The Framingham prediction rule is not valid in a European population of treated hypertensive patients.

Background: Stratification of population groups according to cardiovascular risk level is recommended for primary prevention.

Objective: To assess whether the Framingham models could accurately predict the absolute risk of coronary heart disease (CHD) and stroke in a large cohort of middle-aged European patients with hypertension, and rank individual patients according to actual risk.

Design: A prospective cohort study comparing the actual risk with that predicted by either the Framingham equations or models derived from the INSIGHT study.

Patients And Setting: From the INSIGHT prospective trial, conducted in eight countries of Western Europe and Israel, we selected 4407 European patients younger than 75 years without previous cardiovascular events.

Interventions: None.

Main Outcome Measures: Major cardiovascular events.

Results: In this population (45% men, mean age 64.1 years), 124 (2.8%) patients had CHD and 96 (2.2%) had strokes after a median follow-up of 3.7 years. Overestimation of absolute CHD risk by the Framingham equation was observed in all countries (from 2% in the UK to 7% in France), whereas predicted risk of stroke was close to the actual risk. However, patients in the highest risk quintile within each country had a threefold greater risk of a cardiovascular event than those in the lowest quintile.

Conclusions: The Framingham models should not be used to predict absolute CHD risk in the European population as a whole. However, these models may be used within each country, provided that cut-off points defining high-risk patients have been determined within each country.