Session Report: Official welcome and large clinical trialsOn this first day of the 11th ESOC 2025 in Helsinki, Finland, Mira Katan and Daniel Strbian welcomed over 4,000 participants from >100 countries who were embraced by the Southern Finnish Sun in Helsinki today in pleasant anticipation for the latest advances in stroke research.
To spark off the session, Debbie Summers from Kansas City, USA and Victor Urrutia from Baltimore, USA presented the results of the OPTIMISTmain trial, a multicentre, stepped wedge, cluster randomised controlled trial testing whether less-intensity monitoring is non-inferior to standard high-intensity monitoring started within 2 hours of the end of intravenous thrombolysis in patients with mild to moderate ischemic stroke (NIHSS <10). Primary outcome was poor functional outcome (mRS 2-6) at 90 days, secondary outcomes included among others, NIHSS and quality of life. Of over 9,000 screened patients, n=4,922 patients were included in the trial. Less-intensity monitoring (lower rate of vital sign checks and neurological assessments) showed no difference in the mRS shift analysis at 90 days compared to standard high-intensity monitoring with a common odds ratio of 1.03. There was also no heterogeneity across subgroups observed. The OPTIMISTmain trial provides “weak level evidence” that low-intensity monitoring is non-inferior to standard monitoring in patients with mild to moderately severe stroke, a patient group which comprises at least one third of all patients receiving intravenous thrombolysis worldwide. Low-intensity monitoring proved to be safe and well accepted by patients, nurses and clinicians and might even be cost-effective due to lower ICU capacity use. In conclusion, hospitals should consider incorporating this approach to enhance systems of care regarding resources and local circumstances. The trial was published simultaneously in The Lancet today: doi: 10.1016/S0140-6736(25)00549-5.
Next, Wei Hu from Hefei, China and Jeffrey Saver from Los Angeles, USA presented the results of the ASSET-IT placebo-controlled randomised trial, which tested if administration of tirofiban within 60 minutes of intravenous thrombolysis (IVT) improves functional outcome in patients with acute ischemic stroke across 38 centers in China. Participants received the study drug (0.4 ug/kg/min for 30 minutes, followed by a maintenance dose of 0.1 ug/kg/min for 23.5 hours) or a placebo infusion initiated within 60 minutes of IVT. Patients were excluded if they were undergoing endovascular treatment (EVT), had atrial fibrillation, an ASPECTS <6 and neurological worsening within 60 minutes after IVT. The study included 832 patients with a near-complete follow-up and well-matched groups with a median NIHSS=6 and an onset to IVT of approx. 160 minutes. Three quarters of all patients received alteplase and one quarter tenecteplase. The trial demonstrated that the tirofiban group experienced a higher rate of excellent functional outcome (mRS 0-1) at 90 days in 66% compared to 55% in the placebo group which was a significant difference. The benefit was most striking in more severely affected and older patients. Regarding good functional outcome (mRS 0-2) also a significant difference in favor of the intervention group was observed. The intervention was considered safe with a low rate of symptomatic intracranial hemorrhage (sICH) at 1.7% in the intervention group. The trial investigators conclude that the study showed a favorable enough safety profile for adjuvant tirofiban in IVT and considered tirofiban a well-suited agent because of a fast on- and offset of the drug. Following six randomised trials on bridging intravenous thrombolysis using alteplase and no clear establishment of non-inferiority or superiority of IVT+EVT or EVT alone in the IRIS meta-analysis, Guangxiong Yuan from Xiangtan, China presented the BRIDGE TNK open-label randomised controlled trial which examined the efficacy and safety of bridging thrombolysis using tenecteplase in acute ischemic stroke within 4.5 hours from time last known well plus thrombectomy against thrombectomy alone. In 39 Chinese centers, 544 patients were randomised and the primary outcome showed that intravenous tenecteplase plus thrombectomy resulted in a higher rate of good functional outcome (mRS 0-2) at 54% vs. 44% in the group of thrombectomy alone (aRR 1.18, 95%CI 1.01-1.39). The secondary outcomes proved to be less robust with only rate of successful reperfusion being significantly different. Safety outcomes i.e. mortality, sICH or any ICH were similar in both groups. In summary, intravenous tenecteplase plus thrombectomy resulted in a higher proportion achieving functional independence than thrombectomy alone, although secondary outcomes were less robust. It also led to a higher proportion of successful reperfusion and achieved a 9-minute reduction in time from puncture to reperfusion, independent of rescue therapy. These results have to be confirmed in other populations. A future trial BRIDGE-TNK EXTEND will commence in October 2025 and will extend the time frame from 4.5 hours to 24 hours after stroke onset. This trial was simultaneously published in the NEJM DOI: 10.1056/NEJMoa2503867.
Next, two studies on medium/distal vessel occlusion stroke were presented. Aikaterini Anastasiou (Basel, Switzerland) presented a sub-analysis of the DISTAL trial titled “Mismatch and saved brain tissue volume in patients with a medium/distal vessel occlusion stroke”. The study’s objective was to determine whether EVT in addition to best medical treatment (BMT) with medium/distal vessel occlusions resulted in more brain tissue volume saved compared to BMT alone. The volume cut-off was set to a delta of ³0.8 of relative volume of initial tissue at risk (i.e. more than 80% of the tissue at risk saved). The study showed that the probability of having a delta relative volume of brain tissue saved of over ³0.8 was higher in the EVT+BMT group compared to the BMT alone group. The proposed volume cut-off was associated with better clinical outcomes in both groups which entangles further research on imaging parameters of outcome after reperfusion treatment.
