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Review
. 2025 Oct 3;3(6):e70053.
doi: 10.1002/cesm.70053. eCollection 2025 Nov.

Long-Term Outcomes of Invasive vs Noninvasive Treatment for Intermittent Claudication: A Systematic Review and Meta-Analysis

Anas Elmahi  1 , Nathalie Doolan  1 , Mohiedin Hezima  1 , Anwar Gowey  1 , Daragh Moneley  1 , Seamus McHugh  1 , Sayed Aly  1 , Peter Naughton  1 , Elrasheid A H Kheirelseid  1
Affiliations
Review

Long-Term Outcomes of Invasive vs Noninvasive Treatment for Intermittent Claudication: A Systematic Review and Meta-Analysis

Anas Elmahi et al. Cochrane Evid Synth Methods. .

Abstract

Background: Intermittent claudication (IC) is a hallmark symptom of peripheral arterial disease (PAD), causing pain and discomfort during physical activity caused by reduced blood flow to the lower extremities. The condition significantly impairs mobility and quality of life (QoL) in affected individuals. Treatment options for IC range from conservative approaches, including best medical therapy (BMT) and supervised exercise therapy (SET), to invasive interventions like angioplasty and open re-vascularization.

Aim: This meta-analysis and systematic review seek to assess the long-term results of invasive procedures concerning Noninvasive treatments for the management of patients with IC.

Methods: A comprehensive search was conducted in October 2024 across databases containing PubMed, MEDLINE, Cochrane Library, Embase, and Scopus. Randomized controlled trials (RCTs) comparing invasive interventions to Noninvasive treatments were included. Primary outcomes were quality of life (QoL), ankle-brachial pressure index (ABPI), and maximum walking distance (MWD). Secondary outcomes were major adverse cardiovascular events (MACE), mortality, complications, and re-intervention rates. Data analysis was conducted using the Cochrane Review Manager 5. Follow-up duration was between 2 and 7 years, longest available between 2 and 7 years; prioritized 2 years when present.

Results: A total of 11 RCTs with 1379 patients were included in the analysis. Invasive treatments demonstrated a significant improvement in MWD and ABPI compared to Noninvasive treatments (MWD pooled Mean Difference (MD) = 64.94 [10.77, 115.12] 95% CI, p = .02, 5 studies, and ABPI pooled MD = 0.15 [0.04, 0.26] 95% CI, p = .006, 5 studies). However, invasive interventions were associated with a higher rate of complications, including increased amputation risk (Pooled odds ratio (OR) = 2.46 [0.44, 13.94] 95% CI, p = .31, 3 studies), though this was not statistically significant. Long-term rates were higher in the Noninvasive treatment group (Pooled OR: 0.56 [0.33, 0.97] 95% CI, p = .04).

Conclusions: Both invasive and Noninvasive treatments are effective in managing IC. Invasive treatments provide greater improvement in blood flow and walking distance, but the risk of complications and re-interventions should be considered in treatment decisions. Further research with larger sample sizes and designed for long-term assessment is needed to assess the cost-effectiveness and long-term outcomes of invasive treatments.

Keywords: intermittent claudication; invasive treatment; meta‐analysis; noninvasive treatment; randomized controlled trials; systematic review.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
PRISMA chart for included studies.
Figure 2
Figure 2
(A) Maximum walking distance (MWD) changes between the groups. (B) Ankle‐Brachial pressure index (ABPI) changes between the groups.
Figure 3
Figure 3
(A) RCTs comparing quality of life (QoL) between the groups using VASCU QoL scales. (B) RCTs comparing quality of life (QoL) between the groups using SF‐36 Physical health outcomes. (C) RCTs comparing quality of life (QoL) between the groups using SF‐36 mental health outcomes.
Figure 4
Figure 4
(A) RCTs comparing amputation rates. (B) RCTs comparing Myocardial infarction rates. (C) RCTs comparing major adverse cardiovascular events (MACE) rates. (D) RCTs comparing the mortality rate between the groups.
Figure 5
Figure 5
Forest plot of the RCTs comparing re‐intervention rates between the two groups.
Figure 6
Figure 6
(A) RCTs comparing Cost‐effectiveness analysis (QUALY) (B) RCTs comparing Cost per QUALY between the groups.
Figure 7
Figure 7
Risk of bias assessment across studies. *Green = Low risk, Yellow = Some concerns, Red = High risk.
See this image and copyright information in PMC

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