Newly Identified Events in the RE-LY Trial

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Abstract
We wish to update our article about the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial (Sept. 17, 2009, issue).1 After the database was locked on August 15, 2009, we identified several additional primary efficacy and safety outcome events during routine clinical site closure visits. These events included two systemic embolic events and nine major hemorrhages. Subsequently, after discussions with the Food and Drug Administration, the primary and secondary efficacy and safety data were checked for consistency, and the study database was reevaluated for possible underreporting of events. To achieve this, all free text, outcomes, and adverse events in the database were searched with the use of multiple algorithms to identify any symptom that might suggest the possibility of any primary or secondary event or bleeding. This included an examination of all decreases in the hemoglobin level by more than 2 g per deciliter between visits, other markers of potential bleeding, new pathologic Q waves on routine electrocardiography (ECG), and any report of weakness or other symptoms that might be potentially related to a stroke. This process resulted in the identification of 81 new events in 80 patients. These included 1 stroke, 1 systemic embolic event, 4 clinical myocardial infarctions, 1 pulmonary embolism, 5 transient ischemic attacks, and 69 major hemorrhages.

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