Intravascular lithotripsy (IVL) is non-inferior to rotational atherectomy for achieving acute post-percutaneous coronary intervention (PCI) minimal stent area in moderate-to-severely calcified coronary lesions, results from a randomised head-to-head trial comparing the two approaches have shown.
Benjamin Honton (Clinique Pasteur, Toulouse, France) presented clinical findings of the ICARE trial, a randomised study comparing the two plaque modification techniques in patients with chronic coronary syndrome at EuroPCR 2026 (19–22 May, Paris, France), with the results simultaneously published in EuroIntervention.
According to Honton, the trial is the largest randomised trial to date to compare the two plaque preparation approaches prior to PCI. Rotational atherectomy, he said, remains the gold standard for addressing calcified coronary lesions, though its usage is relatively limited. IVL, on the other hand, has had relatively broad adoption, but there have been few head-to-head trials to compare the two modalities.
Honton and colleagues included 169 patients in their analysis, of which, 86 underwent rotational atherectomy and 83 underwent IVL. Baseline characteristics of the two groups were balanced.
The trial had efficacy and clinical endpoints, with investigators assessing minimal stent area (MSA) measurements using optical frequency domain imaging (OFDI) as well as looking at major adverse cardiac events (MACE) after 12 months, including cardiac death, all myocardial infarction (MI) and target lesion revascularisation (TLR).
Honton reported that IVL was non inferior to rotational atherectomy for the primary endpoint of post-stent MSA, which measured 6.0±2.3mm2 in the IVL group compared to 5.9±2.2mm2 in the rotational atherectomy group, with a p for non-inferiority of <0.05.
Rates of adequate geometrical stent expansion were identical in the two groups, standing at 65.1%, though the incidence of major strut malapposition, whereby the struts of the implanted drug-eluting stent (DES) come away from the arterial wall, was more frequently observed in the rotational atherectomy group, where it occurred in 80.2% of cases compared to 57.8% in the IVL group (p=0.002). Speaking to Cardiovascular News, Honton highlighted that there was a very high prevalence of calcified nodules—48%—reflecting the marked anatomical complexity of the lesions treated, a factor which may have contributed to the occurrence of major strut malapposition.
Honton and colleagues also reported that there was no difference between the groups in terms of periprocedural outcomes, with 12-month rates of target lesion failure standing at 1.2% for rotational atherectomy and 2.4% for IVL after 12 months (p=0.61).
Investigators acknowledged several limitations for the ICARE trial, including the relatively small sample size, the choice of MSA as the primary endpoint, and that it was a relatively selected patient population with exclusions including left main lesions and chronic total occlusions (CTOs). Honton also pointed out to Cardiovascular News that, as the trial is a mechanistic trial, it was powered to demonstrate non-inferiority for the imaging endpoint—MSA—but not for clinical outcomes.
He also underscored the importance of the use of intracoronary imaging in the results achieved in the trial. “Intracoronary imaging is probably the key driver of the favourable procedural results observed in ICARE,” he commented. “Once the calcified lesion has been properly characterised, both plaque-modification strategies—IVL and rotational atherectomy—can achieve excellent results when appropriately selected.”
