Table CSummary SOE for KQ 3: Comparative effectiveness and safety of treatments for CLIa

ComparisonOutcome
SOE
Results or Effect Estimate (95% Confidence Interval)
Endovascular intervention vs. usual care in CLI and IC-CLI populationsAll-cause mortality

SOE=Insufficient
CLI-Obs (3 studies, 562 patients)
Inconclusive evidence due to imprecision.

IC-CLI-Obs (1 study, 107 patients)
Inconclusive evidence due to imprecision, with 1 study reporting similar mortality rates.
Amputation
SOE=Insufficient
CLI-Obs (3 studies, 562 patients)
Inconclusive evidence due to heterogeneity in reporting amputation rates across studies.

IC-CLI-Obs (1 study, 107 patients)
Inconclusive evidence due to imprecision, with 1 study reporting a nonsignificant difference.
Amputation-free survival

SOE=Insufficient
CLI-Obs (1 study, 70 patients)
Inconclusive evidence due to imprecision, with 1 study reporting AFS rates (endovascular group 60%, usual care 47%).
Length of stay

SOE=Insufficient
CLI-Obs (3 studies, 562 patients)
Inconclusive evidence due to inconsistent and imprecise results across studies.
Nonfatal stroke
Nonfatal MI
Composite cardiovascular events
MWD or absolute claudication distance
Initial claudication distance or pain-free walking distance
Quality of life
Primary patency
Secondary patency
Wound healing
Analog pain scale
Modifiers of effectiveness (subgroups)
Safety concerns
Safety concerns (subgroups)

SOE=Insufficient
All PAD populations and study design (0 studies)
Endovascular vs. surgical revascularization in CLI and IC-CLI populationsAll-cause mortality less than or equal to 6 months

SOE=Low
CLI-Obs (11 studies, 8,249 patients), OR 0.85 (0.57 to 1.27)
CLI-RCT (1 study, 452 patients), OR 0.51 (0.20 to 1.35)
Favors endovascular.

IC-CLI-Obs (2 studies, 823 patients), OR 0.45 (0.18 to 1.09)
Favors endovascular.
All-cause mortality at 1 to 2 years

SOE=Low
CLI-Obs (12 studies, 7,850 patients), OR 1.01 (0.80 to 1.28)
No difference.

IC-CLI-Obs (2 studies, 145 patients), OR 0.51 (0.20 to 1.31)

IC-CLI-RCT (2 studies, 130 patients), OR 0.81 (0.23 to 2.82)
Favors endovascular.
All-cause mortality at 3 or more years

SOE=Low (CLI)

SOE=Insufficient (IC-CLI)
CLI-Obs (7 studies, 7,176 patients), OR 1.05 (0.54 to 2.06)
CLI-RCT (1 study, 452 patients), OR 1.07 (0.73 to 1.56)
No difference.

IC-CLI-RCT (1 study, 58 patients) OR 0.88 (0.28 to 2.73)
Inconclusive evidence due to imprecision.
Nonfatal MI

SOE=Insufficient
CLI-RCT (1 study, 452 patients)
Inconclusive evidence due to imprecision, with 1 study reporting MI rates (endovascular group 3% and surgical group 8%).
Amputation at <2 years

SOE=Low (CLI)

SOE=Insufficient (IC-CLI)
CLI-Obs (11 studies, 4,490 patients), OR 0.73 (0.48 to 1.09)
CLI-RCT (1 study, 452 patients), OR 1.23 (0.72 to 2.11)
No difference.

IC-CLI-Obs (2 studies, 823 patients), OR 1.11 (0.40 to 3.05)
IC-CLI-RCT (2 studies, 130 patients), OR 0.22 (0.05 to 1.07)
Inconclusive evidence due to imprecision.
Amputation at 2 to 3 years

SOE=Low (CLI)

SOE=Insufficient (IC-CLI)
CLI-Obs (4 studies, 3,187 patients), OR 1.08 (0.62 to 1.89)
CLI-RCT (1 study, 452 patients), OR 1.02 (0.64 to 1.63)
No difference.

