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

NCT00721136 | Completed Results

• 1 other identifier: NA_00011273
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Bradycardia; Tachycardia; Atrial Fibrillation; Valvular Heart Disease

Keywords

bleeding; anticoagulation; pacemaker; implantable cardioverter-defibrillator; patients undergoing implantation of a pacemaker or defibrillator (ICD)"

Outcome Measures

Primary Outcomes (3)

• Bleeding Complication

  Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.

  30 days

• Thromboembolic Events

  30 days

• Anticoagulant Related Complications

  Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia

  30 days

Study Arms (4)

1

EXPERIMENTAL

Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.

Drug: continue warfarin through the procedure

2

ACTIVE COMPARATOR

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

3

EXPERIMENTAL

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

4

ACTIVE COMPARATOR

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.

Interventions

continue warfarin through the procedure DRUG

The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.

1; 3

Hold warfarin DRUG

For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.

2

Warfarin held with heparin transition. DRUG

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.

4

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unwilling to participate in trial

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Howard County General Hospital

Columbia, Maryland, 21045, United States

Location

MeSH Terms

Conditions

Bradycardia; Tachycardia; Atrial Fibrillation; Heart Valve Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Limitations and Caveats

Evaluation period was limited to 4-6 weeks after implantation and mean INR levels in the warfarin continuation group did not reach levels above 2.5. This was a single center trial with experienced electrophysiologists using a common technique.

Results Point of Contact

• Title: Charles Henrikson, MD
• Organization: Johns Hopkins Medical Institutions

chenriks@jhmi.edu

503 494 7400

Study Officials

• Alan Cheng, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-07

Locations

US (2)