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Worsening Clinical Outcome with Increasing Number of So-Called Off-Label or Unapproved Indications for Use of drug eluting stents

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World Journal of Cardiovascular Diseases 2016年第7期6卷 224-234页

作者： Anders M. Galløe Ulrik Abildgaard Henning Kelbæk Niels Bligaard Jørgen L. Jeppesen Leif Thuesen Peter R. Hansen Department of Cardiology Zealand University Hospital Roskilde Denmark Department of Cardiology Copenhagen University Hospital Gentofte Denmark Department of Cardiology Copenhagen University Hospital Bispebjerg Denmark Department of Medicine Copenhagen University Hospital Glostrup Denmark Department of Cardiology Aalborg University Hospital Aalborg Denmark

Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.

关键词： drug eluting stents

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Value of a new post-procedural intravascular ultrasound score in predicting target vessel revascularization after coronary drug-eluting stents implantation

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2012年第8期13卷 624-630页

作者： Kai XU Ya-ling HAN Quan-min JING Shou-li WANG Ying-yan MA Xiao-zeng WANG Geng WANG Zu-lu WANG Department of Cardiology Shenyang Northern HospitalShenyang 110016China

Objective:There is no simple or feasible post-procedural intravascular ultrasound (IVUS) score to predict major adverse cardiac events (MACE) in patients undergoing drug-eluting stents (DES) implantation. The aim of this study is to validate a new IVUS score for predicting MACE. Methods:A total of 295 patients (with 322 lesions) were enrolled. IVUS score was calculated in each lesion based on five IVUS morphological characteristics:inflow/outflow disease, malapposition, underexpansion, tissue protrusion, and edge dissection (iMUTE score). We assigned two points to an underexpansion and one point for each presence of other factors. Patients were divided into low score (iMUTE score<2, n=137) and high score (iMUTE score≥2, n=158) groups. Results:At one year follow-up, a trend was seen in favor of the low iMUTE score group in MACE (3.65% vs. 10.10%; P=0.052), and there was more target vessel revascularization (TVR) in the high iMUTE score group compared with low score group (6.96% vs. 1.46%; P=0.044). Low iMUTE score was an independent predictor of freedom from TVR at one year (adjusted hazard ratio (HR) 0.5, 95% confidence interval (CI) 0.1-0.8; P=0.02). Conclusions:Post-procedural IVUS iMUTE scoring was simple and feasible in clinical practice, and can provide independent prognostic value for TVR in patients undergoing DES implantation.

关键词： Intravascular ultrasound drug eluting stents Scoring schemes percutaneous coronary intervention

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Real world clinical performance of the zotarolimus eluting coronary stent system in Chinese patients： a prospective, multicenter registry study

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Chinese Medical Journal 2011年第20期124卷 3255-3259页

作者： HAN Ya-ling CHEN Ji-yan XU Bo YAN Hong-bing WANG Le-feng LI Wei-min CONG Hong-liang JING Quan-min WANG Shou-li XU Kai WANG Wei-min HUO Yong Department of Cardiology Institute of Cardiovascular Research of People＇s Liberation Army Shenyang Northern Hospital Shenyang Liaoning 110840 China Department of Cardiology Guangdong General Hospital Guangdong Academy of Medical Sciences Guangzhou Guangdong 510080. China

Background Early clinical trials with the Endeavor zotarolimus eluting stent （ZES） in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 5 years of follow-up. The aim of this clinical registry study was to evaluate real world clinical performance of the ZES coronary system in Chinese patients. Methods The China Endeavor Registry is a prospective, multicenter registry assessing the safety of the ZES system in a real world patient population. It was conducted at 46 centers in China in routine treatment of patients with coronary artery stenosis, including patients with clinical characteristics or lesion types that are often excluded from randomized controlled trials. The registry included 2210 adult patients who underwent single-vessel or multi-vessel percutaneous coronary intervention. The primary end point was the rate of major adverse cardiac events （MACE） at 12 months. Results The 12-month rate of MACE for all patients in the registry was 3.03%. Cardiac death or myocardial infarction rate was 1.28% and target lesion revascularization rate was 1.66%, non-target lesion target vessel revascularization （TVR） was 0.52%, TVR was 2.18%, and target vessel failure was 3.22%. There was only one case of emergent cardiac bypass surgery. The 12-month overall incidence of all Academic Research Consortium （ARC）-defined stent thrombosis was 0.43%. Conclusion Mid-term results from the real-world China Endeavor Registry suggest that Endeavor ZES was safe and effective in Chinese patients.

