Non-St Elevated Myocardial Infarction

LAS VEGAS, Nov. 1, 2023 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the third of four Late-Breaking Clinical Trial sessions at the VIVA23 conference, hosted at Wynn Las Vegas. VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 5 late-breaking clinical trial presentations. A Multicenter Trial Evaluation of the Neuroguard Carotid Artery Stent System With Integrated Embolic Protection: 30-Day and 1-year Outcomes of PERFORMANCE II Presented by: William A. Gray, MD The PERFORMANCE II study is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Neuroguard IEP 3-in-1 carotid stent and postdilation balloon system with integrated embolic protection (Contego Medical, Inc.) for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy. A total of 305 patients were enrolled at 40 sites in the United States and Europe. The study's primary endpoint is the 30-day rate of major adverse events, defined as death, all stroke, and myocardial infarction within 30 days of the index procedure, plus ipsilateral stroke between day 31 and 1 year. Events were adjudicated by an independent clinical events committee, and angiograms and duplex ultrasounds were evaluated by an independent core lab. Of the 305 patients enrolled, the mean age was 70, and 20% were symptomatic. 230 (75%) patients had physiologic high-risk criteria, and 75 (25%) patients had anatomic high-risk criteria. The mean baseline angiographic stenosis was 85%, and 34% of lesions were severely calcified. At 30 days, the all-stroke rate was 1.31% (4 patients) and 0.98% (3 patients) in an intention-to-treat and per-protocol analysis, respectively. There were no major strokes, no contralateral strokes, one (0.3%) death (cardiovascular), and two (0.7%) non–ST-segment elevation myocardial infarctions through 30-day follow-up. Among asymptomatic patients, the 30-day stroke rate was 0.81% (2 patients). There was one (0.37%) minor ipsilateral stroke between day 31 and 1 year. There were no major strokes and no neurological deaths at 1 year. Target lesion revascularization through 1 year was 1.47% (4 patients). These 1-year outcomes of the PERFORMANCE II study demonstrate the safety and durability of the Neuroguard carotid stent system in a high-surgical-risk patient population and are the lowest event rates ever reported in an adequately powered, multicenter trial of any type of carotid revascularization, regardless of patient risk. Acute Clinical and 90-Day Functional Outcomes in Pulmonary Embolism Patients Treated With Computer Assisted Vacuum Thrombectomy: Interim Analysis of the STRIKE-PE Study Presented by: Ido Weinberg, MD The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra, Inc.) for the treatment of pulmonary embolism (PE). This prospective, international, multicenter study will enroll 600 patients with acute PE symptoms of ≤ 14 days and a right ventricular/left ventricular (RV/LV) ratio ≥ 0.9. Primary endpoints are the change in RV/LV ratio from baseline to 48 hours postprocedure and the incidence of major adverse events (MAEs) at 48 hours. Secondary endpoints include functional outcome measures. We report acute clinical and 90-day functional outcomes from an interim analysis. This