Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo Lesions of Large Coronary Arteries

Abstract

Background and ObjectivesUse of drug-coated balloon (DCB)-only strategy for revascularization of native large coronary artery lesions is on the rise. The long-term efficacy of this approach for bifurcation and non-bifurcation lesions remains unknown. We aim to assess the long-term clinical outcomes of DCB-only strategy for the treatment of de novo bifurcation and non-bifurcation lesions in large coronary arteries.MethodsThis multicenter, prospective, observational study enrolled 119 patients with de novo coronary lesions in vessels ≥2.75 mm. The primary end point was the rate of clinically driven target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR). Patients were followed up for a median of 2 years.ResultsOf 119 patients with 138 lesions, 66 patients (75 lesions) had bifurcation and 53 patients (63 lesions) had non-bifurcation lesions. Average reference vessel diameter was 3.1 ± 0.3 mm, and there was no difference in bifurcation and non-bifurcation group (3.0 ± 0.3 vs. 3.1 ± 0.3mm; p = 0.27). At 2-year follow-up, the TLF occurred in five (4.2%), TLR in four (3.4%), and target vessel revascularization (TVR) in five (4.2%) cases. The frequency of TLR and TVR was higher in the non-bifurcation group (p = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups (p = 0.17). The cumulative incidence of TLF (Kaplan–Meier estimates) was also not different in the two groups (log-rank p = 0.11).ConclusionDCB-only strategy for de novo lesions in large coronary arteries appears to be safe and effective for both bifurcation and non-bifurcation lesions. Further randomized clinical trials are warranted to confirm the value of DCB-only strategy in de novo bifurcation lesions of large vessels.

Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels

“…Data on the long-term efficacy of DCB in large coronary vessels are scantbecause in most of the studies the follow up is lower than 1 year. A longer follow up (2 years) is available in the study of Hu et al 18 that evaluated the efficacy of a paclitaxelcoated DCB in de novo lesions ≥2.75 mm showing a TLR of 3.4%, similar to the one observed here in the cohort of de novo lesions.…”

“…Data on the long‐term efficacy of DCB in large coronary vessels are scantbecause in most of the studies the follow up is lower than 1 year. A longer follow up (2 years) is available in the study of Hu et al 18 that evaluated the efficacy of a paclitaxel‐coated DCB in de novo lesions ≥2.75 mm showing a TLR of 3.4%, similar to the one observed here in the cohort of de novo lesions. In our study too, the follow up was extended up 2 years demonstrating a TLR of 9% in the whole population but only a 4% rate in the de novo sub‐group, representing the largest registry with the longest follow up testing a sirolimus DCB in the treatment of large coronary vessel.…”

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

“…However, the safety and efficacy of DCB treatment beyond 3 years for de novo coronary lesions remain unestablished, and previous studies of de novo non-small coronary lesions have reported conflicting results limited by the absence of a control group treated with DES implantation. 11 21 22 …”

“…Recent observational studies have indicated that the efficacy and safety of DCB treatment are comparable for de novo non-small coronary lesions and small vessel disease. 10 11 Her, et al 10 demonstrated that target vessel failure (TVF) rates were similar between groups at 3.4 years of follow-up (large vessel group, 7.0% vs. small vessel group, 7.9%; p =0.596). Another recent meta-analysis indicated that DCB treatment was non-inferior to DES implantation for de novo large coronary lesions in terms of target lesion revascularization at 6–9 months of follow-up [risk ratio (RR):1.17; 95% CI: 0.46–2.95; p =0.746].…”

Drug-coated balloons for treating de novo lesions in large coronary vessels: A case report

“…Pre-dilation is the most important factor that needs to be considered when treating coronary arteries[ 16 ]. To prevent the requirement of dissection during semi-compliant balloon dilation, the ratio of the balloon and vessel diameter should be between 0.8 and 1.0[ 17 ].…”