rivaroxaban and Atrial-Flutter

Thrombo-embolic prophylaxis is a key element within the therapy of atrial fibrillation/atrial flutter. Besides new oral anticoagulants the concept of left atrial appendage occlusion has approved to be a good alternative option, especially in patients with increased risk of bleeding.

Topics: Anticoagulants; Atrial Appendage; Atrial Fibrillation; Atrial Flutter; Benzimidazoles; beta-Alanine; Combined Modality Therapy; Contraindications; Dabigatran; Hemorrhage; Morpholines; Pyrazoles; Pyridones; Risk Assessment; Rivaroxaban; Thiophenes; Thromboembolism; Vitamin K

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.

Topics: Administration, Oral; Aspirin; Atrial Fibrillation; Atrial Flutter; Bioprosthesis; Brazil; Cause of Death; Creatinine; Embolism; Factor Xa Inhibitors; Heart Valve Prosthesis; Hemorrhage; Hospitalization; Humans; Ischemic Attack, Transient; Mitral Valve; Rivaroxaban; Sample Size; Stroke; Surgical Procedures, Operative; Thrombosis; Treatment Outcome; Warfarin

Non-vitamin K antagonist oral anticoagulants including rivaroxaban are widely used for stroke prevention in patients with atrial fibrillation (AF). We investigated the relationship between plasma biomarkers (indicative of thrombogenesis, fibrinolysis and inflammation) and left atrial thrombus resolution after rivaroxaban treatment.. This was an ancillary analysis of the X-TRA study, which was a prospective interventional study evaluating the use of rivaroxaban for left atrial/left atrial appendage (LA/LAA) thrombus resolution in AF patients. We assessed various biomarkers of thrombogenesis/fibrinolysis [D-dimer, plasminogen activator inhibitor-1 (PAI-1), prothrombin fragment 1 + 2 (F1,2), thrombin-antithrombin (TAT) complexes, von Willebrand factor (vWF)] and inflammation [high-sensitivity interleukin-6 (hsIL-6), and high-sensitivity C-reactive protein (hsCRP)], measured at baseline and after 6 weeks' of rivaroxaban treatment.. There was a significant decrease in the mean levels of hsCRP, D-dimer, vWF, and TAT from baseline to end of treatment with rivaroxaban. Although none of the thrombogenesis/fibrinolysis biomarkers showed a significant relationship with thrombus resolution, high inflammatory biomarkers at baseline were significantly associated with an increased chance of the thrombus being completely resolved (hsIL-6) or reduced/resolved (hsCRP).. Biomarkers of inflammation are significantly associated with LA/LAA thrombus outcomes in AF patients prospectively treated with rivaroxaban.

Topics: Administration, Oral; Aged; Anticoagulants; Atrial Fibrillation; Atrial Flutter; Biomarkers; Echocardiography; Female; Fibrinolysis; Heart Atria; Heart Diseases; Humans; Male; Middle Aged; Prospective Studies; Rivaroxaban; Thrombosis

Non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran or rivaroxaban are alternatives to vitamin K antagonists (VKAs) for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) and atrial flutter (AFL). Incidences of risk factors for left atrium (LA) and left atrial appendage (LAA) thrombus formation, such as dense spontaneous echo contrast (SEC), low LAA velocity (LAAV) <20 cm/s under treatment with dabigatran and rivaroxaban in comparison with VKAs are unknown.. Any LA abnormality occurred in 9, 3, and 5 % of patients receiving VKA, dabigatran, and rivaroxaban, respectively. The most frequent abnormality was LAA thrombus (VKA: 4 %, dabigatran: 0 %, rivaroxaban: 2 %) and low LAAV of less than 20 cm/s (VKA: 4 %, dabigatran: 1 %, rivaroxaban: 1 %), followed by dense SEC (VKA: 2 %, dabigatran: 1 %, rivaroxaban: 2 %). Results of uni- and multivariate analyses revealed a numerically lower but not significantly different frequency of any LA abnormality under dabigatran (OR 0.4, 95 % Cl 0.08 - 1.88, p = 0.25) and rivaroxaban (OR 0.65, 95 % Cl 0.22 - 1.98, p = 0.45) compared to VKA.. With respect to the incidence of LA abnormalities, dabigatran and rivaroxaban are not inferior to VKA.

