These webinars feature expert physicians in their field, and I'm very excited for today's presentation. The American Society for Gastrointestinal Endoscopy appreciates your participation in tonight's event, Practical Approach in the Management of Anticoagulation in the Setting of GI Bleeding. My name is Marilyn Amador, and I will be the facilitator for this presentation. Before we get started, just a few housekeeping items. We want to make this session interactive, so feel free to ask questions at any time by clicking the Q&A feature on the bottom of your screen. Once you click on that feature, you can type in your question and hit return to submit the message. Please note that this presentation is being recorded and will be posted within two business days on GILeap, ASG's online learning platform. You will have ongoing access to the recording and GILeap as part of your registration. Now, it is my pleasure to hand over the presentation to our GI fellow moderators, Dr. Ana Silverman and Kevin Song, both from the Mayo Clinic in Scottsdale, Arizona. Hello, everyone. Thank you for joining us tonight. My name's Kevin, and I would like to first introduce my amazing colleague and friend, Dr. Ana Silverman. Dr. Silverman is a second year GI fellow at Mayo Clinic in Arizona. She intends to focus on care and advocacy of patients with IBD. She's an active physician data scientist, and her research interests include repurposing real-world clinical data, specifically natural language processing of clinical note-free texts. Beyond work, she enjoys traveling and constantly improving her homemade ice cream recipes. Thank you so much, Kevin. It is really a joy to introduce Kevin Song, who's a third year GI fellow and co-chief fellow at Mayo Clinic in Arizona. His clinical and research interests include both benign and malignant esophageal disorders, as well as small bowel bleeding. Kevin is a strong proponent of health equity and serves on the ACG Diversity, Equity, and Inclusion Committee. And outside of work, Kevin's life mostly resolves around his dog, Kona, who may make a guest appearance this evening if he's not otherwise napping under the bed. And with that, I have the pleasure of introducing our content expert for today. Excuse me, today's ASG Indo Hangout. Dr. Nia Abraham is the professor of medicine at Mayo Clinic and a consultant in the Division of Gastroenterology and Hepatology and Healthcare Policy Research. She is the medical director of Mayo Clinic Cardio-Gastroenterology Clinic and a federally funded investigator at the intersection of cardiology and gastrointestinal disorders. Investigating how antibiotic drugs contribute to the gastrointestinal bleeding in the cardiac patient, the elderly, and the highly comorbid. Dr. Abraham is the primary author of the 2022 ACG CAG Clinical Practice Guideline, Management of Anticoagulant and Antibiotic During the Acute Gastrointestinal Bleed and the Periodontoscopic Period. Among her many... So with that in mind, we'll start with our ASG Indo Hangout for GI Followers, Practical Approaches of Management of Anticoagulation and the Setting of GI Bleed. So we'll start out with the management of acute GI bleed. And this is our first case. A 77 year old male with past medical history of atrial fibrillation on Warfarin presents with large volume hematochezia. On presentation exam was significant ill-appearing male and heart rate of 110 and blood pressure 85 over 62. Labs revealed hemoglobin of 6.7 from the baseline of 13.9, INR of 5.3 and platelet count of 234. The patient was not responsive to fluid resuscitation and blood transfusion, and he was transferred to the ICU and started on pressors. And the first question that we really need to answer when we were approaching a case such as this is how do you define life-threatening hemorrhage? And as it turns out, the definition is really one of the following. It's hypovolemic shock with severe hypotension requiring pressors, associated decrease of hemoglobin greater than five grams per deciliter, requiring transfusion of greater than five units of PACRBC, or causing death, or as Dr. Abraham would say, the rules of five. Do you have anything else to comment on this particular topic, Dr. Abraham? Thank you, Kevin. This ability to identify the life-threatening hemorrhage is incredibly important when it comes to your overall management approach to, with regard to a patient who's having an acute bleed, who is on anticoagulants, because it's the triage point. And that whether or not your patient is or is not having a life-threatening hemorrhage then will inform what you will choose to do for your management strategy. So yes, really important, you know this definition. The rule of fives, either the patient's dropped their hemoglobin by five grams per deciliter, or has needed over five units of PAC cells, or they are still hypovolemically compromised, requiring pressers. Hopefully they're not dead, then this is a moot point. So then it's patients who are at real risk of mortality. Thank you. I think that's a very great commentary on this particular topic. And so let's jump on to our first question. So knowing that this is a case of life-threatening hemorrhage what is the optimal approach of managing this patient's super therapeutic INR in the pre-procedural setting? And is it A, large volume fresh frozen plasma, FFP transfusion? Is it B, IV vitamin K infusion? C, platelet transfusion? Or D, prothrombin complex concentrate infusion or PCC? And we'll give it maybe 30 seconds or so for everyone to vote. So perfect. So most of everyone who responded mentioned D as the answer and that is the correct choice here. So let's go through why we say this. So when it comes to, and by the way, this is the companion guide to the ACG CAG guidelines. So when looking at this initial assessment of patient of acute GI bleed with warfarin, the most important question you have to answer for yourself is this really a life-threatening bleed or not? And if it's deemed yes by the definition which we quote on the first, then the management really should be