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, Rajendra K.; Chakravarthi, P.I.S.; Shetty, Ranjith; Ramchandra, Padmakumar; Polavarapu, Raghava Sarma; Wander, G.S.; Mohan, Bishav; Banker, D.; Dharmadhikari, Aniruddha; Bansal, Shyam Sundar; Jain, Neeraj; Solanki, Dharmesh; Dhakaan, Jagdish; Sharma, Ved P.; Mohanan, Padhinhare P.; Ashokan, Parayaru Kottayal; Manjunath, Bagur Venkat; Hiregoudar, Narendra; Patil, Chandrashekar; Balakrishnan, Narasimha

doi:10.1016/j.ihj.2016.09.007

Cited by 20 publications

(19 citation statements)

References 22 publications

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“…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 and meriT-3 trials in treating single de novo and complex lesions [8][9][10] . In the present randomised study, we compared the safety and efficacy of the biodegradable polymer-coated BioMime SES with the XIENCE family (XIENCE V ® , PRIME ® or Xpedition ® ; Abbott Vascular, Santa Clara, CA, USA) of durable polymer-coated everolimus-eluting coronary stents (EES) in patients undergoing PCI with up to two de novo native coronary artery lesions.…”

Section: Introductionmentioning

confidence: 99%

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

Abizaid¹,

Kedev²,

Kedhi³

et al. 2018

EuroIntervention

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Section: Introductionmentioning

confidence: 99%

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

Abizaid¹,

Kedev²,

Kedhi³

et al. 2018

EuroIntervention

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“…In clinical practice, all different Imported DES are considered as equally effective and it is the reason for grouping them together. Similarly, total event rates of Indigenous DES of this registry are same as in published reports 13 ,14. The limitations of this study include that not all DES are represented and there is relatively high proportion of Release R and Promus family of DES.…”

Section: Discussionmentioning

confidence: 60%

One-year clinical outcomes of different coronary drug eluting stents—Data from a prospective registry

Sastry

Nallamalla

Kumar

et al. 2018

Indian Heart Journal

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We compared one-year clinical outcomes of different drug eluting stents (DES) used in a prospective observation registry maintained in two hospitals over three years. The primary endpoint was combination of all-cause mortality, stent thrombosis and revascularization. There was no significant difference among different DES. We grouped DES into well-evaluated Imported DES (Imported group), which used to be expensive prior to price control and economical Indian DES (Indigenous group) that lack supportive clinical trials. One-year follow-up data was available in 99% of Indigenous group (n=1856) and 98.5% of Imported group (n=1539). After propensity score matching, there were 1310 matched pairs. There was no significant difference between two groups in the primary end-point or each of the components.

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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: 89%

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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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

Abstract: REF/2016/07/011808.

Cited by 20 publications

References 22 publications

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

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

One-year clinical outcomes of different coronary drug eluting stents—Data from a prospective registry

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

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