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Stroke Treatment Academic Industry Roundtable: The Next Generation of Endovascular Trials.

ABSTRACT: The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on recently available level I evidence of benefit from endovascular therapy (ET) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in ET.Three key directions for advancing the field were identified: (1) development of systems of care for ET in large vessel occlusion stroke, (2) development of therapeutic approaches adjunctive to ET, and (3) exploring clinical benefit of ET in patient population insufficiently studied in recent trials. Methodological issues such as optimal trial design and outcome measures have also been addressed.Development of systems of care strategies should be geared both toward ensuring broad access to ET for eligible patients and toward shortening time to reperfusion to the minimum possible. Adjunctive therapy development includes neuroprotective approaches, adjuvant microcirculatory/collateral enhancing strategies, and periprocedural management. Future research priorities seeking to expand the eligible patient population are to determine benefit of ET in patients presenting beyond conventional time windows, in patients with large baseline ischemic core lesions, and in other important subgroups.Research priorities in ET for large vessel occlusion stroke are to improve systems of care, investigate effective adjuvant therapies, and explore whether patient eligibility could be expanded.

SUBMITTER: Jovin TG

PROVIDER: S-EPMC5552183 | biostudies-other | 2016 Oct

REPOSITORIES: biostudies-other

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Project description:The management of acute ischemic stroke is rapidly developing.Although acute ischemic stroke is a major cause of adult disability and death, the number of patients requiring emergency endovascular intervention remains unknown, but is a fraction of the overall stroke population. Public health initiatives endeavor to raise public awareness about acute stroke to improve triage for emergency treatment, and the medical community is working to develop stroke services at community and academic medical centers throughout the United States. There is an Accreditation Council for Graduate Medical Education–approved pathway for training in endovascular surgical neuroradiology, the specialty designed to train physicians specifically to treat cerebrovascular diseases. Primary and comprehensive stroke center designations have been defined, yet questions remain about the best delivery model. Telemedicine is available to help community medical centers cope with the complexity of stroke triage and treatment. Should comprehensive care be provided at every community center, or should patients with complex medical needs be triaged to major stroke centers with high-level surgical,intensive care, and endovascular capabilities? Although the answers to these and other questions about stroke care delivery remain unanswered owing to the paucity of empirical data, we are convinced that stroke care regionalization is crucial for delivery of high-quality comprehensive ischemic stroke treatment. A stroke team available 24 hours per day, 7 days per week requires specialty skills in stroke neurology, endovascular surgical neuroradiology, neurosurgery, neurointensive care, anesthesiology, nursing, and technical support for optimal success. Several physician groups with divergent training backgrounds (i.e., interventional neuroradiology, neurosurgery,neurology, peripheral interventional radiology, and cardiology) lay claim to the treatment of stroke patients,particularly the endovascular or interventional methods. Few would challenge neurologists over the responsibility for emergency evaluation and triage of stroke victims for intra intravenous fibrinolysis, even though emergency physicians are most commonly the first to evaluate these patients. There are many unanswered questions about the role of imaging in defining best treatment. Perfusion imaging with CT or MRI appears to have relevance even though its role remains undefined and is the subject of ongoing research. Meanwhile, investigators are exploring new, and perhaps more specific,imaging methods with cerebral metabolic rate of oxygen and cellular acid-base imbalance. There are currently 6 ongoing trials of stroke intervention, many with proprietary technologies and private funding, competing for the same patient population as multicenter trials funded by the NIH. At the same time, much of the interventional stroke treatment currently occurs outside of trials in the community and academic settings without the collection of much-needed data. Market forces will certainly shape future stroke therapy, but it is unclear whether the current combination of private and public funding for these endeavors is the best method of development.

Project description:ImportanceAcute ischemic stroke is a leading cause of death and disability worldwide. Several recent clinical trials have shown that endovascular treatment improves clinical outcomes among patients with acute ischemic stroke.ObjectiveTo provide an overall and precise estimate of the efficacy of endovascular treatment predominantly using second-generation mechanical thrombectomy devices (stent-retriever devices) compared to medical management on clinical and functional outcomes among patients with acute ischemic stroke.Data sourcesMEDLINE, EMBASE, Cochrane Collaboration Central Register of Controlled Clinical Trials, Web of Science, and NIH ClinicalTrials.gov were searched through November 2015.Study selectionSearches returned 3,045 articles. After removal of duplicates, two authors independently screened titles and abstracts to assess eligibility of 2,495 potentially relevant publications. From these, 38 full-text publications were more closely assessed. Finally, 5 randomized controlled trials of endovascular treatment with predominant use of retrievable stents were selected.Data extraction and synthesisThree authors independently extracted information on participant and trial characteristics and clinical events using a standardized protocol. Random effects models were used to pool endovascular treatment effects across outcomes.Main outcomes and measuresThe primary outcome was better functional outcome as measured on the modified Rankin Scale at 90 days of follow-up. Secondary outcomes included all-cause mortality and symptomatic intra-cerebral hemorrhage.ResultsFive trials representing 1,287 patients were included. Overall, patients randomized to endovascular therapy experienced 2.22 times greater odds of better functional outcome compared to those randomized to medical management (95% CI, 1.66 to 2.98; P < 0.0001). Endovascular therapy was not associated with mortality [OR (95% CI), 0.78 (0.54, 1.12); P = 0.1056] or symptomatic intracerebral hemorrhage [OR (95% CI), 1.19 (0.69, 2.05); P = 0.5348]. Meta-regression analysis suggested that shorter times from stroke onset to groin puncture and from stroke onset to reperfusion result in better functional outcomes in ischemic stroke patients (P = 0.0077 and P = 0.0089). There were no significant differences in the beneficial effects of endovascular treatment on functional outcomes across categories of gender, age, stroke severity, ischemic changes on computed tomography, or intravenous tissue plasminogen activator administration.Conclusions and relevanceThis meta-analysis demonstrated superior functional outcomes in subjects receiving endovascular treatment compared to medical management. Further, this analysis showed that acute ischemic stroke patients may receive enhanced functional benefit from earlier endovascular treatment.

