rivaroxaban and Chronic-Disease

People with chronic heart failure (HF) are at risk of thromboembolic events, including stroke, pulmonary embolism, and peripheral arterial embolism; coronary ischaemic events also contribute to the progression of HF. The use of long-term oral anticoagulation is established in certain populations, including people with HF and atrial fibrillation (AF), but there is wide variation in the indications and use of oral anticoagulation in the broader HF population.. To determine whether long-term oral anticoagulation reduces total deaths and stroke in people with heart failure in sinus rhythm.. We updated the searches in CENTRAL, MEDLINE, and Embase in March 2020. We screened reference lists of papers and abstracts from national and international cardiovascular meetings to identify unpublished studies. We contacted relevant authors to obtain further data. We did not apply any language restrictions.. Randomised controlled trials (RCT) comparing oral anticoagulants with placebo or no treatment in adults with HF, with treatment duration of at least one month. We made inclusion decisions in duplicate, and resolved any disagreements between review authors by discussion, or a third party.. Two review authors independently assessed trials for inclusion, and assessed the risks and benefits of antithrombotic therapy by calculating odds ratio (OR), accompanied by the 95% confidence intervals (CI).. We identified three RCTs (5498 participants). One RCT compared warfarin, aspirin, and no antithrombotic therapy, the second compared warfarin with placebo in participants with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease. We pooled data from the studies that compared warfarin with a placebo or no treatment. We are uncertain if there is an effect on all-cause death (OR 0.66, 95% CI 0.36 to 1.18; 2 studies, 324 participants; low-certainty evidence); warfarin may increase the risk of major bleeding events (OR 5.98, 95% CI 1.71 to 20.93, NNTH 17). 2 studies, 324 participants; low-certainty evidence). None of the studies reported stroke as an individual outcome. Rivaroxaban makes little to no difference to all-cause death compared with placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, 5022 participants; high-certainty evidence). Rivaroxaban probably reduces the risk of stroke compared to placebo (OR 0.67, 95% CI 0.47 to 0.95; NNTB 101; 1 study, 5022 participants; moderate-certainty evidence), and probably increases the risk of major bleeding events (OR 1.65, 95% CI 1.17 to 2.33; NNTH 79; 1 study, 5008 participants; moderate-certainty evidence).. Based on the three RCTs, there is no evidence that oral anticoagulant therapy modifies mortality in people with HF in sinus rhythm. The evidence is uncertain if warfarin has any effect on all-cause death compared to placebo or no treatment, but it may increase the risk of major bleeding events. There is no evidence of a difference in the effect of rivaroxaban on all-cause death compared to placebo. It probably reduces the risk of stroke, but probably increases the risk of major bleedings. The available evidence does not support the routine use of anticoagulation in people with HF who remain in sinus rhythm.

Topics: Administration, Oral; Anticoagulants; Aspirin; Cardiomyopathy, Dilated; Chronic Disease; Heart Failure; Heart Rate; Hemorrhage; Humans; Placebo Effect; Placebos; Randomized Controlled Trials as Topic; Rivaroxaban; Stroke; Thromboembolism; Warfarin

In this review, the role of the rivaroxaban-plus-aspirin approach (dual pathway inhibition - DPI) in patients with chronic coronary syndrome (CCS) and to perform practical recommendations about its use was updated.. The contents of this review were proposed in an expert meeting. To identify relevant articles, a systematic search of Medline/Embase was performed (to July 2019), using the key words 'rivaroxaban', 'vascular dose', 'COMPASS' and 'coronary artery disease' in the search strategy.. Despite current antithrombotic strategies (single/dual antiplatelet therapy) have decreased rates of recurrent cardiovascular events among patients with CCS, residual risk remains unacceptably high. The COMPASS trial showed in CCS patients that compared with aspirin 100 mg rivaroxaban 2.5 mg bid plus aspirin 100 mg reduced the risk of major cardiac events, cardiovascular hospitalization and mortality, without an increase of intracranial or fatal bleedings. Importantly, residual risk with the rivaroxaban plus aspirin approach was lower than with different dual antiplatelet therapy regimens. The rivaroxaban plus aspirin strategy is of particular benefit in patients with CCS and high-risk cardiovascular feature (i.e. ≥2 vascular beds, heart failure, renal insufficiency, peripheral artery disease, previous stroke or diabetes) and should be considered in these populations.

