Trial Details:

Acronym: Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction

Purpose: To evaluate bivalirudin vesus the combination of heparin with abciximab (Reopro) during ST elevation MI treatment AND to evaluate paclitaxel stents (drug eluting stents) versus bare metal stents

Format: Double-blind, multicenter, randomized control trial

Treatment Group: Bivalirudin

Control Group: Heparin/abciximab

Number of Patients: 3,602

Inclusion Criteria: 

  • Age > 18
  • Symptoms < 12 hours
  • ST elevation in 2 contiguous leads OR new left bundle branch block OR true posterior MI

Exclusion Criteria:

  • Contraindications to study medications
  • Prior administration of anticoagulants during current hospitalization
  • Use of warfarin
  • Bleeding disorder
  • Intracranial mass, aneurysm or AV malformation
  • Prior stroke or TIA within 6 months
  • Refusal to receive blood transfusion
  • Any permanent neurologic deficit
  • Gastrointestinal or genitourinary bleeding within the previous 2 months
  • Major surgery in the prior 6 weeks
  • Known platelet count of < 100,000
  • Hemoglobin < 10 g/dL
  • Coronary stent within 30 days
  • Planned elective surgery requiring cessation of dual anti-platelet therapy within the next 6 months
  • Serious illiness that would limit life expectancy to < 1 year (i.e. metastatic cancer)

Follow-up: 3+ years

Primary Endpoint:

  • Major bleeding
  • Composite of major bleeding, major adverse cardiac events (MACE = death, reinfarction, target vessel revascularization and stroke)


Evaluated bivalirudin versus unfractionated heparin with abciximab during ST elevation MI at 30 days. Bivalirudin had fewer adverse events, less major bleeding and reduced death from cardiac causes. There was no difference in major adverse cardiac events (MACE) or stent thrombosis at 30 days. Subsequent follow-up confirmed at 1 and 3 years the benefit of bivalirudin.

Paclitaxel stent versus bare metal stent was also evaluated for efficacy. Paclitaxel stents had significantly reduced ischemia driven revascularization at 1 and 3 years compared to bare metal stents. There is no mortality benefit and no difference in stent thrombosis.

Original Publication:

Stone GW, et al. N Engl J Med. 2008;doi:10.1056/NEJMoa0708191.

Mehran R, et al. Lancet. 2009;doi:10.1016/S0140-6736(09)61484-7.

Stone GW, et al. N Engl J Med. 2009;doi:10.1056/NEJMoa0810116.

Stone GW, et al. Lancet. 2011;doi:10.1016/S0140-6736(11)60764-2.