Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

Study Overview
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Brief Summary
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The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

Detailed Description
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Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography.

Official Title
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Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients

Conditions
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Cardiac Pacing, Complications, Venous Thrombosis

Intervention / Treatment
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* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices left ventricular ejection fraction ≤0.40 and/or previous transvenous temporary leads ipsilateral to the permanent device implant Exclusion Criteria: history of venous thromboembolism atrial fibrillation coagulopathy or platelet disorder malignancy gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months abnormal prothrombin time (PT)or an international normalized ratio (INR) >40%, or treated with oral anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Single daily dose of Placebo during six months | Drug: Warfarin<br>* Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months<br>* Other names: oral anticoagulants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous obstructions observed by digital subtraction venography |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of anticoagulant therapy, morbidity and overall mortality |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac pacing, pacing complication, venous thrombosis, warfarin, anticoagulation, randomized trial