Michael Hilll from Calgary, Canada presented a secondary analysis of the ESCAPE-MeVO trial “Association of Imaging Features with Prognosis and Effect of Reperfusion Therapies in Patients with Medium Vessel Occlusion Stroke”. The initial trial was done in 5 countries including 530 patients with an average NIHSS=8 and showed no significant difference in functional outcomes despite a trend to better outcomes in the interventional arm. In this sub-analysis of imaging data, more proximal occlusions, poorer collaterals and multiple MeVOs were associated with a worse outcome, as expected. A possible effect modification was shown by collateral status with patients with poor collaterals seeming to be harmed by EVT and patients with good collaterals having a benefit from EVT. These interesting results need to be confirmed because the effect was small and the former trial was not powered to confirm this interaction. The pooled data from all similar trials might answer this question. Also, the effect size seemed to be driven by time. Early treatment (<180 min after onset) resulted in a strong benefit whereas late treatment (>180 min after onset) was associated with harm. Prof. Hill concludes that the more distal the occlusion, the lower the importance of collaterals seems to be and the more distal, the less time we have to initiate a beneficial intervention. These data re-emphasise the urgent need for speed in acute treatment, so it’s back to the future: “time is brain”.
Next, Diana Aguiar de Sousa presented the long-anticipated results of the EXCOA-CVT multi-center cluster-randomised trial, which investigated the optimal duration of oral anticoagulation after cerebral venous thrombosis, comparing short-term (3–6 months) with long-term (12 months) treatment. Guidelines based on observational data recommend a wide range of treatment time from 3-12 months. The trial was accompanied by an observational cohort study and followed patients for 12 months including the observational period of another year. Both the trial and the observational study showed no difference in the risk of recurrent venous thromboembolism or major bleeding in both groups despite a numerically higher rate of deaths between short (3-6 months) and long-term (12 months) anticoagulation during the first 12 months of follow-up. The findings suggest that prolonging anticoagulation may not offer an early clinical benefit in patients with cerebral venous thrombosis and implies a shared decision-making regime in clinical practice, tailored to the individual patient.
The last part of the session focused on post-stroke care and three studies were presented. Natasha Anne Lannin from Melbourne, Australia presented the final results of the prospective, blinded endpoint, Phase III randomised HOME REHAB trial. The trial tested the effectiveness of an occupational therapist-led pre-discharge home visit compared to in-hospital discharge planning after the first stroke. In 304 randomised patients, the intervention showed no difference regarding activity participation at 4 weeks and 6 months and functional outcome at 6 months compared to in-hospital discharge planning. Also, the median duration of rehabilitation remained similar in both groups. At the moment, the ideal discharge planning for acute ischemic stroke patients is yet to be determined
Rafael Bourry (Hamburg, Germany) followed with the results of the STROCARE trial, a multi-centre, non-randomised sequentially controlled interventional study evaluating a cross-sectoral, coordinated care model after stroke. Recent trials on post-stroke care like SANO, STROKE-CARD and iNSPIRE-TMS reported heterogenous results on stroke recurrence, mortality, risk factor management and quality of life. A total of 470 patients were analysed at 12 and 24 months after stroke and 71% completed the final follow up. The study showed no difference in self-reported physical quality of life after 12 and 24 months. Also, the study showed no differences in the secondary outcomes, including mortality. However, the intervention group showed better functional outcomes after 12 and 24 months with a mean mRS of 1.28 vs 0.71 at one year and 1.05 vs. 0.62 at 2 years in favor of the intervention group. In conclusion, there is an effect of post-stroke care in functional outcome, however the strong mismatch between functional outcome and self-reported outcome measures requires further investigation.
The final presentation was held by Torunn Askim (Trondheim, Norway) who presented the results of the LAST-LONG pragmatic multi-center randomised controlled trial, which investigated the effectiveness of regular follow-up by a stroke coordinator to prevent functional decline after stroke. Stroke patients with an mRS <5 and a persistent impairment were included 3 months after stroke. Follow-up was gathered at 6, 12 and 18 months. The intervention (LAST-LONG checklist) consisted of multiple modalities i.e. health/lifestyle goals, physical function, cognition, and mood and social function. The intervention included 18 monthly meetings, at least 50% face-to-face, motivational interviewing and shared decision making. An attendance rate >75% was defined as good adherence. A total of 301 patients were randomised in well balanced groups, included ischemic and hemorrhagic stroke. The intervention was feasible with 63% attending >75% of meetings, the primary outcome showed no superiority to standard care regarding functional outcomes at all timepoints. Secondary outcomes were neutral including Barthel Index, MoCA, Six minutes walk test and the Trail making test, though the data might imply a trend towards better outcomes at a later follow-up. The study team implies that an extension of follow might show a reasonable effect of this intervention after all.
The first large clinical trial session brought us amazing new evidence on a wide range of topics including acute management, reperfusion therapy, cerebral venous thrombosis and post-stroke care and made the audience of over 4,000 participants hungry for more in the next days of the 11th European Stroke Organization Conference here in Helsinki, Finland.
