The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may represent a barrier for some patients. Therefore, the aim of this study was to evaluate innovative rivaroxaban-containing formulations designed to eliminate the food effect to ensure reliable absorption and thus to improve patient adherence with the treatment. Three prototypes (Cocrystal, HPMCP and Kollidon) with rivaroxaban were developed and their bioavailability and food effect in comparison to the reference product was tested in open label, randomized, single oral dose, crossover studies, where test products were administered under fasting and fed conditions and the reference product was administered under fed conditions. Comparable bioavailability for all tested prototypes both under fed and fasting conditions was demonstrated as the 90% confidence intervals of the geometric mean ratios for area under the concentration-time curve remained within the standard acceptance range of 80.00%-125.00%. An innovative immediate release form of rivaroxaban with no food effect on drug bioavailability has been developed, which may represent an important step toward increasing adherence, improving treatment outcome and reducing health care costs.

• MeSH
• aplikace orální MeSH
• biologická dostupnost * MeSH
• dospělí MeSH
• inhibitory faktoru Xa farmakokinetika   aplikace a dávkování   MeSH
• interakce mezi potravou a léky * MeSH
• jídla MeSH
• klinické křížové studie * MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• omezení příjmu potravy * MeSH
• příprava léků metody   MeSH
• rivaroxaban * farmakokinetika   aplikace a dávkování   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• inhibitory faktoru Xa MeSH
• rivaroxaban * MeSH

BACKGROUND AND PURPOSE: The ANNEXA-4 trial measured hemostatic efficacy of andexanet alfa in patients with major bleeding taking factor Xa inhibitors. A proportion of this was traumatic and nontraumatic intracranial bleeding. Different measurements were applied in the trial including volumetrics to assess for intracranial bleeding depending on the compartment involved. We aimed to determine the most reliable way to measure intracranial hemorrhage (ICrH) volume by comparing individual brain compartment and total ICrH volume. METHODS: Thirty patients were randomly selected from the ANNEXA-4 database to assess measurement of ICrH volume by compartment and in total. Total and compartmental hemorrhage volumes were measured by five readers using Quantomo software. Each reader measured baseline hemorrhage volumes twice separated by 1 week. Twenty-eight different ANNEXA-4 subjects were also randomly selected to assess intra-rater reliability of total ICrH volume measurement change at baseline and 12-h follow up, performed by three readers twice to assess hemostatic efficacy categories used in ANNEXA-4. RESULTS: Compartmental minimal detectable change percentages (MDC%) ranged between 9.72 and 224.13, with the greatest measurement error occurring in patients with a subdural hemorrhage. Total ICrH volume measurements had the lowest MDC%, which ranged between 6.57 and 33.52 depending on the reader. CONCLUSION: Measurement of total ICrH volumes is more accurate than volume by compartment with less measurement error. Determination of hemostatic efficacy was consistent across readers, and within the same reader, as well as when compared to consensus read. Volumetric analysis of intracranial hemostatic efficacy is feasible and reliable when using total ICrH volumes.

• Klíčová slova
• neuroimaging, neurology, neuroscience, stroke,
• MeSH
• dospělí MeSH
• faktor Xa * MeSH
• inhibitory faktoru Xa aplikace a dávkování   terapeutické užití   MeSH
• intrakraniální krvácení * MeSH
• lidé středního věku MeSH
• lidé MeSH
• mozek diagnostické zobrazování   MeSH
• rekombinantní proteiny aplikace a dávkování   MeSH
• reprodukovatelnost výsledků MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• faktor Xa * MeSH
• inhibitory faktoru Xa MeSH
• PRT064445 MeSH Prohlížeč
• rekombinantní proteiny MeSH

The management of patients with atrial fibrillation (AF) has rapidly changed with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs) and changes in the use of rhythm control therapy. The prevention of thromboembolic events European Registry in Atrial Fibrillation Prolongation Registry (PREFER Prolongation) enrolled consecutive patients with AF on NOACs between 2014 and 2016 in a multicentre, prospective, observational study with one-year follow-up, focusing on the time of introduction of NOACs. Overall, 3783 patients were enrolled, with follow-up information available in 3223 (85%). Mean age was 72.2 ± 9.4 years, 40% were women, mean CHA2DS2VASc score was 3.4 ± 1.6, and 2587 (88.6%) had a CHA2DS2VASc score ≥ 2. Rivaroxaban was used in half of patients, and dabigatran and apixaban were used in about a quarter of patients each; edoxaban was not available for use in Europe at the time. Major cardiovascular event rate was low: serious events occurred in 74 patients (84 events, 2%), including 24 strokes (1%), 62 major bleeds (2%), of which 30 were life-threatening (1%) and 3 intracranial (0.1%), and 28 acute coronary syndromes (1%). Mortality was 2%. Antiarrhythmic drugs were used in about 50% of patients, catheter ablation in 5%. Adverse events were low in this contemporary European cohort of unselected AF patients treated with NOACs already at the time of their first introduction, despite high thromboembolic risk.

