Periprocedural Stroke and Management of Major Bleeding Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation

Introduction: Women undergoing atrial fibrillation catheter ablation (AFCA) have higher rates of vascular complications and major bleeding. However, studies have been underpowered to detect differences in rare complications such as stroke/transient ischemic attack (TIA) and procedural mortality. Methods: We performed a systematic review of databases (PubMed, World of Science, Embase) to identify studies published since 2010 reporting AFCA complications by gender. Six complications of interest were: 1) vascular/groin complications; 2) pericardial effusion/tamponade; 3) stroke/TIA; 4) permanent phrenic nerve injury; 5) major bleeding & 6) procedural mortality. For meta-analysis, random effects models were used when heterogeneity between studies was ≥ 50% (vascular complications, major bleeding) and fixed effects models for other endpoints. Results: Of 5716 citations, 19 studies met inclusion criteria, comprising 244,353 patients undergoing AFCA, of whom 33% were women. Women were older (65.3 ± 11.2 vs. 60.4 ± 13.2 years), more likely hypertensive (60.6 vs. 55.5%) and diabetic (18.3 vs. 16.5%) and had higher CHA 2 DS 2 -VASc scores (3.0 ± 1.8 vs. 1.4 ± 1.4) (p<0.0001 for all comparisons). The rates of all 6 complications were significantly higher in women (Table). However, despite statistically significant differences, the overall incidences of major complications were very low in both genders: stroke/TIA (women 0.51 vs. men 0.39%) and procedural mortality (women 0.25 vs. men 0.18%). Conclusion: Women experience significantly higher rates of AFCA complications. However, the incidence of major procedural complications is very low in both genders. The higher rate of complications in women may be partially attributable to older age and a higher prevalence of comorbidities at the time of ablation. More detailed studies are needed to better define the mechanisms of increased risk in women and to identify strategies for closing the gender gap.

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Abstract 19660: Scoring System to Predict Major Bleeding Complications in Atrial Fibrillation Patients With Oral Anticoagulant After Drug-eluting Stent Implantation

Circulation ◽

10.1161/circ.132.suppl_3.19660 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Norihiro Kobayashi ◽

Yoshiaki Ito ◽

Keisuke Hirano ◽

Masahiro Yamawaki ◽

Motoharu Araki ◽

...

Keyword(s):

Atrial Fibrillation ◽

Logistic Regression ◽

Major Bleeding ◽

Scoring System ◽

Oral Anticoagulant ◽

Logistic Regression Model ◽

Risk Group ◽

Bleeding Complications ◽

Drug Eluting Stent ◽

Drug Eluting

Background: We aimed to introduce scoring system to predict major bleeding complications after triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) and drug-eluting stent (DES) implantation. Methods: Between April 2007 and December 2011, 119 patients with AF and DES implantation were enrolled in this study. All of these patients received oral anticoagulant therapy and dual antiplatelet therapy (DAPT). We investigated the incidence of major bleeding complications including intracranial and gastrointestinal bleeding. Each variables which seem to be associated with major bleeding complications were analyzed using the univariate logistic regression model. All variables tested in univariate analysis with p<0.10 were included in multivariate logistic regression model. The scores for each variables were transformed from regression coefficients and computed in a total score. Results: The mean follow-up period was 43.6 ± 25.5 month. The incidence of major bleeding was 17.6%. In multivariate analysis, age > 75 (OR 3.67, 95%CI 1.01-13.3, p = 0.048), continuation of DAPT (OR 7.85, 95%CI 1.50-41.2, p = 0.015), INR > 2.2 (OR 9.19, 95%CI 2.65-31.9, p < 0.001) were predictors of major bleeding complications. Each item’s score ranged from 0 to 2 and the total score ranged from 0 to 5. The area under the receiver operating characteristics curve revealed that there was 82.8% accuracy in the total scores predicting the likelihood of major bleeding complications. The rate of major bleeding complications was 2.3% in low-risk group (scores 0-1), 20.0% in moderate-risk group (scores 2-3), and 53.3% in high-risk group (scores 4-5) (p<0.001). Conclusions: This scoring system is useful for the risk stratification of major bleeding complications in AF patients with TAT after DES implantation.

