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Ferromagnetic Bare Metal Stent for Endothelial Cell Capture and Retention
Published on: September 18, 2015
Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial
Wouter S Remkes1, Erik A Badings2, Renicus S Hermanides1
1Isala heart centre , Zwolle , The Netherlands.
Insights
Everolimus-eluting stents (EES) safely reduce restenosis in non-ST elevation myocardial infarction (NSTEMI) patients compared to bare-metal stents (BMS). This study found EES significantly decreased both angiographic and clinical restenosis rates, improving patient outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- Drug-eluting stents (DES) superiority is established in STEMI but lacking in NSTEMI.
- Bare-metal stents (BMS) are a common treatment for NSTEMI.
- Randomized data on DES in NSTEMI is limited.
Purpose of the Study:
- To investigate the safety and efficacy of everolimus-eluting stents (EES) versus BMS in NSTEMI patients.
- To assess the impact of EES on restenosis rates in NSTEMI.
- To compare clinical outcomes between EES and BMS in NSTEMI.
Main Methods:
- Randomized controlled trial (ELISA-3 and RELI groups) comparing EES (Xience V) with BMS (Vision).
- Angiographic substudy endpoint: minimal luminal diameter (MLD) at 9-month follow-up.
- Clinical follow-up endpoint: major adverse cardiac events (MACE), stent thrombosis (ST), and target vessel revascularization at 2 years.
Main Results:
- EES group showed significantly larger MLD (2.37 mm vs 1.84 mm, p<0.001) and lower binary restenosis (1.9% vs 16.7%, p=0.007) at 9 months.
- Pooled analysis revealed lower target vessel revascularization with EES (4.0% vs 10.4%, p=0.009) over 2 years.
- No significant difference in MACE or stent thrombosis between EES and BMS groups.
Conclusions:
- Everolimus-eluting stents (EES) are safe and effective in NSTEMI patients.
- EES significantly reduces both angiographic and clinical restenosis compared to BMS.
- EES offers improved outcomes in NSTEMI patients undergoing stenting.
Objective:
The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS.
Methods:
ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome.
Results:
178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively.
Conclusions:
In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163.
Trial Registration Number:
39230163; Post-results.
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