Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk A Prespecified Secondary Analysis of a Randomized Clinical Trial /

Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patie...

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Main Authors: Landi Antonio
Alasnag Mirvat
Heg Dik
Frigoli Enrico
Malik Fazila Tun Nesa
Gomez-Blazquez Ivan
Pourbaix Suzanne
Chieffo Alaide
Spaulding Christian
Sainz Fermin
Routledge Helen
Andò Giuseppe
Testa Luca
Sciahbasi Alessandro
Contractor Hussain
Jepson Nigel
Mieres Juan
Imran Syed Saqib
Noor Husam
Smits Pieter C
Valgimigli Marco
Kollaborációs szervezet: MASTER DAPT Investigators
Merkely Béla
Ungi Imre
Format: Article
Published: 2024
Series:JAMA CARDIOLOGY 9 No. 1
Subjects:
doi:10.1001/jamacardio.2023.4316

mtmt:34573779
Online Access:http://publicatio.bibl.u-szeged.hu/29531
Description
Summary:Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR.This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022.Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups.One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB).Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI.These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events.ClinicalTrials.gov Identifier: NCT03023020.
Physical Description:35-44
ISSN:2380-6583