Key result
Biodegradable polymer biolimus-eluting stents show no benefit over durable polymer stents for major ACS events.
Why the study?
Data directly comparing various drug-eluting stents with short-duration DAPT were limited, particularly in patients with ACS.
Do biodegradable polymer biolimus-eluting stents (BP-BES) reduce the composite of cardiac death, myocardial infarction, or stent thrombosis compared to durable polymer everolimus-eluting (DP-EES) or zotarolimus-eluting stents (DP-ZES) in patients with ACS across short or prolonged DAPT durations?
RCT (n=2,712)
Open-label
1:1:1 ratio
Yes
Do biodegradable polymer biolimus-eluting stents (BP-BES) reduce the composite of cardiac death, myocardial infarction, or stent thrombosis compared to durable polymer everolimus-eluting (DP-EES) or zotarolimus-eluting stents (DP-ZES) in patients with ACS across short or prolonged DAPT durations?
In patients with ACS, biodegradable polymer biolimus-eluting stents showed similar rates of cardiac death, MI, or stent thrombosis compared to durable polymer everolimus- or zotarolimus-eluting stents, regardless of DAPT duration.
Answers are grounded in this paper and cite their sources.
Supports clinician choice between platforms in ACS; confirms comparable safety across DAPT durations.
BACKGROUND: Data on direct comparison between various drug-eluting stents with short duration dual antiplatelet therapy (DAPT) are limited, especially in patients with acute coronary syndrome (ACS). 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 ACS according to different durations of DAPT. METHODS: In the SMART-DATE trial, 2,712 patients with ACS underwent randomisation for allocation of DAPT (6 months [n=1,357] or 12 months or longer [n=1,355]) and type of stent (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). The primary endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. RESULTS: At 18 months, the primary endpoint was attained by 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, the 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 versus DP-EES or DP-ZES across a short or prolonged duration of DAPT after ACS.
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Jang et al. (2021) conducted an RCT in Acute coronary syndrome (n=2,712). Biodegradable polymer biolimus-eluting stents (BP-BES) vs. Durable polymer everolimus-eluting stents (DP-EES) or zotarolimus-eluting stents (DP-ZES) was evaluated on Composite of cardiac death, myocardial infarction, or stent thrombosis (HR 1.29, 95% CI 0.70-2.39, p=0.42). Biodegradable polymer biolimus-eluting stents resulted in similar rates of cardiac death, MI, or stent thrombosis at 18 months compared to durable polymer stents in ACS patients (HR 1.29, p=0.42).
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