Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Henrikson, MD - Cardiology/Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00721136
First received: July 21, 2008
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Bradycardia
Tachycardia
Atrial Fibrillation
Valvular Heart Disease
Drug: continue warfarin through the procedure
Drug: Hold warfarin
Drug: Warfarin held with heparin transition.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • bleeding complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
Drug: continue warfarin through the procedure
The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
Active Comparator: 2
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
Drug: Hold warfarin
For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
Experimental: 3
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.
Drug: continue warfarin through the procedure
The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
Active Comparator: 4
High risk patients randomized to holding coumadin for 4-5 days and using "bridging" anticoagulation with heparin while the coumadin is held.
Drug: Warfarin held with heparin transition.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for clinically indicated permanent pacemaker or implantable cardioverter-defibrillator
  • currently on chronic warfarin therapy

Exclusion Criteria:

  • unwilling to participate in trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721136

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Howard County General Hospital
Columbia, Maryland, United States, 21045
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Alan Cheng, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Charles Henrikson, MD - Cardiology/Medicine, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00721136     History of Changes
Other Study ID Numbers: NA_00011273
Study First Received: July 21, 2008
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
bleeding
anticoagulation
pacemaker
implantable cardioverter-defibrillator
patients undergoing implantation of a pacemaker or defibrillator (ICD)"

Additional relevant MeSH terms:
Heart Diseases
Atrial Fibrillation
Tachycardia
Bradycardia
Heart Valve Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heparin
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014