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One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

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World Journal of Cardiovascular Diseases 2017年第8期7卷 233-242页

作者： Sridhar Kasturi Shailender Singh Vijay Kumar Shanivaram Kondal Rao Gollamandala Ganesh Mathan Shiva Kumar Bandimida Manikandhar Pendyala Chandrashekar Challa Sunshine Heart Institute Hyderabad India

Background: The biodegradable polymer-coated sirolimus-eluting coro-nary stent (SES) system for the treatment of coronary artery disease (CAD) has been implanted in a real-world patient population. Aim: The present study was designed to evaluate the safety and performance of MetaforTM sirolimus- eluting coronary stent (SES) system in consecutive patients with CAD in a real-world patient population. Methods: All the consecutive 251 patients who underwent percutaneous coronary interventions with the use of Metafor sirolimus-eluting stents were included in this study. Patients were clinically/tele- phonically followed-up at one-year from August 2015 to August 2016. We observed and analyzed major adverse cardiac event (MACE) defined as the aggregate of cardiac death, myocardial infarction (MI), and any target lesion revascularization (TLR) at one-year. Also, stent thrombosis (ST) was observed at one-year patients follow-up. Results: We collected and analyzed the data for 251 patients. Out of 251 participants, 191 (76.1%) were males, 95 (37.8%) patients had diabetes, 117 (46.6%) had ST-segment-elevation myocardial infarction (STEMI), and 134 (53.4%) had hypertension. Mean patient age was 56.35 ± 11.23 years. A total of 295 lesions were treated, out of which 13.6% of the lesions were the long lesion of ≥40 mm. At one-year, MACE occurred in 4 (1.6%) of 251 patients, consisting of 2 (0.8%) cardiac deaths, 2 (0.8%) MI, and 0 (0%) TLR. Stent thrombosis was reported in one patient (0.4%). Conclusions: This retrospective data demonstrated excellent safety and performance of Metafor SES in a “real-world” consecutive CAD patient, indicating low rates of MACE and ST at one-year follow-up.

关键词： Drug-Eluting Stents cobalt-chromium Hybrid Cell Design Percutaneous Coronary Intervention

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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

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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

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Biodegradable polymer stents vs second generation drug eluting stents:A meta-analysis and systematic review of randomized controlled trials

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World Journal of Cardiology 2016年第2期8卷 240-246页

作者： Bhavi Pandya Sainath Gaddam Muhammad Raza Deepak Asti Nikhil Nalluri Thomas Vazzana Ruben Kandov James Lafferty Department of Internal Medicine Staten Island University Hospital Department of Cardiology Staten Island University Hospital

AIM: To evaluate the premise, that biodegradable polymer drug eluting stents(BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents(PP-DES), we pooled the data from all the available randomized control trials(RCT) comparing the clinical performance of both these ***: A systematic literature search of Pub Med, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. RESULTS: A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis(OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization(OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction(OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths(OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths(OR = 0.96, 95%CI: 0.80-1.17, P = 0.71).CONCLUSION: BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.

关键词： Stent design Drug eluting stent Zotarolimus eluting stent cobalt-chromium stent Biodegradable drug eluting stent

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