Topics: Aspirin; Chronic Disease; Coronary Artery Disease; Drug Therapy, Combination; Factor Xa Inhibitors; Hospitalization; Humans; Platelet Aggregation Inhibitors; Rivaroxaban; Syndrome

Heart failure (HF) and atrial fibrillation (AF) frequently coexist and share a reciprocal relationship. The presence of AF increases the propensity to HF and can worsen its severity as well as escalating the risk of stroke. Despite the proven efficacy of vitamin K antagonists and warfarin for stroke prevention in AF, their use is beset by numerous problems. These include their slow onset and offset of action, unpredictability of response, the need for frequent coagulant monitoring and serious concerns around the increased risks of intracranial and major bleeding. Three recently approved novel anticoagulants (dabigatran, rivaroxaban and apixaban) are already challenging warfarin use in AF. They have a predictable therapeutic response and a wide therapeutic range and do not necessitate coagulation monitoring. In this article, the relationship between HF and AF and the mechanisms for their compounded stroke risk are reviewed. The evidence to support the use of these three NOACs amongst patients with AF and HF is further explored.

Topics: Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Chronic Disease; Dabigatran; Drug Monitoring; Heart Failure; Hemorrhage; Humans; Morpholines; Outcome Assessment, Health Care; Pyrazoles; Pyridones; Risk Assessment; Rivaroxaban; Severity of Illness Index; Stroke; Thiophenes; Warfarin

Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by the obstruction of the main pulmonary artery due to thrombosis and vascular remodeling. Regarding the need for anticoagulant therapy in CTEPH patients, this study aimed to compare rivaroxaban with warfarin in terms of its efficacy and safety in patients undergoing endarterectomy surgery.. The study was a parallel clinical trial in patients who underwent endarterectomy following CTEPH. A total of 96 patients were randomly selected and assigned to two groups: warfarin-treated (control) and rivaroxaban-treated (intervention). Patients were clinically assessed for re-thrombosis, re-admission, bleeding, and mortality in the first, third, and sixth months after surgery.. There was no significant difference in the occurrence of thrombosis between the two groups within the first, third-, and sixth-months post-surgery (p=0.52, 1, 0.38 respectively). Moreover, the mortality rate (p=0.9), bleeding rate (p=0.06), and re-admission rate (p=0.15) showed no significant differences between the two groups.. Rivaroxaban may be as effective as warfarin in treating CTEPH patients after endarterectomy in the short term and can be used as an anticoagulant in these patients. However, studies with long-term follow-ups are needed to consolidate the strategy of treating these patients with rivaroxaban.

Topics: Anticoagulants; Chronic Disease; Endarterectomy; Hemorrhage; Humans; Hypertension, Pulmonary; Pulmonary Embolism; Rivaroxaban; Thrombosis; Treatment Outcome; Warfarin

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.. 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 (. More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.

Topics: Aged; Anticoagulants; Aspirin; Chronic Disease; Coronary Artery Disease; Double-Blind Method; Drug Therapy, Combination; Factor Xa Inhibitors; Female; Fibrinolytic Agents; Heart Disease Risk Factors; Humans; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Recurrence; Risk Assessment; Rivaroxaban; Secondary Prevention; Time Factors; Treatment Outcome

