BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn 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<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
Cancer-associated thrombosis (CAT) poses a significant disease burden and the incidence in Asian populations is increasing. Anticoagulation is the cornerstone of treatment, but can be challenging due to the high bleeding risk in some cancers and the high risk of recurrent venous thromboembolism (VTE) in patients with malignancies. Direct oral anticoagulants (DOACs) are well established as first-choice treatments for VTE in non-cancer patients, offering a more convenient and less invasive treatment option than low-molecular-weight heparin (LMWH). Asian patients have exhibited comparable efficacy and safety outcomes with other races in trials of DOACs for VTE in the general population. Although no specific data are available in Asian patients with CAT, results from randomized controlled trials of apixaban, edoxaban, or rivaroxaban versus the LMWH, dalteparin, indicate that DOACs are a reasonable alternative to LMWH for anticoagulation in Asian patients with CAT. This is further supported by analyses of real-world data in Asian populations demonstrating the efficacy and safety of DOACs in Asian patients with CAT. Apixaban, edoxaban, or rivaroxaban are recommended in the most recently updated international guidelines as first-line therapy for CAT in patients without gastrointestinal or genitourinary cancers and at low risk of bleeding. An increased risk of major gastrointestinal bleeding was evident with edoxaban or rivaroxaban, but not apixaban, versus dalteparin in the clinical trials, suggesting that apixaban could be a safe alternative to LMWH in patients with gastrointestinal malignancies. Determining the optimal anticoagulant therapy for patients with CAT requires careful consideration of bleeding risk, tumor type, renal function, drug–drug interactions, financial costs, and patients’ needs and preferences.
Non-vitamin K antagonist oral anticoagulants (NOACs) are a new class of anticoagulant drugs used in the prevention and treatment of venous thromboembolism (VTE) and atrial fibrillation (AF). Anticoagulation requires the integration of the correct type and dose of oral anticoagulants based on patient characteristic, and therefore therapy needs to be individualized for each patient. Growing scientific evidence from studies on NOACs has led to a better understanding of their benefits and safety. A large amount of available data creates a necessity for an adaptable practical document for the usage of NOACs in India. The current consensus, developed by experts from India, aims to give recommendations on various frequently raised clinical questions with regards to NOACs and its usage. This practical document provides a platform upon which future guidelines, policies, training, and education for the use of NOACs can be tailored.
Background Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. Objective To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. Methods Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. Results The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). Conclusions The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.
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