Balancing innovation and safety in percutaneous treatment of coronary artery calcification: the evolving role of cutting balloon technology

Background Cutting balloon (CB) angioplasty is one of several approaches to lesion preparation in calcified coronary artery disease. Its comparative efficacy, safety, and optimal use remain incompletely defined. Aims To critically appraise clinical studies and emerging technical concepts concerning CB angioplasty, with particular attention to evidence strength, patient selection, and safety. Methods This narrative review discusses selected randomised trials, observational studies, mechanistic investigations, and emerging reports concerning CB-based lesion preparation. Findings Randomised studies have reported improvements in selected acute imaging endpoints, but findings differ across populations and treatment strategies. Observational studies suggest progressive lumen gain during sequential CB inflations; however, these observations do not establish an optimal inflation protocol. Evidence for comparative long-term clinical benefit and rare device-related complications remains limited. Reported procedural cost differences should not be equated with generalisable cost-effectiveness. Inflation above the device's rated burst pressure constitutes off-label use and falls outside the manufacturer's recommended pressure limits. The Index of Device Efficiency (IDE) remains an exploratory metric rather than a validated treatment target. Conclusion CB may be considered among complementary calcium-modification options in appropriately selected lesions. Device choice should reflect anatomy, crossability, imaging findings, and patient risk. Current evidence does not justify routine high-pressure iterative CB use beyond device labelling or universal IDE-guided treatment targets.