rivaroxaban and Heart-Valve-Diseases

New oral anticoagulant drugs are emerging as alternatives to warfarin for the prevention of stroke in patients with non-valvular atrial fibrillation. Two agents are direct factor Xa inhibitors (rivaroxaban and apixaban), and the third is a direct thrombin inhibitor (dabigatran). They have been separately compared to warfarin in large randomised trials. Our objective was to indirectly compare the three agents to each other for major efficacy and safety outcomes. Studies were assessed for comparability and the odds ratios of selected outcomes for each anticoagulant versus one another were estimated indirectly. The three cohorts differed significantly in terms of CHADS(2) score and the number of individuals with a past history of stroke, transient ischemic attack or systemic embolism. The estimated odds ratio of stroke or systemic embolism was 1.35 for rivaroxaban vs dabigatran 150 mg (p=0.04), 0.97 for rivaroxaban versus dabigatran 110 mg (p=0.81), 1.22 for apixaban versus dabigatran 150 mg (p=0.18), 0.88 for apixaban versus dabigatran 110 mg (p=0.34) and 0.90 for apixaban versus rivaroxaban (p=0.43). The estimated odds ratio of major bleeding was 1.10 for rivaroxaban versus dabigatran 150 mg (p=0.36), 1.28 for rivaroxaban versus dabigatran 110 mg (p=0.02), 0.74 for apixaban versus dabigatran 150 mg (p=0.004), 0.87 for apixaban versus dabigatran 110 mg (p=0.17) and 0.68 for apixaban versus rivaroxaban (p<0.001). In conclusion, the available data indicate no significant difference in efficacy between dabigatran 150 mg and apixaban for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation. It appears however that apixaban is associated with less major bleeding than dabigatran 150 mg or rivaroxaban and that rivaroxaban is less effective than dabigatran 150 mg in preventing stroke or systemic embolism. Such an indirect comparison should be used only to generate hypotheses which need to be tested in a dedicated randomised trial comparing the three drugs directly.

Topics: Aged; Anticoagulants; Antithrombins; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Clinical Trials, Phase III as Topic; Dabigatran; Embolism; Factor Xa Inhibitors; Female; Heart Valve Diseases; Hemorrhage; Humans; Ischemic Attack, Transient; Male; Morpholines; Multicenter Studies as Topic; Pyrazoles; Pyridones; Randomized Controlled Trials as Topic; Rivaroxaban; Secondary Prevention; Severity of Illness Index; Stroke; Thiophenes; Thrombophilia; Vitamin K; Warfarin

Although apixaban and rivaroxaban are commonly used in patients with atrial fibrillation (AF) and valvular heart disease (VHD), there is limited evidence comparing the 2 drugs in these patients.. To emulate a target trial of effectiveness and safety of apixaban and rivaroxaban in patients with AF and VHD.. New-user, active comparator, cohort study design.. Commercial health insurance database from 1 January 2013 to 31 December 2020.. New users of apixaban or rivaroxaban who had a diagnosis of AF and VHD before initiation of anticoagulant therapy.. The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of gastrointestinal or intracranial bleeding. Cox proportional hazards regression with a robust variance estimator was used to estimate hazard ratios (HRs) and 95% CIs.. When compared with rivaroxaban in a propensity score-matched cohort of 19 894 patients (9947 receiving each drug), apixaban was associated with a lower rate of ischemic stroke or systemic embolism (HR, 0.57 [95% CI, 0.40 to 0.80]) and bleeding (HR, 0.51 [CI, 0.41 to 0.62]). The absolute reduction in the probability of stroke or systemic embolism with apixaban compared with rivaroxaban was 0.0026 within 6 months and 0.011 within 1 year of treatment initiation. The absolute reduction in the probability of bleeding events with apixaban compared with rivaroxaban was 0.012 within 6 months and 0.019 within 1 year of treatment initiation.. Short follow-up time and inability to ascertain some types of VHD.. In this study of patients with AF and VHD, patients receiving apixaban had a lower risk for ischemic stroke or systemic embolism and for bleeding when compared with those receiving rivaroxaban.. National Institutes of Health.

