Journal of vascular surgery
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Randomized Controlled Trial Comparative Study
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Endovenous laser therapy (EVLT) for ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity compared with high ligation and stripping (HL/S). Only a few randomized trials have reported early results. This prospective randomized trial compared EVLT (980 nm) and HL/S results at 1 and 2 years after the intervention. ⋯ Abolition of GSV reflux and improvement in quality of life was similar after HL/S and EVLT. After EVLT, however, two GSVs were found completely reopened and five were partially reopened, which was significantly higher than after HL/S. A prolonged follow-up is ongoing.
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Randomized Controlled Trial Multicenter Study
Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial.
Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. ⋯ The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.
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Randomized Controlled Trial Comparative Study
Prospective randomized study comparing the clinical outcomes between inferior vena cava Greenfield and TrapEase filters.
Although anticoagulation remains the mainstay of treatment for deep venous thrombosis, the use of inferior vena cava (IVC) filters when anticoagulation has failed or when contraindicated remains a safe and effective treatment. Greenfield (Boston Scientific, Natick, Mass) and TrapEase (Cordis, Bridgewater, NJ) filters are arguably among the most popular filtration devices. The Greenfield filter (12F introducer) has been in use for >30 years and has been well studied. The TrapEase filter (6F introducer) has been used since 2000, with a limited number of studies. Good guidelines to help determine which filter to use in any given situation are lacking; therefore, this randomized study prospectively compared the clinical outcomes (access-site thrombosis, filter thrombosis, and symptomatic pulmonary embolism [PE]) between these filters. ⋯ A higher rate of symptomatic IVC/IV thrombosis is associated with TrapEase filter placement. However, the TrapEase filter still has a selective clinical role in the prevention of thromboembolism in selected patients who are coagulopathic. This is the first randomized prospective study comparing IVC filters since their inception in 1967.
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Randomized Controlled Trial
Ferritin levels, inflammatory biomarkers, and mortality in peripheral arterial disease: a substudy of the Iron (Fe) and Atherosclerosis Study (FeAST) Trial.
This study delineated correlations between ferritin, inflammatory biomarkers, and mortality in a cohort of 100 cancer-free patients with peripheral arterial disease (PAD) participating in the Veterans Affairs (VA) Cooperative Study #410, the Iron (Fe) and Atherosclerosis Study (FeAST). FeAST, a prospective, randomized, single-blind clinical trial, tested the hypothesis that reduction of iron stores using phlebotomy would influence clinical outcomes in 1227 PAD patients randomized to iron reduction or control groups. The effects of statin administration were also examined in the Sierra Nevada Health Care (SNHC) cohort by measuring serum ferritin levels at entry and during the 6-year study period. No difference was documented between treatment groups in all-cause mortality and secondary outcomes of death plus nonfatal myocardial infarction and stroke. Iron reduction in the main study caused a significant age-related improvement in cardiovascular disease outcomes, new cancer diagnoses, and cancer-specific death. ⋯ These data demonstrate statistical correlations between levels of ferritin, inflammatory biomarkers, and mortality in this subset of patients with PAD.
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Randomized Controlled Trial Multicenter Study Comparative Study
Preliminary results of carotid revascularization endarterectomy vs stenting trial (CREST).