Endovascular revascularisation versus conservative management for intermittent claudication

Farzin Fakhry; Hugo JP Fokkenrood; Sandra Spronk; Joep AW Teijink; Ellen V Rouwet; M G Myriam Hunink

doi:10.1002/14651858.CD010512.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Health‐related quality of life (mean differences between groups).

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Figure 5

Health‐related quality of life (mean differences between groups).

A: Femoropoliteal trial.
B: Aortoiliac trial.

¹ In this study, the comparison was endovascular revascularisation plus supervised exercise versus supervised exercise.
² In this study, the comparison was endovascular revascularisation plus pharmacotherapy with cilostazol versus cilostazol.

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Analysis 1.1

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 1 Maximum walking distance.

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Analysis 1.2

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 2 Maximum walking distance (long‐term).

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Analysis 1.3

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 3 Pain‐free walking distance.

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Analysis 1.4

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 4 Pain‐free walking distance (long‐term).

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Analysis 1.5

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 5 Secondary invasive interventions.

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Analysis 1.6

Comparison 1 Endovascular revascularisation versus no specific therapy except verbal advice to exercise, Outcome 6 Mortality.

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Analysis 2.1

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 1 Maximum walking distance.

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Analysis 2.2

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 2 Maximum walking distance (long‐term).

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Analysis 2.3

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 3 Pain‐free walking distance.

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Analysis 2.4

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 4 Pain‐free walking distance (long‐term).

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Analysis 2.5

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 5 Secondary invasive interventions.

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Analysis 2.6

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 6 Quality of life (disease‐specific).

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Analysis 2.7

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 7 Mortality.

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Analysis 2.8

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 8 Sensitivity analysis: maximum walking distance.

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Analysis 2.9

Comparison 2 Endovasular revascularisation versus conservative therapy in form of supervised exercise, Outcome 9 Sensitivity analysis: pain‐free walking distance.

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Analysis 3.1

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 1 Maximum walking distance.

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Analysis 3.2

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 2 Maximum walking distance (long‐term).

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Analysis 3.3

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 3 Pain‐free walking distance.

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Analysis 3.4

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 4 Pain‐free walking distance (long‐term).

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Analysis 3.5

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 5 Secondary invasive interventions.

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Analysis 3.6

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 6 Quality of life (disease‐specific).

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Analysis 3.7

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 7 Mortality.

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Analysis 3.8

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 8 Sensitivity analysis: maximum walking distance.

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Analysis 3.9

Comparison 3 Endovascular revascularisation plus conservative therapy versus conservative therapy, Outcome 9 Sensitivity analysis: pain‐free walking distance.

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Summary of findings for the main comparison. Endovascular revascularisation compared with no specific therapy for intermittent claudication except verbal advice to exercise

Endovascular revascularisation compared with no specific therapy for intermittent claudication except verbal advice to exercise
Patient or population: intermittent claudication Setting: hospital Intervention: endovascular revascularisation Comparison: no specific therapy¹
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no specific therapy	Risk with endovascular revascularisation
Maximum walking distance	‐	Mean maximum walking distance in the intervention group was 0.70 standard deviations higher (0.31 higher to 1.08 higher).	‐	125 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Maximum walking distance (long‐term)	‐	Mean maximum walking distance at long term in the intervention group was 0.67 standard deviations higher (0.30 lower to 1.63 higher).	‐	103 (2 RCTs)	⊕⊕⊝⊝ LOW ^3,4,5
Pain‐free walking distance	‐	Mean pain‐free walking distance in the intervention group was 1.29 standard deviations higher (0.90 higher to 1.68 higher).	‐	125 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Pain‐free walking distance (long‐term)	‐	Mean pain‐free walking distance at long term in the intervention group was 0.69 standard deviations higher (0.45 lower to 1.82 higher).	‐	103 (2 RCTs)	⊕⊕⊝⊝ LOW ^3,4,5
Secondary invasive interventions	Study population		OR 0.81 (0.12 to 5.28)	118 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^3,4
	83 per 1000	69 per 1000 (11 to 324)
Quality of life (disease‐specific)	See comments.	See comments.	‐	‐	‐	One study reported no significant differences in disease‐specific QoL between study groups after 2 years without providing data
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Pooled standardised mean differences were interpreted using rules of thumb (< 0.40 = small, 0.40 to 0.70 = moderate, > 0.70 = large effect) as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). CI: confidence interval; OR: odds ratio; QoL: quality of life; RCT: randomised controlled trial.
GRADE Working Group grades of evidence. High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹ Treatment consisted of cardiovascular risk factor management and only verbal exercise advice without any form of supervision. ² In two studies, risk of bias on three or more domains judged as "unclear"; therefore quality of the evidence downgraded one level. ³ The possibility of publication bias could not be ruled out, yet we did not consider it sufficient to downgrade the quality of the evidence. ⁴ Small sample size with wide confidence interval for treatment effect; therefore quality of the evidence downgraded one level. ⁵ Evidence of inconsistency due to substantial heterogeneity between studies; therefore quality of the evidence downgraded one level.

