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Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated sirolimus-eluting Stent in an Unselected Real-World Population

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International Journal of Clinical Medicine 2014年第5期5卷 206-215页

作者： Prakash Chandwani Atul D. Abhyankar Jayesh S. Prajapati Sanjay C. Porwal Ashok S. Thakkar Apollo Hospitals International Limited Gandhinagar India Heart and General Hospital Jaipur India KLEs Dr. PrabhakarKore Hospital & Medical Research Centre Belgaum India Sahajanand Medical Tech. Pvt. Ltd. Surat India Shree B.D. Mehta Mahavir Heart Institute Surat India

OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core? sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core? stent in a “real-world” setting.

关键词： Coronary Artery Disease Biodegradable Polymer sirolimus-eluting Stent

Safety and Efficacy of Ultra-Thin, Biodegradable Polymer Coated sirolimus-eluting Supralimus-Core Stents in Real-World Patients: Outcomes at 24-Month Follow-Up

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World Journal of Cardiovascular Diseases 2018年第11期8卷 523-532页

作者： Kala Jeethender Kumar Jain Subash Dasarapu Sai Satish Oruganti Jyotsna Maddury Srinivas Bhyravavajhala Rama Kumari Nuthalapati Vanaparthi Satya Bharathi Lakshmi Rajender Betham Anil Kumar Enikapalli Nizam’s Institute of Medical Sciences Hyderabad Telangana India

Aim: The purpose of this registry was to establish long-term safety and efficacy through implantation of Supralimus-Core sirolimus-eluting stents (SES) in real-world patients with coronary artery disease (CAD). Methods:The present registry was a retrospective, singe-arm, single-centre, investigator-initiated registry. A total of 372 consecutive patients were implanted with Supralimus-Core SES between January 2015 and November 2016. The primary endpoints were major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR) at 24 months. The secondary endpoints were all-cause death and all separate components of the primary endpoint. Additional endpoints included events of stent thrombosis classified as definite, probable, and possible stent thrombosis. Follow-ups were conducted at 30-days, 6-months, 12-months and 24-months after the index procedure. Results: The mean age of the registry population was 56.3 ± 11.1 years. Males constituted 276 (74.2%) patients. Hypertensives, diabetics, alcoholics, tobacco chewers and smokers comprised 198 (53.2%), 160 (43.0%), 93 (25.0%), 91 (24.5%) and 88 (23.7%) of the registry population, respectively. The mean length and diameter of stents implanted was 19.3 ± 8.8 mm and 2.9 ± 0.3 mm, respectively. At the 24-month follow-up, MACE was reported in 14 (3.8%) patients. Cardiac death, MI, TLR and TVR was reported in 7 (1.9%), 4 (1.1%), 3 (0.8%) and 4 (1.1%) patients, respectively. Overall stent thrombosis occurred in 4 (1.1%) patients. Conclusions: The low MACE rate of 3.8% at the 24-month follow-up indicates favorable long-term results after implantation of the ultra-thin strut Supralimus-Core SES in all-comer, real-world patients.

关键词： Biodegradable Polymer Cobalt-Chromium Coronary Artery Disease Drug eluting Stents Percutaneous Coronary Intervention sirolimus-eluting Stent

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

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World Journal of Cardiovascular Diseases 2017年第5期7卷 163-173页

作者： Vithala Surya Prakasa Rao A. S. V. Narayana Rao Pannala Lakshmi Narasimha Kapardhi Priyen Kantilal Shah Revanur Viswanath Satyajit Govindrao Mehetre Avanindra Kumar Srivastava Department of Cardiology Apollo Hospitals Hyderabad India

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 *** 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.

关键词： Biodegradable Polymer Cobalt-Chromium Metafor SES sirolimus-eluting Stent Stent Thrombosis

A Randomized Controlled Trial of a Biodegradable Polymer,Microcrystalline sirolimus-eluting Stent(MiStent)versus Another Biodegradable Polymer sirolimus-eluting Stent(TIVOLI):The DESSOLVE-C Trial

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Cardiology Discovery 2023年第1期3卷 1-8页

作者： Bin Wang Sicong Ma Zhiyong Wang Li Zhang Hanjun Pei Yang Zheng Yuejin Yang Zheng Zhang Xinqun Hu Ziwen Ren Feng Zhang Changqian Wang Renqiang Yang Zhiming Yang Yuexi Wang Guosheng Fu Yu Cao Zuyi Yuan Kai Xu Xin Zhao Bo Xu Miaohan Qiu Quanmin Jing Department of Cardiology General Hospital of Northern Theater CommandShenyangLiaoning 110015China Department of Cardiology People’s Hospital of Inner Mongolia Autonomous RegionHohhotInner Mongolia 010017China Department of Cardiology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Cardiology The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and TechnologyBaotouInner Mongolia 014000China Department of Cardiology The First Clinical Hospital of Jilin UniversityChangchunJilin 130021China Department of Cardiology Fuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100037China Department of Cardiology The First Hospital of Lanzhou UniversityLanzhouGansu 730000China Department of Cardiology Second Xiangya Hospital of Central South UniversityChangshaHunan 410011China Department of Cardiology TEDA International Cardiovascular HospitalTianjin 300457China Department of Cardiology Shanghai Ninth People’s HospitalShanghai Jiao Tong University School of MedicineShanghai 201999China Department of Cardiology Second Affiliated Hospital of Nanchang UniversityNanchangJiangxi 330000China Department of Cardiology Second Hospital of Shanxi Medical UniversityTaiyuanShanxi 031100China Department of Cardiology Affiliated Hospital of Inner Mongolia Medical UniversityHohhotInner Mongolia 010110China Department of Cardiology School of MedicineSir Run Run Shaw HospitalBiomedical Research CenterZhejiang UniversityHangzhouZhejiang 310016China Department of Cardiology Third Xiangya HospitalCentral South UniversityChangshaHunan 410013China Department of Cardiology The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxi 710061China

Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are *** study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI ***::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 *** primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 *** secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year ***::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat *** was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.

关键词： Drug-eluting stents MiStent Microcrystalline Biodegradable polymer sirolimus-eluting stent de novo coronary lesion