Compared with drug-eluting stent (DES) implantation, use of drug-coated balloons (DCB) as an alternative for treating de novo coronary artery disease (CAD) was associated with a significantly higher rate of cardiovascular death, target vessel myocardial infarction (TV-MI) and clinically and physiologically indicated target lesion revascularization at three years, based on outcomes from REC-CAGEFREE 1, presented at TCT 2025 and simultaneously published in JACC.

The REC-CAGEFREE 1 trial, conducted across 43 sites in China, randomly assigned 2,272 patients with de novo CAD to either DCB with the option of rescue stenting (n=1,133) or DES (n=1,139) following successful lesion pre-dilation. The primary outcome was the device-oriented composite endpoint (DoCE), which included cardiovascular death, TV-MI, and clinically and physiologically indicated target lesion revascularization.

Results showed at three years DoCE occurred in 8% of patients in the DCB group compared with 5% in the DES group (difference, 3.21%; 95% CI, 1.17-5.26; p=0.002). Importantly, the higher DoCE rate in the DCB group was primarily due to the increased incidence of clinically and physiologically indicated target lesion revascularization. Cardiovascular mortality and TV-MI rates were similar between groups.

In other findings, 9.4% of patients in the DCB group received rescue DES. Of those patients, 10% had DoCE at three years. For patients in the DCB group without rescue stenting, 7.9% had DoCE.

"Based on current data, we considered that DES should remain the preferred treatment option for patients with de novo [CAD], especially in the large vessels," said Ling Tao, MD, PhD; Xingqiang He, MD, et al.

Over the course of three years, Tao and colleagues said DoCE occurred more frequently with DCB compared to DES in the first year, but this gap gradually decreased over the subsequent years. "This risk pattern highlights the need for long-term follow-up to understand the impact of DCBs on vessels," they said.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Acute Coronary Syndrome