Although acetylsalicylic acid is of proven benefit for secondary prevention in patients with cardiovascular disease, the risk of recurrent ischemic events remains high. Intensification of antithrombotic therapy with more potent antiplatelet drugs, dual antiplatelet therapy, or vitamin K antagonists further reduces the risk of major adverse cardiovascular events compared with acetylsalicylic acid alone but increases the risk of bleeding without reducing mortality. In patients with prior coronary artery disease or peripheral arterial disease the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial revealed that compared with acetylsalicylic acid alone, dual pathway inhibition with low-dose rivaroxaban (2.5 mg twice-daily), an oral factor Xa inhibitor, plus acetylsalicylic acid reduced major adverse cardiovascular event by 24%, major adverse limb events by 47%, and mortality by 18%. Major bleeding was increased by 70%, but there was no increase in fatal or intracranial bleeding. This article (1) reviews the results of the COMPASS trial, (2) explains why dual pathway inhibition is superior to antiplatelet or anticoagulant therapy alone, (3) compares the results with rivaroxaban plus aspirin with those with other antithrombotic regimens, and (4) provides insight into how best to apply the COMPASS results into practice.

Topics: Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Cardiovascular Diseases; Chronic Disease; Coronary Artery Disease; Drug Therapy, Combination; Factor Xa Inhibitors; Female; Fibrinolytic Agents; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Recurrence; Research Design; Rivaroxaban; Secondary Prevention; Stroke

Whether anticoagulation benefits patients with heart failure (HF) in sinus rhythm is uncertain. The COMMANDER HF randomized clinical trial evaluated the effects of adding low-dose rivaroxaban to antiplatelet therapy in patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm. Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.. To examine whether low-dose rivaroxaban was associated with reduced thromboembolic events in patients enrolled in the COMMANDER HF trial.. Post hoc analysis of the COMMANDER HF multicenter, randomized, double-blind, placebo-controlled trial in patients with CAD and worsening HF. The trial randomized 5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017. Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history. Patients were randomized in a 1:1 ratio. Analysis was conducted from June 2018 and January 2019.. Patients were randomly assigned to receive 2.5 mg of rivaroxaban given orally twice daily or placebo in addition to their standard therapy.. For this post hoc analysis, a thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths because not all of these are caused by thromboembolic events.. Of 5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years. Over a median (interquartile range) follow-up of 19.6 (11.7-30.8) months, fewer patients assigned to rivaroxaban compared with placebo had a thromboembolic event including sudden/unwitnessed deaths: 328 (13.1%) vs 390 (15.5%) (hazard ratio, 0.83; 95% CI, 0.72-0.96; P = .01). When sudden/unwitnessed deaths were excluded, the results analyzing thromboembolic events were similar: 153 (6.1%) vs 190 patients (7.6%) with an event (hazard ratio, 0.80; 95% CI, 0.64-0.98; P = .04).. In this study, thromboembolic events occurred frequently in patients with HF, CAD, and sinus rhythm. Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect. While consistent with other studies, these results require confirmation in prospective randomized clinical trials.. ClinicalTrials.gov identifier: NCT01877915.

Topics: Aged; Aspirin; Chronic Disease; Coronary Artery Disease; Death, Sudden; Disease Progression; Double-Blind Method; Drug Therapy, Combination; Factor Xa Inhibitors; Female; Heart Failure; Humans; Male; Middle Aged; Mortality; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Pulmonary Embolism; Rivaroxaban; Stroke; Stroke Volume; Thienopyridines; Thromboembolism; Venous Thrombosis

