare the use of these strategies for paroxysmal and persistent AF.

Mobile Health Technology to Improve Care for Patients With Atrial Fibrillation.

BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines, and lack of consideration of patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management. OBJECTIVE: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care. METHODS: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk. RESULTS: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05). CONCLUSIONS: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation.

This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m2) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40-5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20-3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90-2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.

Circumferential pulmonary vein antrum ablation for the treatment of paroxysmal atrial fibrillation: A randomized controlled trial.

BACKGROUND: It remains unclear whether the curative result of paroxysmal atrial fibrillation (PAF) is a result of pulmonary vein (PV) isolation, PV antrum modification (PVAM), or both. We hypothesized that sufficient antrum modification (PVAM) is as important as PV isolation (PVI) for atrial fibrillation (AF) control and that PVAM can be evaluated by quantified lesion deployment using a force-sensing catheter. METHODS AND RESULTS: Patients of symptomatic PAF were randomly assigned 2:1 into a PVAM group or a circumferential PV isolation (CPVI) group. In the PVAM group, circumferential quantitative ablation evaluated by automatical VisiTag module was performed. In the CPVI group, conventional circumferential ablation was performed to achieve the end point of all-PV isolation. In total, 180 patients with PAF were enrolled and randomly assigned to either the PVAM group (n = 120) or the CPVI group (n = 60). A total of 179 patients successfully underwent ablation. In the PVAM group, 68 patients achieved all PVI (PVAM-PVI), while 51 did not (PVAM-non-PVI). At 18 months, there was no significant difference in the maintenance of sinus rhythm between the PVAM and CPVI groups (84.9 vs 79.7%, P = .382). The PVAM-PVI subgroup demonstrated a higher arrhythmia-free survival compared with the PVAM-non-PVI subgroup (92.6 vs 74.5%, P = .006) and the CPVI group (92.6 vs 79.7%, P = .036). CONCLUSIONS: The trial shows that sufficient force-sensing guided PVAM can result in satisfying outcomes in PAF patients. Notably, sufficient PVAM with all-PV isolated will further increase the success rate.

Association between clinical risk scores and mortality in atrial fibrillation: Systematic review and network meta-regression of 669,000 patients.

AIMS: Many clinical scores for risk stratification in patients with atrial fibrillation have been proposed, and some have been useful in predicting all-cause mortality. We aim to analyse the relationship between clinical risk score and all-cause death occurrence in atrial fibrillation patients. METHODS: We performed a systematic search in PubMed and Scopus from inception to 22 July 2017. We considered the following scores: ATRIA-Stroke, ATRIA-Bleeding, CHADS2, CHA2DS2-VASc, HAS-BLED, HATCH and ORBIT. Papers reporting data about scores and all-cause death rates were considered. RESULTS: Fifty studies and 71 scores groups were included in the analysis, with 669,217 patients. Data on ATRIA-Bleeding, CHADS2, CHA2DS2-VASc and HAS-BLED were available. All the scores were significantly associated with an increased risk for all-cause death. All the scores showed modest predictive ability at five years (c-indexes (95% confidence interval) CHADS2: 0.64 (0.63-0.65), CHA2DS2-VASc: 0.62 (0.61-0.64), HAS-BLED: 0.62 (0.58-0.66)). Network meta-regression found no significant differences in predictive ability. CHA2DS2-VASc score had consistently high negative predictive value (≥94%) at one, three and five years of follow-up; conversely it showed the highest probability of being the best performing score (63% at one year, 60% at three years, 68% at five years). CONCLUSION: In atrial fibrillation patients, contemporary clinical risk scores are associated with an increased risk of all-cause death. Use of these scores for death prediction in atrial fibrillation patients could be considered as part of holistic clinical assessment. The CHA2DS2-VASc score had consistently high negative predictive value during follow-up and the highest probability of being the best performing clinical score.

Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease.

BACKGROUND: There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease. METHODS: In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority. RESULTS: The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority). CONCLUSIONS: As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.).

Multimodality Imaging for Best Dealing With Patients in Atrial Arrhythmias.

The management of atrial fibrillation (AF) is not only a clinical challenge but also an imaging challenge. The role of different imaging modalities to estimate the thromboembolic risk in AF is a key clinical question. The present review summarizes the advances of myocardial imaging in the stratification of thromboembolic risk, diagnosis, and management of left atrial thrombosis in patients with AF. These imaging techniques are also important for understanding arrhythmias and their consequences. It is becoming fundamental for guiding therapy. Still, large studies are required, but be sure that left atrial imaging will become more and more clinically fundamental.

Integrated Care Management of Patients With Atrial Fibrillation and Risk of Cardiovascular Events: The ABC (Atrial fibrillation Better Care) Pathway in the ATHERO-AF Study Cohort.

