TEMPORAL DISCORDANCE BETWEEN ATRIAL FIBRILLATION AND INTRACRANIAL HEMORRHAGE OR MAJOR BLEEDING AMONG PATIENTS WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES: IMPLICATIONS FOR ORAL ANTICOAGULATION MANAGEMENT

Introduction: After diagnosis of atrial fibrillation (AF), oral anticoagulation (OAC) is taken daily and may increase risk of bleeding, even during AF-free periods. We explored temporal discordance between AF and major bleeding events (MBE) in patients with cardiovascular implantable electronic devices (CIED). Methods: We linked Veterans Administration (VA) and Medicare data to CIED remote monitoring data. Analyses were restricted to Medtronic cardiac rhythm devices with atrial leads, which provide a daily, continuous measure of AF burden. We identified the earliest date of monitoring and searched for a subsequent MBE (including but not limited to intracranial hemorrhaging, gastrointestinal bleeds, and vascular bleeds) from 2004 to 2015. We restricted analysis to patients with <75% coverage of remote monitoring in the 90 days before and after MBE and with OAC prescription and pill coverage in the 90 days prior and on day of MBE. Patients were categorized into 4 groups based on the presence of AF ≥ 6 minutes on any of the 90 days on or prior to MBE and 90 days after MBE: NO/NO, NO/YES, YES/NO, YES/YES. Results: There were 189 patients meeting inclusion criteria (69±9.4 years, CHA 2 DS 2 -VASc 4.3±1.4). Of these, 99 (52%) of patients had no AF≥ 6 min in the 90 days on or before MBE (NO/NO). Among all patients, there were 3 ischemic strokes, 2 ICH, 33 MBE, and 83 deaths following the index MBE. Across all categories, the risk of recurrent MBE and death was substantially higher than stroke or ICH and only 7% with no AF pre had AF post (NO/YES). (TABLE) Conclusion: Among CIED patients on OAC, most did not have AF at the time of MBE. Risk of MBE and death was substantially higher than stroke or ICH and call into question rationale to remain on indefinite OAC. Long-term AF monitoring may prove useful and requires evaluation.

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INTRACRANIAL HEMORRHAGE IN PATIENTS WITH ATRIAL FIBRILLATION RECEIVING ORAL ANTICOAGULATION WITH WARFARIN OR EDOXABAN

10.26226/morressier.5ab8f559d462b8029238c76e ◽

2018 ◽

Author(s):

Sarah Nelson

Keyword(s):

Atrial Fibrillation ◽

Intracranial Hemorrhage ◽

Oral Anticoagulation

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Safety of early anticoagulation in patients treated with urgent reperfusion for acute ischemic stroke related to non-valvular atrial fibrillation

European Heart Journal ◽

10.1093/ehjci/ehaa946.2431 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Giustozzi

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Primary Outcome ◽

Oral Anticoagulants ◽

Early Recurrence ◽

Optimal Timing ◽

Hemorrhagic Event

Abstract Background The optimal timing for starting anticoagulation after an acute ischemic stroke related to non-valvular atrial fibrillation (AF) remains a challenge, especially in patients treated with systemic thrombolysis or mechanical thrombectomy. Purpose We aimed to assess the rates of early recurrence and major bleeding in patients with acute ischemic stroke and AF treated with thrombolytic therapy and/or thrombectomy who received oral anticoagulants for secondary prevention. Methods We combined the dataset of the RAF and the RAF-NOACs studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and AF treated with either vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Results A total of 2,159 patients were included in the RAF and RAF-NOACs trials, of which 564 patients (26%) were treated with urgent reperfusion therapy. After acute stroke, 505 (90%) patients treated with reperfusion and 1,287 out of the 1,595 (81%) patients not treated with reperfusion started oral anticoagulation. Timing of starting oral anticoagulation was similar in reperfusion-treated and untreated patients (13.5±23.3 vs 12.3±18.3 days, respectively, p=0.287). At 90 days, the composite rate of recurrence and major bleeding occurred in 37 (7%) of patients treated with reperfusion treatment and in 139 (9%) of untreated patients (p=0.127). Twenty-four (4%) reperfusion-treated patients and 82 (5%) untreated patients had early recurrence while major bleeding occurred in 13 (2%) treated and in 64 (4%) untreated patients, respectively. Seven patients in the untreated group experienced both an ischemic and hemorrhagic event. Figure 1 shows the risk of early recurrence and major bleeding over time in patients treated and not treated with reperfusion treatments. The use of NOACs was associated with a favorable rate of the primary outcome compared to VKAs (Odd ratio 0.4, 95% Confidence Interval 0.3–0.7). Conclusions Reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with AF-related acute ischemic stroke who started anticoagulant treatment. Figure 1 Funding Acknowledgement Type of funding source: None

