Critical appraisal of trials for validation of 'risk-guided' cardiovascular disease prevention therapy.

Cardiovascular risk management in the primary prevention population is impeded by the fact that risk scores do not identify properly a low-moderate risk population that could benefit from the use of preventive strategies. Current risk scores are further limited by their complexity and the lack of applicability to special patient populations and the real-life clinical setting, which deters their use. Clinical trials with risk factor interventions have been based on either a treat-to-target or fire-and-forget strategy and have used cardiovascular mortality or major events as their primary endpoint. These endpoints may not be appropriate for assessing cardiovascular benefit in low-moderate risk patients. Cardiovascular risk assessment should guide the strategy for risk factor intervention; however, this needs to be more clearly defined in low-intermediate risk patients.