Use of Drug-Coated Balloons in De Novo Lesions in Large Coronary Vessels

Drug-coated balloon (DCB) angioplasty is emerging as a novel treatment for coronary artery disease. Studies evaluating this strategy have demonstrated clinically non-inferior outcomes compared with those of drug-eluting stent (DES) implantation in patients with in-stent restenosis and de novo disease in small vessels. However, evidence for the use of DCBs in large coronary vessels is limited.

Utilización de balones cubiertos de fármacos en lesiones de novo en grandes vasos coronarios

Observational, retrospective cohort study DCB 3.0 included a total of 93 consecutive patients with coronary artery disease who were treated with DCB angioplasty for de novo lesions (n = 100) in large coronary vessels at two medical centers, from July 2020 to June 2022.

Inclusion criteria for this study were as follows: 1) presence of a de novo lesion in a vessel with a diameter greater than 3.0 mm, and 2) angioplasty using a DCB with a diameter of 3.0 mm or more, regardless of simultaneous DES implantation.

Patients included in the study had an average age of 68 ± 11 years, and most of them were men. The average SYNTAX score was 22 and, in 83% of cases, the clinical presentation was chronic coronary syndrome. The most frequently treated artery was the anterior descending artery, in 48% of patients, followed by the circumflex artery. The average lesion length was 45 ± 26 mm, and the treated vessels had an average diameter of 3.2 ± 0.3 mm.

In 70% of the lesions (n = 70), the intention-to-treat (ITT) strategy applied was DCB angioplasty only, while 6% of cases (n = 6) underwent rescue DES implantation. In the remaining lesions (30%), the chosen alternative was a hybrid DCB+DES strategy, which tended to be longer (59.9 ± 22.5 mm vs. 38.1 ± 25.8 mm; p <0.001). Intravascular ultrasound was used in 40% of cases.

Most of the DCBs used were coated with sirolimus (77%), while paclitaxel-coated balloons were used in 18% of cases. The average number of DCBs per lesion was 1.4 ± 0.8. The balloons used had a diameter of 3.1 ± 0.3 mm and a length of 35 ± 22 mm, and were inflated to a pressure of 12 ± 3 atm. The incidence of angiographically evident coronary artery dissection was 52% (n = 52). The mean follow-up for this cohort was 350 days.

Regarding outcomes, the incidence of treated vessel failure was 5.1%: 1.5% in the DCB group and 10.7% in the DCB + DES hybrid group (P = 0.0073). There were no cases of cardiac death or myocardial infarction in the treated vessel. The incidence of revascularization in the treated vessel was 6.6%.

The key findings of this study suggest that DCB angioplasty, whether alone or in combination with DES implantation, is safe and effective for the treatment of long de novo lesions in large coronary vessels, potentially reducing the need for DES implantation. Results from a prospective study (Colombo A. et al. Drug-coated balloons as a first choice for patients with de novo lesions: pros and cons. Eurointervention) are expected to provide more robust evidence for this strategy in the future.