Treatment efficacy and risk of bleeding among cancer patients treated for Venous Thromboembolism with Dabigatran Compared to Warfarin

Introduction@#The special needs of cancer patients offer unique challenges in treating them for venous thromboembolism (VTE). Dabigatran is a novel oral anticoagulant (NOAC) that may be comparable to warfarin in clinical benefit and risks of bleeding. A meta-analysis and systematic review was performed to compare efficacy of prevention of VTE recurrence and risks of bleeding with dabigatran compared to warfarin. @*Methods@#Randomized-controlled trials (RCTs) from various sources comparing dabigatran with warfarin for the prevention of recurrence of VTE were then retrieved and analyzed. The efficacy outcomes looked into was recurrence of VTE and mortality related to VTE while the primary safety outcome looked into was major bleeding. @*Results@#This meta-analysis, which included the studies, RECOVER I, RECOVER II, REMEDY showed that VTE and VTErelated deaths occurred in six out of 174 (3.4%) of cancer patients treated with dabigatran while four out of 166 (3.6%) cancer patients treated with warfarin with a relative risk of 1.44 with a 95% CI of 0.41, 5.03 showing no significant difference between dabigatran and warfarin. The REMEDY trial included a total of 60 cancer patients from a total of 1,430 patients in the dabigatran group versus 59 cancer patients from a total of 1,426 patients in the warfarin group. Under the outcome of major bleeding event, among all patients who received dabigatran, 13 patients had major bleeding events, while among those who received warfarin, 25 patients had major bleeding events with a hazard ratio of 0.52 and 95% CI of 0.27-1.02. With the RECOVER I, and RECOVER II, among cancer patients analysed, four patients of the 105 who received dabigatran had major bleeding; while three of the 100 patients who received warfarin had major bleeding with a HR of 1.23 (95% CI of 0.28-5.5). @*Conclusion@#The authors conclude that dabigatran is comparable to warfarin in the prevention of recurrence of VTE among cancer patients in terms of both benefits and risks.

Hemorrhagic pericarditis associated with rivaroxaban in an atrial fibrillation patient with pacemaker

Rivaroxaban is a new oral anticoagulant used for the prevention of stroke in patients with atrial fibrillation. Hemorrhagic pericarditis is known to occur with rivaroxaban; however, only a few case reports in the literature describe such events. Recently, we experienced hemorrhagic pericarditis that treated with rivaroxaban for anticoagulation of newly diagnosed, non valvular AF patients with pacemaker. An 83 year old male with permanent pacemaker receiving rivaroxaban 20 mg daily once for 3 months presented at our emergency department complaining of exertional dyspnea. ECG showed intermittent atrial pacing failure and echocardiography showed large amount of pericardial effusion. After urgent pericardiocentesis, which resulted in removal of 500cc bloody fluid, there was an immediate and dramatic improvement in the patient's clinical state. He was discharged without anticoagulation therapy due to concern for further bleeding. This case highlight the potential for bleeding complications associated with novel anticoagulants. Rivaroxaban is being used with increasing frequently in outpatient care. However, no available laboratory test specifically measures the anticoagulant effect of rivaroxaban. Also, in the events of serious bleeding, no specific antidotes, reversal agents were available. Clinicians should be aware of the possibility of hemopericardium in patients treated with anticoagulants, including rivaroxaban who presented with cardiomegaly.

Retrospective Analysis on Anticoagulant Therapy with Rivaroxaban in Atrial Fibrillation Patients after Ra-diofrequency Catheter Ablation / 中国药师

Objective:To evaluate the effectiveness and safety of anticoagulant therapy with rivaroxaban in atrial fibrillation( AF) pa-tients after radiofrequency catheter ablation( RFCA) . Methods:A retrospective analysis was performed in the study. Totally 141 AF pa-tients with RFCA in our hospital were enrolled from January 2014 to October 2015. The patients were divided into rivaroxaban group(70 patients)and warfarin group (71 patients). In rivaroxaban group,rivaroxaban(10 mg, po,qd)was given for at least 3 months after RFCA. In warfarin group,low molecular heparin (100 IU·kg-1,ih) was given before RFCA, and standard dose of warfarin (3-5 mg,po,qd) was given for at least 3 months by adjusting the INR within the range of 2. 0-3. 0 after RFCA as bridging therapy. The death rate, throm-boem bolism events and bleeding events between the groups were evaluated and companed groups. Results: There were no significant differences in baseline characteristics between the groups except the diastolic pressure. There were no significant differences in the death and thromboembolism events(transient cerebral ischemia , ischemic encephalopathy, 2/70 vs 4/71,P>0. 05)between the groups. There were no TIMI major bleeding events in both groups. There were no significant differences in minor bleeding events between the groups (3/70 vs 4/71,P>0. 05). Conclusion: Compared with those of warfarin,the effectiveness and safety of rivaroxaban show the similar effect in AF patients after RFCA. Rivaroxaban can be safely and effectively used in AF patients with low or middle risk of thromboembo-lism after RFCA.

