Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions

BACKGROUND: Percutaneous coronary intervention in severely calcified lesions is associated with an increased risk for procedural complications and impaired clinical outcomes. Intravascular lithotripsy is a balloon-based technique that uses pressure waves to fracture calcified plaques. However, no randomized evidence supports the routine use of lithotripsy in clinical practice. OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of adding lithotripsy to conventional lesion preparation in severely calcified lesions. METHODS: In an international and assessor-blinded trial, patients with severely calcified coronary lesions were randomized to lesion preparation with vs without lithotripsy before stent implantation. The primary composite endpoint consisted of procedural failure (failed or no stent delivery, or residual area stenosis ≥20% by optical coherence tomography) or target vessel failure (cardiac death, myocardial infarction, or clinically driven revascularization) at 1 year. RESULTS: Ninety-nine patients were randomized to lithotripsy and 101 patients to conventional lesion preparation. The primary endpoint occurred in 35 patients (35%) in the lithotripsy group vs 52 patients (52%) in the conventional group (RR: 0.69; 95% CI: 0.48-0.97; P = 0.02). Residual area stenosis ≥20% was the most frequent component of the primary endpoint and occurred in 32 patients (32%) in the lithotripsy group vs 45 patients (45%) in the conventional group (RR: 0.73; 95% CI: 0.49-1.04). Safety endpoints did not differ between groups. CONCLUSIONS: Adding lithotripsy to lesion preparation using conventional techniques before stent implantation in severely calcified lesions reduced the combined incidence of procedural failure or target vessel failure at 1 year. The reduced incidence was driven primarily by a reduction in residual area stenosis ≥20%. (Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions [BALI]; NCT04253171).