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A novel biodegradable polymer-coated sirolimus-eluting stent:1-year results of the HELIOS registry

Chinese Medical Journal 2023年第15期136卷 1848-1854页

作者： Bo Zheng Yi Liu Ruining Zhang Wangwei Yang Fangju Su Rutao Wang Dapeng Chen Guidong Shen Yumin Qiu Lianmin Wang Chang Chen Zhongwei Wu Fei Li Jiayi Li Chengxiang Li Chao Gao Ling Tao for the HELIOS Investigators Department of Cardiology Xijing HospitalAir Force Medical UniversityXi’anShaanxi 710032China Department of Cardiology Radboud UniversityNijmegenThe Netherlands Department of Cardiology National University of IrelandGalwayGalwayIreland Internal Medicine of Heart Centre General Hospital of Ningxia Medical UniversityYinchuanNingxia 750003China Department of Cardiology Ankang City Central HospitalAnkangShaanxi 725099China Department of Cardiovascular Cardio-cerebrovascular Hospital affiliated to Ningxia Medical UniversityYinchuanNingxia 750002China Department of Cardiology Mudanjiang Cardiovascular hospitalMudanjiangHarbin 157011China Department of Cardiology the First Affiliated Hospital of Shantou University Medical CollegeShantouGuangdong 515041China Department of Cardiology Western Central Hospital of Hainan ProvinceDanzhouHainan 571700China 不详

Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.

关键词： Percutaneous coronary interventions Titanium oxide film sirolimus-eluting stent Target lesion failure HELIOS

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A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease： 8-month angiographic and 2-year clinical follow-up results

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Chinese Medical Journal 2011年第6期124卷 811-816页

作者： XU Bo DOU Ke-fei HAN Ya-ling LU Shu-zheng YANG Yue-jin HUO Yong WANG Le-feng CHEN Yun-dai WANG Hai-chang LI Wei-min CHEN Ji-yan WANG Lei WANG Yong GE Jun-bo LI Wei GAO Run-lin Cardiac Catheterization Laboratory Cardiovascular Institute and Fuwai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China Department of Cardiology Cardiovascular Institute and Fuwai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100037 China Department of Cardiology Shenyang Northern HospitalShenyang Liaoning 110015 China Department of Cardiology Beijing Anzhen Hospital Capital Medical University Beijing 100029 China Department of Cardiology Peking University First HospitalBeijing 100044 China Department of Cardiology Beijing Chao-Yang Hospital Capital Medical University Beijing 100020 China Department of Cardiology Chinese People's Liberation Army General Hospital Beijing 100853 China Department of Cardiology Xijing Hospital Fourth Military Medical University Xi'an Shaanxi 710032 China Department of Cardiology First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang 150001 China Department of Cardiology Guangdong Provincial Cardiovascular Institute Guangzhou Guangdong 510080 China Department of Cardiology Beijing Friendship Hospital Capital Medical University Beijing 100050 China Department of Cardiology China-Japan Friendship HospitalBeijing 100029 China Department of Cardiology Zhongshan Hospital Fudan UniversityShanghai 200032 China National Center for Cardiovascular Diseases of China Beijing 100037 China

Background Available drug-eluting stents （DES） have achieved great success in reducing restenosis rates. Recently,investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid （PLGA） polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.Methods A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients （TIVOLI group： 168 patients; ENDEAVOR group：156 patients） at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions （lesion length ≤40 mm,reference vessel diameter 2.25-4.00 mm）. The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years,including major adverse cardiac events （cardiac death,myocardial infarction, or target-lesion revascularization） and stent thrombosis.Results Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group （in-stent （0.25±0.33） mm vs. （0.57±0.55） mm, diff （95% CI）-0.23 （-0.32, -0.14）, P 〈0.0001; in-segment （0.25±-0.33） mm vs. （0.42±-0.55） mm, diff （95% CI） -0.13 （-0.23, -0.02）,P=0.0083）. The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group （P=0.0229）. Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization （4.2% vs. 9.6%, P=0.0495） at 2 years. The two-year major adverse cardiac events （MACE） rate was lower for the TIVOLI group, but not significant

