Impact of drinking status on outcomes with drug-coated balloon versus drug-eluting stent for de novo coronary lesions: insights from the REC-CAGEFREE I trial

Abstract Background The impact of drinking status on outcomes in patients treated with drug-coated balloon (DCB) versus drug-eluting stent (DES) for de novo coronary lesions remains unclear. Methods REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2,272 patients to paclitaxel-coated balloon with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo coronary lesions, regardless of vessel diameter. In this subgroup analysis, participants were stratified by baseline drinking status into non-drinkers and drinkers. The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. Cox proportional hazards regression with inverse probability of treatment weighting (IPTW) was used to compare between-group differences. Results Among 2,128 (93.7%) participants with available baseline drinking status, 513 (24.1%) were drinkers. At 2 years, compared to non-drinkers (83/1615 [5.2%]), drinkers (22/513 [4.3%]) were associated with a numerically similar risk of DoCE (HR IPTW : 0.89, 95%CI 0.47–1.70; P = 0.727). For non-drinkers, DoCE occurred in 53/816 (6.5%) and 30/799 (3.8%) of participants in the DCB group and DES group (HR IPTW : 1.67, 95%CI 1.05–2.67; P = 0.032) respectively. For drinkers, DoCE occurred in 15/250 (6.0%) and 7/263 (2.7%) of participants in the DCB group and DES group (HR IPTW : 2.17, 95%CI 0.80–5.84; P = 0.120) respectively. There was no significant interaction between drinking status and treatment strategies ( P interaction = 0.628). Conclusions Compared to non-drinkers, drinkers were associated with a numerically similar risk of DoCE. The treatment effect of DCB versus DES did not differ significantly according to drinking status. However, given the observational nature of the study, these results should be interpreted as hypothesis-generating only. Trial registration Registered on ClinicalTrials.gov (NCT04561739) on September 3, 2020.

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Journal
European journal of medical research
Published
2026-06-13
DOI
https://doi.org/10.1186/s40001-026-04568-6
Primary Topic
Coronary Interventions and Diagnostics
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article
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article

Impact of drinking status on outcomes with drug-coated balloon versus drug-eluting stent for de novo coronary lesions: insights from the REC-CAGEFREE I trial

温尚煜, H Q Chen, Zheng Ji, C Li et al.
European journal of medical research
Coronary Interventions and Diagnostics
article

Impact of drinking status on outcomes with drug-coated balloon versus drug-eluting stent for de novo coronary lesions: insights from the REC-CAGEFREE I trial

温尚煜, H Q Chen, Zheng Ji, C Li, Fang Wang, Xing Qin, Yuping Gao, Muwei Li, Zhiwei Jiang, Junkui Wang, Guidong Shen, Zeqi Zheng, Wangwei Yang, Yuanzhe Jin, Yingxian Sun, Chen Wang, Yan Wu, Xi Zhang, Zhihui Zhang, Hongfei Xi, Jun Jiang, Fan Ouyang, Chao Gao, Jian An, Jielai Xia, Zhiyong Yin, Yi-Xiang Wang, Fangjun Mou, Zhenfei Fang, Zhexun Lian, Jianzheng Liu, Xingqiang He, Yanyan Jia, Bin Zhu, Hong Jiang, Guotao Fu, Yang Wang, Rui Zhu, Lei Song, Qing Yang, Ming Yuan, Feng Bai, Mingxing Wu, William Wijns, Yoshinobu Onuma, Zhaohui MengLing Tao, Scot Garg, on behalf of the REC-CAGEFREE I Investigators, Jun Luo, Robert-Jan van Geuns, Xuefeng Guang, Zhibing Lu, Hongwei Pan, Shaoliang Chen, Lang Hong, Xianxian Zhao, Duolao WangLing Tao, Hesong Zeng, Lin Zhong, Sigan Hu, Ruining Zhang, Hua Wang, Ping Yang, Tao Hu, Feng Yang, Patrick W. Serruys, Bo Yu, Chun Liang, Yu Cao, Davide Capodanno, Yunlong Xia, Chengxing Shen, Zhan Gao, Ling Tao, Yaojun Zhang, Jie Deng, Defeng Pan, Likun Ma, Duolao Wang
article en

Abstract

Abstract Background The impact of drinking status on outcomes in patients treated with drug-coated balloon (DCB) versus drug-eluting stent (DES) for de novo coronary lesions remains unclear. Methods REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2,272 patients to paclitaxel-coated balloon with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo coronary lesions, regardless of vessel diameter. In this subgroup analysis, participants were stratified by baseline drinking status into non-drinkers and drinkers. The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. Cox proportional hazards regression with inverse probability of treatment weighting (IPTW) was used to compare between-group differences. Results Among 2,128 (93.7%) participants with available baseline drinking status, 513 (24.1%) were drinkers. At 2 years, compared to non-drinkers (83/1615 [5.2%]), drinkers (22/513 [4.3%]) were associated with a numerically similar risk of DoCE (HR IPTW : 0.89, 95%CI 0.47–1.70; P = 0.727). For non-drinkers, DoCE occurred in 53/816 (6.5%) and 30/799 (3.8%) of participants in the DCB group and DES group (HR IPTW : 1.67, 95%CI 1.05–2.67; P = 0.032) respectively. For drinkers, DoCE occurred in 15/250 (6.0%) and 7/263 (2.7%) of participants in the DCB group and DES group (HR IPTW : 2.17, 95%CI 0.80–5.84; P = 0.120) respectively. There was no significant interaction between drinking status and treatment strategies ( P interaction = 0.628). Conclusions Compared to non-drinkers, drinkers were associated with a numerically similar risk of DoCE. The treatment effect of DCB versus DES did not differ significantly according to drinking status. However, given the observational nature of the study, these results should be interpreted as hypothesis-generating only. Trial registration Registered on ClinicalTrials.gov (NCT04561739) on September 3, 2020.

European journal of medical research
Qingdao University (CN), University of Science and Technology of China (CN), Capital Medical University (CN), University of Lancashire (GB), Ollscoil na Gaillimhe – University of Galway (IE), Liverpool School of Tropical Medicine (GB), Yuhuangding Hospital (CN), Wuhan University (CN), Fourth Affiliated Hospital of China Medical University (CN), Affiliated Hospital of Qingdao University (CN), Tianjin Fourth Central Hospital (CN), Renmin Hospital of Wuhan University (CN), Hunan Provincial People's Hospital (CN), Beijing Friendship Hospital (CN), First Affiliated Hospital of Bengbu Medical College (CN), Statistical Research (United States) (US), Xijing Hospital (CN), Tongji Hospital (CN), Royal Blackburn Teaching Hospital (GB), Shanxi Cardiovascular Hospital (CN), China Medical University (CN), Air Force Medical University (CN)
Good health and well-being
Openalex Percentile: Top 5%
Coronary Interventions and Diagnostics
DOIOpen Access PDFOpenAlex
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