Summary of findings for the main comparison. Endovascular revascularisation compared with no specific therapy for intermittent claudication except verbal advice to exercise

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Summary of findings 2. Endovascular revascularisation compared with conservative therapy for intermittent claudication

Endovascular revascularisation compared with conservative therapy for intermittent claudication
Patient or population: intermittent claudication Setting: hospital Intervention: endovascular revascularisation Comparison: conservative therapy (i.e. supervised exercise)¹
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with conservative therapy	Risk with endovascular revascularisation
Maximum walking distance	‐	Mean maximum walking distance in the intervention group was 0.42 standard deviations lower (0.87 lower to 0.04 higher).	‐	345 (5 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Maximum walking distance (long‐term)	‐	Mean maximum walking distance at long term in the intervention group was 0.02 standard deviations lower (0.36 lower to 0.32 higher).	‐	184 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^3,4
Pain‐free walking distance	‐	Mean pain‐free walking distance in the intervention group was 0.05 standard deviations lower (0.38 lower to 0.29 higher).	‐	345 (5 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Pain‐free walking distance (long‐term)	‐	Mean pain‐free walking distance at long term in the intervention group was 0.11 standard deviations higher (0.26 lower to 0.48 higher).	‐	147 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^3,5
Secondary invasive interventions	Study population		OR 1.40 (0.7 to 2.8)	395 (4 RCTs)	⊕⊕⊕⊕ HIGH ³
	82 per 1000	112 per 1000 (59 to 201)
Quality of life (disease‐specific)	‐	Mean quality of life (disease‐specific) in the intervention group was 0.18 standard deviations higher (0.04 lower to 0.41 higher).	‐	301 (3 RCTs)	⊕⊕⊕⊕ HIGH ³
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Pooled standardised mean differences were interpreted using rules of thumb (< 0.40 = small, 0.40 to 0.70 = moderate, > 0.70 = large effect), as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial.
GRADE Working Group grades of evidence. High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹ Supervised exercise consisted of only supervised exercise in four studies and a combination of supervised exercise and pharmacotherapy with cilostazol in one study. ² Evidence of inconsistency due to substantial heterogeneity between studies; therefore quality of the evidence downgraded one level. ³ The possibility of publication bias could not be ruled out, yet we did not consider it sufficient to downgrade the quality of the evidence. ⁴ In one of three studies, risk of attrition bias judged as "high"; therefore quality of the evidence downgraded one level. ⁵ Small sample size with wide confidence interval for treatment effect; therefore quality of the evidence downgraded one level.

Summary of findings 2. Endovascular revascularisation compared with conservative therapy for intermittent claudication

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Summary of findings 3. Endovascular revascularisation plus conservative therapy compared with conservative therapy alone for intermittent claudication

