SYNERGY (Superior Yield of the NewStrategy of Enoxaparin, Revascularizationand Glycoprotein IIb/IIIa Inhibitors)
SYNERGY (Superior Yield of the New Strategy of Enoxaparin,Revascularization and Glycoprotein IIb/IIIa Inhibitors)K Mahaffey (Duke University, Durham, NC), J Ferguson (Texas Heart Institute, Houston, TX)American College of Cardiology 2004 Scientific Sessions• Population and treatment: 10000 high-risk ACS patients (median age of 68) Randomized to enoxaparin (1mg/kg sc every 12 hours) or UFH (60 U/kg bolus then 12 U/kg per hr adjusted to an aPTT of 50 to 70 seconds)• Outcomes: Primary end point: death/MI at 30 days Secondary end points: incidence of death or nonfatal MI at 14 days; the combined incidence of all-cause mortality, nonfatal MI, stroke, or recurrent ischemia requiring revascularization; and individual components of this composite at 14 and 30 days after enrollment Primary safety end point: incidence of major bleeding or stroke UFH=unfractionated heparin
SYNERGY: Results (efficacy)• Enoxaparin is as effective as UFH in the prevention of the primary end pointMajor clinical end points at 30 daysEnd point Enoxaparin UFH p (n=4993), % (n=4985), %Death/MI 14 14.5 NSDeath 3.2 3.1 NSMI 11.7 12.7 NSStroke 1.0 0.9 NSHemorrhagic stroke <0.1 <0.1 NS
SYNERGY: Results (safety)• GUSTOa severe bleeding was not significantly different between the two groups• There was an increase in TIMI major bleeding and in hemoglobin and hematocrit dropb with enoxaparinBleeding outcomesBleeding definition Enoxaparin UFH p (n=4993), % (n=4985), %GUSTO severe bleeding 2.9 2.4 0.107Hemoglobin and hematocrit drop/ICH 15.2 12.5 0.001TIMI major bleeding (all) 9.1 7.6 0.008TIMI major bleeding (CABG) 6.8 5.9 0.081TIMI major bleeding (non-CABG) 2.4 1.7 0.025Transfusions 17.0 16.0 0.155 a. Severe bleeding leading to hemodynamic compromise or intracranial hemorrhage (ICH) b. Hemoglobin drop more than 5 g/dL or hematocrit drop of 15% or greater
SYNERGY: Commentary*"TIMI major bleeding is not a mickey-mouse end point. I would like to see the datain detail before deciding whether the bleeding is a serious worry or not. But at theend of the day, if you have two drugs that give the same benefit but one increasesbleeding, I would think very carefully before using that one." - Dr Salim Yusuf"If you look at SYNERGY in isolation, you probably wouldnt use enoxaparin. Youhave to look at the totality of the evidence and best way of doing this is without anycrossover." - Dr Robert Califf (principal investigator) *All comments from SYNERGY: Enoxaparin as effective as heparin but bleeding may be an issue (http://www.theheart.org/article/221047.do)
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