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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月13日

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  • Hongfei Xi,
  • Chen Wang,
  • Tao Hu,
  • Hong Jiang,
  • Zhiyong Yin,
  • Shangyu Wen,
  • Yuanzhe Jin,
  • Hui Chen,
  • Ming Yuan,
  • Lin Zhong,
  • Sigan Hu,
  • Zhexun Lian,
  • Hesong Zeng,
  • Hongwei Pan,
  • Jian An,
  • Xing Qin,
  • Yunlong Xia,
  • Wangwei Yang,
  • Fangjun Mou,
  • Jianzheng Liu,
  • Guotao Fu,
  • Xingqiang He,
  • Bin Zhu,
  • Zhiwei Jiang,
  • Scot Garg,
  • Yoshinobu Onuma,
  • Duolao Wang,
  • Patrick W. Serruys,
  • Chao Gao,
  • Ling Tao,
  • Ling Tao,
  • Patrick W. Serruys,
  • William Wijns,
  • Davide Capodanno,
  • Robert-Jan van Geuns,
  • Scot Garg,
  • Duolao WangLing Tao,
  • Fan Ouyang,
  • Zhihui Zhang,
  • Guidong Shen,
  • Mingxing Wu,
  • Ping Yang,
  • Likun Ma,
  • Feng Yang,
  • Zheng Ji,
  • Hua Wang,
  • Yanqing Wu,
  • Zhenfei Fang,
  • Hong Jiang,
  • Shangyu Wen,
  • Yuanzhe Jin,
  • Hui Chen,
  • Lin Zhong,
  • Sigan Hu,
  • Zhexun Lian,
  • Hesong Zeng,
  • Hongwei Pan,
  • Jian An,
  • Muwei Li,
  • Chun Liang,
  • Lang Hong,
  • Zeqi Zheng,
  • Jun Luo,
  • Defeng Pan,
  • Chengxing Shen,
  • Xuefeng Guang,
  • Yuping Gao,
  • Rui Zhu,
  • Zhibing Lu,
  • Yaojun Zhang,
  • Junkui Wang,
  • Feng Bai,
  • Qing Yang,
  • Xianxian Zhao,
  • Shaoliang Chen,
  • Chunjian Li,
  • Yu Cao,
  • Yingxian Sun,
  • Zhaohui MengLing Tao,
  • Chao Gao,
  • Xingqiang He,
  • Yanyan Jia,
  • Zhiwei Jiang,
  • Jie Deng,
  • Jun Jiang,
  • Zhan Gao,
  • Xiling Zhang,
  • Bo Yu,
  • Lei Song,
  • Jielai Xia,
  • Duolao Wang,
  • Zhiwei Jiang,
  • Yang Wang,
  • Jianzheng Liu,
  • Guotao Fu,
  • Xingqiang He,
  • Ruining Zhang,
  • Jing Wang,
  • Fang Wang,
  • Li Jiang,
  • Dan Wu,
  • Menghua Chang,
  • Qianqian Huang,
  • Qiong Huang,
  • Hui Li,
  • Xin Du,
  • Yuan Zhang,
  • Bingyue Zhao,
  • Hongye Ji,
  • Panpan Wang,
  • Xiaoyue Liu,
  • Yifan Fu,
  • Huiqin Guan,
  • Fufang Deng,
  • Qiaoyu He,
  • Bailu Wang,
  • Yao Yao,
  • Fufang Deng,
  • Tingting Zhang,
  • Bin Zhu,
  • Ping Wang,
  • Yunpeng Liu,
  • Rutao Wang,
  • Bo Wang,
  • Xing Qin,
  • Yunlong Xia,
  • Jinglong Zhang,
  • Chujie Zhang,
  • Gaoli Wei,
  • Aiyuan Cheng,
  • Tao Su,
  • Yang Zhao,
  • Yuehao Lv,
  • Xiongwei Bai,
  • Dongdong Li,
  • Yishuo Wang,
  • Zhe Cui,
  • Wangwei Yang,
  • Fangjun Mou

摘要

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 (HRIPTW: 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 (HRIPTW: 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 (HRIPTW: 2.17, 95%CI 0.80–5.84; P = 0.120) respectively. There was no significant interaction between drinking status and treatment strategies (Pinteraction = 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.