Key result
Titanium-nitride-oxide-coated bioactive stents yield comparable MACE to everolimus-eluting stents in diabetic ACS patients.
Why the study?
The long-term outcomes of titanium-nitride-oxide-coated bioactive stents versus everolimus-eluting stents in diabetic patients with ACS treated by early PCI were not well characterized.
Do diabetic patients with acute coronary syndrome undergoing early percutaneous coronary intervention have worse long-term outcomes compared to non-diabetics, and how do titanium-nitride-oxide-coated bioactive stents compare to everolimus-eluting stents in this population?
RCT (n=827)
1:1
Do diabetic patients with acute coronary syndrome undergoing early percutaneous coronary intervention have worse long-term outcomes compared to non-diabetics, and how do titanium-nitride-oxide-coated bioactive stents compare to everolimus-eluting stents in this population?
Absolute Event Rate: 18.5% vs 28%
p-value: p=0.18
Diabetic patients presenting with ACS and treated with early PCI have worse long-term clinical outcomes driven by cardiac death, though outcomes between titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents remain comparable in this high-risk subgroup.
Diabetics with ACS post-PCI face higher cardiac death risk than non-diabetics; post-hoc analysis leaves open dedicated trials in this subgroup.
BACKGROUND: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We performed a post-hoc analysis of diabetic versus non-diabetic patients from the trial. METHODS: We randomised 827 patients (1:1) with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR). Follow-up was planned yearly through 7 years. RESULTS: Of 827 patients, 140 (16.9%) were diabetic; of these, 36 (25.7%) were insulin-treated. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in diabetics versus non-diabetics (23.6% versus 13.7%, respectively, p = 0.003), mainly driven by more frequent cardiac death (7.9% versus 2.2%, respectively, p = 0.002). The rates of non-fatal MI, ischaemia-driven TLR were comparable (p > 0.05 for all). In diabetic patients, MACE was comparable between the two stent arms (18.5% versus 28.0%, for BAS versus EES, respectively, p = 0.18). CONCLUSIONS: Diabetic patients treated with early percutaneous coronary intervention for ACS had worse long-term outcome, compared with non-diabetics, mainly driven by more frequent cardiac death. The long-term outcome of BAS was comparable to EES in diabetics. Key Messages Diabetic patients presenting with acute coronary syndrome who were treated with early percutaneous coronary intervention had worse long-term clinical outcome, compared with non-diabetics, mainly driven by a high incidence of cardiac death. Age independently predicted both major adverse cardiac events and cardiac death in diabetic patients. The long-term clinical outcome of titanium-nitride-oxide-coated bioactive stents was comparable to that of everolimus-eluting stents in the diabetic, as well as in the non-diabetic subgroup.
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Karjalainen et al. (2016) conducted an RCT in acute coronary syndrome (ACS) (n=827). titanium-nitride-oxide-coated bioactive stents (BAS) vs. everolimus-eluting stents (EES) was evaluated on major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR) (p=0.18). In diabetic patients with acute coronary syndrome, titanium-nitride-oxide-coated bioactive stents yielded comparable MACE rates to everolimus-eluting stents (18.5% vs 28.0%; P=0.18).
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