Table 14Detailed SOE for clopidogrel plus aspirin versus aspirin monotherapy in adults with PAD at 2 years

Population
Study Design
Number of Studies (Total Patients)
Risk of BiasConsistencyDirectnessPrecisionSOE and Magnitude of Effect Effect Estimate (95% CI)
All-cause mortality
Symptomatic-asymptomatic
RCT
1 (3096)
1 low riskNADirectPreciseHR 0.89 (0.68 to 1.16)
No difference
Moderate SOE
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNADirectImpreciseHR 1.44 (0.77 to 2.69)
Inconclusive
Insufficient SOE
IC-CLI
(post-PTA)
RCT
1 (80)
1 low riskNADirectImpreciseOR 0.33 (0.01 to 8.22)
Inconclusive
Insufficient SOE
Nonfatal MI
Symptomatic-asymptomatic
RCT
1 (3096)
1 low riskNADirectPreciseHR 0.63 (0.42 to 0.95)
Favors dual antiplatelet
Low SOE
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNADirectImpreciseHR 0.81 (0.32 to 2.06)
Inconclusive
Insufficient SOE
Nonfatal stroke
Symptomatic-asymptomatic
RCT
1 (3096)
1 low riskNADirectImpreciseHR 0.79 (0.51 to 1.22)
No difference
Low SOE
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNADirectImpreciseHR 1.02 (0.41 to 2.55)
No difference
Low SOE
Cardiovascular mortality
Symptomatic-asymptomatic
RCT
1(3096)
1 low riskNADirectImpreciseHR 0.92 (0.66 to 1.29)
No difference
Low SOE
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNADirectImpreciseHR 1.44 (0.77 to 2.69)
Inconclusive
Insufficient SOE
Composite cardiovascular events
Symptomatic-asymptomatic
RCT
1 (3096)
1 low riskNADirectPreciseHR 0.85 (0.66 to 1.09)
No difference
Moderate SOE
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNADirectImpreciseHR 1.09 (0.65 to 1.82)
No difference
Low SOE
IC-CLI
(post-PTA)
RCT
1 (80)
1 low riskNADirectImpreciseOR 0.71 (0.28 to 1.81)
Inconclusive
Insufficient SOE
Modifiers of effectiveness (subgroups)
IC-CLI
(postbypass)
RCT
1 (851)
1 low riskNANANAPatients with prosthetic graft had lower cardiovascular events on DAPT
Insufficient SOE
Safety concerns
All
RCT
4 (4079)
4 low riskNANANACASPAR study showed statistically significant higher rates of moderate and minor bleeding with DAPT; CHARISMA study showed statistically significant higher rate of minor bleeding with DAPT; Cassar study showed more bruising with DAPT but no significant difference in GI bleed or hematoma; MIRROR study showed no significant difference in bleeding
Insufficient SOE
Functional outcomes
Quality of life
Safety concerns (subgroups)
0NANANANAInsufficient SOE

Abbreviations: CI=confidence interval; CLI=critical limb ischemia; DAPT=dual antiplatelet therapy; GI=gastrointestinal; HR=hazard ratio; IC=intermittent claudication; MI=myocardial infarction; NA=not applicable; OR=odds ratio; RCT=randomized controlled trial; SOE=strength of evidence.

From: Results

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.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.