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Introduction by the Convenors
APACHE-AF: APIXABAN VERSUS ANTICOAGULATION AFTER ANTICOGULATION-ASSOCIATED INTRACEREBRAL HAEMORRHAGE IN PATIENTS WITH ATRIAL FIBRILLATION: A RANDOMISED, OPEN-LABEL, PHASE 2 TRIAL.
Abstract
Group Name
The APACHE-AF Trial Investigators
Background And Aims
In patients with atrial fibrillation who survived an anticoagulation-associated intracerebral haemorrhage (ICH) it is unclear whether restarting or avoiding anticoagulation is the best long-term treatment for the prevention of stroke or systemic thromboembolism.
Methods
APACHE-AF is a phase II, prospective, randomised, open-label clinical trial with blinded endpoint assessment at 16 hospitals in the Netherlands. We recruited adults with a history of atrial fibrillation and ICH during treatment with oral anticoagulation in whom clinical equipoise existed on the optimal stroke prevention therapy. The target recruitment was 100 participants. Participants were randomised to apixaban 5mg twice daily or to avoiding anticoagulation. We followed participants for the occurrence of vascular death or non-fatal stroke (primary outcome), other vascular events (secondary outcome: all major vascular events) and other serious adverse events. We calculated annual event rates with 95% confidence intervals of the primary outcome in each of the two treatment groups using intention-to-treat analysis, and compared the rates of all-cause death, stroke, ischaemic stroke, ICH, other major haemorrhage, systemic embolism, and functional outcome between participants treated with apixaban and those who are treated with no anticoagulation (antiplatelet drug or no antithrombotic drugs).
Results
Between 16 January 2015 and 6 July 2020, 101 participants (46% female, median age 77 years) were recruited at a median of 46 (IQR 21-74) days after ICH. Participants were followed for a median of 2.2 (IQR 1.0-3.1) years.
Conclusions
Final results will be presented at the conference.
Trial Registration Number
NTR4526; NCT02565693.
EFFECTS OF LONG-TERM ORAL ANTICOAGULATION FOR ATRIAL FIBRILLATION AFTER SPONTANEOUS INTRACRANIAL HAEMORRHAGE: THE START OR STOP ANTICOAGULANTS RANDOMISED TRIAL (SOSTART)
Abstract
Group Name
Start Or STop Anticoagulants Randomised Trial (SoSTART) Collaboration
Background And Aims
For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage (ICrH) with permanent/persistent/paroxysmal atrial fibrillation (AF), it is unclear whether starting full treatment dose oral anticoagulation (OAC) is safe and results in a beneficial net reduction of all major vascular events compared with avoiding OAC. In this safety phase trial, we investigated whether the risk of recurrent spontaneous ICrH is sufficiently low after starting OAC (i.e. non-inferior to avoiding OAC) to justify a definitive trial.
Methods
SoSTART was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 67 hospitals in the UK. We recruited adults (≥18 years) who survived for 24 h after spontaneous ICrH, had AF, and CHA2DS2-VASc score ≥2. Computerised randomisation incorporating minimisation allocated participants (1:1) to avoid or start long-term (≥1 year) full treatment dose OAC (either a non-vitamin K antagonist direct oral anticoagulant [DOAC] or vitamin K antagonist if a DOAC could not be used, chosen by the patient’s physician before randomisation). We followed randomised participants for ≥1 year for a primary outcome of recurrent symptomatic spontaneous ICrH, and symptomatic serious vascular events as exploratory outcomes. We analysed outcomes using Cox proportional hazards regression adjusted for minimisation covariates, during all available follow-up. SoSTART is registered (NCT03153150).
Results
The results will be available after database lock for a late-breaking presentation at the conference.
Conclusions
The effects of long-term OAC for AF after ICH will be determined by the COCROACH meta-analysis (PROSPERO 2021 CRD42021246133) of SoSTART and similar randomised trials (APACHE-AF [NCT02565693], NASPAF-ICH [NCT02998905], STATICH [NCT03186729], A3ICH [NCT03243175], ASPIRE [NCT03907046], ENRICH-AF [NCT03950076] & PRESTIGE-AF [NCT03996772]).
