Clinical trial NCT00721136: Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Official title: Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Tachycardia
Atrial Fibrillation
Valvular Heart Disease
Keywords: bleeding
anticoagulation
pacemaker
implantable cardioverter-defibrillator
patients undergoing implantation of a pacemaker or defibrillator (ICD)"
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Bleeding Complication
timeFrame: 30 days
measure: Thromboembolic Events
timeFrame: 30 days
measure: Anticoagulant Related Complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alan Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: