Table 14:

Characteristics of Included Acute or Subacute Deep Vein Thrombosis Studies

Author, year, country	Study design (recruitment period)	Population (inclusion/exclusion criteria)	Methodological approach	Study groups		Follow-up period
				MT	Comparator
Baker et al, 201294 United States	Retrospective, single centre (June 2004 to October 2011)	N = 83 Iliofemoral DVT	Venography in all patients Selection of catheter and methodological approach was at the discretion of each investigator	n = 64 UAT EKOS	n = 19 CDT rtPA: urokinase or tenecteplase	Median 35 mo (range 20-55 mo)
Engelberger et al, 20152 Switzerland	Randomized controlled clinical trial, single centre (November 2011 to November 2013)	N = 48 Symptomatic acute (symptoms < 2 wk) proximal DVT Iliac or common femoral veins Confirmed by Duplex sonography 18-75 y of age Exclusion: unable to tolerate the procedure (e.g., allergic to heparin or rtPA), pregnant, or established PTS or other DVT in the same leg in the previous 2 y	All patients received heparin as a combination of UFH or LMWH, and the same rtPA for 15 h with intermittent pneumatic compression devices on both legs during procedure Same catheter system used in both study groups, but the ultrasound was only used in the MT group Adjunctive angioplasty and stenting for residual venous stenosis	n = 24 UAT EKOS for the duration of the 15 h rtPA Additional rheolytic thrombectomy as required for 10-24 h AngioJet, OR Additional EKOS	n = 24 CDT rtPA for 15 h	3 mo
Ezelsoy et al, 201595 Turkey	Retrospective, single centre (June 2013 to June 2014)	N = 50 Acute DVT (symptoms < 14 d) In the upper thigh Exclusion: contraindicated to receive thrombolytic treatment, had major surgery within 1 mo, or severe renal failure	All patients received warfarin sodium before hospital discharge and recommended compression therapy for 1 yr	n = 25 PMT Cleaner 6F rotational device rtPA, procedure continued until vein considered clean of thrombus	n = 25 LMWH	Median: 14 mo (range 6-18 mo)
PEARL registry Garcia et al, 201585 United States and Europe	Multisite, international registry (January 2007 to June 2013)	N = 329 Lower extremity DVT	No treatment techniques specified, methodological approach by the treating physician	n = 115 PMT AngioJet n = 172 RT with PMT and CDT	n = 13 RT without lytic agent n = 29 RT with CDT	12 mo
Huang et al, 201596 China	Retrospective, single centre (November 2010 to November 2013)	N = 34 Acute proximal DVT > 1 yr follow up period 3 died and 2 lost to follow-up within the first 12 mo. They were excluded as it is unclear what treatment they received	Acute DVT diagnoses with Wells’ score PMT recommended in patients with contraindications to CDT; otherwise, decision made in consultation with patient	n = 16 PMT AngioJet	n = 18 CDT	12 mo
Huang et al, 202197 China	Retrospective, single centre (September 2013 to September 2015)	N = 131 Acute iliofemoral DVT	PMT was used in patients who had contraindications to CDT All patients had at least a 5-yr follow up Additional anticoagulation and endovascular methods (e.g., balloon and stents) used as required	n = 65 PMT AngioJet	n = 66 CDT	5 y
Kuo et al, 201798 Taiwan	Prospective, single centre (January 2009 to December 2013)	N = 61 Acute iliofemoral DVT Acute: ≤ 21 d > 2-y follow up Exclusion: patients with contraindications to anticoagulants and severe renal failure	Duplex sonography confirmed DVT All patients received LMWH after admission	n = 30 PMT AngioJet OR Balloon crush technique with urokinase, or withdrawing balloon while aspirating thrombus	n = 31 CDT	2 y
Lee et al, 202099 Korea	Retrospective, before/after, single centre (May 2017 to December 2018)	N = 40 Acute iliofemoral DVT ≤ 14 d from symptom onset	All patients received CDT PMT available from June, 2018	n = 20 PMT (after CDT) AngioJet	n = 20 Manual aspiration (after CDT)	Mean 14.3 mo (SD ± 5.3 mo)
Li et al, 2020100 China	Retrospective, single centre (September 2015 to August 2019)	N = 126 (among 120 individuals) Acute iliofemoral DVT Exclusion: contraindication to thrombolysis therapy or severe renal impairment	All patients treated with enoxaparin Intervention choice at the discretion of the treating surgeon	n = 61 PMT AngioJet Patients received urokinase just prior to PMT	n = 65 Manual aspiration thrombectomy	Median: 6.4 mo (range: 4-12 mo)
