Severely calcified coronary lesions represent a therapeutic challenge and have been associated with higher rates of failed percutaneous coronary intervention (PCI), and a negative impact on long-term outcomes. In this context, researchers evaluated whether intravascular lithotripsy (IVL) is superior to conventional lesion preparation prior stenting.
200 patients with angiographically severe calcification were included, and were randomized to either IVL or conventional preparation. All patients underwent optical coherence tomography (OCT), and rotational atherectomy was allowed if predefined criteria were met.
The primary endpoint included procedural failure (defined as non-viable stenting or ≥20% residual stenosis on OCT) and target vessel failure (TVF), which included acute MI, clinically driven revascularization, or cardiac death.
The conventional strategy involved non-compliant balloons (82%), cutting/scoring balloons (57%), and ultra-high-pressure balloons (3%). Rotational atherectomy was used in 31% of IVL patients and 42% of conventional patients.
Results showed a primary endpoint incidence of 35.4% in the IVL group vs. 51.5% in the conventional preparation group (RR 0.69; 95% CI 0.48–0.97; p=0.02).
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As regards periprocedural complications, no significant differences were observed in AMI rate, flow-limiting dissections, or perforations.
The authors concluded that in severely calcified lesions, IVL reduced the incidence of procedural failure or TVF at one year with no increase of procedure-related adverse events.
Presented by A. T. Kristensen during the Major Late Breaking Trials session, EuroPCR 2025, May 21, Paris, France.
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