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New in Coagulation

Monday, October 10, 2016

What's New in Coagulation - October 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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Trevo Clot Retrievers Approved for Use With tPA

Author: Robert Lowes

The Trevo ProVue and Trevo XP ProVue Retrievers have been FDA approved for use in conjunction with tissue plasminogen activator (tPA) for acute ischemic strokes. This approval can aid in the reduction of devastating disabilities that are associated with these strokes. The retrievers are inserted into the occluded blood vessel via a catheter. They are used within 6 hours of onset of symptoms and post tPA administration. The approval was based on a clinical trial outcome that demonstrated when the Trevo device was used 29% were functionally independent 3 months post stroke versus 19%.

Factor Xa Reversal Agent Shows Rapid Effectiveness in Preliminary Results

Author: Larry Hand

The drug Andexanet alfa (AndexXa, Portola Pharmaceuticals), a factor Xa inhibitor antidote was developed to reverse the effects of factor Xa inhibitors. The drug worked quickly and was well tolerated in reversing acute anticoagulant-related, potentially life-threatening bleeding, This was observed in the Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4) study in patients who required reversal due to acute bleeding from apixaban, rivaroxaban or edoxaban. Site of bleeding were gastrointestinal and intracranial.

Andexanet alfa was given as a bolus (15-300 minutes), then via infusion for 2 hours. An 89-94% decrease in anti-factor Xa activity was noted within 30 minutes of bolus, dependent on the drug given. Thrombotic events occurred within 3 days of andexanet in four patients (6%) and by 30 days in 12 (18%). Eighteen patients (27%) restarted anticoagulation by 30 days. Ten deaths (15%) occurred within 30 days, six of them attributed to cardiovascular causes.

Some Women With VTE May Be Able to Stop Anticoagulants

Author: Larry Hand

A presentation at the European Society of Cardiology revealed that women who have a low clinical decision score and safely discontinue taking anticoagulants after unprovoked VTE. This is contrary to guidelines which recommend lifelong anticoagulants. The scoring system was based on 1. Hyperpigmentation, edema or redness (HER), 2. A D-dimer (D), 3. Obesity (O), and 4. Older age (O). (HERDOO)

Women with two or more HERDOO points had a 14% risk of recurrent blood clots in the year after stopping anticoagulants in the derivation study, versus women with zero or 1 HERDOO points had a 1.6% risk of recurrent blood clots. Anticoagulants can be discontinued if the stated risk is <5% after 1 year.

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ACS by Plaque Erosion? No Stent, Dual Antiplatelets May be Enough: Early Data

Author: Marlene Busko

Stent implant may not be necessary in patients arriving at the ED who present with plaque erosion versus plaque rupture. Anticoagulant therapy may be sufficient to restore blood flow. It is possible to distinguish from plaque rupture from plaque erosion using optical coherence tomography. Plaque erosion has different morphological characteristics such as preserved vascular integrity, larger lumen and visible platelets. Aspirin and ticagrelor appear to be the therapy of choice. Further studies are required to determine if this less invasive treatment leads to long-term successful outcomes.

An uncontrolled, prospective proof-of-concept study in patients with ACS including STEMI, was conducted.They identified 405 patients who had analyzable OCT images, and of these, 103 patients (25.4%) had plaque erosion, whereas 60.7% had plaque rupture and the rest had neither. Treatment included DAPT, and UFH, they had coronary angiography, and GPIIb/IIIa inhibitors or manual aspiration thrombectomy.

Of these, 60 patients with plaque erosion formed the study cohort: they had a residual diameter stenosis of <70% on angiogram with TIMI flow grade 3 and were stable and asymptomatic. The patients received unfractionated heparin or low-molecular-weight heparin for 3 days and continued treatment with DAPT (with aspirin [100 mg/day] and ticagrelor [90 mg, twice per day]). A total of 55 of the 60 patients completed the 1-month follow-up. A total of 47 of 60 patients (78%) had a >50% reduction of thrombus volume measured by OCT at 1 month, the study's primary end point.Moreover, 22 of 60 patients (34%) had no visible thrombus at 1 month.