关键词： drug eluting stents Asian continental ancestry group registries

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State of the art contemporary treatment of patients with ST elevationmyocardial infarction： pre- and in-hospital organization, devices anddrugs

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Chinese Medical Journal 2014年第6期127卷 1133-1140页

作者： Mikkel Malby Schoos Roxana Mehran The Zena and Michael A.Wiener Cardiovascular Institute The Icahn School of Medicine at Mount Sinai New York NY 10029-6574USA

Objective To review the presentation,diagnosis and recent developments in the pharmacological and invasive treatment of ST elevation myocardial infarction (STEMI) with a special focus on health-care organization in order to increase accessibility of primary pemutaneous coronary intervention (PCI).Data sources Data were obtained from English publications on STEMI *** formal systematic review was conducted,but an effort was made to be *** selection Studies were selected if they contained data relevant to the ***,data from clinical randomized trials,meta-analyses,guidelines and a few recent reviews are *** The described clinical approach to acute myocardial infarction (AMI) has been a continuum of scientific results and translation into clinical practice over the last four decades since the advent of thrombolytic *** has resulted in a dramatic in-hospital mortality decrease from 30% in the 1960s to the present 5%.The biggest survival benefits have undoubtedly been achieved after the advent of reperfusion *** contemporary treatment of STEMI,additional treatment effects on survival have to be sought in the very early admission phase,as the current mortality hazard drops significantly after the first critical days to continuously very low levels after *** Optimal treatment of STEMI patients is best performed with a widely accessible reperfusion strategy,preferably primary PCI,with contemporary peri-procedural anti-thrombotic treatment and device *** of reperfusion strategies is increased by efficient STEMI networks applying prehospital triage with digital tele-transmission of electrocardiograms (ECGs) and seamless patient transitions between health-care *** treatments of complicated STEMI with out-of hospital cardiac arrest and/or cardiogenic shock underline the necessity of structured referral systems,preferably immediately after the initial

关键词： acute myocardial infarction ST elevation myocardial infarction primary percutaneous coronary intervention fibrinolysis pre-hospital triage antiplatelet therapy antithrombotic therapy drug eluting stents cardiogenic shock out-ofhospital cardiac arrest

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Complex coronary lesions and rotational atherectomy:one hospital's experience

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2012年第8期13卷 645-651页

作者： Jun JIANG Yong SUN Mei-xiang XIANG Liang DONG Xian-bao LIU Xin-yang HU Yan FENG Jian-an WANG Department of Cardiology the Second Affiliated HospitalSchool of MedicineZhejiang UniversityHangzhou 310009China Cardiovascular Key Lab of Zhejiang Province the Second Affiliated HospitalSchool of MedicineZhejiang UniversityHangzhou 310009China

Objective:To evaluate the safety and effectiveness of rotational atherectomy followed by drug eluting stent (DES) implantation in patients with complex coronary lesions. Methods:From August 2006 to August 2012, 253 consecutive patients with 289 lesions and who underwent rotational atherectomy in our center were enrolled in this study. Results:The overall procedure success rate was 98% with the cost of two (0.8%) coronary perforations, three (1.2%) dissections, five (2.0%) slow flows or no flows, three (1.2%) peri-procedure myocardial infarctions, and two (0.8%) in hospital deaths. During follow-up (mean three years), one (0.4%) patient died, two (0.8%) patients had acute myocardial infarction, 14 (5.5%) had restenosis, and target lesion revascularization occurred in eight patients (3.2%). Conclusions:Rotational atherectomy followed by DES implantation is a safe and effective technique for patients with complex coronary lesions, especially calcified and non-dilatable lesions.

