European Stroke Organisation Guidelines Research Articles

The 4.5-Hour Time Window for Intravenous Thrombolysis With Intravenous Tissue-Type Plasminogen Activator Is Not Firmly Established

Most stroke neurologists would likely choose to treat this patient with intravenous tissue-type plasminogen activator (IV tPA) assuming the treatment could be initiated within 4.5 hours from stroke onset. In fact, the American Heart Association and European Stroke Organization guidelines both recommend treatment of selected patients in the 3- to 4.5-hour time window. IV tPA is approved in this time window in 15 countries in Europe and several other countries around the world. In the United States, however, the Food and Drug Administration declined an application by Genentech to extend the time window for treatment beyond 3 hours. The evidence supporting the benefit of treatment in the 3- to 4.5-hour time window includes the results of European Cooperative Acute Stroke Study (ECASS) III,1 a randomized controlled trial enrolling 821 patients. Three prior randomized controlled trials (ECASS, ECASS II, Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke [ATLANTIS]) and 1 subsequent trial (Third International Stroke Trial [IST-3]) attempting to extend the time window for IV tPA beyond 3 hours failed to show significant benefit. In addition, an updated meta-analysis of 7012 patients in 12 IV tPA trials found that the major benefit occurred in patients treated within 3 hours with no significant effect of IV tPA in almost 5000 patients treated 3 to 6 hours after stroke onset (odds ratio, 1.07; 95% confidence interval, …

Age and gender disparities in the risk of carotid revascularization procedures

The potential effect of age and gender stratification in the outcome of patients with carotid artery stenosis undergoing carotid revascularization procedures (CRP) may have important implications in clinical practice. Both European Stroke Organization and American Heart Association guidelines suggest that age and sex should be taken into account when selecting a CRP for an individual patient. We reviewed available literature data through Medline and Embase. Our search was based on the combination of terms: age, gender, sex, carotid artery stenosis, carotid artery stenting (CAS) and carotid endarterectomy (CEA). Postoperative stroke and mortality rates increased with age after any CRP (CEA or CAS), especially in patients aged over 75 years. Older patients with carotid artery stenosis undergoing CAS were found to have a nearly double risk of stroke or death compared with CEA, while CEA was found to benefit more patients aged over 70 years with symptomatic carotid artery stenosis. Male patients with symptomatic or asymptomatic carotid artery stenosis had lower stroke/mortality rates and benefited more from CEA compared with females. For the periprocedural risk of stroke or death in patients with carotid artery stenosis after CAS no sex differences were found. Therefore, CEA appears to have lower perioperative risks than CAS in patients aged over 70 years, and thus should be the treatment of choice if not contraindicated. The periprocedural risk of CEA is lower in men than in women, while there was no effect of gender on the periprocedural risk of CAS.

ANTIPLATELET THERAPY: NEW INSIGHTS ON THE SECONDARY PREVENTION OF STROKE

Antiplatelet agents represent an important part of the therapeutic armamentarium in the prevention of stroke. Among them, aspirin is the gold standard but its chronic use has been associated with gastric intolerance, gastrointestinal and systemic hemorrhages and drug-resistance. Triflusal is a new antiplatelet agent from the family of salicylates but is not derived from aspirin and has a more selective mechanism of action : inhibition of thromboxane A2 in the platelet with no effect on prostacyclin biosynthesis in the endothelium. In the quest for the search of new antiplatelet agents, triflusal has shown a similar relative risk reduction than aspirin for the prevention of stroke but with reduced severe hemorrhagic side effects. The efficacy and better safety profile of triflusal vs aspirin in the secondary prevention of stroke has been demonstrated in major, randomized and double blind clinical trials and confirmed after a long term study with a mean follow up of 17 years, as well as in a Cochrane meta-analysis. Aspirin, but not triflusal, increased antihypertensive therapy requirements during long term treatment in the secondary prevention of stroke. In patients with atrial fibrillation, the combination of oral anticoagulants with triflusal has shown increased efficacy versus the standard oral single anticoagulation treatment with no increase of haemorrhagic risk. Studies have shown that the risk of upper gastrointestinal bleeding associated with the use of triflusal was negligible whereas the hemorrhagic risk associated with the use of aspirin, including low doses aspirin, was evident. Triflusal was well tolerated in asthmatic patients with aspirin-exacerbated –respiratory-diseases. The efficacy of triflusal in secondary prevention of stroke and its better safety profile when compared to aspirin has been recognized in important International Guidelines including the European Stroke Organization Guidelines.

