Key result
Paclitaxel-coated balloons increase 2-year major device-related events ~127% vs. sirolimus-eluting stents.
Why the study?
Do paclitaxel-coated balloons improve outcomes compared to sirolimus-eluting stents in patients with de novo lesions, and does chronic kidney disease status affect this?
RCT (n=2,272)
randomized
Yes
Do paclitaxel-coated balloons improve outcomes compared to sirolimus-eluting stents in patients with de novo lesions, and does chronic kidney disease status affect this?
Effect estimate: 2.27 (95% CI 1.38-3.72)
p-value: p=0.002
In patients with de novo coronary lesions, drug-coated balloons were associated with a higher risk of device-oriented composite endpoints compared to drug-eluting stents at 2 years, regardless of baseline chronic kidney disease status.
Sirolimus-eluting stents should be preferred over paclitaxel-coated balloons for de novo lesions; challenges paclitaxel-coated balloon use irrespective of CKD status.
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: : 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.
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Bai et al. (2025) conducted an RCT in de novo lesions (n=2,272). Paclitaxel-coated balloons vs. Second-generation sirolimus-eluting stents was evaluated on device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically-indicated target lesion revascularization) at 2 years (2.27, 95% CI 1.38-3.72, p=0.002). Paclitaxel-coated balloons were associated with a higher risk of the device-oriented composite endpoint at 2 years compared to sirolimus-eluting stents (estimate 2.27; 95% CI 1.38-3.72; p=0.002).
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