Abstract: Background: Coronary intravascular lithotripsy (IVL) demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. The purpose of this study is to assess the safety and effectiveness of IVL in calcified coronary lesions in a real-life, all-comers setting. Methods: EPIC18-REPLICA study (NCT04298307) is a prospective, observational, multicenter registry that enrolled consecutive patients with calcified lesions treated with IVL at operator discretion. The primary effectiveness endpoint was procedural success defined as successful IVL delivery, final in-stent stenosis <20% and absence of in-hospital MACE (death, myocardial infarction or Target Vessel Revascularization). Core-lab QCA of the target lesion has been performed prior to and immediately after the IVL, and after stent implantation. The primary safety endpoint was freedom from MACE at 30 days. A substudy comparing outcomes in acute vs chronic coronary syndrome (ACS vs CCS) was planned. Results: Patients (n = 426) were enrolled at 26 Spanish sites; IVL delivery was successful in 422 (99.1%). 268 patients (62.9%) had ACS on admission. The primary effectiveness end point was 90.4% in the whole population, 94.2% in CCS and 88.3% in ACS patients (p=0.046). There were no differences in angiographical success after IVL between CCS and ACS patients (94.9% vs 91.7%, p=0.22). The primary safety endpoint occurred in 20 patients (4.8%): 3 CCS patients (2.0%) and 17 ACS patients (6.4%) (HR 4.50 (96%CI [1.03-19,68], p=0.046, as shown in Figure). Conclusions: Coronary IVL is a safe procedure and effectively facilitates stent implantation in severely calcified lesions in a real-life setting. Compared to patients with CCS, patients with ACS on admission had similar angiographic success but higher 30-days MACE.

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