Journal of vascular surgery
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Randomized Controlled Trial Multicenter Study
Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis.
The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. ⋯ Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.
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Randomized Controlled Trial Comparative Study
Prospective randomized trial of routine versus selective shunting in carotid endarterectomy based on stump pressure.
The use of shunting in carotid endarterectomy (CEA) is controversial. This randomized trial compared the results of routine (RS) vs selective shunting (SS) based on stump pressure (SP). ⋯ RS and SS were associated with a low stroke rate. Both methods are acceptable, and surgeons should select the method with which they are more comfortable.
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Randomized Controlled Trial Comparative Study
Comparison of low-strength compression stockings with bandages for the treatment of recalcitrant venous ulcers.
To compare the proportion and rate of healing, pain, and quality of life of low-strength medical compression stockings (MCS) with traditional bandages applied for the treatment of recalcitrant venous leg ulcers. ⋯ Our study illustrates the difficulty of bringing large and long-standing venous ulcers to heal. The effect of compression with MCS was not different from that of compression with bandages. Both treatments alleviated pain promptly. Quality of life was improved only in patients whose ulcers had healed.
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Randomized Controlled Trial Multicenter Study Comparative Study
The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results.
The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) completed randomization on July 18, 2008. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), the trial has enrolled 2,522 participants across North America and is the largest randomized clinical trial (RCT) comparing the efficacy of carotid artery stenting (CAS) to carotid endarterectomy (CEA). ⋯ Credentialing of interventionalists also included a review of additional CAS procedures enrolled into a CREST lead-in phase prior to entering patients into the randomized trial; 1564 patients were enrolled in the lead-in, the final pathway for the largest credentialing effort to date for any clinical trial. CREST will provide long-term follow-up after carotid revascularization based on systematic ultrasonographic and neurologic surveillance, and on quality of life and cost-effectiveness comparisons between CAS and CEA in the setting of a RCT. We present a brief description of the CREST protocol, impediments that were overcome during the trial, salient results from the lead-in phase of the trial, a summary of enrollment activities and characteristics of the final cohort, and a timeline for anticipated results from the randomized phase.
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Randomized Controlled Trial Comparative Study
Randomized controlled trial of aspirin and clopidogrel versus aspirin and placebo on markers of smooth muscle proliferation before and after peripheral angioplasty.
In peripheral arterial disease (PAD) patients, a limiting factor in the success of percutaneous transluminal angioplasty (PTA) is the development of restenosis secondary to vascular smooth muscle cell (SMC) proliferation. Following endothelial damage and platelet activation, there is release of factors and adhesion molecules which affect SMC proliferation. The aim of this study was to determine the effect of combination antiplatelet therapy (clopidogrel and aspirin compared with aspirin and placebo) on the ability of plasma from PAD patients undergoing PTA to stimulate SMCs in vitro. We further aimed to investigate the effect of combination treatment on the levels of circulating adhesion molecules and factors, which are known to mediate SMC proliferation in experimental models. ⋯ High rates of restenosis remain the major limitation of peripheral arterial angioplasty and stenting.The restenotic lesion occurs secondary to platelet activation, released circulating factors, and subsequent smooth musclecell proliferation and migration into the intima. Methods to limit the restenotic lesion are poorly understood. This paperinvestigates the effect of PTA on smooth muscle cell activation and the release of factors in plasma which mediate SMCproliferation. It also examines the effect of combination antiplatelet therapy as a potential therapeutic strategy.