Technical research on Partner /Miranda Sirolimus-eluting Coronary Stent System* Yang Ming (Senior Engineer), Lepu Medical Technologies (Beijing) Co. Ltd, September 2005 This article systemetically summarized research data and analysis results of radial strength, flexibility, drug coating material and technology, and clinical trials accumulated during the research and development process of Lepu Company s Partner /Miranda drug eluting stent. A huge number of data confirm that Partner /Miranda stent has achieved an advanced level among similar products. Introduction. In the last 20 years with people s elevated living standard and increased ageing population, the incidence of coronary heart disease in China showed a significant up trend. To timely apply and promote new research findings and new techniques in clinical practice, benefiting as many patients possible, is an urgent task in the present field of cardiology. The development of percutaneous coronary intervention (PCI) represents the most outstanding advancement in the field of cardiology. The sirolimus-eluting stent launched by Johnson & Johnson Cordis Company in 2002 was another milestone in the development of percutaneous coronary intervention (PCI). A new-generation domestic sirolimus-eluting stent system launched by Lepu Company is beneficial to many coronary heart disease patients in China. We believe that, as indicated by its name, Partner / Miranda drug eluting stent will become the most loyal and reliable partner of cardiologists and heart disease centers in China. This article briefly summarized a variety of performance data accumulated during the research and development process of Partner / Miranda drug eluting stent, and compared it with drug stents produced by famous international enterprises.
Clinical Application of China-Made Rapamycin-Eluting System in Emergency interventional Treatment of Acute Myocardial Infarction Cheng Hui. Tu Jihong, Yan Youliang, Gao Zhaobo Department of Internal Cardiology, Third affiliated hospital of Nanchang University, Jiangxi Nanchang, China / Chinese Book Classified Number: R542-2+2. Literature Indentification Code: A, Article number: 1009-8194(2006)10-0000-00 To investigate the safety and efficacy of China-made Rapamycin-eluting system (Partner / Miranda )* in emergency interventional treatment of acute myocardial infarction. 56 patients with AMI from November, 2005 to June 2006 were included. All patients received Emergency PCI within 12h after the onset. Immediate therapeutic effect and follow-up outcome were analyzed. Emergency interventional treatment was successful in all the 56 patients. A total of 58 Partner /Miranda were implanted. There were 3 cases of slow blood flow during the surgery. There was no severe related complication. Within 2-7 (4±2) months of follow-up, 3 patients were hospitalized because of recurrent chest pain. Two were confirmed as new lesion of other coronary branch by coronary arteriography, while the other one was in-stent restenosis and treatment by another interventional therapy. No cardiac event was found in Other patients. Out of the 56 patients, 6 patients underwent recheck and treatment by arteriography and there was no in-stent restenosis. China-made rapamycin drug-eluting system (Partner /Miranda ) was safe and effective in Emergency interventional treatment of acute myocardial infaction.
Partner /Miranda stents for crush technique in coronary bifurcation: Immediately and short-time follow up results. Xu-Ze Sheng, Spong Zhiyan, Ma Zengcai, et al Department of Cardiology, Changzbou Central Hospital, Changzhou, 061001, China To estimate the security and validation of crush technique in the therapy of coronary bifurcation lesions by our national sirolimus-eluting stent (Partner /Miranda ). After coronary angiography, crush technique was used to accomplish the main branch and side branch lesions in truly bifurcation lesions (Medina type 1.1.1.). Six months later, coronary angiography was reexamined. There were 30 patients enrolled and total 31 of bifurcation lesions. The mean age was 61.7± 11.2 years, made was 66.7%. The 31 bifurcation lesions included: LAD-D (51.6%), LM-LAD and LCX (32.3%), RCA-PL and PD (9.7%) and LCX-OM (6.5%). The non-compliance balloon was used to expand lesions by high pressure (58.1%), finally the kissing balloon technique was completed (96.8%). The stent number in main branch and side branch vessels was 1.5±0.55 vs 1.1±0.34, the length was (37.2±1,2) mm vs (21.6±0.83) mm, the diameter was (3.27±0.51) mm vs (2.76±0.48) mm. The rate of main cardiac event (MACE) after PCI was 3.3%. It is security and validation to treat the bifurcation lesions by crush technique with Partner / Miranda Sirolimus-eluting stent, and this stent is more attractive in the therapy of complicated coronary lesions in our country because of lower fee-for-service.
