By Thomas S. May
ORLANDO, FL -- May 14, 2007 -- Patients with renal insufficiency (RI) who undergo percutaneous coronary intervention (PCI) are at increased risk of bleeding complications if they are given glycoprotein IIb/IIIa inhibitors (GPIs), according to a study presented here at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI).
The study was done by a research team headed by Marc Cohen, MD, professor of medicine, Mount Sinai School of Medicine, and director, division of cardiology, Newark Beth Israel Medical Center, Newark, New Jersey, United States.
Dr. Cohen and colleagues performed a subanalysis of the Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients (STEEPLE) trial, which was a prospective, open-label, randomised trial in 3,528 patients undergoing elective PCI. The study's findings were presented on May 11th.
Patients received either intravenous enoxaparin (0.5 or 0.75 mg/kg) or unfractionated heparin (UFH), a low molecular weight heparin, stratified by GPI use. For the purposes of this analysis, patients receiving UFH and those receiving enoxaparin were combined into one group.
A total of 1,423 (40%) patients received a GPI and 659 (19%) had renal insufficiency, defined as a creatinine clearance (CrCl) <60 mL/min. Of the 659 patients with renal insufficiency, 224 (34%) received a GPI.
A subanalysis of the trial showed that major and minor bleeding was significantly more common in patients receiving a GPI than in those who did not (2.7% vs 1.1%, P =.0007), and in patients with renal insufficiency than those without (2.7% vs. 1.5%, P =.037).
Patients with renal insufficiency who received a GPI had significantly more major bleeding than those who did not receive a GPI (4.9% vs. 2.2%, P =.02). This increase in major bleeding was independent of the anticoagulation regimen. Renal insufficiency did not affect the incidence of bleeding in patients who did not receive a GPI.
These results indicate that major bleeding is related to GPI use in patients with renal insufficiency undergoing elective PCI, the authors concluded. They can also serve as a reminder for clinicians of the need to more appropriately dose GPIs in the setting of renal insufficiency, according to Dr. Cohen.
"Adjusting the dose in patients with renal insufficiency could significantly reduce bleeding complications in PCI," he said.
Funding for this study was provided by Sanofi Aventis, manufacturers of Lovenox (enoxaparin sodium).
[Presentation title: Use of Glycoprotein IIb/IIIa Inhibitors in Patients With Renal Insufficiency Undergoing Elective Percutaneous Coronary Intervention is Associated With Increased Major Bleeding: A Sub-Analysis of The Steeple Trial. AbstractD-47]
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