Intermittent Claudication

SELUTION SLR™ Drug-Eluting Balloon (DEB) achieves amongst the highest reported patency for any drug-eluting or drug-coated technology at 3 years in the SELUTION SFA Japan Trial, with 81.5% primary patency. SELUTION SLR™ DEB demonstrates real-world effectiveness and consistency across complex and varied patient populations. The SUCCESS Study 12-month primary endpoint showed: Freedom from CD-TLR – overall population of 91.1%, claudicants 91.3%, and CLTI 90.3%. MIAMI LAKES, Fla., April 24, 2025 /PRNewswire/ -- Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). The SUCCESS PTA Study 12-month results were presented on April 23 at the Charing Cross Symposium in London. The SELUTION SFA Japan Trial 3-year results followed on April 25 at the Japan Endovascular Treatment Conference in Osaka. The studies confirm the sustained efficacy and safety of SELUTION SLR™ DEB in treating complex peripheral artery disease (PAD) across diverse, real-world patient populations, favorably matching best-in-class benchmarks from paclitaxel-eluting technologies. Continue Reading Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). 3-Year Results – SELUTION SFA Japan Trial: First Sirolimus DEB with Proven Long-Term Outcomes The SELUTION SFA Japan trial, a prospective, single-arm trial conducted at 13 sites across Japan, evaluated the performance of SELUTION SLR™ DEB in 134 complex patients. At 3 years, SELUTION SLR™ DEB demonstrated primary patency of 81.5% and freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) of 93.8%. These results demonstrate that SELUTION SLR™ DEB is the only drug-eluting technology with core-lab adjudicated 3-year patency over 80%. "SELUTION SLR™ DEB represents the next evolution in Leave-Nothing-Behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period," said Dr. Iida, MD, of the Cardiovascular Division at Osaka Police Hospital, Japan and Study Principal Investigator. 12-Month Outcomes – The SUCCESS PTA Study: Real-World Results in a PAD Population The SUCCESS PTA Study is a prospective, observational global registry evaluating SELUTION SLR™ DEB in 723 patients across 27 sites in Europe, Asia, and South America. The study population reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). The primary endpoint—freedom from CD-TLR at 12 months—was consistently high: 91.1% in the overall population, 91.3% in claudicants, and 90.3% in CLTI patients. Clinical improvements were seen across the patient cohorts with 88.1% of patients improving by at least one Rutherford category. "Leveraging SELUTION SLR™ DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts," said Dr. Michael Lichtenberg, Chief of Interventional Angiology at Klinikum Hochsauerland, Germany, CMO and Director of Vascular Center Clinic, Germany, and Study Principal Investigator. "These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients." Drug Elution, Done Better – Sustained Sirolimus Release Improves Outcomes "At Cordis, our focus is always on advancing therapies that offer meaningful, lasting impact for patients—and these results do exactly that," said Dr. George Adams, Chief Medical Officer at Cordis. "The SELUTION SLR™ studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations. This is the kind of innovation that truly elevates patient care." About Cordis Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have been committed to improving patient lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to be the heart of innovation to transform cardiovascular care. For more information about Cordis, please visit Cordis.com and follow Cordis on LinkedIn. Media Contact: Kelly May Director of Corporate Communications [email protected] SOURCE Cordis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

