scholarly journals Prediction of Residual Stroke Risk in Anticoagulated Patients with Atrial Fibrillation: mCARS

2021 ◽  
Vol 10 (15) ◽  
pp. 3357
Author(s):  
Wern Yew Ding ◽  
José Miguel Rivera-Caravaca ◽  
Francisco Marin ◽  
Christian Torp-Pedersen ◽  
Vanessa Roldán ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Real World ◽  
Stroke Risk ◽  
Risk Estimation ◽  
Absolute Risk ◽  
Oral Anticoagulants ◽  
Absolute Risk Reduction ◽  
The Real ◽  
Anticoagulated Patients

Our ability to evaluate residual stroke risk despite anticoagulation in atrial fibrillation (AF) is currently lacking. The Calculator of Absolute Stroke Risk (CARS) has been proposed to predict 1-year absolute stroke risk in non-anticoagulated patients. We aimed to determine whether a modified CARS (mCARS) may be used to assess the residual stroke risk in anticoagulated AF patients from ‘real-world’ and ‘clinical trial’ cohorts. We studied patient-level data of anticoagulated AF patients from the real-world Murcia AF Project and AMADEUS clinical trial. Individual mCARS were estimated for each patient. None of the patients were treated with non-vitamin K antagonist oral anticoagulants. The predicted residual stroke risk was compared to actual stroke risk. 3503 patients were included (2205 [62.9%] clinical trial and 1298 [37.1%] real-world). There was wide variation of CARS for each category of CHA2DS2-VASc score in both cohorts. Average predicted residual stroke risk by mCARS (1.8 ± 1.8%) was identical to actual stroke risk (1.8% [95% CI, 1.3–2.4]) in the clinical trial, and broadly similar in the real-world (2.1 ± 1.9% vs. 2.4% [95% CI, 1.6–3.4]). AUCs of mCARS for prediction of stroke events in the clinical trial and real-world were 0.678 (95% CI, 0.598–0.758) and 0.712 [95% CI, 0.618–0.805], respectively. mCARS was able to refine stroke risk estimation for each point of the CHA2DS2-VASc score in both cohorts. Personalised residual 1-year absolute stroke risk in anticoagulated AF patients may be estimated using mCARS, thereby allowing an assessment of the absolute risk reduction of treatment and facilitating a patient-centred approach in the management of AF. Such identification of patients with high residual stroke risk could help target more aggressive interventions and follow-up.

scholarly journals Novel tool for predicting residual stroke risk in atrial fibrillation: mCARS

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
WY Ding ◽  
JM Rivera-Caravaca ◽  
F Marin ◽  
C Torp-Pedersen ◽  
V Roldan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Real World ◽  
Stroke Risk ◽  
Risk Estimation ◽  
The Real ◽  
Funding Sources ◽  
Level Data ◽  
Aggressive Interventions

