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Coronary Lithotripsy in Calcified Coronary Arteries
Quick Takes
- Treatment with coronary intravascular lithotripsy (IVL) was feasible in the vast majority of lesions and less than one third of lesions had a final stenosis ≥20% despite 49% of lesions considered undilatable prior to IVL.
- Immediate and 30-day outcomes were excellent, with a very low rate of MACE despite the high-risk nature of the patient population.
- The durability of the clinical benefits associated with IVL-optimized stent implantation needs to be determined with longer-term clinical follow-up studies.
Study Questions:
What is the performance of coronary intravascular lithotripsy (IVL) in calcified coronary lesions in a real-life, all-comers, setting?
Methods:
The investigators prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain in the REPLICA-EPIC18 (Registry of Coronary Lithotripsy in Spain) study. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. A multivariate logistic regression analysis was performed to identify clinical, angiographical, and procedural variables that predicted a final stent stenosis ≥20%; the model included variables that were related to final stent stenosis ≥20% in the univariate analysis (p < 0.2), age, and sex.
Results:
A total of 426 patients (456 lesions) were included, 63% of them presenting with ACS. IVL delivery was successful in 99% of cases. Prior to IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [p = 0.073]).
Conclusions:
The authors report that coronary IVL is a feasible and safe procedure in a “real-life” setting, effectively facilitating stent implantation in severely calcified lesions.
Perspective:
This real-life study reports that treatment with coronary IVL was feasible in the vast majority of lesions and that less than one third of lesions had a final stenosis ≥20% despite 49% of lesions considered undilatable prior to IVL. Furthermore, immediate and 30-day outcomes were excellent, with a very low rate of MACE despite the high-risk nature of the patient population. However, the durability of the clinical benefits associated with IVL-optimized stent implantation needs to be determined with longer-term clinical follow-up. The observed trend towards higher 30-day MACE in ACS patients with IVL also needs further assessment.
Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention
Keywords: Acute Coronary Syndrome, Lithotripsy
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