Prediction of ischemic stroke in different populations: a comparison of absolute stroke risk and CHA2DS2-VASc in real-world and clinical trial patients

2021 ◽  
Author(s):  
José Miguel Rivera-Caravaca ◽  
Wern Yew Ding ◽  
Francisco Marín ◽  
Vanessa Roldán ◽  
Gregory Y.H. Lip
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Real World ◽  
Stroke Risk ◽  
Different Populations

Abstract T P102: Recurrent Stroke Risk in Patients With ICAD Treated With Aggressive Medical Management: A Comparison With The Sammpris Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Rajbeer S Sangha ◽  
Carlos Corado ◽  
Richard A Bernstein ◽  
Ilana Ruff ◽  
Yvonne Curran ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Real World ◽  
Medical Management ◽  
Stroke Risk ◽  
Recurrent Stroke ◽  
High Dose ◽  
Stroke Subtype ◽  
Anterior Circulation ◽  
Intracranial Atherosclerotic Disease ◽  
Aggressive Medical Management

Background: Since the SAMMPRIS trial, aggressive medical management (AMM) with the use of dual antiplatelets (aspirin, clopidogrel) and high dose statin therapy has been standard of care for patients with symptomatic intracranial atherosclerotic disease (ICAD). However, there is limited data on the “real-world” application of this regimen. We hypothesized that 30-day recurrent stroke risk among patients treated with AMM would be similar to that in SAMMPRIS medically-treated patients. Methods: Using the prospective Northwestern University Brain Attack Registry, we identified all patients admitted between 8/1/12 and 1/31/14 with 1) confirmed ischemic stroke or transient ischemic attack (TIA); 2) independently adjudicated symptomatic ICAD; and 3) discharged on AMM. At 30 days (28-35 day window) post-stroke, patients or proxies were contacted by telephone to review events and outcomes. We also utilized an electronic surveillance system of hospital records at any of 3 health system hospitals with confirmation by manual review of the medical record in all instances of reported recurrent stroke or TIA. Ischemic stroke in the territory of the symptomatic stenotic artery was the primary outcome. We calculated 30-day rate of stroke in the territory of the stenotic artery and 95% confidence intervals using the Wald method and compared it with that reported in the SAMMPRIS trial. Results: Among 36 patients who met study criteria, 13 (36.1%) were female and mean age was 65.4 (± 9.7) years. Median initial NIHSS score was 4 (interquartile range 0-17). Symptomatic ICAD was localized to the anterior circulation in 21 (58%) patients and posterior circulation in 15 (41.7%). At 30 days, 3 of the 36 patients (8.3%, 95% CI 2.1-22.6%) had recurrent stroke compared to 5.8% in the medical arm of SAMMPRIS (p=0.47). An additional 3 patients (8.3%) experienced TIA within 30 days. Conclusions: In a single-center observational cohort study, we found that AMM in patients with symptomatic ICAD yielded similar rates of recurrent stroke at 30-days as observed in the SAMMPRIS trial. Our study provides “real-world” confirmation of the potential benefits of AMM in this high-risk stroke subtype.

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 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 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.

Abstract P57: Risk Factors for Incidentally Discovered Silent Brain Infarcts and White Matter Disease in a Real World Cohort Identified by Artificial Intelligence

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Lester Y Leung ◽  
Yichen Zhou ◽  
Sunyang Fu ◽  
Chengyi Zheng ◽  
Hongfang Liu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ischemic Stroke ◽  
White Matter ◽  
Language Processing ◽  
Real World ◽  
Stroke Risk ◽  
Advanced Age ◽  
White Matter Disease ◽  
Brain Infarcts ◽  
Increased Risk

Introduction: Silent brain infarcts (SBIs) and white matter disease (WMD) are highly prevalent and associated with increased risk of ischemic stroke in patients with traditional stroke risk factors (RFs) in prospective cohort studies. Their frequency and associations with stroke RFs have not been well described in real world populations. Methods: This was a cross-sectional study of patients age ≥ 50 in the Kaiser Permanente-Southern California (KPSC) health system between 2009-2019 with a head CT or MRI for non-stroke indications and no history of ischemic stroke, transient ischemic attack, or dementia. A natural language processing (NLP) algorithm developed at Mayo Clinic and Tufts Medical Center was applied to the KPSC EHR to identify individuals with reported SBIs or WMD. Multivariable Poisson regression with robust error variance was used to estimate risk ratios of demographics, stroke RFs (from the Framingham Stroke Risk Score), and scan modality on the presence of SBIs or WMD. Results: Among 262,875 individuals, the NLP identified 13,154 (5.0%) with SBIs and 78,330 (29.8%) with WMD. Stroke RFs were highly prevalent in this cohort. The majority underwent CTs (74.8%) instead of MRIs as their initial neuroimaging. After adjustment for demographics and RFs, advanced age demonstrated a strong association with increased risk of SBIs and WMD (table). MRI was associated with a reduced risk of reported SBIs (ARR: 0.87, 95% CI 0.83-0.91) and an increased risk of reported WMD (ARR 2.86, 95% CI 2.83-2.90). Despite being prevalent, traditional stroke RFs had weak associations with increased risk of SBIs or increased risk of WMD. Conclusions: Advanced age is strongly associated with incidentally discovered SBIs and WMD on neuroimaging studies obtained in routine care. The development of SBIs and WMD may not be fully attributable to traditional stroke RFs.

Improved Outcomes after Reperfusion Therapies for Ischemic Stroke: A “Real-world” Study in a Developing Country

2020 ◽  
Vol 17 (4) ◽  
pp. 361-375
Author(s):  
Victor C. Schulz ◽  
Pedro S.C. de Magalhaes ◽  
Camila C. Carneiro ◽  
Julia I.T. da Silva ◽  
Vivian N. Silva ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Real World ◽  
Time Window ◽  
Functional Dependence ◽  
Developed Countries ◽  
First Year ◽  
Middle Income ◽  
Probability Of Survival ◽  
Stroke Center ◽  
Cerebral Reperfusion

Background: It is unknown if improvements in ischemic stroke (IS) outcomes reported after cerebral reperfusion therapies (CRT) in developed countries are also applicable to the “real world” scenario of low and middle-income countries. We aimed to measure the long-term outcomes of severe IS treated or not with CRT in Brazil. Methods: Patients from a stroke center of a state-run hospital were included. We compared the survival probability and functional status at 3 and 12 months in patients with severe IS treated or not with CRT. From 2010 to 2011, we performed intravenous reperfusion when patients arrived within 4.5 h time-window (IVT group) and after 2011, mechanical thrombectomy (MT) combined or not with intravenous alteplase (IAT group). Those who arrived >4.5 h in 2010-2011 and >6 h in 2012-2017 did not undergo CRT (NCRT group). Results: From 2010 to 2017, we registered 917 patients: 74% (677/917) in the NCRT group, 19% (178/917) in the IVT group and 7% (62/917) in the IAT group. Compared to the NCRT group, IVT patients had a 28% higher (HR: 0.72; 95% CI 0.53-0.96) 3-month adjusted probability of survival and risk of functional dependence was 19% lower (adjusted RR: 0.81; 95% CI 0.73-0.91). For those who underwent MT, the adjusted probability of survival was 59 % higher (HR: 0.41; 95% CI 0.21-0.77) and the risk of functional dependence was 21% lower (adjusted RR: 0.79; 95% CI 0.66-094). These outcomes remained significantly better throughout the first year. Conclusion: CRT led to better outcomes in patients with severe IS in Brazil.

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