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Bivalirudin = abciximab + heparin for non-STEMI

Clinical Question:
Is bivalirudin at least as effective as abciximab plus heparin in patients with acute coronary syndrome and non-ST-elevation myocardial infarction?

Bottom Line:
Bivalirudin is similarly effective, and possibly a bit safer, than the combination of abciximab and heparin for patients with acute coronary syndrome and non-ST-elevation myocardial infarction (non-STEMI). (LOE = 1b)

Reference:
Kastrati A, Neumann FJ, Schulz S, et al, for the ISAR-REACT 4 Trial Investigators. Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction. N Engl J Med 2011;365(21):1980-1989.  [PMID:22077909]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Industry

Allocation:
Concealed

Setting:
Inpatient (any location)

Synopsis:
Antithrombotic therapy is important during the period after percutaneous coronary intervention (PCI), particularly in high-risk patients with acute coronary syndrome. One option is the glycoprotein IIb/IIIa inhibitor abciximab plus heparin; another is the direct thrombin inhibitor bivalirudin. The 2 have been shown to be comparable in a previous study of STEMI. A previous study of patients with non-STEMI included many without acute coronary syndrom and many who did not undergo PCI. The current study randomized adults with acute coronary syndrome (prolonged, accelerating, or recurrent angina) and elevated cardiac biomarkers who were undergoing PCI. A total of 1721 patients were randomized to receive either abciximab plus unfractionated heparin (0.25 mg/kg abciximab bolus, plus 0.125 mcg/kg/min for 12 hours, plus 70 units/kg heparin bolus) or bivalirudin (0.75 mg/kg bolus, plus 1.75 mg/kg/hour during the procedure). Groups were balanced at the start of the study, analysis was by intention to treat, and allocation was concealed. The mean age of patients was 67 years, 23% were women, 30% had diabetes, and 56% had 3-vessel coronary disease. At 30 days, there was no difference between groups regarding the "all bad things" composite cardiovascular outcome. Major bleeding was somewhat more common with abciximab plus heparin (4.6% vs 2.6%; P < .05; number needed to treat to harm = 50), though much of this was access site bleeding, and major bleeding as defined by the TIMI study criteria did not differ between groups. Significant thrombocytopenia occurred in 10 patients in the abciximab plus heparin group and none in the bivalirudin group (P < .002).

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