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Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding
The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a prospective, randomized, multicenter clinical trial of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) as prevention for stroke in patients with symptomatic stenosis greater than or equal to 50%. CREST is sponsored by the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH), with additional support by a device manufacturer, and will provide data to the US Food and Drug Administration (FDA) for evaluation of a stent device. Because of budget constraints for CREST, Health Care Financing Administration (HCFA) reimbursement for hospital costs incurred by CREST patients will be essential. The involvement of academic scientists, industry, and three separate government agencies (NIH, FDA, HCFA) has presented many challenges in conducting the trial. A review of the pathways followed to meet these challenges may be helpful to others seeking to facilitate sharing of the costs and burdens of conducting innovative clinical research.
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Noninferiority trials
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In one of the biggest dilemmas facing cardiovascular clinical research, clinical trials are increasingly being required to show benefits on clinical end-points rather than surrogate end-points, while at the same time the incremental benefits of newer treatments are getting smaller. These two factors have a huge impact on sample size, which has led some investigators to design trials to show that the new treatment has an effect similar to that of the standard, rather than outright superiority. Recent examples of fibrinolytic trials that have demonstrated similar effects of two drugs are ASSENT (Assessment of the Safety and Efficacy of a New Thrombolytic)-2, GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries)-III, and COBALT (Continuous Infusion Versus Double-Bolus Administration of Alteplase) [1,2,3,4]. However, as discussed by several authors [5,6,7,8], there are issues with trials of this type that make them considerably less credible than superiority trials.
Debate: The slippery slope of surrogate outcomes
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Surrogate outcomes are frequently used in cardiovascular disease research. A concern is that changes in surrogate markers may not reflect changes in disease outcomes. Two recent clinical trials (Heart and Estrogen/Progestin Replacement Study [HERS], and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial [ALLHAT]) underscore this problem since their results contradicted what was expected based on the surrogate outcomes. The current regulatory policy to allow new therapies to be introduced onto the market based solely on surrogate outcomes may need to be reviewed.
Use of diffusion and perfusion magnetic resonance imaging as a tool in acute stroke clinical trials
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In light of the slow progress in developing effective therapies for ischemic stroke, magnetic resonance imaging techniques have emerged as new tools in stroke clinical trials. Rapid imaging with magnetic resonance imaging, diffusion weighted imaging, perfusion imaging and angiography are being incorporated into phase II and phase III stroke trials to optimize patient selection based on positive imaging diagnosis of the ischemic pathophysiology specifically related to a drug's mechanism of action and as a direct biomarker of the effect of a treatment's effect on the brain.
Debate: A subversive view of subsets - a dissident clinician's opinion
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Clinical trialists and statisticians are very wary of subgroup analysis, for good reasons. Clinicians have to deal with situations in which subgroups of patients differ widely from one another in their prognosis and response to treatment. Few trials are large enough to demonstrate convincingly these differences in outcome, but often provide suggestive evidence. Should we ignore this and treat all patients as the same, or should we allow dubious statistical evidence to buttress biological plausibility in making clinical decisions?
ELITE II and Val-HeFT are different trials: together what do they tell us?
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The Losartan Heart Failure Survival Study (ELITE II) and the Valsartan Heart Failure Trial (Val-HeFT) both evaluated the efficacy and tolerability of a selective angiotensin II receptor antagonist on morbidity and mortality in patients with symptomatic heart failure. The trials differed, however, in terms of their primary hypothesis, study design, and treatment regimens, and this must be taken into consideration when comparing and interpreting the data from these studies. The data are in many ways complementary, and add to our understanding of the optimal treatment of symptomatic heart failure. Additional studies are needed, however, to fully define the role of angiotensin II receptor antagonists in the management of this very heterogeneous group of patients.
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