Table DResearch gaps

CriteriaEvidence GapReasonType of Studies To Consider
PatientsComparative effectiveness of therapies for PAD subpopulations of interest, including subgroups based on age, sex, race, risk factors, comorbidities and PAD classification (all KQs)Insufficient informationRCTs and potentially patient-level meta-analyses of existing/future RCTs
Low representation of women and minorities (all KQs)Insufficient informationRCTs and prospective registries with oversampling of female and minority populations
Interventions/comparatorsComparative effectiveness of new antiplatelet medications to aspirin or clopidogrel (KQ 1)Insufficient informationRCTs
Comparative effectiveness of DAPT to antiplatelet monotherapy (KQ 1)Imprecise and inconsistent informationRCTs
Comparative effectiveness of endovascular and surgical revascularization in CLI (KQ 3)Imprecise and inconsistent informationRCTs
OutcomesComparative effectiveness of available therapies on functional capacity, quality of life in IC patients (KQ 2)Imprecise and inconsistent informationRCTs or prospective cohort studies using standardized measures of patient-centered outcomes
Comparative effectiveness of available therapies on functional capacity, quality of life in CLI patients (KQ 3)Insufficient informationRCTs or prospective cohort studies using standardized measures of patient-centered outcomes
Comparative effectiveness of available therapies on mortality (all-cause or cardiovascular), nonfatal MI, nonfatal stroke, and composite vascular events in the IC and CLI populations (KQ 2 and KQ 3)Insufficient informationRCTs adequately powered to assess short- and long-term cardiovascular outcomes
Comparative effectiveness of available therapies in impacting healthcare utilitization (KQ 2 and KQ 3)Insufficient informationObservational studies
Comparative safety of available therapies, focusing on harms such as such as bleeding, infection, and adverse drug reactions (KQ 2 and KQ 3, especially the exercise, endovascular, and surgical therapies)Insufficient informationReporting from RCTs and observational studies
SettingsLimited settings need larger real world populations represented (all KQs)Insufficient informationLarge, real-world registries

Abbreviations: CLI=critical limb ischemia; IC=intermittent claudication; DAPT=dual antiplatelet therapy; KQ=Key Question; PAD=peripheral artery disease; RCTs=randomized controlled trials.

From: Executive Summary

Cover of Treatment Strategies for Patients With Peripheral Artery Disease
Treatment Strategies for Patients With Peripheral Artery Disease [Internet].
Comparative Effectiveness Reviews, No. 118.
Jones WS, Schmit KM, Vemulapalli S, et al.

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