A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window

TY - JOUR

T1 - A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window

AU - Bendszus, Martin

AU - Bonekamp, Susanne

AU - Berge, Eivind

AU - Boutitie, Florent

AU - Brouwer, Patrick

AU - Gizewski, Elke

AU - Krajina, Antonin

AU - Pierot, Laurent

AU - Randall, Gary

AU - Simonsen, Claus Z

AU - Zeleňák, Kamil

AU - Fiehler, Jens

AU - Thomalla, Götz

PY - 2019/1

Y1 - 2019/1

N2 - RATIONALE: The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well).DESIGN: TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3-5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized.OUTCOMES: Primary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4-6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment.DISCUSSION: TENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).

AB - RATIONALE: The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well).DESIGN: TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3-5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized.OUTCOMES: Primary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4-6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment.DISCUSSION: TENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Brain Ischemia/mortality

KW - Disease Progression

KW - Endovascular Procedures

KW - Europe

KW - Female

KW - Fibrinolytic Agents/therapeutic use

KW - Humans

KW - Male

KW - Middle Aged

KW - Severity of Illness Index

KW - Stroke/mortality

KW - Survival Analysis

KW - Thrombectomy

KW - Time Factors

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1177/1747493018798558

DO - 10.1177/1747493018798558

M3 - SCORING: Journal article

C2 - 30156479

VL - 14

SP - 87

EP - 93

JO - INT J STROKE

JF - INT J STROKE

SN - 1747-4930

IS - 1

ER -