Topics: Anticoagulants; Atrial Fibrillation; Cohort Studies; Embolism; Heart Valve Diseases; Hemorrhage; Humans; Ischemic Stroke; Rivaroxaban; Stroke

Mechanical heart valves (MHV) are extremely durable, but they require permanent use of anticoagulation to prevent thromboembolic events. The only approved therapeutic options are vitamin K antagonists (VKAs), such as warfarin. As a drug class, clinical management is difficult, therefore new alternatives need to be evaluated.. RIWA is a phase II/III, prospective, open-label, randomized, pilot study designed to investigate oral rivaroxaban 15 mg twice daily compared with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in patients with MHV, from August 2018 to December 2019. Patients will undergo transesophageal echocardiography at the beginning and the end of the study (follow-up time 90 days). On an explanatory basis, all events will be analyzed, including stroke, peripheral systemic embolism, valve thrombosis, significant bleeding and death.. Warfarin and similar VKAs are standard therapy for patients with an MHV. Even with the appropriate use of therapy, the incidence of thromboembolic events is high at 1-4% per year. Furthermore, bleeding risk is significant, ranging from 2 to 9% per year. The new frontier to be overcome in relation to use of the new oral anticoagulants is undoubtedly in patients with MHV. A significant portion of people with MHV worldwide will benefit if noninferiority of these new agents is confirmed.. ClinicalTrials.gov identifier: NCT03566303. Recruitment Status: Recruiting. First Posted: 25 June 2018. Last Update Posted: 25 June 2018.

Topics: Adolescent; Adult; Aged; Anticoagulants; Cardiac Surgical Procedures; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Echocardiography, Transesophageal; Heart Valve Diseases; Heart Valves; Humans; Middle Aged; Pilot Projects; Prospective Studies; Randomized Controlled Trials as Topic; Rivaroxaban; Warfarin; Young Adult

Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure.. GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions.. GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.

Topics: Aortic Valve Stenosis; Aspirin; Cardiovascular Diseases; Cause of Death; Clopidogrel; Drug Therapy, Combination; Embolism; Factor Xa Inhibitors; Heart Valve Diseases; Humans; Mortality; Myocardial Infarction; Platelet Aggregation Inhibitors; Postoperative Care; Pulmonary Embolism; Rivaroxaban; Stroke; Thrombosis; Ticlopidine; Transcatheter Aortic Valve Replacement; Venous Thrombosis

The risks of thromboembolism and major bleeding in atrial fibrillation (AF) patients were assessed according to the "Evaluated Heartvalves, Rheumatic or Artificial" (EHRA) classification. Additionally, the safety and efficacy of vitamin K antagonists (VKAs) and non-VKA oral anticoagulants (NOACs) were compared in AF patients with EHRA type 2 valvular heart disease (VHD) versus those with no VHD.. AF patients enrolled in the "Jordan Atrial Fibrillation (JoFib)" study were followed up for thromboembolic events and major bleeding at 30, 180, and 365 days. Patients in the EHRA type 2 VHD and non-VHD groups were sub-grouped to compare different OACs.. 2020 AF patients were recruited. The thromboembolic risk was higher in EHRA type 2 VHD patients compared to non-VHD controls. Major bleeding also occurred at higher rates in EHRA type 2 patients. In addition, NOACs were more effective in preventing thromboembolic events than VKAs and non-anticoagulation in EHRA type 2 VHD patients. Furthermore, EHRA type 2 VHD patients taking rivaroxaban had significantly less thromboembolic risk than their non-anticoagulated counterparts. At the same time, apixaban and warfarin did not significantly lower the risk of thromboembolism compared to non-anticoagulation.. AF patients with EHRA type 2 VHD are at significant risk of thromboembolism and major bleeding. Furthermore, NOACs were more effective than VKAs in preventing thromboembolic events in this group of patients without conferring an added risk of major bleeding. Moreover, rivaroxaban appears to be particularly efficacious.

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Heart Valve Diseases; Hemorrhage; Humans; Jordan; Rivaroxaban; Stroke; Thromboembolism

Topics: Calcinosis; Heart Valve Diseases; Heart Valves; Humans; Kidney; Rivaroxaban

We compared the effectiveness and safety outcomes of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in patients with AF and VHD, as these patients have been partially excluded from clinical trials.. This retrospective cohort study was conducted using the National Health Insurance Research Database in Taiwan. Patients with AF and VHD and above 20 years of age, who were prescribed oral anticoagulants such as warfarin, dabigatran, rivaroxaban, and apixaban, were included. Propensity score matching was performed to balance intergroup differences. The Cox proportional hazards model was used to compare the effectiveness and safety of warfarin and NOACs.. We included 5833 NOAC-warfarin pairs, 3001 dabigatran-warfarin pairs and 2595 rivaroxaban-warfarin pairs. Warfarin and NOACs had similar risk of ischemic stroke (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.79-1.06;. NOACs had a comparable risk of ischemic stroke and bleeding in patients with AF and VHD, and reduced the risk of venous thromboembolism, intracranial hemorrhage, and mortality, compared to warfarin. Therefore, NOAC is an effective and safe alternative to warfarin in these patients.

