Thrombolytic-Free Mechanical Thrombectomy vs. Catheter-Directed Thrombolysis for Acute Iliofemoral DVT: A Systematic Review and Meta-Analysis

Moultrie, GA

BACKGROUND

Acute iliofemoral deep vein thrombosis (DVT) affects approximately 250,000 Americans annually, with 50–80% developing post-thrombotic syndrome (PTS) on anticoagulation alone. Catheter-directed thrombolysis (CDT) reduces PTS but requires ICU admission and carries significant hemorrhagic risk. Novel aspiration-based, thrombolytic-free mechanical thrombectomy (MT) systems — ClotTriever, Indigo Lightning 12, and Aspirex S — offer lytic-free single-session treatment, yet no systematic review has compared these directly to CDT.

METHODS

A PRISMA 2020–compliant systematic review and meta-analysis was performed. PubMed/MEDLINE, Cochrane CENTRAL, EMBASE, and ClinicalTrials.gov were searched for studies comparing thrombolytic-free MT to CDT/PMCDT or anticoagulation in adults (≥18 years) with imaging-confirmed acute iliofemoral DVT. Primary outcome was PTS at 6 and 12 months (Villalta scale). Secondary outcomes included major bleeding (ISTH), venous patency, hemoglobinuria/AKI, ICU admission, and hospital LOS. Pooled odds ratios (ORs) were calculated using a DerSimonian-Laird random-effects model.

RESULTS

Preliminary screening identified 847 records, yielding 5 eligible studies (n = 712) for meta-analysis. Lytic-free MT was associated with significantly lower overall PTS compared to CDT (OR 0.55, 95% CI 0.43–0.71, p < 0.001, I² = 18%). Severe PTS/venous ulceration was reduced by 66% (OR 0.34, p = 0.001). Major bleeding was also significantly lower with MT (OR 0.58, p = 0.001). Venous patency at 6 months favoured MT (OR 1.89, p = 0.002). ICU admission was markedly reduced (OR 0.41, p < 0.001). In landmark trial comparison, lytic-free MT (CLOUT registry, Marston 2024) achieved 12-month PTS of 17% vs. 38% with anticoagulation (p < 0.001), outperforming both CDT (CaVenT: 41.1%, p = 0.047) and PMCDT (ATTRACT: 47.4%, p = 0.31 vs. anticoagulation). Notably, hemoglobinuria/AKI was significantly elevated with AngioJetrheolytic devices only (OR 20.08) and was not observed with aspiration-based systems.

CONCLUSIONS

Thrombolytic-free MT achieves superior PTS reduction with lower bleeding risk and ICU utilization compared to CDT. Aspiration-based devices appear safest, enabling outpatient single-session management. These findings support a paradigm shift toward lytic-free MT for acute iliofemoral DVT and will inform updated clinical practice guidelines upon full PRISMA synthesis.