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 receivedthienopyridines. 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.
RCT Entities:
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.
Authors: Matthew M Y Lee; Mark C Petrie; Paul Rocchiccioli; Joanne Simpson; Colette E Jackson; David S Corcoran; Kenneth Mangion; Ammani Brown; Pio Cialdella; Novalia P Sidik; Margaret B McEntegart; Aadil Shaukat; Alan P Rae; Stuart H M Hood; Eileen E Peat; Iain N Findlay; Clare L Murphy; Alistair J Cormack; Nikolay B Bukov; Kanarath P Balachandran; Keith G Oldroyd; Ian Ford; Olivia Wu; Alex McConnachie; Sarah J E Barry; Colin Berry Journal: Circ Cardiovasc Interv Date: 2019-07-31 Impact factor: 6.546
Authors: Alexandre de Matos Soeiro; Pedro Gabriel Melo de Barros E Silva; Eduardo Alberto de Castro Roque; Aline Siqueira Bossa; Maria Cristina César; Sheila Aparecida Simões; Mariana Yumi Okada; Tatiana de Carvalho Andreucci Torres Leal; Fátima Cristina Monteiro Pedroti; Múcio Tavares de Oliveira Journal: Arq Bras Cardiol Date: 2016-08-29 Impact factor: 2.000