CLINICAL OUTCOMES, PROCEDURAL SUCCESS, AND SAFETY OF INTRAVASCULAR LITHOTRIPSY FOR SEVERELY CALCIFIED CORONARY LESIONS: A PROSPECTIVE SINGLE-CENTER REAL-WORLD STUDY

Abstract

Background: Severe coronary artery calcification remains a major challenge during percutaneous coronary intervention (PCI), often resulting in inadequate lesion preparation, suboptimal stent expansion, and increased procedural complications. Intravascular lithotripsy (IVL) has emerged as a novel calcium-modification technique that uses acoustic pressure waves to fracture vascular calcium and facilitate optimal stent deployment. However, real-world data regarding its effectiveness and safety remain limited. Objectives: To evaluate the clinical outcomes, procedural success, and safety of IVL-assisted PCI in patients with severely calcified coronary lesions in a prospective single-center real-world setting. Materials and Methods: This prospective observational study included 110 consecutive patients with severely calcified coronary artery lesions who underwent IVL-assisted PCI at a tertiary care center. Baseline demographic, clinical, angiographic, procedural, and follow-up data were prospectively collected. The primary endpoint was procedural success, defined as successful stent implantation with residual stenosis <30% and final TIMI grade 3 flow without in-hospital major adverse cardiac events (MACE). Secondary endpoints included device success, angiographic success, procedural complications, and 30-day clinical outcomes. Results: The mean age of the study population was 66.4 ± 9.8 years, and 76.4% were male. Hypertension (73.6%), dyslipidemia (61.8%), and diabetes mellitus (49.1%) were the most prevalent cardiovascular risk factors. Acute coronary syndrome was present in 61.8% of patients. The left anterior descending artery was the most frequently treated vessel (47.3%), while multivessel disease was observed in 43.6% of patients. Conclusion: Intravascular lithotripsy is a highly effective and safe calcium-modification strategy for the treatment of severely calcified coronary lesions. The high procedural success rates, low complication rates, and favorable short-term clinical outcomes observed in this study support the routine use of IVL in complex calcified coronary artery disease.