Coronary Revascularization in Diabetic Patients

描述（由申请人提供）： FREEDOM是一项多中心、前瞻性、随机临床试验，比较了冠状动脉旁路移植术（CABG）与使用西罗莫司洗脱支架的经皮冠状动脉支架植入术在糖尿病多支血管病变患者中的疗效。 本研究的主要目的是比较使用西罗莫司洗脱支架的多支血管支架植入策略与CABG在5年随访中的死亡率。 研究人群将包括2300例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）（至少2支主要心外膜冠状动脉中有2处或2处以上狭窄病变）的患者（1150例/组），适合PCI支架植入术或手术血运重建术。 将对所有受试者进行筛选，以确保入组研究前符合所有入选和排除标准。 在入组研究之前，将获得书面知情同意书。 符合合格标准的患者将按照1：1的比例随机分配至CABG组或使用西罗莫司洗脱支架的多支血管支架植入组。 该研究的主要结局是5年期间支架组和CABG组之间的死亡率差异。 将评估以下次要终点：1）第1、2、3和4年的生存功能; 2）30天、6个月和12个月时住院期间MACCE的单个组分; 3）随机化前和随机化后每6个月直至5年的生活质量; 4）术前和术后6个月、1年和5年的神经认知功能;和5）成本效益分析、住院时间、资源利用、重复住院和重复血运重建事件。 我们计划在18个月的时间里在100个临床中心招募所有患者。

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.