Potential net clinical benefit of population-wide implementation of apixaban and dabigatran among European patients with atrial fibrillation

2013 ◽  
Vol 109 (02) ◽  
pp. 328-336 ◽  
Author(s):  
Ron Pisters ◽  
Robby Nieuwlaat ◽  
Deirdre Lane ◽  
Harry Crijns ◽  
Gregory Lip
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Clinical Benefit ◽  
Vitamin K Antagonists ◽  
The Novel ◽  
Major Cardiovascular Events ◽  
Numbers Needed To Treat ◽  
One Year ◽  
Net Clinical Benefit

SummaryVitamin K antagonists (e.g. warfarin) are commonly underutilised, due to limitations such as the need for monitoring, in high-risk atrial fibrillation (AF) patients. We therefore aimed to model the potential impact on clinical outcomes in patients with AF with the use of the novel oral anticoagulant (OAC) drugs, apixaban and dabigatran. We identified all high-risk (CHA2DS2-VASc score ≥2) patients with non-valvular AF and known one-year follow-up from the EuroHeart Survey on AF (EHS-AF). We modelled the expected numbers of clinical events on the novel OACs using published hazard ratios from their respective phase 3 clinical trials and calculated the numbers needed to treat and the mathematical net clinical benefit. Our analysis included 3,400 patients [39% females; mean (SD) age 67 (12) years; CHA2DS2-VASc score 3.0 (1.8)] of which 330 were excluded from the modelling analysis due to concomitant use of OAC and antiplatelet drugs. During one-year follow- up, 108 (3.2%) patients experienced thromboembolism, 51 (1.5%) major bleeds and 146 (4.3%) died. Compared to current treatments (i.e. warfarin, aspirin or nothing) the use of apixaban in highrisk patients would have potentially prevented an additional 17 deaths, 27 strokes and eight major bleeds within this cohort. With use of dabigatran 150 mg BID, 34 strokes could have been prevented and for dabigatran110 mg BID, 16 strokes and six major bleeds would be avoided. Extrapolation of the data from the EHS-AF to the whole of Europe would translate into the prevention of an additional 64,573 major cardiovascular events and deaths each year among patients with a CHA2DS2-VASc ≥2, by the use of apixaban, 43,235 with the use of dabigatran 150 mg bid and 27,272 with the use of dabigatran 110 mg bid. In conclusion, based on this modelling exercise, the utilisation of apixaban and dabigatran for thromboprophylaxis could provide a profound annual mathematical net clinical benefit on stroke and major bleeds, in European AF patients.Note: The editorial process for this paper was fully handled by Prof. C. Weber, Editor in Chief.

scholarly journals Association of Oral Anticoagulation With Stroke in Atrial Fibrillation or Heart Failure: A Comparative Meta-Analysis

Stroke ◽  
2021 ◽  
Author(s):  
Catriona Reddin ◽  
Conor Judge ◽  
Elaine Loughlin ◽  
Robert Murphy ◽  
Maria Costello ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Treatment Effect ◽  
Oral Anticoagulation ◽  
Clinical Benefit ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Major Hemorrhage ◽  
Net Clinical Benefit

Background and Purpose: Atrial fibrillation and heart failure with reduced ejection fraction (HFrEF) are common sources of cardioembolism. While oral anticoagulation is strongly recommended for atrial fibrillation, there are marked variations in guideline recommendations for HFrEF due to uncertainty about net clinical benefit. This systematic review and meta-analysis evaluates the comparative association of oral anticoagulation with stroke and other cardiovascular risk in populations with atrial fibrillation or HFrEF in sinus rhythm and identify factors mediating different estimates of net clinical benefit. Methods: PubMed and Embase were searched from database inception to November 20, 2019 for randomized clinical trials comparing oral anticoagulation to control. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall and within atrial fibrillation and HFrEF trials. Differences in treatment effect were assessed by estimating I 2 among all trials and testing the between-trial-population P -interaction. The primary outcome measure was all stroke. Secondary outcome measures were ischemic stroke, hemorrhagic stroke, mortality, myocardial infarction, and major hemorrhage. Results: Twenty-one trials were eligible for inclusion, 15 (n=19 332) in atrial fibrillation (mean follow-up: 23.1 months), and 6 (n=9866) in HFrEF (mean follow-up: 23.9 months). There were differences in primary outcomes between trial populations, with all-cause mortality included for 95.2% of HFrEF trial population versus 0.38% for atrial fibrillation. Mortality was higher in controls groups of HFrEF populations (19.0% versus 9.6%) but rates of stroke lower (3.1% versus 7.0%) compared with atrial fibrillation. The association of oral anticoagulation with all stroke was consistent for atrial fibrillation (odds ratio, 0.51 [95% CI, 0.42–0.63]) and HFrEF (odds ratio, 0.61 [95% CI, 0.47–0.79]; I 2 =12.4%; P interaction=0.31). There were no statistically significant differences in the association of oral anticoagulation with cardiovascular events, mortality or bleeding between populations. Conclusions: The relative association of oral anticoagulation with stroke risk, and other cardiovascular outcomes, is similar for patients with atrial fibrillation and HFrEF. Differences in the primary outcomes employed by trials in HFrEF, compared with atrial fibrillation, may have contributed to differing conclusions of the relative efficacy of oral anticoagulation.

Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a ‘real world’ nationwide cohort study

2011 ◽  
Vol 106 (10) ◽  
pp. 739-749 ◽  
Author(s):  
Gregory Lip ◽  
Jesper Lindhardsen ◽  
Deirdre Lane ◽  
Ole Ahlehoff ◽  
Morten Hansen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Clinical Benefit ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Chads2 Score ◽  
Risk Of Bleeding ◽  
Hazard Ratios ◽  
Increased Risk ◽  
Net Clinical Benefit

SummaryIt was the aim of this study to determine the efficacy and safety of vitamin K antagonists (VKAs) and acetylsalicylic acid (ASA) in patients with non-valvular atrial fibrillation (AF), with separate analyses according to predicted thromboembolic and bleeding risk. By individual levellinkage of nationwide registries, we identified all patients discharged with non-valvular AF in Denmark (n=132,372). For every patient, the risk of stroke and bleeding was calculated by CHADS2, CHA2DS2-VASc, and HAS-BLED. During follow-up, treatment with VKA and ASA was determined time-dependently. VKA consistently lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73–1.90), 1.14 (1.06–1.23), and 1.86 (1.78–1.95) for ASA, VKA+ASA, and no treatment, respectively, compared to VKA. The risk of bleeding was increased with VKA, ASA, and VKA+ASA compared to no treatment, the hazard ratios were: 1.0 (VKA; reference), 0.93 (ASA; 0.89–0.97), 1.64 (VKA+ASA; 1.55–1.74), and 0.84 (no treatment; 0.81–0.88), respectively. There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS2 score of ≥ 0, and CHA2DS2-VASc score of ≥ 1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism.

scholarly journals Total NT-proBNP, a novel biomarker in atrial fibrillation. A mechanistic analysis of the GISSI-AF trial

2020 ◽  
Author(s):  
Lidia Staszewsky ◽  
Jennifer Meessen ◽  
Deborah Novelli ◽  
Ulla Wienhues-Thelen ◽  
Marcello Disertori ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Sinus Rhythm ◽  
Myocardial Injury ◽  
The Novel ◽  
Circulating Biomarkers ◽  
History Of ◽  
One Year ◽  
Af Recurrence

AbstractObjective(1) to test the association with prevalent and incident atrial fibrillation (AF), and prognosis of total N-terminal pro-B type natriuretic peptide (total NT-proBNP) and of a panel of biomarkers; (2) to assess iwhether the extent of glycosylation affects the relation of NT-proBNP with AF.MethodsIn a sub-study of the GISSI-AF trial on 382 patients in sinus rhythm with a history of AF, echocardiographic variables and eight circulating biomarkers were serially assayed over one year. The relations between circulating baseline biomarkers and AF and the risk of CV events, were assessed by Cox-analysis models adjusting the first by clinical variables, the second by clinical variables and the echocardiographic left-atrial-minimum-volume-index (LAVImin).ResultsOver a median follow-up of 365 days, 203/382 patients (53.1%) had at least one recurrence of AF and 16.3% were hospitalized for cardiovascular (CV) reasons. Total NT-proBNP, NT-proBNP, angiopoietin 2 (Ang2), myosin binding protein (MyBPC3) and bone morphogenic protein-10 (BMP-10) were strongly associated to ongoing AF. Natriuretic peptides and MyBPC3 predicted recurrent AF but this lost significance after adjustment for LAVImin. NT-proBNP and Ang2 predicted CV hospitalization even after adjustment for LAVImin, HR95%CI: 2.20 [1.02-4.80] and 5.26 [1.16-23.79].ConclusionsThe association of AF recurrence with the novel biomarker total NT-proBNP, is similar to that of NT-proBNP, suggesting no influence of glycosylation. Ang2, MyBPC3 and BMP10 were strongly associated with AF, indicating a possible role of extracellular matrix and myocardial injury. Abstract-words=233Key messagesWhat is already known on this subject?It is still complicated to predict the recurrence of AF in patients in sinus rhythm with a recent history of AF. Though several biomarkers have been associated with AF, few of them have proved to be independent predictors for recurrent AF or cardiovascular (CV) events. Their predictive sensitivity and specificity is modest at best. Previous studies showed that NT-proBNP was possibly the strongest predictor of recurrent AF and CV hospitalization. Natriuretic peptides circulate to a large extent as glycosylated molecules and a novel assay is now available to measure the glycosylated and non-glycosylated NT-proBNP in plasma, the total NT-proBNP. The extent of glycosylation varies in different diseases.What might this study add?No studies have assessed (a) the extent of NT-proBNP glycosylation in AF, or (b) the association and predictive value in patients with AF of total NT-proBNP. A multimarker approach, ratter than one based on a single biomarker, might predict AF better.The relation with AF of the novel biomarker, total NT-proBNP, is as strong as that of NT-proBNP, suggesting no-influence of glycosylation.Two biomarkers, MyBPC3, secreted few minutes after myocardial injury and Ang-2, involved in inflammation and coagulation, were strongly associated to AF.How might this impact on clinical practice?The identification of novel circulating biomarkers could have a direct impact on clinical practice when predicting the occurrence of AF, but unfortunately current data do not allow predictions based on biomarkers.The associations of different biomarkers with ongoing AF may cast light on the mechanisms of triggering and maintenance of AF.Strengths and limitations of this studyThe data came from to a multicenter randomized clinical trial with available concomitant serial echocardiographic and circulating biomarkers recorded and evaluated centrally, hence with minimal bias; AF recurrence during a 12-month follow up was checked weekly by trans-telephonic electrocardiographic monitoring, and with 12-lead ECG every six months.A comparative analysis of total NT-proBNP with other novel biomarkers and echocardiographic variables has never been done so far. The possible added value of total NT-proBNP to the benchmark biomarker NT-proBNP was assessed on the basis of different dimensions of performance, as recently proposed for new biomarkers. The main limitations are (1) the relatively small numbers of patients with AF during follow-up visits, (2) the very low prevalence of patients with other cardiac diseases such as coronary artery disease and heart failure, and (3) consequently, the low incidence of clinical events in one-year follow-up.

