Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation: Outcomes and treatment effect across different levels of risk

Campbell D. Joyner, Ron J G Peters, Rizwan Afzal, Susan Chrolavicius, Shamir R. Mehta, Keith A A Fox, Christopher B. Granger, Maria Grazia Franzosi, Marcus Flather, Andrzej Budaj, Jean Pierre Bassand, Salim Yusuf

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50%. The objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS). Methods: We analyzed efficacy and safety according to the GRACE admission risk score. Results: The impact of fondaparinux versus enoxaparin on the primary outcome of death, myocardial infarction, and refractory ischemia at 180 days was similar in the low-, intermediate-, and high-risk groups: 7.0% versus 7.7% (hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.75-1.08), 10.2% versus 11.3% (HR 0.89, 95% CI 0.77-1.03), and 20.1% versus 21.1% (HR 0.95, 95% CI 0.85-1.06). Major bleeding rates were higher with increasing GRACE risk scores: 2.2%, 3.2%, and 4.1% in the low, intermediate, and high-risk groups. Six-month mortality was 2.2%, 4.2%, and 12.3% in the 3 groups. The risk of major bleeding was substantially lower with fondaparinux in all groups: 1.6% versus 2.9% (HR 0.55, 95% CI 0.39-0.77), 2.2% versus 4.1% (HR 0.53, 95% CI 0.40-0.70), 2.8% versus 5.5% (HR 0.50, 95% CI 0.38-0.64). Conclusion: The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.

Original languageEnglish
Pages (from-to)502-508
Number of pages7
JournalAmerican Heart Journal
Volume157
Issue number3
DOIs
Publication statusPublished - Mar 2009

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Enoxaparin
Acute Coronary Syndrome
Registries
Confidence Intervals
Hemorrhage
Safety
Mortality
fondaparinux
Ischemia
Myocardial Infarction
Organizations

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation : Outcomes and treatment effect across different levels of risk. / Joyner, Campbell D.; Peters, Ron J G; Afzal, Rizwan; Chrolavicius, Susan; Mehta, Shamir R.; Fox, Keith A A; Granger, Christopher B.; Franzosi, Maria Grazia; Flather, Marcus; Budaj, Andrzej; Bassand, Jean Pierre; Yusuf, Salim.

In: American Heart Journal, Vol. 157, No. 3, 03.2009, p. 502-508.

Research output: Contribution to journalArticle

Joyner, CD, Peters, RJG, Afzal, R, Chrolavicius, S, Mehta, SR, Fox, KAA, Granger, CB, Franzosi, MG, Flather, M, Budaj, A, Bassand, JP & Yusuf, S 2009, 'Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation: Outcomes and treatment effect across different levels of risk', American Heart Journal, vol. 157, no. 3, pp. 502-508. https://doi.org/10.1016/j.ahj.2008.10.028
Joyner, Campbell D. ; Peters, Ron J G ; Afzal, Rizwan ; Chrolavicius, Susan ; Mehta, Shamir R. ; Fox, Keith A A ; Granger, Christopher B. ; Franzosi, Maria Grazia ; Flather, Marcus ; Budaj, Andrzej ; Bassand, Jean Pierre ; Yusuf, Salim. / Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation : Outcomes and treatment effect across different levels of risk. In: American Heart Journal. 2009 ; Vol. 157, No. 3. pp. 502-508.
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title = "Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation: Outcomes and treatment effect across different levels of risk",
abstract = "Background: The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50{\%}. The objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS). Methods: We analyzed efficacy and safety according to the GRACE admission risk score. Results: The impact of fondaparinux versus enoxaparin on the primary outcome of death, myocardial infarction, and refractory ischemia at 180 days was similar in the low-, intermediate-, and high-risk groups: 7.0{\%} versus 7.7{\%} (hazard ratio [HR] 0.90, 95{\%} confidence interval [CI] 0.75-1.08), 10.2{\%} versus 11.3{\%} (HR 0.89, 95{\%} CI 0.77-1.03), and 20.1{\%} versus 21.1{\%} (HR 0.95, 95{\%} CI 0.85-1.06). Major bleeding rates were higher with increasing GRACE risk scores: 2.2{\%}, 3.2{\%}, and 4.1{\%} in the low, intermediate, and high-risk groups. Six-month mortality was 2.2{\%}, 4.2{\%}, and 12.3{\%} in the 3 groups. The risk of major bleeding was substantially lower with fondaparinux in all groups: 1.6{\%} versus 2.9{\%} (HR 0.55, 95{\%} CI 0.39-0.77), 2.2{\%} versus 4.1{\%} (HR 0.53, 95{\%} CI 0.40-0.70), 2.8{\%} versus 5.5{\%} (HR 0.50, 95{\%} CI 0.38-0.64). Conclusion: The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.",
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T1 - Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation

T2 - Outcomes and treatment effect across different levels of risk

AU - Joyner, Campbell D.

AU - Peters, Ron J G

AU - Afzal, Rizwan

AU - Chrolavicius, Susan

AU - Mehta, Shamir R.

AU - Fox, Keith A A

AU - Granger, Christopher B.

AU - Franzosi, Maria Grazia

AU - Flather, Marcus

AU - Budaj, Andrzej

AU - Bassand, Jean Pierre

AU - Yusuf, Salim

PY - 2009/3

Y1 - 2009/3

N2 - Background: The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50%. The objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS). Methods: We analyzed efficacy and safety according to the GRACE admission risk score. Results: The impact of fondaparinux versus enoxaparin on the primary outcome of death, myocardial infarction, and refractory ischemia at 180 days was similar in the low-, intermediate-, and high-risk groups: 7.0% versus 7.7% (hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.75-1.08), 10.2% versus 11.3% (HR 0.89, 95% CI 0.77-1.03), and 20.1% versus 21.1% (HR 0.95, 95% CI 0.85-1.06). Major bleeding rates were higher with increasing GRACE risk scores: 2.2%, 3.2%, and 4.1% in the low, intermediate, and high-risk groups. Six-month mortality was 2.2%, 4.2%, and 12.3% in the 3 groups. The risk of major bleeding was substantially lower with fondaparinux in all groups: 1.6% versus 2.9% (HR 0.55, 95% CI 0.39-0.77), 2.2% versus 4.1% (HR 0.53, 95% CI 0.40-0.70), 2.8% versus 5.5% (HR 0.50, 95% CI 0.38-0.64). Conclusion: The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.

AB - Background: The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50%. The objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS). Methods: We analyzed efficacy and safety according to the GRACE admission risk score. Results: The impact of fondaparinux versus enoxaparin on the primary outcome of death, myocardial infarction, and refractory ischemia at 180 days was similar in the low-, intermediate-, and high-risk groups: 7.0% versus 7.7% (hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.75-1.08), 10.2% versus 11.3% (HR 0.89, 95% CI 0.77-1.03), and 20.1% versus 21.1% (HR 0.95, 95% CI 0.85-1.06). Major bleeding rates were higher with increasing GRACE risk scores: 2.2%, 3.2%, and 4.1% in the low, intermediate, and high-risk groups. Six-month mortality was 2.2%, 4.2%, and 12.3% in the 3 groups. The risk of major bleeding was substantially lower with fondaparinux in all groups: 1.6% versus 2.9% (HR 0.55, 95% CI 0.39-0.77), 2.2% versus 4.1% (HR 0.53, 95% CI 0.40-0.70), 2.8% versus 5.5% (HR 0.50, 95% CI 0.38-0.64). Conclusion: The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.

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