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Pooled analysis of trials comparing titanium-nitride-oxide-coated stents with paclitaxel-eluting stents in patients
Pasi P Karjalainen1, Fausto Biancari, Antti Ylitalo
1Satakunta Central Hospital, Sairaalantie 3, Pori, 28500, Finland. pasi.karjalainen@satshp.fi
Abstract:
We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive stents (BAS) with paclitaxel-eluting stents (PES) in 1,774 patients. All patients were followed for 12 months. The primary outcomes of interest were recurrent myocardial infarction (MI), death and target lesion revascularization (TLR). Secondary endpoints were stent thrombosis (ST) and major adverse cardiac events (MACE) including MI, death and TLR. There were 922 patients in the BAS group and 852 in the PES group. BAS significantly reduced the risk of recurrent MI (2.7% vs. 5.6%; risk ratio 0.50, 95% CI 0.31-0.81; p = 0.004) and MACE (8.9% vs. 12.6%; risk ratio 0.71, 95% CI 0.54-0.94; p = 0.02) during the 12 months of follow up. In contrast, the differences between BAS and PES were not statistically significant with respect to TLR (risk ratio 0.98, 95% CI 0.68-1.41), death (risk ratio 0.96, 95% CI 0.61-1.51) and definite ST (risk ratio 0.28, 95% CI 0.05-1.47). In conclusion, the results of this analysis suggest that BAS is effective in reducing TLR and improves clinical outcomes by reducing MI and MACE compared with PES.
Insights
Titanium-nitride-oxide-coated bioactive stents (BAS) significantly reduced recurrent myocardial infarction (MI) and major adverse cardiac events (MACE) compared to paclitaxel-eluting stents (PES). BAS demonstrated improved clinical outcomes in patients over 12 months.
Area of Science:
- Cardiology
- Biomaterials Science
- Interventional Cardiology
Background:
- Coronary artery disease management often involves percutaneous coronary intervention (PCI) with stenting.
- Drug-eluting stents (DES) are widely used, but concerns regarding long-term safety persist.
- Bioactive stents offer a novel approach to stent coating technology.
Purpose of the Study:
- To compare the efficacy and safety of titanium-nitride-oxide-coated bioactive stents (BAS) versus paclitaxel-eluting stents (PES).
- To evaluate outcomes including recurrent myocardial infarction (MI), death, target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE).
Main Methods:
- A pooled analysis of three randomized controlled trials involving 1,774 patients.
- Patients were randomized to receive either BAS or PES.
- Follow-up was conducted for 12 months, assessing primary and secondary endpoints.
Main Results:
- BAS significantly reduced the risk of recurrent MI (2.7% vs. 5.6%; p = 0.004) and MACE (8.9% vs. 12.6%; p = 0.02) compared to PES.
- No statistically significant differences were observed between BAS and PES for TLR, death, or definite ST.
- Risk ratio for recurrent MI was 0.50 (95% CI 0.31-0.81) and for MACE was 0.71 (95% CI 0.54-0.94).
Conclusions:
- Bioactive stents (BAS) demonstrate superior clinical outcomes compared to paclitaxel-eluting stents (PES) over 12 months.
- BAS effectively reduces the incidence of recurrent myocardial infarction and major adverse cardiac events.
- The findings suggest BAS is a promising alternative for coronary stenting, improving patient outcomes.