scholarly journals Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Alexander Sedaghat ◽  
Vivian Vij ◽  
Baravan Al-Kassou ◽  
Steffen Gloekler ◽  
Roberto Galea ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Vitamin K Antagonists ◽  
Treatment Success ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Treatment Regimens

Background: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. Methods: One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. Results: DRT was detected after a median of 93 days (interquartile range, 54–161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA 2 DS 2 -VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P =0.29; mortality: 31.3% versus 13.1%, P =0.05). Conclusions: A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.

Epicardial cryoablation as surgical treatment for atrial fibrillation: One year follow up in 84 patients

2008 ◽  
Vol 56 (S 1) ◽  
Author(s):  
R Uhl ◽  
I Marcolino ◽  
E Zimmer ◽  
F Beyersdorf ◽  
E Eschenbruch
Keyword(s):  
Atrial Fibrillation ◽  
Surgical Treatment ◽  
One Year

scholarly journals B-PO02-073 ONE-YEAR FOLLOW-UP AFTER WIDE-AREA PULMONARY VEIN ISOLATION USING THE VISUALLY GUIDED LASER BALLOON FOR ATRIAL FIBRILLATION

Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S125-S126
Author(s):  
Takashi Yamasaki ◽  
Tetsuhisa Hattori Keisuke Ohta ◽  
Nobuyuki Miyai, Reo Nakamura ◽  
Takayoshi Sawanishi Noriyuki Kinosita ◽  
Ken Kakita
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Wide Area ◽  
Visually Guided ◽  
One Year ◽  
Laser Balloon

scholarly journals Cardiovascular risk factors associated with acute myocardial infarction and stroke in the MADIABETES cohort

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
M. A. Salinero-Fort ◽  
F. J. San Andrés-Rebollo ◽  
J. Cárdenas-Valladolid ◽  
M. Méndez-Bailón ◽  
R. M. Chico-Moraleja ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Antihypertensive Drugs ◽  
Hdl Cholesterol ◽  
First Year ◽  
Backward Elimination ◽  
One Year ◽  
Time Varying Covariates

AbstractWe aimed to develop two models to estimate first AMI and stroke/TIA, respectively, in type 2 diabetes mellitus patients, by applying backward elimination to the following variables: age, sex, duration of diabetes, smoking, BMI, and use of antihyperglycemic drugs, statins, and aspirin. As time-varying covariates, we analyzed blood pressure, albuminuria, lipid profile, HbA1c, retinopathy, neuropathy, and atrial fibrillation (only in stroke/TIA model). Both models were stratified by antihypertensive drugs. We evaluated 2980 patients (52.8% women; 67.3 ± 11.2 years) with 24,159 person-years of follow-up. We recorded 114 cases of AMI and 185 cases of stroke/TIA. The factors that were independently associated with first AMI were age (≥ 75 years vs. < 75 years) (p = 0.019), higher HbA1c (> 64 mmol/mol vs. < 53 mmol/mol) (p = 0.003), HDL-cholesterol (0.90–1.81 mmol/L vs. < 0.90 mmol/L) (p = 0.002), and diastolic blood pressure (65–85 mmHg vs. < 65 mmHg) (p < 0.001). The factors that were independently associated with first stroke/TIA were age (≥ 75 years vs. < 60 years) (p < 0.001), atrial fibrillation (first year after the diagnosis vs. more than one year) (p = 0.001), glomerular filtration rate (per each 15 mL/min/1.73 m2 decrease) (p < 0.001), total cholesterol (3.88–6.46 mmol/L vs. < 3.88 mmol/L) (p < 0.001), triglycerides (per each increment of 1.13 mmol/L) (p = 0.031), albuminuria (p < 0.001), neuropathy (p = 0.01), and retinopathy (p = 0.023).

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