Reviwer: Dr. Betül Balaban Koçaş

Name of the Study : Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention- TWILIGHT

Published in Congress: ACC 2021

Full Text Link: https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2019/09/24/23/30/TWILIGHT

Background: Potent P2Y12 receptor inhibitor monotherapy following shortened dual antiplatelet therapy reduces bleeding after percutaneous coronary interventions without increasing ischemic events.

Objective: In the TWILIGHT study, in patients with at least one high risk factor for ischemia or bleeding who underwent successful percutaneous coronary intervention with a drug-eluting stent; the safety and efficacy of ticagrelor monotherapy after a short course of dual antiplatelet therapy (3 months) was compared with that of a longer course of dual antiplatelet therapy (12 months).

Method: Eligible patients were) 1: 1 randomized as those who continued dual antiplatelet therapy with aspirin+ticagrelor for 3 months followed by ticagrelor monotherapy (n = 3,555) and those who continued dual antiplatelet therapy with aspirin+ticagrelor for an additional 12 months (n = 3,564). The dose of aspirin was 81-100 mg per day, and the dose of ticagrelor was 90 mg twice a day. The follow-up period of the study was 12 months, the mean patient age was 65, and 76% of the patients were male and 38% had diabetes. Patients with successful percutaneous coronary intervention with at least one drug-eluting stent, discharged with aspirin+ticagrelor regimen, at least one additional clinical and angiographic feature associated with a high risk of ischemic or bleeding events, and no ischemic or bleeding event within 3 months of discharge were included in the study. 29% of the study population consisted of patients with a previous myocardial infarction, 42% with prior PCI, and 64% with the diagnosis of unstable angina / non-ST-elevation myocardial infarction.

Results: The primary endpoint at 12-month follow-up was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding, 4.0% versus 7.1% for ticagrelor monotherapy versus aspirin+ticagrelor. (p < 0.001). The primary ischemic combined outcome was all-cause death, myocardial infarction, stroke: 3.9% vs. 3.9% (p <0.001 for noninferiority) and myocardial infarction 2.7% vs. 2.7%. Secondary outcomes were stent thrombosis (definite + probable) 0.4% vs. 0.6% (p <0.05); ischemic stroke: 0.5% vs. 0.2% (p> 0.05).

Conclusion: The results of this study suggest that short-term dual antiplatelet therapy (3 months) followed by 12 months of ticagrelor monotherapy results in less bleeding and meets the criteria for non-inferiority for ischemic events compared to longer-term dual antiplatelet therapy (additional 12 months) in patients with successful percutaneous coronary intervention with a drug-eluting stent and at high ischemic or bleeding risk. Results were similar in subgroups of patients with non-ST-elevation myocardial infarction, diabetes mellitus, gender, and patients undergoing complex percutaneous intervention.

Interpretation: In the light of these findings, it can be safely considered to continue single antiplatelet therapy with ticagrelor 3 months after the procedure in patients who have a drug-eluting stent implanted due to non-ST-elevation myocardial infarction or chronic coronary syndromes and who have a high risk of both ischemia and bleeding. However, it should be noted that patients with ST elevation myocardial infarction were not included in the study.