interim analysis included 150 patients (mean age, 61.3 years; 54.7% male; 5.3% with high-risk PE; 94.7% with intermediate-risk PE). Patients presented with high thrombus burden (modified Miller score ≥ 12) in 80.7% of cases. Mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours postthrombectomy (∆ 25.7%; P < .0001). Four (2.7%) patients experienced an MAE(s) within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased (P < .0001). Borg dyspnea scale significantly improved from presentation to discharge and from presentation to 90-day follow-up (P < .0001). The 6-minute walk test distance significantly improved from discharge to 90-day follow-up (P < .0001). At 90-day follow-up, the New York Heart Association class proportion distribution was similar to that reported before the acute PE episode (P = .39). STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety. At 90-day follow-up, treatment with CAVT with the Indigo aspiration system improved patients' functional capacity by reducing dyspnea, increasing aerobic endurance, and improving cardiac symptoms. 30-Day Results From the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System Presented by: D. Christopher Metzger, MD C-GUARDIANS is a pivotal FDA investigational device exemption trial designed to evaluate safety and efficacy of the neuroprotective CGuard carotid stent (InspireMD, Inc.) in treating symptomatic and asymptomatic patients with carotid stenosis at a high risk for carotid endarterectomy (CEA). From July 2021 to June 2023, 316 patients (mean age, 69.0 years; 31.6% female; 25% symptomatic) were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union. Procedures were performed utilizing the CGuard self-expanding stent, incorporating its patented woven Micronet mesh sleeve with small pore size of 150 µm designed to prevent plaque protrusion, utilizing approved embolic protection systems intraprocedurally. The primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, and myocardial infarction (DSMI) through 30 days post–index procedure and (2) ipsilateral stroke from day 31 to day 365 postprocedure. All events were adjudicated by a clinical events committee. Intraprocedural cerebral protection utilized approved distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days, total major adverse events included a cumulative DSMI of 0.95% and a cumulative stroke and death rate of 0.95% (intent to treat, 0.95%; per protocol, 0.63%). Events included an in-hospital retinal stroke and a clinically silent troponin elevation, with two additional strokes at 30 days, including a patient who did not take dual antiplatelet therapy (protocol violation). In the C-GUARDIANS pivotal trial, stenting with the CGuard carotid stent system in patients with obstructive carotid artery disease and at high risk for CEA had an overall stroke and death rate of 0.95% from the postprocedural interval to 30-day follow-up. The results support a potential "neuroprotective" effect of the CGuard stent from the procedure to 30-day follow-up. Stellarex Vascular E-Registry (SAVER) Gender Subgroup Analysis Presented by: Marianne Brodmann, MD The Stellarex Vascular E-Registry (SAVER) was a multicenter, international, prospective