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• 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bio mime arm | Active Comparator | ultrathin stent arm |
|
| Ultimaster arm | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | testing its safety and efficacy at long term follow up after primary percutaneous intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | 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 | From enrollment and followed up for one year |
| MACE | Major adverse cardiac events (MACE) as a composite of cardiac death, any MI and clinically driven target vessel revascularization (CD-TVR) | From enrollment and followed up for one year |
| Late lumen Loss | Late lumen loss: the difference between the minimal luminal diameter (MLD) after stent implantation and after at least 9 months post procedure | From enrollment and followed up for one year |
| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented composite end points | Device-oriented composite end points (DOCE): Defined as Cardiovascular death, MI (not clearly attributable to a non-target vessel) and TLR (clinically driven) | From enrollment and followed up for one year |
| Patient-oriented composite end points |
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Inclusion criteria:
•All patients with ST-segment elevation myocardial infarction and diagnosed according to the last guidelines.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdy algowhary, MD | Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt. | Principal Investigator |
| Salwa R Demitry, MD | Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut | Asyut | Alsabeel | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29957593 | Result | Valdes-Chavarri M, Kedev S, Neskovic AN, Moris de la Tassa C, Zivkovic M, Trillo Nouche R, Vazquez Gonzalez N, Bartorelli AL, Antoniucci D, Tamburino C, Colombo A, Abizaid AA, McFadden E, Garcia-Garcia HM, Milasinovic D, Stankovic G. Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study. EuroIntervention. 2019 Apr 5;14(18):e1836-e1842. doi: 10.4244/EIJ-D-17-01087. | |
| 29945934 |
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|
Patient-oriented composite end points (POCE): Defined as all-cause mortality, any stroke, Any MI (includes non-target vessel territory) and Any revascularization |
| From enrollment and followed up for one year |
| stent thrombosis | Definite stent thrombosis: The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria: A) Acute onset of ischemic symptoms at rest B) New electrocardiographic changes suggestive of acute ischemia C) Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction). Probable stent thrombosis Regardless of the time after the index procedure, any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause. Timing of ST (duration after stent implantation) Acute: 0-24 h & Sub-acute >24 h-30 d & Late >30 d-1 y & Very late >1 y | From enrollment and followed up for one year |
| Result |
| Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456. |
| 28498849 | Result | Poder TG, Erraji J, Coulibaly LP, Koffi K. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis. PLoS One. 2017 May 12;12(5):e0177476. doi: 10.1371/journal.pone.0177476. eCollection 2017. |
| 30222120 | Result | Abizaid A, Kedev S, Kedhi E, Talwar S, Erglis A, Hlinomaz O, Masotti M, Fath-Ordoubadi F, Lemos PA, Milewski K, Botelho R, Costa R, Bangalore S. Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial. EuroIntervention. 2018 Dec 7;14(11):e1207-e1214. doi: 10.4244/EIJ-D-18-00762. |