Therapeutic Effect of Partner /Miranda Coronary Stent in the Treatment of Coronary Artery Disease and Clinical Follow-up. Huo Wong1), Li Zhangquan2), He Ben3), Chen Shaoliang4), Yu Bo, Li Kang5), Wang Dongqi7), Fu Guosheng8), Wang Ningfu8), Ma Genshan9), Ynag Zhijian10), Wang Jian an11), Shen Xiangqian12), Qi Guoxian13), Qu Peng19), Cao Xuebin14), Ma Yitong7), Li Boa15), Zheng Qiangsun16), Dong Pingshuan17), Cai Shanglong18). / 1) First Hospital of Peking University, 2) Peoples Hospital of Liaoning Provence, 3) Shanghai Renji Hospiital, 4) Nanjing First Hospital, 5) Second Affiliated Hospital of Harbin, 6) Beijing Xuanwu Hospital, 7) Affiliated Hospital of Xian Jiantong University, 8) Zhejiang Shaoyifu Hospital, 9) Jiangsu Zhongda Hospital, 10) People s Hospital of Jiangsu Province, 11) Second Affiliated Hospital of Zhejiang University, 12) Second Hospital of Hunan Xiangya Medical College, 13) First Affiliated Hospital of Chinese Medical University, 14) 252 Military Hospital, 15) Shanxi institute of cardiovascular disease, 16) Tangdu Hospital of the Forth Military Medical Univeristy, 17) First Affiliated Hospital of Henan Technology University, 18) Qingdao Medical College Affiliated Hospital, 19) Second Hospital of Dalian Medical University. To evaluate the safety and therapeutic effect of China-made Partner /Miranda coronary Stent in the treatment of coronary artery disease. Retrospectively analysis was performed on 1352 patients with coronary artery disease who were treated by insertion of Partner /Miranda coronary stents in 21 heart centers. Cardiac death, myocardial infarction, target vessel remodeling rate, main adverse cardiac event (MACE) and incidence of in-stent thrombogenesis within I year were observed. Partner /Miranda stents were inserted into 1869 lesions in 1352 patients, among were 23.3% diabetic, 90.49% were with acute coronary syndrome. Type C lesion accounted for 30.98%, branch lesion accounted for 11.13%, and chronic occlusive lesion accounted for 7.81%. Average length of target lesion vessel was 21.99±10.57 mm, average stenosis was 88.18%±10.93%, reference vessel diameter was 3.17±1.81mm, and maximum dilation pressure was 13.77± 3.01 atm. Lesion that needed pre-balloon dilation was 78.12% while lesion that needed after-balloon dilation was 25.79%. The results of follow-up showed that accumulated incidence of cardiac death, myocardial infarction, target vessel remodeling, MACE within 12 months was 0.52%, 0.96%, 2.14% and 3.62% respectively, all within acceptable range. One year accumulated incidence of thrombus (0.66%) was similar with the results od other studies. The result of one-year follow-up that China-made Partner /Miranda coronary stent had Good safety and efficacy
Efficacy of Partner /Miranda Stent in Patient with Coronary Heart Disease. HAO Dongqin, LIU Henliang, ZHAO Youmin, et al. Department of Cardiology, the Fifth People s Hospital of Zhengzhou, Zhengzhou 450003, China To evaluate the effects and security of the Partner /Miranda stent (homemade Sirolimuseluting stent) in patients with coronary heart disease (CHD). Total 268 patients with CHD treated with 481 Partner /Miranda stents. Among the 268 patients, 136 were with acute myocardial infarction (AMI1) and 132 were with unstable angina. The immediate angiographic outcome, complication in the procedure, six months follow-up results, including main adverse cardiac events (MACE) and angiographic results, were assessed. A successful stenting procedure was achieved in 99.2% patients. Sub-acute in-stent thrombosis occurred in 1 patient, 2 patients died during operation and hospitalization. The MACE rate was 1.1% during hospitalization and 2.3% during 6 months follow-up. At 6 months, angiographic results showed that in-stent restenosis rate (ISR) was 5.4%. The target vessel revascularization rate was 5.4%. Partner /Miranda stent implantation in patients with CHD is safe and effective, the ISR rate and TLR rate are significantly lower than those of bare metal stents.
