Key result
Titanium-nitride-oxide-coated bioactive stents were non-inferior to everolimus-eluting stents for cardiac death, MI, or TLR (HR 1.04; 95% CI 0.81-1.32; P=0.001 for non-inferiority).
Why the study?
Do titanium-nitride-oxide-coated bioactive stents (BAS) prevent cardiac death, non-fatal MI, or ischaemia-driven TLR compared to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS)?
RCT (n=827)
1:1
Do titanium-nitride-oxide-coated bioactive stents (BAS) prevent cardiac death, non-fatal MI, or ischaemia-driven TLR compared to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS)?
Hazard Ratio: 1.04 (95% CI 0.81–1.32)
Absolute Event Rate: 9.6% vs 9%
p-value: p=0.81, p for non-inferiority =0.001
In patients with ACS, titanium-nitride-oxide-coated bioactive stents were non-inferior to everolimus-eluting stents for the composite of cardiac death, non-fatal MI, or ischaemia-driven TLR at 12 months.
BAS non-inferior to EES for 12-month MACE in ACS; leaves open confirmation in larger randomized trials.
AIMS: Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively). CONCLUSIONS: In patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.
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Karjalainen et al. (2012) 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 composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) (HR 1.04, 95% CI 0.81-1.32, p=0.81, p for non-inferiority =0.001). Titanium-nitride-oxide-coated bioactive stents were non-inferior to everolimus-eluting stents for cardiac death, MI, or TLR (HR 1.04; 95% CI 0.81-1.32; P=0.001 for non-inferiority).
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