The Stroke Prevention Programme: a programme of research to inform optimal stroke prevention in primary care
Fletcher K., Mant J., McManus R., Hobbs R.
BackgroundThe management of cardiovascular (CV) risk factors in community populations is suboptimal. The aim of this programme was to explore the role of three approaches [use of a ‘polypill’; self-management of hypertension; and more intensive targets for blood pressure (BP) lowering after stroke] to improve prevention of CV disease (CVD) in the community.Research questions(1) Is it more cost-effective to titrate treatments to target levels of cholesterol and BP or to use fixed doses of statins and BP-lowering agents (polypill strategy)? (2) Will telemonitoring and self-management improve BP control in people on treatment for hypertension or with a history of stroke/transient ischaemic attack (TIA) in primary care and are they cost-effective? (3) In people with a history of stroke/TIA, can intensive BP-lowering targets be achieved in a primary care setting and what impact will this have on health outcomes and cost-effectiveness?DesignMixed methods, comprising three randomised controlled trials (RCTs); five cost-effectiveness analyses; qualitative studies; analysis of electronic general practice data; a screening study; a systematic review; and a questionnaire study.SettingUK general practices, predominantly from the West Midlands and the east of England.ParticipantsAdults registered with participating general practices. Inclusion criteria varied from study to study.InterventionsA polypill – a fixed-dose combination pill containing three antihypertensive medicines and simvastatin – compared with current practice and with optimal implementation of national guidelines; self-monitoring of BP with self-titration of medication, compared with usual care; and an intensive target for systolic BP of < 130 mmHg or a 10 mmHg reduction if baseline BP is < 140 mmHg, compared with a target of < 140 mmHg.ResultsFor patients known to be at high risk of CVD, treatment as per guidelines was the most cost-effective strategy. For people with unknown CV risk aged ≥ 50 years, offering a polypill is cost-effective [incremental cost-effectiveness ratio (ICER) of £8115 per quality-adjusted life-year (QALY)] compared with a strategy of screening and treating according to national guidelines. Both results were sensitive to the cost of the polypill. Self-management in people with uncontrolled hypertension led to a 5.4 mmHg [95% confidence interval (CI) 2.4 to 8.5 mmHg] reduction in systolic BP at 1 year, compared with usual care. It was cost-effective for men (ICER of £1624 per QALY) and women (ICER of £4923 per QALY). In people with stroke and other high-risk groups, self-management led to a 9.2 mmHg (95% CI 5.7 to 12.7 mmHg) reduction in systolic BP at 1 year compared with usual care and dominated (lower cost and better outcome) usual care. Aiming for the more intensive BP target after stroke led to a 2.9 mmHg (95% CI 0.2 to 5.7 mmHg) greater reduction in BP and dominated the 140 mmHg target.ConclusionsPotential for a polypill needs to be further explored in RCTs. Self-management should be offered to people with poorly controlled BP. Management of BP in the post-stroke population should focus on achieving a < 140 mmHg target.Trial registrationCurrent Controlled Trials ISRCTN17585681, ISRCTN87171227 and ISRCTN29062286.FundingThe National Institute for Health Research (NIHR) Programme Grants for Applied Research programme. Additional funding was provided by the NIHR National School for Primary Care Research, the NIHR Career Development Fellowship and the Department of Health Policy Research Programme.