OBJECTIVE: To investigate the impact on cardiovascular events (CVEs) in a real-world population of patients with atrial fibrillation (AF) by implementing the Atrial fibrillation Better Care (ABC: A, Avoid stroke with anticoagulation; B, better symptom management; C, Cardiovascular and comorbidity risk management) pathway. PATIENTS AND METHODS: This prospective single-center cohort study included 907 consecutive patients with nonvalvular AF on vitamin K antagonists from February 2008 to December 2016. The A, B, and C groups were defined as follows: "A" by a Time in Therapeutic Range ≥65%; "B" by a European Heart Rhythm Association (EHRA) symptom scale I-II, and "C" as optimized cardiovascular comorbidity management. Primary end point was a composite outcome of CVEs. RESULTS: During a median follow-up of 36.9 months (interquartile range [IQR] 20.0-57.5; 3022 patient-years), 118 CVEs occurred (3.9% per year; 95% confidence interval [CI], 3.2-4.7). Symptomatic patients (EHRA III-IV) had a higher risk of CVEs compared with those in EHRA I (hazard ratio [HR], 2.73, 95% CI, 1.61-4.63, P<.001). Optimally managed patients in the ABC group (n=198) had a lower risk of CVEs (1.8 [95% CI, 0.9-3.0] vs 4.5% [95% CI, 3.7-5.5] per year, P=.001) compared with those presenting with at least 1 suboptimal ABC factor (HR, 0.40, 95% CI, 0.22-0.74, P=.003). This association was evident using multivariate Cox proportional regression analysis (HR, 0.44, 95% CI, 0.24-0.80, P=.007). CONCLUSION: Integrated care management according to the ABC pathway resulted in a significantly lower rate of CVEs, suggesting a clear benefit of a holistic approach to optimize the management of patients with AF. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01882114.

Non-Vitamin K Antagonist Oral Anticoagulants in the Treatment of Atrial Fibrillation.

Atrial fibrillation (AF) increases a patient's stroke risk four- to five-fold. Anticoagulation with the vitamin K antagonist (VKA) warfarin reduces the risk of stroke by 67%, but warfarin carries a significant risk of major bleeding and has unpredictable pharmacodynamics with a narrow therapeutic window, necessitating frequent monitoring of its anticoagulant effect. The non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban provide more predictable anticoagulant activity than warfarin with a lower risk of major bleeding, and each is noninferior to warfarin for the prevention of stroke. All have earned regulatory approval in the past eight years. At least one of the NOACs is approved for use in all patients with AF, except those with mechanical valves and rheumatic mitral valve disease, for whom warfarin remains the only option. Recent clinical trials have shown that antithrombotic regimens including NOACs are safe and effective in patients with AF who need potent antiplatelet therapy.

Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS.

AIMS: Based on Phase III data, non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with atrial fibrillation. To determine whether trial outcomes translate into similar event rates in unselected patients, this analysis compared outcomes from the real-world XANTUS study with those from the Phase III ROCKET AF study. METHODS AND RESULTS: Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061 rivaroxaban-treated patients from ROCKET AF, using the matching-adjusted indirect comparison (MAIC) method. For the primary analysis, CHADS2 scores and gender were selected as relevant variables. Adjusted annualized incidence rates for XANTUS were calculated and compared with incidence rates from ROCKET AF-the ratio of these rates ('MAIC ratio') was used as a relative effect estimate. Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF. The rate of all-cause death was higher in XANTUS (3.22%/year vs. 1.87%/year; MAIC ratio 1.72; 95% CI 1.31-2.27), but the rates of vascular death were similar (1.83%/year vs. 1.53%/year; MAIC ratio 1.19; 95% CI 0.84-1.70). Sensitivity analyses weighted by different baseline characteristics supported these results. CONCLUSION: The low rates of major bleeding and stroke in XANTUS were consistent with results from ROCKET AF. All-cause death, but not vascular death, was higher in XANTUS, as expected in an unselected real-world population.

Management of atrial fibrillation in the emergency room and in the cardiology ward: the BLITZ AF study.

