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Clinical Trial2020 Nov 3;EIJ-D-20-00556.

JOURNAL：Eurointervention. Article Link

A randomized comparison of Coronary Stents according to Short or Prolonged durations of Dual Antiplatelet Therapy in patients with Acute Coronary Syndromes: a pre-specified analysis of the SMART-DATE trial

WJ Jang, JB Lee, YB Song et al. Keywords: 6-month vs. 12-month DAPT; ACS; DES

ABSTRACT

AIMS - We sought to compare biodegradable-polymer biolimus-eluting stents(BP-BES) with durable-polymer everolimus-eluting(DP-EES) and zotarolimus-eluting stents(DP-ZES) in patients with acute coronary syndrome(ACS) according to different duration of dual antiplatelet therapy(DAPT).


METHODS AND RESULTS - In the SMART-DATE trial, 2712 patients with ACS underwent randomization for allocation of DAPT (6-month [n=1357] or 12-month or longer [n=1355]) and type of stents (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). At 18 months, primary endpoint (a composite of cardiac death, myocardial infarction, or stent thrombosis) was 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI 0.70-2.39, p=0.42 for BP-BES vs. DP-EES and HR 1.23, 95% CI 0.67-2.26, p=0.50 for BP-BES vs. DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, pinteraction=0.48 and BP-BES vs. DP-ZES, pinteraction=0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, per-protocol analysis showed similar results.


CONCLUSIONS - The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.
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