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Incidence and outcomes of patients with atrial fibrillation and major bleeding complications: from the TREAT-AF study

Journal of Interventional Cardiac Electrophysiology ◽

10.1007/s10840-020-00873-0 ◽

2020 ◽

Author(s):

Alexander C. Perino ◽

Daniel W. Kaiser ◽

Randall J. Lee ◽

Jun Fan ◽

Mariam Askari ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Bleeding Complications

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Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and cancer a meta-analysis

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-020-02304-3 ◽

2020 ◽

Cited By ~ 2

Author(s):

Marco Valerio Mariani ◽

Michele Magnocavallo ◽

Martina Straito ◽

Agostino Piro ◽

Paolo Severino ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Major Bleeding ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Significant Risk ◽

Bleeding Complications ◽

Efficacy And Safety

Abstract Background Direct oral anticoagulants (DOACs) are recommended as first-line anticoagulants in patients with atrial fibrillation (AF). However, in patients with cancer and AF the efficacy and safety of DOACs are not well established. Objective We performed a meta-analysis comparing available data regarding the efficacy and safety of DOACs vs vitamin K antagonists (VKAs) in cancer patients with non-valvular AF. Methods An online search of Pubmed and EMBASE libraries (from inception to May, 1 2020) was performed, in addition to manual screening. Nine studies were considered eligible for the meta-analysis involving 46,424 DOACs users and 182,797 VKA users. Results The use of DOACs was associated with reduced risks of systemic embolism or any stroke (RR 0.65; 95% CI 0.52–0.81; p 0.001), ischemic stroke (RR 0.84; 95% CI 0.74–0.95; p 0.007) and hemorrhagic stroke (RR 0.61; 95% CI 0.52–0.71; p 0.00001) as compared to VKA group. DOAC use was associated with significantly reduced risks of major bleeding (RR 0.68; 95% CI 0.50–0.92; p 0.01) and intracranial or gastrointestinal bleeding (RR 0.64; 95% CI 0.47–0.88; p 0.006). Compared to VKA, DOACs provided a non-statistically significant risk reduction of the outcomes major bleeding or non-major clinically relevant bleeding (RR 0.94; 95% CI 0.78–1.13; p 0.50) and any bleeding (RR 0.91; 95% CI 0.78–1.06; p 0.24). Conclusions In comparison to VKA, DOACs were associated with a significant reduction of the rates of thromboembolic events and major bleeding complications in patients with AF and cancer. Further studies are needed to confirm our results.

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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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Major bleeding complications related to combined antithrombotic therapy in atrial fibrillation patients 12 months after coronary artery stenting

Journal of Cardiology ◽

10.1016/j.jjcc.2014.08.013 ◽

2015 ◽

Vol 65 (3) ◽

pp. 197-202 ◽

Cited By ~ 14

Author(s):

Hideki Kawai ◽

Eiichi Watanabe ◽

Mayumi Yamamoto ◽

Hiroto Harigaya ◽

Kan Sano ◽

...

Keyword(s):

Atrial Fibrillation ◽

Coronary Artery ◽

Major Bleeding ◽

Antithrombotic Therapy ◽

Bleeding Complications ◽

Coronary Artery Stenting

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Ximelagatran Versus Warfarin: A Comparison of Bleeding Outcomes in Patients with Nonvalvular Atrial Fibrillation.

Blood ◽

10.1182/blood.v104.11.1765.1765 ◽

2004 ◽

Vol 104 (11) ◽

pp. 1765-1765

Author(s):

