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Does switching to ticagrelor monotherapy after 3 months of dual antiplatelet therapy reduce net adverse clinical events (a composite of major bleeding and major adverse cardiac and cerebrovascular events) among patients with acute coronary syndrome treated with drug-eluting stents?
In this randomized clinical trial that included 3056 patients with acute coronary syndrome, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, significantly reduced net adverse clinical events at 1 year (3.9% vs 5.9%).
Among patients with acute coronary syndrome treated with new-generation drug-eluting stents, use of ticagrelor monotherapy after 3 months of dual antiplatelet therapy resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and adverse cardiac and cerebrovascular events at 1 year.
Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS).
To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents.
Design, Setting, and Participants
A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019.
Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529).
Main Outcomes and Measures
The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events.
Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, −1.98% [95% CI, −3.50% to −0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).
Conclusions and Relevance
Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial.
ClinicalTrials.gov Identifier: NCT02494895
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Yangsoo Jang, MD, PhD, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, 03722, Seoul, South Korea (firstname.lastname@example.org).
Accepted for Publication: April 22, 2020.
Author Contributions: Dr Jang had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs B.-K. Kim and S.-J. Hong contributed equally to this work.
Concept and design: B.-K. Kim, S.-J. Hong, Y.-H. Cho, S. Cho, Jeon, D.-K. Cho, B.-K. Hong, Ahn, Shin, Nam, J.-S. Kim, Choi, M.-K. Hong, Jang.
Acquisition, analysis, or interpretation of data: B.-K. Kim, S.-J. Hong, Y.-H. Cho, Yun, Y.-H. Kim, Suh, J.Y. Cho, Her, S. Cho, Jeon, Yoo, D.-K. Cho, B.-K. Hong, Kwon, Shin, Nam, J.-S. Kim, Ko, Choi, M.-K. Hong, Jang.
Drafting of the manuscript: B.-K. Kim, S.-J. Hong, Yun, Y.-H. Kim, Suh, J.Y. Cho, Jeon, D.-K. Cho, B.-K. Hong, Kwon, J.-S. Kim, M.-K. Hong, Jang.
Critical revision of the manuscript for important intellectual content: B.-K. Kim, S.-J. Hong, Y.-H. Cho, Suh, Her, S. Cho, Jeon, Yoo, Ahn, Shin, Nam, J.-S. Kim, Ko, Choi, M.-K. Hong, Jang.
Statistical analysis: B.-K. Kim, S.-J. Hong, Suh, Her, Jeon, Shin, Nam, J.-S. Kim, Jang.
Obtained funding: Jeon, Jang.
Administrative, technical, or material support: B.-K. Kim, S.-J. Hong, Yun, Y.-H. Kim, J.Y. Cho, Her, S. Cho, Jeon, D.-K. Cho, Kwon, Ahn, Shin, J.-S. Kim, Choi, M.-K. Hong, Jang.
Supervision: B.-K. Kim, S. Cho, Jeon, D.-K. Cho, B.-K. Hong, Kwon, J.-S. Kim, Choi, M.-K. Hong, Jang.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by the Cardiovascular Research Center, Seoul, South Korea and funded by Biotronik (Bülach, Switzerland).
Role of the Funder/Sponsor: Biotronik had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
The TICO Investigators: Yangsoo Jang, MD, Yonsei University, Severance Hospital, Seoul; Bum-Kee Hong, MD, Yonsei University, Gangnam Severance Hospital, Seoul; Seung-Hwan Lee, Wonju Christian Hospital, Wonju; Myung-Ho Yoon, Ajou University Hospital, Suwon; Jin-Bae Lee, Daegu Catholic University Medical Center, Daegu; Jung-Hee Lee, Yeungnam University Medical Center, Daegu; Woong Cheol Kang, Gachon Gil University Hospital, Incheon; Sungsoo Cho, Dankook University Hospital, Cheonan; Kyeong Ho Yun, MD, PhD, Wonkwang University Hospital, Iksan; Ki-Hwan Kwon, Ewha Womans University Mokdong Hospital, Seoul; Sang-Yong Yoo, MD, PhD, GangNeung Asan Hospital, Gangneung; Sang-Ho Park, Soonchunhyang University Hospital Cheonan, Cheonan; Jang-Hwan Bae, Chungbuk National University Hospital, Chungbuk; Jong-Pil Park, Presbyterian Medical Center, Jeonju; Doo-Il Kim, Inje University Haeundae Paik Hospital, Busan; Jung-Ho Heo, Kosin University Gospel Hospital, Busan; Yon-Hyeong Cho, Myongji Hospital, Hanyang University, Goyang; Woong-Kil Choi, Konkuk University Chungju Hospital, Chungju; Jin-Man Cho, Kyung Hee University Gandong Hospital, Gangdong; Hyun-Hee Choi, Hallym University Chuncheon Scared Hospital, Chuncheon; Yong Hoon Kim, Kangwon National University School of Medicine, Chuncheon; Seung-Ki Yoo, Seoul Eulji Hospital, Seoul; Kee-Seok Kim, Jeju National University Hostpial, Jeju; Yoon-Kyoung Cho, Keimyung University Dongsan Hospital, Daegu; Kook-Jin Chun, Pusan National University Yangsan Hospital, Yangsan; Moo-Hyun Kim, Dong-A University Hospital, Busan; Dong Woon Jeon, National Health Insurance Service Ilsan Hospital, Goyang; Eui Im, Yonsei University Yongin Severance Hospital, Yongin; Jung-Rae Cho, Hallym University Kangnam Sacred Heart Hospital, Seoul; Gwang-Soo Cha, Pusan National University Hospital, Busan; Tae-Hyun Yang, Inje University Busan Paik Hospital, Busan; Seung-Yul Lee, Wonkwang University Sanbon Hospital, Gunpo; Won Kim, Kyung Hee University Hospital, Seoul; Woo-Jung Park, Hallym University Sacred Heart Hospital, Anyang; Sang-Wook Kim, Chung-Ang University Hospital, Seoul; Hee-Yul Kim, St Mary's Hospital, The Catholic University, Bucheon; Woo-Jung Cheon, Samgsung Changwon Hospital, Changwon; Sung-Woo Kwon, Inha University Hospital, Incheon.
Data Sharing Statement: See Supplement 3.
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