• Klíčová slova
• Anticoagulants, Atrial fibrillation, Bleeding, Major cardiac or cerebrovascular events, NOAC, Registry,
• MeSH
• aplikace orální MeSH
• dabigatran aplikace a dávkování   MeSH
• fibrilace síní farmakoterapie   mortalita   MeSH
• inhibitory faktoru Xa aplikace a dávkování   MeSH
• lidé MeSH
• prospektivní studie MeSH
• pyrazoly aplikace a dávkování   MeSH
• pyridony aplikace a dávkování   MeSH
• registrace MeSH
• rivaroxaban aplikace a dávkování   MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• Geografické názvy
• Evropa epidemiologie   MeSH
• Názvy látek
• apixaban MeSH Prohlížeč
• dabigatran MeSH
• inhibitory faktoru Xa MeSH
• pyrazoly MeSH
• pyridony MeSH
• rivaroxaban MeSH

BACKGROUND: Venous thromboembolism (VTE) is a frequent cause of morbidity and mortality in patients with cancer. Moreover, management of VTE is frequently connected with complications, namely risk of recurrent VTE and bleeding. Low molecular weight heparins (LMWH) therapy administrated for 3-6 months is currently considered a standard for the treatment of cancer-associated VTE (CA-VTE). Direct oral factor Xa inhibitors (FXaI) apixaban, edoxaban and rivaroxaban have emerged as a new possibility for long-term antithrombotic therapy for VTE. These agents expose several advantages in individuals with cancer, and might overcome several disadvantages connected with LMWH therapy. PURPOSE: First clinical studies with oral FXaI for the treatment of CA-VTE with very promising results were recently published. The article summarizes current data regarding the use of oral FXaI in the treatment of CA-VTE.

• Klíčová slova
• Deep vein thrombosis, Pulmonary embolism, cancer-associated venous thromboembolic disease, deep vein thrombosis, direct oral factor Xa inhibitors, pulmonary embolism,
• MeSH
• aplikace orální MeSH
• fibrinolytika aplikace a dávkování   terapeutické užití   MeSH
• heparin nízkomolekulární terapeutické užití   MeSH
• inhibitory faktoru Xa aplikace a dávkování   terapeutické užití   MeSH
• lidé MeSH
• nádory komplikace   MeSH
• pyrazoly aplikace a dávkování   terapeutické užití   MeSH
• pyridiny aplikace a dávkování   terapeutické užití   MeSH
• pyridony aplikace a dávkování   terapeutické užití   MeSH
• rivaroxaban aplikace a dávkování   terapeutické užití   MeSH
• thiazoly aplikace a dávkování   terapeutické užití   MeSH
• trombóza farmakoterapie   etiologie   prevence a kontrola   MeSH
• žilní tromboembolie farmakoterapie   etiologie   prevence a kontrola   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• apixaban MeSH Prohlížeč
• edoxaban MeSH Prohlížeč
• fibrinolytika MeSH
• heparin nízkomolekulární MeSH
• inhibitory faktoru Xa MeSH
• pyrazoly MeSH
• pyridiny MeSH
• pyridony MeSH
• rivaroxaban MeSH
• thiazoly 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.

• Klíčová slova
• Cerebrovascular atherosclerosis, ESUS, Embolic stroke, Intracranial atherosclerosis, Randomized trial, Rivaroxaban,
• 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
• Názvy látek
• Aspirin MeSH
• fibrinolytika MeSH
• inhibitory agregace trombocytů MeSH
• inhibitory faktoru Xa MeSH
• rivaroxaban MeSH

