Abstract 3302: Outcomes in Elderly Patients Treated with Bivalirudin Monotherapy Versus Glycoprotein IIb/IIIa Inhibitors with Heparin or LMWH: Results from the Randomized ACUITY Trial
Background: Elderly patients with NSTE-ACS are at high risk for ischemic cardiac events and for bleeding complications associated with current anti-thrombotic regimens. We sought to explore outcomes in the elderly population in the ACUITY trial, which focused on an early invasive strategy in patients with NSTE-ACS.
Methods: We explored composite ischemia events (death, MI or unplanned revascularization) and non-CABG major bleeding (composite including blood transfusions), and the net clinical outcome (death, MI, unplanned revascularization or non-CABG major bleeding) at 30 days in 4 age groups: <55, 55– 65, 65–75 and ≥75 years. This analysis was limited to the patients who were randomized to bivalirudin (Bival) monotherapy versus heparin (Hep) or LMWH with glycoprotein IIb/IIIa inhibitors (GPI). Patients were sub-randomized to upstream or in-lab (only for PCI) GPI. The Cochrane-Armitage test was performed for trends across the 4 age strata.
Results: Of the 13,819 patients enrolled (age range: 20 to 95), 45.0% (6224 pts) were ≥ 65 and 17.7% (2441 pts) were ≥ 75. In the prespecified subgroup of age <65, the composite ischemic outcomes, major non-CABG bleeding, and net clinical benefit with Bival alone and GPI with Hep/LMWH was 9.5% vs. 8.9% (p-value for interaction=0.93 versus age ≥65), 4.4% vs. 7.8% (p-interact=0.56), 12.9% vs. 14.7% (p-interact=0.69), respectively. The age specific outcomes are shown in table⇓:
Conclusions: Elderly patients had similar ischemic outcomes, lower non-CABG major bleeding and similar net clinical outcomes at 30 days with bivalirudin monotherapy compared with GPI and Hep/LMWH as did younger patients in the ACUITY trial. Bivalirudin monotherapy is a reasonable treatment strategy for elderly patients undergoing an early invasive strategy in NSTE-ACS.