The role of fondaparinux as an adjunct to thrombolytic therapy in acute myocardial infarction: a subgroup analysis of the OASIS-6 trial.
OBJECTIVE
No antithrombotic therapy has been shown to reduce mortality when used with thrombolytics in acute myocardial infarction (AMI). In the OASIS-6 trial, fondaparinux significantly reduced mortality and reinfarction without increasing bleeding in 12 092 patients with acute ST elevation MI.


RESULTS
We report the results of a subgroup analysis in the 5436 patients (45%) receiving thrombolytics. According to local practice, 4415 patients did not have an indication for unfractionated heparin (stratum 1) and 1021 did (stratum 2). Fondaparinux reduced the primary study outcome of death or MI at 30 days [Hazard ratio (HR) 0.79, 95% confidence interval (CI) 0.68-0.92] with consistent reductions in both mortality (HR and CI) and reinfarction (HR and CI). There was a non-significantly lower rate of stroke (HR 0.77, CI 0.48-1.25). The risk of severe bleeding was significantly reduced (HR 0.62, CI 0.40-0.94), and thus the balance of benefit and risk (death, MI and severe haemorrhage) was clearly reduced by fondaparinux (HR 0.77, 95% CI 0.67-0.90). Results were consistent in the two strata, by the different types of thrombolytics and across various time intervals from symptom onset to treatment.


CONCLUSIONS
In STEMI patients treated with thrombolytic agents (predominantly streptokinase), fondaparinux significantly reduced the risk of death, re-MI and severe bleeds.
Peters
Ron J G
RJ
Department of Cardiology, Academic Medical Center, Room F3-236, P.O. Box 22660, 1100 DD Amsterdam, The Netherlands. r.j.peters@amc.uva.nl
Joyner
Campbell
C
Bassand
Jean-Pierre
JP
Afzal
Rizwan
R
Chrolavicius
Susan
S
Mehta
Shamir R
SR
Oldgren
Jonas
J
Wallentin
Lars
L
Budaj
Andrzej
A
Fox
Keith A
KA
Yusuf
Salim
S
D000925:Anticoagulants / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D000077425:Fondaparinux; D006470:Hemorrhage / Q000453:epidemiology; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D011134:Polysaccharides / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D055502:Secondary Prevention; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D005343:Fibrinolytic Agents; D011134:Polysaccharides; D006493:Heparin; D000077425:Fondaparinux