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TOPLINE: 

Direct oral anticoagulants (DOACs) reduced the risk for ischaemic stroke by 95% in intracerebral haemorrhage (ICH) survivors with atrial fibrillation but increased the risk for recurrent ICH nearly 11-fold, a new trial showed.

METHODOLOGY:

• This multicentre, open-label, randomised, phase 3 trial (PRESTIGE-AF) enrolled 319 participants across 75 hospitals in six countries in Europe between 2019 and 2023.
• Patients (median age, 79 years; 35% women) with spontaneous ICH, atrial fibrillation, an indication for anticoagulation, and a modified Rankin Scale score ≤ 4 were randomly assigned to receive either DOAC (n = 158) or no anticoagulation (n = 161).
• Primary endpoints were first incident ischaemic stroke and first recurrent ICH, with a median follow-up of 1.4 years.
• Secondary endpoints included all stroke, systemic embolism, major adverse cardiac events, cardiovascular mortality, all-cause mortality, and net clinical benefit. Secondary safety endpoints were intracranial haemorrhage and major bleeding events.

TAKEAWAY:

• Compared with no anticoagulation, DOAC treatment significantly reduced the occurrence of first ischaemic stroke (hazard ratio [HR], 0.05; P < .0001).
• The risk for recurrent ICH was substantially higher with DOACs (HR, 10.89; 90% CI, 1.95-60.72) than with no anticoagulation.
• Serious adverse events occurred in 44% of patients in the DOAC group vs 55% of patients in the no anticoagulation group, with mortality rates of 10% vs 13%, respectively.
• Although mortality was lower in the DOAC group, intracranial bleeding (6.25 vs 0.82 per 100 patient-years) and major bleeding (8.75 vs 2.05 per 100 patient-years) occurred more frequently in the DOAC group than in the no anticoagulation group.

IN PRACTICE:

"Treatment with DOACs substantially decreased the risk of ischaemic stroke but also increased the risk of recurrent intracerebral haemorrhage and other types of major bleeding. To further improve stroke prevention in these vulnerable patients, additional evidence is needed from ongoing trials and the COCROACH meta-analysis of randomised data, as well as the evaluation of safer medical or mechanical alternatives for selected patients," the authors wrote.

SOURCE:

The study was led by Roland Veltkamp, MD, Imperial College London, London, United Kingdom. It was published online on February 26 in The Lancet.

LIMITATIONS:

The study was limited by the low number of primary outcome events and the short follow-up period, resulting in broad CIs. The open-label design may have influenced results. The generalisability of the study findings was restricted due to under-representation of women and exclusion of patients with severe disability. Additionally, the small sample size prevented the analysis of differential effects among various DOAC types. The study was not sufficiently powered to assess secondary endpoints. Furthermore, variability in ICH classification and the small number of events limited subgroup analyses. 

DISCLOSURES:

This study was sponsored by Imperial College London and was funded by the European Commission as part of the Horizon 2020 research and innovation programme. Several authors reported receiving research funding, consulting fees, or honoraria from or serving on advisory boards of various pharmaceutical companies and institutions. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.