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Dabigatran; Heart Valve Diseases; Humans; Retrospective Studies; Rivaroxaban; Stroke; Treatment Outcome

This 37-year-old man presented with left sided facial warmth and numbness associated with new sudden-onset right hemiparesis. The patient first developed sudden numbness of his left lip and warmth in left ear which travelled to the rest of left face. His past medical history was significant for hypertension, Hodgkin lymphoma treated with radiation therapy at the age of 10, and sleeve gastrectomy for obesity 1 year ago complicated by bilateral ischaemic cerebral infarctions with residual left hemiparesis. No acute infarcts were found on MRI. Transesophageal echocardiography revealed a complex atheroma near the sinotubular junction in ascending aorta.

Topics: Adult; Anticholesteremic Agents; Aortic Valve; Aspirin; Echocardiography, Transesophageal; Factor Xa Inhibitors; Heart Valve Diseases; Humans; Male; Paresis; Rivaroxaban; Rosuvastatin Calcium; Stroke; Treatment Outcome

INTRODUCTION Atrial fibrillation (AF) is the most common cardiac arrhythmia with a significant risk of morbidity and mortality. Non-vitamin K antagonist oral anticoagulants are the first‑line drugs in stroke prevention in patients with AF. Oral anticoagulant (OAC) therapy may differ between medical centers. OBJECTIVES We compared the clinical characteristics of AF patients treated with OAC in a district and an academic hospital. PATIENTS AND METHODS We analyzed 3528 patients from the multicenter retrospective CRAFT study: 2666 patients from the academic hospital and 862 patients from the district hospital. Their baseline clinical characteristics were compared. RESULTS Patients treated in the district hospital were older (mean [SD] age, 73.9 [10.3] years vs 66.0 [13.4] years; P <0.001) and more likely female (49.1% vs 37.4%; P <0.001). Patients treated in the academic hospital more frequently had paroxysmal AF, while those in the district hospital, permanent AF. The latter group was also more likely to have comorbidities and a higher frequency of previous bleeding episodes or anemia. The groups did not differ regarding kidney function. In both groups, patients were significantly more likely to be on rivaroxaban than on dabigatran. The group treated in the district hospital were at higher risk of thromboembolic events than the other gruop (mean [SD] CHA2DS2VASc score, 4.6 [1.7] vs 3.05 [2.0]; P <0.001), as well as of hemorrhagic events (mean [SD] HASBLED score, 0.6 [0.7] vs 0.4 [0.6]; P <0.001). CONCLUSIONS Patients with AF treated with OACs in the district and academic hospitals have different clinical characteristics. Patients treated in the district hospital were older, had more comorbidities, more frequently had permanent AF, and were at higher risk of thromboembolic and bleeding events than patients treated in the academic hospital.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Dabigatran; Female; Heart Valve Diseases; Hospitals, District; Hospitals, University; Humans; Male; Middle Aged; Retrospective Studies; Risk Factors; Rivaroxaban; Stroke; Thromboembolism

We examined a large community-based sample of patients with atrial fibrillation (AF) and valvular heart disease (VHD) (excluding prosthetic valves) with a goal to compare outcomes among patients with AF, with and without VHD, taking warfarin, dabigatran, and rivaroxaban.. We identified Medicare beneficiaries enrolled in Medicare Part D benefit plan from 2011 to 2013 with newly diagnosed AF (18 137 patients with VHD [dabigatran, 1979; rivaroxaban, 2027; warfarin, 14 131] and 85 596 patients without VHD [dabigatran, 13 522; rivaroxaban, 14 257; warfarin, 57 817]). Primary outcomes of all-cause mortality, ischemic strokes, major bleeding, and myocardial infarction were compared across the 3 anticoagulants using 3-way propensity-matched samples. After propensity matching, a total of 5871 patients with VHD and 40 221 patients without VHD and AF were studied. Both dabigatran and rivaroxaban were associated with significantly lower risk of death in patients with VHD with AF (dabigatran versus warfarin: hazard ratio, 0.71; 95% confidence interval, 0.52-0.98;. In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism.