James D. Douketis ◽

Karin Arneklev ◽

Samuel Goldhaber ◽

John Spandorfer ◽

Frank Halperin ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Lower Risk ◽

Case Fatality Rate ◽

Time Course ◽

Case Fatality ◽

Annual Incidence ◽

Bleeding Complications ◽

Fatality Rate ◽

Nonvalvular Atrial Fibrillation

Abstract Background: The conventional anticoagulant management of patients with nonvalvular atrial fibrillation (AF) involves warfarin, administered to achieve a target international normalized ratio (INR) of 2.0–3.0. Ximelagatran is a novel oral direct thrombin inhibitor that, unlike warfarin, has a predictable anticoagulant effect and does not require dose adjustments based on the INR. In the SPORTIF III and V trials, ximelagatran was as effective as warfarin in preventing stroke and other thromboembolic complications in patients with nonvalvular AF. However, these studies were not designed to determine if ximelagatran was associated with a lower risk of major bleeding. Furthermore, these studies did not compare the case-fatality rate, time course, and anatomic sites of bleeding in ximelagatran- and warfarin-treated patients. Methods: We undertook a pooled analysis of the SPORTIF III and V trials that involved 7329 patients with AF who received oral ximelagatran, 36 mg twice daily, or warfarin, administered to achieve a target INR of 2.0–3.0. Patients had nonvalvular AF and 1 or more risk factors for stroke: hypertension; age ≥75 yrs; previous stroke, transient ischemic attack or systemic embolism; left ventricular dysfunction; age ≥65 yrs and coronary artery disease; or age ≥65 yrs and diabetes. Major exclusion criteria were: mitral stenosis; previous heart valve surgery; transient AF; and increased risk for bleeding. Bleeding event rates were compared using Fisher’s exact test and the log-rank test and were expressed as the number of bleeds per year. The case-fatality rate of major bleeding was defined as the number of fatal bleeds divided by fatal plus nonfatal bleeds. Results: The annual incidence of major bleeding was 2.0% in ximelagatran-treated patients and 2.7% in warfarin-treated patients (P = 0.029). The annual incidence of any (major or minor) bleeding was 31.7% in ximelagatran-treated patients and 38.8% in warfarin-treated patients (P < 0.0001). If episodes of intracranial hemorrhage were excluded, the annual incidence of major bleeding was 1.9% in ximelagatran-treated patients and 2.4% in warfarin-treated patients (P = 0.054). The case-fatality rate of major bleeding was 8.2% in ximelagatran-treated and 8.1% in warfarin-treated patients (P = 0.98). The time course and anatomic sites of major bleeding were not significantly different in ximelagatran-treated and warfarin-treated patients. Most bleeds involved the gastrointestinal tract, urinary tract or soft tissues. Conclusion: In patients with nonvalvular AF who require long-term anticoagulation, treatment with oral ximelagatran, 36 mg twice daily, is associated with a lower risk of bleeding complications than warfarin.

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Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽

10.1182/blood.v120.21.502.502 ◽

2012 ◽

Vol 120 (21) ◽

pp. 502-502

Author(s):

Vera Gelbricht ◽

Sebastian Werth ◽

Christina Koehler ◽

Ulrike Haensel ◽

Luise Tittl ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Cardiovascular Events ◽

Safety Data ◽

Real Life ◽

Bleeding Complications ◽

Efficacy And Safety ◽

Daily Care ◽

Short Period

Abstract Abstract 502 Background: In the RE-LY trial, dabigatran (DB) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF), which lead to approval in many countries. However, patients in RCT‘s present a selected population treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives: To evaluate the efficacy, safety and management issues of dabigatran anticoagulation in AF in daily care. Patients and methods: In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July31th 2012, 938 patients were registered. Of these, 201 received DB for AF (table 1). The population in our registry is older than in RELY (74.2 vs. 71.5 years) and has a higher CHADS2-Score (2.7 vs. 2.1). Interestingly, 110 mg BID was the preferred dosage in DB patients (55.7%) despite the fact that these patients had higher CHADS2-scores than patients receiving 150 mg BID (2.3 vs. 2.9). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications. Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 86.8 patient years. During FU, Three patients (1.5%) experienced major cardiovascular events (xyz) and another two patients (1.0%) minor cardiovascular events (syncope). Until now, no deaths occurred. Bleeding complications were frequent (14.9%) but major bleeding was rare (n=3; 1.5%) none of which was fatal. At 3 month, 93% of patients were still taking DB but switch to other anticoagulants increased between 3 and 6 month, mainly due to side effects or incompliance. Conclusion: In unselected patients in daily care, DB is effective and safe with low rates of cardiovascular or major bleeding events. However, within 6 month, about 20% of patients are switched to other anticoagulants. Long-term data will be reported. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

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