Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source

Diener, Hans-Christoph; Sacco, Ralph L.; Easton, J. Donald; Granger, Christopher B.; Bernstein, Richard A.; Uchiyama, Shinichiro; Kreuzer, Jörg; Cronin, Lisa; Cotton, Daniel; Grauer, Claudia; Brueckmann, Martina; Chernyatina, Marina Alexandrovna; Donnan, Geoffrey A; Ferro, José M.; Grond, Martin; Kallmünzer, Bernd; Krupiński, Jerzy; Lee, Byung Chul; Lemmens, Robin; Masjuán, Jaime; Одинак, М. М.; Saver, Jeffrey L.; Schellinger, Peter D.; Toni, Danilo; Toyoda, Kazunori

doi:10.1056/nejmoa1813959

Cited by 603 publications

(488 citation statements)

References 17 publications

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“…We identified 21 ESUS (3.7% of the IS cohort) and 211 CE patients (37.1% of the IS cohort). Baseline characteristics and outcomes between ESUS patients and CE patients are presented in Table 1 [5][6][7][8][9][10][11][12][13][14][15][16][17]; P < .001), had higher prevalence of smoking (57.1 vs 15.6%, P < .001), had less often positive family history for cardiovascular disease (38.1 vs 73%, P < .001). Male sex was less common in ESUS (28.6 vs 59.2%; P = .007).…”

Section: Resultsmentioning

confidence: 99%

Clinical and Neuroimaging Characteristics in Embolic Stroke of Undetermined versus Cardioembolic Origin: A Population‐Based Study

Tsivgoulis

Kargiotis

Katsanos

et al. 2019

Journal of Neuroimaging

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BACKGROUND AND PURPOSE: Evidence suggests that cardioembolism represents the underlying mechanism in the minority of embolic strokes of undetermined source (ESUS). In this population-based study, we sought to compare the clinical and imaging characteristics as well as outcomes in patients with ESUS and cardioembolic stroke (CE). METHODS: We included consecutive patients with first-ever ischemic stroke (IS) from the previously published populationbased Evros-Stroke-Registry identified as ESUS or CE according to standardized criteria. Baseline characteristics, admission NIHSS scores, cerebral edema, hemorrhagic transformation, stroke recurrence, functional outcomes (determined by modified Rankin Scale [mRS] scores), and mortality rates were recorded during the 1-year follow-up period. RESULTS: We identified 21 ESUS (3.7% of IS) and 211 CE (37.1% of IS) cases. Patients with ESUS were younger (median age: 68 years [interquartile range [IQR]: 61-75] vs 80 years [IQR: 75-84]; P < .001), had lower median admission NIHSS scores (4 points [IQR: 2-8] vs 10 points [IQR: 5-17]; P < .001), and lower prevalence of cerebral edema on neuroimaging studies (0 vs. 33.3%, P = .002). Functional outcomes were more favorable in ESUS at 28 (median mRS score: 2 [IQR: 1-3] vs 4 [IQR: 4-5]; P < .001), 90 (median mRS score: 1 [IQR: 0-2] vs 4 [IQR: 3-5]; P < .001), and 365 days (median mRS score: 1 [IQR: 0-2] vs 4 [IQR: 2-4]; P < 0.001). At 1-year, the mortality rate was lower in ESUS (0% [95% confidence interval [CI]: 0-13.5%] vs 34.6% [95% CI: 28.2-41.0%]; P < .001); the 1-year recurrent rate was also lower numerically (0% [95% CI: 0-13.5%] vs 9.5% [95% CI: 5.5-13.4%]; P = .140) but this difference failed to reach statistical significance due to the small study population. CONCLUSIONS: The clinical and neuroimaging profiles as well as clinical outcomes vary substantially between ESUS and CE indicating different underlying mechanisms.

