Outcomes of the Use of Drug Coated Balloons in the Treatment of De Novo Coronary Lesions

Drug coated balloon (DCB) angioplasty offers a novel strategy for treating coronary artery disease. Studies assessing this strategy have shown clinical outcomes comparable to drug-eluting stents’ (DES) in patients with in-stent restenosis and de novo disease in small vessels. However, evidence for the use of DCB in large coronary vessels is limited.

Resultados de la utilización de balones recubiertos de fármacos para el tratamiento de lesiones coronarias de novo

This observational, retrospective study DCB 3.0 included a total of 93 consecutive patients with coronary artery disease treated with DCB angioplasty for de novo lesions (n = 100) in large coronary vessels in 2 centers between July 2020 and June 2022.

Inclusion criteria were: 1) presence of a de novo lesion in a vessel with diameter greater than 3.0 mm, and 2) angioplasty using a DCB with 3.0 mm diameter or greater, regardless concomitant DES stenting.

Patients were mean age 68 ± 11 years, and were mostly men. Mean SYNTAX score was 22 and chronic coronary syndrome was the clinical presentation in 83% of cases. The most treated artery was the anterior descending (48% of patients), followed by the circumflex. Mean lesion length was 45 ± 26 mm, and treated vessels were 3.2 ± 0.3 mm in diameter.

The intention-to-treat (ITT) strategy was DCB angioplasty only for 70% of lesions (n = 70), with 6% of cases (n = 6) undergoing rescue DES implantation. The remaining lesions (30%) received 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 DCBs were sirolimus coated (77%), while paclitaxel-coated balloons were used in 18% of cases. Mean number of DCBs per lesion was 1.4 ± 0.8 and balloons were 3.1 ± 0.3 mm in diameter, 35 ± 22 mm long, and were inflated to 12 ± 3 atm. The incidence of angiographically evident coronary artery dissection was 52% (n = 52). Mean follow-up for this cohort was 350 days.

As regards outcomes, the incidence of target 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 target vessel related MI. Target vessel revascularization incidence was 6.6%.

Key findings suggest DCB angioplasty, either alone or in combination with DES stenting, is safe and effective to treat long de novo lesions in large coronary vessels, and leads to the reduction of DES stenting procedures. We look forward to the outcomes of a prospective study (Colombo A. et al. Drug-coated balloons as a first choice for patients with de novo lesions: pros and cons. Eurointervention) to further support this strategy with stronger evidence.