Periodic Reporting for period 3 - TENSION (Efficacy and safety of thrombectomy in stroke with extended lesion and extended time window: a randomized, controlled trial)
Periodo di rendicontazione: 2021-01-01 al 2022-06-30
The results RESCUE-Japan-LIMIT trial, which demonstrated a benefit of thrombectomy as compared to standard care in patients with large vessel occlusion and MRI-defined ASPECTS of 3-5 within 6 hours of symptom onset, were published, and the Steering Committee decided to continue enrollment in TENSION, as the results of this trial cannot be transferred to the target population of TENSION.
All trial-related boards and committees are working effectively. The image core lab is continuously evaluating all images acquired within the trial, and the quality of image judgement by local investigators is good. A scientific analysis of interobserver agreement of the first 100 TENSION investigators completing the image training was published providing further insights into the expected variance in image judgement results. The DSMB has evaluated the 2nd and 3rd annual safety report and did not have any safety concerns but encouraged continuation of the trial. The Statistical Analysis Plan for the trial was finalized based on the final study protocol. For health-economic analysis, a Markov model structure is being developed to evaluate the long-term economic consequences of endovascular thrombectomy compared with best medical care, and to estimate the influence on health-related quality of life. Dissemination, communication and exploitation activities were continued, including regular meetings of the Innovation and Exploitation Management Board and round-table meetings with members of the industry and scientific societies. Initiated by the TENSION consortium, together with the coordinating investigators of the other ongoing and completed trials of thrombectomy in patients with low ASPECTS a pooled analysis of the individual trials is planned, and an analysis plan was drafted.
TENSION will provide effective treatment to a large new group of patients. The large group of severe stroke patients that is studied in TENSION has been neglected by previous thrombectomy trials. There is no convincing evidence for the benefit of thrombectomy and current guidelines do not provide specific treatment for these patients. Moreover, information on the effect of thrombectomy for acute stroke is largely limited to a single device, while in clinical practice numerous devices are used. Finally, there is only limited information on quality of life after stroke thrombectomy. TENSION progresses beyond the state of the art by addressing these open questions by providing evidence for the benefit of thrombectomy in this new group of patients, providing data on the use of different devices for thrombectomy, and providing information on quality of life after thrombectomy for severe stroke. The results of our trial will end uncertainty allow future treatment decisions based on evidence.
TENSION addresses an important health problem in the EU and has the potential to provide a manifest benefit for individual patients, doctors involved in the management of stroke, and the society at large. The annual costs of stroke in Europe are estimated at more than € 64 billion, of which about two thirds are direct healthcare costs, and 4 million DALYs are lost each year due to stroke in the EU. We expect the following impacts: At the individual patients’ level, TENSION will provide evidence for more effective and safe treatment of severe stroke; TENSION will improve functional outcome and avert death and disability in individual stroke patient; At the societal level, TENSION will reduce the burden of death and disability from severe stroke. TENSION will increase the target population for effective thrombectomy; TENSION will reduce the costs of stroke care by reduction of disability and dependency; TENSION will support health equity across Europe by providing evidence of the benefit of thrombectomy in different European countries with diverse healthcare systems.