to consider PCC. Now, on the other hand, if this is not a life-threatening bleed then the guidelines suggest against FFP or vitamin K and does not make a recommendation for or against PCC. And before I turn it over to Dr. Abraham, so in summary, what we have for patients on warfarin who are hospitalized under observation with acute GI bleed, the guidelines suggest PCC administration when compared with FFP administration. And this is because PCC is rapid and reliable for correction by NR. Yes, that's exactly correct. And I'm glad to see 75% of you chose PCC because when we wrote the 2016 ASGE guideline, that wasn't the case and we were still giving FFP. Remember, fresh frozen plasma, you require a large volume of fresh frozen plasma to even modestly decrease an INR. And that fresh frozen plasma actually has to be transfused very slowly or you run into risks of pulmonary edema or other transfusion associated complications. In comparison, PCC is remarkably effective and reliable at correcting your INR. And within a half an hour to 90 minutes max, you can have a normal INR. And remember when a patient's got a GI bleed, you want to be dealing with this endoscopically promptly. You don't want to be waiting for transfusion parameters to change. So that's why we recommend in the setting of life-threatening hemorrhage to go to PCC. Perfect. And just to remind everyone, the Q&A is also open as well. So if you have any questions, feel free to let us know and we will try to answer them in due time. Okay. So thank you for that. And so the next question or the next case I should say is, so this is a 50-year-old female with past medical history of atrial fibrillation on the pixivine and presenting with melanoma. She denies any dizziness. The patient is vitally stable and her hemoglobin has declined from 13.5 to 8.4 and her creatinine is 1.1. And the question here is, what is the optimal approach for management of this patient's direct acting oral anticoagulant or DOAC in the pre-procedural setting? Is it A, no reversal agents needed? B, PCC. C, Aderocizumab. Or D, indexnet alpha. Perfect. So most of everyone, 76% mentioned it's A, no reversal agents needed. So let's go through this. So that is absolutely the correct answer here. PCC is a reversal agent for DOAC in the setting of life-threatening hemorrhage, whereas Aderocizumab is a reversal agent for dabigatrin and can be considered with life-threatening GI bleed in the hospitalized patients. And indexnet alpha is a reversal agent for ribaroxivine and pixivine if taken within 24 hours. And it has increased risk of thromboembolism and also increased cost. So it can be considered in life-threatening GI bleed in the hospitalized patients. So what does the guidelines say? Again, this is the companion guide to the ACG and CAG guidelines. Again, we start out with a patient who has a QGI bleed who was on DOAC. And the first question, just as in the case of Warfarin, is to answer whether this is a life-threatening bleed or not. If the answer is no, such as this case, then the guidelines suggest against DOAC-specific anti-reversal agents or PCC. So if this is a life-threatening bleed, then the management should be to consider DOAC-specific direct reversal agent or PCC. Dr. Abraham. Yeah, so this is an important paradigm shift when it comes to the management of DOAC-related GI bleeds. DOACs have only been available since 2010. And when the first DOAC was made available, which was davagatran, there was a lot of concern among people who were prescribing it because folks were really in that paradigm of having a reversal agent for their anticoagulant. So there was a lot of emphasis in pharma to create reversal agents for the individual DOACs that then became available. But what we've seen since in the data and the literature is that you need to shift your paradigm from thinking that if a patient has a GI bleed on a DOAC, you immediately need a reversal agent. You should be selective about the patients in whom you use a reversal agent. So the take-home point is no routine use of a reversal agent in DOACs-related GI bleed because all of the reversal agents do have a risk of thromboembolism. PCC, it's about 7% to 8%, which is the same as fresh frozen plasma, which has been traditionally the gold standard for a reversal agent comparison. Idaricizumab is 5% to 7%. So if the patient's on davagatran, it's a very, it has a life-threatening hemorrhage. It's a very effective and safe reversal agent choice. But indexonate alpha is a different kettle of fish. It's a different kind of molecule. It actually doesn't eliminate the DOAC from the circulation. It just temporarily binds the DOAC. So two hours after the infusion, you have a rebound in anticoagulant effect. And all of this is associated with a thromboembolism rate that can be as high as 12 to 30% based on the study. So that's really problematic. The other reason why we don't recommend going specifically to indexonate alpha is because of the cost. When it first became available, it was $44,500 per dose, which has then been studied at half dose. So that drops it down to $22,500, but that's still a lot of money, especially when you compare it to PCC, which has a price tag between $1,500 and $2,500 per dose based on where, you know, the pharmacy management plan that your patient is on. So again, no routine reversal agents used for DOACs. If the patient's got a life-threatening hemorrhage, and you know what the definition is now, then you should consider a reversal agent if the drug has been taken within the last 24 hours. And then you can, and if the patient checks all those boxes, then it's a choice between a DOAC-specific reversal agent or PCC, knowing that PCC is really safe and cheap. Now you say, okay, they don't have a life-threatening GI bleed. What should I do? Remember the pathophysiology of DOACs in the human body. As long as the patient has normal or are close to normal functioning kidneys, these agents have a very short half-life. So the first thing you should be doing when you're assessing these patients in the emergency