rivaroxaban and Arrhythmias--Cardiac

Patients who require perioperative anticoagulation during cardiac implantable electronic device surgery are at increased risk for bleeding complications. The BRUISE CONTROL trial demonstrated that continuing warfarin was safer than heparin bridging, reducing the incidence of clinically significant pocket hematoma. Novel oral anticoagulants are being increasingly prescribed in place of warfarin. The best perioperative management of these new anticoagulants is unknown.. A randomized controlled trial to investigate whether a strategy of continued vs interrupted novel oral anticoagulant (dabigatran, rivaroxaban, or apixaban) at the time of device surgery, in patients with moderate to high risk of arterial thromboembolic events, reduces the incidence of clinically significant hematoma (defined as a hematoma requiring reoperation and/or resulting in prolongation of hospitalization, and/or requiring interruption of anticoagulation). The secondary outcomes include components of the primary outcome, composite of all other major perioperative bleeding events, thromboembolic events, all-cause mortality, cost-effectiveness, patient quality of life, perioperative pain, and satisfaction. Planned analyses include descriptive statistics of all baseline variables. For the primary outcome, interrupted vs continued novel oral anticoagulant arms will be compared using the χ(2) test. If any clinically significant differences are identified, a logistic regression analysis will be conducted. Quality of life will be assessed using EuroQol-5D, and perioperative pain using a visual analog scale.. BRUISE CONTROL-2 is a randomized trial evaluating the best strategy to manage novel oral anticoagulants at the time of device surgery. We hypothesize that device surgery can be performed safely without interruption of these medications.

Topics: Administration, Oral; Anticoagulants; Arrhythmias, Cardiac; Canada; Cause of Death; Dabigatran; Defibrillators, Implantable; Dose-Response Relationship, Drug; Hemorrhage; Humans; Incidence; Pacemaker, Artificial; Practice Guidelines as Topic; Preoperative Care; Prospective Studies; Pyrazoles; Pyridones; Rivaroxaban; Survival Rate; Thromboembolism; Warfarin

We conducted a prospective, single-center, active controlled study from July 2013 to January 2015, in Chinese patients with rapid ventricular arrhythmia who had received radiofrequency catheter ablation (RFCA) treatment to determine formation of lower extremity deep vein thrombosis (LDVT) post RFCA procedure, and evaluated the effect of rivaroxaban on LDVT. Patients with asymptomatic pulmonary thromboembolism who had not received any other anticoagulant and had received no more than 36 hours of treatment with unfractionated heparin were included. Post RFCA procedure, patients received either rivaroxaban (10 mg/d for 14 days beginning 2-3 hours post-operation; n = 86) or aspirin (100 mg/d for 3 months beginning 2-3 hours post-operation; n = 90). The primary outcome was a composite of LDVT occurrence, change in diameter of femoral veins, and safety outcomes that were analyzed based on major or minor bleeding events. In addition, blood flow velocity was determined. No complete occlusive thrombus or bleeding events were reported with either of the group. The lower incidence rate of non-occluded thrombus in rivaroxaban (5.8%) compared to the aspirin group (16.7%) indicates rivaroxaban may be administered post-RFCA to prevent and treat femoral venous thrombosis in a secure and effective way with a faster inset of action than standard aspirin therapy.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Arrhythmias, Cardiac; Aspirin; Catheter Ablation; China; Female; Femoral Vein; Humans; Lower Extremity; Male; Middle Aged; Prospective Studies; Rivaroxaban; Treatment Outcome; Venous Thrombosis; Young Adult

Topics: Arrhythmias, Cardiac; Factor Xa Inhibitors; Humans; Platelet Activation; Receptor, PAR-2; Rivaroxaban

Topics: Aged; Anticoagulants; Arrhythmias, Cardiac; Asthenia; Choice Behavior; Disease Management; Fondaparinux; Heparin; Humans; Male; Polysaccharides; Rivaroxaban; Treatment Outcome

Direct oral anticoagulants (DOACs) are effective for stroke prevention in nonvalvular atrial fibrillation (AF). Cardioversion (CV) is frequently performed in patients with AF or flutter. To further explore the safety profile of DOACs in the context of CV, we sought to assess the prevalence of intracardiac thrombi under DOAC therapy in comparison with treatment with vitamin K antagonists. A total of 672 transesophageal echocardiograms performed in 643 patients with a history of nonvalvular AF were analyzed. The median CHA2DS2-VASc score was 4. Cases were stratified according to anticoagulation with dabigatran (n = 79), rivaroxaban (n = 122), phenprocoumon (n = 180), or bridging therapy (n = 287). In a subgroup analysis, only patients receiving phenprocoumon with an international normalized ratio ≥2 on the day of the investigation or on DOAC therapy for ≥3 weeks were considered. The prevalence of intracardiac thrombi under phenprocoumon was significantly higher than under DOACs (phenprocoumon, 17.8%; all DOACs, 3.9%; dabigatran, 3.8%; rivaroxaban, 4.1%) and showed no significant difference to bridging therapy (12.5%). In patients with sufficient short-term anticoagulation, similar differences between DOAC and phenprocoumon groups were observed (phenprocoumon, 18.4%; all DOACs, 3.8%; dabigatran, 0%; rivaroxaban, 6.6%). The influence of anticoagulation medication on thrombus rates was confirmed after adjusting for baseline intergroup differences regarding left atrial size and CHA2DS2-VASc score. In conclusion, the prevalence of intracardiac thrombi was lower under DOAC therapy than under phenprocoumon in this high-risk patient cohort. Safety of CV during DOAC treatment requires further prospective evaluation.

Topics: Aged; Anticoagulants; Arrhythmias, Cardiac; Benzimidazoles; beta-Alanine; Cohort Studies; Dabigatran; Electric Countershock; Female; Humans; Male; Middle Aged; Morpholines; Phenprocoumon; Prevalence; Rivaroxaban; Thiophenes; Thrombosis; Vitamin K