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Oral anticoagulation after catheter ablation of atrial fibrillation and the associated risk of thromboembolic events and intracranial hemorrhage: A systematic review and meta‐analysis

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.14052 ◽

2019 ◽

Vol 30 (8) ◽

pp. 1250-1257 ◽

Cited By ~ 6

Author(s):

Jorge Romero ◽

Roberto C. Cerrud‐Rodriguez ◽

Juan C. Diaz ◽

Daniel Rodriguez ◽

Samiullah Arshad ◽

...

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Catheter Ablation ◽

Intracranial Hemorrhage ◽

Oral Anticoagulation ◽

Meta Analysis ◽

Thromboembolic Events

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Population-Based Screening for Atrial Fibrillation

Circulation Research ◽

10.1161/circresaha.120.316341 ◽

2020 ◽

Vol 127 (1) ◽

pp. 143-154 ◽

Cited By ~ 4

Author(s):

Shaan Khurshid ◽

Jeffrey S. Healey ◽

William F. McIntyre ◽

Steven A. Lubitz

Keyword(s):

Atrial Fibrillation ◽

Current Literature ◽

Oral Anticoagulation ◽

Electronic Devices ◽

Population Based ◽

Consensus Guidelines ◽

Consumer Electronic ◽

Receive Treatment

Atrial fibrillation (AF) is a common and morbid arrhythmia. Stroke is a major hazard of AF and may be preventable with oral anticoagulation. Yet since AF is often asymptomatic, many individuals with AF may be unaware and do not receive treatment that could prevent a stroke. Screening for AF has gained substantial attention in recent years as several studies have demonstrated that screening is feasible. Advances in technology have enabled a variety of approaches to facilitate screening for AF using both medical-prescribed devices as well as consumer electronic devices capable of detecting AF. Yet controversy about the utility of AF screening remains owing to concerns about potential harms resulting from screening in the absence of randomized data demonstrating effectiveness of screening on outcomes such as stroke and bleeding. In this review, we summarize current literature, present technology, population-based screening considerations, and consensus guidelines addressing the role of AF screening in practice.

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3054Efficacy and safety of non-vitamin K oral anticoagulants in patients with atrial fibrillation and cancer

European Heart Journal ◽

10.1093/eurheartj/ehz745.0021 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

I Cavallari ◽

G Verolino ◽

G Patti

Keyword(s):

Atrial Fibrillation ◽

Venous Thromboembolism ◽

Intracranial Hemorrhage ◽

Major Bleeding ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Efficacy And Safety ◽

