Abstract TP408: Temporal Relationship of AF and Oral Anticoagulation to Major Bleeding Events in Patients with Cardiovascular Implantable Electronic Devices

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Mariam Askari ◽  
Paul D Zielger ◽  
Susan K Schmitt ◽  
Jun Fan ◽  
Aditya J Ullal ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Remote Monitoring ◽  
Electronic Devices ◽  
Continuous Measure ◽  
Bleeding Events ◽  
Cardiovascular Implantable Electronic Devices ◽  
Before And After ◽  
Increase Risk ◽  
Major Bleeding Events

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.

scholarly journals Risk of major bleeding during extended oral anticoagulation in patients with first unprovoked venous thromboembolism: a systematic review and meta-analysis protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Faizan Khan ◽  
Miriam Kimpton ◽  
Tobias Tritschler ◽  
Grégoire Le Gal ◽  
Brian Hutton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Background The optimal duration of anticoagulation after a first unprovoked venous thromboembolism (VTE) remains controversial. Deciding to stop or continue anticoagulant therapy indefinitely after completing 3 to 6 months of initial treatment requires balancing the long-term risk of recurrent VTE if anticoagulation is stopped against the long-term risk of major bleeding if anticoagulation is continued. However, knowledge of the long-term risk for major bleeding events during extended anticoagulation in this patient population is limited. We plan to conduct a systematic review and meta-analysis to quantify the risk for major bleeding events during extended oral anticoagulation in patients with first unprovoked VTE. Methods Electronic databases including MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials will be systematically searched with the assistance of an information specialist (from inception to March 1, 2019) to identify randomized controlled trials and prospective cohort studies reporting major bleeding during extended oral anticoagulation in patients with first unprovoked VTE, who have completed at least 3 months of initial anticoagulant therapy. Study selection, risk of bias assessment, and data extraction will be performed independently by at least two investigators. The number of major bleeding events and person-years of follow-up will be used to calculate the rate (events per 100 person-years) with its 95% confidence interval for each study cohort, during clinically relevant time periods of extended anticoagulant therapy. Results will be pooled using random effect meta-analysis. Discussion The planned systematic review and meta-analysis will provide reliable estimates of the risk for major bleeding events during extended anticoagulation. This information will help inform patient prognosis and assist clinicians with balancing the risks and benefits of treatment to guide management of unprovoked VTE. Systematic review registration PROSPERO CRD42019128597.

P10 A possible link between sarcopenia and major bleeding risk among patients with atrial fibrillation treated with oral anticoagulation undergoing coronary stenting

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
K Tsuchida ◽  
K Tanaka ◽  
K Nakano ◽  
R Akagawa ◽  
N Oyanagi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Skeletal Muscle ◽  
Muscle Mass ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Skeletal Muscle Mass ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Background/Introduction In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with stent implantation, oral anticoagulation (OAC) plus dual antiplatelet therapy (DAPT) increases the risk of bleeding. The PRECISE-DAPT (P-DAPT) and DAPT scores were created to predict increased bleeding versus ischemic risk in patients undergoing DAPT. However, not much information is available on predicting bleeding risk associated with OAC concomitant with DAPT in patients with AF treated with coronary stents. Physical frailty or sarcopenia is considered an emerging predictor for bleeding in AF patients. Purpose To investigate the relationship between skeletal muscle mass and major bleeding risk in AF patients undergoing PCI and subsequent OAC and DAPT. Methods A total of 1,234 consecutive patients after PCI using newer-generation drug eluting stents were evaluated. An anti-thrombotic regimen without OAC was given to 1,077 patients, whereas OAC was required in 157 patients (12.7%) including AF (n = 96). The P-DAPT, DAPT, and HAS-BLED scores were calculated for each of the patients. Any out-of-hospital major bleeding events were identified based on BARC criteria during a median follow-up of 2.9 years. The fat-free mass index (FFMI; kg/m2) was calculated to evaluate skeletal muscle mass as follows: (7.38 + 0.02908 × urinary creatinine (mg/day)) / (height squared (m2)). A Cox proportional hazards model was used to test the significance of the FFMI and these risk scores as predictors of major bleeding, defined as BARC 3 or 5 events in AF patients. The receiver operating characteristic curve (ROC) analyses were used to examine the predictive ability of the FFMI and these scores to identify patients with major bleeding events. Results Major bleeding events were observed in 9 (9.3%) patients. Major bleeding was associated with a lower FFMI (hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.36-0.79; p = 0.002), and higher P-DAPT score (HR, 1.07; 95% CI, 1.02-1.11; p = 0.003), but not with the DAPT (HR, 0.71; 95% CI, 0.45-1.12; p = 0.147) and the HAS-BLED score (HR, 1.00; 95% CI, 0.48-2.09; p = 0.990). In the non-OAC cohort, major bleeding was related to a higher P-DAPT score (HR, 1.05; 95% CI, 1.02-1.07; p &lt; 0.0001), but the FFMI (HR, 0.89; 95% CI, 0.73-1.09; p = 0.265) and the DAPT score were not correlated. C-statistics for major bleeding events were 0.82 (95% CI, 0.71-0.93, p = 0.001) for the FFMI and 0.79 (95% CI, 0.68-0.90, p = 0.004) for the P-DAPT score. Conclusions Assessment of the FFMI for screening sarcopenia is useful to predict major bleedings specifically in patients with AF undergoing coronary stenting. Both the FFMI and P-DAPT could successfully predict major bleedings in AF patients after PCI. Whether novel bleeding risk scores combined with measuring body composition adequately identify high risk patients needs to be validated.