关键词： TIVOLI stent biodegradable polymer sirolimus-eluting stent clinical outcome

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Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients： one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

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Chinese Medical Journal 2011年第6期124卷 817-824页

作者： LI Yan LI Cheng-xiang WANG Hai-chang XU Bo FANG Wei-yi GE Jun-bo WANG Wei-min CHEN Jack-P SHEN Wen-kuang JIANG Hong CONG Hong-liang PU Xiao-qun QIN Yong-wen JIN Hui-gen CAO Yu FIREMAN Investigators Department of Cardiology Xijing Hospital Affiliated to Fourth Military Medical University Xi'an Shaanxi 710032 China Department of Cardiology FuWai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100037 China Department of Cardiology Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai 200030 China Department of Cardiology Shanghai Zhongshan Hospital Affiliated to Shanghai Fudan University School of MedicineShanghai 200032 China Department of Cardiology Peking University People's HospitalBeijing 100044 China Saint Joseph's Heart and Vascular Institute and Northside Hospital Atlanta GA USA Mayo Clinic 200 First St SW Rochester MN 55905 USA Department of Cardiology People's Hopsital Affiliated to Wuhan University Wuhan Hubei 430060 China Department of Cardiology Tianjin Chest Hospital Tianjin 300051China Department of Cardiology Xiangya First Affiliated HospitalCentral South University Changsha Hunan 410008 China Department of Cardiology Changhai Hospital Affiliated to Second Military Medical University Shanghai 200433 China Putuo Districit Central Hospital Shanghai 200060 China Department of Cardiology Xiangya Third Affiliated HospitalCentral South Universtiy Changha Hunan 410008 China Xiangtan Central Hospital Xiangtan Hunan 411100 China

Background Off-label application of drug-eluting stents （DES） during percutaneous coronary intervention （PCI） was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent （SES） in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.Results Long lesions （59.2%）, multi-vessel disease （50.4%）, and small vessel disease （31.6%） were mostly found in angiography. Major adverse cardiac events （MACE） occurred in 51 （5.1%） patients at 1 year clinical follow-up,including cardiac mortality in 6 （0.6%）, non-fatal myocardial infarction in 11 （1.1%）, and target lesion revascularization in 36 （3.5%） of the patients. Definite and probable stent thrombosis （ST） by Academic Research Consortium （ARC） definition occurred in 12 （1.36%） patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was （0.21±0.40） mm in-segment and （0.23±0.36） mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-

关键词： coronary artery disease sirolimus-eluting stent off-label use,＂ clinical outcomes

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Effects of sirolimus-eluting stent on calcified coronary lesions

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Chinese Medical Journal 2008年第1期121卷 6-11页

作者： LI Jian-jun XU Bo YANG Yue-jin CHEN Ji-lin QIAO Shu-bing MA Wei-hua QIN Xue-wen YAO Min LIU Hai-bo WU Yong-jian YUAN Jin-qing CHEN Jue YOU Shi-jie DAI Jun XIA Ran GAO Run-lin Department of Cardiology Fuwai Hospital Chinese Academy ofMedical Sciences Peking Union Medical College Beijing 100037China

Background Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents （SES） for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.Mothods A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group （n=-264） and calcification group （n=-189）. Lesions treated with SES were subjected to quantitative coronary angiography （QCA） immediately and 8 months following stenting. Results Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; instent restenosis： 3.8% vs 4.2%; P=0.081; in-segment restenosis： 8.7% vs 10.6%, P=0.503. The target lesion revascularization （TLR） was also not significantly different between the two groups; 4.9% vs 6.9%, P=0.378. In addition, the in-stent late loss was similar in both groups; （0.16±0.40） mm vs （0.17±0.33） mm, P〉0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P〉0.05. Conclusion Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.

