WSC 2025 | Arguments against the use of intravenous thrombolysis for ischemic stroke in patients on DOACs

There are actually four arguments against a routine use outside of trials. The first one is safety concerns. It is said that there is no bleeding signal, but I think this is misleading. We should not forget that these ideas or this evidence comes from observational data and we only have observational data or we have indirect data like a study called ARISE or MOST. Those trials examine adjunctive agents like argatroban or eptifibatide, but they have actually nothing to do with the question we are dealing with here, which is thrombolysis while the patient is on DOAC use. And then there are animal models. I can only warn everybody not to pay too much attention to animal studies. We know from experience that what’s safe in animals might not be in humans. For example, the metabolism and coagulation in animals, at least in rats and mice, is totally different from humans. And the second argument is that there is a lack of robust evidence. As I said, there are only observational data, but there are no randomized control trials on the issue. There are some interesting methodologically wise sophisticated ways to simulate or emulate randomized control trials. But again, these attempts do use data from retrospective data or from observational studies. And we have learned many times that in the past we had promising results from observational trials but they were then disproven by randomized control trials. So my point is we should be careful. The third argument is uncertainty about drug level measurements and decision making. It is said that plasma levels, they are not available everywhere or it takes too long, which is certainly true, but that does not justify treating patients blind, for example. And the final argument is clinical responsibility and patient safety. It is, I think, our ethical responsibility as a clinician to pay attention first, to do no harm to patients. We should not forget that the problem we are dealing here with is the chance of suffering from an intracranial bleeding, and that is not a minor side effect, that’s a catastrophe. And so these were my arguments against routine use of thrombolysis in patients who have a stroke and while they are on a direct oral anticoagulant. And so I’m voting for including patients like these into randomized control trials.

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