Topics: Aged; Atrial Fibrillation; Atrial Flutter; Atrial Function, Left; Dabigatran; Electrocardiography; Female; Heart Atria; Humans; Male; Middle Aged; Rivaroxaban; Thrombosis; Vitamin K

Direct oral anticoagulants (DOACs) have a favorable bleeding risk profile in patients with atrial fibrillation (AF). However, the safety of individual DOACs relative to warfarin for specific bleeding outcomes is less certain. We identified 423,450 patients with AF between 2013 to 2015 in the NCDR PINNACLE national ambulatory registry matched to the Centers for Medicare and Medicaid Services database. Outcomes included time to first major bleed, intracranial hemorrhage (ICH), major gastrointestinal bleed (GIB), or other major bleed. We estimated the association of OAC with bleeding using Cox proportional hazard models. The median duration of follow-up was 1.4 years. OACs were used in 64% of AF patients (66% warfarin, 15% rivaroxaban, 12% dabigatran, and 7% apixaban). A major bleeding event occurred in 6.9% of patients. Compared with warfarin users, fewer patients experienced ICH with the use of rivaroxaban (HR 0.73; 95% CI 0.64 to 0.84), dabigatran (HR 0.56; 95% CI 0.48 to 0.65), and apixaban (HR 0.70; 95% CI 0.55 to 0.90). The risk of major GIB was higher in rivaroxaban users (HR 1.20; 95% CI 1.12 to 1.27), and lower in dabigatran (HR 0.88; 95% CI 0.82 to 0.95) and apixaban (HR 0.84; 95% CI 0.74 to 0.95) users. For any DOAC versus warfarin, age (≥75 or <75 years) interacted with major bleeding (HR 0.93 vs 0.78; p <0.001), GIB (HR 1.10 vs 0.82; p <0.001), and other major bleeding (HR 0.93 vs 0.80; p <0.001). In conclusion, our results suggest that the safety of DOACs is superior to warfarin in AF patients, except with rivaroxaban and GIB. Age ≥75 years attenuated the relative safety benefits of DOACs.

Topics: Administration, Oral; Aged; Anticoagulants; Atrial Fibrillation; Atrial Flutter; Female; Hemorrhage; Humans; Male; Outpatients; Registries; Risk Factors; Rivaroxaban; United States; Warfarin

Rivaroxaban (Xarelto; Johnson & Johnson Services, Inc) is a direct oral anticoagulant (DOAC) that works by directly inhibiting the active site of factor Xa (FXa). Rivaroxaban is metabolized and cleared via the kidney and liver. The results of various studies have shown that patients with severe renal impairment should receive reduced dosages of rivaroxaban or another anticoagulant due to impaired clearance. Although it is not required, monitoring rivaroxaban is useful in some conditions; however, the assays required for such monitoring are not readily available. Herein, we present a case of a 68-year-old Caucasian male patient who was receiving rivaroxaban (20 mg/day) for atrial flutter and had mild renal impairment. The patient was found to have increased effect of rivaroxaban due to further impairment of renal clearance caused by several renally cleared medications. This case highlights the importance of closely examining the renal function of and medication list for a patient before starting DOACs such as rivaroxaban.

Topics: Aged; Atrial Flutter; Factor Xa Inhibitors; Hemorrhage; Humans; Male; Metabolic Clearance Rate; Prothrombin Time; Renal Insufficiency; Rivaroxaban

