Short and Long-term Outcomes of Biodegradable Coated Stent (Biomime Versus Ultimaster) Deployed in STEMI Patients Undergoing Primary Percutaneous Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Target vessel failure
Study Overview
Brief Summary
- To evaluate clinical safety of the device in terms of Deaths, any stroke and Myocardial Infarction up to 1 year in both study groups to prove non inferiority of biomime stent
- To evaluate presence of Target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent
- To evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent
Detailed Description
• Drug-eluting stents (DES) represent a key advance in percutaneous coronary interventions (PCI) owing to their ability to inhibit neointimal proliferation, which lowers the need for repeat revascularisation However, older-generation DES have been shown to increase the risk of late restenosis and stent thrombosis. Efforts to reduce these risks include improvements in stent platforms, polymer carriers, and drug selection. Thinner struts reduce vessel wall injury, decrease inflammation and promote fast endothelialisation.The second-generation thin-strut DES have been shown to reduce the risk of restenosis, stent thrombosis and myocardial infarction (MI) or possibly death when compared with older-generation DES or bare metal stents. Moreover, the newer generation of biodegradable polymer stents has the potential to reduce the inflammatory reaction of the arterial wall and minimise the risk of late restenosis and thrombus formation More recently, ultra-thin (<70 μm) DES have been shown to improve outcomes further compared with second-generation DES.The BioMime™ (Meril Life Sciences Pvt. Ltd., Vapi, India) is an ultra-thin sirolimus-eluting coronary stent (SES) with an established preliminary safety and efficacy record in the previous meriT-1, meriT-2, meriT-3 and meriT-4 trials in treating single de novo and complex lesions.The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges which lead to Lesser Edge Dissections during expansion and Adequate Side Branch Access, coated with biocompatible and bioabsorbable polymers, PLLA (poly-L-lactic acid) and PLGA (poly-lactic-co-glycolic acid) for Faster Healing
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients with ST-segment elevation myocardial infarction and diagnosed according to the last guidelines.
Exclusion Criteria
- •Left ventricular ejection fraction ≤30%.
- •Killip class III or IV at presentation.
- •Extreme vessel tortuosity or lesion angulation (˂45˚).
- •Severe calcification proximal to or within the target lesion.
- •Bifurcation lesions with side branch diameter >2 mm.
- •Mechanical complication of STEMI.
- •Severe comorbidity such as malignancy
Arms & Interventions
bio mime arm
ultrathin stent arm
Intervention: The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges (Device)
Ultimaster arm
The Ultimaster® (Terumo CorporationTokyo, Japan) consists of the Kaname stent platform, abluminally coated with poly D,L-lactic acid-polycaprolactone (PDLLA-PCL) as a carrier of the immunosuppressant drug sirolimus (3.9 μg/mm stent length). The purpose of the gradient coating is to reduce potential cracking and delamination of the polymer. The drug release profile allows an initial stronger release immediately following stent implantation. Then the drug is released continuously until the polymer bioabsorption is completed within three to four months. For a stent size of 3.0×15 mm, the median maximum concentration (Cmax) was 36.8 pg/mL (range between 22.9 and 41.5 pg/mL), according to the previously published detailed information on the pharmacokinetic profile
Intervention: The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges (Device)
Outcomes
Primary Outcomes
Target vessel failure
Time Frame: From enrollment and followed up for one year
Target vessel failure (TVF): defined as cardiac death that cannot be clearly attributed to a vessel other than the target vessel, target vessel MI, and clinically driven target vessel revascularization
MACE
Time Frame: From enrollment and followed up for one year
Major adverse cardiac events (MACE) as a composite of cardiac death, any MI and clinically driven target vessel revascularization (CD-TVR)
Late lumen Loss
Time Frame: From enrollment and followed up for one year
Late lumen loss: the difference between the minimal luminal diameter (MLD) after stent implantation and after at least 9 months post procedure
Secondary Outcomes
- Device-oriented composite end points(From enrollment and followed up for one year)
- Patient-oriented composite end points(From enrollment and followed up for one year)
- stent thrombosis(From enrollment and followed up for one year)
Investigators
Amr Ahmed Abdelnazeer
Short and long-term Outcomes of biodegradable coated stent (biomime versus ultimaster) deployed in STEMI patients undergoing primary percutaneous intervention
Assiut University