Abstract Funding Acknowledgements Type of funding sources: None. Background Recently, CARS was proposed to predict 1-year absolute stroke risk in non-anticoagulated patients with atrial fibrillation (AF). We aimed to determine whether a modified CARS (mCARS) may be used to assess the residual stroke risk in anticoagulated AF patients. Methods We studied patient-level data of anticoagulated AF patients from the real-world Murcia AF Project and AMADEUS clinical trial. Individual mCARS was estimated for each patient using an estimated 64% risk reduction with anticoagulation. Results 3,503 patients were included (2,205 [62.9%] clinical trial and 1,298 [37.1%] real-world). In the clinical trial cohort, the median age was 71 (IQR 65-77) and CHA2DS2-VASc score 3 (IQR 2-4). In the real-world cohort, the median age was 76 (IQR 70-81) and CHA2DS2-VASc score 4 (IQR 3-5). At 1-year, there were 40 and 31 stroke events in the clinical trial and real-world cohorts, respectively. Average predicted residual stroke risk by mCARS was identical to actual stroke risk (1.8 [±1.8%] vs. 1.8% [95% CI, 1.3-2.4]) in the clinical trial, and broadly similar in the real-world (2.1 [±1.9%] vs. 2.4% [95% CI, 1.6-3.4]). Additionally, these values were comparable across the subgroups stratified by CHA2DS2-VASc score in both cohorts. AUCs of mCARS for prediction of stroke events in the clinical trial and real-world were 0.678 (95% CI, 0.598-0.758) and 0.712 (95% CI, 0.618-0.805), respectively. In an exploratory analysis, we found that mCARS was able to refine stroke risk estimation for each point of the CHA2DS2-VASc score in both cohorts. Conclusion Personalised residual 1-year absolute stroke risk in anticoagulated AF patients may be estimated using mCARS. Such patients with high residual stroke risk may benefit from more aggressive interventions and follow-up. Absolute 1-year stroke risk Clinical Trial Real-World Median (IQR) Range Median (IQR) Range CHA2DS2-VASc score 0 NA 0.9 (0.6 - 1.3) 0.2 - 1.4 CHA2DS2-VASc score 1 1.1 (0.7 - 1.4) 0.2 - 2.0 1.4 (0.9 - 1.7) 0.2 - 13.0 CHA2DS2-VASc score 2 2.0 (1.5 - 2.4) 0.3 - 10.8 2.1 (1.5 - 2.6) 0.3 - 10.8 CHA2DS2-VASc score 3 2.6 (2.1 - 3.4) 0.4 - 13.3 2.8 (2.5 - 3.4) 0.9 - 13.3 CHA2DS2-VASc score 4 3.6 (2.8 - 5.6) 0.3 - 18.1 3.9 (3.3 - 5.0) 1.1 - 21.0 CHA2DS2-VASc score 5 6.7 (3.6 - 14.0) 1.9 - 20.9 4.8 (3.9 - 12.2) 1.2 - 21.0 CHA2DS2-VASc score 6 13.6 (5.5 - 15.8) 2.4 - 21.8 12.8 (4.8 - 16.7) 2.2 - 21.8 CHA2DS2-VASc score 7 15.7 (14.5 - 17.4) 4.5 - 21.9 15.6 (5.9 - 17.5) 4.1 - 23.5 CHA2DS2-VASc score 8 16.5 (14.0 - 18.5) 13.1 - 20.3 16.9 (15.7 - 19.5) 13.6 - 21.0 IQR, interquartile range; NA, not applicable.

scholarly journals Number needed to treat for net effect of anticoagulation in atrial fibrillation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
WY Ding ◽  
JM Rivera-Caravaca ◽  
F Marin ◽  
G Li ◽  
V Roldan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Major Bleeding ◽  
Real World ◽  
Stroke Risk ◽  
Absolute Risk ◽  
Baseline Risk ◽  
Number Needed To Treat ◽  
Bleeding Events ◽  
Risk Increase

Abstract Funding Acknowledgements Type of funding sources: None. Background The benefit of oral anticoagulation (OAC) in atrial fibrillation (AF) must be balanced against any potential risk of harm. We aimed to evaluate the "NNT for net effect" (NNTnet) using CARS in anticoagulated patients with AF. Methods We used patient-level data from the real-world Murcia AF Project and AMADEUS clinical trial. Baseline risk of stroke was calculated using CARS while major bleeding was estimated from prior studies. Stroke and major bleeding events at 1-year were determined. NNTnet was calculated as a reciprocal of the net effect of ARR with OAC (NNTnet= 1 / (ARRstroke - ARIbleeding)). Results 3,511 patients were included (1,306 [37.2%] real-world patients and 2,205 [62.8%] clinical trial). The absolute 1-year stroke risk was similar across both cohorts and the main results are presented in the Table. In both cohorts, the NNTnet was significantly lower in patients with an excess stroke risk of ≥2% by CARS. Among real-world patients with a very high (>10%) baseline stroke risk, the use of OAC was associated with an ARRstroke of 10.9% and ARIbleeding of 1.2%, generating an overall NNTnet of 11. In the clinical trial, the use of OAC was associated with an ARRstroke of 11.0% and ARIbleeding of 0.6%, generating an overall NNTnet of 10. Conclusion Overall, the NNTnet approach in AF incorporates information regarding baseline risk of stroke and major bleeding, and relative effects of OAC with the potential to include multiple additional outcomes and weighting of events based on their perceived effects by individual patients. This simple and intuitive metric may be useful to improve communication and optimise the patient-centred management of AF. NNT in Real-World and Clinical Trial Real-World Clinical Trial Ischaemic stroke risk at 1-year Baseline risk without anticoagulation (%) 5.7% (95% CI 5.5 - 6.0) 5.1% (95% CI 4.9 - 5.3) Anticoagulation-mediated risk (%) 1.7% (95% CI 1.1 - 2.6) 1.3% (95% CI 0.8 - 1.8) Absolute risk reduction (%) 4.0% 3.8% NNTbenefit 25 27 Major bleeding risk at 1-year Baseline risk without anticoagulation (%) 2.3% 2.3% Anticoagulation-mediated risk (%) 3.3% (95% CI 2.4 - 4.4) 3.9% (95% CI 3.1 - 4.8) Absolute risk increase (%) 1.0% 1.6% NNTharm 100 63 NNTnet 34 46

