Trial Outcomes & Findings for Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation (NCT NCT00721136)
NCT ID: NCT00721136
Last Updated: 2017-08-31
Results Overview
Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
30 days
Results posted on
2017-08-31
Participant Flow
Two patients from each treatment arm were excluded from the analysis. Three of these patients withdrew after being told of the treatment assignment, and one patient's procedure was cancelled owing to need for a left ventricular assist device.
Participant milestones
| Measure |
Moderate Risk Continuing Warfarin (Coumadin)
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin (Coumadin)
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin (Coumadin)
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
High Risk Holding Warfarin (Coumadin)
These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
8
|
8
|
|
Overall Study
COMPLETED
|
42
|
42
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Baseline characteristics by cohort
| Measure |
Moderate Risk Continuing Warfarin
n=42 Participants
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=42 Participants
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=8 Participants
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.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
High Risk Holding Warfarin
n=8 Participants
These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
50 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
50 Participants
n=146 Participants
|
|
Age, Continuous
|
72.9 years
STANDARD_DEVIATION 11.4 • n=39 Participants
|
68.8 years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
72.9 years
STANDARD_DEVIATION 11.4 • n=35 Participants
|
68.8 years
STANDARD_DEVIATION 11.7 • n=31 Participants
|
71.5 years
STANDARD_DEVIATION 11.6 • n=146 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
42 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
58 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=39 Participants
|
42 participants
n=41 Participants
|
8 participants
n=35 Participants
|
8 participants
n=31 Participants
|
100 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).
Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.
Outcome measures
| Measure |
Moderate Risk Continuing Warfarin
n=39 Participants
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=41 Participants
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=7 Participants
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
High Risk Holding Warfarin
n=8 Participants
These high risk patients randomized to holding warfarin for 4-
|
|---|---|---|---|---|
|
Bleeding Complication
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Moderate Risk Continuing Warfarin
n=39 Participants
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=41 Participants
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=7 Participants
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
High Risk Holding Warfarin
n=8 Participants
These high risk patients randomized to holding warfarin for 4-
|
|---|---|---|---|---|
|
Thromboembolic Events
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 30 daysDefined as warfarin induced skin necrosis or heparin-induced thrombocytopenia
Outcome measures
| Measure |
Moderate Risk Continuing Warfarin
n=39 Participants
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=41 Participants
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=7 Participants
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
High Risk Holding Warfarin
n=8 Participants
These high risk patients randomized to holding warfarin for 4-
|
|---|---|---|---|---|
|
Anticoagulant Related Complications
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
Moderate Risk Continuing Warfarin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Risk Holding Warfarin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
High Risk Continuing Warfarin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk Holding Warfarin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moderate Risk Continuing Warfarin
n=42 participants at risk
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=42 participants at risk
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=8 participants at risk
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
|
High Risk Holding Warfarin
n=8 participants at risk
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
|
|---|---|---|---|---|
|
Vascular disorders
Transient Ischemic Attack
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
Other adverse events
| Measure |
Moderate Risk Continuing Warfarin
n=42 participants at risk
Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
|
Moderate Risk Holding Warfarin
n=42 participants at risk
Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
|
High Risk Continuing Warfarin
n=8 participants at risk
High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
|
High Risk Holding Warfarin
n=8 participants at risk
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pocket Hematoma
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Pericardial Effusion
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Charles Henrikson, MD
Johns Hopkins Medical Institutions
Phone: 503 494 7400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place