Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up.

Area of Science:

• Interventional Cardiology
• Cardiovascular Research
• Medical Device Technology

Background:

• Calcified coronary lesions pose a significant challenge during percutaneous coronary intervention, often limiting stent expansion and increasing procedural risks.
• Coronary lithotripsy (CL) utilizes pulsatile low-energy waves to fracture calcified plaque, aiming to improve vessel compliance and facilitate successful stent implantation.

Purpose of the Study:

• To evaluate the safety, effectiveness, and long-term durability of coronary lithotripsy (CL) in a real-world, multicenter patient registry.
• To assess the clinical outcomes of CL in an unselected, high-risk population with complex calcified coronary lesions.

Main Methods:

• Prospective, multicenter, single-arm study of consecutive patients undergoing CL for calcified lesions.
• Inclusion of 109 patients (128 lesions) with a median follow-up of 20 months.
• Primary endpoint: Major Adverse Cardiovascular Event (MACE) rate, defined as death, target-lesion revascularization (TLR), or myocardial infarction (MI).

Main Results:

• Successful CL achieved in 99% of cases with a 30-day MACE rate of 98%.
• The study population comprised elderly patients (mean age 74) with high rates of comorbidities including diabetes (58%) and renal insufficiency (32%).
• Long-term MACE rate was low at 5.6%.

Conclusions:

• This real-world registry confirms the safety and long-term efficacy of coronary lithotripsy for treating calcified coronary lesions.
• CL is a valuable tool in percutaneous coronary intervention, demonstrating a low MACE rate in a high-risk, unselected patient population.
• The findings support the use of CL to improve procedural success and long-term clinical benefit in complex coronary artery disease.