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New in Coagulation

Tuesday, November 8, 2016

What's New in Coagulation - November 2016

Written By Donna Castellone, MS, MT (ASCP) SH | LinkedIn

Want to be in the know? Check out our monthly compilation of the latest studies, guidelines, and discussions in coagulation.

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Fewer Major Bleeds, Same Strokes, on Dabigatran vs Rivaroxaban for AF: Medicare Cohort

This article looks at a cohort of elderly patients (>65 years of age) with AF and how dabigatran (150mg 2/day) and rivaroxaban (20mg, 1/day) provide protection against VTE. Based on the outcome dabigatran was found to be safer with a statistically significant decrease in bleeding (ICH and GI). Both NOACs had equivalent reductions in stroke risk.

Bivalirudin Doesn't Cut CV Events vs Heparin in ACS: MATRIX

This study compared the results of adverse events in ACS patients with or without ST elevation on patients being treated with either unfractionated heparin versus bivalirudin. No reduction in events were seen. (5.9% adverse events bivalirudin and 6.5% UFH with ST segment elevation) (15.9% adverse events bivalirudin and 16.4% UFH without ST segment elevation). Additional findings noted bleeding less common with bivalirudin but no difference in stent thrombosis with both treatment groups. Bivalirudin was associated with a lower risk of stroke compared with heparin in patients with ST segment elevation but a higher risk of stroke in patients without ST segment elevation.

New Guidelines Recommend NOACs to Prevent VTE

The new chest guidelines on antithrombotic therapy for pulmonary embolism and deep vein thrombosis (DVT) includes 54 recommendations. There is one recommendation that is an important change from the previous ACCP guidelines. It recommends to use novel oral anticoagulants (NOACs) rather than warfarin as the first choice to anticoagulate all noncancer patients who have pulmonary embolism or DVT. The 4 NOACs that are FDA approved for this use are: dabigatran, rivaroxaban, apixaban, and edoxaban. Their efficacy is the same as warfarin, but are safer with far fewer major bleeding complications [and] minor bleeding complications, and less intracranial hemorrhage. They are prescribed in a fixed dose, do not require monitoring, and do not require bridging with LMWH. There is an observation of an increased utilization of NOACs and the decrease use of warfarin.

FDA Finds Faulty INR Monitor Did Not Affect ROCKET AF Results

In the ROCKET AF trial which was conducted to monitor anticoagulation in patients randomly assigned to receive warfarin compared with the group receiving rivaroxaban an Alere INRatio system was used. However this device was part of a class I recall by the FDA because of its potential to generate inaccurate results. It was speculated that the device could have made the warfarin results appear worse than they were are falsely low reading could have caused warfarin doses to be unnecessarily increased resulting in increased bleeding. The FDA conducted their own studies and found out that the monitor did not significantly affect the trial's overall results. Their conclusion was that rivaroxaban is a safe and effective alternative to warfarin in patients with AF.

Pulmonary Embolism Blamed for One in Six Syncope Episodes in Italian Study

The New England Journal of Medicine published a study in which Italian researchers confirmed pulmonary embolism (PE) in about one in six patients admitted to 11 hospitals for a first episode of syncope during a 2-year period. This appears to account for the sudden loss of consciousness in up to 17% of cases. A high pretest probability with the Wells score should prompt investigation for a PE. Syncope was defined as a transient loss of consciousness with rapid onset, short duration and spontaneous resolution. PE was identified in 17.3% of elderly (mean age 76) patients.


Direct Oral Anticoagulants: A Patient-Centered Review

Jenna M. Solomon, PharmD; Anne L. Hume, PharmD, FCCP, BCPS
Journal for Nurse Practitioners. 2016;12(8):523-529.

Abstract and Introduction

Abstract Since 2010, 4 new oral anticoagulants have been approved by the Food and Drug Administration with additional drugs in development. Major studies of atrial fibrillation and venous thromboembolism have shown the noninferiority, and the potential superiority, of these anticoagulants compared with warfarin. However, important limitations exist in these studies including suboptimal warfarin management and the inclusion of few participants with significant chronic kidney disease and concomitant drug therapy. The new oral anticoagulants offer both advantages and disadvantages over standard warfarin therapy.

Introduction Although effective in treating deep venous thrombosis (DVT) and pulmonary embolism (PE), as well as reducing the risk of stroke in atrial fibrillation (AF), the safe use of warfarin is challenging, especially in older adults.

