Title: Endovascular Stenting for Vertebral Artery Stenosis
Topic: Interventional Cardiology
Date Posted: 3/11/2010
Author(s): Jenkins JS, Patel SN, White CJ, et al.
Citation: J Am Coll Cardiol 2010;55:538-542.
Clinical Trial: No
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JACC Article: Endovascular Stenting for Vertebral Artery Stenosis
Study Question: Is catheter-based therapy for symptomatic vertebral artery stenosis (VAS) safe and durable?
Methods: One-hundred five patients from 1995-2006 with symptomatic VAS (112 arteries, 71% male) underwent stent placement for extracranial (91%) and intracranial (9%), primarily in the V1 segment (83%). By angiography, 57 patients (54%) had bilateral VAS, 71 patients (68%) had concomitant carotid disease, and 43 patients (41%) had a prior stroke.
Results: A total of 133 stents were placed, which were primarily balloon-expandable bare metal (114). Procedural and clinical success was achieved in 105 (100%) and 95 (90.5%) patients, respectively. One-year follow-up was obtained in 87 (82.9%) patients, of which 69 patients (79.3%) remained symptom-free. Median follow-up was 29.1 months, with 74% of patients asymptomatic at last follow-up. At 1 year, 6 patients (5.7%) had died and 5 patients (5%) had a posterior circulation stroke.
Conclusions: The authors concluded that in “experienced hands,” stenting for symptomatic VAS has a very high procedural and clinical success rate, with few periprocedural complications, and is associated with durable symptom resolution in the majority of patients. They concluded that "endovascular stenting of vertebral artery atherosclerotic disease is safe and effective compared with surgical controls” (historical controls implied) “and should be considered first-line therapy for this disease.”
Perspective: Symptomatic VAS is a morbid and lethal disease, carrying a 5-year 30-35% risk of stroke and a 2-year mortality for medically managed patients of 30%. Despite this relative failure of medical therapy to prevent strokes in these patients, surgical revascularization is rarely performed, also due to the relatively high morbidity and mortality rates associated with surgery. Clearly, an endovascular option for the treatment of these patients is obviously attractive. While most of these stents were placed in the proximal vertebral artery, which has been reported to be less treacherous for stenting than the V2-V4 vertebral artery segments, the present report contains an order of magnitude of more patients than the next largest series. The authors of this large series document outstanding results, stenting a cohort of complex patients with vertebrobasilar disease. Let’s see if this approach becomes standard of care for this disease. Gilbert Upchurch, Jr., M.D.
Title: Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus
Topic: Prevention/Vascular
Date Posted: 3/14/2010
Author(s): The ACCORD Study Group.
Citation: N Engl J Med 2010;Mar 14:[Epub ahead of print].
Clinical Trial: yes
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Trial: Action to Control Cardiovascular Risk in Diabetes Lipid Trial (ACCORD Lipid)
Study Question: Does combination therapy with a statin plus a fibrate, as compared with statin monotherapy, reduce risk for cardiovascular disease (CVD) in patients with type 2 diabetes who are at high risk for CVD?
Methods: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study was designed to examine the effects of intensive blood glucose control and either blood pressure or plasma lipid control on cardiovascular outcomes. The trial includes 10,251 diabetics from 77 sites in the United States and Canada. In the ACCORD Lipid study, 5,518 subjects were treated with open-label simvastatin (40 mg/day or less), with randomization of masked fenofibrate or placebo. All subjects had type 2 diabetes, defined as glycated hemoglobin (HgA1c) of 7.5% or greater and were at high risk for CVD (defined as evidence of clinical CVD [age 40-79 years] or two additional risk factors [age range 55-79 years]). Baseline lipid criteria included having a low-density lipoprotein cholesterol (LDL-C) between 60 and 180 mg/dl, high-density lipoprotein cholesterol (HDL-C) of 55 or less for women or blacks, 50 or less for all others, and triglycerides below 750 mg/dl not on lipid therapy (400 mg/dl if on lipid-lowering therapy). Fasting lipids were measured at 4, 8, and 12 weeks and annually thereafter. Secondary outcomes included the combination of the primary outcomes and revascularization or hospitalization for congestive heart failure. The primary outcomes of interest were first occurrence of nonfatal myocardial infarction, nonfatal stroke, or CVD death. Mean follow-up was 4.7 years.
Results: Subjects had a mean age of 62 years, 31% were female and 37% had a history of CVD. Use of statin therapy prior to enrollment was present in 66% of the study population. Mean LDL-C on treatment was 81.1 mg/dl in the fibrate group and 80.0 mg/dl in the placebo group. Mean HDL-C on treatment was 41.2 mg/dl in the fibrate group and 40.5 mg/dl in the placebo group. Annual rate of CVD events was 2.2% in the fenofibrate plus simvastatin groups and 2.4% in the placebo group (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.79-1.08; p = 0.32). No significant differences between the two groups were observed for the secondary outcomes (HR, 0.94; 95% CI, 0.85-1.05; p = 0.30). Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (HR, 0.91; 95% CI, 0.75-1.10). In prespecified subgroup analysis, men appeared to have a benefit as opposed to women (p = 0.01 for interaction). In addition, the investigators observed a possible interaction according to the lipid subgroup, with a potential benefit for patients with both high triglycerides and low HDL-C levels at baseline (p = 0.057 for interaction).
Conclusions: The authors concluded that simvastatin plus fenofibrate did not reduce nonfatal myocardial infarction or stroke, and also did not reduce CVD mortality compared to simvastatin alone. Thus, these findings from ACCORD Lipid do not support the use of combination therapy (statin plus a fibrate) in high-risk patients with diabetes.
Perspective: This study provides data for clinicians treating diabetes who are at high risk for CVD, suggesting that therapy with statins should remain the core management strategy in prevention of CV events. However, the subgroup analysis warrants further evaluation; given the difference observed in benefits related to gender, statins without fibrate may be the treatment strategy of choice. Elizabeth A. Jackson, M.D., F.A.C.C.