Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial

Yuehao Lv; Feng Yang; Xiongwei Bai; Hua Wang; Yanqing Wu; Zhenfei Fang; Jingyu Zhou; Haokao Gao; Tao Hu; Dongdong Sun; Qiong Wang; Zhiyong Yin; Shangyu Wen; Yuanzhe Jin; Lang Hong; Jianzheng Liu; Guotao Fu; Ruining Zhang; Xingqiang He; Bin Zhu; Zhiwei Jiang; Jielai Xia; Davide Capodanno; Scot Garg; Yoshinobu Onuma; Duolao Wang; Patrick W. Serruys; Ling Tao; Chao Gao

doi:10.1002/ccd.70679

Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial

Yuehao Lv
, Feng Yang
, Xiongwei Bai
, Hua Wang
, Yanqing Wu
, Zhenfei Fang
, Jingyu Zhou
, Haokao Gao
, Tao Hu
, Dongdong Sun
, Qiong Wang
, Zhiyong Yin
, Shangyu Wen
, Yuanzhe Jin
, Lang Hong
, Jianzheng Liu
, Guotao Fu
, Ruining Zhang
, Xingqiang He
, Bin Zhu

Zhiwei Jiang, Jielai Xia, Davide Capodanno, Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W. Serruys, Ling Tao, Chao Gao

Clinical Sciences

Xijing Hospital
The First Hospital of Kunming
Sichuan University
Nanchang University
Central South University
Tianjin Fourth Central Hospital
China Medical University
Jiangxi Provincial People's Hospital
Beijing KeyTech Statistical Consulting
Air Force Medical University
University of Catania
East Lancashire Hospitals NHS Trust
University of Central Lancashire
University of Galway
University of Science and Technology of China

Research output: Contribution to journal › Article › peer-review

Abstract

Background: For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce. This analysis aims to compare DCBs versus DES for treating long de novo coronary lesions.

Aims: To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions.

Methods: REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years.

Results: 2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HR_IPTW: 2.46, 95% CI: 1.07–5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HR_IPTW: 1.52, 95% CI: 1.03–2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (P_interaction = 0.460).

Conclusion: DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.

Original language	English
Journal	Catheterization and Cardiovascular Interventions
DOIs	https://doi.org/10.1002/ccd.70679
Publication status	Published - 27 May 2026

Keywords

coronary artery disease
drug-coated balloon
drug-eluting stent
lesion length
long lesion

Access to Document

10.1002/ccd.70679

Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions-Insights From the REC-CAGEFREE I TrialAccepted author manuscript, 1.56 MBLicence: CC BY

Cite this

Lv, Y., Yang, F., Bai, X., Wang, H., Wu, Y., Fang, Z., Zhou, J., Gao, H., Hu, T., Sun, D., Wang, Q., Yin, Z., Wen, S., Jin, Y., Hong, L., Liu, J., Fu, G., Zhang, R., He, X., ... Gao, C. (2026). Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial. Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.70679

@article{c036651b34ff486ca6df187f9366ca0f,

title = "Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial",

abstract = "Background: For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce. This analysis aims to compare DCBs versus DES for treating long de novo coronary lesions. Aims: To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions. Methods: REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years. Results: 2,223 (97.8\%) participants with available angiograms were included, of which 302 (13.6\%) had long lesions and 1921 (86.4\%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0\%) and 121/1921 (6.3\%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6\%) and 10/181 (5.6\%) in the DCBs and DES groups, respectively (HRIPTW: 2.46, 95\% CI: 1.07–5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7\%) and 46/938 (4.9\%) in the DCBs and DES groups, respectively (HRIPTW: 1.52, 95\% CI: 1.03–2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (Pinteraction = 0.460). Conclusion: DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.",

keywords = "coronary artery disease, drug-coated balloon, drug-eluting stent, lesion length, long lesion",

author = "Yuehao Lv and Feng Yang and Xiongwei Bai and Hua Wang and Yanqing Wu and Zhenfei Fang and Jingyu Zhou and Haokao Gao and Tao Hu and Dongdong Sun and Qiong Wang and Zhiyong Yin and Shangyu Wen and Yuanzhe Jin and Lang Hong and Jianzheng Liu and Guotao Fu and Ruining Zhang and Xingqiang He and Bin Zhu and Zhiwei Jiang and Jielai Xia and Davide Capodanno and Scot Garg and Yoshinobu Onuma and Duolao Wang and Serruys, \{Patrick W.\} and Ling Tao and Chao Gao",

year = "2026",

month = may,

day = "27",

doi = "10.1002/ccd.70679",

language = "English",

journal = "Catheterization and Cardiovascular Interventions",

issn = "1522-1946",

publisher = "John Wiley and Sons Inc",

}

Lv, Y, Yang, F, Bai, X, Wang, H, Wu, Y, Fang, Z, Zhou, J, Gao, H, Hu, T, Sun, D, Wang, Q, Yin, Z, Wen, S, Jin, Y, Hong, L, Liu, J, Fu, G, Zhang, R, He, X, Zhu, B, Jiang, Z, Xia, J, Capodanno, D, Garg, S, Onuma, Y, Wang, D, Serruys, PW, Tao, L & Gao, C 2026, 'Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial', Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.70679

TY - JOUR

T1 - Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial

AU - Lv, Yuehao

AU - Yang, Feng

AU - Bai, Xiongwei

AU - Wang, Hua

AU - Wu, Yanqing

AU - Fang, Zhenfei

AU - Zhou, Jingyu

AU - Gao, Haokao

AU - Hu, Tao

AU - Sun, Dongdong

AU - Wang, Qiong

AU - Yin, Zhiyong

AU - Wen, Shangyu

AU - Jin, Yuanzhe

AU - Hong, Lang

AU - Liu, Jianzheng

AU - Fu, Guotao

AU - Zhang, Ruining

AU - He, Xingqiang

AU - Zhu, Bin

AU - Jiang, Zhiwei

AU - Xia, Jielai

AU - Capodanno, Davide

AU - Garg, Scot

AU - Onuma, Yoshinobu

AU - Wang, Duolao

AU - Serruys, Patrick W.

AU - Tao, Ling

AU - Gao, Chao

PY - 2026/5/27

Y1 - 2026/5/27

N2 - Background: For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce. This analysis aims to compare DCBs versus DES for treating long de novo coronary lesions. Aims: To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions. Methods: REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years. Results: 2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HRIPTW: 2.46, 95% CI: 1.07–5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HRIPTW: 1.52, 95% CI: 1.03–2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (Pinteraction = 0.460). Conclusion: DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.

AB - Background: For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce. This analysis aims to compare DCBs versus DES for treating long de novo coronary lesions. Aims: To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions. Methods: REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years. Results: 2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HRIPTW: 2.46, 95% CI: 1.07–5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HRIPTW: 1.52, 95% CI: 1.03–2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (Pinteraction = 0.460). Conclusion: DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.

KW - coronary artery disease

KW - drug-coated balloon

KW - drug-eluting stent

KW - lesion length

KW - long lesion

U2 - 10.1002/ccd.70679

DO - 10.1002/ccd.70679

M3 - Article

AN - SCOPUS:105040381532

SN - 1522-1946

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

ER -

Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial

Abstract

Keywords

Access to Document

Fingerprint

Cite this