Final results of the CAPAS trial

Area of Science:

• Cardiovascular Interventions
• Interventional Cardiology
• Medical Device Technology

Background:

• The Cutting Balloon (CB) is a novel angioplasty device featuring integrated blades designed to create controlled incisions.
• These incisions aim to facilitate vessel dilation while minimizing severe tearing injury.
• The CB technology holds potential for reducing restenosis and improving clinical outcomes in coronary interventions.

Purpose of the Study:

• To compare the efficacy and safety of Cutting Balloon angioplasty (CBA) versus conventional balloon angioplasty (PTCA).
• To evaluate the impact of CBA on restenosis rates and clinical outcomes in patients with small coronary arteries.

Main Methods:

• A randomized trial involving 248 lesions (120 CBA, 128 PTCA) with type B/C lesions and reference diameter <3.0 mm.
• Quantitative coronary angiography performed pre- and post-procedure, and at 3-month follow-up.
• Primary endpoint: restenosis (>50% diameter stenosis). Secondary endpoint: 1-year clinical event rates.

Main Results:

• Postprocedural and 3-month follow-up diameter stenosis were lower in the CBA group (26.2% vs 28.9%; 40.8% vs 47.5%).
• Significantly lower restenosis rates were observed with CBA compared to PTCA (25.2% vs 41.5%, P =.009).
• One-year event-free survival was higher in the CBA group (72.8%) versus the PTCA group (61.0%, P =.047).

Conclusions:

• Cutting Balloon angioplasty demonstrates superior angiographic outcomes in small coronary arteries.
• CBA offers improved clinical outcomes compared to PTCA in this patient population.
• The findings support the use of CBA for treating complex lesions in small coronary vessels.