Clinical trial NCT00621491: Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation
Official title: Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacing
Complications
Venous Thrombosis
Keywords: cardiac pacing
pacing complication
venous thrombosis
warfarin
anticoagulation
randomized trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-02-22
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of venous obstructions observed by digital subtraction venography
timeFrame: Six months
Secondary outcomes:
measure: Safety of anticoagulant therapy, morbidity and overall mortality
timeFrame: Six months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Roberto Costa, MD PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Katia R Silva, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa R, Da Silva KR, Rached R, Martinelli Filho M, Carnevale FC, Moreira LF, Stolf NA. Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.
citation: Silva KR, Costa R, Abi Rached R, Martinelli Filho M, Caldas JG, Carnevale FC, Moreira LF, Stolf NA. Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis. Rev Bras Cir Cardiovasc. 2008 Oct-Dec;23(4):542-9. doi: 10.1590/s0102-76382008000400015. English, Portuguese.