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New in Coagulation

Sunday, February 5, 2017

What's New in Coagulation - February 2017

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.

Please note - many linked teasers require registered account/subscription in order to view the full articles. Medscape registration is free of charge.

New FDA Watch List Dominated by Cardio, Cancer Drugs

Based on the FDA Adverse Event reporting system, cardiovascular drugs and cancer drugs top the list. However, four anticoagulants made the third-quarter list owing to reports of patients experiencing vasculitis. Three of the anticoagulants - apixaban (Eliquis, Bristol-Myers Squibb), edoxaban tosylate (Savaysa, Daiichi Sankyo), and rivaroxaban (Xarelto, Janssen Pharmaceuticals) - are direct factor Xa inhibitors. The fourth, dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals), is a direct thrombin inhibitor. The FDA then looks to see if there is a link between the drug and the adverse events, this can then prompt further action including a risk evaluation and if required the drug can be pulled from the market.

(Too) Many Patients With AF Stop Warfarin Within a Year

A study published in JAMA Cardiology noted there is a high rate of patients with AF who have had electrical cardioversion or radiofrequency ablation discontinue warfarin. Based on this study 36.7% of patients discontinue therapy within a year. This also makes it difficult to know if the therapies are effective. This study only looked at warfarin and not the DOACs, so there is no information on how they are used.

FDA Review Underway for Eptacog Beta in Hemophilia

Data from the PERSEPT (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials), has supported the FDA review for recombinant Coagulation Factor VIIa (eptacog beta, activated). This is potential treatment for congenital hemophilia A or B with inhibitors.

Emicizumab Prophylaxis Reduced Number of Bleeds in Hemophilia A Trial

The HAVEN 1 study evaluated Emicizumab for prophylaxis in patients with hemophilia A and FVIII inhibitors. This is an investigational bispecific monoclonal antibody. The study evaluated the safety and efficacy of once weekly injections in patients > 12 years of age (n=109) with the primary endpoint being the number of bleeds. A statistically significant reduction in bleeds were found when comparing patients who did not receive prophylaxis or in those that had gotten bypassing agents.

Single Dose of LMWH Could Potentially Interfere with DVT Diagnosis

When paired samples were collected on 50 patients for D-dimer testing pre-administration of LMWH versus post dose of LMWH, can reduce the identification of a deep vein thrombosis. When a sample for D-dimer testing was taking post a single administration of LMWH a 16.4% reduction was seen in d-dimer results. This is most important in borderline d-dimer results, in which could become normal resulting in a patient not getting an ultrasound, which would miss the DVT diagnosis.

Dal Antiplatelet Tx Similar to Aspirin Post-CABG in Diabetes
No difference in cardiovascular, bleeding outcomes in patients with diabetes reeiving DAPT, aspirin

When comparing DAPT and aspirin alone in patients post coronary artery bypass grafting patients with diabetes, there was no significant difference in bleeding outcomes. The researchers found that 68.4 and 31.6 percent of patients, respectively, received DAPT and aspirin alone at 30 days post-CABG. The five-year primary composite outcome did not differ significantly between DAPT- and aspirin-treated patients (12.6 versus 16 percent; adjusted hazard ratio, 0.83; 95 percent confidence interval, 0.54 to 1.27; P = 0.39). This suggests that the routine used of DAPT may not be warranted.

Many Ischemic Stroke Survivors Not Prescribed Anticoagulants
Reasons for not prescribing OAC include fall risk, poor prognosis, bleeding history, older age, dementia

A retrospective study of ischemic stroke patients showed that 44% of patients were not prescribed an oral anticoagulant. The reasons they were not prescribed were due to: fall risk, poor prognosis, bleeding history, participant or family refusal, older age, and dementia. At one year, up to 42.5% of those patients not receiving OAC had died. The focus should be on strategies to mitigate fall risks so patients can benefit from OAC.

