http://www.medpagetoday.com/Cardiolo...ndrome/tb/1684
MedPage Today Action Points
- Advise patients who ask about bleeding with angioplasty that drugs used to treat ischemia can increase risk of bleeding associated with stenting and other percutaneous interventions.
- This study was published as an abstract and presented orally as a late-breaking report at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
ESC: Lovenox Reduces Bleeding in Elective Angioplasty
By Peggy Peck, Senior Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine.
September 07, 2005
Also covered by: Forbes
Review
STOCKHOLM, Sept. 7-Just 24 hours after the anti-coagulant Lovenox (enxaparin) came up short on safety compared with Arixtra (fondaparinux), investigators reported that the drug significantly reduces the risk of major bleeding in patients undergoing elective angioplasty.
During a late breaking clinical trials session at the European Society of Cardiology Congress 2005, Gilles Montalescot, M.D., Ph.D., of Centre Hospitalier Universitaire Pitié-Salpétrière in Paris said patients treated with Lovenox "had a 57% reduction in major bleeds compared with patients receiving unfractionated heparin."
The major bleed rate in patients treated with Lovenox at 0.75 mg was 1.2% compared with a 2.8% major bleed rate in the unfractionated heparin arm (P=0.007).
"Safety," Dr. Montalescot said, "is clearly the most important issue with these drugs. Enoxaparin is safer."
A day earlier, results of a trial of 20,000 acute coronary syndrome patients reported that Arixtra reduced bleeding by 47% compared with Lovenox. Asked about those results, Dr. Montalescot said that the patient populations in the two studies are different, which makes it difficult to compare the results.
Moreover, he noted, in the earlier trial results, a study known as Organization to Assess Strategies for Ischemic Syndromes (OASIS-5), some patients received both Arixtra and unfractioned heparin, "so the findings are not so clear" as the results from his trial. The latter is called Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE), which had no crossover.
American Heart Association president Robert Eckel, M.D., a professor at the University of Colorado Health Sciences Center in Denver, agreed that it is difficult to compare OASIS and STEEPLE. He said the STEEPLE results suggest that Lovenox reduces bleeding risk.
"With two million percutaneous coronary interventions performed worldwide each year, widespread introduction of [Lovenox] would reduce complications in major and minor bleeding by one third," said Dr. Montalescot.
The 3,528-patient study was conducted at 124 sites in nine countries in Europe, North America, and Australasia, he said. Patients were randomized to one of two doses of IV Lovenox (0.5 mg/kg or 0.75 mg/kg) or to an activated clotting time adjusted unfractionated heparin regimen.
One thousand and seventy patients were randomized to low dose Lovenox, 1,228 to 0.75 mg and 1,230 to unfractionated heparin.
The low-dose Lovenox arm was halted in December 2004 after the data safety monitoring board reported an excess of all cause mortality in that arm, but Dr. Montalescot did not report the exact mortality data. The overall bleeding rate in the Lovenox 0.75 arm was 6.6% compared with 8.7% in the unfractionated heparin arm (P=0.052).
Dr. Montalescot said age over 75, female gender, and use of glycoprotein IIb/IIIa inhibitors were all associated with increased risk of bleeding.
The study was funded by the French drug maker Sanofi-Aventis, which makes Lovenox.
Related article:
Primary source: European Society of Cardiology Congress 2005
Source reference:
Montalescot G "STEEPLE: Safety and Efficacy of Enoxaparin in Precutaneous Coronary Intervention Patients, an International Randomized Evaluation." Number 2574.
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