Clinical outcomes of drug coated balloon in coronary lesions: 3-year follow-up of CAGE FREE Registry

Abstract

Abstract Background Intervention with drug-coated balloons (DCB) is based on a leave-nothing-behind concept and has been recommended as the first-line treatment modality for in-stent restenosis (ISR) and small-vessel disease. However, DCB treated for de novo lesions and comparison between DCB treatment for de novo lesions and ISR has not been fully elucidated. Purpose To report and compare 3-year clinical outcomes between DCB treatment for ISR and de novo disease, and identify the risk factors of adverse events after DCB intervention. Methods The study population was derived from the CAGE FREE Registry, which was a prospective, dedicated DCB treated all-comers registry in ISR and/or de novo lesions. The primary outcome was vessel-oriented composite endpoint (VoCE) at 3 years, defined as a composite of vessel-related cardiac death, vessel-related myocardial infarction (MI), and target vessel revascularization (TVR). Results A total of 2473 consecutive patients with 2804 lesions were enrolled. DCB treated in 1478 patients with 1669 de novo lesions and 995 ISR patients with 1135 lesions. The median duration of follow-up was 2.5 years (IQR 1.8-3.2) overall. At 3 years, the rate of VoCE was 12.1% (vessel-related cardiac death: 3.0%, vessel-related MI: 2.2%, and TVR: 7.8%) in the overall cohort. Patients with ISR treated with DCB had a higher rate of 3-year VoCE than those with de novo lesions (16.8% vs. 8.9%, HR: 2.00, 95%CI: 1.56-2.57, p<0.001), with the HR remaining significant after adjustment (IPTW adjusted HR: 1.79, 95%CI: 1.37-2.35). In terms of procedure-related factors, TIMI flow after PCI less than grade 3 and residual stenosis more than 25% were independent risk factors of 3-year VoCE for patients with de novo lesions. In patients with ISR, residual stenosis more than 25% had a higher risk of 3-year VoCE, whereas TIMI flow after PCI less than grade 3 only had a trend. Conclusion Patients with ISR treated with DCB had a higher rate of 3-year VoCE than those with de novo lesions. DCB appears to be an attractive alternative treatment for de novo coronary lesions. Residual stenosis ≤25% combined with TIMI flow grade 3 should be attempted after DCB angioplasty.Kaplan Meier curve for 3-year VoCE