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

Background And Objectives: Use 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 bifurcation and non-bifurcation lesions in large coronary arteries.

Methods: This multicenter, prospective, observational study enrolled 119 patients with 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.

Results: Of 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; = 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 ( = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups ( = 0.17). The cumulative incidence of TLF (Kaplan-Meier estimates) was also not different in the two groups (log-rank = 0.11).

Conclusion: DCB-only strategy for 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 bifurcation lesions of large vessels.