scholarly journals 473 Propensity-matched comparison of left atrial appendage occlusion and direct oral anticoagulation for thromboembolic prevention in octogenarians

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Michele Magnocavallo ◽  
Domenico Giovanni Della Rocca ◽  
Carlo Lavalle ◽  
Cristina Chimenti ◽  
Gianni Carola ◽  
...  
Keyword(s):  
Risk Reduction ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Treatment Strategies ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Left Atrial Appendage Occlusion ◽  
Watchman Device ◽  
Major Bleeding Events

Abstract Aims A significant amount of atrial fibrillation patients does not receive appropriate anticoagulation, owing to contraindications and side effects. Octogenarians have higher competing comorbidities with a remarkable bleeding/thromboembolic (TE) risk. We aimed at analysing the clinical outcomes of LAAO compared with direct oral anticoagulation (DOAC) in octogenarians. Methods and results Data were extracted from two prospective databases including 488 LAAO and 825 DOAC patients. Patients aged 80 years or older accounted for 37.1% (n = 181) and 39.5% (n = 326). In order to attenuate the imbalance in covariates between the groups, a propensity score matching technique was used (covariates: age, sex, CHA2DS2-VASc, and HAS-BLED scores, follow-up duration; tolerance 0.02). This method resulted in matched populations with 108 octogenarian patients per group. The annual stroke/transient ischaemic attack (TIA) risk was estimated based on the CHA2DS2-VASc, and compared to the annualized observed risk, owing to calculate the % risk reduction associated with the two treatment strategies. A total of 216 octogenarians were included in the analysis (84 ± 3 years; CHA2DS2-VASc: 4.9 ± 1.4, HAS-BLED: 3.1 ± 0.9). A Watchman device was successfully deployed in all LAAO ≥ 80 patients; periprocedural adverse events were observed in 2.8% (n = 3) of LAAO patients. During a follow-up of 13 ± 4 months, 3 (2.8%) TE complications (1 stroke, 2 TIA) occurred in LAAO ≥ 80 pts and 4 (3.7%; 1 stroke, 3 TIA) in DOAC ≥ 80 pts (P = 0.99). The annualized risk of stroke/TIA was 2.5% in the first and 3.5% in the second group. Based on the estimated annual TE risk according to the CHA2DS2-VASc score, the % risk reduction after LAAO and DOAC was 54.5% and 36.4%, respectively. Major bleeding events were 3 [1 intracranial, 2 gastrointestinal (GI)] LAAO ≥ 80 pts, and 3 (2 intracranial, 1GI) in DOAC ≥ 80 pts (2.8% in both groups). Minor bleeding events were significantly higher in DOAC ≥ 80 pts [13.0% (n = 14) vs. 2.7% (n = 3); RR: 4.7, 95% CI: 1.4–15.7; P = 0.009]. Conclusions LAAO was safe and similar to DOAC at preventing ischaemic/major bleeding events in a matched population of patients aged ≥80 years. A significantly higher incidence of minor bleeding events was observed in the DOAC group.

