Criteria for exclusion/inclusion in the study
| Inclusion criteria |
| Age ≥18 y |
| First episode of proximal VTE of lower limbs and/or PE that was: |
| idiopathic or associated with one or more of following factors: |
| minor, arthroscopic, or laparoscopic general surgery |
| pregnancy or puerperium |
| contraceptive or replacement hormonal therapy |
| long trip (>6 h) |
| minor trauma (not requiring hospitalization, plaster casting, or immobilization) |
| hospitalization in a medical hospital |
| reduced mobility (not complete immobilization) |
| Anticoagulation therapy (VKA, INR 2.0-3.0) for at least 3 mo |
| Ability to provide informed consent |
| Prespecified criteria for exclusion |
| Age <18 y |
| Duration of anticoagulation <3 mo |
| Inability or refusal to give consent |
| Limited life expectation (<1 y) |
| Increased systolic pulmonary arterial pressure (values ≥35 mm Hg [or ≥40 mm Hg if BMI ≥30 or age ≥75 y] estimated with echocardiography) |
| Geographical inaccessibility |
| Venous thrombosis in different sites (upper limbs, splanchnic veins, jugular or cerebral veins) |
| Pregnancy or puerperium (first 6 weeks after birth) at the time of screening examination |
| Severe renal (creatinine level >2 mg/dL [177 μmol/L]) or liver failure (eg, acute hepatitis, chronic active hepatitis, or cirrhosis; or an alanine aminotransferase level that was 3 times the upper limit of the normal range or higher) |
| Criteria for short anticoagulation |
| VTE post major surgery (within 3 mo) |
| VTE post bed resting (≥4 d) |
| VTE post major trauma (within 3 mo) |
| VTE post plasters or immobilization (within 3 mo) |
| High bleeding risk |
| Criteria for extended anticoagulation |
| >1 documented VTE episode (proximal DVT and/or PE) |
| Active cancer or hematologic disease |
| Antithrombin deficiency |
| Antiphospholipid antibody syndrome (Sydney criteria) |
| PE with shock or life-threatening prolonged hypotension |
| Different indications for anticoagulation |
| Severe cardiorspiratory insufficiency (NYHA 3 or 4) |
| Inclusion criteria |
| Age ≥18 y |
| First episode of proximal VTE of lower limbs and/or PE that was: |
| idiopathic or associated with one or more of following factors: |
| minor, arthroscopic, or laparoscopic general surgery |
| pregnancy or puerperium |
| contraceptive or replacement hormonal therapy |
| long trip (>6 h) |
| minor trauma (not requiring hospitalization, plaster casting, or immobilization) |
| hospitalization in a medical hospital |
| reduced mobility (not complete immobilization) |
| Anticoagulation therapy (VKA, INR 2.0-3.0) for at least 3 mo |
| Ability to provide informed consent |
| Prespecified criteria for exclusion |
| Age <18 y |
| Duration of anticoagulation <3 mo |
| Inability or refusal to give consent |
| Limited life expectation (<1 y) |
| Increased systolic pulmonary arterial pressure (values ≥35 mm Hg [or ≥40 mm Hg if BMI ≥30 or age ≥75 y] estimated with echocardiography) |
| Geographical inaccessibility |
| Venous thrombosis in different sites (upper limbs, splanchnic veins, jugular or cerebral veins) |
| Pregnancy or puerperium (first 6 weeks after birth) at the time of screening examination |
| Severe renal (creatinine level >2 mg/dL [177 μmol/L]) or liver failure (eg, acute hepatitis, chronic active hepatitis, or cirrhosis; or an alanine aminotransferase level that was 3 times the upper limit of the normal range or higher) |
| Criteria for short anticoagulation |
| VTE post major surgery (within 3 mo) |
| VTE post bed resting (≥4 d) |
| VTE post major trauma (within 3 mo) |
| VTE post plasters or immobilization (within 3 mo) |
| High bleeding risk |
| Criteria for extended anticoagulation |
| >1 documented VTE episode (proximal DVT and/or PE) |
| Active cancer or hematologic disease |
| Antithrombin deficiency |
| Antiphospholipid antibody syndrome (Sydney criteria) |
| PE with shock or life-threatening prolonged hypotension |
| Different indications for anticoagulation |
| Severe cardiorspiratory insufficiency (NYHA 3 or 4) |
BMI, body mass index; INR, international normalized ratio; NYHA, New York Heart Association.