Patients with chronic coronary artery disease or peripheral artery disease and history of heart failure (HF) are at high risk for major adverse cardiovascular events. We explored the effects of rivaroxaban with or without aspirin in these patients.. The COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized 27 395 participants with chronic coronary artery disease or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg alone. Patients with New York Heart Association functional class III or IV HF or left ventricular ejection fraction (EF) <30% were excluded. The primary major adverse cardiovascular events outcome comprised cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome was major bleeding using modified International Society of Thrombosis and Haemostasis criteria. Investigators recorded a history of HF and EF at baseline, if available. We examined the effects of rivaroxaban on major adverse cardiovascular events and major bleeding in patients with or without a history of HF and an EF <40% or ≥40% at baseline.. Of the 5902 participants (22%) with a history of HF, 4971 (84%) had EF recorded at baseline, and 12% had EF <40%. Rivaroxaban and aspirin had similar relative reduction in major adverse cardiovascular events compared with aspirin in participants with HF (5.5% versus 7.9%; hazard ratio [HR], 0.68; 95% CI, 0.53-0.86) and those without HF (3.8% versus 4.7%; HR, 0.79; 95% CI, 0.68-0.93; P for interaction 0.28) but larger absolute risk reduction in those with HF (HF absolute risk reduction 2.4%, number needed to treat=42; no HF absolute risk reduction 1.0%, number needed to treat=103). The primary major adverse cardiovascular events outcome was not statistically different between those with EF <40% (HR, 0.88; 95% CI, 0.55-1.42) and ≥40% (HR, 0.81; 95% CI, 0.67-0.98; P for interaction 0.36). The excess hazard for major bleeding was not different in participants with HF (2.5% versus 1.8%; HR, 1.36; 95% CI, 0.88-2.09) than in those without HF (3.3% versus 1.9%; HR, 1.79; 95% CI, 1.45-2.21; P for interaction 0.26). There were no significant differences in the primary outcomes with rivaroxaban alone.. In patients with chronic coronary artery disease or peripheral artery disease and a history of mild or moderate HF, combination rivaroxaban and aspirin compared with aspirin alone produces similar relative but larger absolute benefits than in those without HF.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.

Topics: Aged; Aspirin; Chronic Disease; Coronary Artery Disease; Double-Blind Method; Drug Therapy, Combination; Factor Xa Inhibitors; Female; Heart Failure; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Rivaroxaban

Heart failure (HF) is associated with a hypercoagulable state that predisposes to thromboembolism and anti-coagulation may improve clinical outcomes. The oral, direct Factor Xa inhibitor, rivaroxaban, has not been studied in patients with HF. We hypothesized that rivaroxaban would also reduce biomarkers of hypercoagulability in patients with HF.. This study consisted of two cohorts: Cohort 1, open-label, actively controlled with enoxaparin 40 mg once daily, included 8 patients with acute decompensated HF; Cohort 2, double-blind and placebo-controlled, included 18 patients with stable, severe New York Heart Association Class III/IV HF.. The pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban were similar across both cohorts. Biomarker assessments were performed in Cohort 2; prothrombin fragment 1.2 (F1.2) mean concentration decreased by 2.7 ng/ml over 7 days with rivaroxaban, and increased by 11.6 ng/ml with placebo, an absolute difference of 14.3 ng/ml (p = 0.0009). A non-significant reduction in rate of increase of D-dimer (DD) and thrombin-anti-thrombin complex (TAT) levels with rivaroxaban was observed over 7 days (p = 0.31 and p = 0.77, respectively).. Rivaroxaban has similar PK/PD in patients with either acute or chronic HF. In vivo, hypercoagulability biomarkers appear to increase over time. Rivaroxaban reversed this trend for F1.2, and may reduce the rate of increase of DD and TAT in patients with stable, severe HF.

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Antithrombin III; Biomarkers; Chronic Disease; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Female; Fibrin Fibrinogen Degradation Products; Fibrinolytic Agents; Heart Failure; Humans; Male; Middle Aged; Morpholines; Peptide Fragments; Peptide Hydrolases; Prothrombin; Rivaroxaban; Thiophenes; Thrombophilia