NeuroThera® Efficacy and Safety Trial – 3 (NEST-3): A Double-Blind, Randomized, Sham-Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy with the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke within 24 h of Stroke Onset

Transcranial laser therapy is undergoing clinical trials in patients with acute ischemic stroke. The NeuroThera® Efficacy and Safety Trial-1 was strongly positive for 90-day functional benefit with transcranial laser therapy, and post hoc analyses of the subsequent NeuroThera® Efficacy and Safety Trial-2 trial suggested a meaningful beneficial effect in patients with moderate to moderately severe ischemic stroke within 24 h of onset. These served as the basis for the NeuroThera® Efficacy and Safety Trial-3 randomized controlled trial. The purpose of this pivotal study was to demonstrate safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. NeuroThera® Efficacy and Safety Trial-3 is a double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study that will enroll 1000 subjects at up to 50 sites. All subjects will receive standard medical management based on the American Stroke Association and European Stroke Organization Guidelines. In addition to standard medical management, both groups will undergo the transcranial laser therapy procedure between 4·5 and 24 h of stroke onset. The study population will be randomized into two arms: the sham control group will receive a sham transcranial laser therapy procedure and the transcranial laser therapy group will receive an active transcranial laser therapy procedure. The randomization ratio will be 1:1 and will be stratified to ensure a balanced subject distribution between study arms. The primary efficacy end point is disability at 90 days (or the last rating), as assessed on the modified Rankin Scale, dichotomized as a success (a score of 0-2) or a failure (a score of 3 to 6).

Endarterectomy for asymptomatic carotid artery stenosis under local anaesthesia

In this article, we present our experience with such operations performed under local anaesthesia. From January 1997 to November 2007, there were 387 patients operated on for asymptomatic carotid stenosis. Patient data were retrospectively evaluated. Thirty-day neurological morbidity and mortality from six different subgroups were analysed and compared. The numbers of perioperative transient ischaemic attacks, as well as surgical and other perioperative complications were also evaluated. Overall morbidity and mortality was 1.8% (seven patients). Stroke was noted in 1.3% (five patients). Transitory ischaemic attacks within the first 30 days were observed in 1.6% (six patients). Only those patients who had intraluminal shunt insertion were found to have significantly higher morbidity and mortality. (p = 0.000018). Myocardial infarction was observed in 0.5% (two patients), one fatal. We have achieved acceptable morbidity and mortality rates (1.8%) according to the parameters set by previous studies such as Asymptomatic Carotid Atherosclerosis Study and Asymptomatic Carotid Stenosis Trial as well as American Heart Association and European Stroke Organisation guidelines. All surgeries were done under local anaesthesia. Shunts were inserted in 22 cases (5.68%).

ORAL ANTIPLATELET THERAPY IN STROKE PREVENTION. MINIREVIEW

Antiplatelet therapy plays a crucial role in the primary and secondary prevention of noncardioembolic ischemic stroke / transient ischemic attacks (IS/TIA). Several antiplatelet agents are available. This review deals with the characteristics of particular antiplatelet agents as well as choice of antiplatelet treatment in various situations, based on the evidence and international recommendations. PubMed and Stroke Trials Registry on-line databases and the European Stroke Organisation Guidelines for Management of IS/TIA 2008 and update of the recommendations of the American Heart Association / American Stroke Association Council 2008 on Stroke were used. Acetylsalicylic acid (ASA) is the only antiplatelet drug used in primary prevention, mainly to reduce the risk of myocardial infarction (MI), but also in women aged 45 years or more and in some patients with non-valvular atrial fibrillation to reduce risk of IS/TIA. In the secondary prevention of noncardioembolic IS/TIA, ASA in combination with long release dipyridamole (DIP) and clopidogrel (CLOP) alone are considered first choice therapies. The choice of the particular antiplatelet agent should be individualized according to the patient risk factor profiles and treatment tolerance. ASA alone or triflusal can be used alternatively in patients who cannot be treated with either ASA+DIP or CLOP. The use of indobufen should be considered only in patients in need of temporary interruption of the antiplatelet therapy. Ticlopidine (TIC) should not be newly introduced into the treatment. Currently, insufficient data are available on the use of cilostazol in IS/TIA prevention.

Evidence-based stroke rehabilitation: an expanded guidance document from the european stroke organisation (ESO) guidelines for management of ischaemic stroke and transient ischaemic attack 2008

Despite recent high-profile advances in our understanding of rehabilitation post-stroke, the evidence base remains weaker than in other areas of stroke management. Under the aegis of the European Stroke Organisation a select committee was assembled to collate and appraise the evidence base for rehabilitation interventions. Following systematic literature searching, relevant abstracts were screened for data quality and relevance. These data were summarized and presented to the members of the expert panel, who, both individually and across group discussions, modified the content. The process was repeated until a final document was produced that all members of the panel and the European Stroke Organisation editorial group were happy with. The final guidelines offer a comprehensive review of post-stroke rehabilitation, incorporating discussion of optimal timing, setting and duration of therapy as well as individual sections on the role of professions allied to medicine; use of assistive technologies and dealing with the common complications encountered during the rehabilitation period. There is a lack of robust evidence for many of the prevalent post-stroke rehabilitation interventions. Available data are discussed and presented as key points; more importantly, specific areas that require further study are also highlighted. Following systematic literature searching, relevant abstracts were screened for data quality and relevance. These data were summarized and presented to the members of the expert panel, who, both individually and across group discussions, modified the content. The process was repeated until a final document was produced that all members of the panel and the European Stroke Organisation editorial group were happy with. The final guidelines offer a comprehensive review of post-stroke rehabilitation, incorporating discussion of optimal timing, setting and duration of therapy as well as individual sections on the role of professions allied to medicine; use of assistive technologies and dealing with the common complications encountered during the rehabilitation period. There is a lack of robust evidence for many of the prevalent post-stroke rehabilitation interventions. Available data are discussed and presented as key points; more importantly, specific areas that require further study are also highlighted.