CRT-700.04 Three-year Clinical Outcomes Of Biomime Sirolimus-eluting Coronary Stent System With A Biodegradable Polymer In Coronary Artery Disease Patients: A Long-term Follow-up Of The meriT-2 Study

Seth, Ashok; Wander, Gurpreet Singh; Sankardas, Mullasari Ajit; Nanjappa, Manjunath Cholenahally; Heggunje, Prabhakara S.; Hardas, Suhas; Kalaricka, M.; Abraham, Sunitha; Vijan, S.G.; Manoj, Rohit; Abizaid, Alexandre

doi:10.1016/j.jcin.2016.12.199

Cited by 3 publications

(7 citation statements)

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“…Moreover, stents other than BioMime SES were used in approximately 15% of lesions in our study. The meriT-2 clinical trial among 250 patients in real-world settings reported a 12-month cumulative MACE rate of 6%, including 0.8% cardiac death and 5.2% of TLR (4.8% clinically indicated TLR) and a ST rate of 0.4% [ 10 ]. The rates of MACE and TLR at 12 months were considerably higher than those in our study.…”

Section: Discussionmentioning

confidence: 99%

“…The BioMime SES has a cobalt-chromium base with an ultra-thin stent platform (65 µm) [ 9 ]. Strut thickness is a major determinant of local inflammation [ 10 ]. Cobalt-chromium metal alloys allow for thinner stent struts, which facilitates crossability without compromising radial strength, fatigue resistance, or radiopacity [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

“…Earlier publications have provided in-depth descriptions of the technical details and distinctive features of the BioMime SES [9][10][11][12]. BioMime SES is a novel balloon-expandable system with a hybrid architecture (closed and open cells) that facilitates morphology-mediated expansion and has an ultra-thin (65 µm) strut.…”

Section: Device Description and Procedural Detailsmentioning

confidence: 99%

“…Ltd, India) is a Conformite Europeenne (CE)-marked new-generation DES system, which incorporates an advanced ultra-thin strut platform (65-µm) covered with a biodegradable polymer to release sirolimus, an antiproliferative drug, in the vessel wall. The clinical safety and efficacy of this stent were demonstrated in meriT-1 [ 9 ], meriT-2 [ 10 ], meriT-3 [ 11 ], and meriT-V [ 12 ] trials. However, in all these trials, the outcomes were assessed for only up to 12 months.…”

Section: Introductionmentioning

confidence: 99%

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Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

Meennahalli Palleda,

Gupta,

Bansal

et al. 2023

Cardiol Res

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Background:The short-term clinical outcomes of first-generation thicker-strut durable polymer-based drug-eluting stents (DES) have been widely examined. However, there is a scarcity on qualitative research on the long-term usage of DES that evaluated the thinner strut biodegradable stents for coronary artery disease. Hence, we sought to investigate the long-term safety and performance of thinner strut biodegradable polymer-based BioMime sirolimus-eluting coronary stent system in real-world patients with symptomatic ischemic heart disease.Methods: This was a retrospective, observational, single-center, post-marketing clinical follow-up study. The primary endpoints were the incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel revascularization (TVR), and target lesion revascularization (TLR) at 1-, 2-, 3-and 4-year follow-ups. The secondary endpoints were cardiac death, MI, TLR, TVR, device and procedural success rates, and stent thrombosis (ST).Results: In all, 1,188 consecutive patients were enrolled, and 1,333 (1,257 de novo and 76 in-stent restenotic lesions) out of 1,565 lesions were treated with the study device. The mean age of patients was 53.26 ± 10.31 years and 86.2% were male. The quantitative coronary angiographic derived mean lesion length and diameter were 29.62 ± 9.62 mm and 3.01 ± 0.29 mm, respectively. The average length and diameter of the study device implanted were 30.89 ± 6.31 mm and 3.17 ± 0.25 mm, respectively. The cumulative incidence of MACE at 1-, 2-, 3-, and 4 years was 0.61%, 1.47%, 2.08%, and 3.40%, respectively, and cumulative deaths due to cardiac causes were 0.61%, 1.13%, 1.22%, and 1.83%, respectively. There were no cases of TLR or TVR at 1-year follow-up. The cumulative rate of TLR at 2-, 3-, and 4 years was 0.35%, 0.87%, and 1.57%, respectively, while that of TVR was 0.61%, 1.47%, and 2.35%, respectively. Three (0.3%) incidences of probable ST occurred during the 6-month follow-up; no new cases were reported further. In subgroup analysis, MACEs were comparable across the long-and short-length stent groups through 4-year follow-up. Conclusions:This long-term study demonstrates the safety and performance of the ultra-thin BioMime sirolimus-eluting stent with satisfactory clinical outcomes in patients with symptomatic ischemic heart disease in real-world scenario.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Device Description and Procedural Detailsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

Meennahalli Palleda,

Gupta,

Bansal

et al. 2023

Cardiol Res

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“…The biodegradable polymer, which acts as a drug carrier, is a thin copolymer formulation combining two biodegradable components namely poly-l-lactic and poly-lactic-co-glycolic acids. The polymer releases into the treated vessel 30–40 days after stent implantation [10]. The first-in-human study of BioMime SES has demonstrated excellent performance in CAD patients including high procedural success (100%) and clinical performance [11].…”

Section: Introductionmentioning

confidence: 99%

Angiographic and clinical outcomes in patients with versus without diabetes mellitus after revascularization with BioMime sirolimus-eluting stent

Yun¹,

Kim

et al. 2022

Coronary Artery Disease

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Introduction Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes. Methods This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure. Results Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P < 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups. Conclusions BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.

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A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial

et al. 2023

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Background Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. Methods The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. Results The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). Conclusions The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

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CRT-700.04 Three-year Clinical Outcomes Of Biomime Sirolimus-eluting Coronary Stent System With A Biodegradable Polymer In Coronary Artery Disease Patients: A Long-term Follow-up Of The meriT-2 Study

Cited by 3 publications

References 0 publications

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

Angiographic and clinical outcomes in patients with versus without diabetes mellitus after revascularization with BioMime sirolimus-eluting stent

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial

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