Venous Thromboembolism
Conditions
Brief summary
Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement 2. Patients 18 years of age or older at the time of recruitment
Exclusion criteria
1. Patients presenting contraindication to prescription of Pradaxa 2. Patients in whom long term Anti vitamin K treatment is indicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Symptomatic Venous Thromboembolic Events | 11 weeks | Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE). |
| Occurrence of Major Bleeding Events | 11 weeks | Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Treatment | 11 weeks | — |
| Proportion of Patients With a Preoperative ALT Measurement | 11 weeks | — |
| Adherence to Treatment | 11 weeks | The adherence to treatment was measured by patient declaration. |
| Concomitant Treatments | 11 weeks | Concomitant treatments prescribed at hospital discharge. |
| Number of Patients Who Switched to Another Anticoagulant Therapy | 11 weeks | Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose. |
| Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 11 weeks | — |
| Dosage of Pradaxa at Initiation | Baseline | — |
| Reasons for Nurse Visits on the Day of Hospital Discharge | 11 weeks | — |
| Frequency of Nurse Visits on the Day of Hospital Discharge | 11 weeks | — |
| Duration of Unplanned Hospitalizations at Visit 3 | 11 weeks | — |
| Reasons for Unplanned Hospitalizations at Visit 3 | 11 weeks | — |
| Reasons for Usual Follow-up | 11 weeks | — |
| Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | 11 weeks | — |
| Duration Between Surgery and First Dose of Pradaxa | 11 weeks | — |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Knee Replacement Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. | 746 |
| Total Hip Replacement Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. | 929 |
| Total | 1,675 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 27 |
| Overall Study | Lack of Efficacy | 15 | 7 |
| Overall Study | No documentation of treatment | 1 | 0 |
| Overall Study | Other | 28 | 75 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Total Knee Replacement | Total Hip Replacement | Total |
|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 9.5 | 67.8 years STANDARD_DEVIATION 11.7 | 68.69 years STANDARD_DEVIATION 10.78 |
| Creatinine clearance | 86.4 mL/min STANDARD_DEVIATION 29.6 | 85.1 mL/min STANDARD_DEVIATION 31.9 | 85.7 mL/min STANDARD_DEVIATION 30.9 |
| Current treatment Amiodarone | 7 participants | 7 participants | 14 participants |
| Current treatment Aspirin | 56 participants | 45 participants | 101 participants |
| Current treatment Clopidogrel | 5 participants | 3 participants | 8 participants |
| Current treatment Hydroquinidin | 0 participants | 0 participants | 0 participants |
| Current treatment NSAID | 92 participants | 125 participants | 217 participants |
| Current treatment Verapamil | 4 participants | 3 participants | 7 participants |
| Duration of the surgery | 80.8 minutes STANDARD_DEVIATION 27.5 | 70.1 minutes STANDARD_DEVIATION 28.6 | 74.9 minutes STANDARD_DEVIATION 28.1 |
| Height | 164.6 cm STANDARD_DEVIATION 9.1 | 166.8 cm STANDARD_DEVIATION 9.1 | 165.8 cm STANDARD_DEVIATION 9.1 |
| Indication for the surgery Inflammatory arthritis | 6 participants | 10 participants | 16 participants |
| Indication for the surgery Osteoarthritis | 701 participants | 818 participants | 1519 participants |
| Indication for the surgery Osteonecrosis | 7 participants | 30 participants | 37 participants |
| Indication for the surgery Other | 2 participants | 9 participants | 11 participants |
| Indication for the surgery Post-trauma | 6 participants | 19 participants | 25 participants |
| Indication for the surgery Repair of existing prothesis | 24 participants | 42 participants | 66 participants |
| Participants with a Alanine Aminotransferase (ALT) of >2x normal upper limit | 29 participants | 40 participants | 69 participants |
| Participants with at least one cardiovascular risk factor | 543 participants | 586 participants | 1129 participants |
| Participants with at least one concomitant disease | 176 participants | 203 participants | 379 participants |
| Participants with at least one thromboembolic risk factor | 151 participants | 145 participants | 296 participants |
| Previous treatment Amiodarone | 7 participants | 7 participants | 14 participants |
| Previous treatment Aspirin | 83 participants | 79 participants | 162 participants |
| Previous treatment Clopidogrel | 12 participants | 15 participants | 27 participants |
