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
Dobrin Vassilev, Niya Mileva, Panayot Panayotov, Vladimir Shurupov, Ilter Pazardzhakli, Gavril Stoev, Slawomir Golebiewski, Gianluca Rigatelli, Robert J. GilABSTRACT
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.