room or on the floors is remember airways, breathing, circulation. It's not airways, breathing, called GI. So it seems for circulation, and you really need to make sure that their hemodynamic status is aggressively managed because most patients with normal functioning kidneys or even mildly abnormal creatinine clearances will be able to excrete the molecule. And that in itself is the most important step towards achieving hemostasis. So a properly resuscitated DOAC GI bleed in the absence of life-threatening parameters should not need a reversal agent. Thank you for that commentary. I think that's very clear, especially with the guidelines and companion guide, which I highly recommend that you read through. It kind of gives you the step-by-step algorithm as far as where you're thinking and in terms of what you should do. And that companion guide is published in the red section of the April Red Journal. So if you're looking for that, and I really do believe the two go together like peanut butter and jelly. It's really hard to figure out the clinical context for using the guideline recommendations because it was created based on a very rigorous grade methodology method. So the companion guide sort of fills in that clinical context that make it easier to use the recommendations. I would say for me personally, it can be kind of hard to find. So you really have to know what to look for. So that's really good to know that it's in the red section of the journal. So moving on to our third case. Now we have a 72-year-old male with recent acute coronary syndrome status post drug-releasing stint eight months ago and currently on aspirin and Prasugrel. He now presents with sudden onset hematemesis and he's feeling dizzy, faint, and is resuscitated with fluids. Mission lab test results revealed hemoglobin of 6.6 from the baseline of 11.1 and platelet count of 325. The question is, what is an optimal approach to management of this patient's dual antiplatelet therapy or DAPT in the pre-procedural setting? Is it A, hold both aspirin and Prasugrel, B, continue both aspirin and Prasugrel, C, hold aspirin and continue Prasugrel, or D, continue aspirin and hold Prasugrel? And if you're on Twitter, I actually posed this question on Twitter about a week ago and we received about 150 responses. And let's see if you guys have the same kind of answer as what we found on Twitter. So we're now in the bonus section of acute GI bleed because we're moving beyond anticoagulants because I think it's important you understand how to manage any of these GI bleeds, regardless of whether or not the patient's on an antiplatelet or an anticoagulant. Perfect. And this is one that I feel like we see quite often in the hospital setting. Certainly here in Arizona, we see that quite often. So it's nice to have a cardio GI expert that we can turn to. So most people, 83% say continue aspirin and hold Prasugrel, and that is the correct answer. And most people say the same thing on Twitter as well. And this is the, again, going back to the companion guide. So initially when the patient has a acute GI bleed and the patient's on aspirin, you have to figure out if the patient is on primary or secondary cardiovascular prevention and know the definition of secondary is if the disease state has already happened and you're trying to prevent them from being worse. So i.e. a patient already has a ACS event, then you are trying to prevent further damage. So the management in this case, the guidelines recommend against holding aspirin. If by some chance the aspirin is held, then the guidelines suggest to restart aspirin on the day hemostasis is endoscopically confirmed. On the other hand, if the aspirin is started on for primary prevention, then the management should be to hold aspirin when you have acute GI bleeding. Dr. April? Yeah, so our patient had dual antiplatelet therapy. So the easy thing to remember is in the setting of acute GI bleeding, you hold the phenopurity. That's your Prasugrel, your Clopidogrel, or your Ticagrelor. But then the question always comes up, well, why shouldn't I hold aspirin? And that's because we know in the setting of GI bleeding, there's randomized control trial data and observational studies showing that if you hold cardiac aspirin that has been prescribed for secondary cardiac prevention, there is an increased risk of death. Okay? And death is a terrible outcome. Doesn't matter if you've managed to deal with an endoscopic lesion and hemostatically controlled it. The fact that you've held that patient's aspirin puts them at a higher risk of death. Okay? And so the number needed to harm for that in sort of the landmark randomized control trial that was published in the Annals of Internal Medicine now quite some time ago, 2010, I believe, was seven, which means you would have had to have held that patient's cardiac aspirin in seven patients to incur one additional death. So don't hold cardiac aspirin if that patient has been prescribed cardiac aspirin for secondary prevention. Primary prevention, which is the patient's watching TV and sees that ad, ask your doctor if such and such aspirin regimen is good for you. I won't name the pharmaceutical company, but primary prevention has now been shown in a number of large cardiac studies to not really have a lot of benefit for the patient in terms of cardiac prevention of adverse events, but is associated with a significant risk of GI disease. So if the patient's taking it as a nutraceutical or for primary prevention, then you can feel more comfortable folding that aspirin before the GI bleed. So always hold the phenoperity, never stop cardiac aspirin prescribed for secondary prevention. And if they're on primary prevention aspirin, this is a good time for an educational moment where both the patient and the provider who's giving them that primary aspirin, primary prevention aspirin regimen. And I think we do have a question here as well. If this patient had PUD-required endoscopic intervention, when is it safe to resume? That's a really important question and I'm glad you asked