First-in-human evaluation of the novel BioMime sirolimus-eluting coronary stent with bioabsorbable polymer for the treatment of single de novo lesions located in native coronary vessels - results from the meriT-1 trial

Dani, Sameer; Costa, Ricardo; Joshi, Hasit; Shah, Jay; Pandya, Rashmit; Virmani, Renu; Sheiban, Imad; Bhatt, Sanjeev; Abizaid, Alexandre

doi:10.4244/eijv9i4a79

Cited by 31 publications

(22 citation statements)

References 27 publications

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“…The sirolimus formulated with the biodegradable polymer releases into the treated vessel during 30–40 days after stent implantation 11 . The first-in-man study of BioMime SES has demonstrated excellent performance in CAD patients including high procedural success (100%) and clinical performance 12 …”

Section: Introductionmentioning

confidence: 99%

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study

Jain

Chakravarthi

Shetty

et al. 2016

Indian Heart Journal

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Section: Introductionmentioning

confidence: 99%

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study

Jain

Chakravarthi

Shetty

et al. 2016

Indian Heart Journal

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“…The BM shares with the well-studied BioMime™ DES technological characteristic (sirolimus elution, biodegradable polymeric carrier and ultrathin stent struts) associated with low late lumen loss and reduced hazard of thrombus formation in both studies [11][12][13][14][15] and meta-analyses [16,17]. The primary safety and efficacy trials meriT-1 [18] and meriT-2 [19] and, more recently, the observational post-marketing multisite registry meriT-3 [14] reported low rates of major adverse cardiovascular events (MACEs) and late stent thrombosis. Finally, the randomized meriT-5 trial [20] demonstrated that BM was non-inferior to the XIENCE DES at 9-month follow-up.…”

Section: Discussionmentioning

confidence: 96%

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses

et al. 2020

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Background: Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far. Methods: We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality. Results: From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization. Conclusion: In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES.

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“…This stent was evaluated in the first-human-use meriT-1 study (NCT01507519) which included 30 patients [106]. The study demonstrated median 8-month in-stent late lumen loss was 0.15 mm [0.09, 0.33].…”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

“…The study demonstrated median 8-month in-stent late lumen loss was 0.15 mm [0.09, 0.33]. At 12 months, no cardiac deaths, MI, TLR, or ST [106]. …”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

Akinapelli¹,

Chen

Roy

et al. 2017

CCR

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Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.

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First-in-human evaluation of the novel BioMime sirolimus-eluting coronary stent with bioabsorbable polymer for the treatment of single de novo lesions located in native coronary vessels - results from the meriT-1 trial

Cited by 31 publications

References 27 publications

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses

Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

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