关键词： Complex coronary lesions Calcified coronary lesions Rotational atherectomy drug eluting stents

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A novel polymer-free dual-drug eluting stent with nanotechonology

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South China Journal of Cardiology 2013年第3期14卷 204-210页

作者：俞梦越张海华徐波吴永健颜红兵陈珏钱杰乔树宾杨跃进高润霖 State Key Laboratory of Cardiovascular Disease Fuwai HospitalNational Center for Cardiovascular DiseaseChinese Academy of Medical Sciences and Peking Union Medical College

Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polymer-free stent system with nanotechnology and elutes rapamycin （1.6 μg/mm2） and probucol （0.8 μg/mm2）. The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography （OCT） findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.

关键词： nanotechnology drug eluting stents polymer-free human trial

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Long Coronary Lesions: Challenging Cases for Percutaneous Coronary Intervention

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International Journal of Clinical Medicine 2016年第1期7卷 89-93页

作者： Julio Núñez Gema Miñana Juan Sanchis Department of Cardiology Hospital Clínico Universitario Valencia Spain

Long coronary lesions are associated with adverse outcomes after percutaneous coronary intervention since the era of plain balloon angioplasty. Long lesion and long stent length are considered as important predictors of restenosis after percutaneous coronary intervention. With the advent of newer generation drug eluting stents, there has been dramatic reduction in the rates of restenosis and repeat revascularization, even in complex cohort of patients with long coronary lesions. We report one such case of long coronary lesion which was intervened successfully with newer generation, thin strut, biodegradable polymer coated sirolimus-eluting stents.

关键词： drug eluting stents Biodegradable Polymer Percutaneous Coronary Intervention Treatment Outcome

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Ministernotomy for minimally invasive coronary artery bypass grafting

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South China Journal of Cardiology 2013年第4期14卷 224-229页

作者：谢斌郭惠明张晓慎 Department of cardiovascular surgery Provincial Cardiovascular Institute Guangdong General Hospital Guangdong Academy of Medical Sciences

Background Through a ministernotomy ＂J shaped approach, left internal mammary artery （LIMA） bypass grafting to the left anterior descending artery （LAD） can be performed safely off-pump. To achieve a complete revascularization, percutaneous coronary interventions （PCI） with drug eluting stent implantation to other coronary arteries was used. We reported outcomes of the treatment of multivessel coronary artery disease with minimally invasive coronary artery bypass （MICAB） and PCI. Methods Between January 2009 and Dec 2012, 14 patients （11 males, 3 females, mean age was 64.8 _ 10.1 years. Two-vessel disease account for 35.7% （5/14） of these patients, three-vessel disease 64.2% （9/14）（Table 1）. All patients underwent a minimally invasive coronary artery bypass grafting via mini-sternotomy ＂J＂ shaped approach. Seven patients were followed by PCI, 7 for obtuse marginal circumflex, 5 for right coronary artery （RCA）. Angiographic assessment of graft patency was performed in all patients during the PCI procedure. The clinical follow-up period lasts from 11-24 months. Results The in-hospital mortality was 0%. There was neither conversion to a full median sternotomy nor intraoperative complications. Ventilation time was 6.6 ＋_ 4.1 h. Blood loss ranged 341 ＋_ 78.8 mL. ICU stay ranged 22.3 _ 12.8 h. Hospital postoperative stay lasted for 6.5 ＋ 1.6 days. Prior to PCI patients showed 100% patent left internal mammary artery. One patient had mediastinitis （Tables 2-3）. Rate of freedom from cardiac reintervention during the follow-up period was 92.8% （13/14）. Conclusions The inferior J-shaped sternotomy is simple, reproducible, and the safest technique for performing minimally invasive coronary bypass surgery. MICAB ＋ PCI is also safe, feasible and efficacious.

关键词： ministernotomy partial-sternotomy minimally invasive coronary artery bypass grafting off-pump hybrid percutaneous coronary interventions drug eluting stents

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