关键词： sirolimus-eluting stent calcification restenosis

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A randomized, prospective, two-center comparison of sirolimus-eluting stent and zotarolimus-eluting stent in acute ST-elevation myocardial infarction： The SEZE trial

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Chinese Medical Journal 2012年第19期125卷 3373-3381页

作者： Woo-Young Chung Jeehoon Kang Young-Seok Cho Hae-Jun Park Han-Mo Yang Jae-Bin Seo Jung-Won Suh Kwang-I1 Kim Tae-Jin Youn Sang-Hyun Kim In-Ho Chae Joo-Hee Zo Myung-A Kim Dong-Ju Choi Seoul National University Boramae Hospital Seoul South Korea Seoul National University Bundang Hospital Seongnam SouthKorea Seoul National University Hospital Seoul South Korea

Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction. Methods This was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1：1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events （a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization）, and late-acquired incomplete stent apposition. Results Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group （（0.49±0.65） mm vs. （0.10±0.46） mm, P=0.001）. Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group （（30.0±17.9）% vs. （17.6±14.0）%, P 〈0.001）. In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition. Conclusions Compared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.

关键词： sirolimus-eluting stent zotarolimus-eluting stent ST elevation myocardial infarction late lumen loss

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Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

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Chinese Medical Journal 2007年第6期120卷 447-451页

作者： XU Bo LI Jian-jun YANG Yue-jin CHEN Ji-lin QIAO Shu-bin QIN Xue-wen MA Wei-hua YAO Min LIU Hai-bo WU Yong-jian YUAN Jin-qing CHEN Jue YOU Shi-jie DAI Jun XIA Ran GAO Run-lin Department of Cardiology Fuwai Hospital Chinese Academy of Medical Sciences ＆ Peking Union Medical College Beijing 100037 China

Background Advanced age independently predicts early and late mortality and major adverse cardiac events （MACE） after percutaneous coronary intervention （PCI）. Randomized clinical trials indicate that siroUmus-eluting stent （SES） implantation reduces target lesion revascularization （TLR）, but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease （CAD） in real-world practice. Methods A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age： a young group （〈65 years old, 244 patients with 369 lesions） and elderly group （≥65 years old, 89 patients with 113 lesions）. Clinical follow-up and quantitative coronary angiography （QCA） were performed seven months after PCh Results Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group （21.3% vs 9.8%, P=-0.006）. Primary success rate was similar in both groups （96.5% in young group vs 95.7% in elderly group, P〉0.05）. During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups （4.7% vs 1.8%; 9.7% vs 8.8%, P〉0.05 respectively）. Both sub-acute and late thrombosis rates were similar in the two groups （0.3% vs 0.9% and 1.2% vs 0.9%, P〉0.05 respectively. TLFI was not significantly different between the two groups （6.5% vs 3.5%;P=-0.246）. The rates of bleeding, stroke, angina rehospitalization during the, follow-up period were also similar in both groups （P〉0.05 respectively）. Conclusion Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.

关键词： sirolimus-eluting stent coronary artery disease angiography restenosis

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Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease： the Nano randomized trial

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Chinese Medical Journal 2014年第11期127卷 2153-2158页

