Impact of High-Normal Blood Pressure on the Risk of Cardiovascular Disease
Ramachandran S. Vasan, M.D., Martin G. Larson, Sc.D., Eric P. Leip, M.S., Jane C. Evans, Ph.D., Christopher J. O'Donnell, M.D., M.P.H., William B. Kannel, M.D., M.P.H., and Daniel Levy, M.D.
Background Information is limited regarding the risk of cardiovasculardisease in persons with high-normal blood pressure (systolicpressure of 130 to 139 mm Hg, diastolic pressure of 85 to 89mm Hg, or both).
Methods We investigated the association between blood-pressurecategory at base line and the incidence of cardiovascular diseaseon follow-up among 6859 participants in the Framingham HeartStudy who were initially free of hypertension and cardiovasculardisease.
Results A stepwise increase in cardiovascular event rates wasnoted in persons with higher base-line blood-pressure categories.The 10-year cumulative incidence of cardiovascular disease insubjects 35 to 64 years of age who had high-normal blood pressurewas 4 percent (95 percent confidence interval, 2 to 5 percent)for women and 8 percent (95 percent confidence interval, 6 to10 percent) for men; in older subjects (those 65 to 90 yearsold), the incidence was 18 percent (95 percent confidence interval,12 to 23 percent) for women and 25 percent (95 percent confidenceinterval, 17 to 34 percent) for men. As compared with optimalblood pressure, high-normal blood pressure was associated witha risk-factor–adjusted hazard ratio for cardiovasculardisease of 2.5 (95 percent confidence interval, 1.6 to 4.1)in women and 1.6 (95 percent confidence interval, 1.1 to 2.2)in men.
Conclusions High-normal blood pressure is associated with anincreased risk of cardiovascular disease. Our findings emphasizethe need to determine whether lowering high-normal blood pressurecan reduce the risk of cardiovascular disease.
Several epidemiologic studies1,2,3,4,5,6,7 have demonstratedthat systolic and diastolic blood pressures have a "strong,continuous, graded and etiologically significant" positive associationwith cardiovascular-disease outcomes.1 These relations are consistentin both men and women, in young, middle-aged, and older subjects,among different racial and ethnic groups,1,2,3,4,5 and withinand between countries.6,7 Although there is a continuum of cardiovascularrisk across levels of blood pressure,1,2,3,4,5,6,7 the classificationof adults according to blood pressure provides a framework fordifferentiating levels of risk associated with various blood-pressurecategories and for defining treatment thresholds and therapeuticgoals.
According to the classification approaches developed by theJoint National Committee on Prevention, Detection, Evaluation,and Treatment of High Blood Pressure (JNC VI)8 and the WorldHealth Organization and the International Society of Hypertension(WHO-ISH),9 nonhypertensive subjects with a systolic pressureof 130 to 139 mm Hg or a diastolic pressure of 85 to 89 mm Hgare categorized as having high-normal blood pressure. Althoughsubjects with high-normal blood pressure are likely to havean elevated risk of cardiovascular disease (given the continuumof risk), there is a paucity of information regarding the absoluteand relative risks of cardiovascular disease in these persons.Although data on fatal coronary events and strokes in personswith high-normal blood pressure are available,10,11 informationon the risk of nonfatal cardiovascular events among people inthis blood-pressure category is limited. We undertook a prospectiveexamination of the risk of cardiovascular disease in men andwomen with high-normal blood pressure.
Methods
Study Sample
The selection criteria and study design of the Framingham HeartStudy have been described previously.12,13 Subjects in the originalcohort who attended examinations 4 (1956 to 1958, 4541 subjects),12 (1972 to 1974, 3261 subjects), or 18 (1984 to 1986, 1825subjects) and participants in the offspring study who attendedexamination 2 (1978 to 1982, 3863 participants) were eligiblefor this investigation. These examinations are referred to asthe "base-line" examinations. Of the 13,490 attendees, subjectswere excluded if they had hypertension (defined as systolicpressure of at least 140 mm Hg, diastolic pressure of at least90 mm Hg, or use of antihypertensive drugs8,9; 5745 subjects[43 percent] were excluded for that reason) or prevalent cardiovasculardisease (478 subjects [3.5 percent]) at the base-line examinations.Another 408 subjects (3 percent) were excluded because informationon the covariates used in the multivariable analyses detailedbelow was incomplete. After the exclusions, 6859 subjects (3892women and 2967 men) remained eligible for this investigation.Original cohort subjects who were eligible at any examinationremained eligible at the next qualifying examination if theyreached that examination free of cardiovascular disease andhypertension.
