BACKGROUND: Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. AIMS: To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. METHODS: At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. RESULTS: Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). CONCLUSIONS: Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.Registration: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.

• MeSH
• Aspirin terapeutické užití   MeSH
• cerebrální krvácení farmakoterapie   MeSH
• cévní mozková příhoda * diagnostické zobrazování   farmakoterapie   prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• embolická cévní mozková příhoda * MeSH
• inhibitory faktoru Xa terapeutické užití   MeSH
• intrakraniální embolie * diagnostické zobrazování   farmakoterapie   epidemiologie   MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• mozkový infarkt diagnostické zobrazování   farmakoterapie   etiologie   MeSH
• prospektivní studie MeSH
• rivaroxaban terapeutické užití   MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

INTRODUCTION: Elderly cryptogenic ischemic stroke (IS) patients with embolic stroke of undetermined source (ESUS) have a high risk of recurrent IS (RIS) compared to other stroke subtypes. In young ESUS patients, different sources of embolism may be a cause and the risk of RIS remains not enough established. The aim was to assess and compare risk of RIS between ESUS and non ESUS patients <50 years. METHODS: The study set consisted of young acute IS patients <50 years enrolled in the prospective HISTORY (Heart and Ischemic STrOke Relationship studY) study registered on ClinicalTrials.gov (NCT01541163). In all analyzed patients, the brain ischemia was confirmed on CT or MRI. All patients underwent identical diagnostic protocol including TEE and long-term ECG-Holter. Cause of IS was assessed according to the ASCOD classification. RESULTS: Of 320 enrolled patients <50 years, 219 (68.4%) were identified as cryptogenic (119 males, mean age 41.4 ± 7.2 years) and 122 (38.1%) patients fulfilled the ESUS criteria. During the follow-up with a median of 34 months, three (2.5%) ESUS and 5 (5.2%) non-ESUS patients suffered from RIS (p = .471). One-year risk of RIS was 0.008 (95% CI: 0-0.025) for ESUS and 0.036 (95% CI: 0-0.076) for non-ESUS patients (p = .262). CONCLUSION: The risk of RIS was very low in ESUS patients and did not differ from those with non-ESUS. Our finding may indicate that antiplatelet therapy can be effective in the secondary prevention in young ESUS patients if high-risk sources of embolization are excluded extensively.

• MeSH
• cévní mozková příhoda * diagnostické zobrazování   epidemiologie   etiologie   MeSH
• dospělí MeSH
• embolická cévní mozková příhoda * MeSH
• intrakraniální embolie * komplikace   diagnostické zobrazování   epidemiologie   MeSH
• ischemická cévní mozková příhoda * MeSH
• ischemie mozku * komplikace   diagnostické zobrazování   epidemiologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• rizikové faktory MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Non-stenotic intracranial and systemic atherosclerosis are associated with ischemic stroke. We report frequency and response to anticoagulant vs. antiplatelet prophylaxis of patients with embolic stroke of undetermined source (ESUS) who have non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis. METHODS: Exploratory analysis of the international NAVIGATE ESUS randomized trial comparing rivaroxaban 15mg daily with aspirin 100mg daily in 7213 patients with recent ESUS. Among participants with results of intracranial arterial imaging with either computed tomographic angiography (CTA) or magnetic resonance angiography (MRA), the frequency and predictors of non-stenotic intracranial and systemic atherosclerosis and responses to antithrombotic therapy were assessed. RESULTS: Among 4723 participants with available intracranial CTA or MRA results (65% of the trial cohort), the prevalence of intracranial atherosclerosis was 16% (n=739). Patient features independently associated with intracranial atherosclerosis included East Asian region (odds ratio 2.7, 95%CI 2.2,3.3) and cervical carotid plaque (odds ratio 2.3, 95%CI 1.9,2.7), among others. The rate of recurrent ischemic stroke averaged 4.8%/year among those with intracranial atherosclerosis vs. 5.0.%/year for those without (HR 0.95, 95%CI 0.65, 1.4). Among those with intracranial atherosclerosis, the recurrent ischemic stroke rate was higher if assigned to rivaroxaban (5.8%/year) vs. aspirin (3.7%/year), but the difference was not statistically significant (HR 1.6, 95%CI 0.78, 3.3). There was trend for the effect of antithrombotic treatments to be different according to the presence or absence of intracranial atherosclerosis (pinteraction=0.09). Among participants with evidence of systemic atherosclerosis by either history or imaging (n=3820), recurrent ischemic stroke rates were similar among those assigned to rivaroxaban (5.5%/year) vs. aspirin (4.9%/year)(HR 1.1, 95%CI 0.84, 1.5). CONCLUSIONS: East Asia region was the strongest factor associated with intracranial atherosclerosis. There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.

