Browsing by Author "Gdovinova, Z"
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- Dabigatran Initiation in Patients with Non-Valvular AF and First Acute Ischaemic Stroke: a Retrospective Observational Study from the SITS RegistryPublication . Escudero-Martinez, I; Mazya, M; Teutsch, C; Lesko, N; Gdovinova, Z; Barbarini, L; Fryze, W; Karlinski, M; Kobayashi, A; Krastev, G; Paiva Nunes, A; Pasztoova, K; Peeters, A; Sobolewski, P; Vilionskis, A; Toni, D; Ahmed, NBackground and objective: The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF). Design: Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018. Participants: European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke. Setting: A multinational, observational monitoring register. Intervention: Dabigatran initiation within 3 months after the ischaemic stroke. Primary and secondary outcomes: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event. Methods: We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation. Results: In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data). Conclusions: Our findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both.
- Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients with Atrial FibrillatioN (ELAN): Protocol for an International, Multicentre, Randomised-Controlled, Two-Arm, Open, Assessor-Blinded TrialPublication . Fischer, U; Trelle, S; Branca, M; Salanti, G; Paciaroni, M; Ferrari, C; Abend, S; Beyeler, S; Strbian, D; Thomalla, G; Ntaios, G; Bonati, L; Michel, P; Nedeltchev, K; Gattringer, T; Sandset, E; Kelly, P; Lemmens, R; Koga, M; Sylaja, P; Aguiar de Sousa, D; Bornstein, N; Gdovinova, Z; Seiffge, D; Gralla, J; Horvath, T; Dawson, JRationale: Direct oral anticoagulants (DOAC) are highly effective in preventing ischaemic strokes in people with atrial fibrillation (AF). However, it is unclear how soon they should be started after acute ischaemic stroke (AIS). Early initiation may reduce early risk of recurrence but might increase the risk of haemorrhagic complications. Aim: To estimate the safety and efficacy of early initiation of DOACs compared to late guideline-based initiation in people with AIS related to AF. Methods and design: An international, multicentre, randomised (1:1) controlled, two-arm, open, assessor-blinded trial is being conducted. Early treatment is defined as DOAC initiation within 48 h of a minor or moderate stroke, or at day 6-7 following major stroke. Late treatment is defined as DOAC initiation after day 3-4 following minor stroke, after day 6-7 following moderate stroke and after day 12-14 following major stroke. Severity of stroke is defined according to imaging assessment of infarct size. Sample size: ELAN will randomise 2000 participants 1:1 to early versus late initiation of DOACs. This assumes a risk difference of 0.5% favouring the early arm, allowing an upper limit of the 95% confidence interval up to 1.5% based on the Miettinen & Nurminen formula. Outcomes: The primary outcome is a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death at 30 ± 3 days after randomisation. Secondary outcomes include the individual components of the primary outcome at 30 ± 3 and 90 ± 7 days and functional status at 90 ± 7 days. Discussion: ELAN will estimate whether there is a clinically important difference in safety and efficacy outcomes following early anticoagulation with a DOAC compared to late guideline-based treatment in neuroimaging-selected people with an AIS due to AF.