Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial

Author:

Zhang Jun-Jie1ORCID,Ye Fei1,Xu Kai2,Kan Jing1,Tao Ling3,Santoso Teguh4,Munawar Muhammad5ORCID,Tresukosol Damras6ORCID,Li Li7,Sheiban Imad8ORCID,Li Feng9ORCID,Tian Nai-Liang10,Rodríguez Alfredo E11,Paiboon Chotnoparatpat12,Lavarra Francesco13,Lu Shu14,Vichairuangthum Kitigon15ORCID,Zeng Hesong16,Chen Lianglong17,Zhang Ruiyan18,Ding Shiqin19,Gao Fengtang20,Jin Zening21,Hong Lang22,Ma Likun23,Wen Shangyu24,Wu Xueming25,Yang Song26,Yin Wei-Hsian27,Zhang Jun28,Wang Yan29,Zheng Yonghong30,Zhou Lei31,Zhou Limin32,Zhu Yuansheng33,Xu Tan34,Wang Xin35,Qu Hong36,Tian Yulong37,Lin Song38,Liu Lijun39,Lu Qinghua40,Li Qihua41,Li Bo42,Jiang Qing43,Han Leng44,Gan Guojun45,Yu Mengyue46,Pan Defeng47,Shang Zhenglu48,Zhao Yanfang49,Liu Zhizhong50,Yuan Ye51,Chen Cynthia52,Stone Gregg W53ORCID,Han Yaling2,Chen Shao-Liang154

Affiliation:

1. Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China

2. Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China

3. Division of Cardiology, Xijing Hospital, 4th Military Medical University, Xi’an, China

4. Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia

5. Division of Cardiology, Binawaluya Cardiac Center, Jakarta, Indonesia

6. Division of Cardiology, Medicine Siriraj Hospital, Bangkok, Thailand

7. Division of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, China

8. Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy

9. Division of Cardiology, Oriental General Hospital, Huainan, China

10. Division of Cardiology, Nanjing Heart Center, Nanjing, China

11. Division of Cardiology, Otamendi Hospital, Buenos Aires, Argentina

12. Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand

13. Division of Cardiology, Jilin Cardiovascular Hospital, Changchun, China

14. Division of Cardiology, Taicang 1st People’s Hospital, Taicang, China

15. Division of Cardiology, Bangplee Hospital, Bangkok, Thailand

16. Division of Cardiology, Wuhan Tongji Hospital, United Medical University, Wuhan, China

17. Division of Cardiology, Fujian Medical University Union Hospital, Fujian Institute of Coronary Artery Disease, Fujian Heart Medical Center, Fuzhou, China

18. Division of Cardiology, Shanghai Ruijin Hospital, Shanghai Communication University, Shanghai, China

19. Division of Cardiology, Xinhua Hospital, Huainan, China

20. Division of Cardiology, Gansu Provincial People’s Hospital, Lanzhou, China

21. Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China

22. Division of Cardiology, Jiangxi Provincial People’s Hospital, Nanchang, China

23. Division of Cardiology, Anhui Provincial Hospital, Hefei, China

24. Division of Cardiology, Tianjin 4th Central Hospital, Tianjin, China

25. Division of Cardiology, Wuxi 3rd People’s Hospital, Wuxi, China

26. Division of Cardiology, Yixing People’s Hospital, Yixing, China

27. Division of Cardiology, Cheng-Hsin General Hospital, Taipei, China

28. Division of Cardiology, Cangzhou Central Hospital, Cangzhou, China

29. Division of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, China

30. Division of Cardiology, Jintan Traditional Chinese Medicine Hospital, Jintan, China

31. Division of Cardiology, Liyang Hospital of Traditional Chinese Medicine, Liyang, China

32. Division of Cardiology, Chuzhou People’s Hospital, Chuzhou, China

33. Division of Cardiology, Huaian 2nd People’s Hospital, Huaian, China

34. Division of Cardiology, Xinyang Central Hospital, Xinyang, China

35. Division of Cardiology, Lianyungang Traditional Chinese Medicine Hospital, Lianyungang, China

36. Division of Cardiology, XuanCheng Central Hospital, Xuancheng, China

37. Division of Cardiology, Xuyi People’s Hospital, Xuyi, China

38. Division of Cardiology, Jintan People’s Hospital, Jintan, China

39. Division of Cardiology, Huainan People’s Hospital, Huainan, China

40. Division of Cardiology, 2nd People’s Hospital, Shandong University, Jinan, China

41. Division of Cardiology, Changzhou Traditional Chinese Medicine Hospital, China

42. Division of Cardiology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China

43. Division of Cardiology, Anqing 1st People’s Hospital, Anqing, China

44. Division of Cardiology, Changshu People’s Hospital, Changshu, China

45. Division of Cardiology, 17th Metallurgical Hospital, Maanshan, China

46. Division of Cardiology, Qingdao Campus of Fuwai Hospital, Qingdao, China

47. Division of Cardiology, Xuzhou 2nd People’s Hospital, Xuzhou, China

48. Division of Cardiology, Wuxi Huishan District People’s Hospital, Wuxi, China

49. Division of Cardiology, Nanjing 81 Hospital, Nanjing, China

50. Division of Cardiology, Hongze People’s Hospital, Huai’an, China

51. Trinity College, University of Toronto, Toronto, Canada

52. Mailman School of Public Health, Columbia University, New York, NY, USA

53. The Zena and Michael A. Wiener Cardiovascular Institute, Ican School of Medicine at Mount Sinai, New York, NY, USA and The Cardiovascular Research Foundation, New York, NY, USA

54. College of Pharmacy, Nanjing Medical University, Nanjing, China

Abstract

Abstract Aim The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. Methods and results In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30–0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20–0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19–1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31–2.37; P = 0.772). Conclusion For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. Study registration http://www.clinicaltrials.com; Identifier: NCT02284750.

Funder

National Science Foundation of China

Jiangsu Provincial Special Program of Medical Science

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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