Analyses from long-term follow up of the landmark ACUITY trial presented today demonstrate that in moderate and high risk acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), treatment with bivalirudin alone resulted in significantly less bleeding at 30 days and comparable composite ischemia and mortality at 1 year than heparin (either unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor regardless of patient risk. The mortality results observed at 1 year with bivalirudin monotherapy were not dependent on the timing of clopidogrel administration.
Switching to bivalirudin monotherapy from prior treatment with unfractionated heparin or enoxaparin was also proven to be safe and effective, enabling patients to achieve the approximate 50% reduction in major bleeding while preserving similar protection from adverse ischemic outcome and death at 1 year.
PCI patients experiencing a non-CABG major bleed had a significantly longer length of hospital stay, 5.0 days vs 3.0 days (p<0.0001), compared with those that did not bleed. Further, a strong association was observed between early bleeding events and late mortality in ACS patients undergoing PCI.
These results suggest bivalirudin monotherapy should be the preferred adjunctive antithrombotic strategy in moderate and high risk ACS patients undergoing PCI and add to the evidence on the relationship between early bleeding and long-term outcome.