Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD

BACKGROUND Owing to the absence of a metallic scaffold, percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) may cause less chronic inflammation and potentially reduce late complications compared to drug-eluting stents (DES). However, in the REC-CAGEFREE I study, the strategy of DCB angioplasty with rescue stenting failed to achieve non-inferiority to intended DES implantation for treating de novo lesions at 2 years. OBJECTIVE To investigate the 3-year outcomes of the REC-CAGEFREE I trial and assess the mid-term effects of DCBs compared to DES. METHODS REC-CAGEFREE I (NCT04561739) was an open-label, randomized, non-inferiority trial conducted across 43 sites in China. After successful lesion pre-dilatation, 2,272 patients with de novo coronary artery disease (irrespective of target vessel diameter) were randomly assigned (1:1) to paclitaxel-coated balloon angioplasty with the option of rescue stenting (DCB arm) versus intended upfront 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 ten years. RESULTS Between February 5th 2021, and May 1st 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 (SD 0.46) mm. Rescue DES implantation after unsatisfactory DCB angioplasty was performed in 106 (9.4%) patients. At 3 years, DoCE occurred in 92 (8.2%) patients in the DCB arm and 56 (5.0%) in the DES arm (difference:3.21%, 95%CI:1.17 to 5.26, p=0.002). Landmark analyses showed that the rate of difference in DoCE at 0 to 1, 1 to 2, and 2 to 3 years was 1.69% (95%CI: 0.32 to 3.06), 1.10% (95%: -0.13 to 2.32), and 0.58% (95% -0.51 to 1.66), respectively (Ptrend=0.023). CONCLUSIONS In patients with de novo coronary artery disease, DCB angioplasty with rescue stenting was associated with a higher rate of DoCE compared to intended DES implantation regarding the device-oriented composite endpoint at 3 years.