registry designed to assess the safety and efficacy of the Stellarex drug-coated balloon (DCB; Philips) in femoral, popliteal, and/or infrapopliteal arteries in a broad, real-world, claudicant or critical limb ischemia patient population. Patients with Rutherford clinical classification 2 to 6 who were indicated for percutaneous transluminal angioplasty were enrolled. The study was conducted with an individual DCB under normal clinical practice. The primary safety outcome was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months. The primary efficacy outcome was freedom from CD-TLR at 12 months. Final 12-month outcomes of the above-the-knee (ATK) cohort were evaluated, and a subgroup analysis was performed to assess differences in outcomes according to gender. The SAVER ATK study demonstrated excellent key safety and efficacy endpoints at 12 months in a real-world population. There were no differences in outcomes when stratified into gender subgroups, demonstrating the strong safety and performance of the Stellarex DCB in both male and female patients. Clinical Outcomes of Sirolimus-Coated Balloons Compared With Standard Balloon Angioplasty for Patients With Chronic Limb-Threatening Ischemia Presented by: Edward Choke, MBBS, PhD Sirolimus-coated balloons (SCBs) are a potential treatment option to improve outcomes for chronic limb-threatening ischemia (CLTI). However, clinical data for this novel treatment for CLTI are lacking. This study aimed to investigate the clinical outcomes of MagicTouch percutaneous transluminal angioplasty (PTA) SCB (Concept Medical, Inc.) compared to plain old balloon angioplasty (POBA) for patients with CLTI. The HOPE registry is a single-center prospective registry of all CLTI patients. Prospective data captured included preprocedure baseline demographics, angioplasty details, and postprocedure clinical outcomes. Consecutive CLTI patients (n = 347) with Rutherford 4, 5, or 6 presentations and de novo infrainguinal artery disease between August 2018 and October 2021 were analyzed. Patients were excluded if they received paclitaxel devices, thrombolysis, or atherectomy devices. Patients were divided into two groups according to whether they received an SCB in addition to POBA (n = 141) or POBA alone (n = 206). There were no statistically significant differences in the baseline demographics and lesion characteristics between the SCB and POBA groups. At 2 years, SCBs were associated with statistically significant higher freedom from clinically driven target lesion revascularization (75.2% vs 66.2%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.97; P = .037), higher amputation-free survival (69.5% vs 55.1%; HR, 0.64; 95% CI, 0.46-0.88; P = .007), and higher survival (72.9% vs 64.3%; HR, 0.71; 95% CI, 0.50-0.99; P = .047). At 2 years, SCBs were also numerically but not statistically significantly associated with higher freedom from major amputation (93.5% vs 87.1%; HR, 0.63; 95% CI, 0.27-1.45; P = .274). Compared to POBA alone, use of SCBs was associated with improved clinical outcomes at 2 years, and no early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCBs for treatment of CLTI. About the VIVA Foundation The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit . SOURCE The VIVA Foundation

