Intravascular lithotripsy in comparison to rotational atherectomy for calcified lesions: the ICARE OFDI randomised trial.

BACKGROUND: The management of calcified coronary lesions remains challenging. Although several devices for advanced plaque modification are available, their relative efficacy is debated. AIMS: We aimed to compare intravascular lithotripsy (IVL)- and rotational atherectomy (RA)-based strategies for calcified plaque preparation during percutaneous coronary interventions (PCI). METHODS: , a one-sided alpha risk of 5%, and a power of 80%, under the assumption of no true difference between groups. The primary endpoint was the minimal stent area (MSA) following stent implantation. The target lesion failure (TLF) rate was analysed after 12 months. RESULTS: , respectively; p for non-inferiority <0.05). Adequate geometrical stent expansion was similar in both groups (RA: 65.1%, IVL: 65.1%; p=0.994), whereas major strut malapposition were more frequently observed in the RA group (RA: 80.2% vs IVL: 57.8%; p=0.002). There was no difference between groups in terms of periprocedural complications. The TLF rates between groups after 12 months were equivalent (RA: 1.2%, IVL: 2.4%; p=0.61). CONCLUSIONS: In this trial, the IVL strategy was non-inferior to the RA strategy regarding MSA for PCI in moderate-to-severe calcified coronary lesions, with a comparable safety profile and equivalent clinical outcomes.