Document Detail


Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design.
MedLine Citation:
PMID:  21536995     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: It is widely supposed, but not well-demonstrated, that cumulative advances in standard care have reduced recurrent stroke and cardiovascular events in secondary prevention trials.
METHODS AND RESULTS: Systematic search identified all randomized, controlled trials of medical secondary stroke prevention therapies published from 1960 to 2009. Randomized, controlled trials narrowly focused on single stroke mechanisms, including atrial fibrillation, cervical carotid stenosis, and intracranial stenosis, were excluded. From control arms of individual trials, we extracted data for baseline characteristics and annual event rates for recurrent stroke, fatal stroke, and major vascular events and analyzed trends over time. Fifty-nine randomized controlled trials were identified, enrolling 66 157 patients in control arms. Over the 5 decade periods, annual event rates declined, per decade, for recurrent stroke by 0.996% (P=0.001), fatal stroke by 0.282% (P=0.003), and major vascular events by 1.331% (P=0.001). Multiple regression analyses identified increasing antithrombotic use and lower blood pressures as major contributors to the decline in recurrent stroke. For recurrent stroke, annual rates fell from 8.71% in trials launched in the 1960s to 6.10% in the 1970s, 5.41% in the 1980s, 4.04% in the 1990s, and 4.98% in the 2000s. The sample size required for a trial to have adequate power to detect a 20% reduction in recurrent stroke increased 2.2-fold during this period.
CONCLUSIONS: Recurrent stroke and vascular event rates have declined substantially over the last 5 decades, with improved blood pressure control and more frequent use of antiplatelet therapy as the leading causes. Considerably larger sample sizes are now needed to demonstrate incremental improvements in medical secondary prevention.
Authors:
Keun-Sik Hong; Sharon Yegiaian; Meng Lee; Juneyoung Lee; Jeffrey L Saver
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review     Date:  2011-05-02
Journal Detail:
Title:  Circulation     Volume:  123     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-05-17     Completed Date:  2011-07-19     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2111-9     Citation Subset:  AIM; IM    
Affiliation:
Department of Neurology, Clinical Research Center, Ilsan Paik Hospital, Inje University, Goyang, Korea.
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MeSH Terms
Descriptor/Qualifier:
Aged
Female
Humans
Incidence
Male
Middle Aged
Randomized Controlled Trials as Topic
Recurrence
Regression Analysis
Retrospective Studies
Risk Factors
Secondary Prevention / trends*
Stroke / epidemiology*,  prevention & control*
United States / epidemiology
Grant Support
ID/Acronym/Agency:
P50 NS044378/NS/NINDS NIH HHS; P50 NS044378-07/NS/NINDS NIH HHS; P50 NS044378-08/NS/NINDS NIH HHS
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