Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Area of Science:

• Cardiovascular Interventions
• Interventional Cardiology
• Medical Device Technology

Background:

• Calcified coronary lesions pose a significant challenge in percutaneous coronary intervention.
• Limited data exist on the safety and efficacy of high-pressure cutting balloons (CB) for these lesions.

Purpose of the Study:

• To compare the effectiveness of high-pressure cutting balloons (CB) versus noncompliant balloons (NCB) in treating calcified coronary lesions.
• To evaluate stent expansion and symmetry following treatment with CB versus NCB.

Main Methods:

• A randomized study comparing CB and NCB in patients with calcified lesions (intravascular ultrasound >100° calcium).
• Primary endpoints included final minimal stent area (MSA) and stent symmetry.
• Secondary endpoints assessed device failure and 1-year clinical outcomes.

Main Results:

• Cutting balloon (CB) treatment resulted in a significantly larger final minimal stent area (MSA) compared to noncompliant balloon (NCB) (8.1 vs. 7.3 mm², p=0.035).
• Higher stent eccentricity was observed with CB use (0.84 vs. 0.8, p=0.013).
• One-year clinical outcomes were comparable between the groups, with three device failures in the CB group.

Conclusions:

• High-pressure cutting balloon (CB) treatment demonstrates a favorable safety profile for calcified coronary lesions.
• CB use is associated with improved stent expansion (larger MSA) and better stent placement (higher eccentricity) compared to NCB.
• The study supports CB as a viable option for complex calcified lesions.