Long-Term Clinical Outcomes of Drug-Coated Balloon Treatment for De Novo Coronary Lesions.

ABSTRACT

PURPOSE: Data are limited on the long-term efficacy and safety of drug-coated balloon (DCB) treatment in comparison to drug-eluting stent (DES) for de novo coronary lesions. We investigated the long-term clinical outcomes of DCB treatment in percutaneous coronary intervention (PCI) for de novo coronary lesions. MATERIALS AND METHODS: A total of 103 patients scheduled for elective PCI for de novo non-small coronary lesions (≥2.5 mm) who were successfully treated with DCB alone were retrospectively compared with 103 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n=13160). All patients were followed for 5 years. The primary endpoint was major adverse cardiac events [MACE; cardiac death, myocardial infarction, stroke, target lesion thrombosis, target vessel revascularization (TVR), and major bleeding] at 5 years. RESULTS: At 5-year clinical follow-up, Kaplan-Meier estimates of the rate of MACE were significantly lower in the DCB group [2.9% vs. 10.7%; hazard ratio (HR) 0.26; 95% confidence interval (CI) 0.07-0.96; log-rank p=0.027]. There was a significantly lower incidence of TVR in the DCB group (1.0% vs. 7.8%; HR 0.12; 95% CI 0.01-0.98; long-rank p=0.015), and there was major bleeding only in the DES group (0.0% vs. 1.9%; log-rank p=0.156). CONCLUSION: At 5-year follow-up, DCB treatment was significantly associated with reduced incidences of MACE and TVR, compared with DES implantation, for de novo coronary lesions.