The aim was to compare the safety and effectiveness of rivaroxaban and warfarin as anticoagulants for treating patients with post-thrombotic syndrome (PTS) with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting.. This single institution retrospective study analysed patients with PTS with chronic iliofemoral venous occlusion who were prescribed rivaroxaban or warfarin for one year after successfully undergoing iliofemoral venous stenting. The primary safety and efficacy endpoints were bleeding complication rate and primary patency rate at one year. Secondary outcomes included Villalta score, symptom recurrence rate, ulcer healing rate, and clinically driven target lesion revascularisation (CD-TLR) rate during follow up.. From January 2016 to December 2017, 154 legs from 154 patients were included in this study (69 in rivaroxaban group and 85 in warfarin group). The groups were well matched for patient demographics, clinical characteristics, and procedural details. There was no significant difference between the rivaroxaban group and warfarin group in bleeding complication rate (10% vs. 16%, p = .23, hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.25 - 1.37) at one year, as well as major bleeding complication rate (0% vs. 2%, p = .20, HR 0.16, 95% CI 0.01 - 2.61) and minor bleeding complication rate (10% vs. 14%, p = .40, HR 0.67, 95% CI 0.27 - 1.66). The primary patency rate was higher in the rivaroxaban group at one year (84% vs. 71%, p = .049, HR 0.50, 95% CI 0.26 - 0.96) and at two years (79% vs. 63%, p = .037, HR 0.52, 95% CI 0.29 - 0.93). At a mean follow up of 24 months (range 1 - 42 months), the rivaroxaban group had a significantly lower post-operative Villalta score (4.87 ± 3.51 vs. 6.88 ± 5.85, p = .010, t = 2.64, 95% CI 0.50 - 3.52), lower rate of symptom recurrence (4% vs. 32%, p < .001), lower CD-TLR rates (3% vs. 13%, p = .039), and higher ulcer healing rate (90% vs. 59%, p = .004) than the warfarin group.. For PTS patients with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting, rivaroxaban probably exhibited similar safety but superior efficacy to warfarin. However, further prospective control studies with large sample size are necessary to confirm the results.

Topics: Aged; Anticoagulants; Chronic Disease; Databases, Factual; Endovascular Procedures; Factor Xa Inhibitors; Female; Femoral Vein; Hemorrhage; Humans; Iliac Vein; Male; Middle Aged; Postthrombotic Syndrome; Registries; Retrospective Studies; Rivaroxaban; Stents; Time Factors; Treatment Outcome; Vascular Patency; Warfarin

Topics: Aspirin; Chronic Disease; Drug Therapy, Combination; Heart Diseases; Humans; Platelet Aggregation; Platelet Function Tests; Rivaroxaban; Thromboxanes

Direct oral anticoagulants (DOACs) are increasingly prescribed to elderly people, but the epidemiologic data for this population remains scarce. We compared the elderly population taking DOACs and those not taking DOACs (noDOAC).. We included individuals over 75 years old, affiliated to Mutualité Sociale Agricole of Burgundy (a French regional health insurance agency), who had been refunded for a prescribed DOAC between 1st and 30th September 2017. The DAOC group (DAOCG) and noDOAC group (noDOACG) were compared in terms of demographic conditions, registered chronic diseases (RCD), and number and types of prescribed drugs. In the DOACG, we compared the type of prescribing physician and laboratory monitoring for novel prescriptions (initial) and prescription refills (≥ 3 months).. Of the 19 798 included patients, 1518 (7.7%) were prescribed DAOCs and 18 280 (92.3%) were not. Mean and median age was 85 years in the 2 groups (DOACG and noDOACG). In the DOACG, there were more men (50% vs 40.2%), more RCD (88.9% vs 68.7%) and more drugs per prescription (6 ± 2.8 vs 5 ± 2.9) (All P < .01). The DOACG also took more antihypertensive drugs. The most commonly prescribed DOACs were apixaban (42.9%) followed by rivaroxaban (38.4%) and dabigatran (18.6%). Complete blood count, serum creatinine and coagulation function tests were requested for 69.4%, 75% and 22.2%, respectively, of patients prescribed DAOCs.. The DOACG had more RCD and drugs per prescription than the noDOACG; routine laboratory monitoring was insufficient. What's known Platelet aggregation inhibitors (low-dose) are recommended for secondary prevention of cardiovascular events in patients suffering from symptomatic atherosclerosis. The main risk of this treatment is bleeding. What's new A prescription for platelet aggregation inhibitors was found in 34% of geriatric inpatients in this prospective study. Compliance to guidelines was better for symptomatic peripheral artery disease than for primary prevention in accordance with recent publications. Geriatric comorbidities had no impact on the prescription of platelet aggregation inhibitors. Underuse of platelet aggregation inhibitors was observed in 11.3% of cases and overuse in 13.7% of cases.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Antihypertensive Agents; Blood Cell Count; Blood Coagulation Tests; Chronic Disease; Creatinine; Dabigatran; Drug Prescriptions; Female; France; Humans; Kidney Function Tests; Male; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Prospective Studies; Pyrazoles; Pyridones; Rivaroxaban

