Long-term Clinical Outcomes of Drug-Coated Balloon Treatment for De Novo Coronary Lesions
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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 percuta neous 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 sec ond-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 revascu larization (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 inci dence 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, com pared with DES implantation, 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 percuta neous 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 sec ond-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 revascu larization (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 inci dence 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, com pared with DES implantation, for de novo coronary lesions.
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