To assess the impact of the introduction of direct oral anticoagulants upon the outcomes from elective electrical cardioversion for atrial fibrillation.. This is a retrospective comparison of delay to elective cardioversion with different anticoagulants. The data was gathered from a large regional hospital from January 2013 to September 2017. There were 3 measured outcomes: 1) the time in weeks from referral to the date of attempted electrical cardioversion; 2) the proportion of patients who were successfully cardioverted; and 3) the proportion of patients who remained in sinus rhythm by the 12 week follow-up. Time-to-cardioversion was non-parametrically distributed so was analysed with Kruskal-Wallis testing and Mann-Whitney-U testing. Maintenance of sinus rhythm was analysed using z-testing.. 1,374 patients were submitted to cardioversion. The referrals for cardioversion were either from primary care or from cardiologists. At the time of cardioversion, 789 cases were anticoagulated on warfarin (W), 215 on apixaban (A) and 370 on rivaroxaban (R). All 3 cohorts were initially compared independently using Kruskal-Wallis testing. This demonstrated a significant difference in the delay (measured in weeks) between the A and W group (A = 7, W = 9, P<0.00001); the R and W group (R = 7, W = 9, P<0.00001) and no difference between R and A (A = 7, R = 7, P = 0.92). As there was no difference between the A and R groups, they were combined to form the AR group. The AR group was compared to the W group using Mann-Whitney-U testing which demonstrated a significant delay between the groups (AR = 7, W = 9, P<0.00001). Excluding patients with prior or unknown attempts of cardioversion (n = 791), the W patients (n = 152) were less successful in achieving sinus rhythm at cardioversion than the AR (n = 431) group (W = 95% vs AR = 99% P = 0.04). However at 12 weeks, incidence of sinus rhythm was significantly different (W = 40% vs AR = 49% P = 0.049). These groups were compared by z testing. At 12 weeks' follow-up there was no statistical difference in rate of adverse consequences between the AR group and the W group, but the rate of adverse consequences was too low to draw further conclusions.. DOACs appear to significantly shorten the latency between the decision to cardiovert and the cardioversion procedure by at least 2 weeks compared to warfarin in a real-world setting. In this study, patients who had not previously been cardioverted who were anticoagulated with warfarin had a significantly lower probability of conversion to sinus rhythm and a significantly lower probability to remain in sinus rhythm at the 12 week follow-up compared to the combined apixaban and rivaroxaban group.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Atrial Flutter; Clinical Decision-Making; Electric Countershock; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pyrazoles; Pyridones; Retrospective Studies; Rivaroxaban; Thromboembolism; Time-to-Treatment; Treatment Outcome; Warfarin

This case series presents 3 patients with acute kidney injury taking apixaban or rivaroxaban and transitioning to a heparin infusion.. Case 1 was a 78-year-old man admitted with respiratory failure, acute decompensated heart failure, and acute kidney injury. He was taking apixaban for atrial flutter. He was transitioned to an i.v. heparin infusion and had 2 consecutive heparin antifactor-Xa levels greater than 2 units/mL. Heparin was held and resumed about 36 hours later when the apixaban anti-Xa level was less than 50 ng/mL. Case 2 was a 55-year-old man admitted with acute kidney injury, taking apixaban for a recent deep vein thrombosis. Apixaban anti-Xa levels were monitored and i.v. heparin was initiated when the level was less than 100 ng/mL, about 56 hours after the last apixaban dose. Case 3 was a 64-year-old woman admitted with sepsis and acute kidney injury taking rivaroxaban for pulmonary embolism, which occurred 2 weeks prior to admission. Rivaroxaban anti-Xa levels were monitored and i.v. heparin was initiated about 36 hours after the last dose when the level was less than 100 ng/mL. The management strategy did not lead to any thrombotic outcomes; however, 1 patient experienced bleeding.. Specific anti-Xa levels for rivaroxaban and apixaban appeared to be helpful in the transition of 3 patients to unfractionated heparin infusions in the setting of acute kidney injury. These levels provided enhanced, individualized care and likely helped avoid over and under anticoagulation.

