Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

University of Sao Paulo

Status: Completed

Conditions: Cardiac Pacing; Complications; Venous Thrombosis

Treatments: Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT00621491

SDC 2273/03/067

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 101 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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101 participants in 1 patient group, including a placebo group

1

Placebo Comparator group

Description:

Single daily dose of Placebo during six months

Treatment:

Drug: Warfarin