Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial

Xiongwei Bai; Haokao Gao; Yuehao Lv; Dongdong Sun; Qiong Wang; Zhiyong Yin; Shangyu Wen; Yuanzhe Jin; Hui Chen; Ming Yuan; Lin Zhong; Sigan Hu; Zhexun Lian; Hesong Zeng; Hongwei Pan; Jianzheng Liu; Guotao Fu; Ruining Zhang; Xingqiang He; Davide Capodanno; Scot Garg; Yoshinobu Onuma; Duolao Wang; Patrick W. Serruys; Chao Gao; Ling Tao

doi:10.1002/ccd.70348

Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial

Xiongwei Bai
, Haokao Gao
, Yuehao Lv
, Dongdong Sun
, Qiong Wang
, Zhiyong Yin
, Shangyu Wen
, Yuanzhe Jin
, Hui Chen
, Ming Yuan
, Lin Zhong
, Sigan Hu
, Zhexun Lian
, Hesong Zeng
, Hongwei Pan
, Jianzheng Liu
, Guotao Fu
, Ruining Zhang
, Xingqiang He
, Davide Capodanno

Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W. Serruys, Chao Gao, Ling Tao

Clinical Sciences

Xijing Hospital
Tianjin Fourth Central Hospital
China Medical University
Capital Medical University
Yantai Yuhuangding Hospital
Bengbu Medical College
Qingdao University
Huazhong University of Science and Technology
Hunan Provincial People's Hospital
University of Science and Technology of China
University of Catania
East Lancashire Hospitals NHS Trust
University of Central Lancashire
University of Galway

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

Abstract

Background: Data regarding the efficacy and safety of drug-coated balloons (DCBs) versus drug-eluting stents (DES) in patients with chronic kidney disease (CKD) remains limited. Aims: To assess the prognosis of DCB versus DES in patients with and without CKD.

Methods: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloons with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified based on the presence of CKD (kidney damage or estimated glomerular filtration rate < 60 mL/min per 1.73 m²) at baseline. 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.

Results: Of 2272 patients enrolled, 203 (8.9%) had CKD, with 95 and 108 treated with DCB and DES, respectively. At 2 years, the risk of DoCE was significantly higher in CKD versus non-CKD patients (22/203 [10.9%] vs. 88/2069 [4.3%], HR_IPTW: 2.14, 95% CI: 1.13−4.07, p = 0.022). There was no significant interaction between CKD and treatment allocation (p_interaction = 0.352). Among CKD patients, DoCE occurred in 12/95 (12.7%) and 10/108 (9.3%) patients in the DCB and DES groups (HR_IPTW: 1.57, 95% CI: 0.66−3.71, p = 0.317), respectively. Among non-CKD patients, DoCE occurred in 60/1038 (5.8%) versus 28/1031 (2.7%) patients in the DCB and DES groups (HR_IPTW: 2.27, 95% CI: 1.38−3.72, p = 0.002), respectively.

Conclusion: Patients with CKD had worse outcomes compared to those without. DCBs were associated with a higher risk of DoCE than DES, irrespective of CKD status. Trial Registration: Unique Identifier: NCT04561739; URL: https://www.clinicaltrials.gov.

Original language	English
Pages (from-to)	304-314
Number of pages	11
Journal	Catheterization and Cardiovascular Interventions
Volume	107
Issue number	1
DOIs	https://doi.org/10.1002/ccd.70348
Publication status	Published - 20 Nov 2025

Keywords

chronic kidney disease
drug-coated balloon
drug-eluting stent

Access to Document

10.1002/ccd.70348

Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents Insights From the REC-CAGEFREE I TrialAccepted author manuscript, 1.5 MBLicence: CC BY

Cite this

Bai, X., Gao, H., Lv, Y., Sun, D., Wang, Q., Yin, Z., Wen, S., Jin, Y., Chen, H., Yuan, M., Zhong, L., Hu, S., Lian, Z., Zeng, H., Pan, H., Liu, J., Fu, G., Zhang, R., He, X., ... Tao, L. (2025). Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial. Catheterization and Cardiovascular Interventions, 107(1), 304-314. https://doi.org/10.1002/ccd.70348

