Coagulation Counseling

FEBRUARY 01, 2009
Anna D. Garrett, PharmD, BCPS, CPP

Dr. Garrett is manager of the Health Education Center at Mission Hospitals in Asheville, North Carolina.

Study Offers New Direction for Antiplatelet Therapy after Stroke

The results of a recent study of anti-platelet therapy for noncardioembolic stroke suggest that clopidogrel is as effective for secondary prevention as aspirin combined with extended-release dipyridamole (ERDP). The ProFESS trial is the largest stroke trial ever performed, with more than 20,000 patients enrolled in 35 different countries. Investigators compared clopidogrel with ERDP/aspirin for secondary stroke prevention. No differences were reported in recurrent stroke rates between the 2 arms of the study (9% over 2.5 years). Bleeding rates were not significantly different.

The investigators concluded that clopidogrel and aspirin/ERDP are similar in efficacy and safety. As a result of this trial, an increase in the use of singleagent clopidogrel for secondary prevention for ischemic stroke is likely.

AHRQ Publishes Guide to Prevention of Venous Thromboembolism

The Agency for Healthcare Research and Quality (AHRQ) of the US Department of Health and Human Services has published a guide, Preventing Hospital-Acquired Venous Thromboembolism, to help hospitals develop and sustain strategies to reduce the incidence of deep vein thrombosis and pulmonary embolism in their surgical patients and other patients.

The free, 50-page guide also includes case studies, as well as examples of chart audit and other forms. Printed copies can be ordered by calling 800-358-9295, or sending an e-mail to .

DVT Awareness Month Is Coming up in March

March is Deep Vein Thrombosis (DVT) Awareness Month. This initiative was started 6 years ago after the death of David Bloom, a reporter, in Iraq. Mr. Bloom was embedded with US forces and was traveling in a tank with military personnel. He died from a pulmonary embolus (PE). His wife, Melanie, is an advocate for DVT awareness and worked with the Coalition to Prevent DVT to have March recognized as DVT Awareness Month.

According to the American Heart Association, up to 2 million Americans are affected annually by DVT. Of those who develop PE, up to 200,000 will die each year. More Americans die annually from DVT/PE than from breast cancer and AIDS combined. According to a national survey sponsored by the American Public Health Association, 74% of Americans have little or no awareness of DVT.

DVT Awareness Month is a perfect time to work with patients and other health care providers to raise awareness of the dangers of DVT and PE. For more information, visit The Web site offers a free risk assessment for the public as well as press releases and other media resources for health care professionals.

Innohep Study Stopped Early Due to Increased Death Rate

The FDA is investigating information it received about the clinical study Innohep in Renal Insufficiency Study (IRIS), which was stopped in February 2008 by the study's Data Safety Monitoring Committee. Interim findings of the study showed an increase in all-cause mortality in patients who received Innohep (tinzaparin). This multicenter European study was designed to evaluate the safety of Innohep, a low-molecular-weight heparin, compared with unfractionated heparin (UFH) in treating deep vein thromboses (DVT) and/or pulmonary emboli (PE) in patients older than 70 years of age who had impaired renal function.

At the time the study was stopped, 350 patients had completed 90 days follow-up. Of these, 23 of the 176 (13%) patients in the Innohep-treated group and 9 of the 174 (5%) patients in the UFH-treated group had died. From the information currently available to the FDA, no clear pattern exists as to the causes of death. The causes of death do not appear to be dose-related. The currently available data are not sufficient to rule out the possibility of another DVT or PE, or both, in patients who received Innohep. Although preliminary data do not appear to indicate a manufacturing problem with Innohep or the UFH used in the study, the FDA cannot rule out this possibility until a thorough analysis of the detailed manufacturing data is completed.