Table 21Detailed SOE for IC therapies by comparator

ComparatorNumber of Studies/Design
(Total Patients)
Risk of BiasConsistencyDirectnessPrecisionSOE and Magnitude of Effect Effect
Estimate (95% CI)
All-cause mortality
Medical therapy vs. usual care4 RCT
(2732)
3 low risk, 1 moderate riskInconsistentDirectImpreciseOR 0.91 (0.62 to 1.35)
No difference
Low SOE
Exercise vs. usual care2 RCT
(238)
1 low risk, 1 moderate riskInconsistentDirectImpreciseOR 0.84 (0.34 to 2.07)
No difference
Low SOE
Endovascular vs. usual care2 RCT, 3 observational
(977)
1 low risk, 4 moderate riskInconsistentDirectImpreciseOR 0.91 (0.34 to 2.45)
No difference
Low SOE
Surgical vs. usual care1 observational
(427)
1 high riskNADirectNot reported10.4% in surgical group, 16.7% in usual care group
Insufficient SOE
Endovascular vs. exercise5 RCT
(710)
1 low risk, 4 moderate riskInconsistentDirectImpreciseOR 0.77 (0.39 to 1.54)
No difference
Low SOE
Endovascular vs. surgical2 observational
(305)
2 moderate riskInconsistentDirectNot reportedResults not reported by treatment group; overall mortality rate ranged from 3 to 8%
Insufficient SOE
Nonfatal MI
Medical therapy vs. usual care2 RCT
(497)
2 low riskInconsistentDirectImpreciseLow event rates in both groups
Inconclusive
Insufficient SOE
Exercise vs. usual care1 RCT
(63)
1 low riskNADirectNot reportedOnly one MI total (in exercise group)
Insufficient SOE
Endovascular vs. usual care1 observational
(479)
Moderate riskNADirectNot reported3.0% in endovascular group, 8.8% in usual care group
Insufficient SOE
Surgical vs. usual care0NANANANAInsufficient SOE
Endovascular vs. exercise1 RCT
(106)
Moderate riskNADirectNANo events occurred in either treatment group
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
Nonfatal stroke
Medical therapy vs. usual care3 RCT
(1932)
3 low riskInconsistentDirectImpreciseLow event rates in both groups
Inconclusive
Insufficient SOE
Exercise vs. usual care1 RCT
(63)
1 low riskNADirectNot reported1 stroke in each group
Insufficient SOE
Endovascular vs. usual care2 observational
(800)
2 moderate riskNADirectNot reportedOne study reported 4 strokes for total study; other study reported 1 stroke in endovascular group, 2 strokes in usual care group
Insufficient SOE
Surgical vs. usual care0NANANANAInsufficient SOE
Endovascular vs. exercise1 RCT
(106)
1 moderate riskNADirectNot reported1 stroke in each group
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
MWD or ACD
Medical therapy vs. usual care6 RCT (cilostazol)
(1632)

3 RCT (pentoxifylline)
(797)
3 low risk, 3 moderate risk

2 moderate risk, 1 high risk
Cilostazol
Consistent

Pentoxifylline
Inconsistent
Cilostazol
Direct

Pentoxifylline
Direct
Cilostazol
Imprecise

Pentoxifylline
Imprecise
ES cilostazol:
0.62 (-0.21 to 1.45) full model
0.61 (-0.20 to 1.42) sensitivity analysis
No difference
Low SOE

ES pentoxifylline: 1.70 (0.36 to 3.04)
Inconclusive
Insufficient SOE
Exercise vs. usual care9 RCT, 2 observational
(624)
4 low risk, 4 moderate risk, 3 high riskConsistentDirectImpreciseES: 0.89 (0.06 to 1.71) full model
0.98 (0.23 to 1.74) sensitivity analysis
Favors exercise
Moderate SOE
Endovascular vs. usual care4 RCT
(285)
2 low risk, 2 moderate riskConsistentDirectImpreciseES: 0.41 (-0.54 to 1.36) full model
0.51 (-0.35 to 1.37) sensitivity analysis
No difference
Low SOE
Endovascular vs. exercise8 RCT
(695)
3 low risk, 5 moderate riskConsistentDirectImpreciseES: -0.47 (-1.41 to 0.46) full model
-0.47 (-1.31 to 0.36) sensitivity analysis
No difference
Moderate SOE
Endovascular + exercise vs. usual care2 RCT
(248)
2 low riskConsistentDirectImpreciseES: 1.08 (-0.37 to 2.53) full model
1.20 (-0.11 to 2.50) sensitivity analysis
Favors endovascular intervention + exercise training
Low SOE
Surgical vs. exercise + medical therapy (pentoxifylline)1 observational
(127)
1 moderate riskNADirectImpreciseMWT improved to >15 min in surgical group and >11 min in exercise + medical therapy group
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
Initial claudication distance or pain-free walking distance
Medical therapy (cilostazol) vs. usual care5 RCT
(1255)
3 low risk, 2 moderate riskInconsistentDirectImpreciseES: 0.63 (-0.03 to 1.29)
No difference
Low SOE
Exercise vs. usual care9 RCT, 1 observational
(396)
4 low risk, 4 moderate risk, 2 high riskInconsistentDirectImpreciseES: 0.69 (0.22 to 1.15)
Favors exercise
Low SOE
Endovascular vs. usual care4 RCT, 1 observational
(281)
2 low risk, 2 moderate risk, 1 high riskInconsistentDirectImpreciseES: 0.79 (0.29 to 1.29)
Favors endovascular intervention
Low SOE
Endovascular vs. exercise5 RCT
(448)
2 low risk, 3 moderate riskInconsistentDirectImpreciseES: 0.10 (-0.38 to 0.58)
No difference
Low SOE
Surgical vs. exercise + medical therapy (pentoxifylline)1 observational
(127)
1 moderate riskNADirectImpreciseCOT improved to >10 min in surgical group and >7 min in exercise + medical therapy group
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
Quality of life
Medical theray (cilostazol) vs. usual care2 RCT
(631)
1 low risk, 1 moderate riskConsistentDirectImpreciseES: 0.44 (0.05 to 0.83)
Favors cilostazol
Low SOE
Exercise vs. usual care4 RCT, 1 observational
(275)
2 low risk, 1 moderate risk, 2 high riskConsistentDirectImpreciseES: 0.56 (0.26 to 0.87)
Favors exercise
Low SOE
Endovascular vs. usual care2 RCT, 2 observational
(576)
2 low risk, 2 moderate riskConsistentDirectImpreciseES: 0.61 (0.30 to 0.93)
Favors endovascular intervention
Low SOE
Surgical vs. usual care2 observational (727)2 moderate riskConsistentDirectImpreciseES: 0.82 (0.26 to 1.39)
Favors surgery
Low SOE
Endovascular vs. exercise4 RCT
(444)
2 low risk, 2 moderate riskConsistentDirectImpreciseES: 0.05 (-0.24 to 0.34)
No difference
Low SOE
Endovascular vs. surgical2 observational
(242)
2 moderate riskConsistentDirectImpreciseES: 0.21 (-0.34 to 0.76)
No difference
Low SOE
Amputation
Medical therapy vs. usual care2 RCT
(497)
2 low riskInconsistentIndirectImpreciseOnly 1 patient underwent amputation
Insufficient SOE
Exercise vs. usual care1 RCT
(31)
1 moderate riskNAIndirectNot reportedOnly 1 patient underwent amputation