@article{01020b5b1dd84ef0ba2aa9a7e245ed69,

title = "Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial",

abstract = "Background: Data regarding the efficacy and safety of drug-coated balloons (DCBs) versus drug-eluting stents (DES) in patients with chronic kidney disease (CKD) remains limited. Aims: To assess the prognosis of DCB versus DES in patients with and without CKD. Methods: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloons with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified based on the presence of CKD (kidney damage or estimated glomerular filtration rate < 60 mL/min per 1.73 m²) at baseline. 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. Results: Of 2272 patients enrolled, 203 (8.9\%) had CKD, with 95 and 108 treated with DCB and DES, respectively. At 2 years, the risk of DoCE was significantly higher in CKD versus non-CKD patients (22/203 [10.9\%] vs. 88/2069 [4.3\%], HRIPTW: 2.14, 95\% CI: 1.13−4.07, p = 0.022). There was no significant interaction between CKD and treatment allocation (pinteraction = 0.352). Among CKD patients, DoCE occurred in 12/95 (12.7\%) and 10/108 (9.3\%) patients in the DCB and DES groups (HRIPTW: 1.57, 95\% CI: 0.66−3.71, p = 0.317), respectively. Among non-CKD patients, DoCE occurred in 60/1038 (5.8\%) versus 28/1031 (2.7\%) patients in the DCB and DES groups (HRIPTW: 2.27, 95\% CI: 1.38−3.72, p = 0.002), respectively.Conclusion: Patients with CKD had worse outcomes compared to those without. DCBs were associated with a higher risk of DoCE than DES, irrespective of CKD status. Trial Registration: Unique Identifier: NCT04561739; URL: https://www.clinicaltrials.gov.",

keywords = "chronic kidney disease, drug-coated balloon, drug-eluting stent",

author = "Xiongwei Bai and Haokao Gao and Yuehao Lv and Dongdong Sun and Qiong Wang and Zhiyong Yin and Shangyu Wen and Yuanzhe Jin and Hui Chen and Ming Yuan and Lin Zhong and Sigan Hu and Zhexun Lian and Hesong Zeng and Hongwei Pan and Jianzheng Liu and Guotao Fu and Ruining Zhang and Xingqiang He and Davide Capodanno and Scot Garg and Yoshinobu Onuma and Duolao Wang and Serruys, \{Patrick W.\} and Chao Gao and Ling Tao",

year = "2025",

month = nov,

day = "20",

doi = "10.1002/ccd.70348",

language = "English",

volume = "107",

pages = "304--314",

journal = "Catheterization and Cardiovascular Interventions",

issn = "1522-1946",

publisher = "John Wiley and Sons Inc",

number = "1",

}

Bai, X, Gao, H, Lv, Y, Sun, D, Wang, Q, Yin, Z, Wen, S, Jin, Y, Chen, H, Yuan, M, Zhong, L, Hu, S, Lian, Z, Zeng, H, Pan, H, Liu, J, Fu, G, Zhang, R, He, X, Capodanno, D, Garg, S, Onuma, Y, Wang, D, Serruys, PW, Gao, C & Tao, L 2025, 'Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial', Catheterization and Cardiovascular Interventions, vol. 107, no. 1, pp. 304-314. https://doi.org/10.1002/ccd.70348

TY - JOUR

T1 - Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial

AU - Bai, Xiongwei

AU - Gao, Haokao

AU - Lv, Yuehao

AU - Sun, Dongdong

AU - Wang, Qiong

AU - Yin, Zhiyong

AU - Wen, Shangyu

AU - Jin, Yuanzhe

AU - Chen, Hui

AU - Yuan, Ming

AU - Zhong, Lin

AU - Hu, Sigan

AU - Lian, Zhexun

AU - Zeng, Hesong

AU - Pan, Hongwei

AU - Liu, Jianzheng

AU - Fu, Guotao

AU - Zhang, Ruining

AU - He, Xingqiang

AU - Capodanno, Davide

AU - Garg, Scot

AU - Onuma, Yoshinobu

AU - Wang, Duolao

AU - Serruys, Patrick W.

