Key result
Carotid intima-media thickness trials predicted the outcomes of morbidity and mortality trials with a positive predictive value of 96% (CI 80-99%) and a negative predictive value of 83% (CI 64-93%).
Why the study?
Do the results of a carotid intima-media thickness (CIMT) trial accurately predict the outcomes of a large-scale morbidity and mortality (M&M) trial?
Systematic Review (n=48)
Do the results of a carotid intima-media thickness (CIMT) trial accurately predict the outcomes of a large-scale morbidity and mortality (M&M) trial?
Effect estimate: PPV 96%, NPV 83% (95% CI 80-99% for PPV; 64-93% for NPV)
CIMT trials demonstrate high predictive value for the outcomes of subsequent morbidity and mortality trials, particularly for lipid-lowering therapies, supporting their use as a decision tool.
CIMT trial results may inform go/no-go decisions for large M&M trials; supports surrogate endpoint validation in atherosclerosis research.
BACKGROUND: Trials with carotid intima-media thickness (CIMT) as primary end point may improve the efficiency of the evaluation of new therapies targeting atherosclerosis considerably, and the results of CIMT trials may be used as a decision tool to help in the choice to launch or not to launch a large-scale morbidity and mortality (M&M) trial. We evaluated the literature to provide evidence to support or refute this proposition. METHODS AND RESULTS: PubMed Medline was systematically searched on May 1, 2012, for randomized double-blind controlled CIMT trials. The agreement between the results from CIMT and M&M trials was assessed, and positive and negative predictive values were calculated. Forty-eight CIMT trials were included. CIMT trials (n=20) on lipid-level modifying therapies are all, except one, in agreement with the M&M trial findings. For blood pressure-lowering trials (n=13), 3 were not congruent with the M&M trial. The positive and negative predictive value (95% confidence interval) of a CIMT trial to predict the outcome of a M&M trial are 96% (80-99%) and 83% (64-93%), respectively. The predictive values are higher for lipid-level modifying therapies than for other therapies. CONCLUSIONS: A CIMT trial positioned before an M&M trial may considerably improve the efficiency of the evaluation of new drug therapies on atherosclerosis and cardiovascular disease risk. Hence, the results of a CIMT trial should be seen as a decision tool to support or refute the start of a large-scale M&M trial on drugs targeting atherosclerosis.
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Peters et al. (2012) conducted a systematic review in Atherosclerosis (n=48). Carotid intima-media thickness (CIMT) trials vs. Morbidity and mortality (M&M) trials was evaluated on Agreement between the results from CIMT and M&M trials (PPV 96%, NPV 83%, 95% CI 80-99% for PPV; 64-93% for NPV). Carotid intima-media thickness trials predicted the outcomes of morbidity and mortality trials with a positive predictive value of 96% (CI 80-99%) and a negative predictive value of 83% (CI 64-93%).
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