点击“蓝字”关注我们编者按外周动脉疾病（PAD）是2型糖尿病 （T2DM） 患者的大血管并发症之一，是一种以动脉狭窄和外周动脉床闭塞为特征的进行性疾病，它可以是有症状的或无症状的。PAD不仅预示全身动脉粥样硬化的“冰山一角”，更是截肢与早期死亡的重要风险信号。因此，识别T2DM人群中易患PAD的高危因素，并进行早期干预至关重要。近期一项发表在Diabetes Research and Clinical Practice杂志的研究结果表明[1]，老年、病程较长、心血管病史、血脂异常和高血压是T2DM人群发生PAD的重要预测因素，提示临床应加强对高危人群的筛查和干预。01T2DM合并PAD的早期识别至关重要PAD是指外周动脉（尤其是下肢）发生动脉粥样硬化狭窄或闭塞所致的供血障碍。其临床表现从无症状、间歇性跛行，到重度肢体缺血甚至坏疽截肢。在T2DM人群中，PAD的患病率远高于普通人群（15.2%~40% vs. 5%~5.6%），而且多为无痛性进展，常被忽视。PAD显著增加心梗、脑卒中和全因死亡风险。更令人担忧的是，T2DM合并PAD患者发生下肢截肢的风险是非糖尿病患者的5倍，平均寿命也明显缩短。因此，识别T2DM人群中易患PAD的高危因素，并进行早期干预至关重要。02五大因素，锁定PAD高危群该系统评价纳入10项研究（6项前瞻性队列研究、4项病例对照研究），共计73 843例T2DM患者。PAD诊断依据包括踝肱指数（ABI）≤0.9、血管造影、彩超或电子病历中的明确记录。结果表明，T2DM患者中与PAD风险显著增加相关的因素包括：年龄≥70岁（OR=3.44）、糖尿病病程≥5年（OR=1.81）、冠心病病史（OR=1.55）、高血压（OR=1.43）、低密度脂蛋白胆固醇（LDL）升高（OR=2.51），而性别、HbA1c水平、肥胖、吸烟、肾小球滤过率下降与PAD无显著相关性。年龄≥ 70岁：年龄是T2DM患者PAD最相关的独立风险因素。老年人血管内皮功能退化、顺应性下降、抗血栓能力减弱，均促进动脉粥样硬化发展。糖尿病病程≥ 5年：长期高血糖暴露会加剧代谢紊乱与慢性炎症，促成动脉硬化斑块形成。研究发现，当T2DM病程达到或超过20年时，PAD的风险相较于病程在10年以内的群体，其风险超过2倍以上。冠心病病史：冠心病作为全身粥样硬化的“标志性”表现，与PAD关系密切。两者常并存，反映系统性血管病。高血压：高血压加速动脉壁机械应力与内皮损伤，增加PAD风险。研究显示，在T2DM早期将血压控制在145/85 mmHg以下，可显著降低PAD的发生率。LDL升高：LDL是形成动脉斑块的主要成分。在所有血脂参数中，只有LDL水平的升高与PAD之间存在明确的正向相关性。因此，强调在T2DM的管理策略中，对LDL的控制仍然是一级预防的核心要素。03“不显著”因素为何仍值得重视？值得注意的是，某些传统风险因素在本研究中未达到统计学显著，但并不意味着其临床意义可被忽略。性别：性别差异在该Meta分析中不显著，但有研究发现女性糖尿病患者更容易发生PAD，可能与其治疗依从性差或临床照护不均有关。HbA1c水平：HbA1c ≥7%的高血糖状态并未在该Meta中显著关联PAD，但其他研究指出HbA1c>10%时PAD风险明显上升。此外，有研究表明，在糖尿病确诊第一年成功将HbA1c控制在7.4%以下可显著降低后续PAD风险。吸烟：吸烟作为已知的心血管风险因素，虽然在本Meta分析中未显示显著影响，但考虑到研究中未量化“烟龄”或“每日支数”，可能低估了其真实效应。事实上，吸烟通过诱导血管收缩、内皮功能损伤和炎症反应，在动脉硬化中起到了加速器的作用。肾小球滤过率下降：估算肾小球滤过率（eGFR）下降在分析中并未与PAD显著相关，但已有多项研究指出慢性肾病（CKD）患者血管钙化与粥样硬化程度更高，可能因本研究中eGFR分层不够细致而低估其作用。肥胖：另一值得讨论的变量是肥胖，本研究显示，在亚洲人群中，肥胖反而与PAD发生呈负相关（OR=0.86），这与“肥胖悖论”现象一致。可能原因在于亚洲T2DM患者多为“非典型肥胖”，BMI虽不高但腹型肥胖显著，中心性脂肪更具代谢危害。因此，腰围或腰臀比等指标在亚洲人群中或许较BMI更能预测血管风险。04结语该项Meta分析结果表明，年龄≥70岁、糖尿病病程≥5年、既往冠状动脉疾病病史、高血压以及LDL水平升高，是T2DM患者发生PAD的主要独立危险因素。这些发现为临床医生提供了重要的风险识别依据，有助于早期评估和预测T2DM患者PAD的发生风险。针对高危个体及时实施预防与干预措施，将有望有效降低PAD的发病率和相关死亡率，提升患者的整体预后与生活质量。参考文献：1.Rosana M, et al. Diabetes Res Clin Pract. 2025. PMID: 40220794声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

WEDNESDAY, April 2, 2025 -- For patients with symptomatic peripheral artery disease and type 2 diabetes , semaglutide use is associated with increased walking distance, according to a study published online March 29 in The Lancet to coincide with the annual meeting of the American College of Cardiology, held from March 29 to 31 in Chicago. Marc P. Bonaca, M.D., from the University of Colorado School of Medicine in Aurora, and colleagues conducted a randomized, placebo-controlled trial at 112 outpatient clinical trial sites in 20 countries. Patients were aged 18 years and older and had type 2 diabetes and peripheral artery disease with intermittent claudication. Participants were randomly allocated to receive subcutaneous semaglutide 1.0 mg once per week for 52 weeks or placebo (396 patients in each group). The researchers found that the estimated median ratio to baseline in maximum walking distance at week 52 was significantly greater in the semaglutide group versus the placebo group (1.21 versus 1.08; estimated treatment ratio, 1.13). Serious adverse events that were possibly or probably related to treatment were reported in five participants (six events) in the semaglutide group and six participants (nine events) in the placebo group; serious gastrointestinal events were the most frequent (two events in two patients in the semaglutide group; five events in three patients in the placebo group). No treatment-related deaths were reported. "These findings support the use of semaglutide in people with peripheral artery disease and type 2 diabetes and suggest that semaglutide should be prioritized among treatments for this population," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Novo Nordisk, which manufactures semaglutide and funded the study.