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Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial

Open access
·2013·The Lancet

Abstract

BACKGROUND Lowering blood pressure (BP) prevents stroke, however optimal target levels of blood reduction to prevent stroke recurrence are lacking. We hypothesized that targeting systolic BP of <130 mmHg would reduce stroke recurrence in patients with recent lacunar stroke. METHODS The Secondary Prevention of Small Subcortical Strokes (SPS3) was a multi-center international trial, involving 3020 patients with recent symptomatic MRI-defined lacunar infarcts randomized to two target levels of systolic BP: a) higher group 130–149 mm Hg vs. b) lower group <130 mm Hg, and followed for a mean of 3.7 years. The primary outcome was all recurrent stroke (including ischemic strokes and intracranial hemorrhages). The study is registered, NCT 00059306. FINDINGS Mean participant age was 63 years; after 1 year mean systolic BP was 138 mm Hg (95% CI 137 to 139) in the higher group and 127 mm Hg (95% CI, 126 to 128) in the lower group. At last study visit, the difference in systolic BP between groups averaged 11 mm Hg (±SD 16). The annualized rate of recurrent stroke in the higher target group was 2.77% (n=152) compared with 2.25% (n=125) in the lower target group (HR 0.81, 95% CI 0.64, 1.03, p-value 0.08). Similar trends were observed for reductions in disabling/fatal stroke (HR 0.81, 95%CI 0.53, 1.23, p-value 0.32) and in the composite outcome of stroke, myocardial infarct or vascular death (HR 0.84, 95%CI 0.68,1.01, p-value 0.10). Intracerebral hemorrhage was reduced by 63% in those assigned to the lower target group (HR 0.37 95% CI, 0.14, 0.89, p-value 0.03). Serious complications of BP lowering were in frequent, and not significantly different in frequency between groups. INTERPRETATION In patients with recent lacunar stroke, targeting asystolic BP of< 130 mm Hg did not significantly reduce all stroke, but markedly reduced intracerebral hemorrhage. The lower target was safe and well tolerated.

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Show all 8 references

Research works printed but not linked: 17

  1. Gueyffier, 1997, Effect of antihypertensive treatment in patients having already suffered from stroke. Gathering the evidence. The INDANA (INdividual Data ANalysis of Antihypertensive intervention trials) Project Collaborators, Stroke, 28, 2557, 10.1161/01.STR.28.12.2557 · DOI
  2. Rashid, 2003, Blood pressure reduction and secondary prevention of stroke and other vascular events: a systematic review, Stroke, 34, 2741, 10.1161/01.STR.0000092488.40085.15 · DOI · Paper page
  3. Sacco, 2006, A population-based study of the incidence and prognosis of lacunar stroke, Neurology, 66, 1335, 10.1212/01.wnl.0000210457.89798.0e · DOI · Paper page
  4. Benavente, 2011, The secondary prevention of small subcortical strokes (SPS3) study, Int J Stroke, 6, 164, 10.1111/j.1747-4949.2010.00573.x · DOI
  5. White, 2012, Clinical features and racial/ethnic differences among the 3020 participants in the secondary prevention of small subcortical strokes (SPS3) trial, J Stroke Cerebrovasc Dis
  6. Hansson, 1992, Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective randomized open blinded end-point, Blood Press, 1, 113, 10.3109/08037059209077502 · DOI · Paper page
  7. Pérgola, 2007, Reliability and validity of blood pressure measurement in the secondary prevention of small subcortical strokes study, Blood Press Monit, 12, 1, 10.1097/MBP.0b013e3280858d5b · DOI
  8. McClure, 2012, Sample size re-estimation in an on-going NIH-sponsored clinical trial: the secondary prevention of small subcortical stroke trial experience, Contemp Clin Trials, 33, 1088, 10.1016/j.cct.2012.06.007 · DOI
  9. 1974, Effect of antihypertensive treatment on stroke recurrence, JAMA, 229, 409, 10.1001/jama.1974.03230420021019 · DOI · Paper page
  10. Chapman, 2004, Effects of a perindopril-based blood pressure-lowering regimen on the risk of recurrent stroke according to stroke subtype and medical history: the PROGRESS Trial, Stroke, 35, 116, 10.1161/01.STR.0000106480.76217.6F · DOI · Paper page
  11. Eriksson, 1995, Atenolol in secondary prevention after stroke, Cerebrovasc Dis, 5, 21, 10.1159/000107813 · DOI
  12. Schrader, 2005, Morbidity and mortality after stroke, eprosartan compared with nitrendipine for secondary prevention: principal results of a prospective randomized controlled study (MOSES), Stroke, 36, 1218, 10.1161/01.STR.0000166048.35740.a9 · DOI · Paper page
  13. 1995, Post-stroke antihypertensive treatment study. A preliminary result, Chin Med J (Engl), 108, 710
  14. Yusuf S, Healey JS, Pogue J, et al. Irbesartan in patients with atrial fibrillation. N Engl J Med 364: 928–38. · DOI
  15. Bousser, 2011, Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial, Lancet, 377, 2013, 10.1016/S0140-6736(11)60600-4 · DOI · Paper page
  16. Hong, 2011, Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design, Circulation, 123, 2111, 10.1161/CIRCULATIONAHA.109.934786 · DOI
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Metadata

Venue
The Lancet
Publisher
Elsevier BV
Published
2013-08
Volume
382
Issue
9891
Pages
507-515
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2127422554
Cited by
749
References
8
FWCI
42.16
Type
journal article
Language
en
Open access
bronze
Funders
US National Institutes of Health-National Institute of Neurological Disorders and Stroke (NIH-NINDS) (U01NS038529)

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Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. (2013). The Lancet. https://doi.org/10.1016/s0140-6736(13)60852-1

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