Trial Registration Number
NCT03153150
SHORT-TERM SYSTOLIC BP VARIABILITY AND FUNCTIONAL OUTCOME AFTER ACUTE ICH: ANALYSES OF POOLED INDIVIDUAL PARTICIPANT DATA
Abstract
Group Name
The Blood pressure in Acute Stroke Collaborators (BASC)
Background And Aims
Our systematic review and study-level meta-analysis found an association between higher short-term systolic BP variability (SBPV) and poor functional outcome after acute intracerebral haemorrhage (ICH), but it was prone to publication bias, and potential confounding by other aspects of SBP control and BP-lowering strategies.
Methods
We pooled individual participant data (IPD) from randomised controlled trials in the Blood pressure in Acute Stroke Collaboration (BASC). Short-term SBPV was defined as the standard deviation (SD) of SBP measures during 1-24 hours after randomisation. Primary outcome was function (distribution of scores on the modified Rankin scale) 90-180 days after randomisation. Meta-analysis used a one-stage approach, adjusted for pre-specified covariables, other summary measures of SBP control, and trial. We assessed the interaction effect of BP-lowering agent and BP-lowering strategy.
Results
5,463 of 6,221 (88%) patients provided the minimum required data for adjusted analyses. A linear association existed between short-term SBPV during 1-24 h after acute ICH and functional outcome: adjusted OR (95%CI) for unfavourable shift in ordinal mRS scores per 10 mm Hg increase in SD of SBP 1.18 (1.11-1.27), p<0.001. Significant interactions existed for most frequently used BP-lowering agent (α-and β-adrenoreceptor blockers OR 1.30 95%CI [1.18-1.44], calcium channel blocker 1.51 [1.18-1.96], magnesium sulfate 1.05 [0.90-1.22], nitrate 1.05 [0.90-1.22], pinteraction<0.001) and for BP-lowering strategy (titrated target-based 1.32 [1.21-1.45], fixed class-based 1.04 [0.93-1.15], pinteraction<0.001).
Conclusions
Early variation in SBP after acute ICH is associated with worse functional outcome, especially in patients receiving intensive, targeted BP reductions with α-and β-adrenoreceptor blockers and calcium channel blockers
Trial Registration Number
Not applicable
EFFECTS OF ANTIPLATELET THERAPY AFTER STROKE DUE TO INTRACEREBRAL HAEMORRHAGE: EXTENDED FOLLOW-UP OF THE RESTART OR STOP ANTITHROMBOTICS RANDOMISED TRIAL (RESTART)
Abstract
Group Name
REstart or STop Antithrombotics Randomised Trial (RESTART) Collaboration
Background And Aims
People surviving stroke due to intracerebral haemorrhage (ICH) are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely has been unclear. The RESTART trial involving survivors of ICH associated with antithrombotic therapy found that starting antiplatelet therapy seemed safe over a median 2·0 years of follow-up (12 [4%] of 268 participants allocated to antiplatelet therapy had recurrent ICH compared with 23 [9%] of 268 participants allocated to avoid antiplatelet therapy [adjusted hazard ratio 0·51 (95% CI 0·25–1·03); p=0·060]). However, the longer-term effects of antiplatelet therapy are uncertain.
Methods
RESTART was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet/anticoagulant) therapy for the prevention of occlusive vascular disease when they developed ICH, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. The main results of the trial reported follow-up for the primary outcome (recurrent ICH) and other major vascular events until November 2018. For these final results of RESTART, we continued follow-up of all randomised participants until November 2020 and analysed outcomes using Cox proportional hazards regression, adjusted for minimisation covariates using all available follow-up. RESTART is registered (ISRCTN71907627).
Results
The results of extended follow-up will be available after database lock for a late-breaking presentation at the conference.
Conclusions
The effects of long-term antiplatelet therapy after ICH will be determined by RESTART and ongoing trials (STATICH [NCT03186729], RESTART-Fr [NCT02966119] & ASPIRING [NCT04522102]).
