Key result
Longitudinal care linked to ~20-percentage-point increase in optimal risk-factor control at 48 months.
Why the study?
Does participation in a clinical trial with biannual monitoring improve vascular risk factor control over time in patients with carotid disease?
Observational (n=2,210)
Yes
Does participation in a clinical trial with biannual monitoring improve vascular risk factor control over time in patients with carotid disease?
Absolute Event Rate: 36.2% vs 16.7%
p-value: p=<0.001
Monitored trial participation improved risk-factor control yet left most patients suboptimally managed; leaves open whether targeted interventions can achieve optimal targets in carotid disease.
BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION URL: ClinicalTrials.gov. Unique identifier: NCT00004732.
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Meschia et al. (2014) conducted an observational in Symptomatic and asymptomatic carotid disease (n=2,210). Usual-care medical management of vascular risk factors vs. Baseline was evaluated on Optimal risk-factor control (concurrent achievement of LDL <100 mg/dL, systolic BP <140 mm Hg, fasting glucose <126 mg/dL, and nonsmoking) at 48 months (p=<0.001). The percentage of patients achieving optimal risk-factor control improved significantly from 16.7% at baseline to 36.2% at 48 months, though nearly two-thirds remained suboptimally managed.
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