scholarly journals Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial

2021 ◽  
Author(s):  
Behnood Bikdeli ◽  
Azita H Talasaz ◽  
Farid Rashidi ◽  
Hooman Bakhshandeh ◽  
Farnaz Rafiee ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Major Bleeding ◽  
Arterial Thrombosis ◽  
Dose Group ◽  
Standard Dose ◽  
Controlled Trial ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Prophylactic Anticoagulation ◽  
Intermediate Dose

Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

A Systematic Review of Anticoagulation Strategies for Patients With Atrial Fibrillation in Critical Care.

2021 ◽  
Author(s):  
Alexandra Jayne Nelson ◽  
Brian W Johnston ◽  
Alicia Achiaa Charlotte Waite ◽  
Gedeon Lemma ◽  
Ingeborg Dorothea Welters
Keyword(s):  
Atrial Fibrillation ◽  
Critical Care ◽  
Critically Ill ◽  
Major Bleeding ◽  
Critically Ill Patients ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
The Impact ◽  
Anticoagulated Patients

Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically ill patients. There is a paucity of data assessing the impact of anticoagulation strategies on clinical outcomes for general critical care patients with AF. Our aim was to assess the existing literature to evaluate the effectiveness of anticoagulation strategies used in critical care for AF. Methodology. A systematic literature search was conducted using MEDLINE, EMBASE, CENTRAL and PubMed databases. Studies reporting anticoagulation strategies for AF in adults admitted to a general critical care setting were assessed for inclusion. Results. Four studies were selected for data extraction. A total of 44087 patients were identified with AF, of which 17.8-49.4% received anticoagulation. The reported incidence of thromboembolic events was 0-1.4% for anticoagulated patients, and 0-1.3% in non-anticoagulated patients. Major bleeding events were reported in three studies and occurred in 7.2-8.6% of the anticoagulated patients and up to 7.1% of the non-anticoagulated patients. Conclusions. There was an increased incidence of major bleeding events in anticoagulated patients with AF in critical care compared to non-anticoagulated patients. There was no significant difference in the incidence of reported thromboembolic events within studies, between patients who did and did not receive anticoagulation. However, the outcomes reported within studies were not standardised, therefore, the generalisability of our results to the general critical care population remains unclear. Further data is required to facilitate an evidence-based assessment of the risks and benefits of anticoagulation for critically ill patients with AF.

scholarly journals B-PO04-048 PATIENT CHARACTERISTICS ASSOCIATED WITH ADHERENCE TO REMOTE MONITORING OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES

Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S298
Author(s):  
Anoop Muniyappa ◽  
Gregory L. Judson ◽  
Hui Shen ◽  
Gary Tarasovsky ◽  
Mary A. Whooley ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Electronic Devices ◽  
Patient Characteristics ◽  
Cardiovascular Implantable Electronic Devices

Assessing the management of major bleeding events in patients treated by direct oral anticoagulant in an emergency department

2021 ◽  
Vol 79 (4) ◽  
pp. 315-324
Author(s):  
Julien Durand ◽  
Stéphanie Parat ◽  
Jean-Christophe Lega ◽  
Yessim Dargaud ◽  
Véronique Potinet ◽  
...  
Keyword(s):  
Emergency Department ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Bleeding Events ◽  
Major Bleeding Events

scholarly journals Concurrent Use of Chinese Herbal Medicine and Anticoagulants May Reduce Major Bleeding Events

2021 ◽  
Author(s):  
Shuo-Min Hsu ◽  
Hung-Jen Lin ◽  
Yi-Wei Kao ◽  
Te-Mao Li ◽  
Ben-Chang Shia ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Major Bleeding ◽  
Lower Risk ◽  
Panax Notoginseng ◽  
Research Database ◽  
Bleeding Events ◽  
Chinese Herbal ◽  
Concurrent Use ◽  
Major Bleeding Events

