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1.
Purpose
To compare the safety and efficacy of heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
Reference
Stone GW, Witzenbichler B, Guagliumi G, et al. for the HORIZONS-AMI Trial Investigators. Bivalirudin during Primary PCI in Acute Myocardial Infarction. N Engl J Med 2008;358:22182230.
HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction
2. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction - TRIAL DESIGN - Design
Prospective, open-label, randomized, multicenter trial.
Patients
3602 patients aged =18 years old who had STEMI of =1 mm in two or more contiguous leads, new left bundle-branch block, or true posterior MI presenting =12 hours after symptom onset. Exclusion criteria included contraindications for or previous administration of the study medications, and any comorbidity that might limit life expectancy to <1 year or interfere with compliance with the protocol.
Follow-up and primary endpoints
Two primary 30-day endpoints: major bleeding unrelated to CABG; and the combination of major bleeding or a composite of major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke).
3. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction - TRIAL DESIGN continued -
Treatment
Bivalirudin: 0.75 mg/kg/h bolus followed by 1.75 mg/kg/h infusion.Heparin: 60 IU/kg body weight bolus, with subsequent boluses targeted to achieve an activated clotting time of 200250 seconds.Glycoprotein IIb/IIIa inhibitor: abciximab, at 0.25 mg/kg bolus, followed by 0.125 g/kg/min infusion up to a maximum of 10 g/min; or double-bolus epifibatide, at 180 g/kg bolus followed by 2.0 g/kg/min infusion, with the second bolus given 10 minutes after the first, and no maximum dose pre-specified.
4. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction - TRIAL DESIGN continued -
5. Compared with heparin plus a glycoprotein IIa/IIIa inhibitor, bivalirudin led, at 30 days, to a significantly reduced rate of the following:
Net adverse clinical events (9.2% vs. 12.1%, respectively; relative risk [RR], 0.76; p=0.005)?
Major bleeding (4.9% vs. 8.3%, respectively; RR, 0.60; p<0.001)?
Death from cardiac causes (1.8% vs. 2.9%, respectively; RR, 0.62; p=0.03)
Death from all causes (2.1% vs. 3.1%, respectively; RR, 0.66; p=0.047)?
There were no significant differences in the rate of major adverse cardiovascular events (5.4% vs. 5.5%, respectively; p=0.95), death from non-cardiac causes (0.2% vs. 0.3%, respectively; p=0.75), reinfarction, target-vessel revascularization, and stroke.
Although rates of stent thrombosis at 30 days were not significantly different, stent thrombosis at =24 h was significantly more common with bivalirudin, at 1.3% vs. 0.3%, respectively; p<0.001)? HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction - RESULTS -
6. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction- RESULTS continued -
7. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction- RESULTS continued -
8. HORIZONS-AMI: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction- SUMMARY -
In patients with STEMI undergoing primary PCI, at 30 days bivalirudin alone reduced the following in comparison with heparin plus routine use of glycoprotein IIb/IIIa inhibitor:
Net adverse clinical events, owing to a significant reduction in major bleeding
Rates of death from cardiac causes and from all causes
An increase in stent thrombosis with bivalirudin =24 hours after PCI was partially offset by a reduction in stent thrombosis between 24 hours and 30 days. There was also no increase in the overall reinfarction rate.