Abstract 19212: Clinical Outcomes More Than 12 Months After PCI in Diabetic Patients With or Without DAPT: Results From the FREEDOM Trial

Background: Diabetic patients have higher risks of recurrent events after PCI. The role of long term dual antiplatelet therapy (DAPT) in such patients remains uncertain. Hypothesis: DAPT therapy would be associated with reduced long-term major cardiovascular events. Methods: We evaluated this in the FREEDOM trial which compared PCI to CABG in diabetic patients with multi-vessels disease. We performed an analysis of all subjects who underwent PCI to assess the composite of all-cause mortality, nonfatal myocardial infarction and stroke from 12 months up to 5 years after PCI for patients on DAPT or ASA alone. We also assessed the occurrence of major bleeding onset in this PCI cohort. Results: Of the 951 patients who underwent PCI in the FREEDOM trial, 682 patients (n=357 on DAPT; n=325 ASA only) had no event at 12 months and were included in this analysis. There was a trend towards increased composite events in the DAPT group compared with the ASA group (adjusted HR:1.48; 95% CI:0.92-2.40,p=0.11). There was no difference in major bleeding from 12 months through 5 years follow-up. Although no significant differences in outcome were observed between the two groups (see table), the baseline characteristics, EuroSCORE, history of myocardial infarction and current smoker, were significantly different. Conclusions: In the FREEDOM trial, prolonged DAPT after 12 months after PCI was not associated with a reduction in the composite ischemic outcome. These findings may reflect decision-making around the use of DAPT in trial patients or unmeasured risk factors.