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Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

ABSTRACT: BACKGROUND 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. TRIAL REGISTRATION NUMBER:SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

SUBMITTER: Escudero-Martinez I

PROVIDER: S-EPMC7247395 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

Escudero-Martinez Irene I Mazya Michael M Teutsch Christine C Lesko Norbert N Gdovinova Zuzana Z Barbarini Leonardo L Fryze Waldemar W Karlinski Michal M Kobayashi Adam A Krastev Georgi G Paiva Nunes Ana A Pasztoova Katarina K Peeters André A Sobolewski Piotr P Vilionskis Aleksandras A Toni Danilo D Ahmed Niaz N

BMJ open 20200519 5

<h4>Background and objective</h4>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).<h4>Design</h4>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.<h4>Participants</h4>European NVAF ...[more]

PMID: 32434935

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Project description:ObjectivesThis study aimed to describe the frequency, determinants and outcomes for assessment of patients who had an acute ischaemic stroke (AIS) for rehabilitation during hospitalisation in China.DesignA registry-based retrospective observational study.Study design and settingsData regarding assessment or rehabilitation were extracted from the Chinese Stroke Center Alliance database from 1 August 2015 to 31 July 2019. Univariate and multivariate analyses were conducted to identify patient and hospital characteristics associated with rehabilitation assessment during acute hospitalisation as well as discharge outcomes.Study cohortWe included 837 897 patients who had a stroke in this study with patient characteristics, admission location, medical history, hospital characteristics and hospital designation.Primary and secondary outcome measuresRehabilitation assessment and discharge outcomes.ResultsAmong 837 897 patients who had a stroke admitted to 1473 hospitals, 615 991 (73.5%) underwent rehabilitation assessment. There were significant variations in the rates of rehabilitation assessment across hospitals (IQR 61.3% vs 92.9%). According to multivariate analysis, guideline recommended care delivery was associated with a higher rehabilitation assessment rate, whereas high/low body mass index, ambulation (OR 0.88; 95% CI 0.87 to 0.90), history of stroke (OR 0.94; 95% CI 0.93 to 0.95), coronary heart disease (OR 0.84; 95% CI 0.82 to 0.85) and atrial fibrillation (OR 0.91; 95% CI 0.89 to 0.94) were associated with a lower rate. Additionally, rehabilitation assessment during hospitalisation was significantly associated with lower in-hospital mortality (OR 0.38; 95% CI 0.35 to 0.41) and a higher probability of discharge to a rehabilitation centre (OR 2.66; 95% CI 2.5 to 2.82).ConclusionsNearly one-quarter of patients who had an AIS do not undergo documented rehabilitation assessment and compliance across hospitals varies. Thus, it is necessary to improve adherence to rehabilitation assessment to improve the quality of medical care for patients who had an AIS.

Project description:ObjectiveTo determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.DesignOngoing, prospective, observational cohort study.Setting16 centres that perform endovascular treatment in the Netherlands.Participants1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.Main outcome measuresThe primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months' follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.ResultsA statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.ConclusionIn routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.

Project description:Background and purposeThe influence of stroke etiology on outcomes after endovascular thrombectomy (EVT) is not well understood. We aimed to investigate whether stroke etiology subgrouped as large artery atherosclerosis (LAA) and cardiac embolism (CE) influences outcomes in large artery occlusion (LAO) treated by EVT.MethodsWe included EVT treated LAO stroke patients registered in the Safe Implementation of Treatment in Stroke (SITS) thrombectomy register between January 1, 2014 and September 3, 2019. Primary outcome was successful reperfusion (modified Treatment in Cerebral Infarction 2b-3). Secondary outcomes were symptomatic intracranial hemorrhage (SICH), 3-month functional independence (modified Ranking Scale 0-2) and death. Multivariable logistic regression models were used for comparisons. In addition, a meta-analysis of aggregate data from the current literature was conducted (PROSPERO, ID 167447).ResultsOf 7,543 patients, 1,903 (25.2%) had LAA, 3,214 (42.6%) CE, and 2,426 (32.2%) unknown, other, or multiple etiologies. LAA patients were younger (66 vs. 74, P<0.001) and had lower National Institutes of Health Stroke Scale score at baseline (15 vs. 16, P<0.001) than CE patients. Multivariable analyses showed that LAA patients had lower odds of successful reperfusion (odds ratio [OR], 0.70; 95% confidence interval [CI], 0.57 to 0.86) and functional independence (OR, 0.74; 95% CI, 0.63 to 0.85), higher risk of death (OR, 1.44; 95% CI, 1.21 to 1.71), but no difference in SICH (OR, 1.09; 95% CI, 0.71 to 1.66) compared to CE patients. The systematic review found 25 studies matching the criteria. The meta-analysis did not find any difference between etiologies.ConclusionsFrom the SITS thrombectomy register, we observed a lower chance of reperfusion and worse outcomes after thrombectomy in patients with LAA compared to CE etiology, despite more favorable baseline characteristics. In contrast, the meta-analysis did not find any difference between etiologies with aggregate data.

Project description:OBJECTIVE:To determine the effect of age and gender on persistence and adherence in patients taking dabigatran for atrial fibrillation. DESIGN:A retrospective observational study over 4 years using refill prescription data from the National Pharmaceutical Database. SETTING:All patients in New Zealand who received dabigatran from July 2011 to September 2015. POPULATION:43?339 people filled at least one prescription of dabigatran. MAIN OUTCOME MEASURES:The proportion of patients with good adherence (treatment available at least 80% of the time), and the proportion at risk of thrombosis (a break in treatment of more than 2?days) measured 6-monthly for 3 years. Medication persistence recorded over 3?years. RESULTS:Persistence was highest in older patients and showed a significant correlation with age (p<0.001); 24% over 70?years had discontinued treatment by 6 months compared with 50% under 50?years. Adherence was highest in the elderly (p<0.001) with 90% of patients over 80?years with good adherence at 12 months compared with 70% in patients aged 50-60?years and less than 60% in those under 50?years. The time at risk of thrombosis showed a similar pattern with 25% below 60?years with inadequate anticoagulation more than 20% of the time. Adherence dropped during the first 18 months of treatment with the most marked fall in those under 50?years. Adherence shows that breaks in treatment are common with 30% of men under 60?years with a break in treatment of at least 28 days during the first 12 months. CONCLUSION:Adherence and persistence correlate with the patient's age. Those over 70?years have high adherence consistent over time whereas younger patients have significantly worse adherence which declines over the first 18 months, with the lowest rate in those under 50?years. Adherence in our study is lower than reported in clinical trials, therefore the benefit of dabigatran in stroke prevention may not be realised in clinical practice especially in younger patients.

Dataset Information

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

Publications

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

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