Coagulation Counseling

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-platelettherapy for noncardioembolicstroke suggest that clopidogrel is aseffective for secondary prevention asaspirin combined with extended-releasedipyridamole (ERDP). The ProFESS trial isthe largest stroke trial ever performed,with more than 20,000 patients enrolledin 35 different countries. Investigatorscompared clopidogrel with ERDP/aspirinfor secondary stroke prevention. Nodifferences were reported in recurrentstroke rates between the 2 arms of thestudy (9% over 2.5 years). Bleeding rateswere not significantly different.

The investigators concluded thatclopidogrel and aspirin/ERDP are similarin efficacy and safety. As a result of thistrial, an increase in the use of singleagentclopidogrel for secondary preventionfor ischemic stroke is likely.

AHRQ Publishes Guide to Prevention of Venous Thromboembolism

The Agency for Healthcare Research andQuality (AHRQ) of the US Departmentof Health and Human Services haspublished a guide, Preventing Hospital-Acquired Venous Thromboembolism,to help hospitals develop and sustainstrategies to reduce the incidence ofdeep vein thrombosis and pulmonaryembolism in their surgical patients andother patients.

The free, 50-page guide also includescase studies, as well as examples ofchart audit and other forms. Printedcopies can be ordered by calling 800-358-9295, or sending an e-mail to

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DVT Awareness Month Is Coming up in March

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

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

DVT Awareness Month is a perfect time to work with patients and other healthcare providers to raise awareness of the dangers of DVT and PE. For more information,visit www.preventdvt.org. The Web site offers a free risk assessment for thepublic 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 itreceived about the clinical study Innohepin Renal Insufficiency Study (IRIS),which was stopped in February 2008by the study's Data Safety MonitoringCommittee. Interim findings of the studyshowed an increase in all-cause mortalityin patients who received Innohep(tinzaparin). This multicenter Europeanstudy was designed to evaluate thesafety of Innohep, a low-molecular-weightheparin, compared with unfractionatedheparin (UFH) in treating deepvein thromboses (DVT) and/or pulmonaryemboli (PE) in patients older than70 years of age who had impaired renalfunction.

At the time the study was stopped,350 patients had completed 90 daysfollow-up. Of these, 23 of the 176 (13%)patients in the Innohep-treated groupand 9 of the 174 (5%) patients in theUFH-treated group had died. From theinformation currently available to theFDA, no clear pattern exists as to thecauses of death. The causes of death donot appear to be dose-related. The currentlyavailable data are not sufficient torule out the possibility of another DVTor PE, or both, in patients who receivedInnohep. Although preliminary data donot appear to indicate a manufacturingproblem with Innohep or the UFH usedin the study, the FDA cannot rule outthis possibility until a thorough analysisof the detailed manufacturing data iscompleted.