Author + information
- Received January 6, 2009
- Revision received March 18, 2009
- Accepted March 24, 2009
- Published online July 28, 2009.
- Sanjit S. Jolly, MD, MSc⁎,⁎ (, )
- David P. Faxon, MD†,
- Keith A.A. Fox, MB, ChB‡,
- Rizwan Afzal, MSc⁎,
- William E. Boden, MD§,
- Petr Widimsky, MD∥,
- P. Gabriel Steg, MD¶,
- Vicent Valentin, MD#,
- Andrez Budaj, MD⁎⁎,
- Christopher B. Granger, MD††,
- Campbell D. Joyner, MD‡‡,
- Susan Chrolavicius, BScN⁎,
- Salim Yusuf, DPhil⁎ and
- Shamir R. Mehta, MD, MSc⁎
- ↵⁎Reprint requests and correspondence:
Dr. Sanjit S. Jolly, McMaster Clinic Room 630, Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada
Objectives This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or thienopyridines.
Background The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown.
Methods Patients with ACS (n =20,078) were randomized as a part of the OASIS 5 trial to receive either fondaparinux or enoxaparin. The use of GP IIb/IIIa inhibitors or thienopyridines was at the discretion of the treating physician. A Cox proportional hazard model was used to compare outcomes.
Results Of the 20,078 patients randomized, 3,630 patients received GP IIb/IIIa and 13,531 received thienopyridines. There was a 40% reduction in major bleeding with fondaparinux compared with enoxaparin in those treated with GP IIb/IIIa (5.2% vs. 8.3%, hazard ratio [HR]: 0.61, p < 0.001). A similar reduction was found in those treated with thienopyridines (3.4% vs. 5.4%, HR: 0.62, p < 0.001). Ischemic events were similar between the groups, resulting in a superior net clinical outcome (death, myocardial infarction, refractory ischemia, or major bleeding) favoring fondaparinux (GP IIb/IIIa subgroup 14.8% vs. 18.9%, HR: 0.77, p = 0.001 and thienopyridines subgroup 11.0% vs. 13.2%, HR: 0.82, p < 0.001).
Conclusions In patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.
The OASIS 5 trial was supported by Sanofi-Aventis, Organon, and GlaxoSmithKline.
Dr. Jolly has received honoraria from GlaxoSmithKline. Dr. Faxon is on the advisory board of Johnson & Johnson and has received a research grant from Boston Scientific. Dr. Fox has received grants and honoraria from Sanofi-Aventis, Bristol-Myers Squibb, and GlaxoSmithKline. Dr. Steg has received a research grant from Sanofi-Aventis. Dr. Budaj is on the advisory boards of Sanofi-Aventis and GlaxoSmithKline, and has received research grants or honoraria for lectures from Sanofi-Aventis, GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim. Dr. Granger has received grant funding from GlaxoSmithKline. Dr. Yusuf has received honoraria, consulting fees, and research grants from GlaxoSmithKline and Sanofi-Aventis. Dr. Mehta has received grant support from GlaxoSmithKline and Sanofi-Aventis, and has received honoraria or consulting fees from GlaxoSmithKline, Sanofi-Aventis, Bristol-Myers Squibb, AstraZeneca, Eli Lilly, and Astellas.
- Received January 6, 2009.
- Revision received March 18, 2009.
- Accepted March 24, 2009.
- American College of Cardiology Foundation