Project description:Background and purposeThrombus perviousness estimates residual flow along a thrombus in acute ischemic stroke, based on radiological images, and may influence the benefit of endovascular treatment for acute ischemic stroke. We aimed to investigate potential endovascular treatment (EVT) effect modification by thrombus perviousness.MethodsWe included 443 patients with thin-slice imaging available, out of 1766 patients from the pooled HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke trials) data set of 7 randomized trials on EVT in the early window (most within 8 hours). Control arm patients (n=233) received intravenous alteplase if eligible (212/233; 91%). Intervention arm patients (n=210) received additional EVT (prior alteplase in 178/210; 85%). Perviousness was quantified by thrombus attenuation increase on admission computed tomography angiography compared with noncontrast computed tomography. Multivariable regression analyses were performed including multiplicative interaction terms between thrombus attenuation increase and treatment allocation. In case of significant interaction, subgroup analyses by treatment arm were performed. Our primary outcome was 90-day functional outcome (modified Rankin Scale score), resulting in an adjusted common odds ratio for a one-step shift towards improved outcome. Secondary outcomes were mortality, successful reperfusion (extended Thrombolysis in Cerebral Infarction score, 2B–3), and follow-up infarct volume (in mL).ResultsIncreased perviousness was associated with improved functional outcome. After adding a multiplicative term of thrombus attenuation increase and treatment allocation, model fit improved significantly (P=0.03), indicating interaction between perviousness and EVT benefit. Control arm patients showed significantly better outcomes with increased perviousness (adjusted common odds ratio, 1.2 [95% CI, 1.1–1.3]). In the EVT arm, no significant association was found (adjusted common odds ratio, 1.0 [95% CI, 0.9–1.1]), and perviousness was not significantly associated with successful reperfusion. Follow-up infarct volume (12% [95% CI, 7.0–17] per 5 Hounsfield units) and chance of mortality (adjusted odds ratio, 0.83 [95% CI, 0.70–0.97]) decreased with higher thrombus attenuation increase in the overall population, without significant treatment interaction.ConclusionsOur study suggests that the benefit of best medical care including alteplase, compared with additional EVT, increases in patients with more pervious thrombi.

Project description:BackgroundClinical research is marked by its multifaceted nature, presenting a multitude of different approaches, designs, and objectives that can complicate the planning, initiation, and conduct of clinical trials. The role and organisation of the sponsor institution are pivotal in this context. We aimed to investigate possible challenges and needs, including their underlying factors, for academia and industry during the set-up and conduct of clinical trials.MethodsWe conducted a cross-sectional survey-based study within an international network of highly qualified academic research institutions (ARIs). The main outcome measures were the regulatory framework for clinical trials, scope and organisation of academic and industry-sponsored trials, funding sources of academic clinical trials, submission and approval process, as well as study conduct of academic vs. industry-sponsored trials.ResultsWe surveyed employees of ARIs with extensive experience in phase I-IV clinical trials. All ARIs participated in academic clinical trials and 90% were involved in industry-sponsored trials. Respondents reported that academic trials faced greater challenges in communication with relevant institutional review boards/ethics committees and competent authorities compared to industry-sponsored trials. Additionally, academic trials were found to have significantly less financial support during their conduct. Specific challenges for academia vs. industry included 'insufficient personnel resources' (60% vs. 50%), 'recruitment problems' (60% vs. 78%) and 'lack of knowledge/experience' (35% vs. 11%).ConclusionsOur findings indicate that industry-sponsored trials encounter fewer issues in set-up, funding, and trial conduct compared to academic trials. Improving collaboration between academic sponsors and ARIs is essential to address these challenges. ARIs provide critical support and guidance for academic researchers, not only in planning and implementing projects, but also in assessing feasibility and securing funding.