Should blood pressure ≥130/80 mm Hg be considered as a cardiovascular disease?

Arterial hypertension (AH) remains one of the most important modifiable cardiovascular risk factors. However, there is still no agreement regarding the cutoff values of blood pressure (BP) for diagnosis and starting of antihypertensive treatment or target BP during antihypertensive therapy. The world largest scientific societies for arterial hypertension—European, American, Canadian, British, and Australian—in the last 3 years published guidelines about detection, evaluation, and treatment of high BP.1-5 Table 1 shows clear difference in BP values for diagnosis, introduction of treatment and target values in the general hypertensive population. The majority of guidelines defined AH when office BP ≥140/90 mm Hg,1, 3-5 whereas only the American recommendations reduced this cutoff on 130/80 mm Hg.2 The implication of these changes in the American guidelines resulted in significant increase in prevalence of AH in United States and consequently of cardiovascular diseases (CVD) reported by American Heart Association earlier this year.6 According to this report, almost the half of the American population (46%) older than 20 years has AH and roughly the same percentage is estimated to have CVD (48%).6 The raising question is if this report shows the realistic situation and should we really consider BP ≥130/80 mm Hg as CVD, which in that case should be inevitably treated, as every other CVD. The Eighth Joint National Committee (JNC 8) guidelines released in the 2014 recommended to treat low-risk hypertensive individuals (ie, without diabetes and chronic kidney disease) aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive individuals younger than 60 years to a BP goal of less 140/90 mm Hg (regardless from diabetes and chronic kidney disease).7 What radically happened from 2014 to 2017 and why American guidelines changed so dramatically? We all know the answer—the SPRINT study.8 In this regard, it is interesting to report the beginning of comment concerning the impact of this study at the time of its publication by the Editor of the New England Journal of Medicine: “This trial will change practice.”9 The SPRINT trial showed the reduction of 27% in the primary composite endpoint for intensive treatment (systolic BP goal <120 mm Hg) compared with standard treatment (SBP <140 mm Hg).8 The impact of intensive treatment on the primary outcome was the same for participants ≥75 years and subjects <75 years. Reported serious adverse events were similar between the intensive treatment group and standard treatment group.8 However, this study has several important limitations that could significantly interfere with the final results that were adopted without hesitation in the American guidelines. First, the SPRINT study included 90% already treated patients and therefore this study did not adequately address the influence of strict AH control in untreated patients with systolic BP 130-139 mm Hg.8 Second, the reduction in mortality was influenced by the reduction in heart failure occurrence and not stroke or myocardial infarction. This is inconsistent with previous findings that demonstrated that better BP control was mainly related to stroke reduction.10, 11 However, the diagnose of heart failure by symptoms and usually only on dyspnea, which reduces or disappears under diuretic therapy (more often used in the intensive treated patients), could raise the question if heart failure was only masked by diuretic therapy in the intensive treated group. Furthermore, it is worth mentioning that the SPRINT study revealed obvious increase in the incidence of side effects, such as hypotension, syncope, and electrolyte abnormalities in the intensive treatment group.8 In the clinical practice, the side effects induce discontinuation of therapy or at least significant reduction in adherence to the prescribed antihypertensive therapy,12 which reflects in extensive loss of protective effects of antihypertensive medications.13 Finally, the BP measurement technique that was used in the SPRINT was different from technique used in other trials, that is, that measurements of BPs in SPRINT were performed fully automated and unobserved. This is critically important point, since systolic BP measured in this way is comparable to, or even lower than daytime ambulatory systolic BP and up to 20 mm Hg lower than conventional systolic BP in the office.14 This means that BPs taken in the SPRINT cannot be directly compared with BPs in other trials and cannot represent a reliable reference for the clinical practice where unattended measurements are not performed. Despite the limitations of the SPRINT study, the Authors of the American guidelines accepted the results of SPRINT and significantly decreased cutoff BP values for diagnosis and introduction of antihypertensive therapy.2 The results regarding CVD morbidity and mortality in studies that adopted the American guidelines showed that outcome was worse in patients with BP ≥130/80 mm Hg. The ATTICA study conducted in Greece showed that stage 1 AH (ie, systolic BP 130-139 mm Hg and diastolic BP 80-89 mm Hg), but not elevated BP (ie, systolic BP 120-129 mm Hg and diastolic BP 70-79 mm Hg), predicted 10-year fatal and non-fatal CVD events in healthy adults.15 The Singapore Chinese Health Study that included 30 636 participants revealed that neither elevated BP nor stage 1 AH was associated with increased risk of CVD mortality compared with normal BP in the whole cohort. Stage 1 AH was related with increased CVD risk only in those <65 years of age and without a history of CVD, but not in those ≥65 years of age or with a history of CVD.16 Similar results were obtained in the Chinese Multi-provincial Cohort Study; the Authors showed that stage 1 AH