scholarly journals Stroke risk based on classification of atrial fibrillation: real-world vs clinical trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
W.Y Ding ◽  
J.M Rivera-Caravaca ◽  
F Marin ◽  
V Roldan ◽  
G.Y.H Lip
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Incidence Rate ◽  
Real World ◽  
Stroke Risk ◽  
Clinical Classification ◽  
Temporal Rhythm ◽  
Anticoagulated Patients ◽  
Trial Participants

Abstract Background The most widely accepted clinical classification of atrial fibrillation (AF) is according to temporal rhythm-based patterns, reflecting the notion that most patients initially suffer from transient episodes that prolong over time due to atrial substrate remodelling as the disease progresses. Therefore, it may be speculated that patients with extended episodes of “continuous” AF (persistent, long-standing persistent and permanent AF) may be at higher risk of stroke complications compared to paroxysmal AF (pAF). However, the risk of stroke according to clinical classification of AF remains poorly defined. In this study, we assessed the impact of AF type on stroke risk in patients with AF from “real-world” and “clinical trial” cohorts. Methods Post-hoc analysis of patient-level data from the Murcia AF Project and AMADEUS trial. All patients were anticoagulated. Patients were grouped into those with pAF and non-pAF. pAF was defined as AF that terminates spontaneously or with intervention within seven days of onset. Non-pAF was defined as AF that lasted longer than seven days, including persistent, long-standing persistent and permanent AF subtypes. Study endpoint was the incidence rate of ischaemic stroke. A modified CHA2DS2-VAS“c” score that applied one additional point for a “c” criterion of continuous AF (i.e. non-pAF) was calculated. Results 5,917 patients were included; 1,361 (23.0%) real-world and 4,556 (77.0%) clinical trial. Real-world patients had a median age of 76 (interquartile range [IQR] 71–81) years with 51.3% females compared to a median age of 71 (IQR 64–77) years with 33.5% females among clinical trial participants. Baseline demographics were comparable in both groups in the real-world cohort but clinical trial participants with non-pAF were older, predominantly male and had more comorbidities compared to those with pAF. Crude stroke rates were comparable between the groups in real-world patients (incidence rate ratio [IRR] 0.72 [95% CI, 0.37–1.28], p=0.259) though clinical trial participants with non-pAF (vs. pAF) had a significantly higher crude rate of stroke events (IRR 4.66 [95% CI, 2.41–9.48], p<0.001). Using multivariable cox regression analysis, AF type was not independently associated with stroke risk in the real-world (adjusted hazard ratio [HR] 1.41 [95% CI, 0.80–2.50], p=0.239) and clinical trial (adjusted HR 1.17 [95% CI, 0.62–2.20], p=0.621) cohorts, after accounting for known risk factors using the CHA2DS2-VASc score. Using receiver operating characteristic curves analysis, we found no significant improvement in the CHA2DS2-VAS“c” compared to CHA2DS2-VASc score in either cohort (p>0.05). Conclusion Overall, there was no association between the temporal rhythm-based patterns of AF and stroke risk among anticoagulated patients, suggesting that this should not be a consideration when assessing the need for anticoagulation in AF. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Effects of the availability of new oral anticoagulants in patients with non-valvular atrial fibrillation in the real world: the NAIF study

2016 ◽  
Vol 10 ◽  
Author(s):  
Francesco Ventrella ◽  
Franco Mastroianni ◽  
Sergio Cappello ◽  
Luigi Iamele ◽  
Samantha Errico ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Chronic Renal Disease ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
High Morbidity ◽  
The Real ◽  
Frequent Use ◽  
Before And After ◽  
Anticoagulated Patients

