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Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation. This may require inpatient hospitalization several days prior to and after the procedure, potentially increasing medical costs and patient inconvenience. Patients undergoing such a process are initiated on heparin while their INRs drift to normal levels. Immediately prior to surgery, heparin is discontinued and restarted several hours after the procedure. Unfortunately, this process has resulted in a high incidence of surgical wound hematomas and other bleeding complications often requiring longer periods of discontinued anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce the incidence of wound hematomas by prolonging the time from surgical wound closure to the reinitiation of heparin. A small randomized trial demonstrated that there was no significant difference in the incidence of wound hematomas whether heparin was started 6 hours or 24 hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent retrospective observational study demonstrated that the incidence of wound hematomas in patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE 2004;27:358-60). Furthermore, a more recent, larger retrospective observational study reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting demonstrated that not only is performing pacemaker and ICD implantations safe without reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly smaller as compared to the strategy of reversing warfarin and initiating periprocedural heparin.
Given these findings, the hypothesis of this randomized study is that pacemaker and ICD implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study will have significant implications on the clinical practice of pacemaker or ICD implantation in this patient population given that no randomized study on this subject has been performed to date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure. |
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| 2 | Active Comparator | Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize). |
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| 3 | Experimental | High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure. |
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| 4 | Active Comparator | High risk patients randomized to holding coumadin for 4-5 days and using "bridging" anticoagulation with heparin while the coumadin is held. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continue warfarin through the procedure | Drug | The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Complication | Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy. | 30 days |
| Thromboembolic Events | 30 days | |
| Anticoagulant Related Complications | Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Cheng, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States | ||
| Howard County General Hospital |
Two patients from each treatment arm were excluded from the analysis. Three of these patients withdrew after being told of the treatment assignment, and one patient's procedure was cancelled owing to need for a left ventricular assist device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Risk Continuing Warfarin (Coumadin) | Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure. These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Hold warfarin | Drug | For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure. |
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| Warfarin held with heparin transition. | Drug | For high risk patients, warfarin is held for 4-5 days prior to the procedure and heparin is given to provide anticoagulation while the INR is subtherapeutic. |
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| Columbia |
| Maryland |
| 21045 |
| United States |
| FG001 |
| Moderate Risk Holding Warfarin (Coumadin) |
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize). These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure. |
| FG002 | High Risk Continuing Warfarin (Coumadin) | High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure. These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. |
| FG003 | High Risk Holding Warfarin (Coumadin) | These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Risk Continuing Warfarin | Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure. These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. |
| BG001 | Moderate Risk Holding Warfarin | Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize). These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure. |
| BG002 | High Risk Continuing Warfarin | High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure. These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. |
| BG003 | High Risk Holding Warfarin | These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Complication | Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy. | Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024). | Posted | Number | participants | 30 days |
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| Primary | Thromboembolic Events | Posted | Number | participants | 30 days |
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| Primary | Anticoagulant Related Complications | Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia | Posted | Number | participants | 30 days |
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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 | Moderate Risk Continuing Warfarin | Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure. These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG001 | Moderate Risk Holding Warfarin | Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize). These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure. | 0 | 42 | 1 | 42 | 1 | 42 |
| EG002 | High Risk Continuing Warfarin | High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | High Risk Holding Warfarin | These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging. | 0 | 8 | 0 | 8 | 2 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attack | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pocket Hematoma | Blood and lymphatic system disorders |
| |||
| Pericardial Effusion | Blood and lymphatic system disorders |
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Evaluation period was limited to 4-6 weeks after implantation and mean INR levels in the warfarin continuation group did not reach levels above 2.5. This was a single center trial with experienced electrophysiologists using a common technique.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Henrikson, MD | Johns Hopkins Medical Institutions | 503 494 7400 | chenriks@jhmi.edu |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| D006349 | Heart Valve Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging. |
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| OG003 | High Risk Holding Warfarin (Coumadin) | These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging. |
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