it. So the rule of thumb is, as soon as you have assured immediate endoscopic hemostasis you restart the phenoperity usually next day. Why is that? The life-saving measure here is the resumption of the dual anti-inflammatory therapy. Okay? And now we have so many options to really lock down that GI bleed, mechanical clips, dual therapy with BICAP and injection therapy. Remember never injection therapy as monotherapy, but we now have all the tools we need to really confidently stop the GI bleed, especially a peptic ulcer disease bleed at the time. So you should get that person right back on their phenoperity agent by the next day. That's a great question and a great answer as well. So continuing with the same case, and again, to remind you, this is a patient with ACS. Let me just answer that. I had an attending class by aspirin as a non-steroidal anti-inflammatory drug. Aspirin is in the same pharmacologic family as a non-steroidal anti-inflammatory drug. So yes, this is technically true. Perfect. So again, this is a patient with ACS who's presenting on dual anti-inflammatory therapy who is presenting with life-threatening hemorrhage. And so the further management of this patient includes platelet transfusion. Is it true or false? And 93% of our participants say false. Perfect. Let's look into this. And that's absolutely the correct answer. So for patients who, and this is the guideline by the way, for patients on anti-platelet agents who are hospitalized or under observation with acute GI bleed, the guidelines suggest against platelet transfusion. I will ask Dr. Abraham a little bit to comment when this will be appropriate for the patient. When this will be appropriate to consider platelet transfusion. And then the reason why we do this is because mortality rates with routine platelet transfusion go up with all comers, whether it's GI bleed or CABG or even intracranial hemorrhage. The one exception that one may consider for a life-threatening bleed is if the platelet count is less than 100. Dr. Abraham. Yeah, this is a really important paradigm shift. A lot of your attendings are probably still requesting that platelets be given and that is not state-of-the-art right now. We've known for a few years now that platelet transfusion in the setting of GI bleed specifically is associated with a very high risk of mortality. Five, almost six-fold increased risk of mortality. And what's nice about the fact that we, what's nice about this recommendation is we see concordance. We see the same phenomenon happening in others settings where cardiac patients are getting routine platelet transfusion. So it all speaks to the same message. And remember, platelets are a biochemically active substance. And that's really where people get into the trouble, get into trouble with putting them at high risk of mortality. It's all of that transfusion medicine stuff that you've probably forgotten, but blood, all of these blood products are biochemically active substances that affect inflammatory markers in the body and platelets being transfused inappropriately is actually a particularly bad setup for death. Now, you'll notice what we put, that there was a threshold of less than 100. And I'll be honest, we really don't know what that ultimate threshold is. In the literature, it ranges between 50 and 100. So I know some of your attendings may be saying, oh, unless it's 50 or less, I'm not giving platelets. Others may say 100 or less. And that's because the literature is a little all over the place. So I can't tell you from an evidence-based perspective that there's an absolute threshold level, which is, no, it's less than this, time to trigger the platelets. It's really important that you consider each patient individually because some patients, and if they have platelets that low, they probably have a hematologist. So you might, I would strongly recommend having a case discussion with that hematologist because their risk benefit for getting platelets, even though it looks like a low number for us as gastroenterologists, may not be favorable. So don't do it routinely and have a conversation with the hematologist if you're even considering it. Right, and I think that's a very important learning point as well, which we didn't really mention here per se, is that when in doubt, you always would talk to your colleagues and never the wrong answer, whether it's a cardiologist or hematologist. And that's particularly true for cardiovascular patients because, as I always like to tell people, and we're going to emphasize when Ana does the elective endoscopy management, the heart always wins, okay? So there's no tug of war between the GI tract and the heart, the heart always wins. So if there's any concerns about the risk benefit, consequences of your management strategy or you're coloring outside the lines and you can't really find the answer in the guideline, take the time to have a multidisciplinary discussion. Perfect. I think that is it from my side. Yeah, I think that's it for acute. So Ana's going to go on to elective. Yeah. Thanks, Kevin. Yes, we will. Thank you so much, Kevin. And let me just make sure I have control of the screen, which I do. Fantastic. So we're going to switch gears to the elective GI procedures. And our first question is going to be a 60-year-old gentleman who has a past medical history of type 2 diabetes and had a drug-eluting stent placed three months ago in the setting of a STEMI. And he's been on aspirin and ticagrelor since this time. Now, prior to his STEMI, he just happened to have a positive fit test a few weeks prior. What would be the appropriate timing of colonoscopy for the positive fit test? And we'll give everyone a little bit of time for that. The first answer is now, what in the world are we waiting for? B, wait four months after stent placement. C, wait at least six months after stent placement, but could consider as long as nine months. D, wait at least a year after stent placement. And let's see what everyone's answers are. Okay, looks like the majority of folks picked C, which is to wait at