OASIS-5 (PCI substudy)

Organization to Assess Strategies for Ischemic Syndromes – 5 (2007)

Condition

Prevention of recurrent events in patients who underwent early percutaneous coronary intervention (PCI)

Close this section

Objective

To compare the efficacy and safety of fondaparinux and enoxaparin in patients enrolled in the OASIS-5 trial who underwent PCI during the study treatment period

Close this section

Trial design

Prespecified subgroup analysis of a randomized, controlled, double-blind study
Active treatment: fondaparinux 2.5 mg p.o. once daily; for PCI fondaparinux 2,5 mg i.v. was given additionally, if PCI was >6 hours from last dose or patients received no GPIIb/IIIa-antagonists. If both was the case, the patients received additionally fondaparinux 5 mg i.v. for the procedure (n=3105)
Control treatment: enoxaparin 1 mg/kg s.c. twice daily (dose reduced to 1 mg/kg once daily in patients with creatinine clearance <30 ml/min); no additional anticoagulant was given, if PCI was <6 hours, and additional i.v. UFH was given, if PCI was >6 hours from last s.c. dose (n=3072)

Close this section

Endpoints

Primary efficacy endpoint: composite of death, myocardial infarction or stroke at days 9, 30, and 180
Primary safety endpoint: major bleeding

Close this section

Trial participants

6.238 patients with acute coronary syndromes (mean age 65 years) eligible for the main OASIS-5 trial, who underwent PCI within 8 days after the acute event

Close this section

Results

Primary efficacy outcome: In the fondaparinux group, 197 of 3105 patients (6.3%) experienced death, myocardial infarction or stroke by day 9, compared with 190 of 3072 patients (6.2%) in the enoxaparin group. By day 30, a primary efficacy endpoint had occurred in 7.4% of the patients in either group, by day 180 in 10.1% of the patients given fondaparinux and in 10.2% of the patients given enoxaparin
Safety outcome: By day 9 major bleeding had occurred in 73 patients (2.4%) in the fondaparinux group compared to 155 patients (5.1%) of the patients in the enoxaparin group. By day 30, major bleeding had occurred in 88 (2.9%) vs. 166 (5.4%), by day 180 in 104 (3.4%) vs. 190 (6.3%) of the patients receiving fondaparinux respectively enoxaparin

Close this section

Summary

Efficacy: Upstream fondaparinux compared with upstream enoxaparin had comparable impact on the primary efficacy endpoint (death, myocardial infarction or stroke) at day 9, 30, and 180
Safety: Fondaparinux substantially reduced major bleeding, resulting in a superior net clinical benefit

Close this section

Reference

Mehta SR, Granger CB, Eikelboom JW, Bassand JP, Wallentin L, Faxon DP, Peters RJG, Budaj A, Afzal R, Chrolavicius S, Fox KA, Yusuf S. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention. J Am Coll Cardiol 2007;50:1742-1751

Close this section

Corresponding author

Shamir R. Mehta, MD, Interventional Cardiology, Hamilton Health Sciences, General Division, McMaster Clinic Room 508, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada, e-mail: smehta@mcmaster.ca

Close this section

Back To List

Recommend pageBack to top