SMART-DATE: 6-month versus 12-month or longer DAPT after PCI in patients with acute coronary syndrome - a randomised, open-label, non-inferiority trial
Reported from the ACC Scientific Sessions 2018 (ACC.18) in Orlando, United States
The SMART DATE trial presented at ACC1.8 and published simultaneously in the Lancet is yet another trial evaluating the duration of antiplatelet therapy in patients with acute coronary syndrome (ACS).
What is the aim of this trial?
This is a randomised open-label trial of 6 month vs. 1 year of dual antiplatelet therapy in patients with UA, STEMI and NSTEMI undergoing PCI with drug eluting stent. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure.
What did the trial show?
There were 2712 patients in total: 1357 in the 6-month DAPT group and 1355 in the 12-month or longer DAPT group. Clopidogrel was used in over 80% of patients. The trial failed to show significant differences in the primary endpoint which occurred in 4.7% in the 6 month group vs. 4.2% in the 1 year group (p=0.51) with significance for the non-inferiority margin of p=0.027. Although there were no differences in the other individual secondary endpoints, 6-month therapy was associated with an excess myocardial infarction compared to 1 year (1.8% vs. 0.8%, HR 2.41, 95% CI 1.15-5.05, p=0.02). Bleeding was numerically higher but not statistically significant with 1 year vs. 6-month groups (3.9% vs. 2.7%, p=0.09).
My take on this trial
Based on the findings of SMART DATE, 6 months of dual antiplatelet therapy with Clopidogrel is not recommended for ACS patients undergoing drug eluting stenting given the occurrence of excess MI with this strategy. In current practice the “novel” antiplatelets that are more potent than Clopidogrel are now standard of care for ACS patients. Several studies are underway evaluating shorter duration of novel agents in the setting of ACS and stenting with drug eluting stents which might be of relevance in the current contemporary care era, and we await the results of these trials.
PCRonline cardio poll results
Prior to the release of the results at ACC.18, we asked our website audience which results they were expecting - view the SMART DATE cardio poll results here.