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Continuation of Warfarin During Pacemaker or Implantable Cardioverter-Defibrillator Implantation: A Randomized Clinical Trial
Study Questions:
How safe is pacemaker or implantable cardioverter-defibrillator (ICD) implantation in the presence of a therapeutic international normalized ratio (INR)?
Methods:
One hundred anticoagulated patients (mean age 71 years) referred for pacemaker/ICD implantation were randomly assigned to warfarin continuation (n = 50) or warfarin discontinuation (n = 50) with the option of heparin bridging (n = 7). The primary endpoint was a composite of thromboembolic and hemorrhagic events, warfarin-induced skin necrosis, and heparin-induced thrombocytopenia.
Results:
The mean INR during the procedure was 2.2 in the warfarin-continuation group and 1.3 in the warfarin-interrupted group. There was a trend toward a lower prevalence of the composite endpoint in the warfarin-continuation group (0%) than in the warfarin-interrupted group (10%), but the difference was not statistically significant.
Conclusions:
In anticoagulated patients, warfarin continuation during device implantation may be preferable to interruption of warfarin.
Perspective:
Prior studies have shown that bleeding complications are more common with heparin than warfarin in patients undergoing device implantation. Therefore, in a comparison of warfarin-continuation versus warfarin-interruption, the routine use of heparin-bridging would maximize the probability of finding an advantage of warfarin continuation over warfarin interruption. One reason this study did not demonstrate a significant difference in outcomes between the two strategies is that only 7/50 patients in the warfarin-interrupted group were bridged with heparin. Another reason is that the study was underpowered to detect a significant difference between the two strategies.
Keywords: Blood Coagulation, Warfarin, Heparin, Pacemaker, Artificial, Defibrillators, Implantable, Thrombocytopenia
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