Endovascular revascularisation plus conservative therapy compared with conservative therapy alone for intermittent claudication
Patient or population: intermittent claudication Setting: hospital Intervention: endovascular revascularisation plus conservative therapy (supervised exercise or pharmacotherapy with cilostazol) Comparison: conservative therapy (supervised exercise or pharmacotherapy with cilostazol)¹
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with conservative therapy	Risk with endovascular revascularisation plus conservative therapy	Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
Conservative therapy consists of supervised exercise
Maximum walking distance	‐	Mean maximum walking distance in the intervention group was 0.26 standard deviations higher (0.13 lower to 0.64 higher).	‐	432 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Maximum walking distance (long‐term)	‐	Mean maximum walking distance at long term in the intervention group was 1.18 standard deviations higher (0.65 higher to 1.70 higher).	‐	106 (1 RCT)	⊕⊕⊝⊝ LOW ^2,4,5
Pain‐free walking distance	‐	Mean pain‐free walking distance in the intervention group was 0.33 standard deviations higher (0.26 lower to 0.93 higher).	‐	305 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Pain‐free walking distance (long‐term)	See comments.	See comments.	‐	‐	‐	None of the studies reported any quantitative data on pain‐free walking distance at long term
Secondary invasive interventions	Study population		OR 0.27 (0.13 to 0.55)	457 (3 RCTs)	⊕⊕⊕⊕ HIGH²
Secondary invasive interventions	164 per 1000	50 per 1000 (25 to 97)	OR 0.27 (0.13 to 0.55)	457 (3 RCTs)	⊕⊕⊕⊕ HIGH²
Quality of life (disease‐specific)	‐	Mean quality of life (disease‐specific) in the intervention group was 0.25 standard deviations higher (0.05 lower to 0.56 higher).	‐	330 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^2,3
Conservative therapy consists of pharmacotherapy (cilostazol)
Maximum walking distance	‐	Mean maximum walking distance in the intervention group was 0.38 standard deviations higher (0.08 higher to 0.68 higher).	‐	186 (2 RCTs)	⊕⊕⊕⊕ HIGH ²
Maximum walking distance (long‐term)	‐	Mean maximum walking distance at long term in the intervention group was 0.72 standard deviations higher (0.09 higher to 1.36 higher).	‐	47 (1 RCT)	See comments.	Only 1 small RCT included in this analysis, no meaningful grading of quality of evidence possible
Pain‐free walking distance	‐	Mean pain‐free walking distance in the intervention group was 0.63 standard deviations higher (0.33 higher to 0.94 higher).	‐	186 (2 RCTs)	⊕⊕⊕⊕ HIGH ²
Pain‐free walking distance (long‐term)	‐	Mean pain‐free walking distance at long‐term in the intervention group was 0.54 standard deviations higher (0.08 lower to 1.17 higher).	‐	47 (1 RCT)	See comments.	Only one small RCT included in this analysis, no meaningful grading of quality of evidence possible
Secondary invasive interventions	Study population		OR 1.83 (0.49 to 6.83)	199 (2 RCTs)	⊕⊕⊕⊕ HIGH ²
Secondary invasive interventions	69 per 1000	120 per 1000 (35 to 337)	OR 1.83 (0.49 to 6.83)	199 (2 RCTs)	⊕⊕⊕⊕ HIGH ²
Quality of life (disease‐specific)	‐	Mean quality of life (disease‐specific) in the intervention group was 0.59 standard deviations higher (0.27 higher to 0.91 higher).	‐	170 (2 RCTs)	⊕⊕⊕⊕ HIGH ²
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Pooled standardised mean differences were interpreted using rules of thumb (< 0.40 = small, 0.40 to 0.70 = moderate, > 0.70 = large effect), as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial.
GRADE Working Group grades of evidence. High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹ Conservative therapy consisted of supervised exercise in three studies and of pharmacotherapy with cilostazol and only advice to exercise in two studies. ² The possibility of publication bias could not be ruled out, yet we did not consider it sufficient to downgrade the quality of the evidence. ³ Evidence of inconsistency due to substantial heterogeneity between studies; therefore quality of the evidence downgraded one level. ⁴ Small sample size with wide confidence interval for treatment effect; therefore quality of the evidence downgraded one level. ⁵ In this study risk of bias on three domains judged as "unclear"; therefore quality of the evidence downgraded one level.

Summary of findings 3. Endovascular revascularisation plus conservative therapy compared with conservative therapy alone for intermittent claudication

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Table 1. Minor complications following endovascular revascularisation

Study	Groin haematoma	Artery dissection
Creasy 1990	3/20	1/20
Fakhry 2015	5/106	2/106
Greenhalgh 2008	8/67	1/67
Murphy 2015	nr	2/46
Nordanstig 2014	1/52	nr
Spronk 2009	6/75	1/75
nr: not reported.

Table 1. Minor complications following endovascular revascularisation

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Comparison 1. Endovascular revascularisation versus no specific therapy except verbal advice to exercise

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Maximum walking distance Show forest plot	3	125	Std. Mean Difference (IV, Random, 95% CI)	0.70 [0.31, 1.08]

2 Maximum walking distance (long‐term) Show forest plot	2	103	Std. Mean Difference (IV, Random, 95% CI)	0.67 [‐0.30, 1.63]

3 Pain‐free walking distance Show forest plot	3	125	Std. Mean Difference (IV, Random, 95% CI)	1.29 [0.90, 1.68]

4 Pain‐free walking distance (long‐term) Show forest plot	2	103	Std. Mean Difference (IV, Random, 95% CI)	0.69 [‐0.45, 1.82]

5 Secondary invasive interventions Show forest plot	2	118	Odds Ratio (M‐H, Random, 95% CI)	0.81 [0.12, 5.28]

6 Mortality Show forest plot	3	136	Odds Ratio (M‐H, Random, 95% CI)	0.75 [0.13, 4.44]

Comparison 1. Endovascular revascularisation versus no specific therapy except verbal advice to exercise

