Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD: 3-Year Follow-Up of REC-CAGEFREE I Trial

Owing to the absence of a metallic scaffold, percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) may cause less chronic inflammation and potentially reduce late complications compared with drug-eluting stents (DES). However, in the REC-CAGEFREE I study, the strategy of DCB angioplasty with rescue stenting failed to achieve noninferiority to intended DES implantation for treating de novo lesions at 2 years.

This study sought to investigate the 3-year outcomes of the REC-CAGEFREE I trial and assess the mid-term effects of DCBs compared with DES.

REC-CAGEFREE I was an open-label, randomized, noninferiority trial conducted across 43 sites in China. After successful lesion predilation, 2,272 patients with de novo coronary artery disease (regardless of target vessel diameter) were randomly assigned (1:1) to paclitaxel-coated balloon angioplasty with the option of rescue stenting (DCB arm) vs up-front deployment of second-generation thin-strut sirolimus-eluting stents (DES arm). The primary outcome was the device-oriented composite endpoint (DOCE; including cardiovascular death, target vessel myocardial infarction [TV-MI], and clinically and physiologically indicated target lesion revascularization [CPI-TLR]) assessed in the intention-to-treat population. The extended follow-up is ongoing and will continue for up to 10 years.

From February 5, 2021, to May 1, 2022, 1,133 patients were randomly assigned to the DCB arm and 1,139 to the DES arm. The median diameter of devices was at 3.00 ± 0.46 mm. Rescue DES implantation after unsatisfactory DCB angioplasty was performed in 106 patients (9.4%). At 3 years, the DOCE occurred in 92 patients (8.2%) in the DCB arm and 56 (5.0%) in the DES arm (difference: 3.21%; 95% CI: 1.17%-5.26%; P = 0.002). Landmark analyses showed that the rates of difference in the DOCE at 0 to 1, 1 to 2, and 2 to 3 years were 1.69% (95% CI: 0.32%-3.06%), 1.10% (95% CI: -0.13% to 2.32%), and 0.58% (95% CI: -0.51% to 1.66%), respectively (P_trend = 0.023).

In patients with de novo coronary artery disease, DCB angioplasty with rescue stenting was associated with a higher rate of the DOCE compared with up-front DES implantation regarding the DOCE at 3 years. (Paclitaxel-Coated Balloon for Treatment of De-Novo Noncomplex Coronary Artery Lesions; NCT04561739).