| Previous treatment Hydroquindin | 0 participants | 0 participants | 0 participants |
| Previous treatment NSAID | 402 participants | 509 participants | 911 participants |
| Previous treatment Verapimil | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 497 Participants | 494 Participants | 991 Participants |
| Sex: Female, Male Male | 249 Participants | 435 Participants | 684 Participants |
| Type of anesthesia Epidural | 0 participants | 1 participants | 1 participants |
| Type of anesthesia General | 463 participants | 742 participants | 1205 participants |
| Type of anesthesia Spinal | 281 participants | 187 participants | 468 participants |
| Type of orthopedic surgery | 746 participants | 929 participants | 1675 participants |
| Weight | 79.6 kilogramm STANDARD_DEVIATION 16.3 | 74.5 kilogramm STANDARD_DEVIATION 15.6 | 76.8 kilogramm STANDARD_DEVIATION 15.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 746 | 0 / 929 |
| serious Total, serious adverse events | 48 / 746 | 37 / 929 |
Outcome results
Primary
Occurrence of Major Bleeding Events
Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Occurrence of Major Bleeding Events | 8 participants |
| Total Hip Replacement | Occurrence of Major Bleeding Events | 16 participants |
Primary
Occurrence of Symptomatic Venous Thromboembolic Events
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Occurrence of Symptomatic Venous Thromboembolic Events | 19 participants |
| Total Hip Replacement | Occurrence of Symptomatic Venous Thromboembolic Events | 5 participants |
Secondary
Adherence to Treatment
The adherence to treatment was measured by patient declaration.
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Replacement | Adherence to Treatment | 98.6 percent | Standard Deviation 24.6 |
| Total Hip Replacement | Adherence to Treatment | 97.3 percent | Standard Deviation 24.6 |
Secondary
Concomitant Treatments
Concomitant treatments prescribed at hospital discharge.
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Knee Replacement | Concomitant Treatments | NSAID | 150 participants |
| Total Knee Replacement | Concomitant Treatments | Clopidogrel | 9 participants |
| Total Knee Replacement | Concomitant Treatments | Verapamil | 4 participants |
| Total Knee Replacement | Concomitant Treatments | Amiodarone | 7 participants |
| Total Knee Replacement | Concomitant Treatments | Aspirin | 79 participants |
| Total Knee Replacement | Concomitant Treatments | Hydroquinidin | 0 participants |
| Total Hip Replacement | Concomitant Treatments | Aspirin | 61 participants |
| Total Hip Replacement | Concomitant Treatments | Verapamil | 3 participants |
| Total Hip Replacement | Concomitant Treatments | NSAID | 143 participants |
| Total Hip Replacement | Concomitant Treatments | Hydroquinidin | 0 participants |
| Total Hip Replacement | Concomitant Treatments | Clopidogrel | 8 participants |
| Total Hip Replacement | Concomitant Treatments | Amiodarone | 6 participants |
Secondary
Dosage of Pradaxa at Initiation
Time frame: Baseline
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Knee Replacement | Dosage of Pradaxa at Initiation | 75 mg/day | 142 participants |
| Total Knee Replacement | Dosage of Pradaxa at Initiation | 110 mg/day | 394 participants |
| Total Knee Replacement | Dosage of Pradaxa at Initiation | 150 mg/day | 80 participants |
| Total Knee Replacement | Dosage of Pradaxa at Initiation | 220mg/day | 130 participants |
| Total Hip Replacement | Dosage of Pradaxa at Initiation | 220mg/day | 228 participants |
| Total Hip Replacement | Dosage of Pradaxa at Initiation | 75 mg/day | 162 participants |
| Total Hip Replacement | Dosage of Pradaxa at Initiation | 150 mg/day | 122 participants |
| Total Hip Replacement | Dosage of Pradaxa at Initiation | 110 mg/day | 417 participants |
Secondary
Duration Between Surgery and First Dose of Pradaxa
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Replacement | Duration Between Surgery and First Dose of Pradaxa | 12.6 hours | Standard Deviation 14.5 |
| Total Hip Replacement | Duration Between Surgery and First Dose of Pradaxa | 14.6 hours | Standard Deviation 16.8 |
Secondary
Duration of Treatment
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Replacement | Duration of Treatment | 27.5 days | Standard Deviation 11.8 |
| Total Hip Replacement | Duration of Treatment | 33.3 days | Standard Deviation 10.4 |
Secondary
Duration of Unplanned Hospitalizations at Visit 3
Time frame: 11 weeks
Population: Outcome measure was not analyzed.