Short-term clinical observation of the domestic and the imported rapamycin-eluting Stent Wei Wenbing, The Cardiovascular Internal Medicine Department of the Shenzhen Futian People s Hospital, Shenzhen of Guangdong, Zip Code 518033 The objective was to investigate the difference in therapeutic effects of the domestic and Imported rapamysin-eluting stent. The paper concluded 107 patients of coronary arteriosclerotic heart disease with Cypher and Partner /Miranda stent implantation since year 2006 in our hospital. When comparing the general statuses of the two groups, p-values were both > 0.05 and showed no statistical significance. As for the characteristics of target blood vessels in the Two groups of patients, p-values was > 0.05 and showed no statistical significance. When comparing the average target vascular diameter and the average target lesion length In the Cypher group and the Partner /Miranda group, they showed Cypher (2.68 0.42 mm) vs Partner /Miranda (2.71 0.31 mm) and Cypher (19.59 6.35 mm) and Partner / Miranda (20.07 6.07 mm). The p-values were > 0.05 and showed no statistical significance. Clinical follow-up lasted 6 months, where both groups of patients did not develop acute and Subacute intra-stent thrombosis, as well as recurrence of myocardial infarction and death. In comparison of primary cardiovascular events, recurrence of pectoris angina, and vascular Reconstruction, p-values were all > 0.05 without statistical significance. Domestic and imported rapamycin-eluting stents have similar short-term therapeutic effects.
Comparison between Partner /Miranda and Cypher rapamycin drug-eluting stent in The treatment of coronary artery disease. Gao Kang, Yang Ming, Wang Qing, Pab Guozhing, Han Ling, Chen Liwei, Cen Qiang., Cardiovasology Center in Hu Xing Hospital, Capital Medical University / Chinese Book Classificatioin Number R541.4, Literature Indentification Code A, Article Number 1681-6667 (2007) 06-0483-04. To compare the manipuility, safety and efficacy of Partner /Miranda and Cypher in clinical application. Retrospective analysis was performed on Partner /Miranda stents which were used from February 2006 to November 2006 in the Cardiovasology Center in Hu Xing Hospital, Capital Medical University. Clinical application during the surgery and within half a year after the surgery was analyzed and compared with that of Cypher stent used in the same period. 1) There were 57 patients in Cypher stent group and 48 patients in the Partner /Miranda stent group. There was no statistical significant difference in number of branches involved. of intervention or average length of stent implanted between the two groups. Both post-operative minimum lumen diameter (MLD) and stenosis were significantly improved. There was significant difference in treatment of intermediated branch lesion, stent diameter and surgery cost, 2) 6 month follow-up completion rate was similar between the two groups. Incidence of major adverse cardiac events within 6 months after the surgery was similar between the two groups. There was no statistical significant difference in incidence of MACE, in-stent restenosis, in-stent thrombosis, non-lethal myocardial infarction, or target vessel revascularization between the two groups within 6 months after the surgery. Partner /Miranda stent was safe and effective in the treatment of coronary artery disease. Its relatively low cost made it more attractive in the clinical application in China.
Study of sixty two cases of left main coronary artery disease treated with Partner / Miranda DES Zhao Yan, Zhang Yun-mei, Zhang Hong, The First People s Hospital of Yunna Province, Kunming, 650021 To evaluate the clinic outcomes of left main artery disease treated with Partner /Miranda drug-eluting stent. August 2005 to April 2007, 62 patients with left main artery disease undergone percutaneous coronary intervention (PCI), and 102 Partner /Miranda stents were implanted. All patients were followed-up for 1-2 years, restenosis, cardiac events and death were analyzed. 102 stents were implanted in 62 patients. Among them 34 patients treated with step crush technique, 3 patients occurred with restenosis and 1 patient with AMI. Partner /Miranda stent is effective in treatment of left main artery disease, double stent is independent risk factor of restenosis.
Overlapping Homemade Partner /Miranda vs Cypher Sirulimus Eluting Stents to Treat Diffuse Disease of Coronary Artery Wang Lei, Wang Ming-sheng, Wang He, et al. Department of Cardiology, Beijing Shijingshan Hospital Beijing, 10043, China To evaluate the efficacy of overlapping homemade Partner /Miranda vs Cypher sirolimus eluting stent to treat diffuse disease of coronary arterial lesions. From January 2005 to January 2008, 128 patients with diffuse de novo coronary lesions underwent overlapping homemade Partner /Miranda sirolimus eluting stent therapy were matching with the other 104 patients receiving overlapping Cypher sirolimus eluting stents therapy. Clinically characteristics and follow-up results were compared between the two groups. Partner /Miranda stent group had more three-vessel lesion and hyperlipoidemia patients, the rest aspects of baseline features in the two groups were similar. 1-year and 2-year followup were all similar Overlapping homemade Partner /Miranda sirolimus eluting stents in patients with a diffuse coronary arterial lesion is relatively safe and associated with good clinical outcomes.
Clinical Application of Partner /Miranda Drug Eluting Stent Huang Bin, Li Xin, Bal Jing, Qin Longfei, Shen Hang. Department of Interventional Therapy, Zhengzhou University Fifth Affiliated Hospital, Hennan Zhengzhou, 450052 To investigate the therapeutic effect and safety of Partner /Miranda drug-eluting stent. 111 patients with coronary artery disease were treated percutaneous coronary intervention with Partner /Miranda drug-eluting stent from January 2006 to December 2006. All patients were followed-up after the surgery to observe the recurrence of chest pain, changes in electrocardiogram and occurrence of major adverse cardiac events. A total of 196 Partner /Miranda drug eluting stents were implanted in 180 lesions in 111 patients. Surgery success rate was 100%. There was no recurrence of chest pain and there was no major adverse cardiac event after surgery. The short-term therapeutic effect of Partner /Miranda rapamycin drug-eluting stent in PCI was satisfying. Its application was safe and convenient.
Effect of Rapamycin Eluting Stent on Level of C-reactive Protein in Patients with Acute coronary Syndrome After Angioplasty. CHEN Hui, Tu-Xie-hiong, YAN You-liang, GAO Zhao-bo. Department of Cardiology, The Third Affiliated Hospital of Nanchang Universtity, Nanchang 330008, China. To compare the effect of domestic produced rapamycin eluting stents (Partner /Miranda ) versus conventional stainless steel stent on the levels of C-reactive protein (CRP) in the patients with acute coronary syndrome after angioplasty. A total of 68 cases of acute coronary syndrome were randomly divided into group A (n=36) and group B (n=32). The patients in group A received domestic produced rapamycin eluting Stent (Partner /Miranda ) while the patients in group B received conventional stainless steel stent. Venous blood samples were taken before, at 12 and 24 hours after angioplasty in both groups, and serum samples were analyzed for CRP by particle-enhanced immumoturbidimetry. Result At before percutaneous transluminal coronary angioplasty, the levels of CRP has no statistical significant difference between the two groups (P > 0.05). At 12 and 24 hours after angioplasty, the levels of CRP has statistical significant difference between the two groups (P < 0.05). Domestic produced rapamycin eluting stent (Partner /Miranda ) could decrease the levels of CRP and possibly suppress inflammatory reaction in the patients with acute coronary syndrome after angioplasty.
The long-term outcomes of the patients with coronary heart disease treated by domestic Partner /Miranda coronary stent. Clinical centers and main investigators involved were: Huo Yong, Chen Ming and Li Jianping from First Hospital of Peking University, Li Zhanquan from the People s Hospital of Liaoning Province, He Ben from Shanghai Renji Hospital, Chen Shaoliang from Nanjing First Hospital, Yu Bo from Second Affiliated Hospital of Harbin, Li Kang from Beijing Xuanwu Hospital, Wang Dongqi from Affiliated Hospital of Xian Jiatong University, Fu Guosheng from Zhejiang Shaoyifu Hospital, Wang Ningfu from Hangzhou First Hospital, Ma Gensham from Jiangsu Zhingda Hospital, Yang Zhijian from the People s Hospital Jiangsu Province, Wang Jianan from the Second Affiliated Hospital of Zhejiang University, Shen Xiangqian from the Second Affiliated Hospital of Hunan Xiangya Medical College, Qi Guoxian and Jia Dalin from the First Affiliated Hospital of Chinese Medical University, Qu Peng from the Second Hospital of Dalian Medical University, Cao Xuebin and Mu Xianyou from the 252 Military Hospital, Ma Yitong from the First Affiliated Hospital of Xinjiang Medical Univerisity, Li Bao from Shanxi Institute of Cardiovascular Disease, Zheng Qiangsum from Tangdu Hospital of the Forth Military Medical University, Deng Pingshuan from the First Affiliated Hospital of Henan Technology University, Cai Shanglang from Qingdao Medical College Affiliated Hospital. To evaluate the safety and efficacy of domestic Partner /Miranda stent in treating coronary artery disease. The 24 month follow-up results of Partner /Miranda coronary stent implantation in 1352 coronary heart disease (CHD) patients were retrospectively analyzed in 21 medical centers. Implantation of 1869 Partner /Miranda coronary stents was successfully performed in 1352 patients. 12 months cumulative cardiac death rate (0.52%), Myocardial Infarction (0.96%), TVR (2,14%), MACE (3.62%); 24 months cumulative cardiac death rate (0.81%), Myocardial Infarction (2.07%), TVR (3.70%), MACE (6.58%) is acceptable and comparable with imported coronary stents. Domestic Partner /Miranda coronary stent can be safely implanted in severe CHD patients with ideal long-term outcomes.
Bibliography 1)Technical research on Partner /Miranda Sirolimus-eluting Coronary Stent System* Yang Ming (Senior Engineer), Lepu Medical Technologies (Beijing) Co. Ltd, September 2005 2) Clinical Application of China-Made Rapamycin-Eluting System in Emergency interventional Treatment of Acute Myocardial Infarction Cheng Hui. Tu Jihong, Yan Youliang, Gao Zhaobo. Department of Internal Cardiology, Third affiliated hospital of Nanchang University, Jiangxi Nanchang, China / Chinese Book Classified Number: R542-2+2. Literature Indentification Code: A, Article number: 1009-8194(2006)10-0000-00 3) Partner /Miranda stents for crush technique in coronary bifurcation: Immediately and short-time follow up results. Xu-Ze Sheng, Spong Zhiyan, Ma Zengcai, et al. Department of Cardiology, Changzbou Central Hospital, Changzhou, 061001, China 4) Therapeutic Effect of Partner /Miranda Coronary Stent in the Treatment of Coronary Artery Disease and Clinical Followup. Huo Wong1), Li Zhangquan2), He Ben3), Chen Shaoliang4), Yu Bo, Li Kang5), Wang Dongqi7), Fu Guosheng8), Wang Ningfu8), Ma Genshan9), Ynag Zhijian10), Wang Jian an11), Shen Xiangqian12), Qi Guoxian13), Qu Peng19), Cao Xuebin14), Ma Yitong7), Li Boa15), Zheng Qiangsun16), Dong Pingshuan17), Cai Shanglong18). / 1) First Hospital of Peking University, 2) Peoples Hospital of Liaoning Provence, 3) Shanghai Renji Hospiital, 4) Nanjing First Hospital, 5) Second Affiliated Hospital of Harbin, 6) Beijing Xuanwu Hospital, 7) Affiliated Hospital of Xian Jiantong University, 8) Zhejiang Shaoyifu Hospital, 9) Jiangsu Zhongda Hospital, 10) People s Hospital of Jiangsu Province, 11) Second Affiliated Hospital of Zhejiang University, 12) Second Hospital of Hunan Xiangya Medical College, 13) First Affiliated Hospital of Chinese Medical University, 14) 252 Military Hospital, 15) Shanxi institute of cardiovascular disease, 16) Tangdu Hospital of the Forth Military Medical Univeristy, 17) First Affiliated Hospital of Henan Technology University, 18) Qingdao Medical College Affiliated Hospital, 19) Second Hospital of Dalian Medical University. 5) Efficacy of Partner /Miranda Stent in Patient with Coronary Heart Disease. HAO Dongqin, LIU Henliang, ZHAO Youmin, et al. Department of Cardiology, the Fifth People s Hospital of Zhengzhou, Zhengzhou 450003, China 6) Short-term clinical observation of the domestic and the imported rapamycin-eluting Stent Wei Wenbing, The Cardiovascular Internal Medicine Department of the Shenzhen Futian People s Hospital, Shenzhen of Guangdong, Zip Code 518033 7) Comparison between Partner /Miranda and Cypher rapamycin drug-eluting stent in The treatment of coronary artery disease. Gao Kang, Yang Ming, Wang Qing, Pab Guozhing, Han Ling, Chen Liwei, Cen Qiang., Cardiovasology Center in Hu Xing Hospital, Capital Medical University / Chinese Book Classification Number R541.4, Literature Indentification Code A, Article Number 1681-6667 (2007) 06-0483-04. 8) Study of sixty two cases of left main coronary artery disease treated with Partner /Miranda DES Zhao Yan, Zhang Yun-mei, Zhang Hong, The First People s Hospital of Yunna Province, Kunming, 650021 9) Overlapping Homemade Partner /Miranda vs Cypher Sirulimus Eluting Stents to Treat Diffuse Disease of Coronary Artery Wang Lei, Wang Ming-sheng, Wang He, et al. Department of Cardiology, Beijing Shijingshan Hospital Beijing, 10043, China 10) Clinical Application of Partner /Miranda Drug Eluting Stent Huang Bin, Li Xin, Bal Jing, Qin Longfei, Shen Hang. Department of Interventional Therapy, Zhengzhou University Fifth Affiliated Hospital, Hennan Zhengzhou, 450052 11) Effect of Rapamycin Eluting Stent on Level of C-reactive Protein in Patients with Acute coronary Syndrome After Angioplasty. CHEN Hui, Tu-Xie-hiong, YAN You-liang, GAO Zhao-bo. Department of Cardiology, The Third Affiliated Hospital of Nanchang Universtity, Nanchang 330008, China. 12) The long-term outcomes of the patients with coronary heart disease treated by domestic Partner /Miranda coronary stent. Clinical centers and main investigators involved were: Huo Yong, Chen Ming and Li Jianping from First Hospital of Peking University, Li Zhanquan from the People s Hospital of Liaoning Province, He Ben from Shanghai Renji Hospital, Chen Shaoliang from Nanjing First Hospital, Yu Bo from Second Affiliated Hospital of Harbin, Li Kang from Beijing Xuanwu Hospital, Wang Dongqi from Affiliated Hospital of Xian Jiatong University, Fu Guosheng from Zhejiang Shaoyifu Hospital, Wang Ningfu from Hangzhou First Hospital, Ma Gensham from Jiangsu Zhingda Hospital, Yang Zhijian from the People s Hospital Jiangsu Province, Wang Jianan from the Second Affiliated Hospital of Zhejiang University, Shen Xiangqian from the Second Affiliated Hospital of Hunan Xiangya Medical College, Qi Guoxian and Jia Dalin from the First Affiliated Hospital of Chinese Medical University, Qu Peng from the Second Hospital of Dalian Medical University, Cao Xuebin and Mu Xianyou from the 252 Military Hospital, Ma Yitong from the First Affiliated Hospital of Xinjiang Medical Univerisity, Li Bao from Shanxi Institute of Cardiovascular Disease, Zheng Qiangsum from Tangdu Hospital of the Forth Military Medical University, Deng Pingshuan from the First Affiliated Hospital of Henan Technology University, Cai Shanglang from Qingdao Medical College Affiliated Hospital.