Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions

REC-CAGEFREE I Investigators

doi:10.1016/j.jcin.2026.02.009

Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions

REC-CAGEFREE I Investigators

Clinical Sciences

Xijing Hospital
The First Affiliated Hospital of USTC
First Hospital of Kunming
Tangshan Workers Hospital
Sichuan University
Nanchang University
Central South University
Renmin Hospital of Wuhan University
Beijing KeyTech Statistical Consulting
Air Force Medical University
University of Catania
University of Galway
East Lancashire Hospitals NHS Trust
University of Central Lancashire

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

1 Citation (Scopus)

Abstract

Background Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain. Objectives The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions.

Methods This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances.

Results A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HR_IPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Of the 798 bifurcation lesions, 719 (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment ( P _interaction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HR_IPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HR_IPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934).

Conclusions DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only.

Original language	English
Pages (from-to)	943-957
Number of pages	15
Journal	JACC: Cardiovascular Interventions
Volume	19
Issue number	8
Early online date	26 Mar 2026
DOIs	https://doi.org/10.1016/j.jcin.2026.02.009
Publication status	Published - 27 Apr 2026

Keywords

coronary bifurcation lesions
drug-coated balloon
drug-eluting stent(s)

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10.1016/j.jcin.2026.02.009

Drug-coated balloon angioplasty versus drug-eluting stents in non-complex coronary bifurcation lesions-the REC-CAGEFREE I trialAccepted author manuscript, 4.9 MBLicence: CC BY

Cite this

@article{056ce633e00f4c63a9b0f533e7ed5caa,

title = "Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions",

abstract = "Background Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain. Objectives The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions. Methods This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances. Results A total of 2,257 of 2,272 participants (99.3\%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0\%) and 64 of 1,484 patients in the nonbifurcation group (4.3\%) (HRIPTW: 1.39; 95\% CI: 0.87-2.21; P = 0.164). Of the 798 bifurcation lesions, 719 (90.1\%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment ( P interaction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3\%) and 18 of 749 (2.4\%) with DES (HRIPTW: 2.67; 95\% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7\%) and 20 of 379 (5.3\%) with DES (HRIPTW: 1.03; 95\% CI: 0.53-2.01; P = 0.934). Conclusions DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only.",

keywords = "coronary bifurcation lesions, drug-coated balloon, drug-eluting stent(s)",

author = "\{REC-CAGEFREE I Investigators\} and Bin Zhu and Fei Li and Jianzheng Liu and Likun Ma and Feng Yang and Zheng Ji 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 Hong Jiang and Guotao Fu and Ruining Zhang and Xingqiang He and Xiaoming Xu and Zhiwei Jiang and Jielai Xia and Duolao Wang and Davide Capodanno and Yoshinobu Onuma and Serruys, \{Patrick W.\} and Scot Garg and Ling Tao and Chao Gao",

year = "2026",

month = apr,

day = "27",

doi = "10.1016/j.jcin.2026.02.009",

language = "English",

volume = "19",

pages = "943--957",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "8",

}

TY - JOUR

T1 - Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions

AU - REC-CAGEFREE I Investigators

AU - Zhu, Bin

AU - Li, Fei

AU - Liu, Jianzheng

AU - Ma, Likun

AU - Yang, Feng

AU - Ji, Zheng

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 - Jiang, Hong

AU - Fu, Guotao

AU - Zhang, Ruining

AU - He, Xingqiang

AU - Xu, Xiaoming

AU - Jiang, Zhiwei

AU - Xia, Jielai

AU - Wang, Duolao

AU - Capodanno, Davide

AU - Onuma, Yoshinobu

AU - Serruys, Patrick W.

AU - Garg, Scot

AU - Tao, Ling

AU - Gao, Chao

PY - 2026/4/27

Y1 - 2026/4/27

N2 - Background Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain. Objectives The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions. Methods This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances. Results A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HRIPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Of the 798 bifurcation lesions, 719 (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment ( P interaction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HRIPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HRIPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934). Conclusions DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only.

AB - Background Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain. Objectives The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions. Methods This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances. Results A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HRIPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Of the 798 bifurcation lesions, 719 (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment ( P interaction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HRIPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HRIPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934). Conclusions DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only.

KW - coronary bifurcation lesions

KW - drug-coated balloon

KW - drug-eluting stent(s)

U2 - 10.1016/j.jcin.2026.02.009

DO - 10.1016/j.jcin.2026.02.009

M3 - Article

C2 - 41885677

AN - SCOPUS:105036697105

SN - 1936-8798

VL - 19

SP - 943

EP - 957

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 8

ER -

Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions

Abstract

Keywords

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