Guidelines recommend anticoagulation to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). In the real world, this treatment is underused, probably for pharmacologic limitations of vitamin-K-antagonist (VKA). The New Oral Anticoagulants (NOAC) overcome many limitations of VKA. The aim of this study was to assess if, after introduction of NOAC, anticoagulated patients are increased. We performed an observational retrospective cohort study about patients with NVAF, hospitalized in Internal Medicine or Geriatrics for any cause in two years, before and after the marketing of NOAC. The results showed: 640 patients enrolled (289 in 2012, 351 in 2015), elderly population (83+7), males 42% females 58%, high morbidity, high thromboembolic (CHA2DS2VASc 5+1,6) and haemorrhagic (HASBLED 2.7+1.2) risks, with frequent chronic renal disease (51% stage >3) and contraindications to anticoagulants (21,6%). Therapy at discharge 2012 vs 2015: VKA 124/289 (43%) vs VKA or NOAC 187/351 (53%) (p<0,01); antiplatelet 114/289 (39%) vs 70/351 (20%) (p<0,0001). For the high comorbidity, frequent use of LMWH: 42/289 (15%) in 2012 vs 77/351 (22%) in 2015. NOAC have increased the adherence to guidelines in prescribing oral anticoagulants in patients with NVAF.

Edoxaban versus placebo, aspirin, or aspirin plus clopidogrel for stroke prevention in atrial fibrillation

2015 ◽  
Vol 114 (08) ◽  
pp. 403-409 ◽  
Author(s):  
Lars Rasmussen ◽  
Torben Larsen ◽  
Andrew Blann ◽  
Flemming Skjøth ◽  
Gregory Lip
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Real World ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Published Data ◽  
Real World Data ◽  
Once Daily ◽  
Increased Risk ◽  
Reduced Risk

SummaryAs non-valvular atrial fibrillation (AF) brings a risk of stroke, oral anticoagulants (OAC) are recommended. In ‘real world’ clinical practice, many patients (who may be, or perceived to be, intolerant of OACs) are either untreated or are treated with anti-platelet agents. We hypothesised that edoxaban has a better net clinical benefit (NCB, balancing the reduction in stroke risk vs increased risk of haemorrhage) than no treatment or anti-platelet agents. We performed a network meta-analysis of published data from 24 studies of 203,394 AF patients to indirectly compare edoxaban with aspirin alone, aspirin plus clopidogrel, and placebo. Edoxaban 30 mg once daily significantly reduced the risk of all stroke, ischaemic stroke and mortality compared to placebo and aspirin. Compared to aspirin plus clopidogrel, there was a lower risk of intra-cranial haemorrhage (ICH). Edoxaban 60 mg once-daily had a reduced risk of any stroke and systemic embolism compared to placebo, aspirin, and aspirin plus clopidogrel. Mortality rates for both edoxaban doses were estimated to be lower compared to any anti-platelet, and significantly lower compared to placebo. With overall reduced risk of ischemic stroke and ICH, both edoxaban doses bring a NCB of mean (SD) 1.68 (0.15) saved events per 100 patients per year compared to anti-platelet drugs in a clinical trial population. The NCB was demonstrated to be lower, at 0.77 (0.12) events saved (p< 0.01) when modeled to data from a ‘real world’ cohort of AF patients. In conclusion, edoxaban is likely to provide even better protection from stroke and ICH than placebo, aspirin alone, or aspirin plus clopidogrel in both clinical trial populations and unselected community populations. Both edoxaban doses would also bring a positive NCB compared to anti-platelet drugs or placebo/non-treatment based on ‘real world’ data.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.

Abstract 18465: Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20 mg QD

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shital Kamble ◽  
Xianying Pan ◽  
Hemant Phatak ◽  
Hugh Kawabata ◽  
Cristina Masseria ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Cox Proportional Hazards Model ◽  
Charlson Comorbidity Index Score ◽  
The Real

