Coronary Revascularization in Diabetic Patients

描述(由申请人提供)： 自由是一项多中心、前瞻性、随机的临床试验，比较了冠状动脉旁路手术(CABG)和使用西罗莫司洗脱支架的经皮冠状动脉支架在糖尿病多血管病变患者中的疗效。该研究的主要目的是比较使用西罗莫司洗脱支架的多血管支架置入术和冠状动脉旁路移植术在5年随访中的死亡率。 研究人群将包括2300名根据美国糖尿病协会诊断为糖尿病和多支冠状动脉疾病(CAD)的患者(每支ARM有1150名患者)。多支冠状动脉疾病(CAD)(至少两个主要心外膜冠状动脉有两个或两个以上狭窄病变)适合接受支架植入或外科血管重建的经皮冠状动脉介入治疗。所有受试者将接受筛选，以确保在进入研究之前满足所有纳入和排除标准。在登记参加这项研究之前，将获得书面知情同意。符合资格标准的患者将按1：1的比例随机接受冠状动脉搭桥术或使用西罗莫司洗脱支架的多支血管支架治疗。 这项研究的主要结果是支架组和冠脉搭桥组在5年期间死亡率的差异。以下次级终点将被评估：1)1年、2年、3年和4年的生存功能；2)MACCE住院30天、6个月和12个月的个别组成部分；3)每6个月至5年随机进行一次随机前后的生活质量；4)手术前和手术后6个月、1年和5年的神经认知功能；以及5)成本-效果分析、住院时间、资源利用、重复住院和重复血管重建事件。 我们计划在18个月内在100个临床地点招募所有患者。

DESCRIPTION (provided by applicant): FREEDOM is a multicenter, prospective, randomized clinical trial comparing coronary artery bypass surgery (CABG) with percutaneous coronary stenting using the Sirolimus-eluting stent in diabetic patients with multivessel disease. The main objective of the study is to compare a multivessel stenting strategy using Sirolimus-eluting stents with CABG with respect to mortality in 5 years of follow-up. The study population will consist of 2300 patients (1150/arm) with diabetes mellitus diagnosed according to the American Diabetes Association, and multivessel coronary artery disease (CAD) (2 or more stenotic lesions in at least 2 major epicardial coronary arteries), amenable to either PCI with stenting or surgical revascularization. All subjects will be screened to ensure that all inclusion and exclusion criteria are fulfilled prior to study entry. A written informed consent will be obtained prior to enrollment in the study. Patients who meet the eligibility criteria will be randomized on a 1:1 basis either to CABG or multivessel stenting using Sirolimus-eluting stents. The primary outcome of the study is the difference in mortality rates between the stent group and the CABG group over the 5-year period. The following secondary endpoints will be assessed: 1) survival functions over years 1, 2, 3 and 4; 2) individual components of MACCE in-hospital at 30 days, 6 months and 12 months; 3) quality of life pre- and post-randomization every 6 months up to 5 years; 4) neuro-cognitive function pre-procedure and 6 months, 1 year and 5 years post-procedure; and 5) cost-effectiveness analyses, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events. We plan to recruit all patients over the course of 18 months at 100 clinical sites.