AIMS: To assess the number of admissions to the emergency room (ER) of patients with atrial fibrillation (AF) or atrial flutter (af) and their subsequent management. To evaluate the clinical profile and the use of antithrombotics and antiarrhythmic therapy in patients with AF admitted to cardiology wards. METHODS AND RESULTS: BLITZ-AF is a multicentre, observational study conducted in 154 centres on patients with AF/af. In each centre, data were collected, retrospectively for 4 weeks in ER and prospectively for 12 weeks in cardiology wards. In ER, there were 6275 admissions. Atrial fibrillation was the main diagnosis in 52.9% of the cases, af in 5.9%. Atrial fibrillation represented 1.0% of all ER admissions and 1.7% of all hospital admissions. A cardioversion has been performed in nearly 25% of the cases. Out of 4126 patients, 52.2% were admitted in cardiology ward; mean age was 74 ± 11 years, 41% were females. Patients with non-valvular AF were 3848 (93.3%); CHA2DS2-VASc score was ≥2 in 87.4%. Cardioversion was attempted in 38.8% of the patients. In-hospital mortality was 1.2%. At discharge, 42.6% of the patients were treated with vitamin K antagonists, 39.5% with direct oral anticoagulants, 13.6% with other antithrombotic drugs, and 4.2% did not take any antithrombotic agent. Rate control strategy was pursued in 47.2%, rhythm control in 44.0%, 45.6% were discharged in sinus rhythm. CONCLUSION: Atrial fibrillation still represents a significant burden on health care system. Oral anticoagulant use increased over time even if compliance with guidelines, with respect to prevention of the risk of stroke, remains suboptimal.

Improved Outcomes by Integrated Care of Anticoagulated Patients with Atrial Fibrillation Using the Simple ABC (Atrial Fibrillation Better Care) Pathway.

BACKGROUND: Integrated care for the clinical management of atrial fibrillation patients is advocated as a holistic way to improve outcomes; the simple Atrial fibrillation Better Care (ABC) pathway has been proposed. The ABC pathway streamlines care as follows: 'A' Avoid stroke; 'B' Better symptom management; 'C' Cardiovascular and Comorbidity optimization. METHODS: We performed a post hoc analysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial. An 'integrated care' approach was defined according to the ABC pathway. Patients fulfilling all criteria were categorized as the 'ABC' group; those not fulfilling all criteria were the 'non-ABC' group. Trial-adjudicated all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization were the main study outcomes. RESULTS: Among the 4060 patients in the original cohort, 3169 (78%) had available data to compare integrated care (ABC; n = 222; 7%) vs non-ABC (n = 2947; 93%) management. Over a median follow-up of 3.7 (interquartile range, 2.8-4.6) years, atrial fibrillation patients managed with integrated care (ABC group) had lower rates for all study outcomes (all P < .001) compared with the non-ABC group. A Cox multivariable regression analysis showed that atrial fibrillation patients managed in the ABC group had a significantly lower risk of all-cause death (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.17-0.75), composite outcome (HR, 0.35; 95% CI, 0.18-0.68), and first hospitalization (HR, 0.65; 95% CI, 0.53-0.80). CONCLUSIONS: The simple ABC pathway allows the streamlining of integrated care for atrial fibrillation patients in a holistic manner and is associated with a lower risk of adverse outcomes (including mortality, stroke/major bleeding/cardiovascular death, and hospitalization).

Dabigatran, Rivaroxaban, and Warfarin in the Oldest Adults with Atrial Fibrillation in Taiwan.

OBJECTIVES: To compare the effectiveness and safety of reduced-dose dabigatran, reduced-dose rivaroxaban, and warfarin in individuals aged 85 and older with atrial fibrillation (AF). DESIGN: Retrospective cohort study. SETTING: Taiwan National Health Insurance claims database, 2011∼2015. PARTICIPANTS: Individuals with AF aged 85 and older (mean 88.6) with incident use of oral anticoagulants between June 1, 2012 and May 31, 2015 (N=4,722; dabigatran 110 mg, n=1,489; rivaroxaban 15 mg/10 mg, n=1,736; warfarin, n=1,497). MEASUREMENTS: Clinical outcomes included all-cause death, cardiovascular death, ischemic stroke, acute myocardial infarction, arterial embolism or thrombosis, intracranial hemorrhage, and gastrointestinal hemorrhage needing transfusion. Propensity score-matched analysis was performed, and the marginal proportional hazards model was used to estimate the relative risk of various clinical outcomes in a matched dabigatran-warfarin cohort (n=1,180 in each group) and a rivaroxaban-warfarin cohort (n=1,207 in each group) RESULTS: Mean follow-up was 6.6 months for the overall population. Dabigatran group participants had lower risks of all-cause death (hazard ratio (HR)=0.59, 95% confidence interval (CI)=0.45-0.77) and cardiovascular death (HR=0.45, 95% CI=0.30-0.68) than warfarin group participants. Rivaroxaban users also had lower risks of all-cause death (HR=0.61, 95% CI=0.47-0.79) and cardiovascular death (HR=0.52, 95% CI=0.35-0.75) than warfarin users. Dabigatran users also had a lower risk of intracranial hemorrhage than warfarin users (HR=0.31, 95% CI=0.10-0.97). CONCLUSION: Individuals with AF aged 85 and older who used reduced-dose dabigatran or reduced-dose rivaroxaban had statistically significantly lower all-cause mortality and cardiovascular mortality than those who used warfarin. Reduced-dose dabigatran was also associated with lower risk of intracranial hemorrhage than warfarin.