Trial Registration Number
ISRCTN71907627
WHEN TO INITIATE DUAL ANTIPLATELET THERAPY USING CILOSTAZOL FOR SECONDARY PREVENTION IN HIGH-RISK ISCHEMIC STROKE: CSPS.COM
Abstract
Group Name
the CSPS.com Trial Investigators
Background And Aims
To determine the optimal timing for initiating long-term dual medication of cilostazol with aspirin or clopidogrel after onset of stroke. Such dual therapy was proven to have a lower risk of ischemic stroke recurrence and a similar risk of bleeding compared to aspirin or clopidogrel alone in patients at high-risk for recurrent ischemic stroke in a randomized controlled trial (CSPS.com).
Methods
A sub-analysis of CSPS.com that randomly assigned 1879 patients between 8 and 180 days of high-risk non-cardioembolic ischemic stroke onset to receive aspirin or clopidogrel alone or a combination of cilostazol with aspirin or clopidogrel. Patients were divided into three groups according to the timing for initiation of trial treatment. The primary efficacy outcome was the first recurrence of ischemic stroke. Safety outcomes included severe or life-threatening bleeding.
Results
There was a significant treatment-by-subgroup interaction for the primary efficacy outcome between trial treatment and trichotomized groups (P=0.002). The recurrence of ischemic stroke was less common with dual therapy than monotherapy in 467 patients initiating the treatment between 15 and 28 days of onset (aHR 0.34, 95% CI 0.12-0.95) and 914 patients initiating at ≥29 days (0.27, 0.12-0.63), and similarly common in 498 patients initiating within 14 days (1.02, 0.51-2.04). Severe or life-threatening bleeding occurred similarly between dual therapy and monotherapy in any trichotomized groups.
Conclusions
Long-term dual antiplatelet therapy using cilostazol was more effective for secondary stroke prevention than monotherapy in patients initiating the medication at 15 days or later.
Trial Registration Number
ClinicalTrials.gov NCT01995370, UMIN Clinical Trials Registry 000012180
ISCHEMIC BENEFIT AND HEMORRHAGE RISK OF TICAGRELOR-ASPIRIN VS. ASPIRIN IN PATIENTS WITH ACUTE ISCHEMIC STROKE OR TIA
Abstract
Group Name
THALES Investigators
Background And Aims
As with many secondary prevention stroke trials, the primary efficacy outcome of THALES included events also counted in the primary safety outcome. We sought to disentangle risk and benefit more clearly, assess their relative impact, and attempt to identify subgroups with disproportionate risk or benefit.
Methods
In a randomized, placebo-controlled, double-blind trial of patients with mild-to-moderate acute noncardioembolic ischemic stroke or high-risk TIA, patients were randomized 1:1 within 24 hours after symptom onset to a 30-day regimen of either ticagrelor plus aspirin (ticagrelor-aspirin) or matching placebo plus aspirin (NCT03354429). For the present analyses, we defined the efficacy outcome, major ischemic events, as the composite of ischemic stroke or non-hemorrhagic death, and defined the safety outcome, major hemorrhage, as intracranial hemorrhage or hemorrhagic death. Net clinical impact was defined as the combination of these two endpoints.
Results
Among 11,016 patients randomized, a major ischemic event occurred in 5.3% of patients in the ticagrelor-aspirin group and in 6.5% in the aspirin group (absolute risk reduction 1.19%, 95% CI 0.31%-2.07%). Major hemorrhage occurred in 22 patients (0.4%) in the ticagrelor-aspirin group and in 6 patients (0.1%) in the aspirin group (absolute risk increase 0.29%, 95% CI 0.10%-0.48%). Net clinical impact favored ticagrelor-aspirin (absolute risk reduction 0.97%, 95% CI 0.08%-1.87%). Findings were similar when different thresholds for disability were applied and for a series of predefined subgroups.
Conclusions
In patients with mild-moderate ischemic stroke or high-risk TIA on aspirin, the ischemic benefits of 30-day treatment with ticagrelor outweigh the risks of hemorrhage.