Liu et al, 2018101 China	Retrospective, single centre (June 2014 to December 2016)	N = 112 Acute (< 15 d) or subacute (15-30 d) of iliofemoral or iliocaval DVT	Low-molecular weight heparin was routine use before intervention performed Balloon dilation and stents used, per criteria defined in advance Intervention selection based on patient status, with those considered to be in good functional status (< 70 y and low risk of bleeding) received CDT. Those with contraindications or higher risk for CDT were allocated to MT	n = 52 PMT AngioJet	n = 60 CDT with urokinase	≤ 12 mo
Lu et al, 201775 United States	Retrospective, single centre (2008-2012)	N = 76 limbs (among 67 individuals) Iliofemoral or femoral popliteal DVT Exclusion: people with recurrent DVT or who are undergoing open thrombectomy	All patients started on heparin at diagnosis Popliteal venogram confirmed diagnosis Treatment choice based on clinical judgement	n = 51 Ultrasound CDT EKOS With tPA AngioJet, at physician discretion	n = 25 CDT With tPA and additional heparin AngioJet, at physician discretion	Mean: 20 mo (SD ± 2.5)
Morrow et al, 201773 United States	Retrospective, single centre (January 2009 to December 2014)	N = 92 Acute venous thrombusab	Procedural method based on physician discretion	n = 5 Percutaneous MT alone Brand not specified, but references to AngioJet n = 26 Percutaneous MT with tPA n = 56 Percutaneous MT with CDT	n = 5 CDT alone	6 mo
CAVA trial Notton et al, 2020102; 20213 Netherlands	Multicentre, randomized single blind trial (May 2010 to September 2017)	N = 181 Acute iliofemoral DVT Treatment within 21 d of symptom onset Inclusion: first event in the limb, aged 18-85 y Exclusion: signs of venous insufficiency or history of renal failure, impaired mobility, or pregnant	All diagnoses were confirmed with compression ultrasound before randomization Patients received standard care anticoagulation and LMWH Thrombolysis was with urokinase for a maximum of 96 h All patients had compression stocking replaced every 6 mo and anticoagulation and usual care after procedure	n = 91 Ultrasound CDT EKOS Additional urokinase as required	n = 93 Standard treatment Additional urokinase as required Treatment provided for up to 96 h	Median: 39 mo (IQR range: 23.3-63.8)
Pouncey et al, 2020103 United Kingdom	Retrospective, single centre (November 2011 to November 2017)	N = 151 Acute or subacute iliofemoral DVT Inclusion: < 28 d from symptom onset Exclusion: contraindications for thrombolysis or anticoagulants, and those who received ultrasound-assisted CDT	Diagnosis confirmed with duplex sonography, CT, or magnetic resonance venography Choice of treatment was at the discretion of the physician	n = 70 PMT AngioJet	n = 81 CDT	12 mo
Shen et al, 2019104 China	Retrospective, single centre (January 2014 to September 2017)	N = 198 Acute iliofemoral DVT Inclusion: 14-90 y of age Exclusion: pregnancy, renal dysfunction, or contraindication to urokinase	Treatment choice was at surgeon discretion Renal protective measures for all patients included saline from 6 h before to up to 24 h after procedure, and hemodialysis as necessary	n = 79 PMT AngioJet	n = 119 CDT	72 h
Tian et al, 2021105 China	Retrospective, single centre (March 2016 to January 2018)	N = 98 Acute, unilateral DVT Exclusion: contraindications to thrombolysis, radiation, or venography, including renal insufficiency or pregnancy	Physicians selected treatment Patients received anticoagulation after treatment; dose and duration depended on severity of DVT	n = 48 PMT AngioJet Dwell time of 15-min; procedure repeated once if necessary	n = 50 CDT With urokinase	Median: 28 mo (SD ± 5.2)
Tichelaar et al, 2016106 Norway	Retrospective, single centre (2002-2011)	N = 94 Iliofemoral or more proximal DVT	All patients treated with LMWH after diagnosis Patients were preferentially treated with ultrasound-assisted CDT starting in 2009	n = 33 Ultrasound-assisted CDT EKOS	n = 62 CDT	Median: 65 mo (range: 15-141 mo)