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

• Klíčová slova
• atrial fibrillation, cardioembolic event, direct oral anticoagulant, left atrial appendage, stroke,
• MeSH
• cévní mozková příhoda * etiologie   prevence a kontrola   MeSH
• fibrilace síní komplikace   diagnóza   farmakoterapie   chirurgie   MeSH
• implantace protézy * škodlivé účinky   přístrojové vybavení   metody   MeSH
• inhibitory faktoru Xa * aplikace a dávkování   škodlivé účinky   MeSH
• kardiochirurgické výkony * škodlivé účinky   přístrojové vybavení   metody   MeSH
• krvácení * chemicky indukované   prevence a kontrola   MeSH
• lidé MeSH
• senioři MeSH
• síňové ouško diagnostické zobrazování   chirurgie   MeSH
• výsledky a postupy - zhodnocení (zdravotní péče) MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• inhibitory faktoru Xa * MeSH

BACKGROUND: Gigantic left atrium is defined in the current literature as an excessive dilatation of the left atrium above 65mm. Chronic mitral valve disease is associated with the development of thrombus in the left atrium in up to 19% of all cases of mitral insufficiency and appropriate treatment must be initiated to prevent thromboembolic events. In order to diagnose thrombi in the left atrium or left atrial appendage, various imaging methods may be used, including cardiac magnetic resonance. CASE PRESENTATION: The case report describes a 73-year-old male who developed recurrent sessile thrombus on the posterior wall of the gigantic left atrium. A large thrombus was first detected following mitral valve surgery despite effective vitamin K antagonist anticoagulation therapy. Echocardiography and cardiac magnetic resonance were used within the diagnostic procedure and to monitor the treatment outcomes. Cardiac magnetic resonance was shown to be beneficial as it provided a more precise description of the intra-atrial masses located on the posterior left atrial wall, and in such situations, is of greater benefit than standard echocardiography. This led to the surgical removal of the intra-atrial mass; nevertheless, it was quickly followed by the recurrence of the thrombus. The anticoagulant therapy was adjusted and fortified by the introduction of acetylsalicylic acid and sequentially clopidogrel, but this also did not resolve the thrombus formation. Finally, employing a combination of rivaroxaban and clopidogrel resulted in partial thrombus regression. Therefore, various pathophysiological aspects of thrombus formation and used anticoagulation strategies are discussed. CONCLUSIONS: We describe a unique case of a recurrent thrombus located on the posterior wall of the gigantic left atrium. Cardiac magnetic resonance was shown to be beneficial in providing a more precise description of the intra-atrial masses located on the posterior left atrial wall as compared to standard echocardiographic examination. Development of a thrombus after mitral valve surgery despite effective anticoagulant therapy and its final resolution by introducing a combination of rivaroxaban and clopidogrel highlights the complex etiopathogenesis of thrombus formation. This supports the potential use of this combination in tailoring an individual personalized therapy for patients with recurrent atrial thrombi.

• Klíčová slova
• Anticoagulant therapy, Atrial fibrillation, Cardiac magnetic resonance, Echocardiography, Gigantic left atrium, Recurrent thrombus,
• MeSH
• anuloplastika mitrální chlopně škodlivé účinky   MeSH
• chirurgická náhrada chlopně škodlivé účinky   MeSH
• inhibitory agregace trombocytů aplikace a dávkování   MeSH
• inhibitory faktoru Xa aplikace a dávkování   MeSH
• klopidogrel aplikace a dávkování   MeSH
• kombinovaná farmakoterapie MeSH
• lidé MeSH
• mitrální insuficience diagnostické zobrazování   chirurgie   MeSH
• nemoci srdce diagnostické zobrazování   farmakoterapie   etiologie   chirurgie   MeSH
• recidiva MeSH
• rivaroxaban aplikace a dávkování   MeSH
• senioři MeSH
• srdeční síně diagnostické zobrazování   účinky léků   chirurgie   MeSH
• trombektomie MeSH
• trombóza diagnostické zobrazování   farmakoterapie   etiologie   chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• kazuistiky MeSH
• práce podpořená grantem MeSH
• Názvy látek
• inhibitory agregace trombocytů MeSH
• inhibitory faktoru Xa MeSH
• klopidogrel MeSH
• rivaroxaban MeSH

AIMS: Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease. METHODS AND RESULTS: We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors (p < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors (p interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors. CONCLUSION: More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.

