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Neurology Clinical Trial Database

PAST-BP

Prevention After Stroke—Blood Pressure

Year of Publication: 2016

Authors: Mant J, McManus RJ, Roalfe A, ..., Hobbs FDR

Journal: BMJ

Citation: Mant J, McManus RJ, Roalfe A, et al. Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke—Blood Pressure) randomised controlled trial. BMJ. 2016;352:i708.

Link: https://doi.org/10.1136/bmj.i708

PDF: https://www.bmj.com/content/bmj/352/bmj.i708.full.pdf


Clinical Question

Does an intensive systolic blood pressure (SBP) target (<130 mm Hg) result in greater BP reduction than a standard target (<140 mm Hg) in patients with a history of stroke or TIA?

Bottom Line

Targeting SBP <130 vs <140 mmHg in post-stroke/TIA primary care patients produced only 2.9 mmHg additional reduction at 12 months (P=0.03). Both arms achieved large reductions (~13-16 mmHg). Only 51% achieved the individualised intensive target. Active management matters more than the specific target. 529 patients, 99 UK practices, open-label.

Major Points

  • Small but significant BP difference: intensive target reduced SBP by additional 2.9 mmHg (95% CI 0.2-5.7; P=0.03) at 12 months.
  • Both arms achieved large reductions: -16.1 mmHg (intensive) vs -12.8 mmHg (standard). >80% in both achieved SBP <140 mmHg.
  • Only 51% achieved the individualised intensive target (<130 mmHg or 10 mmHg reduction). Clinician/patient reluctance common near target.
  • Intensive target increased workload: more GP visits (median 2 vs 1; P<0.001), more nurse visits, more treatment intensifications (458 vs 278; P<0.001).
  • Higher withdrawal in intensive arm: 20% vs 12% (P=0.02) — despite no objective increase in side effects.
  • Only 6 cardiovascular events total (1 intensive, 5 standard) — grossly underpowered for clinical endpoints.
  • Pragmatic primary care trial: 529 patients, 99 UK practices. Prevalent population including 51-54% TIA-only.
  • Authors conclude a full pragmatic trial of intensive targets in primary care is not warranted.

Design

Study Type: Randomized, open-label, primary care-based controlled trial

Randomization: 1

Blinding: Open-label

Enrollment Period: 2009–2011

Follow-up Duration: 12 months

Centers: 99

Countries: United Kingdom

Sample Size: 529

Analysis: Mixed models adjusting for baseline BP, age group (<80, ≥80), sex, diabetes, atrial fibrillation, and general practice (random effect); principal analysis was complete case, with multiple imputation as sensitivity analysis


Inclusion Criteria

  • History of stroke or TIA (on general practice stroke/TIA register)
  • Systolic BP ≥125 mm Hg
  • Registered at participating UK general practices
  • Able to provide informed consent

Exclusion Criteria

  • Already taking ≥3 antihypertensive agents
  • Postural drop in SBP >20 mm Hg on standing
  • Already being treated to a 130 mm Hg SBP target
  • Unable to provide informed consent
  • Insufficient corroborative evidence of stroke or TIA

Baseline Characteristics

CharacteristicControlActive
Age (mean)71.771.9
Female (%)4141
Systolic BP (mean ± SD)142.2 ± 13.4142.9 ± 14.0
Diabetes (%)1010
Previous stroke (%)4649
Previous TIA (%)5451

Arms

FieldIntensive BP TargetControl
InterventionTarget SBP <130 mm Hg (or 10 mm Hg reduction if baseline <140 mm Hg)Target SBP <140 mm Hg
Duration12 months12 months

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Change in systolic blood pressure from baseline to 12 monthsPrimary−12.8 mm Hg−16.1 mm Hg0.03
SBP <140 mm Hg achieved at 12 monthsSecondary82% (161/197)82% (150/182)0.59
SBP <130 mm Hg achieved at 12 monthsSecondary54% (107/197)57% (103/182)0.36
Major cardiovascular events (composite)Secondary5 events1 eventHR 0.19 (95% CI 0.02–1.87)0.16
Emergency hospital admissionsSecondary7.8% per year12.8% per yearHR 1.56 (95% CI 0.84–2.93)0.16
Fall-related admissionsSecondary2 admissions2 admissions
Fall-related admissionsAdverse2 admissions2 admissions
Reported symptoms at 12 monthsAdverseNo significant differenceNo significant difference across 16 symptoms in Table 4All NS
Treatment changes due to side effectsAdverse30 changes77 changes<0.001

Subgroup Analysis

No significant interaction by baseline SBP (<140, ≥140), age group (<80, ≥80), diabetes, or atrial fibrillation


Criticisms

  • Open-label design introduces potential bias
  • Relatively short follow-up (12 months)
  • Underpowered for clinical outcomes such as recurrent stroke or cardiovascular events
  • 28% missing primary outcome data with differential loss to follow-up in intensive arm
  • Trial population younger and less disabled than typical prevalent cerebrovascular disease population; over-represented TIA-only patients

Funding

UK National Institute for Health Research (NIHR; Stroke Prevention in Primary Care, Programme Grant for Applied Research, RP-PG-0606-1153) and an NIHR Professorship (RJMcM).

Based on: PAST-BP (BMJ, 2016)

Authors: Mant J, McManus RJ, Roalfe A, ..., Hobbs FDR

Citation: Mant J, McManus RJ, Roalfe A, et al. Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke—Blood Pressure) randomised controlled trial. BMJ. 2016;352:i708.

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