May 29, 2023

James Douketis, MD, McMaster University, Hamilton, Ontario, discusses the the PAUSE (the Perioperative Anticoagulant Use for Surgery Evaluation) study, in which researchers found that patients with atrial fibrillation taking direct oral anticoagulants (DOACs) were able to safely stop taking them before and after elective surgeries and other invasive procedures.

It’s called the pause study which is an acronym for perioperative anticoagulation and surgery evaluation and it deals with patients who are taking an anticoagulant but one of the newer ones the so-called direct oral anticoagulants or doe acts and dealing with how to manage these patients when they require the interruption of their anticoagulant for a surgery or an

Invasive procedure first of all it’s a very common clinical problem we estimate that there are probably between five and seven million people worldwide who are have to deal with this issue and the trial itself looked at patients who were receiving one of the three deluxe ipic seban rivaroxaban or dabigatran and in total there were three thousand seven patients

Recruited about 1200 in the apixaban cohort 700 in the dabigatran cohort and 1,100 in the rivaroxaban cohort so this was a standardized perioperative management approach that we used and it was the first of its kind actually and the the premise was that we wanted we hypothesized that if we looked at dholak specific interruption and resumption protocols without

Any heparin bridging and without any preoperative coagulation testing we felt that this protocol would be safe for patient care how did we define safety well we estimated that rates of major bleeding which are quite serious would be around 1% and rates of arterial thrombosis stroke tiaa would be around 0.5% and actually the results of her study bore out what we

Had hypothesized and that rates of major bleeding were between 0.9 and 1.8 in the three different cohorts and rates of arterial thrombosis amor between point two and point six and we had adequate power to exclude a rate of arterial table embolism and each of those cohorts of less than 1.5 percent and also adequate power in to exclude a rate of major bleeding of

2% in the dabigatran cohort just slightly in the pixum bank cohort but not quite in the rivaroxaban cohort because there the the rate of bleeding was a little bit higher at 1.8% but overall a study found that with this protocol that we felt was standardized but very importantly easy to use the rates of serious adverse events in this case major bleeding were less

Than 2% arterial thrombosis were less than 1% who’s dealing with a patient who was taking one of these anticoagulants and there are more more of them in the coming years and whether that person is a surgeon and anesthesiologist or a family physician dealing with patient having a procedure it provides them a very precise but at the same time very simple guidance

On how to manage that patient when to interrupt when it’s safe to interrupt when it’s safe to resume after the surgery or procedure so the overall intent is to minimize the risk for stroke and thromboembolism and at the same time minimize the risk for serious bleeding i think that this is an area that has been of great uncertainty to clinicians the dull acts have

Been around for almost a decade but one of the major unanswered questions has been how to deal with people who require such a surgery or procedure we think that this study will inform that issue that which is very common it’ll help clinicians manage their patients and it will provide the evidence base for at practice guidelines so we hope that it will have a

Considerable impact on patient management optimizing reducing the risk for adverse events but also allowing that peer at that care to be streamlined so you don’t you know need to cancel procedures and surgeries and you know put risk patients out inconvenience from that standpoint also in addition to the mitigation of risk standpoint

Transcribed from video
James Douketis, MD: Interrupting Direct Oral Anticoagulants for Surgery Is Safe and Effective By DocWire