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| |  Argatroban Provides Anticoagulation For Patients Intolerant Of Heparin ORLANDO, FL -- November 12, 1997 -- Loyola University researchers announced today that an investigational anticoagulant, argatroban (Novastan®), can replace heparin in heparin-induced thrombocytopenia (HIT) patients undergoing balloon angioplasty (percutaneous transluminal coronary angioplasty, or PTCA). The announcement was made at the American Heart Association’s 70th Annual Scientific Session. The study found that 98 percent of the argatroban-treated HIT patients had favorable outcomes from their PTCA procedures as compared to 94 percent of patients treated with heparin in a historical control group. The study involved 50 patients with a history of HIT, meaning they were allergic to heparin, the standard for injectable anticoagulant therapy. They received argatroban at a dose of 350 µg/kg bolus followed by continuous infusion. The researchers compared the study results to more than 5,000 previous non-HIT patients treated with heparin during PTCA. Aside from the presence or absence of HIT, other patients characteristics were similar in the two groups. "Argatroban appears at least as effective as heparin in providing anticoagulation during balloon angioplasty," said the study’s lead investigator, Bruce Lewis, M.D., chief of cardiology at Catholic Health Partners. "The study suggests that the argatroban-treated patients actually fared better than the heparin-treated historical controls. " "This is a much safer alternative than heparin for patients with HIT because it provides effective anticoagulation with fewer complications. In this study, bleeding complications occurred in one of 50 patients." While not widely known and underdiagnosed, HIT is by no means rare and is a serious cardiovascular condition. It is an immune disorder caused by the development of antibodies to the complex of heparin and a blood protein called platelet factor 4 (PF4). Furthermore, up to 30 percent of heparin-treated patients have the antibody to the heparin PF4 complex and are therefore predisposed to developing HIT. HIT is characterized by a reduction of platelet count occurring after heparin exposure and may lead to Heparin-Induced Thrombocytopenia-Thromboric Syndrome (HITTS). Within 30 days of developing HIT, 52.8 percent of HIT patients will develop this syndrome which is associated with complications such as pulmonary embolism, stroke, skin necrosis, and limb gangrene. The mortality rate if HITTS occurs is estimated to be as high as 35 percent. Patients undergoing balloon angioplasty need anticoagulation during the procedure to prevent unwanted clotting. Administration of heparin to patients with HIT may not only lead to unwanted clotting, but may also significantly reduce platelet levels. This study shows that argatroban can provide the anticoagulation that HIT patients need during PTCA. "During our research, we found that argatroban was easier to use than heparin," Dr. Lewis added. "The combination of argatroban’s fast onset of action and its rapid elimination from the body make it easier to adjust the dose to achieve the required degree of anticoagulation."
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