Clinical Outcomes After Scoring-Balloon and Sirolimus-Eluting Balloon Strategy in Diffuse Small-Vessel Coronary Artery Disease (SCA-DEB Study): A Single-Center Prospective Study.

BACKGROUND

The treatment of diffuse coronary artery disease is challenging, with high rates of repeat revascularization without satisfactory treatment.

AIMS: We designed a prospective, single-center, single-arm study to evaluate the feasibility and safety of a new strategy for the treatment of diffuse, small-vessel coronary artery disease using a systematic combination of Scoring-balloon Angioplasty and Sirolimus-eluting balloon Angioplasty.

METHODS

We included patients with diffuse (lesion length ≥ 20 mm) and small vessel (diameter 1.5-2.75 mm) coronary disease. Patients with STEMI, left main stenosis, and a life expectancy of less than 24 months were excluded. The procedure strategy was scoring-balloon angioplasty (SBA), 1:1 diameter ratio with distal reference plus sirolimus-eluting balloon angioplasty (SEB) using Mozec balloon (Meril, India).

RESULTS

From December 2022 until June 2025, 167 patients with 194 vessels were included. The mean age was 67 ± 9 years, 71% males, 92% with dyslipidemia, and 44% diabetics. The left anterior descending artery was the most frequently treated vessel (66%). The mean reference vessel diameter was 2.1 ± 0.74 mm, MLD 0.71 ± 0.31 mm, and %DS 67 ± 14%. The mean lesion length was 35 ± 15 mm. For a median clinical follow-up of 15 [8-29] months, the overall rate of MACE was 5.4%, 4.8% patients had TLR, and the total percentage of POCE was 10.2%.

CONCLUSIONS

A novel strategy using a combination of scoring balloon angioplasty followed by sirolimus-eluting balloon inflation for the treatment of diffuse coronary artery disease yields promising angiographic and clinical outcomes.