least six months after stent placement, but can consider as long as nine months. And look how many people picked, 24% picked A. So this is a really important topic to discuss. It is, it is. So the folks who picked C are absolutely correct. We should wait at least six months after stent placement, but could even consider as long as nine months. And let's go into why that is. So the big question to ask is when should we be deferring elective cases? And just like Dr. Abraham alluded to, we should be deferring elective exams until the patient is no longer high risk. Just like she said, the heart always wins. So we want to optimize the patients until they're no longer high risk, and then we can do the elective case. Now, this also begs the question, which exams are elective? And this includes colon cancer screening, FIT positive exams, screener surveillance for ferrets or pharisees, as well as exams for FIT positive tests or disorders of the gut-brain interaction. And how long we're going to defer the case for is really going to be dependent upon what type of stent was placed, as well as if it was placed in the setting of acute coronary syndrome or ACS. So we're going to wait for one month if a patient had a bare metal stent placed not in the setting of ACS. We're going to wait two months if the patient had a bare metal stent placed in the setting of ACS. We're going to wait three months if the patient had a TIA or stroke, a DVT or PE, as well as ACS without a stent placed. And finally, we're going to wait six months or even could consider up to nine months in the setting of a drug-eluting stent, regardless of whether ACS was present at the time of stent placement. And Dr. Abraham, do you have any other advice to offer our participants? Yes, thank you, Ana. The key thing here is do no harm, all right? Do no harm. Elective cases are elective for a reason, all right? And I know people get really excited about FIT positive, which is why we included that as our particular elective situation. There's been very interesting data published in the last year or two showing that if patients are FIT positive and they are followed longitudinally out, when is that sort of tipping point for when the risk of them getting a cancer is so great that they've essentially gone past the window where that FIT positive test should have been addressed? And what we know is that it's between six and nine months. The good news is if you've got a patient who's got drug-eluting stents in it, even in the setting of ACS, you only need to have them on dual antiplatelet therapy without interruption for a minimum of six months. There's now really good studies in the cardiac literature showing that a minimum of six months is what you need for the protection of that patient to prevent thromboembolic events and stent occlusion. Remember, once stent occlusion occurs, 30 percent of patients die. Death is a bad outcome. So you never want to be talking to a judge saying, well, the patient had bloating and I did an endoscopy and this is what happened. That's just not going to fly. So six months. It's going to be very unusual for you to have to wait nine months for to deal with a FIT positive test. But it's important that you understand who these high risk patients are and counsel patients who you see, because for them, the bloating may be the most pressing thing going on in their medical life right now. But you need to be able to provide that perspective because you don't want to do any harm and the heart always wins. That's fantastic advice, Dr. Abrahams. Thank you so much. So in addition, we want to go over the management of antiplatelet agents in the setting of elective endoscopic periods for patients who are on dual antiplatelet therapy for secondary cardiovascular prevention. This is another theme coming up, just like Kevin mentioned, we're going to continue the aspirin. So no stopping of aspirin for elective endoscopic procedures, whereas for clopidogrel and ticagrelor, we're going to hold them five days prior to the procedure and we're going to stop prasugrel for seven days prior to the procedure. And Dr. Abraham, do you have any other thoughts on the management of antiplatelet agents specifically in the elective endoscopic period? Yes, I want to highlight the difference between the stopping periods or the temporary interruption based on the agents. I often see seven days for everybody or worse still people cut it in the middle and say six days. The stopping periods are FDA mandated after studies were done for these drugs in the process to get approval in the setting of surgical procedures. So there were independent studies done on temporary interruption to find out what the appropriate time period should be. So it's important that you know that clopidogrel and ticagrelor are five days prior to the procedure. You do not need, more is not better. I tell cardiac patients that all the time in cardio GI clinic, because they're like, oh, I'll stop it for a week. I'll stop it for 10 days. No, that's when you get past that tipping point where they're not getting the antiplatelet protection that they need. Prazegrel because of its biochemical makeup and its chemical pharmacodynamics needs a little bit more. So if you don't know the difference between these agents and you are, have not appreciated the difference between these agents that are just doing seven days and everybody it's time to get on board with the right timing. Thank you so much, Dr. Abraham. And oh, and I just want to go back to that topic. The reason why we made that so explicit in this guideline, because the ASG 2016 guideline that I also participated in writing, we left it as a range five to seven days. So I think a lot of your attendings may have that in their head. So it's important that you share with them that we have far more clarity now because that 2016 ASG guideline, we finished writing it in 2015. And we've come a long way since then. So we now have been able to, to better define the right period of temporary interruption. So it's no longer five to seven days. It's very