High-Risk Patients A related study from Italy looked at who gained the greatest benefit of bivalirudin monotherapy (BIV) in the treatment of STEMI patients undergoing primary PCI and found the patient cohort that gained the most was the highest risk subject population. According to the lead researcher, Guido Parodi, MD, PhD, FESC, Associate Chief Invasive Cardiology, Careggi Hospital, University of Florence (Florence, Italy), "It was completely contrary to our expectations. In particular, we found that in those patients at the highest risk for dying at one year, randomization to bivalirudin instead of heparin plus a GPIIb/IIIa antagonist appeared to provide the greatest mortality benefit."
In this substudy of the HORIZONS-AMI trial, bivalirudin monotherapy (BIV) was compared to unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI). BIV resulted in a reduction of major bleeding, a decrease in 30-day and 1-year mortality and enhanced freedom from net adverse clinical events (NACE) in patients with STEMI undergoing primary PCI. Whether the beneficial effects of BIV are related to patient risk category is not known.
In HORIZONS-AMI, 3,602 STEMI patients were treated within 12 hours of symptom onset and underwent primary PCI to BIV monotherapy vs. UFH+GPI. Patients were classified as low (score from 0 to 2), medium (score from 3 to 5), and high risk (score >5) according to the CADILLAC Risk Score based on 7 clinical variables (baseline EF<40%, renal insufficiency, Killip class ≥ 2, final TIMI flow< 3, age > 65, anemia, and 3V disease).
Among 2,530 evaluable HORIZONS-AMI trial patients, 1,522 pts (60%) were classified as low risk, 531 patients (21%) were classified as medium risk and 477 patients (19%) were classified as high risk.
Among high risk patients, there was a significantly lower rate of myocardial infarction (3.6% vs. 7.9%) and non-significant trends toward less stent thrombosis (2.
|Contact: Judy Romero|
Cardiovascular Research Foundation