Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.


Journal

Journal of thrombosis and thrombolysis
ISSN: 1573-742X
Titre abrégé: J Thromb Thrombolysis
Pays: Netherlands
ID NLM: 9502018

Informations de publication

Date de publication:
Oct 2021
Historique:
accepted: 26 03 2021
pubmed: 14 4 2021
medline: 1 3 2022
entrez: 13 4 2021
Statut: ppublish

Résumé

Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study. REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.

Sections du résumé

BACKGROUND BACKGROUND
Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study.
METHODS METHODS
REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months.
RESULTS RESULTS
From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender.
CONCLUSIONS CONCLUSIONS
The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.

Identifiants

pubmed: 33847862
doi: 10.1007/s11239-021-02439-x
pii: 10.1007/s11239-021-02439-x
doi:

Substances chimiques

Platelet Aggregation Inhibitors 0

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

797-807

Informations de copyright

© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

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Auteurs

M Verdoia (M)

AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.

H Suryapranata (H)

Radboud University Medical Center, Nijmegen, The Netherlands.

S Damen (S)

Radboud University Medical Center, Nijmegen, The Netherlands.

C Camaro (C)

Radboud University Medical Center, Nijmegen, The Netherlands.

E Benit (E)

Jessa Ziekenhuis, Hasselt, Belgium.

L Barbieri (L)

AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.

S Rasoul (S)

Atrium Medical Center, Heerlen, The Netherlands.

H B Liew (HB)

Queen Elizabeth II, Sabah, Malaysia.

J Polad (J)

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.

W A W Ahmad (WAW)

University Malaya, Kuala Lumpur, Malaysia.

R Zambahari (R)

National Heart Institute, Kuala Lumpur, Malaysia.

J Lalmand (J)

Centre Hospitalier Universitaire, Charleroi, Belgium.

R J van der Schaaf (RJ)

Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.

T H Koh (TH)

National Heart Center, Singapore, Singapore.

P Timmermans (P)

Jessa Ziekenhuis, Hasselt, Belgium.

D Dilling-Boer (D)

Jessa Ziekenhuis, Hasselt, Belgium.

L F Veenstra (LF)

Atrium Medical Center, Heerlen, The Netherlands.

A W J Van't Hof (AWJ)

Isala Hospital, Zwolle, The Netherlands.

S W L Lee (SWL)

Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.

V Roolvink (V)

Isala Hospital, Zwolle, The Netherlands.

E Ligtenberg (E)

OrbusNeich Medical BV, Hoevelaken, The Netherlands.

S Postma (S)

Diagram BV, Zwolle, The Netherlands.

E J J Kolkman (EJJ)

Radboud University Medical Center, Nijmegen, The Netherlands.
Diagram BV, Zwolle, The Netherlands.

M A Brouwer (MA)

Radboud University Medical Center, Nijmegen, The Netherlands.

E Kedhi (E)

Erasmus Hospital, Bruxelles, Belgium.

G De Luca (G)

AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy. giuseppe.deluca@med.uniupo.it.

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