much dictated by the athena-purity that they've been prescribed. Wonderful. Thank you. That's very, very helpful. So we'll move on to our next case, which is a 67 year old woman with extensive ulcerative colitis since age 35, who happens to be an endoscopic clinician on betalizumab. And she also has hypertension as well as non-valvular atrial fibrillation on a PIXIVAN. And she's due for dysplasia surveillance colonoscopy. When should we be holding for a PIXIVAN in the elective endoscopic period? Is it five days prior to procedure, three days prior to procedure, two days prior to procedure, or the day prior to procedure? And we'll take a moment for everyone to put in their thoughts. I think this is one that certainly surprised me when I was reading through the guidelines. Yes, exactly. I'm eager to hear what you have to say about this. Well, let's see what the spread is like. Okay. Oh, very good. So this is confusion. That's good. We like confusion. That's what this endo hangout's all about. Yes. So the majority of respondents said two days prior to procedure. And just like Kevin alluded to, this really, for me, was the most surprising guidance in this new updated guidelines. And I think this will be a huge practice change for most folks in this peri-endoscopic elective area, where I think previously we had been holding the DOACs for two days prior. But the updated guidance is that for general GI procedures, we should be holding the day prior and the day of. And so this will be much clearer on this next slide. So everyone who answered D was correct. So how to approach the management of DOACs in the elective peri-endoscopic period. If it's a general GI procedure, we should hold the DOAC the day prior to the procedure. This means the day prior, as well as the day of the procedure, is a total hold of two days. For advanced GI procedures, we should be holding the DOACs two days prior to procedure, which means the two days prior to procedure, as well as the day of the procedure, is three days. And we should be resuming DOACs in most patients the day after the procedure. This also is thought to be most helpful as long as endoscopic hemostasis was achieved, if there was any bleeding in the elective case. Say you removed a polyp and there was some bleeding and you clipped it, you achieved hemostasis, then the DOAC should be resumed the next day. Now there's also some guidance that the companion guide gave us, which is that they suggest that a maximum of 48 to 72 hours post-procedure for the holding of DOACs if you're concerned about bleeding. And I am sure Dr. Abraham has plenty of helpful thoughts on this really practice-changing concept. Yeah, there's a lot to unpack on this one slide. So I'm going to thank you, Anna, for sort of teeing this up. We're going to take this bullet by bullet, because this is the one place you guys who are here on this endo hangout will be able to help your attendings make better choices, because this has really changed since 2016. So first, let me clarify that what do we mean by a general GI procedure? Well, in the new guideline, as well as in the companion dissemination tool, you will see a table that lists procedures, endoscopic procedures, based on their likelihood of post-procedural bleeding. And when you look at that list, essentially our diagnostic procedures with and without biopsies, which is this particular patient, and diagnostic procedures with removal of diminutive polyps would be in that low risk of post-procedural bleeding, as well as things like EUS without FNA, ERCP with dilation of ducts without sphincterotomy and essentially stonework. APC, low risk, right? That's an important change. Enteral stenting, low risk. So it's really important that you be familiar with that list, because based on that patient's planned procedure and the post-procedural risk of bleeding, that's going to dictate whether or not you need to hold the DOAC for two days versus three days. Anything else that's not on that list is advanced. And why is it considered advanced? Well, it's because there is a higher than 2% risk of post-procedural bleeding in the absence of DOACs, and that risk can go up as high as 5% to 7% in a patient who's on DOACs. So that's a higher risk, and so that is why that period of temporary interruption has to be a little longer. But the good news is, if you've been functioning in the 2016 guideline world, you will remember, and your attendees are going to remember, that I used to always instruct people to look at the creatinine clearance of the patient, right? And we weren't used to doing that, and I can't tell you how many people complained about that, because that was just sort of out of the GI world to care about the EGFR of the patient. And the reason why we said that was because the FDA studies that got all these DOACs approved were based on the creatinine clearance in terms of anticipation of the residual anticoagulant effect in the patient. In other words, the worse your creatinine clearance, the longer the anticoagulant effects that's circulating in your blood, so you would need a longer period of temporary interruption. Luckily, in 2019, a pivotal study was published called the PAWS Cohort Study. This was a large study of over 3,000 patients done internationally, Europe, Canada, and the United States, where patients who are on all the DOACs and were planned to have any kind of surgical procedure, including endoscopy, were then triaged to being to an algorithm that they either held the procedure, the DOAC, two days before or three days before. Two days before was for low-risk bleeding procedures that included all of the GI procedures, all 586 of those patients. And what they found was this standardized algorithm of temporary interruption pre-procedure on the day of the procedure with resumption the next day was associated with a very low risk of post-procedural bleeding and less than a 1% risk of mortality or thromboembolism. Now, the principal investigator of that PAWS study happened to be the hemostasis expert on our, well, didn't happen to be, I asked him