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Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial

Authors
 Sung-Jin Hong  ;  Seung-Jun Lee  ;  Yongsung Suh  ;  Kyeong Ho Yun  ;  Tae Soo Kang  ;  Sanghoon Shin  ;  Sung Woo Kwon  ;  Jun-Won Lee  ;  Deok-Kyu Cho  ;  Jong-Kwan Park  ;  Jang-Whan Bae  ;  Woong Cheol Kang  ;  Seunghwan Kim  ;  Yong-Joon Lee  ;  Chul-Min Ahn  ;  Jung-Sun Kim  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Yangsoo Jang  ;  Myeong-Ki Hong  ;  T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators 
Citation
 CIRCULATION, Vol.149(8) : 562-573, 2024-02 
Journal Title
CIRCULATION
ISSN
 0009-7322 
Issue Date
2024-02
MeSH
Acute Coronary Syndrome* / drug therapy ; Acute Coronary Syndrome* / surgery ; Aspirin / therapeutic use ; Drug Therapy, Combination ; Drug-Eluting Stents* / adverse effects ; Hemorrhage / etiology ; Humans ; Middle Aged ; Myocardial Infarction* / drug therapy ; Percutaneous Coronary Intervention* / adverse effects ; Percutaneous Coronary Intervention* / methods ; Platelet Aggregation Inhibitors / therapeutic use ; Stroke* / etiology ; Thrombosis* / etiology ; Ticagrelor / adverse effects ; Treatment Outcome
Keywords
acute coronary syndrome ; antiplatelet agent ; aspirin ; drug-eluting stents
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.
Full Text
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.066943
DOI
10.1161/circulationaha.123.066943
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Lee, Yong Joon(이용준)
Cho, Deok Kyu(조덕규)
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198798
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