Aim: Limited data are available on the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). The study purpose was to compare the first major bleeding event risk among non valvular atrial fibrillation patients (NVAF) patients newly initiated on dose-adjusted warfarin versus apixaban 5mg BID, dabigatran 150mg BID, or rivaroxaban 20 mg QD. Methods: Retrospective cohort study was conducted using MarketScan® commercial & Medicare supplemental database from 01/2012 to 12/2013. NVAF patients 18+ years with ≥1 year baseline and newly prescribed oral anticoagulant from 01/01/2013 to 12/31/2013 were included. Major bleeding was defined as bleeding requiring hospitalization on the index drug during the supply duration or within 30 days after the last supply day of the last prescription. A Cox proportional hazards model was used to estimate the hazard ratios (HR) of major bleeding adjusted for age, sex, baseline comorbidities and comedications. Results: Among 26,604 patients, 2,057 (7.73%) were newly initiated on apixaban 5mg, 3,768 (14.16%) on dabigatran 150mg, 8,066 (30.32%) on rivaroxaban 20mg and 12,713 (47.79%) on warfarin. Patients initiating warfarin (72.5±11.9 yrs) and apixaban 5mg (67.0±11.4 yrs) were older as compared to rivaroxaban 20mg (65.2±11.4 yrs) and dabigatran 150mg (65.4±11.5 yrs). Patients initiating warfarin had higher CHA 2 DS 2- VASc score (3.22±1.65) and Charlson comorbidity index score (2.37±2.33) (P <0.0001 across all treatments) as compared to those initiating NOACs. After adjusting for baseline characteristics, patients newly initiated on apixaban 5mg BID had significantly lower risk of major bleeding (HR: 0.53, 95% CI: 0.29-0.97, P=0.0399) as compared to those initiated on warfarin (Table). Conclusion: Among newly anticoagulated NVAF patients in the real world setting, as compared to dose adjusted warfarin, only patients initiating on apixaban 5mg BID were associated with significantly lower risk of major bleeding.

Nonvitamin-K-antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and previous stroke or transient ischemic attack: An updated systematic review and meta-analysis of randomized controlled trials

2017 ◽  
Vol 12 (6) ◽  
pp. 589-596 ◽  
Author(s):  
George Ntaios ◽  
Vasileios Papavasileiou ◽  
Hans-Chris Diener ◽  
Konstantinos Makaritsis ◽  
Patrik Michel
Keyword(s):  
Atrial Fibrillation ◽  
Relative Risk ◽  
Risk Reduction ◽  
Relative Risk Reduction ◽  
Absolute Risk ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Absolute Risk Reduction ◽  
Number Needed To Treat ◽  
Ischemic Attack

Background In a previous systematic review and meta-analysis, we assessed the efficacy and safety of nonvitamin-K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and stroke or transient ischemic attack. Since then, new information became available. Aim The aim of the present work was to update the results of the previous systematic review and meta-analysis. Methods We searched PubMed until 24 August 2016 for randomized controlled trials using the following search items: “atrial fibrillation” and “anticoagulation” and “warfarin” and “previous stroke or transient ischemic attack.” Eligible studies had to be phase III trials in patients with atrial fibrillation comparing warfarin with nonvitamin-K antagonist oral anticoagulants currently on the market or with the intention to be brought to the market in North America or Europe. The outcomes assessed in the efficacy analysis included stroke or systemic embolism, stroke, ischemic or unknown stroke, disabling or fatal stroke, hemorrhagic stroke, cardiovascular death, death from any cause, and myocardial infarction. The outcomes assessed in the safety analysis included major bleeding, intracranial bleeding, and major gastrointestinal bleeding. We performed fixed effects analyses on intention-to-treat basis. Results Among 183 potentially eligible articles, four were included in the meta-analysis. In 20,500 patients, compared to warfarin, nonvitamin-K antagonist oral anticoagulants were associated with a significant reduction of stroke/systemic embolism (relative risk reduction: 13.7%, absolute risk reduction: 0.78%, number needed to treat to prevent one event: 127), hemorrhagic stroke (relative risk reduction: 50.0%, absolute risk reduction: 0.63%, number needed to treat: 157), any stroke (relative risk reduction: 13.1%, absolute risk reduction: 0.7%, number needed to treat: 142), and intracranial hemorrhage (relative risk reduction: 46.1%, absolute risk reduction: 0.88%, number needed to treat: 113) over 1.8–2.8 years. Conclusions This updated meta-analysis in 20,500 atrial fibrillation patients with previous stroke or transient ischemic attack shows that compared to warfarin non-vitamin-K antagonist oral anticoagulants are associated with a significant reduction of stroke, stroke or systemic embolism, hemorrhagic stroke, and intracranial bleeding.

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