AU - Gao, Chao

AU - Tao, Ling

PY - 2025/11/20

Y1 - 2025/11/20

N2 - Background: Data regarding the efficacy and safety of drug-coated balloons (DCBs) versus drug-eluting stents (DES) in patients with chronic kidney disease (CKD) remains limited. Aims: To assess the prognosis of DCB versus DES in patients with and without CKD. Methods: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloons with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified based on the presence of CKD (kidney damage or estimated glomerular filtration rate < 60 mL/min per 1.73 m²) at baseline. 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. Results: Of 2272 patients enrolled, 203 (8.9%) had CKD, with 95 and 108 treated with DCB and DES, respectively. At 2 years, the risk of DoCE was significantly higher in CKD versus non-CKD patients (22/203 [10.9%] vs. 88/2069 [4.3%], HRIPTW: 2.14, 95% CI: 1.13−4.07, p = 0.022). There was no significant interaction between CKD and treatment allocation (pinteraction = 0.352). Among CKD patients, DoCE occurred in 12/95 (12.7%) and 10/108 (9.3%) patients in the DCB and DES groups (HRIPTW: 1.57, 95% CI: 0.66−3.71, p = 0.317), respectively. Among non-CKD patients, DoCE occurred in 60/1038 (5.8%) versus 28/1031 (2.7%) patients in the DCB and DES groups (HRIPTW: 2.27, 95% CI: 1.38−3.72, p = 0.002), respectively.Conclusion: Patients with CKD had worse outcomes compared to those without. DCBs were associated with a higher risk of DoCE than DES, irrespective of CKD status. Trial Registration: Unique Identifier: NCT04561739; URL: https://www.clinicaltrials.gov.

AB - Background: Data regarding the efficacy and safety of drug-coated balloons (DCBs) versus drug-eluting stents (DES) in patients with chronic kidney disease (CKD) remains limited. Aims: To assess the prognosis of DCB versus DES in patients with and without CKD. Methods: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloons with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified based on the presence of CKD (kidney damage or estimated glomerular filtration rate < 60 mL/min per 1.73 m²) at baseline. 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. Results: Of 2272 patients enrolled, 203 (8.9%) had CKD, with 95 and 108 treated with DCB and DES, respectively. At 2 years, the risk of DoCE was significantly higher in CKD versus non-CKD patients (22/203 [10.9%] vs. 88/2069 [4.3%], HRIPTW: 2.14, 95% CI: 1.13−4.07, p = 0.022). There was no significant interaction between CKD and treatment allocation (pinteraction = 0.352). Among CKD patients, DoCE occurred in 12/95 (12.7%) and 10/108 (9.3%) patients in the DCB and DES groups (HRIPTW: 1.57, 95% CI: 0.66−3.71, p = 0.317), respectively. Among non-CKD patients, DoCE occurred in 60/1038 (5.8%) versus 28/1031 (2.7%) patients in the DCB and DES groups (HRIPTW: 2.27, 95% CI: 1.38−3.72, p = 0.002), respectively.Conclusion: Patients with CKD had worse outcomes compared to those without. DCBs were associated with a higher risk of DoCE than DES, irrespective of CKD status. Trial Registration: Unique Identifier: NCT04561739; URL: https://www.clinicaltrials.gov.

KW - chronic kidney disease

KW - drug-coated balloon

KW - drug-eluting stent

U2 - 10.1002/ccd.70348

DO - 10.1002/ccd.70348

M3 - Article

C2 - 41264778

AN - SCOPUS:105022630620

SN - 1522-1946

VL - 107

SP - 304

EP - 314

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

IS - 1

ER -

Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial

Abstract

Keywords

Access to Document

Fingerprint

Cite this