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. 2023 Nov 24;12(2):101726. doi: 10.1016/j.jvsv.2023.101726

Supplementary Table I (online only).

Inclusion and exclusion criteria in the analyzed trials

Author Inclusion criteria Exclusion criteria Patient selection according to thrombus location close to the junction
Marchiori A et al, 200218
  • 1) Symptomatic thrombophlebitis of the GSV,

  • 2) confirmed by ultrasonography,

  • 3) proximal (ie, above-knee) venous system.

  • 1) Under 18 years,

  • 2) thrombotic involvement of the SFJ (<1 cm from the junction),

  • 3) concomitant DVT,

  • 4) previous DVT not followed by complete, ultrasound-confirmed recanalization,

  • 5) clinical suspicion of PE,

  • 6) previous thigh SVT,

  • 7) congenital or acquired bleeding disorders,

  • 8) known hypersensitivity or contraindications to heparin,

  • 9) anticoagulant therapy ongoing or required for concomitant diseases,

  • 10) body weight <50 kg,

  • 11) pregnancy.

SVT within 1 cm of the SFJ excluded
STENOX, 200319
  • 1) Older than 18

  • 2) weighing 45 to 110 kg

  • 3) acute SVT of lower limbs

  • 4) confirmed by ultrasound

  • 5) at least 5 cm long

  • 1) 2 or more SVT,

  • 2) SVT following sclerotherapy,

  • 3) DVT on initial DUS,

  • 4) documented PE,

  • 5) pregnant, breastfeeding, or not using contraception (if women of childbearing age),

  • 6) known thrombophilia,

  • 7) uncontrolled arterial hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure >110 mm Hg, or both),

  • 8) previous or active peptic ulcer,

  • 9) bacterial endocarditis, stroke within the previous 3 months,

  • 10) other conditions favoring hemorrhage,

  • 11) history of hypersensitivity to heparins,

  • 12) heparin-induced thrombocytopenia,

  • 13) hypersensitivity to paracetamol or NSAIDs,

  • 14) serum creatinine concentration above 1.81 mg/dL (>160 μmol/L),

  • 15) platelet count below 100×103/μL,

  • 16) prothrombin ratio below 60%,

  • 17) contraindication to elastic bandages or support stockings,

  • 18) patients who required anticoagulant therapy,

  • 19) patients who required ligation of the SFJ,

  • 20) patients who required thrombectomy

  • 21) received any type of anticoagulant therapy or NSAIDs for more than 48 hours

Those who required ligation or full therapeutic anticoagulation excluded
Lozano FS et al, 200320
  • 1) Internal saphenous thrombophlebitis above the knee close to its junction with the femoral vein

  • 2) met the basic selection requirements for patients eligible for outpatient treatment of DVT.

  • 3) underwent echo-Doppler (to determine the extension of SVT and the condition of the deep venous system lower limbs)

  • 1) Associated DVT,

  • 2) treatment with oral anticoagulants,

  • 3) known systemic disorders (neoplasm or thrombophilia).

SVT with thrombus close to the junction included
Prandoni P et al (VESALIO), 200521
  • 1) Recent (<10 days) clinical symptoms suggestive of acute SVT of the legs

  • 2) a thrombus involving the GSV and extending up to 3 cm from the SFJ confirmed by ultrasonography,

  • 3) the contemporary presence of DVT excluded by ultrasonography

  • 1) Younger than 18 years,

  • 2) pregnant,

  • 3) received saphenectomy,

  • 4) a history of previous (<1 year) SVT in the affected leg,

  • 5) concurrent or previous VTE,

  • 6) congenital or acquired bleeding disorders contraindicating heparin treatment,

  • 7) thrombocytopenia (platelet count <100×109/L),

  • 8) ongoing anticoagulant or antiplatelet therapy for other indications,

  • 9) received full-dose anticoagulants for more than 48 h,

  • 10) known thrombophilia,

  • 11) known hypersensitivity to heparin or derivatives,

  • 12) active gastro-duodenal ulcer,

  • 13) active cancer,

  • 14) severe renal insufficiency (serum creatinine level >180 mmol/L),

  • 15) severe hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg),

  • 16) previous hemorrhagic stroke or a recent (<1 month) ischemic stroke.

SVT within 3 cm of the SFJ excluded
Decousus H et al (CALISTO), 201022
  • 1) 18 years of age or older,

  • 2) acute, symptomatic lower-limb SVT.

