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Available online 25 December 2021
Body mass index and efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndromes
Índice de masa corporal y eficacia y seguridad del ticagrelor frente al prasugrel en pacientes con síndrome coronario agudo
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Shqipdona Lahua,b, Michael Behnesc, Gjin Ndrepepaa, Franz-Josef Neumannd, Dirk Sibbingb,e, Isabell Bernlochnerb,f, Maurizio Menichellig, Katharina Mayera, Gert Richardth, Senta Gewalta, Dominick J. Angiolilloi, John Joseph Coughlana, Alp Aytekina,b, Bernhard Witzenbichlerj, Willibald Hochholzerd, Salvatore Cassesea, Sebastian Kufnera, Erion Xhepaa, Hendrik B. Sagera,b, Michael Jonera,b, Massimiliano Fusaroa, Karl-Ludwig Laugwitzb,f, Heribert Schunkerta,b, Stefanie Schüpkea,b, Adnan Kastratia,b,
Corresponding author
kastrati@dhm.mhn.de

Corresponding author at: Corresponding author: Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany..
, Ibrahim Akinc
a Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
b German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany
c First Department of Medicine, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
d Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany
e Cardiology, Klinik der Universität München, Ludwig – Maximilians – University, Munich, Germany
f Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum Rechts der Isar, Munich, Germany
g Cardiology, Ospedale Fabrizio Spaziani, Frosinone, Italy
h Department of Cardiology and Angiology, Heart Center Bad Segeberg, Bad Segeberg, Germany
i Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA
j Cardiology & Pneumology, Helios Amper-Klinikum Dachau, Dachau, Germany
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Abstract
Introduction and objectives

The efficacy and safety of ticagrelor vs prasugrel in patients with acute coronary syndromes (ACS) according to body mass index (BMI) remain unstudied. We assessed the efficacy and safety of ticagrelor vs prasugrel in patients with ACS according to BMI.

Methods

Patients (n=3987) were grouped into 3 categories: normal weight (BMI <25kg/m2; n=1084), overweight (BMI ≥ 25 to <30kg/m2; n=1890), and obesity (BMI ≥ 30kg/m2; n=1013). The primary efficacy endpoint was the 1 year incidence of all-cause death, myocardial infarction, or stroke. The secondary safety endpoint was the 1 year incidence of Bleeding Academic Research Consortium type 3 to 5 bleeding.

Results

The primary endpoint occurred in 63 patients assigned to ticagrelor and 39 patients assigned to prasugrel in the normal weight group (11.7% vs 7.5%; HR, 1.62; 95%CI, 1.09-2.42; P=.018), 78 patients assigned to ticagrelor and 58 patients assigned to prasugrel in the overweight group (8.3% vs 6.2%; HR, 1.36; 95%CI, 0.97-1.91; P=.076), and 43 patients assigned to ticagrelor and 37 patients assigned to prasugrel in the obesity group (8.6% vs 7.3%; HR, 1.18; 95%CI, 0.76-1.84; P=.451). The 1-year incidence of bleeding events did not differ between ticagrelor and prasugrel in patients with normal weight (6.5% vs 6.6%; P=.990), overweight (5.6% vs 5.0%; P=.566) or obesity (4.4% vs 2.8%; P=.219). There was no significant treatment arm-by-BMI interaction regarding the primary endpoint (Pint=.578) or secondary endpoint (Pint=.596).

Conclusions

In patients with ACS, BMI did not significantly impact the treatment effect of ticagrelor vs prasugrel in terms of efficacy or safety.

Clinical Trial Registration: NCT01944800.

Keywords:
Acute coronary syndrome
Body mass index
Percutaneous coronary intervention
Prasugrel
Ticagrelor.
Abbreviations:
ACS
BARC
BMI
ISAR-REACT
PCI
Resumen
Introducción y objetivos

Siguen sin estudio la eficacia y la seguridad del ticagrelor frente al prasugrel en pacientes con síndrome coronario agudo (SCA) según el índice de masa corporal (IMC). Se evaluaron la eficacia y la seguridad del ticagrelor frente a prasugrel en pacientes con SCA según el IMC.

Métodos

Se agrupó a los pacientes (n=3.987) en 3 categorías: con peso normal (IMC <25; n=1.084), sobrepeso (IMC ≥ 25-<30; n=1.890) y obesidad (IMC ≥ 30; n=1.013). El objetivo primario de eficacia fue la incidencia de muerte por cualquier causa, infarto de miocardio o accidente cerebrovascular a 1 año. El objetivo secundario de seguridad fue la incidencia de hemorragias de tipo 3-5 de la Bleeding Academic Research Consortium a 1 año.

Resultados

El objetivo primario se produjo en 63 pacientes asignados a ticagrelor y 39 asignados a prasugrel en el grupo de peso normal (el 11,7 frente al 7,5%; HR=1,62; IC95%, 1,09-2,42; p=0,018), 78 pacientes asignados a ticagrelor y 58 asignados a prasugrel en el grupo de sobrepeso (el 8,3 frente al 6,2%; HR=1,36; IC95%, 0,97-1,91; p=0,076) y 43 pacientes asignados a ticagrelor y 37 asignados a prasugrel en el grupo de obesidad (el 8,6 frente al 7,3%; HR=1,18; IC95%, 0,76-1,84; p=0,451). La incidencia de eventos hemorrágicos a 1 año en los pacientes con peso normal (el 6,5 frente al 6,6%; p=0,990), sobrepeso (el 5,6 frente al 5,0%; p=0,566) u obesidad (el 4,4 frente al 2,8%; p=0,219) no difirió entre el ticagrelor y el prasugrel. No hubo una interacción significativa entre el brazo de tratamiento y el IMC en relación con el objetivo primario (pinteracción=0,578) o el secundario (pinteracción=0,596).

Conclusiones

En pacientes con SCA, el IMC no influyó significativamente en el efecto del tratamiento con ticagrelor en términos de eficacia o seguridad frente al prasugrel.

Palabras clave:
Síndrome coronario agudo
Índice de masa corporal
Intervención coronaria percutánea
Prasugrel
Ticagrelor

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