increased CVD risk in young and middle-aged Chinese adults, but not in those age ≥60 years.17 Bundy et al18 in the large meta-analysis that included 144,200 patients revealed that treated patients with systolic BP 120-124 mm Hg had lower CVD risk than hypertensive treated patients with systolic BP 130-134 mm Hg. On the other hand, meta-analysis that included 47 991 participants with high-normal and normal BP showed no significant benefits in individuals at low to moderate risk (21 128 individuals), whereas a significant reduction in stroke risk (60%) was found in individuals at high to very high risk (26 863 individuals).19 One should be careful in the interpretation of the mentioned studies because they retrospectively used newly proposed lower cutoff values for BP (<130/80 mm Hg). Furthermore, studies were not designed to investigate the effect of antihypertensive in patients with systolic BP 130-139 mm Hg and diastolic BP 80-89 mm Hg, but to evaluate the effect of these BP values on CVD occurrence in untreated individuals or the effect of these BP values during antihypertensive therapy. Meta-analyses from our research group showed that BP 120-139/80-89 mm Hg (prehypertension defined by the JNC 7 report) was associated with abnormal LV geometric patterns, as well as with increase in left ventricular mass index and left atrial diameter and worse left ventricular diastolic function.20, 21 The cardiac impairment was intermediate, between normotensive and hypertensive patients. Therefore, we do not question the negative influence of BP 130-139 mm Hg on cardiac remodeling, CVD morbidity, or mortality. However, we still do not support qualification of BP values between 130 and 139 mm Hg as CVD because there are no data which show that treatment of the individuals (previously untreated for AH) with low-to-moderate CVD risk would be beneficial. A recent study showed that adoption of the American guidelines would result in a near doubling in the prevalence of hypertension in Canada.22 These changes would largely affect individuals who are <65 years old and at low-to-moderate cardiovascular risk.22 The acceptance of new cutoff values would also significantly increased costs with still uncertain benefit. There is no doubt that strict control is of a great benefit in patients with moderate-to-severe CVD risk who have comorbidities such as diabetes, renal failure, heart failure, previous myocardial infarction or stroke, or peripheral arterial disease. Guidelines for the management of AH all over the world agree with this, but cutoff of 130/80 mm Hg for normal BP still remains largely debatable. The European and Canadian guidelines1, 3 were published after the American recommendation2 and SPRINT study,8 but their Authors still decided not to change the normal cutoff values due to the lack of evidence. The concurrent risk factors such as prediabetes, diabetes, overweight, obesity, smoking, and decreased physical activity should not be forgotten in patients with ≥130/80 mm Hg. The National Health and Nutrition Examination Surveys between 1999 and 2012 showed that the prevalence of prehypertension (defined as systolic BP 120-139 mm Hg and diastolic BP 80-89 mm Hg) decreased from 31.2% to 28.2%, whereas the prevalence of other risk factors significantly increased in the same period: prediabetes (9.6% to 21.6%), diabetes mellitus (6.0% to 8.5%), overweight (33.5% to 37.3%), obesity (30.6% to 35.2%) and reduced physical activity (40.0% to 43.9%).23 Proscribing antihypertensive therapy, we should not encourage our patients with aforementioned risk factors to ignore these risk factors. On the contrary, we should advise and support them in weight reduction, physical exercise, cigarette and alcohol cease, adequate diet with normal sodium intake, and stress management. With the early introduction of therapy, we are sending the wrong message to our patients that the only solution for their health problems is medications and not profound change in lifestyle which is mostly helping in management of other risk factors. Non-pharmacologic approach in BP > 130/80 mm Hg should be the only approach in patients with mild-to-moderate CVD risk and these BP values should be still concerned as risk factor and not as CVD. If BP >130/80 mm Hg is CVD than prediabetes and overweight should also be concerned as diseases and not as risk factors. In clinical practice reducing cutoff values for normal BP to 130/80 mm Hg will probably result in close monitoring of BP in individuals with borderline BP and better BP control in hypertensive patients. Clinicians will not try to reach 130/80 mm Hg, but they will give their best to maintain BP close to 140/90 mm Hg. In different previous guidelines, BP cutoff values for introduction of antihypertensive therapy were more flexible (140-160 mm Hg) and clinicians were satisfied with BP 150/90 mm Hg during antihypertensive treatment or they hesitated to start with antihypertensive treatment even when BP was continuously increased. The American guidelines encourage strict BP control and stimulate doctors to treat AH more seriously than before and this is significant advantage. There is no data that confirm the beneficial effect of antihypertensive treatment in the previously untreated patients with BP 130-139/80-89 mm Hg. The findings from the SPRINT study showed that strict BP control would result with significant increase in the prevalence of adverse effects, which would consequently reduce the compliance to antihypertensive therapy and cause more significant problems than BP 130-139/80-89 mm Hg. Further longitudinal investigations are necessary to validate newly proposed cutoff BP values. Until then, BP 130-139/80-89 mm Hg should be considered as a risk factor and not CVD. None.

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