Meschia James F, Voeks Jenifer H, Leimgruber Pierre P, Mantese Vito A, Timaran Carlos H, Chiu David, Demaerschalk Bart M, Howard Virginia J, Hughes Susan E, Longbottom Mary, Howard Annie Green, Brott Thomas G
Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., M.L., T.G.B.).
Department of Neurosciences, Medical University of South Carolina, Charleston, SC (J.H.V.).
J Am Heart Assoc. 2014 Nov 26;3(6):e001180. doi: 10.1161/JAHA.114.001180.
The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) is a multicenter randomized trial of stenting versus endarterectomy in patients with symptomatic and asymptomatic carotid disease. This study assesses management of vascular risk factors.
Management was provided by the patient's physician, with biannual monitoring results collected by the local site. Therapeutic targets were low-density lipoprotein, cholesterol <100 mg/dL, systolic blood pressure <140 mm Hg, fasting blood glucose <126 mg/dL, and nonsmoking status. Optimal control was defined as achieving all 4 goals concurrently. Generalized estimating equations were used to compare risk factors at baseline with those observed in scheduled follow-up visits for up to 48 months. In the analysis cohort of 2210, significant improvements in risk-factor control were observed across risk factors for all follow-up visits compared with baseline. At 48 months, achievement of the low-density lipoprotein cholesterol goal improved from 59.1% to 73.6% (P<0.001), achievement of the systolic blood pressure goal improved from 51.6% to 65.1% (P<0.001), achievement of the glucose goal improved from 74.9% to 80.7% (P=0.0101), and nonsmoking improved from 74.4% to 80.9% (P<0.0001). The percentage with optimal risk-factor control also improved significantly, from 16.7% to 36.2% (P<0.001), but nearly 2 of 3 study participants did not achieve optimal control during the study.
Site-based risk-factor control improved significantly in the first 6 months and over the long term in CREST but was often suboptimal. Intensive medical management should be considered for future trials of carotid revascularization.
ClinicalTrials.gov. Unique identifier: NCT00004732.
颈动脉血运重建内膜切除术与支架置入术试验(CREST)是一项针对有症状和无症状颈动脉疾病患者的支架置入术与内膜切除术的多中心随机试验。本研究评估血管危险因素的管理情况。
由患者的医生进行管理,当地研究点每半年收集一次监测结果。治疗目标为低密度脂蛋白胆固醇<100mg/dL、收缩压<140mmHg、空腹血糖<126mg/dL以及戒烟。最佳控制定义为同时实现所有4个目标。使用广义估计方程将基线时的危险因素与在长达48个月的定期随访中观察到的危险因素进行比较。在2210例分析队列中,与基线相比,所有随访时各危险因素的控制情况均有显著改善。在48个月时,低密度脂蛋白胆固醇目标的实现率从59.1%提高到73.6%(P<0.001),收缩压目标的实现率从51.6%提高到65.1%(P<0.001),血糖目标的实现率从74.9%提高到80.7%(P = 0.0101),戒烟率从74.4%提高到80.9%(P<0.0001)。最佳危险因素控制的百分比也显著提高,从16.7%提高到36.2%(P<0.001),但近三分之二的研究参与者在研究期间未实现最佳控制。
在CREST研究中,基于研究点的危险因素控制在最初6个月及长期内均有显著改善,但通常未达最佳状态。在未来的颈动脉血运重建试验中应考虑强化医疗管理。
ClinicalTrials.gov。唯一标识符:NCT00004732。