Xience Receives CE Mark for Short and Ultrashort DAPT Schemes

Dual antiplatelet therapy (DAPT) one month after angioplasty with Xience stent was approved in Europe for patients with high risk of bleeding.

Xience recibe el CE Mark para esquemas cortos y ultracortos de DAPT

 

The CE Mark approval comes after studies Xience 28 and Xience 90 are published.

Immediately after authorization, Abbot was fast to announce what they consider to be the shortest approved scheme with the most used stent worldwide.

The XIENCE Short DAPT program tested the safety of 1-month and 3-month dual antiplatelet therapy in 3600 patients.

XIENCE 90 included over 2000 patients who received dual antiplatelet therapy for 3 months, while XIENCE 28 included about 1500 patients and a course of only 1 month. Both were open, prospective, non-randomized studies that compared patients with historical control cohorts.

All patients included presented a high risk of bleeding based on, at least, one of the following characteristics: >75 years of age, chronic anticoagulant agent use, previous major bleeding within a year since index angioplasty, history of stroke, renal failure, coagulation alterations, or anemia.


Read also: Is Loading NSTEMI with DAPT Convenient?


Se excluyeron los pacientes con supradesnivel del ST, fracción de eyección <30% o pacientes que tenían planeada una cirugía en los próximos meses.

Luego de la angioplastia índice con el stent XIENCE los pacientes recibieron aspirina más un inhibidor del receptor P2Y12. Luego de 1 o 3 meses (dependiendo del estudio) continuaron sólo con aspirina.

Tanto el estudio XIENCE 90 como el XIENCE 28 demostraron la no inferioridad con respecto al punto final primario de muerte o infarto vs controles del estudio XIENCE V all-comers.

El punto final secundario de sangrado BARC 2 a 5 resultó de 5.1% con 3 meses de doble antiagregación vs 7% en los controles (p=0.0063 para superioridad). El grupo que recibió un mes mostró una tasa de sangrado del 4.9% vs 5.9% de los controles (p=0.19 para superioridad).


Read also: TCT 2020 | Xience in Favor of Short Dual Antiaggregation Therapy with High Bleeding Risk.


Los sangrados mayores (BARC 3 a 5) resultaron mucho menos frecuentes en ambos estudios. Para XIENCE 90 la tasa de sangrado mayor fue del 2.2% vs 6.3% de los controles (p<0.0001) y para XIENCE 28 de 2.2% vs 4.5% de los controles (p=0.0015).

Esta nueva aprobación para el uso no solo es buena noticia para el stent Xience sino también para la aspirina. Contra la moda de un esquema corto seguido por monoterapia de un inhibidor P2Y12, los estudios Xience 28 y 90 continuaron la monoterapia con aspirina. 

Parece claro el beneficio y, sobre todo, la seguridad de un esquema corto. También es probable que exista un “efecto de clase” para todos los DES actuales, aunque todavía no es evidente con qué droga debe continuar la monoterapia.

Original Title: Abbott’s Xience stent receives European approval for one-month dual anti-platelet therapy (DAPT) for high bleeding risk patients.

Reference: Published and accessed on: April 6, 2021.


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