Secondary
Frequency of Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Replacement | Frequency of Nurse Visits on the Day of Hospital Discharge | Wound dressing care | 2.3 times per week | Standard Deviation 0.9 |
| Total Knee Replacement | Frequency of Nurse Visits on the Day of Hospital Discharge | Blood sample for platelet count | 1.7 times per week | Standard Deviation 0.5 |
| Total Hip Replacement | Frequency of Nurse Visits on the Day of Hospital Discharge | Wound dressing care | 2.5 times per week | Standard Deviation 0.9 |
| Total Hip Replacement | Frequency of Nurse Visits on the Day of Hospital Discharge | Blood sample for platelet count | 1.7 times per week | Standard Deviation 0.5 |
Secondary
Number of Patients Who Switched to Another Anticoagulant Therapy
Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Time frame: 11 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Number of Patients Who Switched to Another Anticoagulant Therapy | 43 participants |
| Total Hip Replacement | Number of Patients Who Switched to Another Anticoagulant Therapy | 45 participants |
Secondary
Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | 420 participants |
| Total Hip Replacement | Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | 584 participants |
Secondary
Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 24 participants |
| Total Hip Replacement | Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 44 participants |
Secondary
Proportion of Patients With a Preoperative ALT Measurement
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Knee Replacement | Proportion of Patients With a Preoperative ALT Measurement | 73.3 percentage of participants |
| Total Hip Replacement | Proportion of Patients With a Preoperative ALT Measurement | 74.5 percentage of participants |
Secondary
Reasons for Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Knee Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Wound dressing care | 366 participants |
| Total Knee Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Blood sample for platelet count | 27 participants |
| Total Knee Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Other care | 29 participants |
| Total Hip Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Wound dressing care | 510 participants |
| Total Hip Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Blood sample for platelet count | 69 participants |
| Total Hip Replacement | Reasons for Nurse Visits on the Day of Hospital Discharge | Other care | 54 participants |
Secondary
Reasons for Unplanned Hospitalizations at Visit 3
Time frame: 11 weeks
Population: Outcome measure was not analyzed.
Secondary
Reasons for Usual Follow-up
Time frame: 11 weeks
Population: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Knee Replacement | Reasons for Usual Follow-up | Re-hospitalization | 11 participants |
| Total Knee Replacement | Reasons for Usual Follow-up | Consultation in the context of usual follow-up | 201 participants |
| Total Knee Replacement | Reasons for Usual Follow-up | Consultation outside the context of usual follow-u | 19 participants |
| Total Hip Replacement | Reasons for Usual Follow-up | Re-hospitalization | 17 participants |
| Total Hip Replacement | Reasons for Usual Follow-up | Consultation in the context of usual follow-up | 292 participants |
| Total Hip Replacement | Reasons for Usual Follow-up | Consultation outside the context of usual follow-u | 28 participants |