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 hocanalysis of the pooled RE-COVER studies, two double-blind randomised “sister” trials evaluating dabigatran versusstandard 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.