title: Prediction of bleeding events in patients with venous thromboembolism on stable anticoagulation treatment.
abstract: Attempts at identifying patients with an elevated risk of bleeding while on anticoagulation following acute venous thromboembolism (VTE) have largely been unsuccessful thus far. We sought to develop a clinical prediction score for bleeding during stable anticoagulation treatment after acute VTE.We performed a post hoc analysis of the pooled RE-COVER studies, two double-blind randomised "sister" trials evaluating dabigatran versus standard treatment in 5107 VTE patients.A score was derived from patients randomised to dabigatran using logistic regression analysis covering the complete follow-up period. The final model, named VTE-BLEED, included six variables and yielded a c-statistic of 0.72 (95% CI 0.67-0.76). Patients from the derivation cohort in the low-risk group (<2 points; 74% of the derivation population) had a bleeding incidence of 2.8% compared to 12.6% in the elevated-risk group (OR 5.0; 95% CI 3.5-7.1). The score proved accurate for our primary end-point, i.e. prediction of major bleeding after day 30 ("stable" anticoagulation), both in patients on dabigatran (c-statistic 0.75, 95% CI 0.61-0.89) and those on warfarin (0.78, 95% CI 0.68-0.86; p=0.77 for difference).The new VTE-BLEED score accurately predicted major bleeding events in VTE patients on stable anticoagulation with both dabigatran and warfarin.
authors.affiliation: Centre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
authors.forename: Frederikus A
authors.initials: FA
authors.lastname: Klok
authors.affiliation: StatSciConsult, Munich, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Hösel
authors.affiliation: Centre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Statistical Programming Pool (S2P), Yaounde, Cameroon.
authors.forename: Wilfrid D
authors.initials: WD
authors.lastname: Yollo
authors.affiliation: Dr Tilke Consulting, Schöneck, Germany.
authors.forename: Clemens
authors.initials: C
authors.lastname: Tilke
authors.affiliation: Dept of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada.
authors.forename: Sam
authors.initials: S
authors.lastname: Schulman
authors.affiliation: Centre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
authors.forename: Mareike
authors.initials: M
authors.lastname: Lankeit
authors.affiliation: Centre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany stavros.konstantinides@unimedizin-mainz.de.|Dept of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece.
authors.forename: Stavros V
authors.initials: SV
authors.lastname: Konstantinides
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use*; D015331:Cohort Studies; D000069604:Dabigatran / Q000008:administration & dosage*; D003627:Data Interpretation, Statistical; D003657:Decision Making; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D008297:Male; D015233:Models, Statistical; D012372:ROC Curve; D012044:Regression Analysis; D012307:Risk Factors; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D054556:Venous Thromboembolism / Q000188:drug therapy*; D014859:Warfarin / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran