Shao-Liang Chen1, Jue-Jie Zhang2, Yaling Han3, Jing Kan2, Lianglong Chen4, Chunguang Qiu5, Tiemin Jiang6, Ling Tao7, Hesong Zeng8, Li Li9, Yong Xia10, Chuanyu Gao11, Teguh Santoso12, Chootopol Paiboon13, Yan Wang14, Tak W Kwan15, Fei Ye16, Nailiang Tian16, Zhizhong Liu2, Song Lin16, Chengzhi Lu17, Shangyu Wen18, Lang Hong19, Qi Zhang20, Imad Sheiban21, Yawei Xu22, Lefeng Wang23, Tanveer S Rab24, Zhanquan Li25, Guanchang Cheng26, Lianqun Cui27, Martin B Leon28, Gregg W Stone29. 1. Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com. 2. Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China. 3. Division of Cardiology, Shenyang Northern Hospital, Shenyang, China. 4. Division of Cardiology, United Hospital, Fujian Medical University, Fuzhou, China. 5. Division of Cardiology, Zhengzhou University First Hospital, Zhengzhou, China. 6. Division of Cardiology, Armed Police Medical University, Tianjin, China. 7. Division of Cardiology, Xijin Hospital, 4th Military Medical University, Xi'an, China. 8. Division of Cardiology, Wuhan Tongji Hospital, United Medical University, Wuhan, China. 9. Division of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, Guangdong, China. 10. Division of Cardiology, Xuzhou Medical University Affiliated Hospital, Xuzhou, China. 11. Division of Cardiology, Henan Provincial People's Hospital, Zhengzhou, China. 12. Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarda, Indonesia. 13. Division of Cardiology, Bankok General Hospital, Bankok, Thailand. 14. Division of Cardiology, Zhongshan Hospital, Xiamen University, Xiamen, China. 15. Division of Cardiology, Beth Israel Hospital, New York, New York. 16. Division of Cardiology, Nanjing Heart Center, Nanjing, China. 17. Division of Cardiology, Tianjin 1(st) Central Hospital, Tianjin, China. 18. Division of Cardiology, Daqin Oil General Hospital, Daqin, China. 19. Division of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China. 20. Division of Cardiology, Shanghai East Hospital, Shanghai, China. 21. Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy. 22. Division of Cardiology, Shanghai 10th People's Hospital, Shanghai, China. 23. Division of Cardiology, Beijing Chaoyang Hospital, Beijing, China. 24. Division of Cardiology, Emory University Hospital, Atlanta, Georgia. 25. Division of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China. 26. Division of Cardiology, Huaihe Hospital, Henan University, Kaifeng, China. 27. Division of Cardiology, Shandong Provincial Hospital, Shandong University, Jinan, China. 28. Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. 29. Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu.
Abstract
BACKGROUND:Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. OBJECTIVES: The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. METHODS: The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. RESULTS:TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. CONCLUSIONS: In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213).
RCT Entities:
BACKGROUND: Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. OBJECTIVES: The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. METHODS: The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. RESULTS: TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. CONCLUSIONS: In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213).
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