作者： Zhang Yaojun Chen Fang Takashi Muramatsu Xu Bo Li Zhanquan Ge Junbo He Qing Yang Zhijian Li Shumei Wang Lefeng Wang Haichang He Ben Li Kang Qi Guoxian Li Tianchang Zeng Hesong Peng Jianjun Jiang Tieming Zeng Qiutang Zhu Jianhua Fu Guosheng Christos V. Bourantas Patrick W. Serruys Huo Yong Department of Cardiology Nanjing First Hospital Nanjing Medical University Nanjing Jiangsu 210006 China Thoraxcenter Erasmus Medical Center Rotterdam 3015CE The Netherlands Department of Cardiology Beijing Fuwai Hospital Beijing 100037 China Department of Cardiology Liaoning Provincial People's Hospital Shenyang Liaoning 110016 China Department of Cardiology Zhongshan Hospital Fudan University Shanghai 200032 China Department of Cardiology Beijing Hospital Beijing 100730 China Department of Cardiology Jiangsu Provincial People's Hospital Nanjing Jiangsu 210029 China Department of Cardiology Second Affiliated Hospital of Jilin University Changchun Jilin Jilin 130041 China Department of Cardiology Beijing Chaoyang Hospital Capital Medical University Beijing 100020 China Department of Cardiology Xijing Hospital The Fourth Military Medical University Xi'an Shanxi 710032 China Department of Cardiology Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200127 China Department of Cardiology Beijing Xuanwu Hospital Capital Medical University Beijing 100053 China Department of Cardiology First Affiliated Hospital of China Medical University Shenyang Liaoning 110001 China Department of Cardiology Beijing Tongren Hospital Capital Medical University Beijing 100730 China Department of Cardiology Affiliated Tongji Hospital Huazhong University of Science and Technology Tongji School of Medicine Wuhan Hubei 430032 China Department of Cardiology Beijing Millennium Monument Hospital Capital Medical University Beijing 100038 China Department of Cardiology Tianjin Armed Policemen Hospital Tianjin 300162 China Department of Cardiology Affiliated Union Medical Hospital of Huazhong University of Science and Technology Tongji School of Medicine Wuhan Hubei 430022 China Department of Cardiology First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang 310003 China Department of Cardiology Sir Run Run Shaw Hospital Zhejiang Unive

Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

关键词： Nano stent polymer-free sirolimus-eluting stent clinical outcomes late lumen loss

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Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

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Chinese Medical Journal 2011年第6期124卷 831-835页

作者： GE Jun-bo ZHANG Feng QIAN Ju-ying GE Lei LIU Xue-bo ZHOU Jun Shanghai Institute of Cardiovascular Diseases Zhongshan Hospital Fudan University Shanghai 200032 China

Background The Firebird 2TM sirolimus-eluting stent （Firebird 2 stent） is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2TM cObalt-Chromium alloy sirolimus-eluting stent registry （FOCUS registry） aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.Methods The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry.Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.Results Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events （MACE） was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction （MI）, and 6 target vessel revascularization （TVR）. At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis （ST） occurred in 0.43% （22/5058） of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.Conclusion The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

关键词： sirolimus-eluting stent percutaneous coronary intervention coronary artery disease cobalt-chromium alloy

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Influence of insulin resistance on long-term outcomes in patients with coronary artery disease after sirolimus-eluting stent implantation

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Chinese Medical Journal 2010年第6期123卷 651-657页

作者： ZHAO Liang-ping LU An-kang SHEN Wei-feng LIU Hai-feng MA Xiao-ye FAN Xiao-ming ZHANG Qi Department of Cardiology Ruijin HospitalShanghai Jiao Tong University School of MedicineShanghai 200025China

Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention（PCI）with sirolimus-eluting stent（SES）implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group（n=104）and non-IR group（n=363）.The patients were followed up for one year.The rate of major adverse cardiac events（MACEs） including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up （all P〈0.05）.IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction（OR=2176,95% CI=1.35-5.47,P=0.034）.Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI（P〈0.05）.Subgroup analysis revealed that IR（OR=3.35,95% CI=1.07-13.59,P=0.013）and multi-vessel disease（OR=2.19,95%CI=1.01-5.14,P=0.044）were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.

关键词： insulin resistance coronary artery disease sirolimus-eluting stent long-term prognosis

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Acute coronary syndrome is an independent risk factor for late incomplete stent apposition after sirolimus-eluting stent implantation

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Chinese Medical Journal 2008年第24期121卷 2504-2508页

作者： ZHANG Rui-yan DU Run ZHU Zheng-bin ZHANG Qi HU Jian LU An-kang ZHANG Jian-sheng SHEN Wei-feng Department of Cardiology Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025 China Institute of Cardiovascular Disease Shanghai Jiao Tong University School of Medicine Shanghai 200025 China

Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.

关键词： acute coronary syndrome sirolimus-eluting stent intravascular ultrasound late incomplete stent apposition

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