Intravascular lithotripsy for calcified coronary lesions: contemporary trends and long-term outcomes in acute myocardial infarction patients — insights from the CLEAR registry

BACKGROUND: Intravascular lithotripsy (IVL) utilizes high-energy sonic waves to create controlled fractures in calcified plaques, facilitating vessel preparation and improving stent apposition. METHODS: The study was designed to evaluate the safety and efficacy of IVL in a patient population that included individuals with acute myocardial infarction (MI). A total of 201 consecutive patients who underwent percutaneous coronary intervention (PCI) using IVL [Shockwave C2 or C2+ (Shockwave Medical Inc, Santa Clara, CA, US)] from April 2020 onward were included in this single-center registry. The study population comprised 76 patients with acute MI (Group 1) and 125 patients with non-MI (Group 2). RESULTS: Left ventricular ejection fraction was lower (46.0% ± 13.1% vs. 50.9% ± 10.5%; p = 0.022), while SYNTAX Score was significantly higher (20.0 ± 11.3 vs. 16.5 ± 10.2; p = 0.059) in Group 1 than in Group 2 (46.0% ± 13.1% vs. 50.9% ± 10.5%; p = 0.022). The overall IVL success rate and procedure success rate were very high (97.5% and 99.5%, respectively). A mean increase in lumen area was observed in Group 1 and Group 2: 5.9 ± 3.7 mm2 vs. 4.5 ± 2.2 mm2 and 237% vs. 239%, respectively. In the long-term follow-up there was no difference in all-cause mortality between Group 1 and Group 2 (9.0% vs. 8.1%; p = 0.997), cardiac death (p = 0.340), repeat MI (p = 0.986) and major adverse cardiovascular events [MACE; cardiac death, myocardial infarction, stroke] (16.8% vs. 9.8%; p = 0.501). Prior chronic kidney disease (CKD), post rota-atherectomy debulking, prior coronary artery bypass graft (CABG) and longer lesions were independent predictors of long-term all-cause mortality. CONCLUSIONS: Intravascular lithotripsy is an effective treatment for the modification of calcified atherosclerotic lesions, with a high success rate and few periprocedural complications. The long-term outcomes achieved in this complex population are satisfactory.