Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial

• Published in: The American heart journal 2023-05, Vol.259, p.1-8
• Main Authors: Malm, Carl Johan, Alfredsson, Joakim, Erlinge, David, Gudbjartsson, Tomas, Gunn, Jarmo, James, Stefan, Møller, Christian H., Nielsen, Susanne J., Sartipy, Ulrik, Tønnessen, Theis, Jeppsson, Anders
• Format: Article
• Language: English
• Subjects: Acetylsalicylic acid; Acute Coronary Syndrome - drug therapy; Acute Coronary Syndrome - surgery; Acute coronary syndromes; Antiplatelet therapy; artery-bypass surgery; Aspirin; Aspirin - therapeutic use; association; benefit; Bypass; Cardiac and Cardiovascular Systems; Cardiology; Cardiovascular disease; Cardiovascular System & Cardiology; Cerebral infarction; Clinical Medicine; Clinical trials; clopidogrel; Consent; Coronary artery; Coronary Artery Bypass; Coronary vessels; Effectiveness; events; graft failure; guidelines; Heart attacks; Heart surgery; Humans; Kardiologi; Klinisk medicin; Medical and Health Sciences; Medicin och hälsovetenskap; Mortality; Myocardial infarction; Observational studies; outcomes; Patients; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors - therapeutic use; Prospective Studies; Randomization; Registries; Surgery; Therapy; Thoracic surgery; ticagrelor; Ticagrelor - therapeutic use; Treatment Outcome
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2023.01.011

The TACSI trial (ClinicalTrials.gov Identifier: NCT03560310) tests the hypothesis that 1-year treatment with dual antiplatelet therapy with acetylsalicylic acid (ASA) and ticagrelor is superior to only ASA after isolated coronary artery bypass grafting (CABG) in patients with acute coronary syndrome. The TACSI trial is an investigator-initiated pragmatic, prospective, multinational, multicenter, open-label, registry-based randomized trial with 1:1 randomization to dual antiplatelet therapy with ASA and ticagrelor or ASA only, in patients undergoing first isolated CABG, with a planned enrollment of 2200 patients at Nordic cardiac surgery centers. The primary efficacy end point is a composite of time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months after randomization. The primary safety end point is time to hospitalization due to major bleeding. Secondary efficacy end points include time to the individual components of the primary end point, cardiovascular death, and rehospitalization due to cardiovascular causes. High-quality health care registries are used to assess primary and secondary end points. The patients will be followed for 10 years. The TACSI trial will give important information useful for guiding the antiplatelet strategy in acute coronary syndrome patients treated with CABG. [Display omitted]