Systemic Embolism ◽

Patients With Cancer ◽

All Cause Mortality

Abstract Background Anticoagulation in patients with cancer and atrial fibrillation (AF) is particularly challenging given the higher risk of both thrombotic and bleeding complications in this setting. Data regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) in AF patients with malignancy remain unclear. Purpose In the present meta-analysis we further investigate the efficacy and safety of NOACs compared to warfarin in patients with AF and cancer assuming that available studies may be individually underpowered for endpoints at low incidence, i.e. stroke, major and intracranial bleeding. Methods We performed a systematic review and meta-analysis of studies comparing the use of NOACs vs. warfarin in AF patients with cancer. Efficacy outcome measures included stroke or systemic embolism, venous thromboembolism and mortality. Safety outcome measures were major bleeding and intracranial hemorrhage. Results We pooled data from 6 identified studies enrolling a total of 31,756 AF patients with cancer. Mean follow-up was 1.7 years. Patients with cancer had significantly increased annualized rates of venous thromboembolism (1.38% vs. 0.74%), major bleeding (9.01% vs. 5.13%), in particular major gastrointestinal bleeding (2.38% vs. 1.60%), and all-cause mortality (17.73% vs. 8.50%) vs. those without (all P values <0.001), whereas the incidence of stroke or systemic embolism and intracranial hemorrhage did not differ. Compared with warfarin, treatment with NOACs nominally decreased the risk of stroke or systemic embolism (5.41% vs. 2.70%; odds ratio, OR; 95% confidence intervals, CI 0.51, 0.26–1.01; P=0.05; Figure), mainly of ischemic stroke (OR 0.56; 95% CI 0.35–0.89; P=0.01), and the risk of venous thromboembolism (OR 0.51; 95% CI 0.42–0.61; P<0.001). In cancer patients receiving NOACs there was a significant reduction of major bleeding (3.95% vs. 4.66%; OR 0.66, 95% CI 0.46–0.94; P=0.02; Figure) and intracranial hemorrhage (0.26% vs. 0.66%; OR 0.25, 95% CI 0.08–0.82; P=0.02) vs. warfarin, with no difference in gastrointestinal major bleeding rates. Conclusion AF patients on oral anticoagulation and concomitant cancer are at higher risk of venous thromboembolism, major bleeding and all-cause mortality. NOACs may represent a safer and more effective alternative to warfarin also in this setting of patients.

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Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

BMC Cardiovascular Disorders ◽

10.1186/s12872-020-01766-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

M. Unverdorben ◽

C. von Heymann ◽

A. Santamaria ◽

M. Saxena ◽

T. Vanassche ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Anticoagulation Therapy ◽

The Elderly ◽

Risk Scores ◽

Bleeding Complications ◽

Thromboembolic Events ◽

Thromboembolic Complications ◽

Coronary Syndrome

Abstract Background Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. Methods Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. Results Of the 1442 patients, 280 (19%) were < 65, 550 (38%) were 65–74, 514 (36%) 75–84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients < 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those > 65, and seven in patients aged > 75 years. Conclusion Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. Trial registration: NCT# 02950168, October 31, 2016

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Antiplatelets in patients with atrial fibrillation: a systematic review and meta-analysis of randomized clinical trials

EP Europace ◽

10.1093/europace/euab116.265 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

A Benz ◽

I Johansson ◽

W Dewilde ◽

RD Lopes ◽

R Mehran ◽

...

Keyword(s):

Atrial Fibrillation ◽

Antiplatelet Therapy ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Randomized Trials ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Antiplatelet Agents ◽

