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Randomized Controlled Trial
. 2017 Jan 17;12(1):e0164608.
doi: 10.1371/journal.pone.0164608. eCollection 2017.

Intensive versus Guideline Blood Pressure and Lipid Lowering in Patients with Previous Stroke: Main Results from the Pilot 'Prevention of Decline in Cognition after Stroke Trial' (PODCAST) Randomised Controlled Trial

Philip M Bath  1 , Polly Scutt  1 , Daniel J Blackburn  2 , Sandeep Ankolekar  1   3 , Kailash Krishnan  1 , Clive Ballard  4 , Alistair Burns  5 , Jonathan Mant  6 , Peter Passmore  7 , Stuart Pocock  8 , John Reckless  9 , Nikola Sprigg  1 , Rob Stewart  10 , Joanna M Wardlaw  11 , Gary A Ford  12 ; PODCAST Trial Investigators
Affiliations
Randomized Controlled Trial

Intensive versus Guideline Blood Pressure and Lipid Lowering in Patients with Previous Stroke: Main Results from the Pilot 'Prevention of Decline in Cognition after Stroke Trial' (PODCAST) Randomised Controlled Trial

Philip M Bath et al. PLoS One. .

Abstract

Background: Stroke is associated with the development of cognitive impairment and dementia. We assessed the effect of intensive blood pressure (BP) and/or lipid lowering on cognitive outcomes in patients with recent stroke in a pilot trial.

Methods: In a multicentre, partial-factorial trial, patients with recent stroke, absence of dementia, and systolic BP (SBP) 125-170 mmHg were assigned randomly to at least 6 months of intensive (target SBP <125 mmHg) or guideline (target SBP <140 mmHg) BP lowering. The subset of patients with ischaemic stroke and total cholesterol 3.0-8.0 mmol/l were also assigned randomly to intensive (target LDL-cholesterol <1.3 mmol/l) or guideline (target LDL-c <3.0 mmol/l) lipid lowering. The primary outcome was the Addenbrooke's Cognitive Examination-Revised (ACE-R).

Results: We enrolled 83 patients, mean age 74.0 (6.8) years, and median 4.5 months after stroke. The median follow-up was 24 months (range 1-48). Mean BP was significantly reduced with intensive compared to guideline treatment (difference -10·6/-5·5 mmHg; p<0·01), as was total/LDL-cholesterol with intensive lipid lowering compared to guideline (difference -0·54/-0·44 mmol/l; p<0·01). The ACE-R score during treatment did not differ for either treatment comparison; mean difference for BP lowering -3.6 (95% CI -9.7 to 2.4), and lipid lowering 4.4 (95% CI -2.1 to 10.9). However, intensive lipid lowering therapy was significantly associated with improved scores for ACE-R at 6 months, trail making A, modified Rankin Scale and Euro-Qol Visual Analogue Scale. There was no difference in rates of dementia or serious adverse events for either comparison.

Conclusion: In patients with recent stroke and normal cognition, intensive BP and lipid lowering were feasible and safe, but did not alter cognition over two years. The association between intensive lipid lowering and improved scores for some secondary outcomes suggests further trials are warranted.

Trial registration: ISRCTN ISRCTN85562386.

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Conflict of interest statement

PMB CB AB JM PP SP JR RS JMW GAF were grant holders for the trial with funding from Alzheimer's Society and Stroke Association. Listing the grant holders does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. CONSORT flow diagram of patient randomisation, follow up, outcome, and withdrawals.
Screening for eligibility was not collected routinely. Data are number/Number (%).
Fig 2
Fig 2. Changes during follow-up in blood pressure and cholesterol by intensive vs guideline groups.
Data are mean and standard error of mean. (A) Systolic and diastolic blood pressure by intensive vs guideline blood pressure lowering groups. (B) Total cholesterol and LDL-cholesterol by intensive vs guideline lipid lowering groups.
Fig 3
Fig 3. Changes in Addenbrooke’s Cognitive Examination-Revised score during follow-up for intensive vs guideline groups.
Data are mean and standard error of mean. (A) Intensive vs guideline blood pressure lowering. (B) Intensive vs guideline lipid lowering.
See this image and copyright information in PMC

References

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