  • 3) at least 5 cm long confirmed by ultrasonography

  • 1) More than 3 weeks between the onset of symptoms and randomization,

  • 2) treated for cancer within the previous 6 months,

  • 3) symptomatic or asymptomatic DVT, symptomatic documented PE,

  • 4) SVT associated with sclerotherapy or placement of an intravenous catheter,

  • 5) within 3 cm of the SFJ,

  • 6) history of SVT within the previous 3 months,

  • 7) DVT or PE within the previous 6 months,

  • 8) received an antithrombotic agent for more than 48 hours (other than aspirin at a dose ≤325 mg per day),

  • 9) received NSAID for more than 72 hours as treatment for the current episode of SVT,

  • 10) if, in the investigator's opinion, required ligation of the SPJ or stripping of varicose veins,

  • 11) major surgery within the previous 3 months,

  • 12) conditions that could confer a predisposition to bleeding, including severe hepatic impairment, a creatinine clearance of less than 30 ml per minute, and a platelet count of less than 100,000 per cubic millimeter,

  • 13) pregnant or not using a reliable contraceptive method.

SVT within 3 cm of the SFJ excluded
Rathbun SW et al, 201223
  • 1) SVT of the lower or upper extremities, objectively confirmed by ultrasound,

  • 2) absence of a current intravenous catheter

  • 1) Receiving anticoagulant therapy, including warfarin, heparin or LMWH for > 24 hour duration

  • 2) concurrent DVT,

  • 3) active, clinically significant bleeding,

  • 4) known hypersensitivity to NSAIDs, heparin or derivatives,

  • 5) currently pregnant or <1 week post-partum,

  • 6) a history of a bleeding gastric or duodenal ulcer in the past year,

  • 7) a history of a hemorrhagic cerebrovascular event in past year,

  • 8) platelet count <100000,

  • 9) known inherited or an acquired bleeding disorder,

  • 10) serum creatinine >2 mg/dL,

  • 11) blood pressure >180/110 at the time of enrollment,

  • 12) weight <40 kg or >135 kg,

  • 13) unable to return for repeat diagnostic testing or follow-up visits.

Not reported
Cosmi B et al (STEFLUX), 201224
  • 1) Age >18 years,

  • 2) weight above 50 kg and <130 kg,

  • 3) SVT of the GSV or short saphenous vein or their collaterals at least 4 cm in length,

  • 4) an ability to provide informed consent

  • 1) SVT within 3 cm of the SFJ or SPJ,

  • 2) documented proximal or distal DVT or PE,

  • 3) SVT secondary to sclerotherapy,

  • 4) pregnancy or puerperium,

  • 5) uncontrolled arterial hypertension (systolic pressure >180 mmHg and diastolic pressure >110 mmHg),

  • 6) active peptic ulcer,

  • 7) bacterial endocarditis, stroke in the previous 3 months,

  • 8) hemorrhagic diathesis, thrombocytopenia (platelets <100000/μL),

  • 9) hypersensitivity to heparin or a history of heparin-induced thrombocytopenia,

  • 10) creatinine >2 mg/dL (>180 μmol/L),

  • 11) heparin therapy (any dose) or anticoagulant therapy for more than 72 hours,

  • 12) in-hospital development of SVT,

  • 13) previous saphenectomy,

  • 14) surgery in the previous 30 days,

  • 15) serious liver disease,

  • 16) use of dextran, mannitol, thrombolytic treatment,

  • 17) chronic use of NSAIDs,

  • 18) active cancer or undergoing chemotherapy or radiotherapy (except adjuvant hormonal therapy),

  • 19) thrombectomy of superficial vein involved,

  • 20) refusal to give informed consent.

SVT within 3 cm of SFJ or SPJ excluded
Spirkoska A et al, 201525
  • 1) Ultrasonographically confirmed first symptomatic presentation,

  • 2) acute SVT of lower extremities (<5 days after the onset of the symptoms),

  • 3) ultrasonographically confirmed thrombus length of at least 10 cm in the GSV, SSV, or major tributaries of the GSV,

  • 4) body weight 65 to 90 kg,

  • 5) age 18 to 85 years.

  • 1) Concomitant DVT and/or PE,

  • 2) thrombosis extending closer than 5 cm to the SFJ or 3 cm to the SPJ,

  • 3) inability to objectively confirm the diagnosis,4) history of previous venous thromboembolism (DVT, PE, or SVT),

  • 5) secondary vein thrombosis as a consequence of previous trauma or intravenous access,

  • 6) contraindications for anticoagulant treatment,

  • 7) thrombocytopenia (<100 × 109/l),

  • 8) previous or recent malignancy, sepsis, autoimmune disorders, pregnancy, hormone therapy,

  • 9) hepatic or renal insufficiency (glomerular filtration rate <50 ml/min/1.73 m2),

  • 10) receiving anti-inflammatory treatment (except aspirin ≤100 mg/ day).