IC-CLI-Obs (1 study, 169 patients), OR 1.00 (0.18 to 5.54)
IC-CLI-RCT (1 study, 86 patients), OR 0.18 (0.02 to 1.29)
Inconclusive evidence due to imprecision.
Amputation after 5 years

SOE=Low
CLI-Obs (7 studies, 3,101 patients), OR 1.06 (0.70 to 1.59)
No difference.
Amputation-free survival at 1 year

SOE=Low
CLI-Obs (2 studies, 1,881 patients), OR 0.76 (0.48 to 1.21)
CLI-RCT (1 study, 452 patients), OR 0.87 (0.58 to 1.30)
No difference.
Amputation-free survival at 2 to 3 years

SOE=Low
CLI-Obs (3 studies, 1,972 patients), OR 0.75 (0.53 to 1.09)
CLI-RCT (1 study, 452 patients), OR 1.22 (0.84 to 1.77)
No difference.
Amputation-free survival after 5 years

SOE=Low
CLI-Obs (4 studies, 2,190 patients), OR 0.89 (0.59 to 1.34)
No difference.
Wound healing

SOE=Insufficient
CLI-Obs (1 study, 91 patients)
Inconclusive evidence due to imprecision, with 1 study reporting similar rates of wound healing in the surgical revascularization group (83%) and endovascular revascularization group (80%).
Primary patency at 1 year

SOE=Moderate (CLI)
SOE=Low (IC-CLI)
CLI-Obs (5 studies, 890 patients), OR 0.63 (0.46 to 0.86)
No difference.

IC-CLI-Obs (3 studies, 328 patients), OR 0.71 (0.40 to 1.28)
IC-CLI-RCT (2 studies, 130 patients), OR 0.40 (0.08 to 1.93)
Favors endovascular intervention.
Primary patency at 2 to 3 years

SOE=Insufficient
CLI-Obs (4 studies, 768 patients), OR 0.77 (0.24 to 2.42)
Inconclusive evidence due to imprecision.

IC-CLI-Obs (2 studies, 231 patients), OR 0.29 (0.15 to 0.55)
IC-CLI-RCT (1 study, 86 patients), OR 0.96 (0.42 to 2.16)
Inconclusive evidence due to imprecision.
Secondary patency at 1 year

SOE=Low (CLI)
SOE=Insufficient (IC-CLI)
CLI-Obs (4 studies, 759 patients), OR 0.57 to (0.40 to 0.82)
Favors endovascular intervention.

IC-CLI-RCT (1 study, 44 patients), OR 0.04 (0.00 to 0.73)
Inconclusive evidence due to imprecision.
Secondary patency at 2 to 3 years

SOE=Low
CLI-Obs (4 studies, 815 patients), OR 0.49 (0.28 to 0.85)
Favors endovascular intervention.
Length of stay

SOE=Insufficient
CLI-Obs (8 studies, 1,745 patients)
CLI-RCT (1 study, 452 patients)
Inconclusive evidence due to inconsistency and imprecision, with individual studies reporting LOS longer in surgical group with large SD in 3 observational studies and no variability reported in 4 observational studies and one RCT.

IC-CLI-Obs (3 studies, 563,935 patients)
IC-CLI-RCT (2 studies, 130 patients)
Inconclusive evidence due to imprecision, with individual studies reporting LOS longer in surgical group with large SD in the observational studies and RCTs.
Modifiers of effectiveness (subgroups)

SOE=Insufficient
All PAD populations and study design (14 studies, 572,188 patients)
Inconclusive evidence due to heterogeneity in subgroups assessed across individual studies and inability to quantitatively synthesize results. One RCT showed higher survival in autologous vein graft compared with prosthetic graft. An observational study showed worse survival in advanced age, renal failure, and with higher PAD severity.
Safety concerns: periprocedural complications

SOE=Insufficient
IC-CLI-Obs (4 studies, 968 patients), OR 1.87 (0.63 to 5.49)
IC-CLI-RCT (2 studies, 130 patients), OR 0.57 (0.14 to 2.26)
Inconclusive evidence due to inconsistency and imprecision with observational studies favoring endovascular while the RCTs favor surgical revascularization.
Safety concerns: infection

SOE=Low
IC-CLI-Obs (2 studies, 823 patients), OR 14.10 (0.43 to 460.70)
IC-CLI-RCT (1 study, 44 patients), OR 12.09 (0.61 to 239.54)
Favors endovascular intervention.
Nonfatal stroke
Composite cardiovascular events
MWD or absolute claudication distance
Initial claudication distance or pain-free walking distance
Quality of life
Analog pain scale
Safety concerns (subgroups)

SOE=Insufficient
All PAD populations and study design (0 studies)
a

Grey background indicates insufficient SOE.

Abbreviations: CLI=critical limb ischemia; IC=intermittent claudication; Obs=observational; OR=odds ratio; PAD=peripheral artery disease; RCT=randomized controlled trial; SD=standard deviation; SOE=strength of evidence.

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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