Stents and Antiplatelet Drugs: Impact on Ischemia and Bleeding in the Elderly

支架和抗血小板药物：对老年人缺血和出血的影响

• 批准号: 8061930
• 负责人: Samip Vasaiwala
• 金额: $ 7.59万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2012-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8061930
• 关键词: Stents; Antiplatelet; Drugs; Impact; Ischemia

DESCRIPTION (provided by applicant): Coronary heart disease is the leading cause of death in the United States. The elderly, those older than 65 years of age, are more likely to have coronary disease and this problem will become even more pervasive as the population ages. Stenting of coronary blockages has become a conventional technique in both the emergency setting of a heart attack as well as more routine therapy to reduce chest pain. In general, there are two types of coronary stents: drug-coated (or drug-eluting stents, DES) and non-drug- coated (or bare metal stents, BMS). Placement of either type of stent requires treatment with clot- preventing medications such as aspirin and clopidogrel or prasugrel to keep them open. The latter two are newer types of medications that work in conjunction with aspirin to reduce the function of cells that help form blood clots in the body (platelets), thereby preventing clot formation on stents (stent thrombosis). Currently, the American College of Cardiology / American Heart Association recommend continuation of these medications for at least one year following DES and for at least one month following BMS placement. Initial studies comparing DES to BMS showed that by reducing scar formation around stents, DES are less likely to close up and require repeat procedures. Recruitment of elderly in these studies was limited and subjects were generally healthier when compared to the community-dwelling elderly. Despite lack of such information, the elderly routinely receive DES during cardiac procedures, requiring the obligatory one-year of anti-platelet drugs. On average, the elderly are more likely to be taking multiple medications, have a lower body weight, and have worse kidney function than the relatively healthier population in randomized trials, thereby putting them at higher risk of drug-drug interactions and unwanted bleeding. Bleeding, which was originally considered just a nuisance in the early days of stenting, has more recently been recognized to increase mortality in patients with coronary heart disease. The balance of possible increased risk of repeat procedures with the use of BMS and potentially increased risk of bleeding with long-term use of dual antiplatelet therapy needs further investigation. The Dual Antiplatelet (DAPT) Study will randomize > 20,000 patients to either 12 versus 30 months of dual antiplatelet drugs. This trial is unique in that it will study all-comers, there is no upper age limit, and will collect data on bleeding, interruptions of medications, and adverse cardiac events. We intend to study the DAPT Study elderly subset and compare differences in effectiveness and risk of dual antiplatelet therapy and stent types. Data on the rate of heart attacks, stroke, repeat procedures, and bleeding from a state-mandated registry which collects information on all stenting procedures in Massachusetts will also be analyzed for 3 and 4 year follow-up. Information obtained from this project will provide guidance to physicians caring for elderly patients toward stenting and medical treatment of coronary heart disease, particularly in regards to type and duration of antiplatelet drugs. PUBLIC HEALTH RELEVANCE: An important aspect of the management of coronary heart disease entails placement of drug coated and uncoated stents in the heart arteries to open up blockages. Medications required to prevent the stents from clotting can also increase the risk of bleeding and safety of these stents and medication in the elderly is not entirely clear based on current available data. The goal of our project is to study the safety and efficacy of these medications and stents in the elderly as part of a 20,000 patient randomized trial of these clot prevention medications and a statewide registry that manages information on all coronary stenting procedures done in Massachusetts.

描述(申请人提供)：在美国，冠心病是导致死亡的主要原因。65岁以上的老年人更容易患上冠状动脉疾病，随着人口老龄化，这个问题将变得更加普遍。冠状动脉阻塞支架置入术已经成为心脏病发作的紧急情况下的一项常规技术，也是减少胸痛的更常规治疗。一般来说，有两种类型的冠状动脉支架：药物涂层(或药物洗脱支架，DES)和非药物涂层(或裸金属支架，BMS)。放置任何一种支架都需要使用防止血栓的药物，如阿司匹林和氯吡格雷或普拉格雷以保持其开放。后两种是较新类型的药物，与阿司匹林联合使用，可以降低帮助在体内形成血栓的细胞(血小板)的功能，从而防止支架上形成血栓(支架血栓)。目前，美国心脏病学会/美国心脏协会建议在DES后至少继续服用这些药物一年，并在BMS放置后至少一个月继续服用这些药物。初步研究比较DES和BMS表明，通过减少支架周围疤痕的形成，DES闭合的可能性较小，需要重复手术。在这些研究中招募老年人的情况有限，与社区居住的老年人相比，受试者通常更健康。尽管缺乏这样的信息，老年人在心脏手术期间经常接受DES，这需要一年的强制性抗血小板药物。平均而言，在随机试验中，与相对健康的人群相比，老年人更有可能服用多种药物，体重较低，肾功能较差，从而使他们面临更高的药物相互作用和不必要的出血风险。出血，在支架植入的早期被认为是一种滋扰，最近被认为会增加冠心病患者的死亡率。使用BMS可能会增加重复手术的风险，长期使用双重抗血小板治疗可能会增加出血风险，这两者之间的平衡需要进一步研究。双重抗血小板(DAPT)研究将使20,000名患者随机接受12个月和30个月的双重抗血小板药物治疗。这项试验的独特之处在于，它将研究所有参与者，没有年龄上限，并将收集有关出血、药物中断和不良心脏事件的数据。我们打算研究DAPT研究老年组，并比较双重抗血小板治疗和支架类型在有效性和风险方面的差异。从州政府规定的登记中收集有关马萨诸塞州所有支架手术信息的心脏病发作、中风、重复手术和出血率的数据也将在3年和4年的随访中进行分析。从这个项目中获得的信息将为护理老年患者的医生提供支架植入和冠心病医疗方面的指导，特别是关于抗血小板药物的类型和持续时间。 公共卫生相关性：冠心病管理的一个重要方面是在心脏动脉内放置药物涂层和未涂层支架，以打开堵塞。防止支架凝结所需的药物也会增加出血的风险，这些支架的安全性，根据目前可用的数据，对老年人的药物治疗并不完全清楚。我们项目的目标是研究这些药物和支架在老年人中的安全性和有效性，作为这些预防血栓药物的2万名患者随机试验的一部分，并建立一个全州登记管理所有在马萨诸塞州进行的冠状动脉支架手术的信息。