TY - JOUR
T1 - Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention
T2 - A TWILIGHT China Substudy
AU - Han, Yaling
AU - Claessen, Bimmer E.
AU - Chen, Shao-Liang
AU - Chunguang, Qiu
AU - Zhou, Yujie
AU - Xu, Yawei
AU - Hailong, Lin
AU - Chen, Jiyan
AU - Qiang, Wu
AU - Zhang, Ruiyan
AU - Luo, Suxin
AU - Li, Yongjun
AU - Zhu, Jianhua
AU - Zhao, Xianxian
AU - Cheng, Xiang
AU - Wang, Jian'an
AU - Su, Xi
AU - Tao, Jianhong
AU - Sun, Yingxian
AU - Wang, Geng
AU - Li, Yi
AU - Bian, Liya
AU - Goel, Ridhima
AU - Sartori, Samantha
AU - Zhang, Zhongjie
AU - Angiolillo, Dominick J.
AU - Cohen, David J.
AU - Gibson, C. Michael
AU - Kastrati, Adnan
AU - Krucoff, Mitchell
AU - Mehta, Shamir R.
AU - Ohman, E. Magnus
AU - Steg, Philippe Gabriel
AU - Liu, Yuqi
AU - Dangas, George
AU - Sharma, Samin
AU - Baber, Usman
AU - Mehran, Roxana
N1 - Funding Information:
Dr Baber reports receiving honoraria from AstraZeneca, Boston Scientific, and Amgen, Inc. Dr Dangas reports receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic. Dr Mehran reports institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, European Cardiovascular Research Center, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; consultant (spouse) from Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals, Ltd, Regeneron Pharmaceuticals; associate editor for ACC and AMA. Dr Angiolillo reports receiving grant support, consulting fees, and honoraria from Amgen, Aralez, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Janssen, Merck, and Sanofi; consulting fees and honoraria from Haemonetics, PhaseBio, PLx Pharma, Pfizer, and the Medicines Company; grant support and fees for review activities from CeloNova; fees for review activities from St. Jude Medical; and grant support from CSL Behring, Eisai, Gilead, Idorsia Pharmaceuticals, Matsutani Chemical Industry, Novartis, Osprey Medical, RenalGuard Solutions, and the Scott R. MacKenzie Foundation. Dr Steg reports research grants from Amarin, Bayer, Sanofi, and Servier; clinical trials (Steering Committee, DSMB or CEC): Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Idorsia, Novartis, Pfizer, Sanofi, Servier; speaker or consultant fees from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Idorsia, Novartis, Pfizer, Sanofi, and Servier. Dr Cohen reports receiving grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, and Abbott Vascular and grant support, paid to his institution, from Boston Scientific. Dr Dangas reports receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic. Dr Mehta reports receiving grant support from and serving on an executive committee and as site investigator for AstraZeneca. Dr Ohman reports receiving consulting fees from 3D Communications, ACI Clinical, Biotie, Cara Therapeutics, Cardinal Health, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Medscape, Milestone Pharmaceuticals, and XyloCor; grant support and consulting fees from Abiomed; and grant support from Chiesi and Portola. Dr Gibson reports receiving grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals; consulting fees from the Medicines Company, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon Corporation, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, PERT Consortium, and GE Healthcare; holding equity in nference; serving as a chief executive officer of the Baim Institute; and receiving grant support, paid to Baim Institute, from Bristol Myers Squibb. The other authors report no conflicts.
Funding Information:
The TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) was funded by AstraZeneca.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - BACKGROUND: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. METHODS: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; P=0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; P=0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points. CONCLUSIONS: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02270242.
AB - BACKGROUND: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. METHODS: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; P=0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; P=0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points. CONCLUSIONS: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02270242.
KW - China
KW - aspirin
KW - hemorrhage
KW - incidence
KW - thrombosis
UR - https://www.scopus.com/pages/publications/85128799898
U2 - 10.1161/CIRCINTERVENTIONS.120.009495
DO - 10.1161/CIRCINTERVENTIONS.120.009495
M3 - Article
C2 - 35317615
SN - 1941-7640
VL - 15
SP - e009495
JO - Circulation. Cardiovascular interventions
JF - Circulation. Cardiovascular interventions
IS - 4
ER -
SDG 3 Good Health and Well-being