Topics: Administration, Oral; Aged; Anticoagulants; Atrial Fibrillation; Dabigatran; Dose-Response Relationship, Drug; Factor Xa Inhibitors; Female; Follow-Up Studies; Heart Valve Diseases; Humans; Male; Medicare; Retrospective Studies; Rivaroxaban; Thromboembolism; Treatment Outcome; United States; Warfarin

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Dabigatran; Heart Valve Diseases; Humans; Rivaroxaban; Stroke

Dabigatran and rivaroxaban are non-vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes.. To compare risks of thromboembolic stroke, intracranial hemorrhage (ICH), major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran or rivaroxaban treatment for stroke prevention.. Retrospective new-user cohort study of 118 891 patients with nonvalvular AF who were 65 years or older, enrolled in fee-for-service Medicare, and who initiated treatment with dabigatran or rivaroxaban from November 4, 2011, through June 30, 2014. Differences in baseline characteristics were adjusted using stabilized inverse probability of treatment weights based on propensity scores. The data analysis was performed from May 7, 2015, through June 30, 2016.. Dabigatran, 150 mg, twice daily; rivaroxaban, 20 mg, once daily.. Adjusted hazard ratios (HRs) for the primary outcomes of thromboembolic stroke, ICH, major extracranial bleeding including major gastrointestinal bleeding, and mortality, with dabigatran as reference. Adjusted incidence rate differences (AIRDs) were also estimated.. A total of 52 240 dabigatran-treated and 66 651 rivaroxaban-treated patients (47% female) contributed 15 524 and 20 199 person-years of on-treatment follow-up, respectively, during which 2537 primary outcome events occurred. Rivaroxaban use was associated with a statistically nonsignificant reduction in thromboembolic stroke (HR, 0.81; 95% CI, 0.65-1.01; P = .07; AIRD = 1.8 fewer cases/1000 person-years), statistically significant increases in ICH (HR, 1.65; 95% CI, 1.20-2.26; P = .002; AIRD = 2.3 excess cases/1000 person-years) and major extracranial bleeding (HR, 1.48; 95% CI, 1.32-1.67; P < .001; AIRD = 13.0 excess cases/1000 person-years), including major gastrointestinal bleeding (HR, 1.40; 95% CI, 1.23-1.59; P < .001; AIRD = 9.4 excess cases/1000 person-years), and with a statistically nonsignificant increase in mortality (HR, 1.15; 95% CI, 1.00-1.32; P = .051; AIRD = 3.1 excess cases/1000 person-years). In patients 75 years or older or with CHADS2 score greater than 2, rivaroxaban use was associated with significantly increased mortality compared with dabigatran use. The excess rate of ICH with rivaroxaban use exceeded its reduced rate of thromboembolic stroke.. Treatment with rivaroxaban 20 mg once daily was associated with statistically significant increases in ICH and major extracranial bleeding, including major gastrointestinal bleeding, compared with dabigatran 150 mg twice daily.

Topics: Aged; Aged, 80 and over; Antithrombins; Atrial Fibrillation; Cohort Studies; Dabigatran; Factor Xa Inhibitors; Female; Follow-Up Studies; Gastrointestinal Hemorrhage; Heart Valve Diseases; Humans; Kaplan-Meier Estimate; Male; Medicare; Retrospective Studies; Risk Factors; Rivaroxaban; Stroke; Treatment Outcome; United States

Topics: Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dabigatran; Heart Valve Diseases; Humans; Morpholines; Pyrazoles; Pyridones; Rivaroxaban; Thiophenes

Topics: Adult; Aortic Valve; Aortic Valve Insufficiency; Bicuspid Aortic Valve Disease; Bioprosthesis; Drug Resistance; Echocardiography, Doppler; Follow-Up Studies; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Male; Mutation; Polymerase Chain Reaction; Polymorphism, Genetic; Postoperative Care; Retreatment; Rivaroxaban; Severity of Illness Index; Treatment Outcome; Vitamin K Epoxide Reductases; Warfarin

Topics: Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dabigatran; Heart Valve Diseases; Humans; International Normalized Ratio; Morpholines; Rivaroxaban; Stroke; Thiophenes; Warfarin