DOI: 10.1177/15266028261467201 ISSN: 1526-6028

Rotational Percutaneous Mechanical Thrombectomy for Acute and Subacute Limb Ischaemia: A Systematic Review and Proportional Meta-Analysis

Benedict Stanberry, Koen Deloose, Yann Gouëffic, Gilles Goyault, Giacomo Isernia, Ralph Jackson, Nils Kucher, Michael Lichtenberg, James McCaslin, Bruno Migliara, Mark Portou, Christos Rammos, Caren Randon, Refaat Salman, Marc Sirvent
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Objective:

Rotational percutaneous mechanical thrombectomy with adjunctive angioplasty, stenting or limited thrombolysis (rPMT+) has become commonplace in the treatment of acute and subacute limb ischaemia (SLI). This systematic review and proportional meta-analysis synthesises the available evidence on its safety and efficacy.

Data Sources:

MEDLINE, Embase and the Cochrane Library.

Review Methods:

We searched for studies (≥10 patients) published since January 1, 2012 (PROSPERO protocol CRD420251015846). Risk of bias was assessed using RoBANS 2. Proportional meta-analysis maximised representative sample sizes by incorporating both single-arm and comparative studies. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) evidence profiles were developed for each outcome of interest.

Results:

Twenty-four studies – 7 comparative and 17 single arm – containing 2954 procedures (2697 rPMT+, 257 controls) met eligibility criteria. There were no randomised controlled trials. The pooled technical success (TS) rate for rPMT+ was 98% (95% confidence interval [CI]: 97%–100%, p < .001). Amputation-free survival (AFS) was 96% (95% CI: 93%–98%, p < .001). Twelve-month primary patency (PP) was 68% (95% CI: 55%–79%, p < .001). The pooled rate of freedom from clinically-driven target lesion revascularisation was 85% (95% CI: 80%–90%, p < .001). No significant differences existed between acute, subacute and mixed subgroups. Procedure-related mortality was 0.5% (11 deaths in 2086 procedures from 17 studies) with most deaths occurring after adjunctive catheter-directed thrombolysis. Major adverse events occurred in 4% of procedures (95% CI: 1%–8%, p < .001) and distal embolisation in 8% (95% CI: 5%–11%, p < .001). rPMT+ reduced length of stay by 1.7 days versus alternatives (95% CI: 3.3%–0.1 days, p < .05). All outcomes demonstrated heterogeneity; GRADE assessment rated evidence certainty as low to very low.

Conclusion:

The evidence available from 24 real-world observational studies of 2954 procedures supports the use of rPMT+ in acute limb ischaemia and SLI – delivering an overall pooled TS rate of 98% and AFS rate of 96% with no significant differences between acute, subacute and mixed subgroups. rPMT+ is associated with shorter hospital stays than either surgery or thrombolysis.

Clinical Impact

This systematic review and proportional meta-analysis synthesises 24 single-arm and comparative non-randomised studies encompassing nearly 3000 procedures to provide a comprehensive assessment of the safety and efficacy of rotational percutaneous mechanical thrombectomy in patients with acute and subacute lower limb ischaemia. It demonstrates that, when used for initial revascularisation prior to adjunctive angioplasty, stenting or limited thrombolysis, this endovascular approach delivers clinically valuable rates of technical success and amputation-free survival with notably high rates of freedom from clinically-driven target lesion revascularisation, acceptable primary patency, low procedural risk and significantly shorter hospital stays.

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