Management of bleeding associated with dabigatran and rivaroxaban: a survey of current practices

University of Minnesota M.S. thesis. Major: Clinical Research. May 2013. Advisor: Mark T. Reding. 1 computer file (PDF); vi, 36 pages.Dabigatran and rivaroxaban are two new oral anticoagulants that have been recently approved as alternatives to warfarin. Clinical trials have shown non-inferiority of the new oral anticoagulants to warfarin for anti-thrombotic effects with equal to decreased bleeding risk. Unfortunately no standard method to assess the level of anticoagulation or reverse the effects of dabigatran or rivaroxaban is available. Current recommended management of bleeding patients taking dabigatran or rivaroxaban is based on expert opinion. To gain information from experience of physicians who have managed hemorrhaging patients, U.S. non-malignant hematologists were surveyed with a 31% response rate. In total, 43 cases of dabigatran associated hemorrhage and 5 cases of rivaroxaban associated bleeding were reported. Factor concentrates were used in 9 cases of dabigatran hemorrhage with perceived effectiveness ranging from 50-80%. A national registry is needed to track management of hemorrhages until antidotes become available

Management of incidental splanchnic vein thrombosis in cancer patients

A 75-year-old male with metastatic pancreatic cancer is undergoing chemotherapy with gemcitabine. A portal vein thrombosis was incidentally found on surveillance CT scan. He does not report any new abdominal pain or ascites. Should anticoagulation be used to treat asymptomatic portal vein thrombosis

Management of cancer‐associated thrombosis with thrombocytopenia: Impact of the ISTH guidance statement

Abstract Background Optimal management of cancer‐associated thrombosis (CAT) in patients with thrombocytopenia remains difficult given competing risks of recurrent thrombosis and increased bleeding. We determine the impact of the ISTH Scientific and Standardization Committee (SCC) guidance on CAT management and thrombocytopenia on platelet transfusion, bleeding, and recurrent thrombosis. Methods A retrospective review was performed of patients with CAT and thrombocytopenia who required anticoagulation for VTE for 11 months before and after implementation of the ISTH SCC guidance. Medical records were reviewed to identify the type of VTE event, number of platelet transfusions, incidence of bleeding, and VTE recurrence within pre‐ and postintervention time periods. Results A total of 41 and 80 cases were included in the preintervention and postintervention periods, respectively. The preintervention group showed a trend toward less acute VTE events (39% vs 55%; P = .05). The postintervention period had an increased per‐patient platelet transfusion (median, 2.5 vs 4; P = .05). Nonmajor bleeding was increased in the postintervention group (2% vs 16%; P = 0.03) and included all six (8%) major hemorrhages (P = .09). There was numerically less recurrent thrombosis in the postintervention group (20% vs 8%; P = .07), which was not significantly different when accounting for acuity of VTE. Management adherence was strong, at 91%, in the postintervention group. Conclusion The ISTH guidance on management of cancer‐associated thrombosis in patients with thrombocytopenia was successfully implemented in an academic medical center. There was no significant difference in bleeding or recurrent thrombosis outcomes after adjusting for acuity of VTE

Management of the Bleeding Patient Receiving New Oral Anticoagulants: A Role for Prothrombin Complex Concentrates

Ease of dosing and simplicity of monitoring make new oral anticoagulants an attractive therapy in a growing range of clinical conditions. However, newer oral anticoagulants interact with the coagulation cascade in different ways than traditional warfarin therapy. Replacement of clotting factors will not reverse the effects of dabigatran, rivaroxaban, or apixaban. Currently, antidotes for these drugs are not widely available. Fortunately, withholding the anticoagulant and dialysis are freqnently effective treatments, particularly with rivaroxaban and dabigatran. Emergent bleeding, however, requires utilization of Prothrombin Complex Concentrates (PCCs). PCCs, in addition to recombinant factor VIIa, are used to activate the clotting system to reverse the effects of the new oral anticoagulants. In cases of refractory or emergent bleeding, the recommended factor concentrate in our protocols differs between the new oral anticoagulants. In patients taking dabigatran, we administer an activated PCC (aPCC) [FELBA] due to reported benefit in human in vitro studies. Based on human clinical trial evidence, the 4-factor PCC (Kcentra) is suggested for patients with refractory rivaroxaban- or apixaban-associated hemorrhage. If bleeding continues, recombinant factor VIIa may be employed. With all of these new procoagulant agents, the risk of thrombosis associated with administration of factor concentrates must be weighed against the relative risk of hemorrhage

