This systematic review and proportional meta-analysis, currently posted as an unreviewed preprint on medRxiv, synthesises the available evidence on the safety and efficacy of rotational percutaneous mechanical thrombectomy with adjunctive angioplasty, stenting or limited thrombolysis (rPMT+) in patients with acute and subacute lower limb ischaemia. The study was conducted in partnership with Becton, Dickinson and Company (BD) and involved a 14-member clinical advisory panel of vascular and endovascular specialists drawn from centres across Europe and Saudi Arabia. To the best of our knowledge, it is the most comprehensive synthesis of the evidence for this class of device to date, encompassing 24 studies and nearly 3,000 procedures.
The clinical problem
Acute limb ischaemia (ALI) is a vascular emergency characterised by a sudden reduction in arterial perfusion that threatens limb viability. Despite significant advances in management, 30-day amputation rates remain at 10–30% and mortality at 15–20%. The condition is typically managed through open surgery or catheter-directed thrombolysis (CDT), but neither approach is without drawbacks: open surgery carries high perioperative mortality, particularly among elderly and frail patients, while CDT requires long infusion times and intensive care monitoring due to bleeding risk. These limitations have driven growing interest in percutaneous mechanical thrombectomy devices that can achieve rapid vessel clearance with a lower procedural burden. The Rotarex™ S device is a widely used example, employing a rotating mechanism to fragment, excise and aspirate thrombus from peripheral arteries. However, it had not been the subject of a randomised controlled trial and the existing non-randomised evidence had not been comprehensively pooled.
Approach
We searched MEDLINE, Embase and the Cochrane Library for studies of ten or more patients published since January 2012, following a prospectively registered PROSPERO protocol (CRD420251015846). Two reviewers independently screened, selected and extracted data. Risk of bias was assessed using the recently revised RoBANS 2 tool and the certainty of the evidence was evaluated using the GRADE approach. Since the majority of included studies were single-arm and non-comparative, we used proportional meta-analysis — a technique that pools event rates across both single-arm and comparative study arms using the Freeman-Tukey double arcsine transformation — to maximise representative sample sizes and generate stable pooled estimates.
Key findings
Twenty-four studies (seven comparative, 17 single-arm) met our eligibility criteria, containing 2,954 procedures. The pooled technical success rate for rPMT+ was 98% (95% CI: 97–100%). Amputation-free survival was 96% (95% CI: 93–98%). Twelve-month primary patency was 68% (95% CI: 55–79%) and freedom from clinically-driven target lesion revascularisation was 85% (95% CI: 80–90%). There were no significant differences in pooled estimates between acute, subacute and mixed subgroups across any of these endpoints.
On the safety side, procedure-related mortality was very low at 0.5% (11 deaths in 2,086 procedures), with most deaths occurring after adjunctive thrombolysis rather than during the thrombectomy itself. Major adverse events occurred in 4% of procedures and distal embolisation in 8%. In all five comparative studies that measured length of stay, rPMT+ patients spent less time in hospital than controls — approximately five fewer days than surgical patients and one fewer day than those receiving CDT alone.
Strengths and limitations
The consistency of favourable outcomes across diverse clinical settings and the large pooled sample provide reasonable confidence that rPMT+ is an effective strategy for appropriately selected patients, supporting its continued inclusion in the European Society of Vascular Surgery’s clinical practice guidelines. However, the evidence base is dominated by retrospective, single-centre studies with high risk of bias. Outcome reporting was inconsistent — only four studies reported all four primary endpoints — and was confounded by considerable definitional heterogeneity across studies. Substantial statistical heterogeneity was observed across practically all endpoints, reflecting differences in symptom severity, lesion characteristics, anatomic locations and the intensity of adjunctive therapy. GRADE certainty was rated as low to very low for all outcomes. Future registry-based studies with mandatory, standardised reporting could provide real-world safety and efficacy data at scale.
Implications
The review demonstrates that rPMT+ delivers consistently high technical success and amputation-free survival, promising freedom from reintervention, acceptable patency, low procedural risk and shorter hospital stays than either open surgery or CDT. These findings have direct relevance for the ongoing health economic evaluation of this device class, where the combination of strong clinical outcomes and reduced resource utilisation strengthens the case for cost-effectiveness in appropriately selected patient populations.
Stanberry B, Deloose K, Gouëffic Y, Goyault G, Isernia G, Jackson R, Kucher N, Lichtenberg M, McCaslin J, Migliara B, Portou M, Rammos C, Randon C, Salman R, Sirvent M. Rotational percutaneous mechanical thrombectomy for acute and subacute limb ischaemia: a systematic review and proportional meta-analysis. medRxiv 2026. DOI: 10.64898/2026.01.06.26343519
This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