Trial Registration Number
NCT03354429
NEUROREGENERATION ENHANCED BY TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) IN STROKE (NETS)
Abstract
Group Name
The NETS Trial Collaboration Group
Background And Aims
Neuroregeneration enhanced by transcranial direct current stimulation (tDCS) in stroke (NETS) is an investigator-initiated, interventional, prospective, randomized, double-blind, placebo-controlled trial and tested efficacy and safety of anodal tDCS (1mA, 20min) to the primary motor cortex of the lesioned hemisphere in the subacute phase (day 5-45) after cerebral ischemia.
Methods
Stimulation was combined with standardized rehabilitative training and applied in 10 sessions over 2 weeks. After 1:1 randomization of 123 patients (11 centers, 3 European countries, 2009-2019), 119 patients entered the intention-to-treat (ITT) population (mean age±SD, 66±12; 63% male). Primary outcome was upper-extremity function 1-7 days after the intervention period, measured by the upper-extremity Fugl-Meyer assessment (UEFMA). Secondary endpoints included multiple scores (e.g., ARAT, nine-hole peg test) at multiple time points up to 12 months.
Results
Baseline variables were comparable, mean NIHSS 3.84±1.95 (IQR, 3-5), mean time since stroke 20±12 days (10-28). The intervention was well tolerated. The adjusted mean improvement of UEFMA from baseline was 9.07 in the placebo group and 8.76 with active stimulation (difference -0.31, 95% CI -2.97-2.35; p=0.820; ITT, ANCOVA). In the per-protocol analysis (94 patients), the respective UEFMA differences were 10.25 for placebo and 10.20 for active stimulation (difference -0.05, 95% CI -3.03-2.93; p=0.972). There were no relevant differences in secondary endpoints. Both groups showed very good long-term recovery (e.g., UEFMA at 12 months 56.21±9.61 [placebo] and 55.76±13.23 [active stimulation]).
Conclusions
In conclusion, anodal tDCS did not enhance upper extremity recovery in a cohort of mild to moderately affected subacute stroke patients.
Trial Registration Number
NCT00909714
TIMING OF ORAL ANTICOAGULANT THERAPY IN ACUTE ISCHEMIC STROKE WITH ATRIAL FIBRILLATION: A REGISTRY-BASED RANDOMISED CONTROLLED STUDY
Abstract
Group Name
The TIMING Investigators
Background And Aims
Guidelines do not provide evidence-based recommendations on the optimal time-point to start non-vitamin K antagonist oral anticoagulants (NOAC) after acute ischemic stroke in patients with atrial fibrillation (AF). We investigated the efficacy and safety of early vs. delayed initiation of NOAC.
Methods
The TIMING study was a registry-based, randomised, non-inferiority, open-label, blinded endpoint study at 34 out of 72 stroke units in Sweden. The Swedish Stroke Register, with an integrated computerised randomisation module, was used for enrolment and follow-up. Patients were within 72 hours from stroke onset randomised (1:1) to early (≤4 days) or delayed (5-10 days) initiation of NOAC. Primary outcome was the composite of recurrent ischemic stroke, symptomatic intracerebral haemorrhage, or all-cause mortality within 90 days. In parallel, a control cohort of patients with acute ischemic stroke and AF receiving early or delayed NOAC within 10 days (without randomisation) was registered.
Results
From April 2017 to December 2020, 888 patients, 78 years (mean), 46% females, were randomized in TIMING, and 9,321 control patients 79 years (mean), 46% females, were registered. Follow-up was at least 90 days for all patients.
Conclusions
This study addresses the important clinical dilemma of NOAC initiation after ischemic stroke in patients with AF. The integration of a randomisation module in the Swedish Stroke Register combines the advantages of a prospective randomised study design with the strengths of a comprehensive clinical register, with the addition of a large control cohort. Study results will be presented at the European Stroke Organisation Conference.
Trial Registration Number
ClinicalTrials.gov Identifier: NCT02961348.