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Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)

Introduccion En la estenosis mitral, el ejercicioproduce un aumento en el gasto y la frecuencia cardiacos,lo que condiciona el incremento en el gradientetransmitral. Sin embargo, no esta establecidoen la estenosis mitral severa el nivel quealcanzan los gradientes al esfuerzo y si el incrementodel gradiente con el esfuerzo es diferente alde las estenosis no severas. Objetivos Evaluar la respuesta al esfuerzo, enpacientes con estenosis mitral severa, de los gradientesen valores absolutos y el incremento conrespecto a los valores basales. Metodos A 48 pacientes con estenosis mitral(edad media: 48,8 ± 11 anos) se les realizaron 50Doppler de esfuerzo sobre cicloergometro en decubito(dos estadios con incrementos de 25 watioscada 3 minutos), obteniendose el gradiente pico ymedio mitral por Doppler continuo ciego. Catorceindividuos con protesis de Bjork mitral normofuncionante,de edad media 50 ± 6 anos, realizarontambien el protocolo. Resultados Se definio un perfil hemodinamicode severidad con los datos de 18 pacientes cuyaarea mitral basal era menor de 1,2 cm2 (grupo I),comparandolos con los datos de los 32 estudios conestenosis mitral de area mayor de 1,1 cm2 (grupoII) y los pacientes con protesis mitral (grupo III).El gradiente medio mitral (mmHg) en el grupo Ifue mayor que en el grupo II en situacion basal (9,3± 3,2 frente a 6,6 ± 2,7; p Conclusiones El Doppler de esfuerzo permite definirun perfil hemodinamico diferente en los pacientescon estenosis mitral severa, y puede utilzarsezarsecomo indicador aislado de severidad en la estenosismitral.