Insufficient SOE
Endovascular vs. usual care1 RCT, 1 observational
(473)
2 moderate riskConsistentIndirectImpreciseAmputation was similar in endovascular and usual care groups
Insufficient SOE
Surgical vs. usual care0NANANANAInsufficient SOE
Endovascular vs. exercise1 RCT
(149)
1 moderate riskNAIndirectNot reportedOne amputation in endovascular group, none in exercise group
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
Primary patency
Secondary patency
Medical therapy vs. usual care0NANANANAInsufficient SOE
Exercise vs. invasive vs. usual care (3-arm study)1 RCT
(225)
1 moderate riskNAIndirectNot reportedVessel patency was only reported in patients undergoing revascularization (endovascular group 59%, surgical group 98%)
Insufficient SOE
Surgical vs. usual care1 observational
(427)
1 high riskNAIndirectNot reportedVessel patency was only reported in patients undergoing revascularization (aortofemoral bypass 95.5%, axillofemoral bypass 83.3%, femorofemoral bypass 95.5%, femoropopliteal bypass (AK) 67.6%, femorofemoral bypass (BK) 45.2%
Insufficient SOE
Endovascular vs. surgical0NANANANAInsufficient SOE
Modifiers of effectiveness (subgroups)
Medical therapy vs. usual care2 RCT
(155)
2 low riskNA (reported different outcomes)DirectNot reportedInconclusive evidence due to individual studies reporting different endpoints
Insufficient SOE
Endovascular vs. usual care1 observational
(526)
1 moderate riskNAIndirectImpreciseQOL scores were better if ABI improvement was >0.1 after successful revascularization
Insufficient SOE
Surgical vs. usual care1 observational
(427)
1 high riskNAIndirectNot reportedPatency rates lower for infrainguinal bypass and synthetic graft vs. suprainguinal and autologous vein graft
Insufficient SOE
Endovascular vs. exercise1 RCT
(56)
1 moderate riskNAIndirectNot reportedNonsignificant MWD improvement in patients with SFA disease treated with PTA
Insufficient SOE
Endovascular vs. surgical1 RCT
(264)
1 moderate riskNAIndirectImprecisePatency rates similar for suprainguinal and infrainguinal reconstruction
Insufficient SOE
Safety concerns
Medical therapy vs. usual care10 RCT
(3485)
5 low risk, 4 moderate risk, 1 high riskConsistentDirectPrecise for headache; imprecise for diarrhea and palpitationsHigher side effects on cilostazol
Headache: OR 3.00 (2.29 to 3.95)
High SOE
Diarrhea: OR 2.51 (1.58 to 3.97)
Moderate SOE
Palpitations: OR 18.11 (5.95 to 55.13)
Moderate SOE
Exercise vs. usual care3 RCT
(107)
2 low risk, 1 moderate riskConsistentIndirectNAAll studies reported no adverse events in exercise or usual care groups
Insufficient SOE
Endovascular vs. usual care2 RCT
(155)
2 low riskInconsistentDirectImpreciseOne study reported no events; other study had low rates of transfusion, dissection, and perforation in the endovascular group
Insufficient SOE
Endovascular vs. exercise5 RCT
(282)
1 low risk, 2 moderate riskInconsistentIndirectImpreciseEndovascular interventions were associated with higher rates of transfusion, dissection/perforation, and hematomas
Insufficient SOE
Composite cardiovascular events
Wound healing
Analog pain scale
Safety concerns (subgroups)
All0NANANANAInsufficient SOE

Abbreviations: ES=effect size; MI=myocardial infarction; MWT=mean walking time; NA=not applicable; OR=odds ratio; QOL=quality of life; 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.

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