Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo 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 de novo bifurcation and non-bifurcation lesions in large coronary arteries. Methods: This 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. 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; 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). Conclusion: DCB-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.

DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study.

OBJECTIVE: To investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon for the treatment of patients with acute coronary syndrome and de novo Medina type 0,1,0 or 0,0,1 left main stem bifurcation lesions. METHODS: In this multicenter, prospective, proof-of-concept study, patients fulfilling the above criteria were enrolled and received treatment with drug-coated balloon combined with provisional drug-eluting stent implantation in the proximal major branches of the left main stem. Patients who declined this revascularization approach were treated with drug-eluting stent implantation 1-2 mm distally to the left anterior descending or left circumflex artery ostium followed by drug-coated balloon therapy for the ostial disease. The primary endpoint of the study was the calculation of percent diameter stenosis on quantitative coronary angiography post-procedure as well as event rate at 8 months follow-up. RESULTS: A total of 30 patients were enrolled in the study; their mean age was 60.3 ± 7.8 years, while 22 (73.3%) were male. Twenty-two patients were treated only with drugcoated balloon and provisional drug-eluting stent implantation and 8 had drug-eluting stent implantation followed by drug-coated balloon therapy of the ostium of the left main stem major branch. All the procedures were successful with no immediate complications. The percent diameter stenosis of lesion decreased significantly post-procedure from 87.5% (80.0-90.0) to 20% (17.5-30.0), P <.001. During the follow-up period, no major adverse cardiac events were reported. CONCLUSIONS: This proof-of-concept study indicates that ostial drug-coated balloon therapy of the left main stem major branches is safe and effective. Larger clinical data and longer follow-up are needed before advocating its regular use in clinical practice.