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Section: Resultsmentioning

confidence: 99%

Clinical and Neuroimaging Characteristics in Embolic Stroke of Undetermined versus Cardioembolic Origin: A Population‐Based Study

Tsivgoulis

Kargiotis

Katsanos

et al. 2019

Journal of Neuroimaging

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“…In particular, large randomized trials comparing apixiban (AVERROES) and doseadjusted dabigatran (RE-SPECT ESUS) to aspirin monotherapy found identical rates of ICH. 10,46 The appropriate timing and safety of re-initiation of OAC therapy after ICH is unknown. Patients with a history of ICH were excluded from randomized clinical trials of OAC for AF.…”

Section: Intracranial Hemorrhagementioning

confidence: 99%

Left atrial appendage closure: A therapy uniquely suited for specific populations of patients with atrial fibrillation

Black‐Maier

Piccini

Granger

2019

Cardiovasc electrophysiol

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Atrial fibrillation (AF) is the most common clinically relevant arrhythmia and confers a fivefold increased risk for stroke. Cardioembolic stroke secondary to AF is a devastating event, but is largely preventable with appropriate oral anticoagulation (OAC). The PROTECT and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage closure (LAAC) device in combination with short‐term warfarin therapy is noninferior to long‐term warfarin with respect to a composite endpoint of stroke, cardiovascular death, and systemic embolism. Importantly, the WATCHMAN confers a significant reduction in life‐threatening bleeding compared to OAC. Although direct‐acting oral anticoagulant (DOAC) are superior to warfarin in eligible patients, several important AF populations exist in whom left atrial appendage (LAA) closure may be preferable to DOAC. Populations warranting strong consideration of LAAC include patients with contraindications to DOAC, end‐stage renal disease, prior intracranial hemorrhage, recurrent gastrointestinal bleeding, and patients undergoing transcatheter aortic valve replacement or left atrial electrical isolation. Device‐related thrombosis is an important complication of LAAC, and DOAC may be preferential to warfarin for prevention and treatment of this complication remains unexplored. Prospective clinical trials comparing DOAC to LAAC in these unique populations are either ongoing or needed.

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“…Therefore, these various approaches to stroke assessment have been investigated in non‐overlapping patient groups and some patients were recruited into a trial of one novel approach, while receiving another (e.g. in a Randomized, double‐blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and Safety of dabigatran versus aspirin in patients with ESUS, RE‐SPECT ESUS, 6% of patients received an ILR). Recruitment into future trials may be harmonised by starting with patients meeting the ESUS definition and adding other markers of risk.…”

Section: Concepts In Stroke Preventionmentioning

confidence: 99%

“…RE‐SPECT ESUS compared dabigatran (150 mg twice per day or 110 mg twice daily depending on age and renal function) and aspirin 100 mg daily. There was no significant difference in the primary outcome of first recurrent stroke (HR 0.85; 95% CI 0.69–1.03).…”

Section: Esus Anticoagulation Trialsmentioning

confidence: 99%

“…In two recent large multicentre randomised controlled trials of patients with ESUS, anticoagulation was not superior to aspirin with respect to secondary ischaemic stroke prevention. 3,14 NAVIGATE ESUS 14 compared rivaroxaban 15 mg daily and aspirin 100 mg daily. The trial was terminated early by the data and safety monitoring committee, following the recruitment of 7213 patients, due to an excess risk of major bleeding with rivaroxaban (HR 2.72; 95% CI 1.68-4.39, P < 0.001), with no significant decrease in the risk of recurrent stroke (HR 1.07; 95% CI 0.87-1.33).…”

Section: Esus Anticoagulation Trialsmentioning

confidence: 99%

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Secondary prevention of ischaemic stroke

Muller

Roizman

Wong

2019

Internal Medicine Journal

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Recent trials within the past few years have influenced not only how we treat patients immediately after acute ischaemic stroke, but also how we investigate for aetiology. With the advent of improved medications, procedures and monitoring devices, modern stroke prevention strategies are more individualised, but the decision‐making process is more complex. We provide an approach to navigating these management options.

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Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source

Cited by 603 publications

References 17 publications

Clinical and Neuroimaging Characteristics in Embolic Stroke of Undetermined versus Cardioembolic Origin: A Population‐Based Study

Clinical and Neuroimaging Characteristics in Embolic Stroke of Undetermined versus Cardioembolic Origin: A Population‐Based Study

Left atrial appendage closure: A therapy uniquely suited for specific populations of patients with atrial fibrillation

Secondary prevention of ischaemic stroke

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