Drug‐Coated Balloons Versus Drug‐Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC‐CAGEFREE I Trial

ABSTRACT Background For long coronary lesions, drug‐coated balloons (DCBs) might be an attractive alternative compared with drug‐eluting stents (DES); however, supporting evidence remains scarce. This analysis aims to compare DCBs versus DES for treating long de novo coronary lesions. Aims To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions. Methods REC‐CAGEFREE I was a non‐inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel‐coated balloon angioplasty with the option of rescue stenting or sirolimus‐eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre‐specified subgroup analysis, patients were stratified by quantitative coronary angiography‐assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device‐oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically‐indicated target lesion revascularization) at 3 years. Results 2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HR IPTW : 2.46, 95% CI: 1.07–5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HR IPTW : 1.52, 95% CI: 1.03–2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (P interaction = 0.460). Conclusion DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.