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Safe, Still Works: Post-ICH Oral Anticoagulation for Atrial Fibrillation

Author: Sue Hughes

A study looked at AF patients who presented with an intracranial hemorrhage and the reintroduction of oral anticoagulant therapy. It was noted that there was a clear reduction in mortality as well as a reduction in ischemic stroke rates versus patients who did not resume OAT. It has always been a challenge to know if and when to restart these ICH patients on OAT. There needs to be a balance the benefit of the OAT versus the risk of additional bleeding. Recommendations presently include a consensus statement of restarting between 4-8 weeks post ICH. However this statement was based on not only ICH.

The study used individual-level data from three nationwide registries. Patients included had been taking oral anticoagulants for AF and had had an incident hemorrhagic stroke(n=1458) or traumatic ICH (n=1206). Those patients who survived the ICH (n=2664) were followed from 14 days after hospital discharge, and whether or not they resumed taking oral anticoagulants and how this affected future outcomes were examined: 91% were on warfarin; 4% were taking dabigatran: 3% rivaroxaban, and 2% apixaban.

Outcomes demonstrated patients having an hemorrhagic stroke with an increased risk of ICH if anticoagulation was resumed versus those with a traumatic stroke and a significantly lower recurrent rate of ICH and treatment.

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Death From Crimean-Congo Hemorrhagic Fever in Spain After Tick Bite

Author: Isabelle Catala

A 62-year-old man died of Crimean-Congo hemorrhagic fever (CCHF) in a Madrid hospital on August 25 after being bitten by a tick during a walk in the countryside in the province of Castile and León. The cause of death was acute liver failure. A nurse who was caring for him also became infected, and is in stable condition. Additionally 190 people who came in contact with these 2 patients are being monitored. The virus has been known in Spain since 2010 due to the importing of animals such as cattle, sheep and goats and transmitted by tick bites. The ticks of the genus Hyalomma contain genetic material from the CCHF virus. The virus is caused by a nairovirus and is symptomatic 5-6 days post tick bite. The mortality rate is 30% with death from severe kidney or liver disease.

Aspirin Overuse May Exceed Underuse in Diabetes

Author: Miriam E. Tucker

A clinical decision support tool may help improved the utilization of adhering to guidelines for aspirin prescribing. Aspirin has been overused more often than it has been underused as primary prevention for cardiovascular disease in patients with diabetes, new research suggests. Also, underuse of aspirin for primary prevention has been more of a problem than overuse in people with reversible cardiovascular risk factors who don't have diabetes, since clinical information to assess this may be lengthy and not completed by the clinician. Cardiovascular Wizard is a tool that automatically identifies people with risk. The tool provides real-time clinical decision support through the electronic health record during patient encounters and prioritizes clinical actions based on patient benefit. Specifically, the tool calculates 10-year atherosclerotic vascular disease (ASCVD) risk and potentially reversible risk percentage and generates individualized goals and priorities. It also promotes shared decision making.

Ticagrelor Safe if Stopped at Least One Day Before CABG

Author: Marilynn Larkin

This cohort of patients presents as a challenge due to the balance required between thrombosis and bleeding in relation to the surgery and optimizing anticoagulant therapy. Pretreating coronary artery bypass grafting (CABG) patients with ticagrelor is safe, if the antithrombotic is discontinued more than 24 hours before surgery, researchers suggest. Current guidelines state ticagrelor should be discontinued 5 days prior to surgery, however this may result in an increased risk of cardiovascular events while waiting for the surgery. A registry of 786 patients were analyzed included those on aspirin alone (n=496) and those on ticagrelor with or without aspirin (n=290). Bleeding rates were similar, however the incidence of platelet transfusion was higher in the ticagrelor group versus aspirin (10.5-6.0%)

Among those in whom the drug was discontinued at least two days before surgery, the incidence of platelet transfusion was 12.4% in the ticagrelor group and 3.6% in the aspirin-alone group. Those receiving treatment one day prior to surgery had an increased rate of severe bleeding.

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