Measurement of Blood Pressure and Covariates
At the base-line examination, all participants underwent a physicalexamination with a medical history taking, laboratory assessmentof risk factors for cardiovascular disease, and routine electrocardiography.The average of two readings of systolic and diastolic pressure,measured with a mercury-column sphygmomanometer by a physicianwhile the subject was seated, was recorded as the base-lineblood pressure. At the base-line examination, the subjects wereclassified into one of the three nonhypertensive blood-pressurecategories on the basis of the criteria of JNC VI and WHO-ISH:optimal (systolic pressure of less than 120 mm Hg and diastolicpressure of less than 80 mm Hg), normal (systolic pressure of120 to 129 mm Hg or diastolic pressure of 80 to 84 mm Hg), orhigh-normal (systolic pressure of 130 to 139 mm Hg or diastolicpressure of 85 to 89 mm Hg).8,9 If the systolic and diastolicpressure readings belonged to different categories, the higherof the two readings was used to assign the blood-pressure category.8,9
Follow-up and Outcome Events
All study participants were monitored for cardiovascular eventsand death. Information about cardiovascular events on follow-upwas obtained with the aid of the medical history, physical examinationas part of the Framingham Heart Study (every two years for theoriginal cohort and every four years for the offspring cohort),hospitalization records, and communication with the subjects'personal physicians. All suspected events were reviewed by apanel of three experienced investigators, who evaluated allpertinent medical records. The primary outcome of interest wasthe time to the occurrence of any of the following major cardiovascularevents during 12 years of follow-up: death due to cardiovasculardisease, recognized myocardial infarction, stroke, or congestiveheart failure. These end points were chosen because they havebeen used as major outcome events in clinical trials demonstratingthat treatment of hypertension reduces the risk of cardiovascularevents.14,15,16 The criteria for these end points have beendescribed previously.17 A diagnosis of recognized myocardialinfarction required the presence of at least two of the followingthree criteria: a history of prolonged chest pain, electrocardiographicchanges consistent with myocardial injury, and elevated cardiac-enzymelevels.
Statistical Analysis
Cardiovascular-event rates for each blood-pressure categorywere calculated by dividing the number of subjects who had suchevents by the number of person-years of observation contributedby subjects within a blood-pressure category. The Kaplan–Meierproduct-limit estimator was used to determine the cumulativeincidence of cardiovascular disease in men and women accordingto their blood-pressure category at base line. Sex-specificmultivariable Cox proportional-hazards regression models,18stratified according to the time of the base-line examination(in four categories, corresponding to offspring-cohort examination2 and original-cohort examinations 4, 12, and 18), were constructedto evaluate the association of the base-line blood-pressurecategory with the occurrence of a first cardiovascular eventduring follow-up, after adjustment for age, body-mass index,smoking status, total cholesterol level, and presence or absenceof diabetes mellitus. In addition, trend models were fittedto investigate whether there was an increase in risk from oneblood-pressure category to the next higher category.
To examine whether the association of a given blood-pressurelevel at base line with the risk of future cardiovascular diseasewas mediated by progression to higher levels of blood pressureover time,19 the blood-pressure category and all covariateswere included in Cox models as time-dependent variables duringfollow-up. For this purpose, the subjects were reclassifiedaccording to their blood pressure at each follow-up examination,with the inclusion of hypertension8,9 as an additional category.Cox models incorporating change in blood-pressure category onfollow-up were also examined. Hazard ratios for cardiovasculardisease, with 95 percent confidence intervals, were calculatedfor subjects with normal blood pressure, high-normal blood pressure,and hypertension; persons with optimal blood pressure servedas the reference group.
Additional analyses that included interaction terms (age withblood-pressure category and calendar decade of examination withblood-pressure category) were also performed. The number neededto treat (i.e., the number of patients who would need to havetheir blood pressure lowered) for five years to prevent onemajor cardiovascular event was estimated for subjects with high-normalblood pressure by taking the reciprocal of the absolute reductionin event rates (assuming a range of reductions in event rateswith treatment).20,21 All analyses were performed with SAS software(SAS Institute, Cary, N.C.), primarily Proc Phreg22 on an UltraSparcworkstation (Sun Microsystems, Palo Alto, Calif.). All reportedP values are two-sided, and a P value of less than 0.05 wasconsidered to indicate statistical significance.
Results
Characteristics of the Study Subjects
At base line, a quarter of the study subjects had high-normalblood pressure, a third had normal blood pressure, and the remainderhad optimal blood pressure (Table 1). A higher proportion ofwomen than men in our study sample had optimal blood pressure.Subjects with high-normal blood pressure were older, had a higherbody-mass index, and had higher serum cholesterol levels thanthose with optimal blood pressure.
Table 1. Base-Line Characteristics of the Study Subjects, According to Blood-Pressure Category at Base Line.