SVT within 5 cm of the SFJ or 3 cm of SPJ excluded
Beyer-Westendorf J et al (SURPRISE), 201714
  • 1) Symptomatic SVT involving a 5 cm or longer segment,

  • 2) confirmed by ultrasound

  • 3) superficial vein above the knee,

  • With at least one of the following risk factors for VTE:

  • - older than 65 years,

  • - male sex,

  • - previous SVT or DVT or PE,

  • - active cancer or history of cancer,

  • - autoimmune disease,

  • - involvement of non-varicose veins.

  • 1) Symptoms for >3 weeks,

  • 2) SVT within 3 cm of the SFJ,

  • 3) treated for the index event for more than 3 days with therapeutic doses of anticoagulants or for >5 days with prophylactic doses,

  • 4) concomitant DVT or another indication for full-dose anticoagulation,

  • 5) severe hepatic disease associated with a coagulopathy,

  • 6) creatinine clearance <30 mL per min,

  • 7) contraindications to anticoagulant treatment.

SVT within 3 cm of SFJ excluded
Kearon C et al, 202026
  • 1) Symptomatic SVT of the leg,

  • 2) at least 5 cm length diagnosed on clinical grounds, with or without, confirmatory findings on an ultrasound examination.

  • 1) <18 years,

  • 2) symptoms present for more than 42 days,

  • 3) receiving or needs to receive an anticoagulant for another indication,

  • 4) SVT has already been treated with >3 days of anticoagulant therapy,

  • 5) SVT judged to require a course of anticoagulant therapy or surgical management,

  • 6) proximal DVT or PE within the past 12 months,

  • 7) SVT associated with sclerotherapy or an intravenous cannula,

  • 8) high risk for bleeding,

  • 9) creatinine clearance less than 30 mL/min,

  • 10) on a medication that is expected to interact importantly with rivaroxaban.

Those who required surgical management or full therapeutic anticoagulation excluded
Ascer E et al, 199527
  • 1) SVT involving the GSV up to within 1 cm of SFJ,

  • 2) confirmed by DUS

  • 1) Absence of trauma or malignancy,

  • 2) no contraindication to anticoagulation.

SVT with thrombus close to the junction included
Gorty S et al, 200428
  • 1) DUS-documented new-onset SVT of leg,

  • 2) a history and physical examination at out office.

  • 1) Incomplete records,

  • 2) lack of follow-up,

  • 3) chronic SVT.

Not reported
Decousus H et al (POST), 20105
  • 1) 18 years or older,

  • 2) symptomatic lower-limb SVT,

  • 3) confirmed by ultrasonography,

  • 4) more than 5 cm in length on ultrasonography.

  • 1) Surgery in the previous 10 days,

  • 2) sclerotherapy in the previous 30 days,

  • 3) follow-up not considered feasible.

Not reported
Sartori M et al, 201629
  • 1) Objectively confirmed SVT diagnosis

  • 1) Younger than 18 years,

  • 2) pregnant or in puerperium,

  • 3) with established diagnosis of concomitant DVT or symptoms attributable to PE,

  • 4) with life expectancy of <3 months,

  • 5) undergoing radiotherapy or chemotherapy,

  • 6) clinical or laboratory findings compatible with disseminated intravascular coagulation, sepsis,

  • 7) clinical or laboratory findings compatible with liver cirrhosis,

  • 8) chronic renal failure with creatinine clearance <30 ml/min,

  • 9) treated with anticoagulant agents other than LMWH,

  • 10) SVT located within 3 cm of the SFJ.

SVT within 3 cm of the SFJ excluded
Samuelson B et al, 201630
  • 1) ICD-9-CM diagnosis code of venous thrombosis,

  • 2) between January 1, 2004 and December 31, 2010,

  • 3) isolated SVT: no evidence of a DVT or PE,

  • 4) medical chart documentation of either ultrasound evidence of a superficial vein clot or a clinical description of SVT,

  • 5) review by second physician reviewer to confirm the diagnosis of SVT.

Not indicated Not reported
Blin P et al, 201731
  • 1) Acute symptomatic spontaneous isolated SVT of the lower limbs,

  • 2) confirmed by compression ultrasonography

  • 1) SVT secondary to sclerotherapy or a venous catheter,

  • 2) concomitant DVT or PE,

  • 3) anticoagulant use for another reason than SVT,

  • 4) clinical trial inclusion.

Not reported
Barco S et al (ICARO), 201732
  • 1) Acute symptomatic isolated SVT diagnosed on compression B-mode ultrasound or echo-color Doppler,

  • 2) previously included in the cross-sectional ICARO study,

  • 3) with available follow-up of a minimum of 30 days.

  • 1) Presence of signs or symptoms of PE and/or an established diagnosis of PE,

  • 2) detection of concomitant DVT,

  • 3) follow-up duration of <30 days.