Topics: Aspirin; Atherosclerosis; Chronic Disease; Clinical Trials as Topic; Death; Drug Therapy, Combination; Factor Xa Inhibitors; Fibrinolytic Agents; Hemorrhage; Humans; Myocardial Infarction; Platelet Aggregation Inhibitors; Rivaroxaban; Secondary Prevention; Stroke; Thrombosis; Vascular Diseases

Despite considerable progress in the field of heart failure about drugs and device therapy, the mortality rate of patients with heart failure remains high. Studies have shown that thromboembolism and stroke are associated with high mortality in patients with heart failure. Although warfarin therapy reduces the rate of ischemic stroke in patients with heart failure, the overall benefit from warfarin in this population seems to be offset by the increased bleeding risk. Thus, whether patients with chronic heart failure might benefit from anticoagulation, especially in patients with sinus rhythm, is still controversial. Rivaroxaban, a new oral anticoagulant, is a selective direct factor Xa inhibitor that is used to reduce thrombin generation, which may bring hope to anticoagulation in patients with heart failure. However, the COMPASS trial and recently published COMMANDER HF trial presented different results. By carefully analyzing 2 clinical trials, we think several factors might explain this different outcome.

Topics: Chronic Disease; Clinical Decision-Making; Evidence-Based Medicine; Factor Xa Inhibitors; Heart Failure; Hemorrhage; Humans; Patient Selection; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Rivaroxaban; Stroke; Thromboembolism; Treatment Outcome

The safety of direct oral anticoagulants (DOACs) in oldest old patients with nonvalvular atrial fibrillation (NVAF) in daily clinical practice has not been systematically assessed. This study examined the safety of DOACs and dicumarol (a vitamin K antagonist) in NVAF geriatric patients.. Prospective study from January 2010 through June 2015, with follow-up through January 2016.. Geriatric medicine department at a tertiary hospital.. A total of 554 outpatients, 75 years or older, diagnosed of NVAF and starting oral anticoagulation.. The main outcome was bleeding, which was classified into major (including those life-threatening) and nonmajor episodes. Statistical analyses were performed with Cox regression.. A total of 351 patients received DOACs and 193 dicumarol. Patients on DOACs were older, with more frequent comorbidities, mobility limitation and disability in activities of daily living, as well as higher mortality, than those treated with dicumarol. The incidence of any bleeding was 19.2/100 person-years among patients on DOACs and 13.7/100 person-years on dicumarol; corresponding figures for major bleeding were 5.2 for those on DOACs, and 3.3 for those on dicumarol. In crude analyses, hazard ratios (95% confidence intervals) for any bleeding, and for mayor bleeding in patients on DOACs vs dicumarol were 1.60 (1.04-2.44) and 2.22 (0.88-5.59), respectively. Excess risk of bleeding associated with DOACs vs dicumarol disappeared after adjustment for clinical characteristics, so that corresponding figures were 1.19 (0.68-2.08) and 1.01 (0.35-2.93). Results did not vary across subgroups of high-risk patients.. In very old patients with NVAF, the higher risk of bleeding associated with DOACs vs dicumarol could be mostly explained by the worse clinical profile of patients receiving DOACs. Risk of bleeding was rather high, and warrants close clinical monitoring.