County Council ◽

Qualitative Interaction

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Dr. Benz reports a personal research grant from the German Heart Foundation (Deutsche Herzstiftung e.V.). Dr. Johansson reports personal unrestricted research grants from Swedish Heart-Lung Foundation (Hjärt-Lungfonden) and from Stockholm County Council (Region Stockholm). Dr. McIntyre holds a fellowship award from the Canadian Institutes for Health Research (CIHR). Dr. Shoamanesh reports funding support from the Marta and Owen Boris Foundation and the Heart and Stroke Foundation of Canada. Background/Introduction: There is an ongoing controversy surrounding the efficacy and safety of antiplatelet agents in patients with atrial fibrillation (AF). Purpose We aimed to systematically assess the effects of antiplatelets on stroke and other outcomes in patients with AF, both receiving oral anticoagulation or not. Methods We searched MEDLINE, Embase and CENTRAL up until September 2020 to identify randomized trials allocating patients with AF to aspirin or a P2Y12 inhibitor, versus control. Where applicable, we obtained unpublished data from study authors. Random-effects models were applied for meta-analysis. Results Based on 21,518 patients from 18 randomized trials, there was no reduction in stroke with antiplatelet therapy (risk ratio [RR] 0.89, 95% confidence interval [CI] 0.76-1.04). There was a significant qualitative interaction according to whether patients were receiving concomitant oral anticoagulation or not (p < 0.001). Without concomitant anticoagulation, antiplatelets reduced stroke (RR 0.77, 95% CI 0.69-0.86), while they appeared to increase stroke with it (RR 1.33, 95% CI 0.98-1.79). A similar pattern emerged for ischaemic stroke. Antiplatelets increased major bleeding (RR 1.54, 95% CI 1.35-1.77) and intracranial haemorrhage (RR 1.64, 95% CI 1.20-2.24), and reduced myocardial infarction (RR 0.79, 95% CI 0.65-0.94), consistently and irrespective of concomitant anticoagulation. Antiplatelets had a neutral effect on mortality (RR 1.02, 95% CI 0.89-1.17). Conclusions Antiplatelet therapy did not reduce stroke and increased major bleeding in patients with AF. Antiplatelets did not affect mortality. Subgroup analysis suggests a reduction in stroke with antiplatelets in patients without concomitant oral anticoagulation, and a corresponding signal for harm in those with it. Abstract Figure.

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P2529Efficacy and safety of oral anticoagulation in nonagenarian patients with atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz748.0858 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

L Dominguez Rodriguez ◽

S Raposeiras Roubin ◽

D Alonso Rodriguez ◽

S J Camacho Freire ◽

E Abuassi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Lower Risk ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Events ◽

The Impact ◽

Similar Risk

Abstract Introduction Embolic prevention with oral anticoagulation is the cornerstone for the management of patients with atrial fibrillation (AF). However, data about the efficacy and safety of oral anticoagulation in nonagenarian patients are limited. We aimed to analyze the impact of oral anticoagulation in mortality, embolic and hemorrhagic events, in patients ≥90 years with non-valvular AF. Methods We used data from a multicentric registry of 1,750 consecutive nonagenarian patients diagnosed of AF between 2013 and 2018. A propensity-matched analysis was performed to match the baseline characteristics of patients treated or not with oral anticoagulants, and for those treated with vitamin K antagonists (VKAs) vs direct oral anticoagulants (DOACs). The impact of oral anticoagulation in the embolic and hemorrhagic risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For embolic risk, we have considered a stroke, pulmonary or peripheral embolism. For bleeding risk, we have considered any bleeding requiring hospital admission. Results The mean of CHA2DS2-VASC and HASBLED scores was 4.5±1.3 and 2.8±1.0 points, respectively. Most of patients were anticoagulated (70.1%; n=1,256). DOACs were used in 709 patients, and VKAs in 517 patients. During a median follow-up of 25.2 months (IQR 12.2–44.3 months), 988 patients died (56.5%), 180 presented embolic events (10.3%), 186 had bleeding events (10.6%), and 29 had intracranial hemorrhage (ICH, 1.7%). After propensity-score matching, anticoagulation (versus non anticoagulation) was associated with lower mortality rate (HR 0.73, 95% CI 0.60–0.89; p=0.002), less mortality and embolic events (HR 0.77, 95% CI 0.64–0.92; p=0.005), but more bleeding events (HR 2.05, 95% CI 1.25–3.35; p=0.004). In comparison with VKAs, DOACs showed similar risk of mortality and embolic events (HR 1.14, 95% CI 0.88–1.47; p=0.337), and similar risk of bleeding events (HR 0.75, 95% CI 0.43–1.28; p=0.287), although a trend to lower risk of ICH was found (HR 0.17, 95% CI 0.02–1.39; p=0.097). Conclusions Among nonagenarian patients with AF, oral anticoagulation was associated with lower all-cause mortality. Although survival free of embolic events was significantly higher in patients with anticoagulation, the risk of major bleeding was twice than in non-anticoagulated patients. There was not differences between VKAs and DOACs in terms of embolic events and total major bleeding. However, compared with VKAs, DOACs were showed a trend to lower risk of ICH.

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