Severe persistent calcification of the coronary arteries has been associated with different factors, such as advanced age, hypertension, dyslipidemia, smoking, and kidney failure, among others, and continues to be one of the challenges to stent implantation because of it impact on device advancing, drug release and adequate positioning.
Intravascular lithotripsy (IVL) is a technique that uses ultrasound through a balloon to treat calcified lesions. However, we currently lack evidence from large studies and, in general, patients with acute coronary syndrome (ACS) have been excluded from them.
The REPLICA EPIC-18 included 422 patients with 456 calcified lesions treated with IVL: 157 (37.2%) presenting chronic coronary syndrome (CCS) and 265 with ACS.
Efficacy primary outcome was defined as successful coronary angioplasty with residual <20% stenosis with no hospital complications, while the safety end point was the presence of major adverse cardiovascular events (MACE) at 30 days, defined as the composite of death, MI or target vessel revascularization (TVR).
Patient mean age was 73, with 84% of patients with hypertension, 52% with diabetes, 17% with peripheral vascular disease, 37% prior MI, 41% prior PCI, 10% prior CABG and 21% kidney function deterioration.
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75% of patients had ACS, 70% presented conserved ventricular function and 6% showed severe ventricular function deterioration.
76% of procedures were done via transradial approach, and 49% of lesions were considered undilatable. The artery most frequent treated with IVL was the anterior descending (44.5%), followed by the right coronary (32%), the circumflex (21.2%) and the left main (11%). Residual stenosis after stenting was 15% ± 13 mm.
The efficacy primary outcome was reached in 66% of cases and the safety end point in 96.4% with a higher trend towards MACE in ACS patients vs CCS patients (4.5% vs. 1.3%; P= 0.073).
There were no significant differences in mortality, MI or TVR.
Lack of stent expansion predictors were obstruction length, reference diameter and obstruction percentage.
Conclusion
Coronary lithotripsy was shown feasible and safe in the “real world”, effectively facilitating stent implantation in severely calcified lesions. Even though ACS patients showed similar successful rates, they presented a tendency towards higher MACE incidence at 30 days, vs. patients with CCS.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries. The REPLICA-EPIC18 Study.
Reference: Oriol Rodriguez-Leor, et al J Am Coll Cardiol Intv 2024;17:756–767.
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