PAST‐BP 2016.
Study characteristics | ||
Methods | Randomised, open‐label, controlled trial. Patients were randomly assigned to an intensive blood pressure target or a standard target. BP was measured by using an automated sphygmomanometer. BP was measured in a standardised way, with the patient seated for five minutes and then six measurements taken at one minute intervals. The reported number was the average of the second and third measurements. The average follow‐up was 1 year. | |
Participants | 529 patients were considered for inclusion if they were in the practice's TIA/stroke register. They were excluded if their baseline SBP was less than 125 mm Hg, they were already taking three or more antihypertensive agents, they had a greater than 20 mm Hg postural change in SBP on standing, they were already being treated to a 130 mm Hg SBP target. 379 participants were included in the analysis | |
Interventions | Systolic BP targets Intensive blood pressure target was defined as < 130 mm Hg or a 10 mm Hg reduction if baseline pressure was < 140 mm Hg, whereas standard target was < 130 mm Hg. |
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Outcomes | The primary outcome was change in SBP between baseline and one year. Clinical events were identified through review of the general practice records. They included fatal and non‐fatal stroke, myocardial infarction, fatal coronary heart disease, or other cardiovascular death, emergency hospital admissions, and deaths. | |
Notes | Funded by the National Institute for Health Research in England | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and investigators not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Clinical events were identified through review of the general practice records, but they were not evaluated by investigators |
Incomplete outcome data (attrition bias) All outcomes | High risk | 16% of patients withdrew from the trial (20% in the intensive target arm and 12% in the standard target arm). Despite that, all patients were followed‐up for clinical events and deaths |
Selective reporting (reporting bias) | High risk | Not all outcomes reported |
Other bias | High risk | A significantly greater number of patients (109 versus 57, P = 0.005) in the intensive target group did not have their BP treatment increased when the BP was above target, mainly due to symptoms attributed to BP drugs and patient not wanting treatment to be intensified |