Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation: Results From the RE-LY Trial

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Abstract

We aimed to estimate absolute benefit and harm from treatment with dabigatran in individual patients with atrial fibrillation, and to select the optimal dose for each individual.

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Use and misuse of the receiver operating characteristic curve in risk prediction.

Nancy R. Cook (2007)

The c statistic, or area under the receiver operating characteristic (ROC) curve, achieved popularity in diagnostic testing, in which the test characteristics of sensitivity and specificity are relevant to discriminating diseased versus nondiseased patients. The c statistic, however, may not be optimal in assessing models that predict future risk or stratify individuals into risk categories. In this setting, calibration is as important to the accurate assessment of risk. For example, a biomarker with an odds ratio of 3 may have little effect on the c statistic, yet an increased level could shift estimated 10-year cardiovascular risk for an individual patient from 8% to 24%, which would lead to different treatment recommendations under current Adult Treatment Panel III guidelines. Accepted risk factors such as lipids, hypertension, and smoking have only marginal impact on the c statistic individually yet lead to more accurate reclassification of large proportions of patients into higher-risk or lower-risk categories. Perfectly calibrated models for complex disease can, in fact, only achieve values for the c statistic well below the theoretical maximum of 1. Use of the c statistic for model selection could thus naively eliminate established risk factors from cardiovascular risk prediction scores. As novel risk factors are discovered, sole reliance on the c statistic to evaluate their utility as risk predictors thus seems ill-advised.

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The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study.

Ziad Hijazi, Jonas Oldgren, Johan Lindbäck … (2016)

The benefit of oral anticoagulation in atrial fibrillation is based on a balance between reduction in ischaemic stroke and increase in major bleeding. We aimed to develop and validate a new biomarker-based risk score to improve the prognostication of major bleeding in patients with atrial fibrillation.

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All-cause mortality in 272 186 patients hospitalized with incident atrial fibrillation 1995–2008: a Swedish nationwide long-term case–control study

Tommy Andersson, Anders Magnuson, Ing-Liss Bryngelsson … (2013)

Aims To evaluate long-term all-cause risk of mortality in women and men hospitalized for the first time with atrial fibrillation (AF) compared with matched controls. Methods and results A total of 272 186 patients (44% women) ≤85 years at the time of hospitalization with incidental AF 1995–2008 and 544 344 matched controls free of in-hospital diagnosis of AF were identified. Patients were followed via record linkage of the Swedish National Patient Registry and the Cause of Death Registry. Using Cox regression models, the long-term relative all-cause mortality risk, adjusted for concomitant diseases, in women vs. controls was 2.15, 1.72, and 1.44 (P < 0.001) in the age categories ≤65, 65–74, and 75–85 years, respectively. The corresponding figures for men were 1.76, 1.36, and 1.24 (P < 0.001). Among concomitant diseases, neoplasm, chronic renal failure, and chronic obstructive pulmonary disease contributed most to the increased all-cause mortality vs. controls. In patients with AF as the primary diagnosis, the relative risk of mortality was 1.63, 1.46, and 1.28 (P < 0.001) in women and 1.45, 1.17, and 1.10 (P < 0.001) in men. Conclusion Atrial fibrillation was an independent risk factor of all-cause mortality in patients with incident AF. The concomitant diseases that contributed most were found outside the thromboembolic risk scores. The highest relative risk of mortality was seen in women and in the youngest patients compared with controls, and the differences between genders in each age category were statistically significant.

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Author and article information

Journal

Title: Circulation

Abbreviated Title: Circulation

Publisher: Ovid Technologies (Wolters Kluwer Health)

ISSN (Print): 0009-7322

ISSN (Electronic): 1524-4539

Publication date Created: June 18 2019

Publication date (Print): June 18 2019

Volume: 139

Issue: 25

Pages: 2846-2856

Affiliations

[1 ]Department of Vascular Medicine, University Medical Center Utrecht, The Netherlands (M.C.S.-S., J.v.d.L., J.A.N.D., F.L.J.V.).

[2 ]Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada (S.J.C., J.W.E.).

[3 ]Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands (Y.v.d.G., M.A.).

[4 ]Department of Cardiology, Academic Medical Center/ University of Amsterdam, The Netherlands (R.J.G.P.).

Article

DOI: 10.1161/CIRCULATIONAHA.118.035266

PubMed ID: 31046423

SO-VID: 6847fca7-f0c8-43e9-a3e2-4f3b4e0f0bfd

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Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation : Results From the RE-LY Trial

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Most cited references 22

Use and misuse of the receiver operating characteristic curve in risk prediction.

The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study.

All-cause mortality in 272 186 patients hospitalized with incident atrial fibrillation 1995–2008: a Swedish nationwide long-term case–control study

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