Original article
Annual Incidence of Confirmed Stent Thrombosis and Clinical Predictors in Patients With ACS Treated With Ticagrelor or PrasugrelIncidencia anual de trombosis del stent confirmadas y factores clínicos predictores en pacientes con SCA tratados con ticagrelor o prasugrel

https://doi.org/10.1016/j.rec.2018.05.021Get rights and content

Abstract

Introduction and objectives

There is little evidence on rates of stent thrombosis (ST) in patients receiving dual antiplatelet therapy (DAPT) with ticagrelor or prasugrel. The aim of this study was to analyze the incidence and predictors of ST after an acute coronary syndrome among patients receiving DAPT with ticagrelor vs prasugrel.

Methods

We used data from the RENAMI registry (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction), analyzing a total of 4123 acute coronary syndrome patients discharged with DAPT with ticagrelor or prasugrel in 11 centers in 6 European countries. The endpoint was definite ST within the first year. A competitive risk analysis was carried out using a Fine and Gray regression model, with death being the competitive event.

Results

A total of 2604 patients received DAPT with ticagrelor and 1519 with prasugrel; ST occurred in 41 patients (1.10%), with a similar cumulative incidence between ticagrelor (1.21%) and prasugrel (0.90%). The independent predictors of ST were age (sHR, 1.03; 95%CI, 1.01-1.06), ST segment elevation (sHR, 2.24; 95%CI, 1.22-4.14), previous myocardial infarction (sHR, 2.56; 95%CI, 1.19-5.49), and serum creatinine (sHR, 1.29; 95%CI, 1.08-1.54).

Conclusions

Stent thrombosis is infrequent in patients receiving DAPT with ticagrelor or prasugrel. The variables associated with an increased risk of ST were advanced age, ST segment elevation, previous myocardial infarction, and serum creatinine.

Resumen

Introducción y objetivos

Hay muy poca evidencia sobre las tasas de trombosis del stent (TS) en pacientes que reciben tratamiento antiagregante plaquetario doble (TAPD) con ticagrelor o prasugrel. El objetivo de este estudio es analizar la incidencia y predictores de la TS tras un síndrome coronario agudo en pacientes que reciben TAPD con ticagrelor frente a prasugrel.

Métodos

Se utilizaron datos del registro RENAMI (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction), y se analizó en total a 4.123 pacientes con síndrome coronario agudo dados de alta con TAPD con ticagrelor o prasugrel en 11 centros de 6 países europeos. Se consideró como evento la TS confirmada en el primer año. Se realizó un análisis de riesgos competitivos mediante un modelo de regresión de Fine y Gray, siendo la muerte el evento competitivo.

Resultados

Recibieron TAPD con ticagrelor 2.604 pacientes y con prasugrel, 1.519; 41 pacientes (1,10%) presentaron TS, con incidencias acumuladas similares entre ticagrelor (1,21%) y prasugrel (0,90%). Los predictores independientes de la TS fueron: la edad (sHR = 1,03; IC95%, 1,01-1,06), la elevación del segmento ST (sHR = 2,24; IC95%, 1,22-4,14), el antecedente de infarto de miocardio (sHR = 2,56; IC95%, 1,19-5,49) y la creatinina sérica (sHR = 1,29; IC95%, 1,08-1,54).

Conclusiones

La TS es infrecuente en pacientes que reciben TAPD con ticagrelor y prasugrel. La edad avanzada, la elevación del segmento ST, el antecedente de infarto y la creatinina sérica son las variables que se asocian con mayor riesgo de TS.

Section snippets

INTRODUCTION

Because patients with acute coronary syndrome (ACS) have excessive platelet reactivity, antiplatelet therapy is vital to prevent new ischemic events.1 New antiplatelet agents such as prasugrel and ticagrelor have been developed in recent years. Both drugs show greater ability than clopidogrel to reduce stent thrombosis (ST).2, 3 However, the available data on the impact of prasugrel and ticagrelor on ST events are mainly derived from clinical trials, and little patient information is available

Study Population

The RENAMI (REgistry of New Antiplatelet therapy in patients with Myocardial Infarction) is a retrospective, observational, multicenter, and international registry involving the voluntary participation of 11 centers from 6 European countries (Spain, Italy, Switzerland, Greece, Serbia, and the United Kingdom). The objective of this unfunded registry is to improve our understanding of ischemic and hemorrhagic complications in patients with ACS treated with DAPT with prasugrel or ticagrelor. All

Study Population Characteristics

The clinical characteristics of the study population are shown in Table 1 according to use of ticagrelor and prasugrel. The 2 drugs clearly display different prescription patterns.

Regarding DAPT, 63.2% of patients (n = 2604) received ticagrelor and 36.8% (n = 1519) received prasugrel. The mean follow-up time was 10.9 ± 2.9 months; 82.9% of patients completed 12 months of follow-up with DAPT (94.4% > 6 months, 88.4% > 9 months).

Bare-metal stents were used in 29.2% of the patients (n = 1205) and

DISCUSSION

The most interesting findings of this study can be summarized in 4 points: a) the incidence of ST in patients with ACS on DAPT with ticagrelor or prasugrel is low, and the risk is highest in the first month; b) age, previous infarction, STEMI presentation, and renal function are the main predictors of ST in patients treated with ticagrelor or prasugrel; c) in patients who received DAPT with ticagrelor or prasugrel, no differences in ST risk were found between bare-metal stents and

CONCLUSIONS

ST was infrequent in patients on DAPT with ticagrelor or prasugrel. Four independent predictors were associated with higher ST risk: previous infarction, STEMI presentation, age, and serum creatinine. Antiplatelet agent and stent type were not associated with an increased risk of ST in the present study. Designs with higher power are required for comparative studies of the ability of prasugrel and ticagrelor to protect against ST.

CONFLICTS OF INTEREST

E. Abu-Assi is an Associate Editor of Revista Española de Cardiología.

WHAT IS KNOWN ABOUT THE TOPIC?

  • Stent thrombosis is a dreaded complication after percutaneous coronary revascularization due to its high lethality. However, its incidence is currently low with the use of bare-metal stents and new-generation DESs. In addition, a reduced ST rate has been found with both ticagrelor and prasugrel vs clopidogrel.

WHAT DOES THIS STUDY ADD?

  • Beyond the pivotal clinical trials (PLATO and TRITON-TIMI), little is known about the incidence and predictors of ST

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