In the past 5 years, dabigatran, rivaroxaban, apixaban, and edoxaban have been approved by the Food and Drug Administration. Labeled indications have included the treatment of DVT and PE, prevention of recurrent DVT and PE, the prevention of stroke in patients with nonvalvular atrial fibrillation (AF), and prophylaxis after joint replacement surgery. The purpose of this review is to present a concise summary of the new oral anticoagulants.

A Retrospective Analysis of the Combined Use of PERC Rule and Wells Score to Exclude Pulmonary Embolism in the Emergency Department

JMG Theunissen; C Scholing; WE van Hasselt; J van der Maten; E ter Avest
Emerg Med J. 2016;33(10):696-701.

Abstract and Introduction

Abstract Background The pulmonary embolism rule-out criteria (PERC) rule is an eight-factor decision rule to support the decision not to order a diagnostic test when the gestalt-based clinical suspicion on pulmonary embolism (PE) is low.

Methods In a retrospective cohort study, we determined the accuracy of a negative PERC (0) in patients with a low Wells score (<2) to rule-out PE, and compared this to the accuracy of the default algorithm used in our hospital (a low Wells score in combination with a negative D-dimer).

Results During the study period, 377 patients with a Wells score <2 were included. CT pulmonary angiography (CTPA) was performed in 86 patients, and V/Q scintigraphy in one patient. PE was diagnosed in 18 patients. 78 patients (21%) had a negative PERC score. When further diagnostic studies would have been omitted in these patients, two (subsegmental) PEs would have been missed, resulting in a sensitivity of 89% (64%–98%) and a negative likelihood ratio (LR–) of 0.52 (0.14–1.97). The default algorithm missed one (subsegmental) PE, resulting in a sensitivity of 95% (71%–99%) and an LR – of 0.25 (0.04–1.73).

Conclusions The combination of a Wells score <2 and a PERC rule of 0 had a suboptimal sensitivity for excluding PE in our sample of patients presenting in the ED. Further studies are warranted to test this algorithm in larger populations.

Pathogenesis, Diagnosis, and Treatment of Venous Thromboembolism in Older Adults

Stacy A. Johnson, MD; G. Paul Eleazer, MD; Matthew T. Rondina, MD, MS
J Am Geriatr Soc. 2016;64(9):1869-1878.

Abstract and Introduction

Abstract Older adults have a significantly greater risk of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, than younger adults. The cause of this greater risk is thought to be multifactorial, including age-related changes in hemostatic factors and greater comorbid conditions and hospitalizations, but is not completely understood. Moreover, VTE remains underrecognized in older adults and may present atypically. Thus, a low index of clinical suspicion is essential when evaluating older adults with possible VTE. Despite this underrecognition in older adults, the diagnostic approach remains similar for all age groups and includes estimation of pretest probability, measurement of the D-dimer, and imaging. Antithrombotic agents are the mainstay of VTE treatment and, when used appropriately, substantially reduce VTE recurrence and complications. The approval of novel oral anticoagulants (NOACs), including dabigatran, rivaroxaban, apixaban, and edoxaban, provide clinicians with new therapeutic options. In some individuals, NOACs may offer advantages over warfarin, including fewer drug interactions, more-predictable anticoagulation, and lower risk of bleeding. Nevertheless, anticoagulation of VTE in older adults should always be performed cautiously, because age is a risk factor for bleeding complications. Identifying modifiable bleeding risk factors and balancing the risks of VTE recurrence with hemorrhage are important considerations when using anticoagulants in older adults.

Introduction The annual incidence of venous thromboembolism (VTE) in the general population is approximately 0.1% (1 in 1,000 persons). The incidence of VTE increases markedly with aging (a nonmodifiable VTE risk factor). For example, the incidence of VTE in adults aged 75 and older is approximately 7–10 times as high as in adults younger than 55. VTE risk rises even more in adults aged 85 and older.[1 - 4] Approximately 60% of all VTE occurs in individuals aged 70 and older, and accordingly, some studies have suggested that 90% or more of the incidence of VTE in the general population can be attributed to aging.[2] Older adults may also be more likely to develop pulmonary embolism (PE) than deep vein thrombosis (DVT) and have higher VTE-associated case-fatality rates than younger adults.[1,5,6]


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