Topics: Acute Kidney Injury; Administration, Oral; Aged; Atrial Flutter; Drug Monitoring; Drug Substitution; Factor Xa Inhibitors; Female; Heparin; Humans; Infusions, Intravenous; Kidney; Male; Middle Aged; Pulmonary Embolism; Pyrazoles; Pyridones; Renal Elimination; Rivaroxaban; Venous Thrombosis

Topics: Atrial Flutter; Female; Humans; Male; Medication Adherence; Middle Aged; Rivaroxaban; Treatment Outcome

Direct oral anticoagulants (DOAC) are being increasingly utilised for stroke prevention in atrial fibrillation (AF) and atrial flutter.. To analyse the adoption and application of these drugs in a regional hospital inpatient cohort and compare with national prescribing data.. Digital medical records identified prescribed anticoagulants for patients admitted with AF and atrial flutter during 2013-2014. Analysis of patient demographics and stroke risk identified trends in prescribing DOAC versus warfarin. For broader comparison, data from the Pharmaceuticals Benefits Scheme were sourced to determine the nation-wide adoption of DOAC.. Of the 615 patients identified, 505 (255 in 2013, 250 in 2014) had sufficient records to include in the study. From 2013 to 2014, DOAC prescriptions increased from 9 to 28% (P < 0.001), warfarin and aspirin remained comparatively stable (38-34%, 22-20%), and those prescribed no medication declined (17-8%, P < 0.001). DOAC were prescribed to patients with lower CHA2 DS2 VASc scores than warfarin (3.6 vs 4.4; P = 0.005), lower HAS-BLED scores (1.7 vs 2.3; P < 0.01), higher glomerular filtration rates; 70 vs 63 ml/min; P = 0.002) and younger age (74 vs 77 years; P = 0.006). Nationally, warfarin prescriptions are higher in total numbers but increasing at a slower rate than DOAC, which increased 10-fold (101 158 in 2013, 1 095 985 in 2014).. DOAC prescribing grew rapidly from 2013 to 2014, regionally and nationally. Warfarin prescriptions have remained stable, indicating that more patients are being appropriately anticoagulated for AF who previously were not. DOAC were found to be prescribed to patients with lower CHA2 DS2 VASc and HAS-BLED scores, younger age and higher glomerular filtration rates. Aspirin therapy remains over utilised in AF.

Topics: Administration, Oral; Age Factors; Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Atrial Flutter; Australia; Dabigatran; Drug Prescriptions; Drug Therapy, Combination; Glomerular Filtration Rate; Humans; Pyrazoles; Pyridones; Retrospective Studies; Risk Factors; Rivaroxaban; Severity of Illness Index; Stroke; Warfarin

Data on left atrial/left atrial appendage (LA/LAA) thrombus resolution after non-vitamin K antagonist (VKA) oral anticoagulant treatment are scarce. The primary objective of X-TRA was to explore the use of rivaroxaban for the resolution of LA/LAA thrombi in patients with nonvalvular atrial fibrillation (AF) or atrial flutter, with the CLOT-AF registry providing retrospective data after standard-of-care therapy in this setting.. X-TRA was a prospective, single-arm, open-label, multicenter study that investigated rivaroxaban treatment for 6 weeks for LA/LAA thrombus resolution in patients with nonvalvular AF or atrial flutter and LA/LAA thrombus confirmed at baseline on a transesophageal echocardiogram (TEE). CLOT-AF retrospectively collected thrombus-related patient outcome data after standard-of-care anticoagulant treatment for 3 to 12 weeks in patients with nonvalvular AF or atrial flutter who had LA/LAA thrombi on TEE recorded in their medical file.. In X-TRA, patients were predominantly (95.0%) from Eastern European countries. The adjudicated thrombus resolution rate was 41.5% (22/53 modified intention-to-treat [mITT] patients, 95% CI 28.1%-55.9%) based on central TEE assessments. Resolved or reduced thrombus was evident in 60.4% (32/53 mITT patients, 95% CI 46.0%-73.6%) of patients. In CLOT-AF, the reported thrombus resolution rate was 62.5% (60/96 mITT patients, 95% CI 52.0%-72.2%) and appeared better in Western European countries (34/50; 68.0%) than in Eastern European countries (26/46; 56.5%).. X-TRA is the first prospective, multicenter study examining LA/LAA thrombus resolution with a non-VKA oral anticoagulant in VKA-naïve patients or in patients with suboptimal VKA therapy. Rivaroxaban could be a potential option for the treatment of LA/LAA thrombi.

