Randomized evaluation of ticagrelor monotherapy after 3-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with new-generation sirolimus-eluting stents: TICO trial rationale and design.

ABSTRACT

BACKGROUND: Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) may optimize ischemic and bleeding risks, particularly for acute coronary syndrome (ACS) patients, because its strategy is less potent than ticagrelor-based DAPT but more potent than aspirin or clopidogrel monotherapy. METHODS: The TICO randomized open-label trial will evaluate whether ticagrelor monotherapy following 3-month DAPT is superior to 12-month ticagrelor-based DAPT in terms of net adverse clinical events (NACE) including efficacy and safety in ACS patients treated with ultrathin bioresorbable polymer sirolimus-eluting stents (BP-SES). Patients undergoing BP-SES implantation for ACS treatment will be randomized in a 11 fashion to the (1) ticagrelor monotherapy group after 3-month DAPT; or the (2) 12-month DAPT group. The primary endpoint is NACE within 12 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding as defined by Thrombolysis in Myocardial Infarction. MACCE includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization. Secondary endpoints included each component of the primary endpoint. CONCLUSIONS: The TICO trial is an ongoing trial evaluating the efficacy and safety of ticagrelor monotherapy following 3-month DAPT exclusively in ACS patients treated with uniform BP-SES. It may provide novel insights regarding the need for adjusted use of DAPT for rebalancing risk-benefit in current practice and changing from the conventional concept of aspirin maintenance to a ticagrelor-based regimen in the management of ACS.