Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome
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Published:2023-02-10
Issue:2
Volume:6
Page:e2255709
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ISSN:2574-3805
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Container-title:JAMA Network Open
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language:en
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Short-container-title:JAMA Netw Open
Author:
Zhou Shenghua1, Xiao Yichao1, Zhou Chonglun2, Zheng Zhaofen3, Jiang Weihong4, Shen Qiang5, Zhu Can6, Pan Hongwei3, Liu Changhui7, Zeng Gaofeng8, Ge Liangqing9, Zhang Yumin10, Ouyang Zewei11, Fu Guang12, Pan Gang13, Chen Feng14, Huang Lihong15, Liu Qiming1, Hu Xinqun16, Fang Zhenfei16, Tang Liang16, Li Xuping16, Zhu Zhaowei16, Tai Shi16, Tu Tao16, Yang Hui16, He Yuhu16, Chen Mingxian16, Peng Daoquan16, Zhao Yanshu16, Xu Danyan16, Tang Jianjun16, Li Jiang16, Chen Yaqin16, Li Yi16, Luo Xiaolan16, Huang Yong16, Xiang Jianqiang16, Guan Qinglin16, Li Xinyang16, Yi Xiaojun16, Tan Fang16, Liu Yan16, Pan Jiang16, Peng Jianqiang16, Yan Sulan16, Liu Zhengyu16, Cui Bo16, Wang Peng16, Tang Yi16, Wen Juan16, Liu Hong16, Weng Chunyan16, Wu Xi16, Yu Jingjia16, Yang Qiong16, Peng Liping16, Li Anying16, Zhang Zhihui16, Zhou Xiaowei16, Tan Huaqing16, Chen Jie16, Yang Zhiyuan16, Liang Zhizhong16, Tang Xiangyu16, Chen Sha16, Zeng Lan16, Wu Yingtao16, Chen Guangyao16, Yan Dihua16, Zhou Lianghui16, Yuan Siqin16, Wu Rong16, Zhou Pei16, Fu Yuzhen16, Huang Youliang16, Tang Wei16, Nie Yang16, Xiang Hongju16, Chen Wei16, Yang Zhiyong16, Wu Yue16, Deng Haishui16, Lei Ming16, Zhang Bailing16, Xiang Xing16, Xue Bingqing16, Xiong Liping16, Xu Xiping16, Feng Xiaojian16, Zhao Jianhua16, Lu Yonghua16, Li Zhengzai16, Zhou Bo16, Li Cheng16, Deng Zibin16, Feng Hongda16, Zhang Xibin16, Wang Guoli16, Chen Zhi16, Zeng Wenxuan16, Shen Di16, Hu Xiangyong16, Chen Xuemei16, Qin Zuoan16, Huang Sulan16, Guo Ning16, Zhang Zhixiang16, Chen Kun16, Gong Bingxing16, Yin Min16, Qin Tao16, Hu Tao16, Yu Jiangbiao16, Zhang Ting16, Guo Xingcheng16, Peng Hui16, Yin Minming16, Zhou Huaineng16, Luo Li16, Xiao Xiaoxia16, Quan Yong16, Liang Weifen16, Wu Yang16, Chen Hang16, Shi Wei16, Liu Aiying16, Liu Yijian16, Ruan Guiyun16, Liu Peng16, Luo Canxiang16, He Lin16, Deng Li16, Sun Shayan16, Yang Shuo16, Wang Sha16, Long Songbing16, Duan Yizhu16, Luo Jin16, Xue Zhengjie16, Chen Luzhu16, Guo Caiyan16, Yin Yongjun16, Wang Yanbo16, Ouyang Fan16, Guo Shuhong16, Liu Weiqing16, Liao Chunfeng16, Lin Dongsheng16, Chen Huijuan16, Ma Lixia16, Luo Hui16, Wu Jianfeng16, Yang Chao16, Liu Yang16, Qin Yingnan16, Liu Fangyao16, Xu Jianqiang16, Tang Juan16, Tang Yixin16, Hu Hengjing16, Zhou Jiming16, Yang Jingyong16, Deng Tingting16, Xiao Ping16, Liu Jun16, Guo Shenyi16, Liu Wenjie16, Zhang Xing16, Li Zhihong16, Zeng Renhua16, Zhou Zhen16, Bao Jianhong16, Zhou Ye16, Wang Xiaojuan16, Huang He16, Zhu Yunlong16, Zhao Wenjiao16, Wu Xianming16, Cai Ming16, Liu Fan16, Jiang Luping16, Li Zehua16, Peng Songquan16, Jin Qiao16, Chen Chun16, Hu Lu16, Zhou Ting16, Wu Pengcui16, Long Xiao16, Huang Yuyan16, Xie Hebin16, Yang Tao16, Ouyang Shao16, Liu Xiang16, Hu Song16, Xing Zhenhua16, Zeng Jianping16, Zhang Yi16,
Affiliation:
1. Department of Cardiology, Second Xiangya Hospital of Central South University, Changsha, People’s Republic of China 2. Department of Cardiology, Xiangxiang People’s Hospital, Xiangxiang, People’s Republic of China 3. Department of Cardiology, Hunan Provincial People’s Hospital, First Affiliated Hospital of Hunan Normal University, Changsha, People’s Republic of China 4. Department of Cardiology, Third Xiangya Hospital of Central South University, Changsha, People’s Republic of China 5. Department of Cardiology, First People’s Hospital of Huaihua, Huaihua, People’s Republic of China 6. Department of Cardiology, First Affiliated Hospital of Jishou University, Jishou, People’s Republic of China 7. Department of Cardiology, First Affiliated Hospital of University of South China, Hengyang, People’s Republic of China 8. Department of Cardiology, Second Affiliated Hospital of University of South China, Hengyang, People’s Republic of China 9. Department of Cardiology, First People’s Hospital of Changde City, Changde, People’s Republic of China 10. Department of Cardiology, Third Hospital of Changsha, Changsha, People’s Republic of China 11. Department of Cardiology, Central Hospital of Shaoyang, Shaoyang, People’s Republic of China 12. Department of Cardiology, First Hospital of Changsha, Changsha, People’s Republic of China 13. Department of Cardiology, First People’s Hospital of Yueyang, Yueyang, People’s Republic of China 14. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, People’s Republic of China 15. Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China 16. for the H-REPLACE Investigators
Abstract
ImportanceParenteral enoxaparin is a preferred anticoagulant used in the acute phase for patients with acute coronary syndrome (ACS). The safety and efficacy of short-term low-dose rivaroxaban in this clinical setting remain unknown.ObjectiveTo compare the safety and efficacy of rivaroxaban vs enoxaparin in the acute phase of ACS.Design, Setting, and ParticipantsThis multicenter, prospective, open-label, active-controlled, equivalence and noninferiority trial was conducted from January 2017 through May 2021 with a 6-month follow-up at 21 hospitals in China. Participants included patients with ACS missing the primary reperfusion window or before selective revascularization. Data were analyzed from November 2021 to November 2022.InterventionsParticipants were randomized 1:1:1 to oral rivaroxaban 2.5 mg or 5 mg or 1 mg/kg subcutaneous enoxaparin twice daily in addition to dual antiplatelet therapy (DAPT; aspirin 100 mg and clopidogrel 75 mg once daily) for a mean of 3.7 days.Main Outcomes and MeasuresThe primary safety end point was bleeding events, as defined by the International Society on Thrombosis and Haemostasis, and the primary efficacy end point was major adverse cardiovascular events (MACEs), including cardiac death, myocardial infarction, rerevascularization, or stroke during the 6-month follow-up.ResultsOf 2055 enrolled patients, 2046 (99.6%) completed the trial (mean [SD] age 65.8 [8.2] years, 1443 [70.5%] male) and were randomized to enoxaparin (680 patients), rivaroxaban 2.5 mg (683 patients), or rivaroxaban 5 mg (683 patients). Bleeding rates were 46 patients (6.8%) in the enoxaparin group, 32 patients (4.7%) in the rivaroxaban 2.5 mg group, and 36 patients (5.3%)in the rivaroxaban 5 mg group (rivaroxaban 2.5 mg vs enoxaparin: noninferiority hazard ratio [HR], 0.68; 95% CI, 0.43 to 1.07; P = .005; rivaroxaban 5 mg vs enoxaparin: noninferiority HR, 0.88; 95% CI, 0.70 to 1.09; P = .001). The incidence of MACEs was similar among groups, and noninferiority was reached in the rivaroxaban 5 mg group (HR, 0.60; 95% CI, 0.31 to 1.16, P = .02) but not in the rivaroxaban 2.5 mg group (HR, 0.68; 95% CI, 0.36 to 1.30; P = .05) compared with the enoxaparin group.Conclusions and RelevanceIn this equivalence and noninferiority trial, oral rivaroxaban 5 mg showed noninferiority to subcutaneous enoxaparin (1 mg/kg) for patients with ACS treated with DAPT during the acute phase. Results of this feasibility study provide useful information for designing future randomized clinical trials with sufficient sample sizes.Trial RegistrationClinicalTrials.gov Identifier: NCT03363035
Publisher
American Medical Association (AMA)
Cited by
3 articles.
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