• MeSH
• Aspirin aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• cévní mozková příhoda diagnostické zobrazování   epidemiologie   prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• fibrinolytika aplikace a dávkování   škodlivé účinky   MeSH
• hodnocení rizik MeSH
• inhibitory agregace trombocytů aplikace a dávkování   škodlivé účinky   MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• intrakraniální arterioskleróza diagnostické zobrazování   farmakoterapie   epidemiologie   MeSH
• intrakraniální embolie diagnostické zobrazování   epidemiologie   prevence a kontrola   MeSH
• lidé středního věku MeSH
• lidé MeSH
• onemocnění periferních arterií diagnostické zobrazování   farmakoterapie   epidemiologie   MeSH
• prevalence MeSH
• recidiva MeSH
• rivaroxaban aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

INTRODUCTION: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. METHODS AND RESULTS: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. CONCLUSIONS: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

• MeSH
• akční potenciály MeSH
• asymptomatické nemoci MeSH
• časové faktory MeSH
• design vybavení MeSH
• difuzní magnetická rezonance MeSH
• fibrilace síní komplikace   diagnóza   patofyziologie   chirurgie   MeSH
• incidence MeSH
• intrakraniální embolie diagnostické zobrazování   epidemiologie   MeSH
• katetrizační ablace škodlivé účinky   přístrojové vybavení   MeSH
• kognice * MeSH
• léčebná irigace škodlivé účinky   přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• pilotní projekty MeSH
• pooperační kognitivní dysfunkce diagnóza   epidemiologie   psychologie   MeSH
• senioři MeSH
• srdeční frekvence MeSH
• srdeční katétry * MeSH
• testy pro posouzení mentálních funkcí a demence MeSH
• venae pulmonales patofyziologie   chirurgie   MeSH
• výsledek terapie MeSH
• zlato * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Německo MeSH

BACKGROUND: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. AIMS: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. METHODS: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. RESULTS: Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. CONCLUSIONS: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.

• MeSH
• Aspirin terapeutické užití   MeSH
• cévní mozková příhoda diagnóza   farmakoterapie   epidemiologie   MeSH
• dvojitá slepá metoda MeSH
• fibrinolytika terapeutické užití   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• inhibitory faktoru Xa terapeutické užití   MeSH
• intrakraniální embolie diagnóza   farmakoterapie   epidemiologie   MeSH
• komorbidita MeSH
• lidé středního věku MeSH
• lidé MeSH
• rasové skupiny MeSH
• rivaroxaban terapeutické užití   MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• sexuální faktory MeSH
• tranzitorní ischemická ataka diagnóza   farmakoterapie   epidemiologie   MeSH
• věkové faktory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

It is unknown if brief episodes of device-detected atrial fibrillation (AF) increase thromboembolic event (TE) risk. METHODS AND RESULTS: TRENDS was a prospective, observational study enrolling patients with > or = 1 stroke risk factor (heart failure, hypertension, age > or = 65 years, diabetes, or prior TE) receiving pacemakers or defibrillators that monitor atrial tachycardia (AT)/AF burden (defined as the longest total AT/AF duration on any given day during the prior 30-day period). This time-varying exposure was updated daily during follow-up and related to TE risk. Annualized TE rates were determined according to AT/AF burden subsets: zero, low (<5.5 hours [median duration of subsets with nonzero burden]), and high (> or = 5.5 hours). A multivariate Cox model provided hazard ratios including terms for stroke risk factors and time-varying AT/AF burden and antithrombotic therapy. Patients (n=2486) had at least 30 days of device data for analysis. During a mean follow-up of 1.4 years, annualized TE risk (including transient ischemic attacks) was 1.1% for zero, 1.1% for low, and 2.4% for high burden subsets of 30-day windows. Compared with zero burden, adjusted hazard ratios (95% CIs) in the low and high burden subsets were 0.98 (0.34 to 2.82, P=0.97) and 2.20 (0.96 to 5.05, P=0.06), respectively. CONCLUSIONS: The TE rate was low compared with patients with traditional AF with similar risk profiles. The data suggest that TE risk is a quantitative function of AT/AF burden. AT/AF burden > or = 5.5 hours on any of 30 prior days appeared to double TE risk. Additional studies are needed to more precisely investigate the relationship between stroke risk and AT/AF burden.

• MeSH
• analýza rozptylu MeSH
• cévní mozková příhoda epidemiologie   etiologie   MeSH
• defibrilátory implantabilní MeSH
• fibrilace síní MeSH
• financování organizované MeSH
• intrakraniální embolie epidemiologie   etiologie   MeSH
• lidé MeSH
• prognóza MeSH
• proporcionální rizikové modely MeSH
• prospektivní studie MeSH
• rizikové faktory MeSH
• rozdělení chí kvadrát MeSH
• senioři MeSH
• tranzitorní ischemická ataka epidemiologie   etiologie   MeSH
• trombolytická terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• multicentrická studie MeSH