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Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials.
Circulation. 2008 Nov 11; 118(20):2038-46.Circ

Abstract

BACKGROUND

The Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) trials evaluated fondaparinux, a synthetic factor Xa inhibitor, in patients with non-ST- and ST-segment elevation acute coronary syndromes, respectively. Combined results for these 2 trials on major efficacy and safety outcomes and data on the effects of fondaparinux in relation to interventional management strategy have not been previously reported.

METHODS AND RESULTS

We performed an individual patient-level combined analysis of 26 512 patients from the OASIS 5 and 6 trials who were randomized in a double-blind fashion to fondaparinux 2.5 mg daily or a heparin-based strategy (dose-adjusted unfractionated heparin or enoxaparin). Results were stratified according to whether an early invasive, a delayed invasive, or an initial conservative management strategy was performed. Fondaparinux was superior to heparin in reducing the composite of death, myocardial infarction, or stroke (8.0% versus 7.2%; hazard ratio [HR], 0.91; P=0.03) and death alone (4.3% versus 3.8%; HR, 0.89; P=0.05). Fondaparinux reduced major bleeding by 41% (3.4% versus 2.1%; HR, 0.59; P<0.00001) and had a more favorable net clinical outcome than heparin (11.1% versus 9.3%; HR, 0.83; P<0.0001). In 19 085 patients treated with an invasive strategy, fondaparinux suppressed ischemic events to an extent similar to heparin and reduced major bleeding by more than one-half, resulting in a superior net clinical outcome (10.8% versus 9.4%; HR, 0.87; P=0.008). A similar benefit also was observed in those treated with a conservative strategy (HR, 0.74; 95% confidence interval, 0.64 to 0.85; P<0.001).

CONCLUSIONS

Compared with a heparin-based strategy, fondaparinux reduced mortality, ischemic events, and major bleeding across the full spectrum of acute coronary syndromes and was associated with a more favorable net clinical outcome in patients undergoing either an invasive or a conservative management strategy.

Authors+Show Affiliations

McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. smehta@mcmaster.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18955665

Citation

Mehta, Shamir R., et al. "Antithrombotic Therapy With Fondaparinux in Relation to Interventional Management Strategy in Patients With ST- and non-ST-segment Elevation Acute Coronary Syndromes: an Individual Patient-level Combined Analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) Randomized Trials." Circulation, vol. 118, no. 20, 2008, pp. 2038-46.
Mehta SR, Boden WE, Eikelboom JW, et al. Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. Circulation. 2008;118(20):2038-46.
Mehta, S. R., Boden, W. E., Eikelboom, J. W., Flather, M., Steg, P. G., Avezum, A., Afzal, R., Piegas, L. S., Faxon, D. P., Widimsky, P., Budaj, A., Chrolavicius, S., Rupprecht, H. J., Jolly, S., Granger, C. B., Fox, K. A., Bassand, J. P., & Yusuf, S. (2008). Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. Circulation, 118(20), 2038-46. https://doi.org/10.1161/CIRCULATIONAHA.108.789479
Mehta SR, et al. Antithrombotic Therapy With Fondaparinux in Relation to Interventional Management Strategy in Patients With ST- and non-ST-segment Elevation Acute Coronary Syndromes: an Individual Patient-level Combined Analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) Randomized Trials. Circulation. 2008 Nov 11;118(20):2038-46. PubMed PMID: 18955665.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. AU - Mehta,Shamir R, AU - Boden,William E, AU - Eikelboom,John W, AU - Flather,Marcus, AU - Steg,P Gabriel, AU - Avezum,Alvaro, AU - Afzal,Rizwan, AU - Piegas,Leopoldo S, AU - Faxon,David P, AU - Widimsky,Petr, AU - Budaj,Andrzej, AU - Chrolavicius,Susan, AU - Rupprecht,Hans-Jurgen, AU - Jolly,Sanjit, AU - Granger,Christopher B, AU - Fox,Keith A A, AU - Bassand,Jean-Pierre, AU - Yusuf,Salim, AU - ,, Y1 - 2008/10/27/ PY - 2008/10/29/pubmed PY - 2008/12/17/medline PY - 2008/10/29/entrez SP - 2038 EP - 46 JF - Circulation JO - Circulation VL - 118 IS - 20 N2 - BACKGROUND: The Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) trials evaluated fondaparinux, a synthetic factor Xa inhibitor, in patients with non-ST- and ST-segment elevation acute coronary syndromes, respectively. Combined results for these 2 trials on major efficacy and safety outcomes and data on the effects of fondaparinux in relation to interventional management strategy have not been previously reported. METHODS AND RESULTS: We performed an individual patient-level combined analysis of 26 512 patients from the OASIS 5 and 6 trials who were randomized in a double-blind fashion to fondaparinux 2.5 mg daily or a heparin-based strategy (dose-adjusted unfractionated heparin or enoxaparin). Results were stratified according to whether an early invasive, a delayed invasive, or an initial conservative management strategy was performed. Fondaparinux was superior to heparin in reducing the composite of death, myocardial infarction, or stroke (8.0% versus 7.2%; hazard ratio [HR], 0.91; P=0.03) and death alone (4.3% versus 3.8%; HR, 0.89; P=0.05). Fondaparinux reduced major bleeding by 41% (3.4% versus 2.1%; HR, 0.59; P<0.00001) and had a more favorable net clinical outcome than heparin (11.1% versus 9.3%; HR, 0.83; P<0.0001). In 19 085 patients treated with an invasive strategy, fondaparinux suppressed ischemic events to an extent similar to heparin and reduced major bleeding by more than one-half, resulting in a superior net clinical outcome (10.8% versus 9.4%; HR, 0.87; P=0.008). A similar benefit also was observed in those treated with a conservative strategy (HR, 0.74; 95% confidence interval, 0.64 to 0.85; P<0.001). CONCLUSIONS: Compared with a heparin-based strategy, fondaparinux reduced mortality, ischemic events, and major bleeding across the full spectrum of acute coronary syndromes and was associated with a more favorable net clinical outcome in patients undergoing either an invasive or a conservative management strategy. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/18955665/Antithrombotic_therapy_with_fondaparinux_in_relation_to_interventional_management_strategy_in_patients_with_ST__and_non_ST_segment_elevation_acute_coronary_syndromes:_an_individual_patient_level_combined_analysis_of_the_Fifth_and_Sixth_Organization_to_Assess_Strategies_in_Ischemic_Syndromes__OASIS_5_and_6__randomized_trials_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.108.789479?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -