한빛사논문
- 조회209
Sung-Jin Hong 1, Seung-Jun Lee 1, Yongsung Suh 2, Kyeong Ho Yun 3, Tae Soo Kang 4, Sanghoon Shin 5, Sung Woo Kwon 6, Jun-Won Lee 7, Deok-Kyu Cho 8, Jong-Kwan Park 9, Jang-Whan Bae 10, Woong Cheol Kang 11, Seunghwan Kim 12, Yong-Joon Lee 1, Chul-Min Ahn 1, Jung-Sun Kim 1, Byeong-Keuk Kim 1, Young-Guk Ko 1, Donghoon Choi 1, Yangsoo Jang 13, Myeong-Ki Hong 1; T-PASS investigators
1Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
2Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.
3Wonkwang University Hospital, Iksan, Korea.
4Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea.
5Ewha Womans University College of Medicine Seoul Hospital, Seoul, Korea.
6Inha University Hospital, Incheon, Korea.
7Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.
8Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea.
9National Health Insurance Service Ilsan Hospital, Goyang, Korea.
10Chungbuk National University College of Medicine, Cheongju, Korea.
11Gachon University Gil Medical Center, Incheon, Korea.
12Inje University Haeundae Paik Hospital, Busan, Korea.
13CHA University College of Medicine, Seongnam, Korea.
* Corresponding Author : Myeong-Ki Hong
Abstract
Background: Stopping aspirin within 1 month after implantation of a drug-eluting stent (DES) for ticagrelor monotherapy has not been exclusively evaluated for patients with acute coronary syndrome (ACS). The aim of this study was to investigate whether ticagrelor monotherapy after <1 month of dual antiplatelet therapy (DAPT) is noninferior to 12 months of ticagrelor-based DAPT for adverse cardiovascular and bleeding events in patients with ACS.
Methods: In this randomized, open-label, non-inferiority trial, 2850 patients with ACS who underwent DES implantation at 24 centres in South Korea were randomly assigned (1:1) to receive either ticagrelor monotherapy (90 mg twice daily) after <1 month of DAPT (n=1426) or 12 months of ticagrelor-based DAPT (n=1424) between Apr 24, 2019, and May 31, 2022. The primary endpoint was the net clinical benefit as a composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding at 1 year after the index procedure in the intention-to-treat population. Key secondary endpoints were the individual components of the primary endpoint.
Results: Among 2850 patients who were randomized (mean age, 61 years; 40% ST-elevation myocardial infarction), 2823 (99.0%) completed the trial. Aspirin was discontinued at a median of 16 days (interquartile range, 12 to 25 days) in the group receiving ticagrelor monotherapy after <1 month of DAPT. The primary endpoint occurred in 40 patients (2.8%) in the group receiving ticagrelor monotherapy after <1-month DAPT, and in 73 patients (5.2%) in the ticagrelor-based 12-month DAPT group (hazard ratio [HR], 0.54 [95% CI, 0.37–0.80]; P<0.001 for noninferiority; P=0.002 for superiority). This finding was consistent in the per-protocol population as a sensitivity analysis. The occurrence of major bleeding was significantly lower in the ticagrelor monotherapy after <1-month DAPT group compared with the 12-month DAPT group (1.2% versus 3.4%; HR, 0.35 [95% CI, 0.20–0.61]; P<0.001).
Conclusions: This study provides evidence that stopping aspirin within 1 month for ticagrelor monotherapy is both noninferior and superior to 12-month DAPT as for the 1-year composite outcome of death, myocardial infarction, stent thrombosis, stroke, and major bleeding, primarily due to a significant reduction in major bleeding, among ACS patients receiving DES implantation. Low event rates which may suggest enrolment of relatively non-high-risk patients should be considered in interpreting the trial.
논문정보
- Research article
- 2024년 02월 (BRIC 등록일 2024-03-12)
- 국내 연구진
- 의약학 > 응용의학
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