Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent

Natsuaki, Masahiro; Kozuma, Ken; Morimoto, Takeshi; Kadota, Kazushige; Muramatsu, Toshiya; Nakagawa, Yoshihisa; Akasaka, Takashi; Igarashi, Keiichi; Tanabe, Kengo; Morino, Yoshihiro; Ishikawa, Takahiro; Nishikawa, Hideo; Awata, Masaki; Abe, Mitsuru; Okada, Hisayuki; Tokura, Y.; Ogata, Nobuhiko; Kimura, Kazuo; Urasawa, Kazushi; Tarutani, Yasuhiro; Shiode, Nobuo; Kimura, Takeshi

doi:10.1016/j.jacc.2013.04.045

Cited by 194 publications

(138 citation statements)

References 8 publications

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“…The NEXT trial reported that one-year clinical outcome after implantation of both biolimus-eluting stent and everolimus-eluting stent was phenomenal, with a low rate of TLR and stent thrombosis [20]. 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].…”

Section: Discussionmentioning

confidence: 99%

“…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%

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

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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“…In the COMPARE II trial, biodegradable polymer biolimus-eluting stents proved non-inferior in direct comparison with durable polymer EES with respect to a composite of cardiac death, myocardial infarction and clinically-indicated target vessel revascularization at one year (12). Similarly, the NEXT trial demonstrated no significant differences between biolimus-eluting stents with a biodegradable polymer and EES with a durable polymer with regard to the primary efficacy endpoint target lesion revascularization at one year (13). Of note, all biodegradable polymer stents used in the trials mentioned above were based on stainless steel platforms with a strut thickness comparable to early generation DES and have not been combined with newer generation metallic platforms.…”

Section: Introductionmentioning

confidence: 99%

Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial

Pilgrim¹,

Roffi

Tüller

et al. 2014

American Heart Journal

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Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial, American Heart Journal (2014), doi: 10.1016/j.ahj.2014 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT

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“…The designs and the 3‐year clinical outcomes of RESET and NEXT have been previously described in detail 5, 6, 7. In short, both RESET and NEXT are prospective, multicenter, randomized “DES versus DES” trials, in which eligible patients were randomly assigned to undergo percutaneous coronary intervention (PCI) with either everolimus‐eluting stents (EES; Xience V, Abbott Vascular, CA/PROMUS, Boston Scientific, MA) or sirolimus‐eluting stents (Cypher/Cypher select/Cypher Select‐plus; Cordis Corporation, Johnson and Johnson, NJ) in the RESET, and with either biolimus‐eluting stents (Nobori, Terumo, Tokyo) or EES in the NEXT.…”

Section: Methodsmentioning

confidence: 99%

“…Qualitative and quantitative coronary angiography (QCA) were assessed utilizing CAAS 5.9 (Pie Medical Imaging, Maastricht, Netherlands). Details of the angiographic analysis were previously presented 5, 6. In a subset of patients enrolled in the angiographic substudy, follow‐up angiography was performed between 240 and 365 days after the index PCI procedure in both the RESET and NEXT trials 7.…”

Section: Methodsmentioning

confidence: 99%

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New‐Generation Drug‐Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials

Watanabe

Morimoto

Shiomi

et al. 2018

JAHA

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BackgroundPrevious intravascular ultrasound studies suggested the association of stent underexpansion with increased risk of stent thrombosis and restenosis. However, no previous study has addressed the association of the suboptimal angiographic result with target‐lesion revascularization (TLR) in patients receiving new‐generation drug‐eluting stents (DES).Methods and Results RESET (Randomized evaluation of sirolimus‐eluting versus everolimus‐eluting stent trial) and NEXT (NOBORI biolimus‐eluting versus XIENCE/PROMUS everolimus‐eluting stent trial) are prospective, multicenter, randomized “DES versus DES” trials; 3196 patients and 3235 patients were enrolled in the RESET and NEXT, respectively. Using the pooled individual patient‐level data, the current study population consisted of 3679 patients who received single‐lesion treatment using new‐generation DES such as everolimus‐eluting stent and biolimus‐eluting stent. The study population was divided into 3 groups according to the residual in‐stent % diameter stenosis (%DS) after stent implantation by offline quantitative coronary angiography assessed in a core angiographic laboratory (optimal group: %DS <10%, intermediate group: %DS=10% to 20%, suboptimal group: %DS ≧20%). The cumulative 3‐year incidence of TLR was significantly higher in the suboptimal group than in the intermediate and optimal groups (9.8% versus 5.8% versus 5.7%, log‐rank P=0.004). Even after adjusting for the clinical, angiographic, and procedural characteristics, the excess TLR risk of the suboptimal group relative to the optimal group remained significant (hazard ratio: 1.65, 95% confidence interval, 1.14–2.41, P=0.009). The excess TLR risk of the suboptimal group relative to the optimal group was consistently seen across all the subgroups including heavy calcification.ConclusionsThe residual angiographic in‐stent %DS ≥20% was associated with increased risk for TLR in patients treated with the new‐generation DES.

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Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent

Cited by 194 publications

References 8 publications

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

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

Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New‐Generation Drug‐Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials

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