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Comparison 2. Endovasular revascularisation versus conservative therapy in form of supervised exercise

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Maximum walking distance Show forest plot	5	345	Std. Mean Difference (IV, Random, 95% CI)	‐0.42 [‐0.87, 0.04]

2 Maximum walking distance (long‐term) Show forest plot	3	184	Std. Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.36, 0.32]

3 Pain‐free walking distance Show forest plot	5	345	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.38, 0.29]

4 Pain‐free walking distance (long‐term) Show forest plot	2	147	Std. Mean Difference (IV, Random, 95% CI)	0.11 [‐0.26, 0.48]

5 Secondary invasive interventions Show forest plot	4	395	Odds Ratio (M‐H, Random, 95% CI)	1.40 [0.70, 2.80]

6 Quality of life (disease‐specific) Show forest plot	3	301	Std. Mean Difference (IV, Random, 95% CI)	0.18 [‐0.04, 0.41]

7 Mortality Show forest plot	5	435	Odds Ratio (M‐H, Random, 95% CI)	0.84 [0.35, 2.00]

8 Sensitivity analysis: maximum walking distance Show forest plot	3	232	Std. Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.98, ‐0.07]

9 Sensitivity analysis: pain‐free walking distance Show forest plot	3	232	Std. Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.46, 0.23]

Comparison 2. Endovasular revascularisation versus conservative therapy in form of supervised exercise

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Comparison 3. Endovascular revascularisation plus conservative therapy versus conservative therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Maximum walking distance Show forest plot	5		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 Supervised exercise therapy	3	432	Std. Mean Difference (IV, Random, 95% CI)	0.26 [‐0.13, 0.64]
1.2 Pharmacotherapy	2	186	Std. Mean Difference (IV, Random, 95% CI)	0.38 [0.08, 0.68]
2 Maximum walking distance (long‐term) Show forest plot	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 Supervised exercise therapy	1	106	Std. Mean Difference (IV, Random, 95% CI)	1.18 [0.65, 1.70]
2.2 Pharmacotherapy	1	47	Std. Mean Difference (IV, Random, 95% CI)	0.72 [0.09, 1.36]
3 Pain‐free walking distance Show forest plot	4		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 Supervised exercise therapy	2	305	Std. Mean Difference (IV, Random, 95% CI)	0.33 [‐0.26, 0.93]
3.2 Pharmacotherapy	2	186	Std. Mean Difference (IV, Random, 95% CI)	0.63 [0.33, 0.94]
4 Pain‐free walking distance (long‐term) Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 Pharmacotherapy	1	47	Std. Mean Difference (IV, Random, 95% CI)	0.54 [‐0.08, 1.17]
5 Secondary invasive interventions Show forest plot	5		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Supervised exercise therapy	3	457	Odds Ratio (M‐H, Random, 95% CI)	0.27 [0.13, 0.55]
5.2 Pharmacotherapy	2	199	Odds Ratio (M‐H, Random, 95% CI)	1.83 [0.49, 6.83]
6 Quality of life (disease‐specific) Show forest plot	4		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

6.1 Supervised exercise therapy	2	330	Std. Mean Difference (IV, Random, 95% CI)	0.25 [‐0.05, 0.56]
6.2 Pharmacotherapy	2	170	Std. Mean Difference (IV, Random, 95% CI)	0.59 [0.27, 0.91]
7 Mortality Show forest plot	5		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Supervised exercise therapy	3	457	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.20, 2.21]
7.2 Pharmacotherapy	2	201	Odds Ratio (M‐H, Random, 95% CI)	1.30 [0.14, 11.92]
8 Sensitivity analysis: maximum walking distance Show forest plot	4		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

8.1 Supervised exercise therapy	2	339	Std. Mean Difference (IV, Random, 95% CI)	0.43 [0.21, 0.65]
8.2 Pharmacotherapy	2	186	Std. Mean Difference (IV, Random, 95% CI)	0.38 [0.08, 0.68]
9 Sensitivity analysis: pain‐free walking distance Show forest plot	3		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

9.1 Supervised exercise therapy	1	212	Std. Mean Difference (IV, Random, 95% CI)	0.62 [0.34, 0.89]
9.2 Pharmacotherapy	2	186	Std. Mean Difference (IV, Random, 95% CI)	0.63 [0.33, 0.94]

Comparison 3. Endovascular revascularisation plus conservative therapy versus conservative therapy

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