Early Experience of Novel Oral Anticoagulants in Catheter Ablation for Atrial Fibrillation: Efficacy and Safety Comparison to Warfarin

PURPOSE: Compared with warfarin, novel oral anticoagulants (NOACs) are convenient to use, although they require a blanking period immediately before radiofrequency catheter ablation for atrial fibrillation (AF). We compared NOACs and uninterrupted warfarin in the peri-procedural period of AF ablation. MATERIALS AND METHODS: We compared 141 patients treated with peri-procedural NOACs (72% men; 58+/-11 years old; 71% with paroxysmal AF) and 281 age-, sex-, AF type-, and history of stroke-matched patients treated with uninterrupted warfarin. NOACs were stopped 24 hours before the procedure and restarted on the same procedure day after hemostasis was achieved. RESULTS: We found no difference in the CHA2DS2-VASc (p=0.376) and HAS-BLED scores (p=0.175) between the groups. The preprocedural anticoagulation duration was significantly shorter in the NOAC group (76.3+/-110.7 days) than in the warfarin group (274.7+/-582.7 days, p<0.001). The intra-procedural total heparin requirement was higher (p<0.001), although mean activated clotting time was shorter (350.0+/-25.0 s vs. 367.4+/-42.9 s, p<0.001), in the NOAC group than in the warfarin group. There was no significant difference in thromboembolic events (1.4% vs. 0%, p=0.111) or major bleeding (1.4% vs. 3.9%, p=0.235) between the NOAC and warfarin groups. Minor stroke occurred in two cases within 10 hours of the procedure (underlying CHA2DS2-VASc scores 0 and 1) in the NOAC group. CONCLUSION: Pre-procedural anticoagulation duration was shorter and intra-procedural heparin requirement was higher with NOAC than with uninterrupted warfarin during AF ablation. Although the peri-procedural thromboembolism and bleeding incidences did not differ, minor stroke occurred in two cases in the NOAC group.

Novel Oral Anticoagulants for the Treatment of Venous Thromboembolism in Cancer Patients

Venous thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, has increased in cancer patients and adversely affects their prognosis. Low-molecular-weight heparins are recommended as efficacious and safe anticoagulation treatment in cancer patients. However, in practice, oral anticoagulation is preferred, especially if longterm or extended treatment is necessary. Novel oral anticoagulants have recently emerged as an alternative to the standard therapy owing to the ease of administration, predictable anticoagulation effect without the need of laboratory monitoring, and fewer drug interactions. These new agents have been shown as effective and safe for the management of cancer-associated thrombosis in ongoing head-to-head comparative trials. Here we review the advances and limitation of current anticoagulant therapies.

Intracranial hemorrhage during administration of a novel oralanticoagulant / Journal of Rural Medicine

<p><b>Objective:</b> Oral anticoagulants are widely administered to patients withatrial fibrillation in order to prevent the onset of cardiogenic embolisms. However,intracranial bleeding during anticoagulant therapy often leads to fatal outcomes.Accordingly, the use of novel oral anticoagulants (NOACs), which less frequently haveintracranial bleeding as a complication, is expanding. A nationwide survey of intracranialbleeding and its prognosis in Japan reported that intracranial bleeding of advancedseverity was not common after NOAC administration. In this report, two cases from ourinstitute are presented.</p><p><b>Patients:</b> Case 1 was an 85-year-old man with a right frontal lobe hemorrhagewhile under dabigatran therapy. Case 2 was an 81-year-old man who had cerebellarhemorrhage while under rivaroxaban therapy.</p><p><b>Result:</b> In both patients, the clinical course progressed without aggravationof bleeding or neurological abnormalities once anticoagulant therapy was discontinued.</p><p><b>Conclusion:</b> These observations suggest that intracranial hemorrhage duringNOAC therapy is easily controlled by discontinuation of the drug. NOAC administration maytherefore be appropriate despite the risk of such severe complications. Further casestudies that include a subgroup analysis with respect to each NOAC or patient backgroundwill be required to establish appropriate guidelines for the prevention of cardiogenicembolisms in patients with atrial fibrillation.</p>