Beneficial impact of intensified multifactorial intervention on risk of stroke: outcome of 21 years of follow-up in the randomised Steno-2 Study

Peter Gæde, Jens Oellgaard, Christina Kruuse, Peter Rossing, Hans-Henrik Parving, Oluf Pedersen, Peter Gæde, Jens Oellgaard, Christina Kruuse, Peter Rossing, Hans-Henrik Parving, Oluf Pedersen

Abstract

Aims/hypothesis: Epidemiological studies have shown that diabetes is a well-established independent but modifiable risk factor for stroke. The aim of this post hoc analysis of data from the Steno-2 Study was to examine whether multiple risk factor intervention reduced the risk for stroke in individuals with type 2 diabetes and microalbuminuria.

Methods: In the Steno-2 Study, 160 individuals with type 2 diabetes and microalbuminuria were randomised to intensified or conventional multiple risk factor intervention, targeting classical cardiovascular disease risk factors for a mean of 7.8 years, and then followed for a total mean of 21.2 years. The primary endpoint in this post hoc analysis was time to first stroke event.

Results: During follow-up, 30 participants experienced a total of 39 strokes. Individuals randomised to conventional therapy were more likely to experience a stroke than those in the intensive-therapy group, with 29 total strokes occurring in 21 participants (26%) in the conventional-therapy group vs a total of ten strokes in nine participants (11%) in the intensive-therapy group (HR 0.31 [95% CI 0.14, 0.69]; p = 0.004). Also, the number of recurrent strokes was significantly reduced with intensive therapy.

Conclusions/interpretation: Intensified multiple risk factor intervention in patients with type 2 diabetes and microalbuminuria reduces the risk for strokes as well as the number of recurrent cerebrovascular events.

Trial registration: ClinicalTrials.gov NCT00320008.

Keywords: Microalbuminuria; Multifactorial intervention; Stroke; Type 2 diabetes.

Figures

Fig. 1
Fig. 1
CONSORT diagram showing participant flow throughout the Steno-2 trial. The first 7.8 years were the active intervention period, after which time the randomisation was neutralised and continued as a post-trial observational follow-up study with all remaining participants being offered the same treatment as the original intensive-therapy group. At the time of randomisation, the mean age was 55.1 years and 66% were male. All participants had microalbuminuria. Reproduced from [8] under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium
Fig. 2
Fig. 2
Cumulative incidence frequency plot of time to first stroke. The hazard for stroke was reduced by 69% in the intensive-therapy group (p=0.004). Solid line, intensive-therapy group; dashed line, conventional-therapy group

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Source: PubMed

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