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Neurology Clinical Trial Database

PAST-BP

PAtient Self-management of blood pressure in Stroke and TIA

Year of Publication: 2016

Authors: Sheppard JP, Hodgkinson J, Riley R, et al.

Journal: Lancet

Citation: Sheppard JP, Hodgkinson J, Riley R, et al. PAST-BP: Intensive blood pressure targets in stroke and TIA. Lancet. 2015;385(9975):1649–1658.

Link: https://doi.org/10.1016/S0140-6736(14)62206-3


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 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 intensive target (<130 mmHg). 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: 2009–2012

Follow-up Duration: 12 months

Centers: 99

Countries: United Kingdom

Sample Size: 529

Analysis: Intention-to-treat; primary outcome was change in SBP from baseline to 12 months using repeated measures ANOVA


Inclusion Criteria

  • Age ≥18 years
  • Diagnosis of stroke or TIA
  • Systolic BP ≥125 mm Hg
  • Registered at participating general practices
  • Able to give informed consent

Exclusion Criteria

  • Severe cognitive impairment
  • Postural hypotension
  • Unwillingness to participate
  • Poor life expectancy

Arms

FieldIntensive BP TargetControl
InterventionTarget SBP <130 mm HgTarget 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
FallsSecondary20%20%NS
Serious adverse eventsSecondary14%15%NS
FallsAdverseEqual between groups (20%)
Serious adverse eventsAdverse14% in standard vs 15% in intensive

Subgroup Analysis

No interaction by age, sex, or baseline BP


Criticisms

  • Open-label design introduces potential bias
  • Relatively short follow-up (12 months)
  • Did not evaluate clinical outcomes such as recurrent stroke or cardiovascular events

Funding

UK National Institute for Health Research

Based on: PAST-BP (Lancet, 2016)

Authors: Sheppard JP, Hodgkinson J, Riley R, et al.

Citation: Sheppard JP, Hodgkinson J, Riley R, et al. PAST-BP: Intensive blood pressure targets in stroke and TIA. Lancet. 2015;385(9975):1649–1658.

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