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J Curve in Patients Randomly Assigned to Different Systolic Blood Pressure Targets: An Experimental Approach to an
Deborah N Kalkman1, Tom F Brouwer2, Jim T Vehmeijer2
1Heart Center, Department of Clinical and Experimental Cardiology (D.N.K., T.F.B., J.T.V., W.R.B., R.E.K., R.d.W., R.J.P.), and Department of Vascular Medicine (B.-J.H.v.d.B.), Academic Medical Center, University of Amsterdam, the Netherlands. Heart Center, Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (W.R.B.). d.n.kalkman@amc.uva.nl.
Insights
Low systolic blood pressure (SBP) is linked to higher cardiovascular risks, forming a J-curve. This study confirms this association is independent of the SBP target, emphasizing the need for clinical trials to assess intensive blood pressure-lowering treatments.
Area of Science:
- Cardiology
- Clinical Trials
- Hypertension Research
Background:
- Low systolic blood pressure (SBP) is associated with increased cardiovascular event risk, a phenomenon known as the J-curve.
- Understanding the relationship between on-treatment SBP levels and adverse outcomes is crucial for managing hypertensive patients.
Purpose of the Study:
- To assess the association between on-treatment systolic blood pressure (SBP) levels and cardiovascular events and all-cause mortality.
- To investigate if the J-curve phenomenon persists across different SBP treatment targets.
Main Methods:
- Pooled data from two large randomized trials involving hypertensive patients at high cardiovascular risk.
- Patients were randomized to intensive (SBP<120 mm Hg) or conventional (SBP<140 mm Hg) treatment.
- Hazard ratios for mortality and cardiovascular events were plotted against mean on-treatment SBP using natural cubic splines.
Main Results:
- The analysis included 13,946 patients with 194,875 SBP measurements.
- A J-curve association was observed for both cardiovascular events and all-cause mortality, with a nadir just below the SBP target.
- Patients in the lowest SBP stratum had higher rates of traditional cardiovascular risk factors and events.
Conclusions:
- Low on-treatment SBP levels are independently associated with increased cardiovascular events and all-cause mortality.
- The J-curve phenomenon aligns with the SBP target, suggesting the relationship is consistent across different treatment goals.
- Randomized clinical trials are essential for establishing the true benefit or risk of intensive blood pressure-lowering strategies.
Background:
Low systolic blood pressure (SBP) values are associated with an increased risk of cardiovascular events, giving rise to the so-called J-curve phenomenon. We assessed the association between on-treatment SBP levels, cardiovascular events, and all-cause mortality in patients randomized to different SBP targets.
Methods:
Data from 2 large randomized trials that randomly allocated hypertensive patients at high risk for cardiovascular disease to intensive (SBP<120 mm Hg) or conventional (SBP<140 mm Hg) treatment were pooled and harmonized for outcomes and follow-up duration. Using natural cubic splines, we plotted the hazard ratio for all-cause mortality and cardiovascular events against the mean on-treatment SBP per treatment group.
Results:
The pooled data consisted of 194 875 on-treatment SBP measurements in 13 946 patients (98.9%). During a median follow-up of 3.3 years, cardiovascular events occurred in 1014 patients (7.3%), and 502 patients died (3.7%). For both blood pressure targets, an identical shape of the J curve was present, with a nadir for cardiovascular events and all-cause mortality just below the SBP target. Patients in the lowest SBP stratum were older, had a higher body mass index, smoked more often, and had a higher frequency of diabetes mellitus and cardiovascular events.
Conclusions:
Low on-treatment SBP levels are associated with increased cardiovascular events and all-cause mortality. This association is independent of the attained blood pressure level because the J curve aligns with the SBP target. Our results suggest that the benefit or risk associated with intensive blood pressure-lowering treatment can be established only via randomized clinical trials.
Clinical Trial Registration:
URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01206062 and NCT00000620.
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