Antithrombotic Treatment for Stroke Prevention in Cervical Artery Dissection: The STOP-CAD Study

Stroke, Ahead of Print. Background:Small, randomized trials of cervical artery dissection (CAD) patients showed conflicting results regarding optimal stroke prevention strategies. We aimed to compare outcomes in patients with CAD treated with antiplatelets versus anticoagulation.Methods:This is a multi-center observational retrospective international study (16 countries, 63 sites) that included CAD patients without major trauma. The exposure was antithrombotic treatment type (anticoagulation vs. antiplatelets) and outcomes were subsequent ischemic stroke and major hemorrhage (intracranial or extracranial hemorrhage). We used adjusted Cox regression with Inverse Probability of Treatment Weighting (IPTW) to determine associations between anticoagulation and study outcomes within 30 and 180 days. The main analysis used an “as treated” cross-over approach and only included outcomes occurring on the above treatments.Results:The study included 3,636 patients [402 (11.1%) received exclusively anticoagulation and 2,453 (67.5%) received exclusively antiplatelets]. By day 180, there were 162 new ischemic strokes (4.4%) and 28 major hemorrhages (0.8%); 87.0% of ischemic strokes occurred by day 30. In adjusted Cox regression with IPTW, compared to antiplatelet therapy, anticoagulation was associated with a non-significantly lower risk of subsequent ischemic stroke by day 30 (adjusted HR 0.71 95% CI 0.45-1.12, p=0.145) and by day 180 (adjusted HR 0.80 95% CI 0.28-2.24, p=0.670). Anticoagulation therapy was not associated with a higher risk of major hemorrhage by day 30 (adjusted HR 1.39 95% CI 0.35-5.45, p=0.637) but was by day 180 (adjusted HR 5.56 95% CI 1.53-20.13, p=0.009). In interaction analyses, patients with occlusive dissection had significantly lower ischemic stroke risk with anticoagulation (adjusted HR 0.40 95% CI 0.18-0.88) (Pinteraction=0.009).Conclusions:Our study does not rule out a benefit of anticoagulation in reducing ischemic stroke risk, particularly in patients with occlusive dissection. If anticoagulation is chosen, it seems reasonable to switch to antiplatelet therapy before 180 days to lower the risk of major bleeding. Large prospective studies are needed to validate our findings.

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Febbraio 2024

Outpatient paracentesis for the management of ovarian hyperstimulation syndrome: study protocol for the STOP-OHSS randomised controlled trial

Introduction
Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.
Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women.

Methods and analysis
This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022.

Ethics and dissemination
London—Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups.

Trial registration number
ISRCTN71978064.

Leggi
Gennaio 2024