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Clinical Outcomes After Scoring-Balloon and Sirolimus-Eluting Balloon Strategy in Diffuse Small-Vessel Coronary
Dobrin Vassilev1,2, Niya Mileva1,3, Panayot Panayotov1,2
1Medica Cor Hospital, Ruse, Bulgaria.
Insights
This study shows a new treatment combining scoring balloon angioplasty and sirolimus-eluting balloons is effective for diffuse coronary artery disease, offering promising results for patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Diffuse coronary artery disease presents significant treatment challenges, often leading to high rates of repeat revascularization.
- Current treatment strategies for diffuse, small-vessel coronary artery disease lack satisfactory outcomes.
Purpose of the Study:
- To evaluate the feasibility and safety of a novel treatment strategy for diffuse, small-vessel coronary artery disease.
- To assess a systematic combination of scoring balloon angioplasty (SBA) and sirolimus-eluting balloon angioplasty (SEB).
Main Methods:
- A prospective, single-center, single-arm study included 167 patients with diffuse (lesion length ≥20 mm) and small vessel (diameter 1.5-2.75 mm) coronary disease.
- The treatment involved SBA followed by SEB (Mozec balloon, Meril).
- Exclusion criteria included STEMI, left main stenosis, and limited life expectancy.
Main Results:
- The study included 167 patients (mean age 67±9 years, 71% male) with 194 treated vessels.
- Mean lesion length was 35±15 mm, with a mean reference vessel diameter of 2.1±0.74 mm.
- At a median follow-up of 15 months, the composite endpoint of Major Adverse Cardiovascular Events (MACE) was 5.4%, Target Lesion Revascularization (TLR) was 4.8%, and Periprocedural Obstetric Complications (POCE) was 10.2%.
Conclusions:
- A novel strategy combining SBA and SEB demonstrates promising angiographic and clinical outcomes for diffuse coronary artery disease.
- This approach offers a potentially effective solution for a challenging patient population.
- Further research is warranted to confirm these findings in larger, diverse cohorts.
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.
