A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. 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. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (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: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

Litoplastia coronaria en lesiones calcificadas: registro multicéntrico de la práctica clínica / Coronary lithoplasty for calcified lesions: real-world multicenter registry

INTRODUCCIÓN Y OBJETIVOS: La litoplastia coronaria (LC) es una técnica con balón que se utiliza para tratar lesiones calcificadas graves. Este estudio describe la experiencia inicial del tratamiento de lesiones calcificadas con LC en una población no seleccionada y de alto riesgo. MÉTODOS: Registro prospectivo, multicéntrico, que incluyó consecutivamente todos los casos con lesiones coronarias calcificadas que se trataron con LC entre agosto de 2018 y agosto de 2019. Los criterios de exclusión fueron lesiones localizadas en vaso pequeño (< 2,5mm) y la presencia de disección previa a la LC. Un laboratorio central independiente realizó la angiografía coronaria cuantitativa y el análisis de la ecocardiografía intravascular/tomografía de coherencia óptica. RESULTADOS: Este registro incluyó a 57 pacientes (66 lesiones). Una población de edad avanzada (72,6±9,4 años) con alta proporción de pacientes diabéticos (56%), enfermedad renal crónica (35%) y enfermedad multivaso (84%). Todas las lesiones eran de tipo B/C. Se predilataron más del 75% de las lesiones con balones semidistensibles/no distensibles o cutting-balloon. Se utilizó rotablación antes de la litoplastia en 5 lesiones (7,6%). En promedio, la LC necesitó 1,17 balones de litoplastia y una media de 60 pulsos. El éxito de la LC se logró en el 98%. En el 13% de los casos, el balón de litoplastia se rompió durante el procedimiento. Hubo pocas complicaciones durante el procedimiento: 2 casos de disección significativa (ninguna relacionada con ruptura del balón de litoplastia), que se trataron con éxito mediante implante de stent farmacoactivo; 1 paciente presentó trombosis del stent 2 días después de someterse con éxito a la revascularización de la lesión objetivo. CONCLUSIONES: Este es un registro multicéntrico de la práctica clínica que respalda la factibilidad, la seguridad y la eficacia a corto plazo de la intervención coronaria percutánea para lesiones coronarias calcificadas utilizando la LC con resultados prometedores en una población no seleccionada y de alto riesgo

INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results