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Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study

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Abstract

Backgrounds

Although drug-eluting stents are the most common interventional devices for patients with coronary disease, drug-coated balloons (DCBs) represent a novel therapeutic alternative in certain scenarios. This prospective, observational all-comers study explored the clinical outcomes of DCB use in patients with coronary lesions.

Methods and results

All patients treated with DCBs were enrolled in this study, including patients with in-stent restenosis (ISR) or de novo lesions. The primary outcome was the target lesion revascularization (TLR) rate at one year.

We enrolled 2306 patients with 2660 lesions and performed DCB angioplasty in 399 patients (17.3%) with ISR and 1907 patients (82.7%) with de novo lesions. During follow-up (366 ± 46 days), the TLR rate was lower in the de novo lesion group (1.31%) compared to the ISR group (7.02%) [odds ratio (OR) 0.176, 95% confidence interval (CI) 0.101–0.305, p < 0.001]. Patients with de novo lesions had a lower yearly incidence of MACE compared to ISR patients (2.73 vs. 9.27%, respectively, OR 0.274, 95% CI 0.177–0.424, p < 0.001) and a lower incidence of any revascularization (5.09 vs. 13.03%, OR 0.358, 95% CI 0.251–0.510, p < 0.001). No significant differences between groups were observed in the rates of cardiac death (OR 0.783, 95% CI 0.258–2.371, p = 0.655) or MI (OR 0.696, 95% CI 0.191–2.540, p = 0.573).

Conclusions

DCB angioplasty in this all-comers, real-world, prospective study was safe and efficient with low TLR and MACE rates. Thus, DCB appears to be an attractive alternative for the stent-less treatment of de novo coronary lesions.

Graphic abstract

ISR in-stent restenosis; OR odds ratio; CI confidence interval; TLR target lesion revascularization; MACE major adverse cardiovascular events; MI myocardial infraction. MACE defined as the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization. Any revascularization includes any percutaneous coronary intervention, and coronary artery bypass grafting.

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Fig. 1

CAD coronary artery disease, DCB drug-coated balloon, ISR in-stent restenosis

Fig. 2

ISR in-stent restenosis, TLR target lesion revascularization, MACE major adverse cardiovascular events, MI myocardial infraction In each panel, the inset shows the same data on an enlarged y axis

Fig. 3

ISR in-stent restenosis, OR odds ratio, CI confidence interval, ACS acute coronary syndrome

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Acknowledgments

We would like to thank all professors (especially Luosha Zhao, Feifei Zhang, Youyou Du and Guanghui Liu) and study students involved in this study. This work was financially supported by Medical Science and Technique Research Plan of He’nan Province (Provincial and Ministerial Co-construction Project) (Grant No. SB201901027 & SB201901010).

Funding

This work was financially supported by Medical Science and Technique Research Plan of He’nan Province (Provincial and Ministerial Co-construction Project) (Grant No. SB201901027 & SB201901010).

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Author notes

  1. Liang Pan and Wenjie Lu contributed equally to this work.

Authors and Affiliations

  1. Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, China

    Liang Pan, Wenjie Lu, Zhanying Han, Xi Wang, Yingguang Shan, Xule Wang, Xiaolin Zheng, Ran Li, Yanjun Zhou, Qiangwei Shi, Shuai Zhou, Wencai Zhang, Sen Guo, Xiaofei Qin, Guoju Sun, Zhenwen Huang & Chunguang Qiu

  2. Department of Cardiovascular Medicine, Jincheng People’s Hospital, No. 456, Wenchang East Road, Jincheng, Shanxi, China

    Sancong Pan & Zhongsheng Qin

  3. Department of Geriatric Cardiology, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, China

    Peng Qin

  4. Department of Cardiology, The Fifth Affiliated Hospital of Zhengzhou University, No. 3, Kangfu Qianjie, Zhengzhou, Henan, China

    Peisheng Zhang

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  1. Liang Pan
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Contributions

Conceptualization: CGQ, WJL, ZYH, and LP. Data curation: SCP, XW, PQ, YGS, YJZ, SZ, QWS, WCZ, SG, XLW, XLZ, RL, PSZ, and ZSQ. Formal analysis: CGQ and LP. Funding and acquisition: CGQ and ZYH. Investigation: all authors. Methodology: CGQ, WJL, and ZYH. Project administration, recources and supervision: CGQ and ZYH. Resources: CGQ, ZYH, GJS, XFQ, SCP, PSZ, and ZWH. Visualization: LP. Writing original draft: LP and WJL. Writing, review and editing: all authors. All authors gave final approval of the manuscript, and agreed to be accountable for all aspects of work ensuring integrity and accuracy.

Corresponding author

Correspondence to Chunguang Qiu.

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The authors declare that this research was conducted in the absence of any commercial or financial relationships that may be construed as a potential conflict of interest.

Ethical approval

The protocol was approved by the First Affiliated Hospital of Zhengzhou University Institutional Review Board/Ethics Committee.

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Informed consent was obtained from all individual participants included in the study.

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Pan, L., Lu, W., Han, Z. et al. Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study. Clin Res Cardiol 111, 732–741 (2022). https://doi.org/10.1007/s00392-021-01895-y

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