Abstract 17598: More Than One in Five Older Veterans are Hospitalized for Bleeding Following Initiation of Warfarin for Atrial Fibrillation

Introduction: Clinicians are hesitant to prescribe oral anticoagulants to older adults with atrial fibrillation (AF) due to concerns over bleeding risk. Hypothesis: As many data on bleeding events are from trials of rigorously selected patients, we hypothesized that major bleeding events (requiring hospitalization) would be more common than previously reported. Methods: We created a retrospective cohort of 31,951 Veterans with AF aged ≥75 years who were new referrals to VA anticoagulation clinics (warfarin) from 1/1/02 - 12/31/12. Patients with comorbid conditions requiring warfarin (e.g. pulmonary embolus) were excluded. Data were extracted from the VA electronic medical record and linked with Medicare claims data for subsequent hospitalizations. The primary outcome was any hospitalization for bleeding. We identified bleeding subtypes by source, and compared characteristics of patients with and without bleeding hospitalizations. Results: Mean population age was 81.1 years, 98.1% were male, and 8.4% were nonwhite. Over a median follow-up period of 2.62 years, 7288 patients (22.8%) were hospitalized for bleeding. There were 12,004 total bleeding events; overall, 980 (13.4%) patients experienced multiple events. The most common bleeding sources (first event) were gastrointestinal (50.8%), genitourinary (21.6%), and intracranial (9.4%) (Figure). The median time to first bleeding event was 1.59 years. Patients hospitalized for bleeding were more likely to have coronary disease (48.4% vs. 40.9%, P<0.01); COPD (28.4% vs. 24.7%, P<0.01); chronic kidney disease (17.8% vs. 16.0%, P<0.01); CHF (34.7% vs. 29.5%, P<0.01), and labile INR (63.3% vs. 53.7%, P<0.01). The rate of hospitalization for stroke over the same time period was 5.0%. Conclusions: After initiating warfarin, over one in five older Veterans are hospitalized for bleeding, most commonly from a gastrointestinal source. Comorbidity burden and labile INR place these patients at increased risk.

Download Full-text

P675Current status of anticoagulation in patients with breast cancer and atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz747.0281 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Pardo Sanz ◽

L M Rincon ◽

P Guedes Ramallo ◽

L Belarte ◽

G De Lara ◽

...

Keyword(s):

Breast Cancer ◽

Atrial Fibrillation ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Bleeding Events ◽

Patients With Cancer ◽

Oncologic Patients

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.

Download Full-text

Anticoagulation Changes Following Major and Clinically Relevant Nonmajor Bleeding Events in Non-valvular Atrial Fibrillation Patients

Journal of Pharmacy Practice ◽

10.1177/08971900211064189 ◽

2021 ◽

pp. 089719002110641

Author(s):

Thane Feldeisen ◽

Constantina Alexandris-Souphis ◽

Brian Haymart ◽

Xiaowen Kong ◽

Eva Kline-Rogers ◽

...

Keyword(s):

Atrial Fibrillation ◽

Drug Class ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Anticoagulation Therapy ◽

Bleeding Event ◽

Bleeding Events ◽

Anticoagulation Management ◽

Anticoagulation Clinics ◽

The Individual

Background Bleeding events are common complications of oral anticoagulant drugs, including both warfarin and the direct oral anticoagulants (DOACs). Some patients have their anticoagulant changed or discontinued after experiencing a bleeding event, while others continue the same treatment. Differences in anticoagulation management between warfarin- and DOAC-treated patients following a bleeding event are unknown. Methods Patients with non-valvular atrial fibrillation from six anticoagulation clinics taking warfarin or DOAC therapy who experienced an International Society of Thrombosis and Haemostasis (ISTH)-defined major or clinically relevant non-major (CRNM) bleeding event were identified between 2016 and 2020. The primary outcome was management of the anticoagulant following bleeding (discontinuation, change in drug class, and restarting of same drug class). DOAC- and warfarin-treated patients were propensity matched based on the individual elements of the CHA2DS2-VASc and HAS-BLED scores as well as the severity of the bleeding event. Results Of the 509 patients on warfarin therapy and 246 on DOAC therapy who experienced a major or CRNM bleeding event, the majority of patients continued anticoagulation therapy. The majority of warfarin (231, 62.6%) and DOAC patients (201, 81.7%) restarted their previous anticoagulation. Conclusion Following a bleeding event, most patients restarted anticoagulation therapy, most often with the same type of anticoagulant that they previously had been taking.

Download Full-text

Continuation or discontinuation of oral anticoagulants after an increase in HAS-BLED scores and the risks of clinical outcomes in patients with atrial fibrillation. a nationwide cohort study

European Heart Journal ◽

10.1093/ehjci/ehaa946.0638 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T.F Chao ◽

J.N Liao ◽

G.Y.H Lip ◽

S.A Chen

Keyword(s):

Atrial Fibrillation ◽

Clinical Outcomes ◽

Oral Anticoagulants ◽

Antiplatelet Agents ◽

Bleeding Risk ◽

Risk Profile ◽

Bleeding Events ◽

Concurrent Use ◽

The Impact

Abstract Background The bleeding risk profile of patients with atrial fibrillation (AF) may change over time and the increment of HAS-BLED score (a validated bleeding risk score) is perceived to result in discontinuations of oral anticoagulants (OACs). The goal of the present study was to investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk (HAS-BLED 0–2). Second, the impact of continuation or discontinuation of OACs on clinical outcomes after patients' bleeding risk profile worsened (ie HAS-BLED increased) were also studied. Methods The present study used the Taiwan nationwide health insurance research (NHIRD) database. From year 2000 to 2015, a total of 24,990 AF patients aged >20 years with a CHA2DS2-VASc score >1 (males) or >2 (females) having a HAS-BLED score of 0–2 who were treated with OACs (warfarin or NOACs) were identified and followed up for changes of the HAS-BLED scores. The risks of clinical outcomes were compared between patients who continued or stopped OAC's once their HAS-BLED score increased to ≥3. Results Mean HAS-BLED score of study population continuously increased from 1.54 (SD 1.63) at baseline, to 3.33 (SD 1.36) at the end of follow up with increasing age and incident comorbidities (Figure A). At end of 1 year, 5,229 (20.9%) patients had an increment of their HAS-BLED score to ≥3, mainly due to newly diagnosed impaired renal function, occurrences of bleeding events and concurrent use of antiplatelet agents or NSAIDs. Among 4,777 patients who consistently had a HAS-BLED score > =3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n=3,715; 77.8%) even after their HAS-BLED score increased to ≥3 were associated with a lower risk of ischemic stroke (aHR 0.601), major bleeding (aHR 0.780), all-cause mortality (aHR 0.876) and any adverse events (aHR 0.748) (Figure B). Conclusions For patients whose HAS-BLED scores increased to ≥3, the continuation of OACs (which occurred in the majority of patients) was associated with better clinical outcomes. An increased HAS-BLED score in AF patients is not a reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. The low risk of bleeding despite continuing OAC in high HAS-BLED score patients may reflect the early reviews and careful follow-up of these “high risk” patients (as recommended in guidelines). Funding Acknowledgement Type of funding source: None

Download Full-text

Assessing Bleeding Risk in Atrial Fibrillation Patients: Comparing a Bleeding Risk Score Based Only on Modifiable Bleeding Risk Factors against the HAS-BLED Score. The AMADEUS Trial

Thrombosis and Haemostasis ◽

10.1160/th17-10-0710 ◽

2017 ◽

Vol 117 (12) ◽

pp. 2261-2266 ◽

Cited By ~ 35

Author(s):

María Esteve-Pastor ◽

José Rivera-Caravaca ◽

Alena Shantsila ◽

Vanessa Roldán ◽

Gregory Lip ◽

...