Relation of Blood-Pressure Category to the Risk of Cardiovascular Disease
During follow-up (mean, 11.1 years; 75,980 person-years), 397study subjects (138 women and 259 men) had a first cardiovascularevent, including 72 deaths from cardiovascular disease (24 womenand 48 men), 190 recognized myocardial infarctions (35 womenand 155 men), 85 strokes (46 women and 39 men), and 50 casesof congestive heart failure (33 women and 17 men). Cardiovascular-eventrates increased in a stepwise manner across the three blood-pressurecategories (Table 2 and Figure 1). Among younger subjects (35to 64 years old) with high-normal blood pressure, the 10-yearcumulative incidence of cardiovascular disease was 4 percent(95 percent confidence interval, 2 to 5 percent) among womenand 8 percent (95 percent confidence interval, 6 to 10 percent)among men. The 10-year cumulative incidence of cardiovasculardisease was particularly high among older subjects (65 to 90years old) of both sexes with high-normal blood pressure (women:18 percent; 95 percent confidence interval, 12 to 23 percent;men: 25 percent; 95 percent confidence interval, 17 to 34 percent).
Figure 1. Cumulative Incidence of Cardiovascular Events in Women (Panel A) and Men (Panel B) without Hypertension, According to Blood-Pressure Category at the Base-Line Examination.
Vertical bars indicate 95 percent confidence intervals. Optimal blood pressure is a systolic pressure of less than 120 mm Hg and a diastolic pressure of less than 80 mm Hg. Normal blood pressure is a systolic pressure of 120 to 129 mm Hg or a diastolic pressure of 80 to 84 mm Hg. High-normal blood pressure is a systolic pressure of 130 to 139 mm Hg or a diastolic pressure of 85 to 89 mm Hg. If the systolic and diastolic pressure readings for a subject were in different categories, the higher of the two categories was used.
As compared with optimal blood pressure, high-normal blood pressurewas associated with a risk-factor–adjusted hazard ratiofor cardiovascular disease of 2.5 (95 percent confidence interval,1.6 to 4.1) among women and 1.6 (95 percent confidence interval,1.1 to 2.2) among men (Table 3). The hazard ratios associatedwith high-normal blood pressure for the two sexes were not significantlydifferent (P=0.10). Normal blood pressure was associated witha risk-factor–adjusted hazard ratio for cardiovasculardisease of 1.5 (95 percent confidence interval, 0.9 to 2.5)among women and 1.3 (95 percent confidence interval, 1.0 to1.9) among men. In the trend models, a stepwise increase inthe risk of cardiovascular disease was noted with an increasein blood-pressure category (Table 3).
Table 3. Results of Sex-Specific Multivariable Cox Proportional-Hazards Regression Models Examining the Relation of Blood-Pressure Category to the Risk of a First Major Cardiovascular Event.
In analyses in which blood pressure and other risk factors duringfollow-up were modeled as time-dependent variables, the associationof high-normal blood pressure with an increased risk of cardiovasculardisease remained significant for men but was attenuated forwomen (Table 3). An increase in blood-pressure category duringfollow-up was associated with an increased risk of cardiovasculardisease (for men, the hazard ratio associated with an increaseof one category was 1.2 [95 percent confidence interval, 1.1to 1.4], P=0.006; for women, it was 1.4 [95 percent confidenceinterval, 1.1 to 1.6], P=0.002). The subject's age and the timeof the base-line examination had no significant interactionwith high-normal blood pressure (P>0.41 for all analyses).
The crude event rates per 1000 person-years in subjects withhigh-normal blood pressure who were 65 years of age or olderwere 19.5 in women and 28.1 in men. The crude event rates per1000 person-years in subjects with high-normal blood pressurewho were below the age of 65 years were 4.7 in women and 9.2in men. On the basis of these absolute cardiovascular-eventrates in subjects with high-normal blood pressure, and assumingrisk reductions of 10 to 30 percent with blood-pressure lowering,we estimate that for subjects with high-normal blood pressurewho are 65 or older, the numbers needed to treat for five yearsto prevent one cardiovascular event range from 24 to 71 in menand from 34 to 102 in women. The corresponding numbers are considerablyhigher in younger subjects, ranging from 73 to 218 in men andfrom 143 to 429 in women.
Discussion
Although numerous investigators have reported cardiovascularrisks associated with elevated blood pressure,1,2,3,4,5,6,7few have presented the absolute and relative risks of cardiovasculardisease according to the blood-pressure categories used in clinicalpractice. High-normal blood pressure rivals mild hypertensionin prevalence in the U.S. adult population.23 Yet, informationregarding the risk of cardiovascular disease associated withthis blood-pressure category is limited to fatal cardiovascularevents.10,11
Our results extend prior reports in several respects. We determinedabsolute cardiovascular-event rates (in addition to relativerisks) for subjects in the three nonhypertensive blood-pressurecategories. We calculated the incidence of major cardiovascularevents, not just fatal events. We have provided data on thecardiovascular risk associated with high-normal blood pressureseparately for middle-aged and elderly subjects and for menand women. Finally, blood-pressure category and risk factorsduring follow-up were used as time-dependent variables in themultivariable analyses.
