TCT 2025: REC-CAGEFREE I Trial Compares Drug-Coated Balloons (DCB) and Drug-Eluting Stents (DES) in De Novo Coronary Lesions

This news is covered by the Medical Dialogues Bureau present at the TCT Conference 2025, being held in San Francisco, USA.

The REC-CAGEFREE I trial found that drug-coated balloons (DCBs) were associated with a higher risk of device-oriented composite events (DoCE) compared with drug-eluting stents (DES) in patients with long de novo coronary artery lesions, while outcomes were comparable for shorter lesions. The findings were presented by Dr. Yuehao Lv on behalf of the REC-CAGEFREE I investigators at TCT 2025.

The multicenter study, conducted across multiple hospitals in China, aimed to compare the safety and efficacy of DCBs versus DES for the treatment of long de novo coronary artery disease, a complex and clinically significant subset where long stent implantation often creates a “full metal jacket,” raising the risk of restenosis and thrombosis. DCBs offer an alternative approach by delivering antiproliferative drugs directly to the arterial wall without leaving a permanent metallic scaffold.

A total of 2,272 patients were enrolled in REC-CAGEFREE I, of whom 2,223 were included in the final analysis after exclusion of those with incomplete baseline imaging. Patients were stratified by lesion length into short (<20 mm, n=1,921) and long (≥20 mm, n=302) groups, then treated with either DCB or DES. Baseline characteristics were well balanced across all subgroups. Long lesions were more frequently located in the right coronary artery and required longer devices and higher rates of cutting or scoring balloon pre-dilatation.

Clinical endpoints were assessed at follow-up using both crude and inverse probability of treatment weighting (IPTW) analyses. The primary endpoint, device-oriented composite events (DoCE), which included cardiac death, target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR), occurred in 4.7% of patients with short lesions and 6.7% of those with long lesions (HR 1.45, 95% CI 0.89–2.36; p=0.13). When stratified by treatment, DCBs showed a higher risk of DoCE compared with DES, particularly in longer lesions, where the relative risk was approximately 2.5-fold greater when lesion length exceeded 15 mm.

Other secondary endpoints, including all-cause mortality, cardiovascular death, stroke, and target lesion revascularization (TLR), were similar between short and long lesion groups. Myocardial infarction (MI) and target vessel MI (TVMI) were more frequent in the long-lesion cohort (MI 4.7% vs. 1.7%, p=0.001; TV-MI 4.0% vs. 1.4%, p=0.002). No significant interaction was observed between lesion length and device type for major adverse outcomes.

Investigators concluded that while DCBs may be a reasonable option for shorter de novo coronary lesions, DES continues to provide superior safety and efficacy for longer lesions requiring more extensive coverage. The trial emphasized that lesion length remains a critical determinant in device selection, particularly given the higher risk of ischemic events in long, diffuse coronary disease.

The REC-CAGEFREE I trial adds important real-world evidence to the growing body of literature on the use of DCBs in de novo lesions, highlighting the need for further prospective randomized trials to confirm long-term outcomes and identify optimal lesion subsets for DCB therapy.

Reference: Yuehao Lv et al., Drug-Coated Balloons Versus Drug Eluting Stents for Patients with Long De Novo Coronary Artery Lesions, Insights from the REC-CAGEFREE I trial, TCT Conference 2025, San Francisco.

https://www.tctconference.com/

About the Study Presenter: Yuehao Lv is a researcher affiliated with Xijing Hospital in Xi'an, Shaanxi, China.