Keyword(s):

Risk Factors ◽

Atrial Fibrillation ◽

Risk Score ◽

Bleeding Event ◽

Bleeding Risk ◽

Clinical Score ◽

International Normalized Ratio ◽

Bleeding Events ◽

Modifiable Factors

Background The HAS-BLED (hypertension, abnormal renal/liver function, previous stroke, bleeding history or predisposition, labile international normalized ratio [INR], elderly and drugs/alcohol consumption) score has been validated in several scenarios but the recent European guidelines does not recommend any clinical score to assess bleeding risk in atrial fibrillation (AF) patients and only focus on modifiable clinical factors. Purpose The aim of this study was to test the hypothesis that the HAS-BLED score would perform at least similarly to an approach only based on modifiable bleeding risk factors (i.e. a ‘modifiable bleeding risk factors score’) for predicting bleeding events. Methods We performed a comparison between the HAS-BLED score and the new ‘modifiable bleeding risk factors score’ in a post hoc analysis in 4,576 patients included in the AMADEUS trial. Results After 347 (interquartile range, 186–457) days of follow-up, 597 patients (13.0%) experienced any clinically relevant bleeding event and 113 (2.5%) had a major bleeding. Only the HAS-BLED score was significantly associated with the risk of any clinically relevant bleeding (Cox's analysis for HAS-BLED ≥ 3: hazard ratio 1.38; 95% confidence interval [CI], 1.10–1.72; p = 0.005). The ‘modifiable bleeding risk factors score’ ≥ 2 were non-significantly associated with any clinical relevant bleeding. The two scores had modest ability in predicting bleeding events. The HAS-BLED score performed best in predicting any clinically relevant bleeding (c-indexes for HAS-BLED, 0.545 [95% CI, 0.530–0.559] vs. the ‘modifiable bleeding risk factors score’, 0.530 [95% CI, 0.515–0.544]; c-index difference 0.015, z-score = 2.063, p = 0.04). The HAS-BLED score with one, two and three modifiable factors performed significantly better than the ‘modifiable bleeding risk factors scores’ with one, two and three modifiable risk factors. Conclusion When compared with an approach only based on modifiable bleeding risk factors proposed by European Society of Cardiology (ESC) AF guidelines, the HAS-BLED score performed significantly better in predicting any clinically relevant bleeding in this clinical trial cohort. While modifiable bleeding risk factors should be addressed in all AF patients, the use of a formal bleeding risk score (HAS-BLED) has better predictive value for bleeding risks, and would help decision-making in identifying ‘high risk’ patients for scheduling reviews and follow-up.

Download Full-text

Abstract 336: Anticoagulation Prescribing Patterns and Rates of Bleeding for People With Cancer and Atrial Fibrillation

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.336 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

Sarah Barker ◽

Adam L Cohen ◽

Rashmee Shah ◽

Anna Catino

Keyword(s):

Atrial Fibrillation ◽

Bleeding Event ◽

Bleeding Risk ◽

Prescribing Patterns ◽

Secondary Outcome ◽

Cancer Type ◽

Bleeding Events ◽

Thrombosis Risk ◽

Increased Risk ◽

Event Rates

Introduction: Atrial fibrillation (AF) is a major cause of stroke and increased mortality among people with cancer. People with cancer have a higher risk of developing AF at time of cancer diagnosis, prior to treatment, and after therapy than patients without cancer. AF management includes anticoagulation (AC) for stroke prophylaxis. Risk stratification tools are used to assess patients’ stroke and bleeding risk. However, such tools have not been validated in people with cancer. Therapeutic AC poses challenges due to increased risk of bleeding, platelet dysfunction, and drug interaction. Given this, therapeutic AC is often deferred despite potentially higher thrombosis risk. We sought to better understand practice patterns of therapeutic AC among people with cancer and AF. Hypothesis: We predicted reduced AC prescribing rates for AF among people with cancer despite high CHA 2 DS 2 -VASc score. Methods: We conducted a retrospective cohort study of people with cancer and AF at a single institution from 2010 to 2018. Cancer type was ascertained from an institutional registry; AF and other characteristics were determined from the electronic medical record. Patients were classified as anticoagulated based on medication orders and lists. Bleeding event rates were assessed using ICD billing codes. The primary outcome was rate of anticoagulant use with a secondary outcome of frequency of bleeding events. Results: We identified 2914 people with cancer and AF. 48% (1406 of 2914) were anticoagulated, and those prescribed AC were older (71.6 ± 9.7 vs. 69.8 ± 11, p<0.01), had higher CHA 2 DS 2 -VASc scores (3.7 ± 1.8 vs. 3.5 ± 1.9, p<0.01), and were more likely to have AF before cancer (49.7% vs. 39.7%p<0.01). People with breast (61%) and skin (66%) cancers had higher rates of AC, while people with hematologic (44%), brain (39%), lung (38%), and gastrointestinal (39%) cancers were less likely to be anticoagulated. Treated patients were more likely to experience a bleeding event (32% vs. 20%, p<0.01). Conclusions: There is a large group of people with cancer and high CHA 2 DS 2 -VASc scores who are not anticoagulated. Further research is needed to determine if this lack of AC is due to bleeding risk, lack of prescribing, or invalid use of CHA 2 DS 2 -VASc stratification in this population. Apparent bleeding rates are higher than previously published.