Thrombosis Risk With PICC in Critically Ill Children

There has been an increase in VTE seen in children associated with central venous catheters placement. After an analysis of 1096 children, almost 6% of children had VTE of those 85% occurred with peripherally inserted central catheters (PICCs). These are the easiest lines to be placed and do not require surgery, so they are most frequently placed. The CIRCLE study is a prospective, multicenter, observational study enrolling children from four hospitals. The results of the study should help to guide clinical decision making, since there are no guidelines for CVC use. The goal is to have direction for CVC insertion regarding type, technique and the need for prophylaxis.

To Anticoagulate or Not? Surgery and Medication

Patients with AF that have to undergo surgery need to balance if patients should take anticoagulants. Without them they have a risk of stroke, being on them they have a risk of bleeding. Nonvalvular AF patients are at a high risk of stroke versus valvular. The American College of Cardiology developed a clinical decision document to determine the risk of bleeding versus clotting to aid in making better informed decisions to improve patient outcomes. It includes when a patient should be removed from a drug, or bridged before, during and after surgery as well as when the patient should continue post operatively.


Which Hormonal Contraceptives Pose a Lower Thrombosis Risk?

Peter Kovacs, MD, PhD

Hormonal Contraception and Thrombosis

Background:Almost one half of all pregnancies are unplanned,[1] making it important for patients to know about effective forms of contraception. Combined hormonal contraceptive preparations (pill, patch, vaginal ring) are not as effective as intrauterine devices or tubal ligation, but offer more protection than barrier or calendar methods.[2] Among the many hormonal preparations, the contraceptive pill is used most often.

Oral contraceptives are not without side effects, however. An increased risk for cardiovascular disease and venous thromboembolism (VTE) in women taking oral contraceptives has been noted.[3,4]

This paper reviewed the risk for thrombosis with hormonal conceptive methods.

Summary:The baseline risk for VTE is 1-2 per 10,000 reproductive-aged women. Epidemiologic studies have shown an increase in VTE risk of about fourfold among users of oral contraceptives, but this still remains less than the risk for VTE of 20 in 10,000 during pregnancy.


CHA2DS2-VASc Score and Risk for Major Bleeding

CHA2DS2-VASc Scores and Major Bleeding in Patients With Nonvascular Atrial Fibrillation Who are Receiving Rivaroxaban

Peacock WF, Tamayo S, Patel M, Sicignano N, Hopf KP, Yuan Z
Ann Emerg Med. 2016 Nov 29. [Epub ahead of print]

Study Summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its diagnosis and management are crucial tasks for emergency physicians. An important aspect of treating patients with AF is reducing their risk for stroke.

The CHA2DS2-VASc score is a validated risk stratification tool used to help determine when the benefit outweighs the risks of anticoagulation for a patient with AF. However, clinicians often find themselves in a difficult predicament when using CHA2DS2VASc scores in deciding to initiate anticoagulation for patients, because of the potential increased risk in major bleeding. Relating to this dilemma, the CHA2DS2-VASc score and its direct relationship to major bleeding risk has not been previously studied.

In this observational, retrospective cohort investigation, researchers sought to elucidate any relationship which may exist between a patient's CHA2DS2-VASc score and the incidence of nontraumatic major bleeding in patients with nonvalvular AF being treated with rivaroxaban. Ten million patient records from the Department of Defense Military Health System were analyzed as part of this study.

Inclusion criteria were a diagnosis of nonvalvular AF and treatment with rivaroxaban from January 1, 2013, to June 30, 2015. A total of 44,793 patients were identified in the analysis.

The primary outcome was major bleeding defined by the Cunningham algorithm, which is a validated database algorithm used to identify major bleeding during hospitalization from administrative data. Researchers analyzed the composition of the patient population studied, including age, gender, and details regarding bleeding events; dosage of rivaroxaban used; and hospitalization details.

A total of 1352 major bleeding events were identified for 1293 patients. The overall major bleeding incidence rate, based on a person's first major bleeding event, was 2.84 (95% confidence interval, 2.69 to 3.00) per 100 person-years. Forty-one patients had a major bleeding-related fatal outcome. Subgroup analysis was further performed to identify risk for bleeding on the basis of total CHA2DS2-VASc score as well as by category of the score itself.

Overall, researchers found that higher CHA2DS2-VASC scores correlated with increased risk for major bleeding, and patients with vascular disease were at the highest risk.


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