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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
| |
| Low intensity without adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Thrombotic Events | The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Deaths | The deaths from all causes | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria: Patients with following diseases within 3 months.
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Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin
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| Name | Affiliation | Role |
|---|---|---|
| zhang zhenlu, PH.D | Wuhan Asia Heart Hospital | Study Director |
| Zhou xin, Doctor | Wuhan Asia Heart Hospital | Study Chair |
| liu ze jin, PH.D | Wuhan Asia Heart Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WAHH | Wuhan | Hubei | 430000 | China | ||
| Wuhan Asia Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31019170 | Derived | Zhang L, Long Y, Xiao H, Yang J, Liu X, Zhang Z. D-Dimer to Predict the Clinical Outcomes in Patients with Mechanical Heart Valve Replacement During Oral Anticoagulation Therapy. Int Heart J. 2019 May 30;60(3):631-636. doi: 10.1536/ihj.18-237. Epub 2019 Apr 25. | |
| 28762606 | Derived | Zhang L, Zheng X, Long Y, Wu M, Chen Y, Yang J, Liu Z, Zhang Z. D-dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial. J Thromb Haemost. 2017 Oct;15(10):1934-1941. doi: 10.1111/jth.13782. Epub 2017 Sep 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Low Intensity Without Adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Warfarin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Low Intensity and Adjusted by Elevated D-dimer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombotic envents | Blood and lymphatic system disorders | Non-systematic Assessment | including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Litao Zhang | Wuhan Asia Heart Hospital | +862765796888 | 8204 | zhengleetau@qq.com |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Plasma
| Wuhan |
| Hubei |
| 430022 |
| China |
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 |
| BG002 | Low Intensity Without Adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Warfarin |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Elevated D-dimer(n) | Number | participants |
|
| OG002 | Low Intensity Without Adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Warfarin |
|
|
| Primary | Thrombotic Events | The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | All Cause Deaths | The deaths from all causes | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| 12 |
| 245 |
| 24 |
| 245 |
| 0 |
| 245 |
| EG001 | D-dimer-guided Adjustmentd of Anticoagutlation Intensity | 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 | 4 | 245 | 9 | 245 | 0 | 245 |
| EG002 | Low Intensity Without Adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Warfarin | 5 | 242 | 20 | 242 | 0 | 242 |
|
| bleeding events | Blood and lymphatic system disorders | Non-systematic Assessment | including 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. |
|
| Deaths from other causes | Cardiac disorders | Non-systematic Assessment | Death from Heart failure,Cancer or unexplained death |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |