Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy

Author:

Han Yaling1ORCID,Claessen Bimmer E.2ORCID,Chen Shao-Liang3,Chunguang Qiu4,Zhou Yujie5ORCID,Xu Yawei6,Hailong Lin7,Chen Jiyan8,Qiang Wu9,Zhang Ruiyan10,Luo Suxin11,Li Yongjun12,Zhu Jianhua13,Zhao Xianxian14,Cheng Xiang15,Wang Jian’an16,Su Xi17,Tao Jianhong18,Sun Yingxian19,Wang Geng1,Li Yi1,Bian Liya1,Goel Ridhima2ORCID,Sartori Samantha2,Zhang Zhongjie2ORCID,Angiolillo Dominick J.20ORCID,Cohen David J.21ORCID,Gibson C. Michael22,Kastrati Adnan23ORCID,Krucoff Mitchell24,Mehta Shamir R.25ORCID,Ohman E. Magnus24,Steg Philippe Gabriel26ORCID,Liu Yuqi27,Dangas George2ORCID,Sharma Samin2ORCID,Baber Usman2,Mehran Roxana2ORCID

Affiliation:

1. Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China (Y.H., G.W., Yi Li, L.B.).

2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (B.E.C., R.G., S. Sartori, Z.Z., G.D., S. Sharma, U.B., R.M.).

3. Department of Cardiology, Nanjing First Hospital Jiangsu, China (S.-L.C.).

4. Department of Cardiology‚ The First Affiliated Hospital of Zhengzhou University, China (Q.C.).

5. Department of Cardiology‚ Beijing Anzhen Hospital Capital Medical University, China (Y.Z.).

6. Department of Cardiology‚ Shanghai Tenth Peoples Hospital, China (Y.X.).

7. Department of Cardiology‚ Dalian Municipal Central Hospital Affiliated of Dalian Medical University, China (L.H.).

8. Department of Cardiology‚ Guangdong Provincial People’s Hospital, Guangzhou, China (J.C.).

9. Department of Cardiology‚ Guizhou Provincial People’s Hospital, Guiyang, China (W.Q.).

10. Department of Cardiology‚ Rui Jin Hospital Shanghai Jiaotong University School of Medicine, Changhai, China (R.Z.).

11. Department of Cardiology‚ The First Affiliated Hospital of Chongqing Medical University, China (S.L.).

12. Department of Cardiology‚ The Second Hospital of Hebei Medical University (4th Ward), Shijiazhuang, China (Yongjun Li).

13. Department of Cardiology‚ The First Affiliated Hospital College of Medicine of Zheijang University, Hangzhou, China (J.Z.).

14. Department of Cardiology‚ Shanghai Changhai Hospital, China (X.Z.).

15. Department of Cardiology‚ Wuhan Union Hospital, China (X.C.).

16. Department of Cardiology‚ The Second Affiliated Hospital of Zhejiang University of Medicine, Hangzhou, China (J.W.).

17. Department of Cardiology‚ WuHan Asia Heart Hospital, China (X.S.).

18. Department of Cardiology‚ Sichuan Provincial People’s Hospital, Chengdu, China (J.T.).

19. Department of Cardiology‚ The First Hospital of China Medical University, Shenyang (Y.S.).

20. Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).

21. Department of Cardiology‚ University of Missouri–Kansas City (D.J.C.).

22. Department of Cardiology‚ Beth Israel Deaconess Medical Center‚ Boston‚ MA (C.M.G.).

23. Department of Cardiology‚ Deutsches Herzzentrum München, Munich, Germany (A.K.).

24. Department of Cardiology‚ Hamilton Health Sciences, Canada (M.K., E.M.O.).

25. Department of Cardiology‚ Duke University Medical Center, Durham‚ NC (S.R.M.).

26. Department of Cardiology‚ Université de Paris, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).

27. Department of Cardiology, People’s Liberation Army General Hospital, Beijing (Y. Liu).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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