精彩内容7月20日，国家药监局官网显示，辽宁海思科制药的磺达肝癸钠注射液一致性评价补充申请获批。米内网数据显示，近年中国公立医疗机构终端磺达肝癸注射剂保持快速增长，2021年销售额突破5亿元后，2022年再创新高，同比增长超过10%，是抗血栓形成药注射剂通用名TOP6品种。磺达肝癸钠注射液用于进行下肢重大骨科手术如髋关节骨折、重大膝关节手术或者髋关节置换术等患者，预防静脉血栓栓塞事件的发生；用于无指征进行紧急（＜120分钟）侵入性治疗（PCI）的不稳定性心绞痛或非ST段抬高心肌梗死（UA/NSTEMI）患者的治疗；用于使用溶栓或初始不接受其它形式再灌注治疗的ST段抬高心肌梗死患者的治疗。2022年中国公立医疗机构终端抗血栓形成药注射剂通用名TOP10来源：米内网中国公立医疗机构药品终端竞争格局米内网数据显示，近年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端磺达肝癸注射剂保持快速增长，2021年销售额突破5亿元后，2022年再创新高，同比增长超过10%，是抗血栓形成药注射剂通用名TOP6品种。磺达肝癸钠注射液有10家企业拥有生产批文，9家国内药企均已过评，江苏恒瑞医药、扬子江江苏紫龙药业、辽宁海思科制药以补充申请获批过评，湖南科伦制药、博瑞制药、吉林津升制药等6家均以仿制4类获批，视同过评。今年以来，海思科有5个产品过评，复方氨基酸注射液(18AA-Ⅶ)、复方氨基酸注射液(18AA-Ⅸ)、利丙双卡因乳膏均为首家过评。截至目前，海思科已有26个产品过评，涵盖全身用抗感染药物、神经系统药物、消化系统及代谢药等多个治疗大类。日前，海思科发布2023年半年度业绩预告，净利润7200万~8000万元，同比增长3.12%~14.58%，其中公司创新药产品环泊酚注射液的销售同比大幅增加，对公司半年度业绩有较好的拉动。资料来源：国家药监局官网、米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

近日，复旦大学附属中山医院葛均波院士团队成功应用由业聚医疗集团控股有限公司（“业聚医疗”）旗下自研的Scoreflex TRIO高压三导丝刻痕球囊导管系统，为一位65岁的冠脉重度狭窄伴钙化患者实施PCI介入治疗，手术非常成功，支架膨胀率90%且贴壁良好，患者术后无并发症发生。该临床研究首例入组的顺利完成，标志着由复旦大学附属中山医院葛均波院士团队作为主要研究者的Scoreflex TRIO全国多中心注册临床研究正式启动。Scoreflex TRIO高压三导丝刻痕球囊导管系统首例术后，葛均波院士团队对产品性能进行了高度评价，认为产品为术者提供了一项安全、有效的治疗选择。据悉，本次手术患者是一名65岁的男性，在2021年10月因突发胸痛至外院就诊，诊断为急性非ST段抬高型心肌梗死，行CAG+PCI术，术中见左室后支80-90%狭窄，LCX（左回旋支）近中段闭塞，于LCX植入支架2枚，2023年1月于左室后支行PTCA术。此前患者为复查冠脉造影到复旦大学附属中山医院就诊。经评估，决定对该患者行高压三导丝刻痕球囊导管系统PCI介入术。经右侧桡动脉行冠脉造影，造影结果显示患者右冠优势型，前降支近段弥漫性病变，最重狭窄70%，前降支中段弥漫性病变，最重狭窄85%伴钙化，长度约30mm，直径3mm，TIMI血流III级；左回旋支近段、中段见支架影，支架内轻度内膜增生，未见再狭窄；左室后支中段狭窄70%；后降支开口狭窄95%，后降支中段狭窄70%。介入治疗靶病变为前降支中段，6F EBU3.5指引导管送至左冠口，将导丝分别送至前降支及第一对角支远段，于前降支送入OCT导管回撤行OCT检查可见脂质斑块，最小管腔面积为1.9m㎡，遂决定进一步行前降支介入治疗。术中使用Scoreflex TRIO 2.5*15m球囊于病变处以8atm*10秒扩张，复查造影残余狭窄改善明显，残余狭窄小于30%，TIMI血流III级；于病变处植入支架一枚以10atm*10秒扩张释放，取非顺应性球囊于支架内16atm*10秒后扩张塑形，复查造影提示支架扩张满意，无残余狭窄，远端TIMI血流III级。复查OCT提示前降支支架扩张满意，贴壁良好，支架膨胀率90%，手术成功。术终患者血压138/82mmHg，心率64次/分，无并发症发生。 首款国产冠脉三导丝刻痕球囊导管，聚力纵向切割模式提高手术安全性和成功率本次手术应用的业聚医疗旗下全资附属公司业聚医疗器械（深圳）有限公司自主原研的Scoreflex TRIO，这是首款国产冠脉三导丝刻痕球囊导管。该产品通过桡或股动脉路径将其沿导引导丝输送至冠状动脉的靶病变处，由球囊自带的两根固有导丝与导引导丝形成外部刻痕组件，可在球囊的管腔表面产生局部高压，使得球囊在较低压力下就能打开冠脉病变和扩张狭窄的冠状动脉，有效扩张病变，并且避免明显内膜撕裂及夹层形成，进而改善血流和心肌灌注。Scoreflex TRIO三导丝刻痕球囊导管作为PCI手术中的预扩张球囊，其聚力纵向切割的扩张模式一方面较普通球囊扩张进一步降低残余狭窄，提高手术成功率；另一方面降低了血管内膜撕裂的发生率，减少血管损伤，降低炎症反应，提高手术安全性，降低再狭窄发生率。高压三导丝刻痕球囊导管利用集中、较低的扩张压力，对血管壁进行聚力纵向切割，而且其纵向切割方式为逐级递增的渐进式扩张切割模式，这种扩张切割模式可以最大程度减少血管内膜损伤，增加最小管腔直径，降低残余狭窄。Scoreflex TRIO的操作方式可在最大程度上减少血管内膜损伤，提高手术安全性及成功率。Scoreflex TRIO已于2021年在日本上市，不仅于去年为业聚医疗的当地销售额带来可观增长，也为无数患者提供有效和安全的医疗解决方案。 业聚医疗已先后在中国内地推出Scoreflex及Scoreflex NC刻痕迹球囊，这两种产品分别是获国家药监局批准的首款刻痕迹球囊及首款高压刻痕迹球囊。随着Scoreflex TRIO于国内正式展开注册临床研究，相信业聚医疗未来将继续为中国内地患者提供更多治疗选择。关于业聚医疗业聚医疗是一家主要的全球医疗器械制造商，专门生产用于经皮冠状动脉介入治疗（PCI）及经皮腔内血管成形术（PTA）的介入器械。总部位于中国香港，业聚医疗的产品销往全球超过70个国家和地区。根据灼识咨询报告，就2021年PCI球囊的销量而言，集团亦是唯一一家总部设在中国，且在包括日本（排名第二）、欧洲（排名第四）及美国（排名第六）在内的所有主要海外PCI球囊市场排名前六的公司。此外，就2021年PTA球囊的销量而言，集团在日本市场排名第三，在美国市场排名第四。集团亦专攻冠状动脉支架产品，并积极将业务扩展至神经血管介入及结构性心脏病领域。截至2022年12月，业聚医疗在全球拥有超过180项授权专利。集团内部研发团队有逾20年积累的产品开发经验，并已开发出世界领先的专有技术。关于葛均波复旦大学附属中山医院心内科主任；中国科学院院士，中国心血管健康联盟主席，主任医师，教授，博士生导师，复旦大学附属中山医院心内科主任，心导管室主任，上海市心血管病研究所所长。世界心脏联盟常务理事，亚太介入心脏病学会主席，国际心脏病大会顾问委员会委员。致力于冠心病病人心肌微循环灌注障碍方面的研究，他对冠状动脉血流缓慢综合征的研究阐述了假性冠状动脉血流储备正常的机制，获九三学社抗击新冠肺炎疫情先进个人荣誉称号、全国先进工作者。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台