HORIZONS AMI trial - Summary & Results

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A study on harmonizing outcomes with revascularization and stents in acute myocardial Infarction (HORIZONS AMI) with 3600 patients with STEMI and symptom onset of less than 12 hours undergoing primary PCI

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  • 1. HORIZONS AMI (Harmonizing Outcomeswith Revascularization and Stents inAcute Myocardial Infarction)
  • 2. HORIZONS AMI (Harmonizing Outcomes withRevascularization and Stents in Acute Myocardial Infarction)GW Stone (Columbia University Medical Center Cardiovascular Research Foundation, NY)TCT 2007 Meeting• Population: 3600 patients with STEMI and symptom onset of less than 12 hours undergoing primary PCI• Treatment: Patients randomized to UFH plus a GP IIb/IIIa inhibitor or to bivalirudin monotherapy stopped at the end of the procedure, plus provisional GP IIb/IIIa inhibitors for large thrombus or refractory no-flow• Primary outcomes: Major bleeding and net adverse clinical events* (NACE) within 30 days UFH=unfractionated heparin *Combination of major bleeding or major adverse CV events, including death, reinfarction, target vessel revascularization for ischemia, and stroke
  • 3. HORIZONS AMI: Results• 24% reduction in NACE and 40% reduction in major bleeding at 30 daysMajor outcomes at 30 days End point UFH–GP IIb/IIIa inhibitors Bivalirudin p, noninferiority p, superiority (%) (%) NACE 12.1 9.2 <0.0001 0.006 Major bleeding 8.3 4.9 <0.0001 <0.0001 MACE 5.5 5.4 — NS MACE=major adverse CV events (defined as all-cause death, reinfarction, ischemic target vessel revascularization, or stroke)
  • 4. HORIZONS AMI: Results• There was a significant reduction in cardiac death at 30 daysDeath at 30 daysEnd point UFH–GP IIb/IIIa inhibitors Bivalirudin p (%) (%)All death 3.1 2.1 0.058Cardiac death 2.9 1.8 0.035
  • 5. HORIZONS AMI: Commentary*"Its going to be hard to find anyone who will have anything critical to say aboutthis. . . When theres a reduction in cardiac mortality, that kind of trumps everythingelse." - Dr Deepak Bhatt"Overall, the results appear to look quite favorable for bivalirudin. . . . It isreasonable to ask whether bivalirudin alone would provide superior outcomescompared with heparin alone during contemporary management of STEMI withprimary PCI. This has important implications for clinical practice.." - Dr Sanjay Kaul *All comments from HORIZONS AMI: Bivalirudin reduces bleeding, adverse clinical events in STEMI (http://www.theheart.org/article/821109.do)
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