The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after PCI in patients with atrial fibrillation (a RE-DUAL PCI subgroup analysis and comparison to other dual antithrombotic therapy trials).
Anticoagulants
/ adverse effects
Atrial Fibrillation
/ complications
Coronary Artery Disease
/ drug therapy
Dabigatran
/ adverse effects
Drug Therapy, Combination
Female
Fibrinolytic Agents
/ adverse effects
Humans
Male
Percutaneous Coronary Intervention
/ adverse effects
Platelet Aggregation Inhibitors
/ adverse effects
Warfarin
/ adverse effects
dual antithrombotic therapy
sex differences
triple therapy
Journal
Clinical cardiology
ISSN: 1932-8737
Titre abrégé: Clin Cardiol
Pays: United States
ID NLM: 7903272
Informations de publication
Date de publication:
Jul 2021
Jul 2021
Historique:
revised:
04
05
2021
received:
20
02
2021
accepted:
12
05
2021
pubmed:
28
5
2021
medline:
16
10
2021
entrez:
27
5
2021
Statut:
ppublish
Résumé
The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively). Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.
Sections du résumé
BACKGROUND
BACKGROUND
The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y
HYPOTHESIS
OBJECTIVE
The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y
METHODS
METHODS
The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint.
RESULTS
RESULTS
A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively).
CONCLUSIONS
CONCLUSIONS
Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.
Identifiants
pubmed: 34042199
doi: 10.1002/clc.23649
pmc: PMC8259156
doi:
Substances chimiques
Anticoagulants
0
Fibrinolytic Agents
0
Platelet Aggregation Inhibitors
0
Warfarin
5Q7ZVV76EI
Dabigatran
I0VM4M70GC
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1002-1010Subventions
Organisme : Boehringer Ingelheim
Informations de copyright
© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.
Références
BMJ. 2012 May 30;344:e3522
pubmed: 22653980
Am Heart J. 2004 Dec;148(6):998-1002
pubmed: 15632884
N Engl J Med. 2016 Dec 22;375(25):2423-2434
pubmed: 27959713
Circulation. 2011 Jun 14;123(23):2681-9
pubmed: 21606391
Lancet. 2019 Oct 12;394(10206):1335-1343
pubmed: 31492505
Clin Cardiol. 2016 Oct;39(10):555-564
pubmed: 27565018
Circulation. 2013 Feb 5;127(5):641-9
pubmed: 23381962
Int J Cardiol. 2018 Oct 15;269:182-191
pubmed: 30025657
J Am Coll Cardiol. 2007 Mar 27;49(12):1362-8
pubmed: 17394970
J Am Coll Cardiol. 2009 Nov 17;54(21):1935-45
pubmed: 19909874
Circ Cardiovasc Qual Outcomes. 2015 Nov;8(6):593-9
pubmed: 26508666
Circulation. 2018 Feb 20;137(8):832-840
pubmed: 29459469
J Am Coll Cardiol. 2005 Mar 15;45(6):832-7
pubmed: 15766815
Heart. 2020 Apr;106(7):534-540
pubmed: 31558571
J Am Coll Cardiol. 2018 Jul 17;72(3):271-282
pubmed: 30012320
Clin Cardiol. 2019 Oct;42(10):1003-1009
pubmed: 31490011
Curr Cardiol Rep. 2010 Jan;12(1):6-13
pubmed: 20425178
Lancet. 2021 Jun 19;397(10292):2385-2438
pubmed: 34010613
J Am Coll Cardiol. 2019 Dec 17;74(24):3013-3022
pubmed: 31865968
Clin Cardiol. 2021 Jul;44(7):1002-1010
pubmed: 34042199
Stroke. 2017 Mar;48(3):778-780
pubmed: 28151397
J Am Heart Assoc. 2017 Jul 19;6(7):
pubmed: 28724655
Lancet. 2013 Mar 30;381(9872):1107-15
pubmed: 23415013
N Engl J Med. 2017 Oct 19;377(16):1513-1524
pubmed: 28844193
Circulation. 2003 Jan 28;107(3):375-7
pubmed: 12551856
Eur Heart J. 2020 Apr 1;41(13):1328-1336
pubmed: 31876924
N Engl J Med. 2019 Apr 18;380(16):1509-1524
pubmed: 30883055
JAMA Cardiol. 2020 Jun 1;5(6):714-722
pubmed: 32211813