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To the Editor, Calcified coronary lesions remain a procedural and clinical challenge associated with higher rates of procedural complications such as stent underexpansion and malapposition leading to an increased risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction (MI), and death.1 While newer drug-eluting stents and advanced devices are considered safer and more effective, there is still a need for atherosclerotic plaque modification techniques that allow for adequate stent expansion and apposition when traditional techniques fail. Cutting and scoring balloons have been designed to treat complex lesions such as fibrotic plaque and calcified lesions.2,3 However, their use may have been limited by problems of crossability and limited evidence supporting their efficacy and safety.4 In addition, the available published literature is based on studies with noninferiority designs and small sample sizes,5 which may not provide adequately powered analyses to evaluate the clinical efficacy of cutting and scoring balloons in patients with native-vessel coronary artery disease (CAD). Therefore, we performed a systematic review and meta-analysis to compare cutting and scoring balloons with conventional balloons (semi- and non-compliant balloons) in patients with native vessel CAD. This meta-analysis was conducted according to the PRISMA guidelines for the reporting of systematic reviews. Two reviewers independently identified...

Sr. Editor: Las lesiones coronarias calcificadas siguen siendo un desafío clínico a la hora de realizar intervenciones, ya que se asociana índices más altos de complicaciones como infraexpansión y mala aposición del stent. Esto conlleva un mayor riesgo de revascularización de la lesión diana (RLD), trombosis del stent, infarto de miocardio (IM) y muerte1. Mientras que los stents farmacoactivos (SFA) de última generación y los dispositivos contemporáneos son más seguros y efectivos, sigue siendo necesario recurrir a técnicas de modificación de la placa ateroesclerótica para una adecuada expansión y aposición de dichos stents cuando fracasan las técnicas convencionales. Los balones de corte están diseñados para tratar lesiones complejas, como placas fibróticas y lesiones calcificadas2,3; no obstante, su uso puede haberse visto limitado por su peor perfil de cruce y poca evidencia que avale su perfil de eficacia y seguridad4. Además, la literatura publicada disponible se basa en estudios con diseños de no inferioridad y tamaños de muestra pequeños5 y no en análisis con la suficiente potencia estadística como para poder valorar la eficacia clínica de los balones de corte en pacientes con enfermedad coronaria (EC) de vaso nativo. En este sentido, se realizó una revisión sistemática y metanálisis para llevar a...

ABSTRACT Introduction and objectives: Although drug-eluting stents are the main treatment in percutaneous coronary interventions (PCI), drug-coated balloons (DCB) represent an appealing alternative as they eliminate the risk of stent thrombosis and avoid leaving any metal structure in the vessel wall. However, limited evidence has been published to date on the vessel wall healing processes, plaque remodeling, plaque composition, and the impact on the coronary microcirculation after percutaneous coronary intervention with DCB (DCB-PCI). Methods: This is investigator-initiated, single-center, single-arm, open-label, pilot study of 30 patients with native vessel disease undergoing DCB-PCI. Intravascular ultrasound and angiography-derived index of microvascular resistance (IMRangio) will be performed before and immediately after PCI, and at 3 months of follow-up. Conclusions: The study aims to provide new evidence on the modification of atherosclerotic plaque in patients with de novo lesions undergoing PCI with DCB. This will be assessed by examining the change in the percentage of atheroma volume and late lumen enlargement using intravascular ultrasound and by evaluating changes in the microcirculation using IMRangio. Registered at Clinicaltrials.gov (NCT06080919). Keywords: Drug-coated balloon. Intravascular ultrasound. Angiography-derived index of microvascular resistance. RESUMEN Introducción y objetivos: Pese a que los stents farmacoactivos son el tratamiento principal en las angioplastias coronarias, los balones farmacoactivos representan una alternativa interesante dado...

RESUMEN Introducción y objetivos: Pese a que los stents farmacoactivos son el tratamiento principal en las angioplastias coronarias, los balones farmacoactivos representan una alternativa interesante dado que eliminan el riesgo de trombosis del stent sin dejar ningún tipo de estructura metálica en la pared del vaso. No obstante, la evidencia en cuanto a los procesos de cicatrización de la pared del vaso, el remodelado, los cambios en la composición de la placa ateroesclerótica y el impacto en la microcirculación coronaria tras el intervencionismo coronario percutáneo (ICP) con balón farmacoactivo aún no se ha esclarecido. Métodos: Estudio piloto abierto, de un solo grupo, iniciado por el investigador, de 30 pacientes con enfermedad de vaso nativo sometidos a ICP con balón farmacoactivo. Se realizará ecografía intravascular y se determinará el índice de resistencia microvascular derivado de la angiografía (angio-IRM) antes, inmediatamente después y a los 3 meses de seguimiento de la angioplastia. Conclusiones: Se aportará nueva evidencia sobre la modificación de la placa en pacientes con enfermedad de vaso nativo tratados con balón farmacoactivo, evaluando el cambio en el porcentaje del volumen de ateroma y el aumento luminal tardío, así como los cambios en la microcirculación mediante angio-IRM. Registrado en Clinicaltrials.gov (NCT06080919).

Summary: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is recommended in revascularization guidelines for intermediate lesions. However, recent studies comparing FFR-guided PCI with non-physiology-guided revascularization have reported conflicting results. PubMed and Embase were searched for studies comparing FFR-guided PCI with non-physiology-guided revascularization strategies (angiography-guided, intracoronary imaging-guided, coronary artery bypass grafting). Data were pooled by meta-analysis using random-effects model. 26 studies enrolling 78,897 patients were included. FFR-guided PCI as compared to non-physiology-guided coronary revascularization had lower risk of all-cause mortality (odds ratio [OR] 0.79 95% confidence interval [CI] 0.64–0.99, I2 = 53%) and myocardial infarction (MI) (OR 0.74 95% CI 0.59–0.93, I2 = 44.7%). However, no differences between groups were found in terms of major adverse cardiac events (MACEs) (OR 0.86 95% CI 0.72–1.03, I2 = 72.3%) and repeat revascularization (OR 1 95% CI 0.82–1.20, I2 = 43.2%). Among patients with coronary artery disease (CAD), FFR-guided PCI as compared to non-physiology-guided revascularization was associated with a lower risk of all-cause mortality and MI.