Download Full-text

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽

10.1161/circ.132.suppl_3.17152 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Benjamin A Steinberg ◽

DaJuanicia N Simon ◽

Laine Thomas ◽

Jack Ansell ◽

Gregg C Fonarow ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Vitamin K ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Recurrent Bleeding ◽

Bleeding Events ◽

Reversal Agents ◽

Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

Download Full-text

Abstract 4784: The Ross Operation: Lessons From Long Term Follow-up

Circulation ◽

10.1161/circ.118.suppl_18.s_943-a ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Laurent de Kerchove ◽

Jean Rubay ◽

Agnès Pasquet ◽

Alain Poncelet ◽

Munir Boodhwani ◽

...

Keyword(s):

Valve Replacement ◽

Bleeding Event ◽

Right Ventricular Outflow Tract ◽

Aortic Insufficiency ◽

Bleeding Events ◽

Ross Operation ◽

Increased Risk ◽

Long Term Follow Up

Background: The Ross operation is considered the procedure of choice for aortic valve replacement in children and represents an attractive alternative in selected young adults. However, long term follow-up has demonstrated high rates of pulmonary autograft failure raising concern regarding its clinical utility. We analyze long term outcomes of our Ross series, focusing on predictors of autograft failure. Methods: Between 1991 and 2006, 260 consecutive patients underwent Ross operation. Mean age was 35±15 years (range: 1 day to 64 years) and 75% were male. The technique for autograft implantation was a full root replacement in 70% (n=183), inclusion cylinder in 28% (n=73) and subcoronary in 2% (n=4). Right ventricular outflow tract (RVOT) was reconstructed with a pulmonary homograft in 94% (n=245) and with a xenograft in 6% (n=15). Mean clinical follow-up (97% complete) was 97±46 months (13 to 196 months). Echocardiographic follow-up was available in 234 survivors (94%). Results: Hospital mortality was 1.9% (n=5) and 7 patients died during follow-up (3 non cardiac). Twelve year overall survival was 93±4% and freedom from autograft reoperation and from autograft valve replacement was 83±7% and 94±5% respectively. Twenty-five patients (9.6%) underwent autograft reoperation either for insufficiency (n=8), autograft or ascending aorta dilatation (n=6), or both (n=11) with no mortality. In 76% (n=19) of these patients, the autograft valve was preserved. Predictors for autograft dilatation (≥45 mm) were preoperative aortic insufficiency and full root technique. RVOT reintervention was required in 10 (4%) patients (reoperations n=7, balloon dilatation n=3). Twelve year freedom from RVOT reintervention was 95±4. Twelve year freedom from thrombo-embolic and bleeding events was 99±1% (1 stroke, 1 TIA, 1 bleeding event). Conclusions: This long terms study confirms the excellent survival after Ross operation with an extremely low rate of thrombo-embolic and bleeding events. Autograft reoperation rate remains acceptable. Full root technique is associated with increased risk of autograft dilatation, and should be avoided especially in adults with preoperative aortic insufficiency. Autograft valve preservation is feasible in autograft reoperation.

