Extending dual antiaggregation therapy (DAT) from 12 to 48 months appears not to offer extra protection after DES implantation in patients with no adverse ischemic events during the first year, neither does it increase the risk of severe bleeding.
The OPTIDUAL study was carried out in 58 centers and included 1.385 patients one year after DES implantation. During that first year, patients had been treated with aspirin and clopidogrel and had not suffered ischemic or bleeding events. This study randomized patients to the same DAT vs. aspirin only for the next 36 months. 2nd generation DES were used in 2/3 of cases and 1st generation DES in the remaining 1/3.
There were no differences in primary outcomes in net adverse clinical events (NACE; a combination of all-cause death, non-fatal infarction, stroke or severe bleeding) between the extended DAT group (5.8%) and the aspirin group (7.5%; p =0.17). Risk rates of components were also similar. However, the post hoc analysis of ischemic results (mortality, stroke or infarction) revealed a certain benefit, with a 4.2% rate in the extended DAT group and a 6.4% in the aspirin only group.
Outcomes were consistent across several pre specified subgroups including the indication of PCI and kind of stent. The thrombosis rate was very low, lower than 0.5% in both groups.