Not reported
Gouveia S et al, 201833
  • 1) Confirmed on compression ultrasonography;

  • 2) leg SVT,

  • 3) absence of co-existent DVT.

  • 1) Active cancer,

  • 2) a thrombus ≤3 cm from SFJ,

  • 3) treatment with other anticoagulant regimens or NSAIDs.

SVT within 3 cm of the SFJ excluded
Geersing GJ et al, 20183
  • 1) ICPC code of SVT in addition to automated ‘free text searching’ in all patient contacts using a variety of synonyms for SVT,

  • 2) the GP clearly described signs and symptoms related to a new SVT diagnosis,

  • 1) Findings were not clearly reported;

  • 2) SVT was only considered in differential diagnosis but finally ‘ruled-out’ (not managed accordingly) by the general practitioner,

  • 3) SVT was part of a patient’s medical history rather than related to current and new complaints.

Not reported
Karathanos C et al (SeVEN), 202134
  • 1) Aged 18 years

  • 2) symptomatic SVT of the legs,

  • 3) thrombus length 5 cm confirmed by DUS,

  • 4) duration of symptoms less than 10 days.

  • 1) Proximal extension of the SVT <3 cm from the SFJ or SPJ,

  • 2) history of DVT or PE within the last 6 months,

  • 3) SVT after sclerotherapy,

  • 4) placement of an intravenous catheter within the past 1 month,

  • 5) body mass index >35 kg/m2 ,

  • 6) receiving medication that affects blood coagulation (acetylsalicylic acid, vitamin K antagonists, dextrane),

  • 7) subjected to spinal or epidural anesthesia within 48 hours prior to study inclusion,

  • 8) history of major surgery within last 3 months,

  • 9) history of cerebral surgery, trauma and/or bleeding within last 1 month.

SVT within 3 cm of the SFJ or SPJ excluded
Karathanos C et al (SeVEN), 202335
  • 1) Aged 18 years2) symptomatic SVT of the legs,

  • 3) thrombus length 5 cm confirmed by DUS,

  • 4) duration of symptoms less than 10 days.

  • 1) Proximal extension of the SVT <3 cm from the saphenofemoral or saphenopoplitelal junction,

  • 2) history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 6 months,

  • 3) SVT after sclerotherapy,

  • 4) placement of an intravenous catheter within the past 1 month,

  • 5) body mass index >35 kg/m2,

  • 6) receiving medication that affect blood coagulation (acetylsalicylic acid, vitamin K antagonists, dextrane),

  • 7) subjected to spinal or epidural anaesthesia within 48 hours prior to study inclusion,

  • 8) history of major surgery within last 3 months,

  • 9) history of cerebral surgery, trauma and/or bleeding within last 1 month.

SVT within 3 cm of the SFJ or SPJ excluded
Clapham R et al, 202236
  • 1) Isolated SVT confirmed by compression ultrasonography.

  • 1) Thrombus within 3 cm of SFJ,

  • 2) conservative management,

  • 3) treatment with alternative antiocoagulant,

  • 4) treatment interrupted due to other conditions.

SVT within 3 cm of the SFJ excluded
Casian D et al., 202237
  • 1) Clinical manifestations of SVT and varicose veins of lower limbs,

  • 2) age 18 years or more,

  • 3) first episode of SVT confirmed by DUS,

  • 4) duration of SVT symptoms ≤14 days.

  • 1) Ipsilateral or contralateral lower limb DVT,

  • 2) SVT of non-varicose veins,

  • 3) SVT associated to treatment of varicose veins (thermal ablation, sclerotherapy),

  • 4) administration of any anticoagulants for more than 48 hours.

Not reported
Rabe E et al (INSIGHTS-SVT), 202338
  • 1) Objectively confirmed acute isolated SVT of the lower extremities,

  • 2) concomitant DVT excluded by compression ultrasound or duplex sonography,

  • 3) no symptoms of PE.

  • 1) Proximal extension of SVT located ≤3 cm from the SFJ,

  • 2) unlikely to comply with the study’s protocol due to cognitive or language limitations,

  • 3) unlikely to be available for 12-month follow-up.

SVT within 3 cm of the SFJ excluded

DUS, Duplex ultrasound scan; DVT, deep vein thrombosis; GP, general practitioner; GSV, great saphenous vein; ICD-CM, International Classification of Diseases, Clinical Modification; ICPC, International Classification of Primary Care; LMWH, low-molecular weight heparin; NSAID, non-steroidal anti-inflammatory drug; PE, pulmonary embolism; SFJ, sapheno-femoral junction; SPJ, sapheno-popliteal junction; SSV, small saphenous vein; SVT, superficial vein thrombosis; VTE, venous thromboembolism.