AHA/ASA Guideline Guidelines for the Prevention of Stroke in ...

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Furie et al Prevention of Stroke in Patients With Stroke and TIA 229Table 1.Applying Classification of Recommendations and Level of Evidence*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of priormyocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak.Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there maybe a very clear clinical consensus that a particular test or therapy is useful or effective.†For recommendations (Class I and IIa; Level of Evidence A and B only) regarding the comparative effectiveness of one treatment with respect to another, thesewords or phrases may be accompanied by the additional terms “in preference to” or “to choose” to indicate the favored intervention. For example, “Treatment A isrecommended in preference to Treatment B for …” or “It is reasonable to choose Treatment A over Treatment B for ….” Studies that support the use of comparatorverbs should involve direct comparisons of the treatments or strategies being evaluated.dations for BP screening and treatment of persons withhypertension are summarized in the American Stroke Association(ASA) Guidelines on the Primary Prevention ofIschemic Stroke 13 and are detailed in the Seventh Report ofthe Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure (JNC 7). 14JNC 7 stresses the importance of lifestyle modifications in themanagement of hypertension. Lifestyle interventions associatedwith reduction of BP include weight loss (including saltrestriction); the consumption of a diet rich in fruits, vegetables,and low-fat dairy products; regular aerobic physicalactivity; and limited alcohol consumption. 14Although numerous randomized trials and meta-analysessupport the importance of treatment of hypertension for preventionof primary cardiovascular disease in general and stroke inparticular, few trials directly address the role of BP treatment insecondary prevention among persons with stroke or TIA. 10,15There is a general lack of definitive data to help guide theimmediate management of elevated BP in the setting of acuteischemic stroke; a cautious approach has been recommended,and the optimal time to initiate therapy remains uncertain. 16A meta-analysis of randomized trials showed that antihypertensivemedications reduced the risk of recurrent strokeafter stroke or TIA. 15 The meta-analysis included 7 randomizedtrials performed through 2002: the Dutch TIA trial(atenolol, a -blocker), 17 Poststroke Antihypertensive TreatmentStudy (PATS; indapamide, a diuretic), 18 Heart OutcomesPrevention Evaluation (HOPE; ramipril, an angiotensin-convertingenzyme inhibitor [ACEI]), 19 and PerindoprilProtection Against Recurrent Stroke Study (PROGRESS;perindopril, an ACEI, with or without indapamide), 20 as well as3 other smaller trials. 21–23 Together these trials included 15 527Downloaded from stroke.ahajournals.org by on March 8, 2011
230 Stroke January 2011Table 2.Definition of Classes and Levels of Evidence Used in AHA RecommendationsClass IClass IIClass IIaClass IIbClass IIITherapeutic recommendationsLevel of Evidence ALevel of Evidence BLevel of Evidence CDiagnostic recommendationsLevel of Evidence ALevel of Evidence BLevel of Evidence CConditions for which there is evidence for and/or general agreement that the procedure or treatment is useful and effectiveConditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of aprocedure or treatmentThe weight of evidence or opinion is in favor of the procedure or treatmentUsefulness/efficacy is less well established by evidence or opinionConditions for which there is evidence and/or general agreement that the procedure or treatment is not useful/effective andin some cases may be harmfulData derived from multiple randomized clinical trials or meta-analysesData derived from a single randomized trial or nonrandomized studiesConsensus opinion of experts, case studies, or standard of careData derived from multiple prospective cohort studies using a reference standard applied by a masked evaluatorData derived from a single grade A study, or one or more case-control studies, or studies using a reference standardapplied by an unmasked evaluatorConsensus opinion of expertsparticipants with transient ischemic stroke, TIA, or intracerebralhemorrhage (ICH) randomized from 3 weeks to 14 months afterthe index event and followed up for 2 to 5 years. No trials testedthe effects of nonpharmacological interventions.Overall, treatment with antihypertensive drugs was associatedwith significant reductions in recurrent strokes (relativerisk [RR], 0.76; 95% confidence interval [CI], 0.63 to 0.92),MI (RR, 0.79; 95% CI, 0.63 to 0.98), and all vascular events(RR, 0.79; 95% CI, 0.66 to 0.95). 15 The impact of BPreduction was similar in the restricted group of subjects withhypertension and when all subjects, including those with andwithout hypertension, were analyzed. Larger reductions insystolic BP were associated with greater reduction in risk ofrecurrent stroke. The small number of trials limited comparisonsbetween antihypertensive medications. Significant reductionsin recurrent stroke were seen with diuretics aloneand in combination with ACEIs but not with -blockers orACEIs used alone; nonetheless, statistical power was limited,particularly for the assessment of -blockers, and calciumchannel blockers and angiotensin receptor blockers were notevaluated in any of the included trials.Since this meta-analysis, 2 additional large-scale randomizedtrials of antihypertensive medications after stroke havebeen published: Morbidity and Mortality After Stroke, EprosartanCompared with Nitrendipine for Secondary Prevention(MOSES), 24 and Prevention Regimen for Effectively AvoidingSecond Strokes (PRoFESS). 25 In MOSES, 1405 subjectswith hypertension and a stroke or TIA within the prior 2 yearswere randomized to eprosartan (an angiotensin receptorblocker) or nitrendipine (a calcium channel blocker). 24 BPreductions were similar with the 2 agents. Total strokes andTIAs (counting recurrent events) were less frequent amongthose randomized to eprosartan (incidence density ratio, 0.75;95% CI, 0.58 to 0.97), and there was a reduction in the riskof primary composite events (death, cardiovascular event, orcerebrovascular event; incidence density ratio, 0.79; 95% CI,0.66 to 0.96). A reduction in TIAs accounted for most of thebenefit in cerebrovascular events, with no significant differencein ischemic strokes, and a more traditional analysis oftime to first cerebrovascular event did not show a benefit ofeprosartan. In PRoFESS, 20 332 subjects with ischemicstroke were randomly assigned to telmisartan or placebowithin 90 days of an ischemic stroke. 25 Telmisartan was notassociated with a reduction in recurrent stroke (hazard ratio[HR], 0.95; 95% CI, 0.86 to 1.04) or major cardiovascularevents (HR, 0.94; 95% CI, 0.87 to 1.01) during mean 2.5-yearfollow-up. The BP-lowering arm in PRoFESS was statisticallyunderpowered. Nonadherence to telmisartan and moreaggressive treatment with other antihypertensive medicationsin the placebo group reduced the difference in BP between thetreatment groups (systolic BP differed by 5.4 mm Hg at 1month and 4.0 mm Hg at 1 year) and may have reduced theimpact of treatment on stroke recurrence. Taken together, aparticular role for angiotensin receptor blockers after strokehas not been confirmed.Recommendations1. BP reduction is recommended for both prevention ofrecurrent stroke and prevention of other vascularevents in persons who have had an ischemic stroke orTIA and are beyond the first 24 hours (Class I; Level ofEvidence A).2. Because this benefit extends to persons with and withouta documented history of hypertension, this recommendationis reasonable for all patients with ischemicstroke or TIA who are considered appropriate for BPreduction (Class IIa; Level of Evidence B).3. An absolute target BP level and reduction are uncertainand should be individualized, but benefit hasbeen associated with an average reduction of approximately10/5 mm Hg, and normal BP levels havebeen defined as
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