Men and women with high-normal blood pressure at base-line examinationhad a higher incidence of cardiovascular disease on follow-upthan those with optimal blood pressure. These relations wereconsistent in both men and women and in both age groups, andthey persisted after adjustment for multiple cardiovascularrisk factors. The rate of cardiovascular events was low amongmen and women with optimal blood pressure, as has been emphasizedby other investigators.24 Furthermore, a continuous gradientof increasing risk across the three nonhypertensive blood-pressurecategories was observed. This finding was further confirmedby tests for trend. In analyses accounting for blood-pressurecategory during follow-up, the association of high-normal bloodpressure with an increased risk of cardiovascular events persistedin men but was attenuated in women.
A 20 percent overall absolute risk of all cardiovascular events(not just major events) at 10 years is considered high and definesthe current threshold for pharmacologic lowering of blood pressurein patients with hypertension, according to some internationalguidelines.9,25,26 In subjects 65 years of age or older in thepresent study, the 10-year absolute rates of major cardiovascularevents associated with high-normal blood pressure exceeded 20percent in men and approached that threshold in women.
If lowering of blood pressure could reduce the five-year absoluterisk of cardiovascular disease by 25 percent in elderly personswith high-normal blood pressure — an assumption basedon the efficacy of blood-pressure lowering in clinical trialsinvolving subjects with hypertension27 — we estimate thatonly 28 men or 41 women would have to have their blood pressurelowered for five years to prevent one major cardiovascular event.These numbers may vary according to the JNC VI risk category.28These estimates are speculative, because there is no evidencethat lowering blood pressure will reduce the risk of cardiovasculardisease in this blood-pressure category. A clinical trial wouldbe needed to determine whether pharmacologic treatment of high-normalblood pressure is beneficial. Our estimates of the number neededto treat could provide a framework for designing such a trial.
Although our results demonstrate that high-normal blood pressureis a marker of an elevated risk of cardiovascular disease, itis uncertain whether the increased risk is attributable solelyto subjects' blood-pressure levels. High-normal blood pressurehas been associated with increased thickness of the carotidintima and media, altered cardiac morphologic features, anddiastolic ventricular dysfunction,29,30,31 which may be precursorsof cardiovascular events. Furthermore, persons in our samplewith high-normal blood pressure frequently had other risk factorsfor cardiovascular disease, as has been reported previously.32The additive effect of more than one risk factor on the riskof cardiovascular disease has been well established.2,11
The prospective study design, the large, community-based sample,and the comprehensive longitudinal surveillance for cardiovascularevents are strengths of the present study. The use of blood-pressurevalues measured on a single occasion is a possible limitation,because it may result in underestimation of the strength ofthe relation between high-normal blood pressure and the incidenceof cardiovascular disease.4,33 Because our study spanned morethan four decades of observation, the absolute event rates reportedmay not be valid for a contemporary cohort. However, when westratified our analyses according to the date of the examinationand tested for an interaction between time period and bloodpressure, we found no interaction, probably because during theperiod of our study, subjects with high-normal blood pressurewere not treated with antihypertensive medication. The factthat our sample was predominantly white limits the generalizabilityof our findings. Moreover, we did not adjust for levels of physicalactivity and high-density lipoprotein cholesterol, because informationregarding these risk factors was not available at the base-lineexaminations.
The recent WHO-ISH report9 emphasized the "rationale for expectinghigh-risk subjects without hypertension to benefit from bloodpressure lowering and the need for clinical trials to investigatethis possibility." Our observational data underscore the needfor additional research to determine whether persons with high-normalblood pressure who are at high risk for cardiovascular disease,such as elderly persons or those with diabetes or multiple riskfactors, will benefit from blood-pressure lowering.
The Framingham Heart Study is supported by a contract (NO1-HC-38038)with the National Heart, Lung, and Blood Institute. Dr. Vasanis the recipient of a research career award (K24 HL 04334-01A1)from the National Heart, Lung, and Blood Institute.
Source Information
From the Framingham Heart Study, Framingham, Mass. (R.S.V., M.G.L., E.P.L., J.C.E., C.J.O., D.L.); the Cardiology Section (R.S.V.) and the Department of Preventive Medicine and Epidemiology (R.S.V., M.G.L., J.C.E., W.B.K., D.L.), Boston University School of Medicine, Boston; the Division of Cardiology, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.O.); the Divisions of Cardiology and Clinical Epidemiology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston (D.L.); and the National Heart, Lung, and Blood Institute, Bethesda, Md. (C.J.O., D.L.).
Address reprint requests to Dr. Vasan at the Framingham Heart Study, 5 Thurber St., Framingham, MA 01702, or at vasan{at}fram.nhlbi.nih.gov.
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