A 9-factor score predicted 2-year risk for bleeding in outpatients with, or at high risk for, atherothrombosis

Derivation cohort (Reduction of Atherothrombosis for Continued Health [REACH] Registry) and validation cohort (Clopidrogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance [CHARISMA] trial).

44 countries (REACH registry) and {32 countries}* (CHARISMA trial).

The derivation cohort (REACH registry) comprised 64 589 patients ≥ 45 years of age (mean age 69 y, 64% men) who had established cerebrovascular, coronary artery, or peripheral arterial disease, or ≥ 3 atherosclerotic risk factors. The validation cohort (CHARISMA trial) comprised 15 603 patients {≥ 45 years of age (median age 64 y, 70% men) who had multiple atherothrombotic risk factors, coronary disease, cerebrovascular disease, or symptomatic peripheral arterial disease}*.

The bleeding risk score included 9 variables (age 55 to 64 y = 2 points, 65 to 74 y = 4, ≥ 75 y = 6; peripheral arterial disease = 1; congestive heart failure = 2; diabetes = 1; no hypercholesterolemia = 1; hypertension = 2; former smoker = 1, current smoker = 2; antiplatelet agents: acetylsalicylic acid = 1, other = 2, both = 4; oral anticoagulants = 4). Maximum score is 23; maximum observed score was 21.

An episode of serious bleeding (nonfatal hemorrhagic stroke or bleeding leading to both hospitalization and transfusion) at 2 years. For the validation cohort, outcome was a combination of severe (fatal bleeding, intracranial hemorrhage, or bleeding causing hemodynamic compromise) and moderate bleeding (requiring transfusion but not resulting in hemodynamic compromise).

804 serious bleeding episodes (1.4%) occurred in the derivation cohort. Risk based on score quartiles is shown in the Table. 487 severe episodes (3.1%) occurred in the validation cohort. Discrimination was similar in the derivation and validation cohorts (c-statistics 0.68 and 0.64, respectively).

A score comprising 9 variables predicted risk for bleeding at 2 years in outpatients with, or at risk for, atherothrombosis.