The REC-CAGEFREE I trial evaluated the safety and efficacy of paclitaxel-coated balloon (DCB) angioplasty versus sirolimus-eluting stent (Firebird2 DES) implantation in patients with de novo coronary lesions.
This was a prospective, multicenter, randomized, non-inferiority trial conducted in 43 centers across China, including 2,046 patients with de novo coronary artery disease — both chronic and acute coronary syndromes — who were eligible for simple PCI (one or two vessels, total length ≤ 60 mm, no left-main involvement, no graft lesions, and no chronic total occlusions).
At three years of follow-up, the primary device-oriented composite endpoint (DoCE: cardiac death, target-vessel MI, and clinically or functionally driven target-lesion revascularization [TLR]) was significantly higher in the DCB group than in the DES group (HR 1.68; 95 % CI 1.21–2.34; p = 0.002). This difference was driven mainly by a greater need for TLR in the DCB arm (HR 2.66; 95 % CI 1.54–4.57; p < 0.001), with no significant differences in cardiac mortality or target-vessel MI. Subgroup analyses showed consistent results in both small and large vessels, with a progressive narrowing of the gap between groups over time.
Conclusion
At three years, DCB use in de novo lesions was associated with a slightly higher rate of device-related events, mainly due to an increased need for TLR, without differences in mortality or MI. The “no permanent implant” strategy remains promising, although these results highlight the need to further optimize patient selection and DCB technology in de novo disease.
Presented by Chao Gao et al. at TCT 2025 (Late-Breaking Clinical Trials), October 27, San Francisco, USA.
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