Browsing by Subject "rivaroxaban"

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  • Pokorney, Sean D.; Piccini, Jonathan P.; Stevens, Susanna R.; Patel, Manesh R.; Pieper, Karen S.; Halperin, Jonathan L.; Breithardt, Gunter; Singer, Daniel E.; Hankey, Graeme J.; Hacke, Werner; Becker, Richard C.; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.; ROCKET AF Steering Comm; Kaste, Markku (2016)
    Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intention-to-treat population. The median age was 73 years, and the mean CHADS(2) score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P= 75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, approximate to 7 in 10 deaths were cardiovascular, whereas
  • NAVIGATE ESUS Steering Comm (2018)
    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.
  • Koivula, Teija (Helsingfors universitet, 2017)
    Atrial fibrillation is the most common sustained cardiac arythmia. It has been estimated that there will be 14 to 17 million atrial fibrillation patients in Europe by the year 2030. In Finland, there are over 50 000 atrial fibrillation patients. The prevalence of atrial fibrillation increases by age. In addition to age, people who have hearth failure, high blood pressure, coronary artery disease, valvular hearth disease, diabetes mellitus, chronic kidney disease or who suffer from obesity have increased prevalence. Atrial fibrillation is usually not a life threatening condition. However, people who suffer from atrial fibrillation have a greater risk of the stroke compared with people who have normal sinus rhythm. Warfarin has been the standard treatment for preventing the stroke in atrial fibrillation patients. However, there are many inconveniences in warfarin therapy such as food and drug interactions and frequent laboratory visits. Therefore, new oral anticoagulants have been introduced to prevent the stroke in non-valvular atrial fibrillation. These new drugs apixaban, dabigatran, edoxaban and rivaroxaban are more expensive than warfarin. Many people suffer from atrial fibrillation and the number of atrial fibrillation patients is increasing. Due to the expected increase in the number of atrial fibrillation patients in future the costs of the new drugs have led to a concern for their impact on the health care budget. The knowledge of the cost-effectiveness of the new anticoagulants is important for decision making. In this Master's thesis, the cost-effectiveness of rivaroxaban was compared with warfarin for stroke prevention in non-valvular atrial fibrillation. Systematic literature review was used as the study method and 363 studies were screened and 23 of them filled the inclusion criteria. One was a previously published systematic review and 22 were cost-utility studies. All of the cost-utility studies had used decision analytic modelling. The studies were conducted in 13 different countries. In the cost-utility studies included in this systematic review there was a great variability in the cost-effectiveness of rivaroxaban compared with warfarin. Rivaroxaban was cost-effective in more than half of the studies, for example in Belgium, Italy, Norway and Singapore. However, in China, Thailand and Slovenia the cost-effectiveness could not be established. Contradictory cost-effectiveness results were obtained in studies conducted in Germany, Canada and USA. The incremental cost-effectiveness ratio varied from 2580 € to 174915 € per quality adjusted life years (QALY) gained with warfarin over all the 22 cost-utility studies. In studies conducted in Europe the incremental cost effectiveness ratio varied from 4188 € 139163 €/QALY gained. In studies where rivaroxaban, apixaban, dabigatran and warfarin were compared together using an indirect comparison or a network meta-analysis it seemed that rivaroxaban was not the optimal treatment. The most common adverse effect of anticoagulation treatment is bleeding. This complication was included in all the cost-utility studies. However, there was only some uniformity of the bleeding events reported. In most cost-utility studies the acute care cost of intracranial hemorrhages was reported and in many studies, also the long term costs. The cost-utility studies included in this systematic review were quite heterogeneous. Because they were done in different countries their health care settings, treatment options and costs were different. There were also differences in cost-effective models. Modell structure, settings, data and assumptions were different. Due to the heterogeneous nature of the studies, no unambiguous answer could be reached to the question concerning the cost-effectiveness of rivaroxaban compared with warfarin. The quality assessment of the cost-utility studies revealed that some quality criteria were not met. Transferability of the results from one country to the other seemed to be poor. The strength of this master's thesis is the comprehensive literature search concerning the cost-effectiveness of rivaroxaban compared with warfarin. Also, the reporting of methods and results are transparent. There are also limitations in this study. One person was conducting the literature search, data extraction and quality assessment. This might have increased the risk for subjective interpretations and errors.
  • NAVIGATE ESUS Investigators; Martinez-Majander, Nicolas; Ntaios, George; Liu, Yan Yun; Ylikotila, Pauli; Joensuu, Heikki; Saarinen, Jukka; Tiainen, Marjaana; Tatlisumak, Turgut (2020)
    Abstract Background Cancer is a frequent finding in ischemic stroke patients. We investigated the frequency of cancer among participants in NAVIGATE ESUS randomized trial and the distribution of outcome events during treatment with aspirin and rivaroxaban. Methods Trial participation required a recent embolic stroke of undetermined source (ESUS). Patients? history of cancer was recorded at time of study entry. During a mean follow-up of 11 months, the effects of aspirin and rivaroxaban treatment on recurrent ischemic stroke, major bleeding, and all-cause mortality were compared between patients with cancer and without cancer. Results Among 7213 randomized patients, 543 (7.5%) had cancer. Of all patients, 3609 were randomized to rivaroxaban (254[7.0%] with cancer) and 3604 patients to aspirin (289[8.0%] with cancer). The annual rate of recurrent ischemic stroke was 4.5% in non-cancer patients in rivaroxaban arm and 4.6% in the aspirin arm (hazard ratio, HR 0.98 [95% CI 0.78-1.24]). In cancer patients, the rate of recurrent ischemic stroke was 7.7% in the rivaroxaban arm and 5.4% in the aspirin arm (HR 1.43 [95% CI 0.71-2.87]). Among cancer patients, the annual rate of major bleeds was nonsignificantly higher for rivaroxaban than aspirin (2.9% versus 1.1%; HR 2.57 [95% CI 0.67-9.96], P for interaction 0.95). All-cause mortality was similar in both groups. Conclusions Our exploratory analyses show that patients with ESUS and a history of cancer had similar rates of recurrent ischemic strokes and all-cause mortality during aspirin and rivaroxaban treatments and that aspirin appeared safer than rivaroxaban in cancer patients regarding major bleeds.