to be on our guideline for that reason because he was the world's expert. And he was very generous because there just wasn't a lot of detail about GI procedures. So Dr. Alan Barkin, who's my co-principal author from Canada, and I asked Dr. Dukaitis, would you give us the raw data on those 586 procedures so we could analyze that and better inform our guidelines? That data was published in an abstract two years ago and it is now currently in press with the Red Journal. And what does it show? It showed that this regimen simplified approach is safe. So no more need to look at EGFR or creatinine clearance. Your attendings will really like this and it's become so much simpler. Wonderful. That is incredibly helpful. I know that this is really a sticky point for many, a moment in the peri-endoscopic period where we get a flurry of messages from the endoscopy nurses. And so I think this is really helpful to spend the time. If you don't know that table for high versus low risk, it is slightly different than the 2016 table based on evidence that's been published. Do what we did in our endoscopy suite. We made copies of it and stuck them in a lot of the fellows rooms, the fellows cubes and attendings offices so people could have that quick reference. Absolutely. And just to allude, we'll get to the list of low bleeding risk procedures in a moment, but I want to take a quick second to change up the case a little bit. The patient we were talking about was on a DOAC, but what if this patient were actually on warfarin for their atrial fibrillation? And if they're on warfarin, should they be bridged prior to the endoscopy? And overall, the guidance that Dr. Abraham and her colleagues gave us in both the guidelines and the guidance companion was that most patients who are on warfarin really should not be bridged prior to the procedure. And patients who may benefit from bridging tend to fall in those who are on this table, those who have mechanical valves, atrial fibrillation with a very high CHADSVAS4 greater than five, history of thromboembolism during anticoagulation interruption, or other major vascular surgeries like carotid endarterectomy or other cardiac valve replacements. And Dr. Abraham, do you want to take a moment to give us any more thoughts on bridging? Yeah, this is really important, folks. Back in 2016, we said the same thing, but we didn't say it as definitively. And that was because we really only had one randomized control trial that didn't have a lot of GI patients and GI procedures in it. So when it comes to the sausage making of guidelines, this is now the eighth one I've written. When you don't have the really good evidence to give a definitive answer, you kind of leave it fuzzy on the edges, and you give ranges and so forth. Since the 2016 guideline was written in 2015, at the end of December of 2015, and now we now have two randomized control trials that have been published, not only the bridge trial, which was the only one which was available on bridging originally, but now something called the PERI-OP2 trial, plus five observational studies, really good quality observational studies, that say the same thing. Routine bridging during warfarin temporary interruption is not associated with a protective benefit for the patient with regard to cardioembolic phenomenon, but is associated with a higher risk of bleeding, all right? So we're doing more harm than good when we routinely bridge these patients. This is going to be something you're going to need to explain, not only to maybe your attendings, but also to internal medicine and hospital internal medicine, and often some of the cardiologists that they are not familiar with the most recent data. However, there are patients who always may benefit from bridging. You never stop warfarin in a patient with a mechanical valve without providing them with a bridge. High CHAD scores, that's a little iffy, because patients with high CHAD scores weren't actually in the bridge trial, but you might have to resuscitate a cardiologist if you don't give low molecular weight heparin to a patient with AFib who has a high CHAD score. Certainly, there are patients who have inherent thrombophilic disorders who have had bad experiences with temporary interruption of warfarin without a bridge, and they've had thromboembolism. That's an important thing to ask when you take the history. Have you ever had a procedure where your warfarin needed to be held? Yes, no. Many of them will have had it with bridging, and has it ever been held without bridging? Oh yeah, and I got a DVT. Well, that's important to know, because that's someone who is not really safe to not bridge. And the major cardiac surgeries, you're not going to be doing elective endoscopy in patients with major cardiac surgery, so it's more for completeness that we included that. That is incredibly helpful. And so if this patient were on warfarin, she has atrial fibrillation, she's due for surveillance colonoscopy, how should we manage her warfarin in the peri-endoscopic period? And because a colonoscopy with biopsies, or even with polypectomies less than 10 millimeters, is a low bleeding risk procedure, we would continue the warfarin without pre-procedural interruption, because the procedure is a low bleeding risk, which this also I think is going to be a very practice-changing paradigm that a lot of us are not quite used to. And so again, just to go over the list of procedures that are low bleeding risk procedures, which means they have a less than 2% 30-day risk of a major bleed. This includes EDDs, push enteroscopies, flexible sigmoidoscopies, colonoscopies, balloon-assisted endoscopies with biopsies, ERCPs with stent, but no sphincterotomy, no tissue sampling, and no polydopalythiasis. So just like Dr. Abraham mentioned, no stone work. EUS without FNA, even enteral stents, APC, balloon dilations. Again, polypectomies that are for small polyps, 10 millimeters or less. Markings such as clipping or tattooing, as well as video capsule endoscopy. And bravo probes, we should add that same thing, mucosal