Abstract 1851: Safety of Aprotinin in CABG Patients: Results of the VA MultiCenter Prospective Randomized ROOBY Trial
Background and Hypothesis: Recently published evidence from an international registry ( JAMA 2007;297:471–479) associated the use of aprotinin during CABG with increased mortality (20.8%) compared with controls (12.7%) and recommended discontinuation of the clinical use of aprotinin as unsafe. Because evidence from registries is generally inferior compared to prospective multicenter randomized trials, we sought to determine if there was increased mortality with the use of aprotinin in a large, prospective randomized CABG trial in the United States. Based on a large body of available literature on the use of antifibrinolytic agents during CABG, we hypothesized that the use of aprotinin would not be associated with excessive mortality in the ROOBY Trial.
Methods: The prospective randomized ROOBY Trial enrolled >2,200 patients over five years at 18 VA cardiac surgery centers in the United States. A planned sub analysis was carried out on 1,750 CABG patients with one year follow up using collected data on the antifibrinolytic agent use.
Results: Aprotinin was used during CABG (either on- or off-pump) by the majority of the centers participating in ROOBY (11/18=61%). One-year mortality for the aprotinin group was 3.2% and the mortality for the control group of patients receiving either no anti-bleeding agents or one of 2 lysine analog antifibrinolytics (aminocaproic acid or tranexamic acid) was 3.5% (p=.59). In addition, the rate of myocardial infarction at one year was similar in the 2 groups (aprotinin 3.2% vs 3.27% for the controls; p=NS). The rate of repeat revascularization at one year was slightly higher in the control group (4.05%) compared to the aprotinin group (2.6%).
Conclusion: In the planned sub analysis of the prospective randomized ROOBY trial, no excessive mortality or morbidity was found to be associated with the use of aprotinin and the recommendation for discontinuation of clinical use of aprotinin in CABG appears unjustified. Adherence to the revised FDA indications for use of aprotinin during CABG should be emphasized.