ATTRACT study Vedantham et al, 201391; 201790; Weinberg et al, 201993; Kahn et al, 202087; Razavi et al, 202089 Subgroup analysis: Comerota et al, 201986; Kearon et al, 201988; Vedantham et al, 202192 United States	Randomized controlled trial, multicentre (December 2009 to December 2014)	N = 692 Acute (< 14 d from symptom onset) proximal DVT Symptomatic, involving the iliac, common femoral, and/or femoral vein 16-75 y of age Exclusion: pregnancy, high risk of bleeding, active cancer, or established PTS Subgroup analysis: Acute Iliofemoral DVT only86 Acute femoral-popliteal deep vein thrombosis88 AngioJet MT only92	All subjects must be candidates for anticoagulation All patients received LMWH or intravenous UFH Sites chose the MT brand they would use before the start of the study If MT did not achieve complete thrombus removal (single session only), rtPA could be infused up to 24 h through multisided hole catheter Investigator choice to conduct additional adjunctive therapy to eliminate residual thrombus, or venous stenosis (e.g., balloon maceration, additional catheter aspiration, or additional rtPA) and stenting was encouraged as needed Patients were randomized to receive no intervention (n = 355) or any procedure (n = 336). For our review, where possible, we compared patients who received AngioJet to those who received only rtPA	n = 336 If the test with rtPA results in good inflow to the popliteal vein: Isolate thrombolysis Trellis (n = 50) OR Oscillating wire intra-thrombus drug dispersion AngioJet (n = 75) If the popliteal vein is occluded or the IVC is involved: Multisided hole catheter rtPA (n = 194) Brand by physician choice	n = 355 No procedural intervention	2 y
Xu et al, 2021107 China	Retrospective, 3 institutions (January 2015 to December 2018)	N = 424 Acute lower extremity DVT Exclusion: previous history of thrombosis or surgery and unilateral DVT, life expectancy < 1 y, or contraindications for treatment	All patients received anticoagulation	n = 186 PMT AngioJet Dwell time of 15 min; procedure repeated as many times as necessary until thrombus cleared (< 30% residual thrombus)	n = 238 CDT Multi-hole catheter, Unifuse, with urokinase	12 mo
Xu et al, 2020108 China	Retrospective, single centre (December 2015 to May 2018)	N = 74 Subacute iliofemoral DVT Inclusion: 15-28 d from symptom onset, severe symptoms before treatment, and confirmed diagnosis by colour Doppler ultrasonography Exclusion: contraindications to treatment	All patients received LMWH after diagnosis	n = 30 PMT AngioJet Dwell time of 30-min, repeated until residual thrombosis was < 30% vein stenosis CDT used after aspiration	n = 44 CDT Unifuse multi-holed catheter	12 mo
Zhu et al, 2020109 China	Case controlled study, 2 centres (February 2015 to October 2016)	N = 65 Acute lower extremity DVT Exclusion: contraindications to treatment (these patients were excluded prior to randomization)	All patients received LMWH and oral warfarin Vein repair (balloon and stent) used as necessary	n = 32 PMT AngioJet Dwell time of 20-30 min, repeated once Thrombolytic catheter was used if residual thrombus remained	n = 33 CDT Multi-hole catheter with urokinase using a micropump Continuous until DVT was unobstructed or complications occurred	Unclear

Abbreviations: ATTRACT, Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis; CDT, catheter directed thrombolysis; DVT, deep vein thrombosis; IQR, interquartile range; IVC, inferior vena cava; LMWH, low molecular weight heparin; MT, mechanical thrombectomy; PEARL, Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths; PMT, pharmacomechanical thrombectomy; PTS, post-thrombotic syndrome; RT, rheolytic thrombectomy; rtPA, recombinant tissue plasminogen activator; SD, standard deviation; UAT, ultrasound-accelerated thrombolysis; UFH, unfractionated heparin.

^aOutcomes are reported under the arterial population group elsewhere in this report (see Table 3 for additional details).

^bFull study included additional 145 patients with arterial thrombosis, evaluated elsewhere in this report.