Download Full-text

Long-term clinical outcomes after major bleeding in patients with atrial fibrillation: the Fushimi AF registry

European Heart Journal - Quality of Care and Clinical Outcomes ◽

10.1093/ehjqcco/qcaa082 ◽

2020 ◽

Author(s):

Hisashi Ogawa ◽

Yoshimori An ◽

Kenjiro Ishigami ◽

Syuhei Ikeda ◽

Kosuke Doi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischaemic Stroke ◽

Clinical Outcomes ◽

Major Bleeding ◽

Bleeding Event ◽

Community Based ◽

Increased Risk ◽

All Cause Mortality

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P < 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P < 0.01), history of major bleeding (7.7% vs. 4.0%; P < 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P < 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P < 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)

Download Full-text

P4745Concomitant oral anticoagulant and antidepressant therapy in patients with atrial fibrillation and risk of stroke and bleeding: a population based cohort study

European Heart Journal ◽

10.1093/eurheartj/ehz745.1121 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

J J Komen ◽

P Hjemdahl ◽

A K Mantel - Teeuwisse ◽

O H Klungel ◽

B Wettermark ◽

...

Keyword(s):

Atrial Fibrillation ◽

Propensity Score ◽

Oral Anticoagulant ◽

Cox Regression ◽

Oral Anticoagulants ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment ◽

Increased Risk ◽

Antidepressant Use

Abstract Background Anticoagulation treatment reduces the risk of stroke but increases the risk of bleeding in atrial fibrillation (AF) patients. Antidepressants use is associated with increased risk for stroke and bleeds. Objective To assess the association between antidepressant use in AF patients with oral anticoagulants and bleeding and stroke risk. Methods All AF patients newly prescribed with an oral anticoagulant in the Stockholm Healthcare database (n=2.3 million inhabitants) from July 2011 until 2016 were included and followed for one year or shorter if they stopped claiming oral anticoagulant treatment or had an outcome of interest. Outcomes were severe bleeds and strokes, requiring acute hospital care. During follow-up, patients were considered exposed to antidepressant after claiming a prescription for the duration of the prescription. With a time-varying Cox regression, we assessed the association between antidepressant use and strokes and bleeds, adjusting for confounders (i.e., age, sex, comorbidities, comedication, and year of inclusion). In addition, we performed a propensity score matched analysis to test the robustness of our findings. Results Of the 30,595 patients included after claiming a prescription for a NOAC (n=13,506) or warfarin (n=17,089), 4 303 claimed a prescription for an antidepressant during follow-up. A total of 712 severe bleeds and 551 strokes were recorded in the cohort. Concomitant oral anticoagulant and antidepressant use was associated with increased rates of severe bleeds (4.7 vs 2.7 per 100 person-years) compared to oral anticoagulant treatment without antidepressant use (aHR 1.42, 95% CI: 1.12–1.80), but not significantly associated with increased stroke rates (3.5 vs 2.1 per 100 person-years, aHR 1.23, 95% CI: 0.93–1.62). No significant differences were observed between different oral anticoagulant classes (i.e., warfarin or NOAC) or different antidepressant classes (i.e., SSRI, TCA, or other antidepressant). Additional propensity-score matched analyses yielded similar results but showed a significantly increased risk for stroke (HR: 1.47, 95% CI: 1.08–2.02). Incidence rates of strokes and bleeds Conclusion Concomitant use of an oral anticoagulant and an antidepressant, irrespective of type, is associated with an increased bleeding risk. Increased awareness and a critical consideration for the need of an antidepressant is recommended in this population. Acknowledgement/Funding Swedish Heart Lung Foundation

Download Full-text

GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

BMJ Open ◽

10.1136/bmjopen-2019-033283 ◽

2019 ◽

Vol 9 (11) ◽

pp. e033283 ◽

Cited By ~ 3

Author(s):

Frederik Dalgaard ◽

Karen Pieper ◽

Freek Verheugt ◽

A John Camm ◽

Keith AA Fox ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischaemic Stroke ◽

Major Bleeding ◽

Risk Model ◽

Oral Anticoagulants ◽

External Validation ◽

Bleeding Risk ◽

Risk Scores ◽

Secondary Outcome

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

Download Full-text