Clinical data for deep vein thrombosis

Based on the RETHRO Swiss Venous Stent registry¹, using an interventional approach for early thrombus removal for symptomatic iliofemoral DVT showed:

• Absence of Post Thrombotic Syndrome (Villalta <5) and freedom from intervention >90% at 2-years
• Very low major bleeding
• Single session pharmacomechanical thrombectomy (PMT) can result no ICU stay

Objectives: 

• Describe the clinical characteristics and outcomes of symptomatic patients with iliofemoral DVT undergoing PMT alone, catheter-directed thrombolysis (CDT) alone and CDT followed by PMT (bail-out) in the Swiss Venous Stent Registry. 
• The primary outcome was the incidence of peri-interventional major and minor bleeding complications (ISTH criteria). Secondary outcomes included the incidence of PTS and stent patency after 3 years. 

Scope: 32 patients in a single session + 19 patients bailout after failed CDT.

Clinical significance (at 22-months):

• Absence of PTS >90%

• 0% major bleeding

• The use of AngioJet for acute iliofemoral DVT appears safe and resulted in high long-term patency and low PTS rates. 

Conclusion: AngioJet can safely be used in conjunction with CDT, or as a viable option for selected patients with iliac vein compression, patent popliteal vein, and absence of IVC thrombus, thereby minimizing the use of thrombolytic agents. 

Reference: Coagulation-monitored, dose-adjusted catheter-directed thrombolysis or pharmaco-mechanical thrombus removal in deep vein thrombosis, DO - 10.1024/0301-1526/a001097¹.

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Objective:  Compare the outcomes of patients with iliofemoral DVT (IFDVT), treated with additional AngioJet™ pharmacomechanical catheter-directed thrombectomy (PCDT) vs. catheter-directed therapy (CDT) alone.

Scope: Retrospective analysis between 2011 and 2017 on all patients that received thrombolysis for symptomatic iliofemoral DVT (IFDVT)

• 151 limbs (139 patients)
  • 70 limbs (63 patients) with PCDT
  • 81 limbes (76 patients) with CDT alone

Clinical significance:

• Overall incidence of PTS at 1 year: 23,5% in both groups
• PMT reduces the number of patients needing lytics and for those who do, they require less dose and for a shorter duration.

Conclusion: The use of PCDT for the treatment of iliofemoral DVT was observed to provide comparable patient outcomes, comparable vessel patency, an acceptable safety profile, and reduced overall lytic dose in comparison of CDT alone.

Reference: Pouncey AL et al. AngioJet™ Pharmacomechanical Thrombectomy and Catheter Directed Thrombolysis vs. Catheter Directed Thrombolysis Alone for the Treatment of Iliofemoral Deep Vein Thrombosis: A Single Centre Retrospective Cohort Study. Eur J Vasc Endovasc Surg 2020;60(4):578-585².

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Objective: Review and analyse published literature evaluating patients treated for iliofemoral DVT (IFDVT) with CDT or systemic thrombolysis alone.

Scope: Twenty articles based on 17 studies (randomised or observational):

• Studies conducted in nine countries
• Published between January 2001 – February 2019
• Total of 1417 patients 

Clinical significance:

• Mechanical thrombectomy increased 6-month cumulative primary patency vs. thrombolysis alone
• Mechanical thrombectomy decreased frequency of major bleeding vs. thrombolysis alone

Conclusion: In patients with IFDVT*, percutaneous mechanical thrombectomy was associated with higher cumulative 6-months primary patency and a lower incidence of major bleedings compared to thrombolysis alone.

Reference: Lichtenberg MKW et al. Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis – a systematic review and meta-analysis. Vasa 2021;50(1):59-67³.

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Objective:  Evaluate the efficacy and safety of endovascular recanalisation, including Acoustic Pulse Thrombolysis (APT) with EKOS, in patients with chronic DVT suffering from PTS.

Scope: 78 patients.  82 limbs. 18 centres in the U.S.

• Iliofemoral DVT diagnosed ≥6 months
• PTS with a Villalta Score ≥8 
• Failure of ≥3 months of conservative therapy

Clinical significance:

• Clinically significant improvements in PTS signs & symptoms with low TPA dose
• Efficacy mean Villalta score improvement 49.7% @ 365 days
• Improvement in patient quality of life 16.9% @ 30 days; 32.8% @ 365 days
• All treatments were for chronic DVT (≥6 months)

Safety:

• Major bleed within 72 hours
• One PE within 30 days of the APT procedure

Efficacy:

• Clinically significant improvements in the signs and symptoms of PTS at a low tPA dose: 18.5 mg and an average of 23 hours of ultrasound therapy
• Primary endpoint met: Reduction in Villalta Score ≥4 at 30 days in ≥ 50% of patients with a mean improvement of 49.7% at 365 days

Conclusion: Long-term data demonstrates that acoustic pulse thrombolysis treatment with venoplasty for chronic DVT patients with PTS significantly improves clinical signs and symptoms and has a lasting impact on patient quality of life.

Reference: Garcia MJ et al. Ultrasound-accelerated thrombolysis and venoplasty for the treatment of post-thrombotic syndrome: Results of the ACCESS PTS Study. J Am Heart Assoc 2020;9(3):e013398⁴.

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Objective: Literature based on six studies published between January 1990 and June 2018 were included in this meta-analysis. The studies eligible were comparing PMT plus CDT or PMT (experimental group) with CDT (control group).

Scope: 6 studies

Clinical significance:

PMT reduces:

• The severity of PTS
• Thrombus score
• Length of hospital stay
• Thrombolysis time vs. cdt

Overview:

Primary outcomes:

• Thrombus score
• Clot reduction grade I event
• Villalta score
• Valvular incompetence event

Secondary outcomes:

• Length of hospital stay
• Thrombolysis time
• Minor bleedings

Reference: Tang T et al. Pharmacomechanical Thrombectomy versus catheter-directed thrombolysis for iliofemoral deep vein thrombosis: A meta-analysis of clinical trials. Clin Appl Thromb Hemost. 2019;25:1-8⁵. 

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Objective: The PEARL Registry is a 2-phase, prospective, multicentre, observational study.

Scope: 329 patients enrolled after treatment with AngioJet™ System at 32 institutions in the U.S. and Europe, from January 2007 to July 2013.

Key findings:

• 1295 venous vessels treated
• 97% showing improvement
• 73% of procedures completed in less than 24 hours
• 34% patients treated in a single session

Conclusion: The PEARL Registry data demonstrate that treatment of DVT with AngioJet™ PCDT is safe and effective and can:

• Reduce the need for concomittant CDT and ICU care,
• Reduce thrombolytic agent dose and infusion time, and
• Consequently reduce the bleeding risk associated with CDT.

Reference: Garcia MJ et al. Endovascular management of deep vein thrombosis with rheolytic thrombectomy: Final report of the prospective multicenter PEARL (Peripheral Use of AngioJet™ Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol 2015;26(6):777-785⁶. 

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