A new study concludes that intravascular lithotripsy (IVL) may offer safer and more effective plaque modification than traditional balloon-based techniques in patients with heavily calcified coronary arteries. Writing in the September 8 issue of JACC: Cardiovascular Interventions, the US-based team found that fractures confirmed by micro-CT and histology were observed in 80% of IVL-treated lesions, 66.7% treated with the CB and 33.3% treated with ultra-high-pressure balloons (UHB). The team also noted medial injury occurred significantly less frequently with IVL (20.0%) compared with the CB (83.3%) and the UHB (100%) (p = 0.012). “In histologic sections with a calcium arc of ≥180°, IVL induced fractures in 100% of sections, all without medial injury, while the CB and UHB caused fractures without medial injury in 16.7% and 20.0% of sections, respectively (p = 0.007),” added the paper’s authors. “For calcium arcs <180°, IVL produced fractures in 57.1% of sections, all without medial injury, compared with the CB (11.1% without medial injury) and UHB (0% without medial injury) (p = 0.008).” Methodology The study, which was also published Monday online, began by randomizing 17 calcified coronary lesions to treatment with IVL (n=5), cutting balloons (n=6) or ultra-high-pressure balloons (n=6). Optical coherence tomography (OCT), micro–computed tomography and histology were used to assess both fracture formation and arterial wall damage. “Although the frequency of calcium fractures within target lesions was comparable across the 3 devices, IVL was associated with significantly less medial injury,” said the paper’s authors, led by Teruo Sekimoto, MD, from CVPath Institute in Gaithersburg, Maryland. “Second, when calcium fractures were further analyzed by categorizing lesions on the basis of the arc of calcium in cross sections, concentric vs eccentric, IVL demonstrated more fractures with less medial injury.” The research team also highlighted that minimizing vessel trauma was clinically important, as medial injury can drive restenosis, uncovered stent struts, and adverse vascular healing. By producing calcium fractures through acoustic energy rather than mechanical force, IVL appeared to reduce this risk. “IVL effectively modifies calcified coronary plaques, achieving calcium fractures across a range of calcification arcs while minimizing medial injury,” they added. “Compared with CBs and UHBs, IVL consistently induced fractures with fewer complications, even in lesions with smaller calcification arcs.” Small sample size The researchers pointed out that results were limited by small sample size, ex vivo design and lesion imbalances. However, the findings reinforced IVL’s potential as a frontline tool for managing calcified coronary lesions and set the stage for further clinical validation. “We commend the investigators for shedding light on a vexing clinical problem,” said an accompanying editorial authored by Heleen M.M. van Beusekom, PhD, from Erasmus MC University Medical Center in Rotterdam, the Netherlands, and Evelyn Regar, MD, PhD, from the Clinical Study Center, LMU Hospital, in Munich. “Heavily calcified lesions remain a relevant clinical and considerable technical challenge with lower success and higher complication rates with percutaneous coronary intervention,” they added. The authors also emphasized that statistical significance did not always align with clinical relevance. “Unfortunately, a definitive answer to the question of which device to use was not achievable, as the small number of observations did not provide adequate statistical power,” they said. They concluded that larger, real-world clinical trials were essential to determine the safest and most effective plaque modification strategy. Source: Sekimoto T, Fujiyoshi K, Kawakami R, et al. Comparison of Vascular Injury From Intravascular Lithotripsy, Cutting, or Ultra-High-Pressure Balloons During Coronary Calcium Modification. JACC Cardiovasc Interv. 2025;18:2093–2104. van Beusekom HMM, Regar E. The Numbers Game: Statistical Significance and Clinical Relevance. JACC Cardiovasc Interv. 2025;18:2105–2106. Image Credit: Syda Productions – stock.adobe.com