Intravascular lithotripsy in comparison to rotational atherectomy for calcified lesions: the ICARE OFDI randomised
Benjamin Honton1, Pascal Motreff2, Jean-Sébastien Mallet3
1Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.
Insights
Intravascular lithotripsy (IVL) demonstrated non-inferiority to rotational atherectomy (RA) in preparing calcified coronary lesions for percutaneous coronary intervention (PCI). Both strategies showed comparable safety and long-term clinical outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Management of calcified coronary lesions presents significant challenges in percutaneous coronary interventions (PCI).
- The comparative efficacy of available plaque modification devices, including intravascular lithotripsy (IVL) and rotational atherectomy (RA), is not well-established.
Purpose of the Study:
- To compare intravascular lithotripsy (IVL) and rotational atherectomy (RA) based strategies for plaque preparation in patients with moderate-to-severe calcified coronary lesions undergoing PCI.
- To assess the non-inferiority of IVL compared to RA in achieving adequate lesion preparation.
Main Methods:
- A multicenter, prospective, randomized non-inferiority trial involving 169 patients with moderate-to-severe calcified coronary lesions.
- Interventions were guided by optical frequency domain imaging, comparing IVL and RA for plaque modification.
- The primary endpoint was minimal stent area (MSA) post-stent implantation; target lesion failure (TLF) was assessed at 12 months.
Main Results:
- IVL was non-inferior to RA for the primary endpoint of minimal stent area (MSA) (6.0±2.3 mm² vs 5.9±2.2 mm²).
- Major strut malapposition was significantly less frequent with IVL (57.8%) compared to RA (80.2%).
- Periprocedural complications and 12-month target lesion failure (TLF) rates were comparable between the IVL and RA groups.
Conclusions:
- The IVL strategy is non-inferior to RA for plaque preparation in moderate-to-severe calcified coronary lesions during PCI.
- IVL offers a comparable safety profile and equivalent clinical outcomes to RA.
- These findings support IVL as an effective alternative for managing complex calcified coronary lesions.
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:
This multicentre, prospective, randomised non-inferiority trial compared IVL with RA for plaque preparation in moderate-to-severe stable calcified coronary lesions. All interventions were guided by optical frequency domain imaging. A non-inferiority margin of 0.75 mm2 was prospectively defined based on prior intracoronary imaging studies, and the sample size calculation was based on a standard deviation of 1.9 mm2, 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:
A total of 169 patients (RA: n=86, IVL: n=83; 81.1% male; mean age 71.8±8.2 years) were included in the final analysis. The baseline characteristics of each group were balanced. Calcified nodules were identified in 48% of the patients. IVL was not inferior to RA for the primary endpoint (6.0±2.3 mm2 vs 5.9±2.2 mm2, 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 was 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.
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