Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) Trial: rationale and design.

BACKGROUND: Despite some concern that recent aspirin ingestion increases blood loss after coronary artery surgery, there is some evidence that this may reduce thrombotic complications. In contrast, antifibrinolytic drugs can reduce blood loss in this setting, but there is concern that they may increase thrombotic complications. Published guidelines are limited by a lack of large randomized trials addressing the risks and benefits of each of these commonly used therapies in cardiac surgery. The ATACAS Trial is a study comparing aspirin, tranexamic acid, or both, with placebo in patients undergoing on-pump or off-pump coronary artery surgery.

METHODS: We discuss the rationale for conducting ATACAS, a 4600-patient, multicenter randomized trial in at-risk coronary artery surgery, and the features of the ATACAS study design (objectives, end points, target population, allocation, treatments, patient follow-up, and analysis).

CONCLUSIONS: The ATACAS Trial will be the largest study yet conducted to ascertain the benefits and risks of aspirin and antifibrinolytic therapy in coronary artery surgery. Results of the trial will guide the routine clinical care of patients in this setting.