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ANAHEIM -- Patients getting cardiac device surgery -- either to place a new pacemaker or defibrillator, or to change parts of an existing device -- don't necessarily have to have non-vitamin K antagonist oral anticoagulant (NOAC or DOAC) therapy halted for their procedure, according to researchers here.

In 2013, the trial showed that device pocket hematomas, which increase the long-term risk of device infection, were reduced by 80% when surgery was performed with continued warfarin treatment in lieu of heparin bridging.

Investigators decided to perform another trial since NOACs have come onto the scene. In BRUISE CONTROL 2, patients randomized to continued or interrupted NOAC therapy ended up having the same 2.1% risk of developing clinically significant hematoma (P=0.973), and this included hematomas that prolonged hospitalization, required interruption of anticoagulation, or required another operation, David Birnie, MB ChB, of the University of Ottawa Heart Institute in Canada, and colleagues reported at the American Heart Association meeting.

Continued NOACs should not be considered a strategy to reduce hematomas, he said. Instead, "the take-home for clinicians is that either strategy may be appropriate depending on the clinical scenario," he said at an AHA press conference. For one, keeping patients on NOACs might make sense if they cannot wait for their anticoagulant effect to dissipate (those with complete heart block and unstable temporary pacing), or if they are at high risk for stroke.

Secondary outcomes such as mortality, any hematoma, and cardiac tamponade, also turned up at statistically indistinguishable rates between groups.

The trial was called to an early stop, its second pre-specified interim analysis having shown there was unlikely to be a 40% relative risk reduction in the primary endpoint. In the end, there were 662 patients -- all with CHA₂DS₂-VASc scores of 2 or greater -- enrolled in 2013-2017 at 16 centers.

Birnie's group started with dabigatran (Pradaxa) as the NOAC of choice for their study and later included apixaban (Eliquis) and rivaroxaban (Xarelto) as options when they landed on the Canadian market.

If patients were randomized to interrupted NOAC therapy, they took their last dose 2 days before surgery ( in the case of rivaroxaban or apixaban) or stopped according to their glomerular filtration rate (dabigatran). All drugs were resumed at the next regular dose timing at least 24 hours after surgery was finished (or a median of 31 hours).

There was one stroke in each arm: in the case of continued NOAC, the patient developed a hematoma on the first post-operative day and had stroke on post-operative day 5; the interrupted NOAC patient had a stroke 2 days after randomization but before anticoagulation was held.

It remains to be seen what is the best NOAC management in other settings, for instance other higher-risk procedures or rheumatic valve disease, commented AHA discussant Mina Chung, MD, of the Cleveland Clinic. For now, the BRUISE CONTROL studies imply that "continued warfarin is preferred over interruption with heparin bridging in avoiding hematomas," she stated.