• Klíčová slova
• Secondary prevention, blood pressure, cardiovascular risk factors, cholesterol, physical activity, rivaroxaban, smoking,
• MeSH
• antikoagulancia aplikace a dávkování   škodlivé účinky   MeSH
• Aspirin aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• chronická nemoc MeSH
• dvojitá slepá metoda MeSH
• fibrinolytika aplikace a dávkování   škodlivé účinky   MeSH
• hodnocení rizik MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• kombinovaná farmakoterapie MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen diagnostické zobrazování   farmakoterapie   mortalita   MeSH
• onemocnění periferních arterií diagnostické zobrazování   farmakoterapie   mortalita   MeSH
• prospektivní studie MeSH
• recidiva MeSH
• rivaroxaban aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory kardiovaskulárních chorob MeSH
• sekundární prevence * 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
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• antikoagulancia MeSH
• Aspirin MeSH
• fibrinolytika MeSH
• inhibitory faktoru Xa MeSH
• rivaroxaban MeSH

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. ClinicalTrials.gov Number: NCT01776424.

• Klíčová slova
• Bacteria, CVD, Reflux, Thrombosis,
• MeSH
• Aspirin aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• dvojitá slepá metoda MeSH
• gastrointestinální krvácení chemicky indukované   prevence a kontrola   MeSH
• hodnocení rizik MeSH
• inhibitory agregace trombocytů aplikace a dávkování   škodlivé účinky   MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• inhibitory protonové pumpy aplikace a dávkování   škodlivé účinky   MeSH
• kardiovaskulární nemoci diagnóza   farmakoterapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• onemocnění periferních arterií diagnóza   farmakoterapie   MeSH
• pantoprazol aplikace a dávkování   škodlivé účinky   MeSH
• prospektivní studie MeSH
• pseudomembranózní enterokolitida chemicky indukované   mikrobiologie   MeSH
• rivaroxaban aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory MeSH
• rozvrh dávkování léků 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
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• Aspirin MeSH
• inhibitory agregace trombocytů MeSH
• inhibitory faktoru Xa MeSH
• inhibitory protonové pumpy MeSH
• pantoprazol MeSH
• rivaroxaban MeSH

Patients with atrial fibrillation (AF) are at an approximately 0.5% to 3% increased risk of thromboembolism during and immediately after catheter ablation. Treatment guidelines recommend periprocedural oral anticoagulation plus unfractionated heparin during ablation. Rivaroxaban and dabigatran are the only non-vitamin K oral anticoagulants for which there are randomized controlled trials assessing uninterrupted anticoagulation in patients undergoing catheter ablation of AF. Edoxaban, a direct factor Xa inhibitor, is noninferior vs warfarin for the prevention of stroke or systemic embolism with less major bleeding in patients with nonvalvular AF. The ELIMINATE-AF (Evaluation of Edoxaban Compared With VKA in Subjects Undergoing Catheter Ablation of Nonvalvular Atrial Fibrillation) trial is a multinational, multicenter, prospective, randomized, open-label, parallel-group, blinded-endpoint evaluation (PROBE) study to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for a dose reduction) vs vitamin K antagonists (VKA) in patients with nonvalvular AF undergoing catheter ablation (http://www.ClinicalTrials.gov: NCT02942576). A total of 560 patients are planned for randomization to edoxaban or VKA (2:1 ratio) to obtain 450 patients fully compliant with the protocol. Patients will complete 21 to 28 days of anticoagulation prior to the ablation and a 90-day post-ablation period. The primary efficacy endpoint is the composite of all-cause death, stroke, and major bleeding. The primary safety endpoint is major bleeding. A magnetic resonance imaging substudy will assess the incidence of silent cerebral lesions post-ablation. ELIMINATE-AF will define the efficacy and safety of edoxaban for uninterrupted oral anticoagulation during catheter ablation of AF.

• Klíčová slova
• Atrial Fibrillation, Catheter Ablation, Direct Oral Anticoagulant, Direct Oral Anticoagulant Edoxaban, Non-Vitamin K Oral Anticoagulants, Periprocedural,
• MeSH
• antikoagulancia aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• cévní mozková příhoda diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• fibrilace síní komplikace   mortalita   patofyziologie   chirurgie   MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• ischemie mozku diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• katetrizační ablace * škodlivé účinky   mortalita   MeSH
• klinické protokoly MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• prospektivní studie MeSH
• pyridiny aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory MeSH
• rozvrh dávkování léků MeSH
• thiazoly aplikace a dávkování   škodlivé účinky   MeSH
• vitamin K antagonisté a inhibitory   MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• warfarin aplikace a dávkování   škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antikoagulancia MeSH
• edoxaban MeSH Prohlížeč
• inhibitory faktoru Xa MeSH
• pyridiny MeSH
• thiazoly MeSH
• vitamin K MeSH
• warfarin MeSH