lifts, right? Perfect. Yeah. So this is a big shift because after 2016, everyone just got in the routine of holding warfarin for five days before all procedures. But since then, there have been a number of studies examining the risk of post-procedural bleeding in patients who are on continuous warfarin, and that's particularly in the setting of polypectomy. And so that's where the evidence comes. There's five large cohort studies, which we pooled to make a mini meta analysis for our guideline. And what we showed was that if they were going for one of these low risk procedures, there was no increased risk of post-procedural bleeding if the patient went through that procedure on continuous warfarin. And there was a non-significant increase in in thromboembolism. So that's why we shifted the guidance, but everything else is high risk, right? And with advanced procedures, you're going to be holding the warfarin for five days. Now, where does this get tricky? If you work in an open access endoscopy setting where you may not have seen this patient before, and you don't want to have to bring that patient back again, because they came in on warfarin, and then you find a big 1.5 centimeter polyp, so you don't want to tattoo it and bring them back another day. In that case, as we do at Mayo, we just have a codified plan to temporarily interrupt warfarin before screening colonoscopy, because we're kind of a one and done facility. We don't have the time or access ability to bring people back. So the assumption is you're going to come for your screening colonoscopy, surveillance colonoscopy, as long as you're clean, we're going to eliminate all the polyps that wind about, regardless of size. That's very helpful, Dr. Abraham. You're right, where you do your procedures certainly augments how you're going to apply these guidelines, but really helpful for folks who are in a setting where they do tend to bring people back for repeat procedures, that if you're not anticipating a large polyp or doing anything with a high bleeding risk, that you can continue the warfarin throughout the peri-endoscopic period. But all those patients that you see for diarrhea, rule out microscopic colitis, you know, all those folks, right, or all those people you want to get a duodenal sample for celiac disease or an HP biopsy, continue the warfarin. Absolutely, absolutely, that's fantastic advice. So to round out all the wonderful information that we've shared this evening, I have some take-home points for us, but before I go to the take-home points, I want to give the participants an opportunity to enter in any questions in the chat box, or even if you're allowed to unmute yourself to ask the questions. I want to make sure that we answer everyone's questions, big or small. Everyone has been in a situation where they've scratched their head, and so what should I do about this anti-platelet or anti-coagulant in the setting of endoscopy, and now is the time you're with the Cardio GI Master to get your questions answered. So I'll give a quick moment for folks to type in any questions before I give our take-home points for the evening. Now that's a good one. I'm going to read it out so everyone can hear. So it seems the ICU team likes to use TEG to correct any coagulopathy. What are your thoughts on TEG? This is a great question. Thank you so much to whoever asked this. Yeah, thank you for asking it. The bottom line answer, and quickly, is there's not sufficient evidence on TEG in the setting of coagulopathy to justify its routine use, so your ICU team is probably getting ahead of themselves. I have to say I see this a lot as well, so I suspect that your ICU is not alone in this practice. Really fantastic and helpful question. All right, let's wrap it up. Kevin? Sounds good. So our take-home points for this evening is to know the definition of life threatening bleed as it's going to change your approach to your acute GI bleeders. PCC is a reliable and rapid correction of INR in the setting of warfarin use. Continue aspirin for secondary prevention both in the acute GI bleeding setting as well as the elective endoscopic period. Defer all elective exams until the patient is no longer high risk. DOAC should be held for general GI procedures a day prior to procedure, whereas advanced procedures are two days prior to procedure. And we should be stopping clopidogrel and ticagrelor five days prior to procedures. And please make good use of the guideline companion to help put all of the guidance from the guidelines into practice day-to-day in the red journal or the red section of the April issue of the red journal. So with that, I'd like to thank Kevin and Anna for doing a masterful job in moderating this session. And Marilyn and Lyme, we'll turn it back to you. All right, thank you again to all our moderators and panelists for tonight's presentation. Before we close out, I just want to let the audience know to make sure to check out our upcoming ASG educational events. Registration is open and many of these programs are available complimentary to ASG training members. Visit the ASG website to register. The next ASG Endo Hangout session will take place on Thursday, January 5th at 7 to 8 30 p.m. Central Time, an advanced endoscopy fellowship. At the conclusion of this webinar, you will receive a short survey. We would appreciate your feedback. As a final reminder, ASG membership for fellows is only $25 per year. If you haven't joined yet, please contact our membership team or go on the ASG website to make sure to sign up. In closing, thank you again to our panelists and moderator for this excellent presentation. And thank you to our audience for making this session interactive. We hope this information is useful to you. And with that, I will conclude our presentation. Have a good night, everyone. Thank you. Good night. Thank you. Thank you.

anticoagulation

antiplatelet therapy

gastrointestinal bleeding

endoscopic procedures

prothrombin complex concentrate

direct-acting oral anticoagulants

reversal agents

interrupting anticoagulation

bridging therapy