Anticoagulant Therapy During Pacemaker Implantation (FINPAC)
Randomized Trial of Uninterrupted Versus Interrupted Anticoagulant Therapy in Patients Undergoing Cardiac Pacing Device Implantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite greatly increased utilization of pacemaker and internal cardioverter-defibrillator (ICD) therapy for various indications in recent years, there are relatively few published studies on bleeding complications associated with the implantation of these devices. The purpose of our study is to assess the incidence and severity of hemorrhagic complications resulting from pacemaker and ICD implantation in patients treated with oral anticoagulant warfarin or acetyl salicylic acid.
There are no unified guidelines regarding warfarin use during pacemaker implantation. A case by case approach is commonly employed regarding whether to interrupt or to continue anticoagulant therapy prior to the procedure. Interrupting the therapy may expose the patient to thromboembolic complications, whereas continuing it can increase the risk of perioperative bleeding. Thus, either approach could potentially increase patient morbidity and prolong the hospital stay. Therefore, an evidence based choice of an appropriate approach in preparing the anticoagulant-treated patients for pacemaker implantation could have significant impact on both patient safety and over-all procedural cost.
We intend to assess the rate of hemorrhagic and thrombotic complications as well as the length of hospital stay associated with pacemaker or ICD implantation in patients randomized either to continue or to interrupt their warfarin treatment. One control group will be formed of pacemaker-receiving patients on acetyl salicylic acid as well as one group of patients on no medications affecting the coagulation system or thrombocyte aggregation. Potential risk factors for bleeding or thromboembolic complications will be searched.
A total of 400 patients will be recruited into this multicenter study conducted at five hospitals in Finland. Warfarin users (n=200) will be randomly allocated into two groups: A. uninterrupted warfarin therapy maintained at accepted intensity (INR 2 to 3), and B. interruption of warfarin 2 days prior to device implantation. Control groups will comprised as described above with one hundred patients in each. The end-points of the study are: occurrences of major bleeding, haemorrhages and hematomas at pacemaker pocket, utilization of adjunctive therapies to control bleeding (e.g. Vitamin K or Fresh frozen plasma), need for surgical wound revision and thromboembolic complications. The duration of hospital stay will also be recorded. At two of the centres (Turku University Hospital and Satakunta Central Hospital) all patients will also be randomly assigned into two groups in which the implantation procedure will either be or not be guided by venous angiography.
Patients willing to participate in the study will receive both verbal and written information on the study and they will be asked to sign an informed consent. All devices will be implanted in a normal fashion according to generally accepted clinical guidelines. A variety of clinical and laboratory variables will be recorded in each study group to identify risk factors for bleeding and thromboembolism.
The aims of our study are to establish among patients implanted with pacemakers (1) whether uninterrupted warfarin therapy will increase the rate and severity of bleeding complications, (2) whether interruption of warfarin results in increased thromboembolic events, (3) whether aspirin treatment increases bleeding complications compared, and we also seek to identify factors predisposing to haemorrhagic complications.
Our main hypothesis is that a cardiac pacing device can be safely implanted without discontinuation of the anticoagulant therapy.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Turku, Finland, 20521
- Turku University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all patients admitted for implantation of a first permanent cardiac pacing device are eligible
Exclusion Criteria:
- known coagulation disorder or bleeding diathesis
- contraindications for pacing device implantation
- mechanical prosthetic heart valve
- other absolute contraindication to interrupt warfarin
- INR (international normalized ratio) above 3.0 2 days prior to implantation
- significant anemia (hemoglobin less than 100 g/L)
- warfarin interrupted before randomization and INR subtherapeutic (below 2.0)
- not to be randomized to venography: contraindications to radiographic contrast dye
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1 Warfarin Uninterrupted
Warfarin therapy is continued without interruption prior to cardiac pacing device implantation
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Warfarin is either interrupted or uninterrupted prior to device implantation
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
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Active Comparator: 2 Warfarin Interrupted
Warfarin therapy is discontinued 2 days prior to cardiac pacing device implantation
|
Warfarin is either interrupted or uninterrupted prior to device implantation
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
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Sham Comparator: 3 Aspirin Group
Patients with aspirin therapy during implantation
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Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
Aspirin is continued without interruption prior to device implantation
Other Names:
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Other: 4 No Antithrombotic Group
No antithrombotic treatment during operations
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Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Measure: rate of haemorrhagic and thromboembolic complications
Time Frame: within first four weeks
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within first four weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Juhani Airaksinen, MD, University of Turku, Turku University Hospital
- Principal Investigator: Petri Korkeila, MD, Turku University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Embolism
- Hemorrhage
- Thrombosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Anticoagulants
- Aspirin
- Warfarin
Other Study ID Numbers
- FINPAC
- TAHD-VARF (Former Protocol ID)
- TV001
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