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Available online 1 October 2023
Nonadherence to ticagrelor versus clopidogrel and clinical outcomes in patients with ACS. Results from the CREA-ARIAM registry
Falta de adherencia a ticagrelor frente a clopidogrel y riesgo de eventos en pacientes con SCA. Resultados del registro CREA-ARIAM
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Manuel Almendro-Deliaa,
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trocor@gmail.com

Corresponding author.
, Gloria Padilla-Rodrígueza, Begoña Hernández-Menesesa, Emilia Blanco-Ponceb, José A. Arboleda-Sánchezc, Juan Carlos Rodríguez-Yáñezd, José Manuel Soto-Blancoe, Isabel Fernández-Garcíaf, José M. Castillo-Caballerog, Juan C. García-Rubiraa, Rafael Hidalgo-Urbanoa
a Unidad de Agudos Cardiovascular, Hospital Universitario Virgen Macarena, Seville, Spain
b Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, Lleida, Spain
c Unidad de Cuidados Intensivos, Hospital Regional Universitario de Málaga, Málaga, Spain
d Unidad de Cuidados Intensivos, Hospital de Puerto Real, Cádiz, Spain
e Unidad de Cuidados Intensivos, Hospital San Cecilio, Granada, Spain
f Unidad de Cuidados Intensivos, Hospital Costa del Sol, Málaga, Spain
g Unidad de Cuidados Intensivos, Hospital Universitario Virgen de la Victoria, Málaga, Spain
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Luis Ortega-Paz, Roxana Mehran, Dominick J. Angiolillo
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Received 28 February 2023. Accepted 16 May 2023
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Tables (5)
Table 1. Baseline characteristics of patients according to dual antiplatelet therapy cessation status
Table 2. Procedural characteristics, medication use and adherence by DAPT cessation status
Table 3. Cumulative incidence and timing of dual antiplatelet therapy cessation according to the predefined patterns of nonadherence
Table 4. Factors associated with premature discontinuation of DAPT
Table 5. Adjusted risk of major adverse cardiac events associated with different patterns of nonadherence to dual antiplatelet therapy within 1 year after acute coronary syndrome
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Additional material (1)
Abstract
Introduction and objectives

Prior studies have not determined whether the effect of dual antiplatelet therapy (DAPT) cessation on the subsequent risk of major adverse cardiac events (MACE) varies by the choice of P2Y12-inhibitor after acute coronary syndrome (ACS).

Methods

We performed a prespecified subanalysis of a multicenter, prospective registry of ACS patients discharged on ticagrelor or clopidogrel between 2015 and2019. Nonadherence to DAPT was categorized as physician-guided discontinuation and disruption due to adverse effects, nonadherence, or bleeding. The association between DAPT cessation and 1-year MACE was analyzed using multivariate time-updated Cox models with inverse probability of censoring weighted estimators.

Results

Out of 2180 patients, 174 (8.3%) prematurely discontinued DAPT (physician-guided, n=126; disruption, n=48). Nonadherent patients were older and had more comorbidities than those on DAPT. Compared with physician-guided discontinuation, disruption occurred earlier after discharge and was more frequent with ticagrelor than with clopidogrel. In time-varying analysis, DAPT cessation was associated with an increased risk of MACE (adjusted HR, 1.32, 95%CI, 1.10-1.76), largely driven by disruption (adjusted HR, 1.47, 95%CI, 1.22-1.73). There was an exponential increase in MACE risk after DAPT cessation within 90 days after ACS, especially after disruption of ticagrelor compared with clopidogrel (Pinteraction<.001). After adjustment for DAPT duration, this interaction was not statistically significant on the additive scale (relative excess risk due to interaction 0.12, 95%CI,0.99-1.24).

Conclusions

In this all-comers registry, 1 in 12 patients prematurely discontinued DAPT within 1 year after ACS. Compared with physician-recommended discontinuation, disruption resulted in a significantly higher risk of MACE. After adjustment for DAPT duration, this association was not moderated by the choice of P2Y12-inhibitor.

Clinical trial registered at ClinicalTrials.gov (Identifier: NCT02500290)

Keywords:
Acute Coronary Syndrome
Dual Anti Platelet Therapy
P2Y12 receptor inhibitor
Medication Adherence
Abbreviations:
ACS
DAPT
IPCW
MACE
P2Y12-i
Resumen
Introducción y objetivos

Una baja adherencia al tratamiento antiagregante plaquetario doble (TAPD) condiciona peor pronóstico tras un síndrome coronario agudo (SCA). Se analizó si el riesgo de eventos adversos cardiovasculares mayores (MACE) tras la interrupción prematura del TAPD varía según el inhibidor del P2Y12.

Métodos

Análisis preespecificado de pacientes con SCA tratados con ticagrelor o clopidogrel entre 2015 y 2019 dentro de un registro prospectivo multicéntrico. Se categorizó la suspensión prematura como indicada por el médico o como interrupción por hemorragia, efectos secundarios o incumplimiento del paciente. La asociación entre la suspensión del TAPD y los MACE se analizó mediante modelos multivariantes de Cox dependientes del tiempo, con estimadores robustos ponderados por probabilidad inversa de censura.

Resultados

De 2.180 pacientes, 174 (8,3%) suspendieron el TAPD precozmente (126 por indicación médica y 48 por disrupción). Los pacientes incumplidores tenían más edad y más comorbilidad que los adherentes. Frente a la suspensión indicada por el médico, la disrupción del TAPD fue más precoz y frecuente con el ticagrelor que con el clopidogrel. La suspensión del TAPD condicionó mayor riesgo de MACE (HRajustada=1,32; IC95%, 1,10-1,76), principalmente en caso de la disrupción (HRajustada=1,47; IC95%, 1,22-1,73). Este riesgo aumentó exponencialmente en los 90 días posteriores al SCA y fue más evidente con ticagrelor (pinteracción<0,001). Tras considerar la duración del TAPD, esta interacción no resultó significativa en la escala aditiva (exceso de riesgo debido a interacción=0,12; IC95%, –0,99 a 1,24).

Conclusiones

En este registro multicéntrico, 1 de cada 12 pacientes suspendió precozmente el TAPD durante el primer año tras el SCA. En comparación con la suspensión indicada por el facultativo, el la disrupción del tratamiento condicionó mayor riesgo de MACE. Tras ajustar la duración del TAPD, esta asociación no se modificó en función del tipo de inhibidor del P2Y12.

Ensayo clínico registrado en ClinicalTrials.gov (Identifier: NCT02500290).

Palabras clave:
Síndrome coronario agudo
Tratamiento antiagregante plaquetario doble
Antagonistas del receptor P2Y12
Adherencia terapéutica

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