Topics: Aged; Aged, 80 and over; Atrial Appendage; Atrial Fibrillation; Atrial Flutter; Echocardiography, Transesophageal; Factor Xa Inhibitors; Female; Heart Atria; Heart Diseases; Humans; Male; Middle Aged; Prospective Studies; Registries; Retrospective Studies; Rivaroxaban; Thrombosis

Direct-current cardioversion (DCCV) for persistent atrial fibrillation or atrial flutter (AF) carries a risk of thromboembolic events (TEs). Therapeutic anticoagulation with warfarin is recommended for 3 to 4 weeks before and 4 weeks after DCCV to reduce TE; however, the safety of short-term anticoagulation with the novel oral anticoagulants (dabigatran and rivaroxaban) before DCCV has not been assessed. A retrospective cohort study was performed on all patients undergoing elective DCCV for AF at Northwestern Memorial Hospital from June 1, 2012 to September 30, 2013. Inclusion criteria included patients taking any of the novel oral anticoagulants for 21 to 60 days before DCCV and successful DCCV to sinus rhythm. Patients were monitored for a minimum of 60 days after DCCV to evaluate for TEs including stroke, transient ischemic attack, systemic emboli, and death. In total, 53 patients (47 men, 89%; age 65±10 years, median 66) were evaluated. Agents used were dabigatran (30 patients, 57%) and rivaroxaban (23 patients, 43%) for an average of 38±9 days. The mean CHADS2 score was 1.2±1.1 (score=0, 26%; 1, 43%; 2, 17%; and >3, 13%). Eleven patients (21%) underwent a transesophageal echocardiography before their DCCV; all showed no thrombus. No patients were found to have episodes of TE within 60 days of DCCV. No patients were found to have major bleeding events. In conclusion, the use of short-term dabigatran or rivaroxaban therapy for DCCV of AF appears safe.

Topics: Administration, Oral; Aged; Anticoagulants; Antithrombins; Atrial Fibrillation; Atrial Flutter; Benzimidazoles; beta-Alanine; Dabigatran; Dose-Response Relationship, Drug; Echocardiography, Transesophageal; Electric Countershock; Electrocardiography; Factor Xa Inhibitors; Female; Follow-Up Studies; Humans; Male; Morpholines; Retrospective Studies; Rivaroxaban; Thiophenes; Thromboembolism; Time Factors; Treatment Outcome

Atrial flutter (AFL) ablation requires optimal periprocedural anticoagulation in order to minimize thromboembolic events/bleeding risk. This study describes the characteristics of patients receiving new oral anticoagulants before AFL ablation and assesses complications.. This multicenter, retrospective study reports ischemic and hemorrhagic predischarge, postprocedural complications.. We evaluated 60 patients (62.3% male; mean age: 69.2 ± 9.7 years; CHA2DS2-VASc score: 2.44 ± 1.46, HAS-BLED score: 1.14 ± 0.7). Twenty-one (35.0%) and 23 patients (38.3%) received twice-daily dabigatran 110 or 150 mg; 16 patients (26.6%) received once-daily rivaroxaban (15 mg [n = 5] or 20 mg [n = 11]). Four cases of postprocedural minor bleeding were reported.. This is the first study assessing new oral anticoagulants for periprocedural anticoagulation, specifically in patients undergoing AFL ablation. No major bleeding was reported. Further prospective investigation is warranted.

Topics: Administration, Oral; Aged; Anticoagulants; Atrial Flutter; Benzimidazoles; beta-Alanine; Catheter Ablation; Dabigatran; Female; Humans; Male; Middle Aged; Morpholines; Pilot Projects; Retrospective Studies; Rivaroxaban; Thiophenes; Treatment Outcome

Topics: Atrial Flutter; Catheter Ablation; Coronary Angiography; Drug Monitoring; Echocardiography, Transesophageal; Electrophysiologic Techniques, Cardiac; Factor Xa Inhibitors; Heart Atria; Heart Failure; Humans; Male; Middle Aged; Morpholines; Rivaroxaban; Thiophenes; Thrombosis; Treatment Outcome