Heart Valve Disease
Conditions
Keywords
mechanical valves replacement, INR, D-dimer, thromboembolic events
Brief summary
The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation. This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.
Detailed description
Background: The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation. Objective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses. Methods: A single-center, prospective study was performed. 748 Patients with mechanical valve replacement who had received oral anticoagulation. The patients were randomly assigned to three groups The intensity of anticoagulation for group one was standard intensity (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times at 3 month later. In case of D-dimer level elevated, adjusted the intensity of anticoagulation to standard level. The endpoint of the study was the subsequent thromboembolic and major bleeding during an average follow-up of 2 years.
Interventions
DRUGWarfarin
Sponsors
Wuhan Asia Heart Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. age\>18years,male or female without pregnancy; 2. Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital; 3. The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).
Exclusion criteria
Patients with following diseases within 3 months. 1. deep venous thromboembolism 2. Pulmonary embolism 3. Aortic dissection 4. stroke 5. Cerebral hemorrhage 6. Myocardial infarction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Events; | Up to 24 months | The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion. |
| Thrombotic Events | 24 months | The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Deaths | Up to 24 months | The deaths from all causes |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Intensity of Anticoagulation After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin | 237 |
| Low Intensity and Adjusted by Elevated D-dimer The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin | 239 |
| Low Intensity Without Adjustment The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin | 234 |
| Total | 710 |
Baseline characteristics
| Characteristic | Standard Intensity of Anticoagulation | Low Intensity and Adjusted by Elevated D-dimer | Low Intensity Without Adjustment | Total |
|---|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 11.5 | 50.4 years STANDARD_DEVIATION 11.9 | 50.1 years STANDARD_DEVIATION 10.9 | 49.8 years STANDARD_DEVIATION 11.3 |
| Elevated D-dimer(n) | 17 participants | 36 participants | 38 participants | 91 participants |
| Sex: Female, Male Female | 113 Participants | 102 Participants | 96 Participants | 311 Participants |
| Sex: Female, Male Male | 124 Participants | 137 Participants | 138 Participants | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 245 | 4 / 245 | 5 / 242 |
| other Total, other adverse events | 0 / 245 | 0 / 245 | 0 / 242 |
| serious Total, serious adverse events | 24 / 245 | 9 / 245 | 20 / 242 |
Outcome results
Primary
Bleeding Events;
The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Intensity of Anticoagulation | Bleeding Events; | 16 Participants |
| Low Intensity and Adjusted by Elevated D-dimer | Bleeding Events; | 3 Participants |
| Low Intensity Without Adjustment | Bleeding Events; | 4 Participants |
Primary
Thrombotic Events
The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Intensity of Anticoagulation | Thrombotic Events | 5 Participants |
| Low Intensity and Adjusted by Elevated D-dimer | Thrombotic Events | 5 Participants |
| Low Intensity Without Adjustment | Thrombotic Events | 14 Participants |
Secondary
All Cause Deaths
The deaths from all causes
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Intensity of Anticoagulation | All Cause Deaths | 12 Participants |
| Low Intensity and Adjusted by Elevated D-dimer | All Cause Deaths | 4 Participants |
| Low Intensity Without Adjustment | All Cause Deaths | 5 Participants |