Abstract Background: This retrospective cohort study investigated the risk of major bleeding events during the concurrent use of Chinese herbal medicine (CHM) and anticoagulants in clinical practice. Methods: A total of 4,470 patients receiving anticoagulant drugs were selected from Taiwan’s National Health Insurance Research Database (NHIRD). Half (n=2,235) were also using CHMs (CHM cohort); the other half were not (non-CHM cohort). Each cohort was matched 1:1 using the propensity score. Chi-square testing and the Student’s t-test were used to examine differences between two cohorts. Cox proportional hazard regression analysis assessed the risks for major bleeding events in each cohort, as well as bleeding risks associated with specific CHM formulas and herbs. Cumulative incidence curves for major bleeding events were calculated using Kaplan-Meier analysis. Results: Compared with the non-CHM cohort, the CHM cohort had a lower risk of overall bleeding events (p < 0.001) including hemorrhagic stroke (p = 0.008), gastrointestinal (GI) bleeding (p < 0.001), urogenital bleeding (p ≤ 0.001) and nasal/ear/eye bleeding (p = 0.004). Single herbs, such as Glycyrrhiza uralensis et Rhizoma, Panax notoginseng, Panax ginseng, Platycodon grandiflorum, Eucommia ulmoides Oliver and formulas, such as Shu Jing Huo Xue Tang, Shao Yao Gan Cao Tang and Ji Sheng Shen Qi Wan were associated with a lower risk of major bleeding events. Conclusions: Using CHMs with anticoagulants appeared to decrease the risk of major bleeding. Further investigations are needed to determine whether CHM can maintain the therapeutic efficacy of anticoagulants while simultaneously reducing potential side effects.Trial registration: Not applicable.

scholarly journals The safety of triple antiplatelet therapy under thromboelastography guidance in patients undergoing stenting for ischemic cerebrovascular disease

2018 ◽  
Vol 11 (4) ◽  
pp. 352-356 ◽  
Author(s):  
Zhonghua Wu ◽  
Ao-Fei Liu ◽  
Ji Zhou ◽  
Yiqun Zhang ◽  
Kai Wang ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Stent Thrombosis ◽  
Major Bleeding ◽  
Artery Stenosis ◽  
Intracranial Artery ◽  
Bleeding Events ◽  
Triple Antiplatelet Therapy ◽  
Intracranial Artery Stenosis ◽  
Major Bleeding Events ◽  
Group 1

ObjectiveTo investigate the safety of triple antiplatelet therapy (TAT) with cilostazol in patients undergoing stenting for extracranial and/or intracranial artery stenosis.MethodsA prospectively collected database was reviewed to identify patients who underwent stenting for extracranial and/or intracranial artery stenosis and showed resistance to aspirin and/or clopidogrel as assessed by pre-stenting thromboelastography (TEG) testing. Patients were assigned to a TAT group and a dual antiplatelet therapy (DAT) group. Major complications were defined as thromboembolic events (transient ischemic attack (TIA), ischemic stroke, and stent thrombosis) or major bleeding events within 30 days, and minor complications were defined as extracranial bleeding that did not require vascular surgery or transfusion within 30 days.ResultsA total of 183 patients were identified. The incidence of major complications was significantly lower in the TAT group than in the DAT group (TAT group vs. DAT group, 1/110 vs. 6/73; P=0.017). TIAs occurred in four patients, with one in the TAT group and three in the DAT group (1/110 vs. 3/73; P=0.303). Ischemic strokes occurred in three patients in the DAT group (TAT group vs. DAT group, P=0.062). No major bleeding events or stent thrombosis was recorded in either group. Two patients (one in each group) experienced minor complications that resolved without additional treatment (1/110 vs. 1/73; P>0.999).ConclusionsTAT under TEG guidance appears to be a safe antiplatelet strategy in patients undergoing stenting for extracranial and/or intracranial artery stenosis. By employing TAT under TEG guidance, favorable outcomes can be achieved in these patients.

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