One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India

Mehta, Ashwin; Chandra, Praveen; Dalal, Jamshed; Shetty, Prabhakar; Desai, Devang; Chocklingam, K.; Prajapati, Jayesh; Kumar, Pramod; Magarkar, Vilas; Vasawada, Apurva; Goyal, B K; Kumar, Viveka; Rao, V. Suryaprakash; Babu, Ramesh; Parikh, Pritesh; Kaul, Upendra; Patil, Aruna B.; Mhetre, Tushar; Rangnekar, Hrishikesh

doi:10.1016/j.ihj.2013.08.031

Cited by 13 publications

(14 citation statements)

References 40 publications

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“…Given the importance of ST in evaluating the overall performance of DES, we estimated the ST rate in our study. The rates of both possible and probable late ST was 0.78% in the present study, which are comparable to those of other standard BP-DES such as sirolimus-eluting Orsiro stents (0.4%), biolimus-eluting Nobori stents (1.2%), and Biolimus A9 stents (0.2%) at 1-year follow-up[14,20]. The low rate of ST observed in our study could be attributed to complete wall apposition of the NeoHexa stent and appropriate endothelial healing over the 1-year period.…”

Section: Discussionsupporting

confidence: 83%

“…We evaluated real-world data of NeoHexa in an unselected clinical practice population with diverse clinical profiles, which included diabetes (39.53%), hypertension (49.61%), bifurcation and thrombotic lesions (11.04%), and ACC/AHA type B and C lesions (94.77%). The presentation of patients was similar to that reported in studies of other similar stents[13,14]. The NeoHexa stent is designed to have thin struts (60 μm) on a cobalt-chromium platform with a unique and innovative “s” link and an alternate “C” link, which provides high radial strength and no foreshortening, making it ideal for all lesion locations including ostial lesions.…”

Section: Discussionmentioning

confidence: 81%

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One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India

Jambunathan¹,

Basavanna²,

Vani³

et al. 2019

WJC

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BACKGROUND Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice. AIM To investigate 1-year clinical outcomes of Neohexa DES in real practice. METHODS Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure. RESULTS A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively. CONCLUSION The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 81%

One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India

Jambunathan¹,

Basavanna²,

Vani³

et al. 2019

WJC

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“…Along with NEXT trial, the NOBORI 2 study also concluded good and sustained performance of biodegradable polymers in high-risk patients with indicative comorbidities and/or complex lesions [21]. Moreover, the safety and performance of biodegradable polymers with limus family of DES were firmly accepted in a real-world patient population [17] [20]. In this study, we collected and analyzed the data of Metafor SES with the perspective to evaluate the safety and performance of Metafor SES.…”

Section: Discussionmentioning

confidence: 99%

“…Ltd., Vapi, India) has been developed with an objective to reduce the adverse effects of existing DES. In a real-world patient population biodegradable polymer have demonstrated excellent safety and performance in CAD patients as quoted in several studies of DES [16] [17]. The Metafor SES (Meril Life Sciences Pvt.…”

Section: Introductionmentioning

confidence: 99%

Safety and Performance of Sirolimus-Eluting Coronary Stent System with Biodegradable Polymer: A Retrospective Analysis in Real-World Patient Population

Rao¹,

Rao²,

Kapardhi³

et al. 2017

WJCD

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Background and Aim: Newer generation coronary stent systems with low profile metallic frame, biodegradable polymer coating and potent but safe anti-restenosis drug from "limus family" are emerging as safe and effective stents. To evaluate the safety and performance of Metafor SES (Meril life Sciences Pvt. Ltd., Vapi, India) in consecutive patients in a real-world population. Methods: The study was a retrospective, non-randomized, single-center study which evaluated the data of 127 patients who underwent percutaneous coronary intervention (PCI) treated with Metafor SES from February 2012 to February 2015 and mean follow-up period of those patients was 3.6 ± 0.6 years. The primary endpoint was a major adverse cardiac event (MACE) including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). In addition, Stent thrombosis (ST) was analyzed at respective follow-up period. Results: A total of 127 patients (mean age: 53.70 ± 8.41 years and 99 males) were included. Among those 80 (63%) patients had hypertension and 58 (45.7%) patients with diabetes mellitus.At follow-up, MACE in form of TLR was observed in 2 (1.6%) patients only. No cardiac death or stent thrombosis was reported in any patient. A total of 169 lesions were treated with the Metafor SES (1.3 stents per lesion). The 38.4% of patients treated with the Metafor SES with lesion length ≥24 mm, and the procedural success was 100%. Conclusions: The lower incidence of MACE in uncontrolled and real world population at long term follow-up clearly depicts the prolonged safety and performance of the Metafor SES.

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“…Of note, transradial PCI procedures were almost 90% and switching from radial to femoral access to complete the stent deployment was never needed. 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.…”

Section: Discussionmentioning

confidence: 90%

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 clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India

Abstract: This registry demonstrates excellent one-year clinical safety and efficacy of BioMatrix stents. The 1-year result shows that BioMatrix stent may be a suitable alternative as compared to contemporary DESs which are currently available in the market for simple as well complex disease.

Cited by 13 publications

References 40 publications

One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India

One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India

Safety and Performance of Sirolimus-Eluting Coronary Stent System with Biodegradable Polymer: A Retrospective Analysis in Real-World Patient Population

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

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