A RIETE registry analysis of recurrent thromboembolism and hemorrhage in patients with catheter-related thrombosis

BACKGROUND: Few studies have investigated the treatment and the outcomes of patients with catheter-related thrombosis (CRT). METHODS: The RIETE registry (Registro Informatizado de Enfermedad TromboEmbólica [Computerized Registry of Patients with Venous Thromboembolism]) is a prospective international registry of consecutive patients with objectively confirmed venous thromboembolism (VTE). We analyzed the characteristics, treatment, and outcomes of patients with CRT. RESULTS: Of 558 patients with CRT, 45 (8%) presented with a pulmonary embolism (PE) concomitantly. More patients had central line-associated thrombosis compared with port systems, but catheter type did not influence the risk of presenting with a PE. Patients with only CRT were more often prescribed low-molecular-weight heparin for the duration of their anticoagulant treatment compared with patients presenting with concomitant PE. VTE recurrences and major bleeding events occurred frequently during treatment with anticoagulation (7 per 100 patient-years and 8.9 per 100 patient years, respectively). The rates of fatal PE recurrences (1.85 per 100 patient-years) and fatal bleeding (2.32 per 100 patient-years) were similar. Patients with an additional transient risk factor for VTE had the lowest risk for VTE recurrences (odds ratio [OR], 0.07; 90% confidence interval [CI], 0.01-0.45) compared with patients with CRT and no additional transient risk factors. PE at presentation increased the risk of recurrent thrombosis by 2.4 times. Renal insufficiency was also an independent predictor of recurrent thrombosis (OR, 3.93; 90% CI, 2.0-7.7). The odds of recurrent thrombosis was decreased by 77% in patients who received anticoagulation therapy for >90 days compared with patients with a shorter treatment (OR, 0.23; 90% CI, 0.1-0.56). CONCLUSIONS: Concomitant PE occurs less frequently in CRT than lower extremity deep venous thrombosis, but it is associated with a worse outcome. CRT occurs in high-risk patients, and duration of anticoagulation must be predicated on balancing these risks.publisher: Elsevier articletitle: A RIETE registry analysis of recurrent thromboembolism and hemorrhage in patients with catheter-related thrombosis journaltitle: Journal of Vascular Surgery: Venous and Lymphatic Disorders articlelink: http://dx.doi.org/10.1016/j.jvsv.2015.03.002 content_type: article copyright: Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.status: publishe

Venous Thromboembolism: A Survey of Oral Anticoagulant Preferences in the Treatment of Challenging Patient Populations.

Venous thromboembolism (VTE) is a highly morbid condition with several available oral anticoagulant treatment options. Numerous studies have been published comparing warfarin to direct oral anticoagulants; however, several populations remain underrepresented in these reports. We surveyed members of The Venous ThromboEmbolism Network U.S. working group regarding their oral anticoagulant preferences for the treatment of VTE in different and challenging populations. In individuals with VTE and no other medical comorbidities, respondents preferred either rivaroxaban (48.7%) or apixaban (48.7%). Apixaban (53.3%) was preferred in elderly individuals with an increased risk of bleeding. Warfarin was preferred in individuals with liver or kidney dysfunction (42% and 47%), altered metabolism (>55%), and antiphospholipid antibody syndrome (84.2%). Low-molecular-weight heparin was preferred in individuals with malignancy (56.6%), followed by edoxaban (23.7%). These findings may help guide clinicians when choosing an anticoagulant in these challenging situations and demonstrate the urgent need for additional study in these groups