Risk score to predict serious bleeding in stable outpatients with or at risk of atherothrombosis

Abstract

AimsTo develop a risk score to quantify bleeding risk in outpatients with or at risk of atherothrombosis.Methods and resultsWe studied patients in the REACH Registry, a cohort of 68 236 patients with/at risk of atherothrombosis. The outcome of interest was serious bleeding (non-fatal haemorrhagic stroke or bleeding leading to hospitalization and transfusion) over 2 years. Risk factors for bleeding were assessed using modified regression analysis. Multiple potential scoring systems based on the least complex models were constructed. Competing scores were compared on their discriminative ability via logistic regression. The score was validated externally using the CHARISMA population. From a final cohort of 56 616 patients, 804 (1.42%, 95% confidence interval 1.32–1.52) experienced serious bleeding between baseline and 2 years. A nine-item bleeding risk score (0–23 points) was constructed (age, peripheral arterial disease, congestive heart failure, diabetes, hypertension, smoking, antiplatelets, oral anticoagulants, hypercholesterolaemia). Observed incidence of bleeding at 2 years was: 0.46% (score ≤6); 0.95% (7–8); 1.25% (9–10); 2.76% (≥11). The score's discriminative performance was consistent in CHARISMA and REACH (c-statistics 0.64 and 0.68, respectively); calibration in the CHARISMA population was very good (modified Hosmer-Lemeshow c2 = 4.74; P = 0.69).ConclusionBleeding risk increased substantially with a score >10. This score can assist clinicians in predicting the risk of serious bleeding and making decisions on antithrombotic therapy in outpatients.

Standardized Bleeding Definitions for Cardiovascular Clinical Trials

“…11,12 Thus, balancing the anti-ischemic benefits against the bleeding risk of antithrombotic agents and interventions is of paramount importance in assessing new therapies and in managing patients. Prior randomized trials comparing antithrombotic agents suggest that a reduction in bleeding events is associated with improved survival.…”

“…[1][2][3][4] However, the combination of multiple pharmacotherapies, including aspirin, platelet P2Y 12 inhibitors, heparin plus glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, and the increasing use of invasive procedures, has also been associated with an increased risk of bleeding.…”

Efficacy and Safety of Vorapaxar in Patients With Prior Ischemic Stroke

“…2 Efforts to improve antiplatelet strategies for secondary prevention after ischemic stroke have revealed a challenging balance between antithrombotic efficacy and bleeding. 1 Because patients with ischemic stroke treated with contemporary antiplatelet therapy are at high risk for both recurrent ischemic and hemorrhagic events, 2,3 there is a need for agents that are both more efficacious and safer.…”

Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets

“…5,6 Different factors have been proposed that increase bleeding risk, including older age, hypertension, and ethnicity. [6][7][8] benefits and risks of antiplatelet therapy for individual patients. Also, risk stratification may guide treatment decisions for other preventive strategies, such as gastroprotective agents.…”

“…Discriminatory performance of the model may be improved by identifying stronger predictors of major bleeding. Previously, 2 models have been developed to predict intracranial hemorrhage in patients with a TIA or ischemic stroke, 24,25 and 1 additional model was developed to predict major bleeding in patients with or at risk of atherothrombosis 7 (table e-13). Considerable overlap exists between predictors in these models and those identified in our study, including age, hypertension, diabetes, smoking, and antiplatelet agents.…”