Drug Monitoring and Reversal Agents for Direct Oral Anticoagulants

Michael B. Bottorff, PharmD: Fall risk is a major component of a discharge counseling strategy for patients who are newly being started on any anticoagulant, including a DOAC (direct oral anticoagulant). It’s inherent that if someone’s on an anticoagulant and they are at-risk for fall, you might even consider not giving them a DOAC or warfarin because of that increased risk for a major bleed (if they do suffer a fall).

There are some studies, though, looking at the rates of major bleeds in people who did have a fall risk versus patients who did not have a fall risk. And some of those studies actually found that you were no more likely to be at a major bleed risk.

Many people were interested in the availability of direct and rapid-acting specific reversal agents for the DOACs, which some considered to be a weakness of those drugs when they first came on to the market. And yet, their use increased over the years, despite the absence of a specific reversing agent. So, I think the availability of a reversing agent is really very specific to a couple of environments that some people are glad to have it for. But in the usual scenario, we’ve been using these agents with increasing regularity, even in the absence of a reversing agent.

The 2 major reasons that you would consider using a rapid-acting specific reversing agent for a DOAC would be for either a major life threatening bleed that you couldn’t control through other mechanisms, or the urgent need for a procedure that has a high bleeding risk associated with it where you don’t want to delay the procedure. Then, you would use the reversing agent so you could more immediately go perform that procedure.

We still need to improve our use of anticoagulants. I think there are a lot of unmet needs that need addressing. If as many as half the patients who should be on anticoagulation aren’t receiving it, I think we need to have better strategies for identifying those people. There’s also data that reveals that people who are at least originally started on an anticoagulant do not necessarily stay on that anticoagulant down the road. A lot of people self-terminate or discontinue their own therapy. So, I think patient compliance strategies is going to be an important component in the future, too.

There are a variety of things that are being investigated in looking at the future of stroke prevention in NVAF (nonvalvular atrial fibrillation). There are atrial appendage closure devices. I’m a pharmacist, so that’s a little bit out of my realm, but I know that continues to be an area of study. Other strategies for stroke prevention in atrial fibrillation (AFib) would include ablation procedures to terminate AFib completely. I think those are improving but, probably, are not yet where we’d like them to be. And then, certainly, the identification and better management of patients with atrial fibrillation who are on anticoagulation to receive the maximum benefit.

Another area that I think there’s research in (there’s a little bit published but I think we need more data) is the appropriate efficacy and safety for patients who received coronary stents but also have atrial fibrillation. We, historically, have treated those people with the respective therapies—antiplatelet drugs that are called for with the stent and, then, full anticoagulation for the atrial fibrillation. Is it possible to identify a safer strategy that still keeps stents open and prevents stroke and atrial fibrillation so we can minimize bleeding and maximize efficacy without necessarily having to use all 3 agents at the same time?