ESOC 2025 | EXCOA-CVT: assessing the benefit of extended anticoagulation after CVT

Yes, so the EXCOA-CVT randomized trial aims to answer a question that has remained unanswered for a very long time. What the evidence that we have on the duration of anticoagulation after cerebral venous thrombosis was mostly derived from what is used for other venous thrombotic events. However, patients that have CVT are not the same as patients that have, for example, deep vein thrombosis. So patients are usually younger. Very often they are females with contraceptive use or other hormonal risk factors. So there are many reasons why the risk is probably different. And there was already some data suggesting that the risk was indeed different in this group. And so the aim was to have good high-quality evidence on the duration of anticoagulation after cerebral venous thrombosis, from a prospective point of view, and especially on the main study, on the cluster randomized evidence on the duration of anticoagulation. So this was the rationale. And then the study design was this cluster randomized design. So centers were randomized either to do what we define as a short-term treatment, which was three to six months of anticoagulation. And this was compared. So the other centers were randomized one-to-one for what we define as a long-term treatment, which is patients would undergo one-year anticoagulation after cerebral venous thrombosis. The population of patients with cerebral venous thrombosis to be included in this cluster randomized trial was a population of patients that had no indication to do permanent anticoagulation. So they had no high-risk factors that would be an indication for permanent anticoagulation. So this is the population that the trial targeted. And the goal was to compare the three to six months versus 12 months anticoagulation. The follow-up of this study is 24 months. However, the follow-up in the final year is still ongoing. And also, the second year is just an observational year in which all patients are already out of anticoagulation and so the period that really compares directly the two policies is this first year. So we were presenting the 12 months follow-up of this study and also this study was complemented by a prospective observational cohort study with a very similar design, but the difference is that the centers established the anticoagulation policy according to their predefined policy or according to their preference. So each center will choose either three to six months or 12 months according to their preferences, and all patients will be treated under the same policy also in those centers that were included in the observational study. So the cluster randomized trial, we included 460 patients and the remaining patients were included in the observational study. And overall, the study had 1,269 patients included with CVT. And we could compare these two policies, both in the cluster randomized trial and in the prospective observational study. So what is the main message from the results in this first 12 months of follow-up? Is that we couldn’t find differences between both the recurrence of venous thrombotic events, which is, let’s say, the efficacy outcome, the primary outcome, and then also concerning bleeding and mortality, there were no significant differences in both arms. However, there were numerically higher rates of death, including vascular death, in patients on the long-term policy, And this, both the older results, including this numerically higher rates of death and vascular death, all data was, the results were quite consistent between the cluster randomized study and the observational study. So overall we can conclude that in this early period of the first 12 months of follow-up there are no differences concerning the recurrence rates and also the bleeding events across groups with short-term and long-term policy. There were numerically higher rates of death and vascular death in patients included and in the long-term policy and of course the long-term follow-up will provide further data on the recurrence in these patients but at that time the policy will be that all patients will be already without anticoagulation but we can also understand if there are some later effects of this policy but overall that’s the conclusion we can’t find a benefit in this early phase of prolonging anticoagulation in patients with acute CVT without an indication for permanent anticoagulation.

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