RESUMEN
Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies. Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.
Asunto(s)
Síndrome Coronario Agudo , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Sirolimus , Humanos , Síndrome Coronario Agudo/cirugía , Síndrome Coronario Agudo/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Stents Liberadores de Fármacos/efectos adversos , Hemorragia/inducido químicamente , Hospitales , Polímeros , Estudios Prospectivos , Sirolimus/efectos adversos , Resultado del Tratamiento , Terapia Antiplaquetaria DobleRESUMEN
Objetivo: El sistema de atención en red por infarto con elevación del segmento ST «Codi Infart¼ se implementó en Cataluña (España) en junio de 2009. El objetivo del estudio fue evaluar el beneficio de la instauración del Codi Infart para las mujeres atendidas en nuestra institución. Método: Las mujeres referidas para angioplastia primaria se dividieron en 2 grupos de acuerdo con el Codi Infart: grupo no-Codi Infart (enero de 2003 a mayo de 2009) y grupo Codi Infart (junio de 2009 a diciembre de 2012); y se compararon lugar de procedencia, periodos, tratamientos recibidos y tasa de eventos cardiovasculares mayores definida como muerte por todas las causas, reinfarto o accidente cerebrovascular durante el ingreso, a 30 y 180 días. Resultados: De una población total de 2,426 pacientes, 501 (20.7%) eran mujeres. De ellas, 186 mujeres (2,09 casos/mes) pertenecían al grupo no-Codi Infart y 315 mujeres (10,16 casos/mes) al grupo Codi Infart. El porcentaje de mujeres atendidas aumentó desde la introducción del Codi Infart(22.2% vs. 18.5%, p = 0.028). Además, inicialmente el grupo Codi Infart presentó mayor porcentaje de mujeres atendidas fuera de nuestra institución (84.1% vs. 16.7%, p < 0.001), y menores tiempos totales de isquemia (220 [155-380] vs. 272 [196-456], p = 0.003), pero no se detectaron diferencias en eventos cardiovasculares mayores a 180 días (14.2% vs. 15.6%, p = 0.692). Conclusiones: La instauración del Codi Infart permitió aumentar de manera notable la tasa y el porcentaje de mujeres con infarto de miocardio con elevación del segmento ST tratadas mediante angioplastia primaria y reducir los tiempos totales de isquemia.
Objective: The ST-segment elevation myocardial infarction network "Codi Infart" was implemented in Catalonia (Spain) in June 2009. The objective of this study was to evaluate the impact of the implementation of the Codi Infart on women. Method: Women referred for primary percutaneous coronary intervention, were divided into two groups according to Codi Infart: Non-Codi Infart group (January 2003 to May 2009) and Codi Infart group (June 2009 to December 2012). Place of first medical contact, time intervals in diagnosis and treatment, treatments received and rate of major cardiovascular adverse events defined as all-cause death, reinfarction or stroke in-hospital, at 30 and 180 days were compared. Results: From a total population of 2,426 patients, 501 (20.7%) were women. One-hundred eighty-six women (2.09 cases/month) belonged to Non-Codi Infart group and 315 women (10.16 cases/month) to Codi Infart group. The percentage of women attended increased since the introduction of CI (22.2% vs. 18.5%, P = .028). In addition, the Codi Infart group had a higher percentage of women initially attended outside our institution (84.1% vs. 16.7%, P < .001), and lower total ischemia time (220 [155-380] vs. 272 [196-456], P = .003). However, no differences in 180-day major cardiovascular adverse events were detected (14.2% vs. 15.6%, P = .692). Conclusions: The implementation of the major cardiovascular adverse events allowed to increase the rate and the percentage of women with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention and reducing total ischemic time.