Topics: Administration, Oral; Age Factors; Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Chronic Disease; Comorbidity; Dabigatran; Dementia; Dicumarol; Disabled Persons; Follow-Up Studies; Hemorrhage; Humans; Mobility Limitation; Prospective Studies; Pyrazoles; Pyridones; Rivaroxaban; Vitamin K

Comparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation (AF) and multiple chronic conditions (MCC) are unknown.. To determine whether there are differences in efficacy and safety of dabigatran, rivaroxaban, and warfarin regarding stroke prevention and bleeding rates, respectively, in elderly patients with AF with MCC.. This retrospective comparative effectiveness analysis included data from the population-based Medicare beneficiaries database, evaluating patients with new AF diagnosed from January 1, 2010, to December 31, 2013, who initiated an oral anticoagulant within 90 days of diagnosis. Patients with CHA2DS2-VASc scores of 1 to 3, 4 to 5, and 6 or higher; HAS-BLED scores of 0 to 1, 2, and 3 or higher; and Gagne comorbidity scores of 0 to 2, 3 to 4, and 5 or higher were categorized as having low, moderate, or high morbidity, respectively. Within morbidity categories, patients receiving dabigatran, rivaroxaban, or warfarin were matched using a 3-way propensity matching, and the relative hazards of stroke, major hemorrhage (MH), and death were evaluated. Data analysis included follow-up from the date of initial anticoagulant use through December 31, 2013.. Rivaroxaban (20 mg once daily), dabigatran (150 mg twice daily), or warfarin therapy.. Ischemic stroke, MH, and death.. The study cohort included 21 979 patients using dabigatran (mean [SD] age, 75.8 [6.4] years; 51.1% female), 23 177 using rivaroxaban (mean [SD] age, 75.8 [6.4] years; 49.9% female), and 101 715 using warfarin (mean [SD] age, 78.5 [7.2] years; 57.3% female). In the propensity-matched cohorts, there were no differences in stroke rates between the 3 oral anticoagulant groups. Dabigatran users had lower hazard of MH compared with warfarin users among patients with low MCC (hazard ratio [HR], 0.62; 95% CI, 0.47-0.83; P < .001; for MCC defined as low CHA2DS2-VASc score), and similar risk in patients with moderate to high MCC. While there was no difference in MH between rivaroxaban and warfarin users, rivaroxaban users had significantly higher MH risk compared with dabigatran users in the medium and high comorbidity groups (HR, 1.24; 95% CI, 1.04-1.48; P = .02 and HR, 1.28; 95% CI, 1.05-1.56; P = .01, respectively). Dabigatran and rivaroxaban users had lower rates of death compared with warfarin users (HR ranged from 0.52-0.84), across comorbidity levels.. Oral anticoagulants are similarly effective in stroke prevention among patients with AF with MCC. However, dabigatran and rivaroxaban use may be associated with lower rates of mortality in patients with MCC.

Topics: Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Chronic Disease; Comorbidity; Dabigatran; Female; Humans; Male; Proportional Hazards Models; Retrospective Studies; Risk Factors; Rivaroxaban; Stroke; Treatment Outcome; United States; Warfarin

Topics: Adult; Age Distribution; Aged; Anticoagulants; Bosentan; Chronic Disease; Female; Humans; Hypertension, Pulmonary; Incidence; Latvia; Male; Middle Aged; Phenylpropionates; Prevalence; Pulmonary Embolism; Pyrazoles; Pyridazines; Pyridones; Registries; Rivaroxaban; Sex Distribution; Sildenafil Citrate; Sulfonamides; Vasodilator Agents; Warfarin; Young Adult

Topics: Adult; Anticoagulants; Chronic Disease; Female; Humans; Hypertension, Pulmonary; Morpholines; Pulmonary Embolism; Rivaroxaban; Thiophenes; Treatment Outcome

Topics: Adolescent; Anticoagulants; Capillaries; Chronic Disease; Factor Xa Inhibitors; Female; Humans; Infarction; Livedo Reticularis; Morpholines; Rivaroxaban; Skin; Thiophenes; Young Adult

Topics: Administration, Oral; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Biomarkers; Chronic Disease; Creatinine; Dabigatran; Fibrinolytic Agents; Glomerular Filtration Rate; Humans; Incidence; Kidney; Kidney Diseases; Morpholines; Netherlands; Patient Selection; Retrospective Studies; Risk Assessment; Risk Factors; Rivaroxaban; Severity of Illness Index; Thiophenes