Tapered Warfarin or Interrupted Warfarin With Heparin Bridging for Pacemaker or Defibrillator Implantation
Status:
Terminated
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Approximately 2 million patients in North America are currently treated with the blood
thinner warfarin. These patients have every year more than 200,000 invasive procedures, for
which warfarin must be stopped to avoid bleeding complication. To protect the patient against
blood clots and stroke while warfarin is stopped, most physicians today order "bridging" with
low-molecular-weight heparin (LMWH). This is another blood thinner and it is injected under
the skin during 3 days before the procedure. For implantation of pacemaker or defibrillator
(27,000/year in Canada) the "bridging" routines vary a lot.The common "bridging" treatment
with LMWH for 3 days before pacemaker surgery causes bleeding in the "pocket" where the
pacemaker is placed in about 5%. For comparison, patients not on any blood thinners develop
this bleeding in 2% after this surgery. "Pocket bleeding" may require evacuation of the blood
collection and may cause infection. "Pocket bleeding" is thus a fairly common and clinically
important but rarely a dangerous bleeding complication. It is a suitable safety endpoint in a
study of "bridging" of blood thinners. LMWH costs $80-120, for which some patients are not
covered. They have to be taught self-injection technique or have a nurse come to their home.
The main hypothesis is if patients on blood thinners can be managed more conveniently before
and after pacemaker surgery, without injections, without increased risk of pocket bleeding.