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Primary Stroke Prevention

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11 Size of Treatment Effect CLASS IIb Benefit ≥ Risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED CLASS III No Benefit or CLASS III Harm ▪Recommendation's usefulness/ efficacy less well established ▪Greater conflicting evidence from multiple randomized trials or meta- analyses ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Sufficient evidence from multiple randomized trials of meta-analyses ▪Recommendation's usefulness/ efficacy less well established ▪Greater conflicting evidence from single randomized trial or nonrandomized studies ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Evidence from single randomized trial or nonrandomized studies ▪Recommendation's usefulness/ efficacy less well established ▪Only diverging expert opinion, case studies, or standard of care ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Only expert opinion, case studies, or standard of care may/might be considered may/might be reasonable usefulness/effectiveness is unknown/ unclear/uncertain or not well established COR III: No Benefit is not recommended is not indicated should not be performed/ administered/other is not useful/ beneficial/effective COR III: Harm potentially harmful causes harm associated with excess morbidity/mortality should not be performed/ administered/other a Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes mellitus, history of prior MI, history of HF, and prior aspirin use. b For comparative-effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. Procedure/ Test Treatment COR III: No benefit Not Helpful No Proven Benefit COR III: Harm Excess Cost w/o Benefit or Harmful Harmful to Patients

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