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Perioperative Management of Dabigatran

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ISTH 2015 – Sam Schulman, ISTH 2015 Congress President, Professor of Medicine, Thrombosis Service, McMaster University – This cohort study evaluates the safety of perioperative management of dabigatran using a specified protocol. Patients treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was pre-specified according to the complexity of the surgery and consequences of a bleeding complication.

I’m sam schulman and i’m working with the blood thinners at mcmaster university in hamilton and both the old ones and the new so the main old one is warfarin or coumadin and i’ve been working with that for 30 years trying to improve life for patients trying to find better ways to use warfarin so for example one study that we published a few years ago was for patients

Who are very stable can they have a decreased burden of the monitoring because with more warfarin you have to go for blood tests all the time and we found in that study which was published in annals of internal medicine that patients could actually wait up to 12 weeks instead of four weeks so that’s just one example of making life easier now i’m also working a

Lot with the new blood thinners and that’s the study that was published right now in circulation on how to manage patients when they go for surgery because when these new drugs are approved they have had large trials that show essentially that they are effective and that they are safe but those large trials do not answer all the practical questions that come up

Afterwards what do you do in case a patient is bleeding which we will hear soon about and what do you do when you need to take the patient for surgery which you will also hear from my colleague here so a but he will talk about warfarin and my study was on one of the new blood thinners the big adjourn but it is applicable to the other two agents as well the problem

With these new agents when they come out and these questions are not resolved is that physicians do whatever they think is best and that can be harmful for patients some of them will stop the blood thinner too early because they’re afraid that the patient is going to bleed during surgery and instead the patient can have a stroke while they’re waiting for surgery

Some of them stop the drug too late and the patient can have a bleeding and the same with restarting the blood thinner after surgery how soon can we do that and then there is another question that it applies both to tamar tell study and my study is do you need while the patient is off the blood thinner taken by mouth to give something by injection and i and my

Colleagues felt that specifically for the new blood thinners that stopped working quite quickly and start working essentially immediately that there is no need to give heparin injections but you see out in the clinics that physicians do that anyhow and that could be harmful that could increase the risk of bleeding when you give additional blood thinners so it is

Important to test the best possible strategy for patients on the new blood thinners and that’s what we did with the bigger trend which we chose because that was the first one out and we had enough patients out in the community on this drug and we could with the help of heart and stroke foundation funding this study evaluate that in 541 patients here in canada and

Our strategy was to stop the drug as late as possible but different for different patients depending on how big is it bleeding risk of the surgery so it’s different if you go for an endoscopy where you just put down a tube and maybe take a biopsy or if you go for brain surgery obviously so so you double the time if you have high-risk surgery between stopping and

The dragon starting surgery but you also have to take into account for these new drugs to more larger big erick smaller bigger extent the kidney function because these new drugs are more or less eliminated from the body by the kidneys and if the kidney function is worse they stay longer in the body so we have to increase the time and more so for the bigger trend

Because it is really dependent on the kidneys so we had between 24 and 96 hours of interruption between the last dose and surgery and then restarting is main is only based on when the patient has stopped bleeding and the bleeding risk of the surgeries so in some patient we started the same evening if they had an endoscopy for instance we could start back the same

Evening otherwise one two or three days depending on the so brain surgery we waited two days and with these 541 patients we had no strokes so this is the worried these are patients with atrial fibrillation irregular heartbeat they are on the blood thinner because you want to prevent stroke and that’s what you don’t want to happen after surgery so we didn’t have

A single one we had one patient with it you call it mini stroke or tiaa its brief neurological deficit that disappears without any residual effects it can last for a few minutes so that happened in one patient so that’s a very low event rate extremely low event rate in 541 patients we had 10 major bleeds but most of these leads they were related to the type of

Surgery so very large surgery one of those four it was for instance a huge tumor that took five hours to operate on one was an open heart surgery in one and some were hip replacements where it was the second time so when you go in the second time and replace hip prosthesis it’s more complicated because the tissues are scarred and and it bleeds more so it was not

Really attributable to the debate john and therefore with one-point-eight percent risk of major bleeding during the 30 day follow-up it’s comparable to other studies it’s a low risk it’s completely acceptable and it’s very hard to get lower than that because when you cut into somebody they have to bleed and if it’s a complicated surgery there is a an increased risk

Of major bleeding so by having this and without using heparin without giving injections with heparin in the meantime and this is very important because as i said to you some of my colleagues think you have to do it and that as by another one of our colleagues being shown actually that it can be detrimental in patients on the bigoted run to do it so we didn’t do

It and so even without that we had this extremely low stroke risk so really there is nothing to gain by injecting the patient with heparin and we need to spread this out that’s why we were happy that it was published in high in high-impact journalist circulation we’re happy that yeah maybe some of you can spread it out patient should not get injections with heparin

Unless they cannot take the tablets after surgery if they have had bowel surgery and the bowel is not working they cannot take my mouth that is an excuse then you have to give injections with a blood thinner until the patient can start taking again so i think that summarizes the study

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Perioperative Management of Dabigatran By Thrombosis.TV