TY - JOUR
T1 - Hierarchical composite outcomes in acute ischaemic stroke with large infarct
T2 - a win ratio analysis of the TENSION trial
AU - TENSION Investigators
AU - Ciobanu-Caraus, Olga
AU - Heesen, Philip
AU - Hill, Michael D.
AU - Bonekamp, Susanne
AU - Fiehler, Jens
AU - Aamodt, Anne Hege
AU - Fuentes, Blanca
AU - Gizewski, Elke R.
AU - Krajina, Antonin
AU - Pierot, Laurent
AU - Simonsen, Claus Z.
AU - Zeleňák, Kamil
AU - Blauenfeldt, Rolf A.
AU - Cheng, Bastian
AU - Denis, Angélique
AU - Deutschmann, Hannes
AU - Dorn, Franziska
AU - Flottmann, Fabian
AU - Gellißen, Susanne
AU - Gerber, Johannes C.
AU - Goyal, Mayank
AU - Haring, Jozef
AU - Herweh, Christian
AU - Hopf-Jensen, Silke
AU - Hua, Vi Tuan
AU - Jensen, Märit
AU - Kastrup, Andreas
AU - Keil, Christiane Fee
AU - Klepanec, Andrej
AU - Kurča, Egon
AU - Mikkelsen, Ronni
AU - Müller-Hülsbeck, Stefan
AU - Münnich, Nico
AU - Pagano, Paolo
AU - Papanagiotou, Panagiotis
AU - Petzold, Gabor C.
AU - Pham, Mirko
AU - Puetz, Volker
AU - Raupach, Jan
AU - Reimann, Gernot
AU - Ringleb, Peter Arthur
AU - Schell, Maximilian
AU - Schlemm, Eckhard
AU - Schönenberger, Silvia
AU - Tennøe, Bjørn
AU - Ulfert, Christian
AU - Vališ, Kateřina
AU - Vítková, Eva
AU - Vollherbst, Dominik F.
AU - Wick, Wolfgang
N1 - Publisher Copyright:
© The Author(s) 2026. Published by Oxford University Press on behalf of the European Stroke Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
PY - 2026/6
Y1 - 2026/6
N2 - Introduction: Traditional endpoints in acute ischaemic stroke trials, most commonly the mRS, incompletely capture the full spectrum of patient outcomes. The win ratio (WR) is a hierarchically structured composite outcome measure that prioritises endpoints according to clinical importance. In this study, we applied win statistics to investigate which components drive the overall treatment effect. Patients and methods: Of 253 patients in the TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) trial, 125 were randomised to EVT + BMT and 128 to BMT alone. Endpoints were ranked hierarchically: (1) time to death, (2) mRS at 12 months, (3) occurrence of any serious adverse event and (4) EuroQOL 5-dimension scores at 12 months. Outcomes were analysed using win statistics. Results: The overall WR was 1.61 (95% CI, 1.19–2.18; P = .002), indicating a relative frequency of wins for EVT + BMT of approximately 60% among untied pairwise comparisons. The win difference was 22.8% (95% CI, 8.3%–36.3%; P = .002), of which 15.7% were attributable to survival. Win ratios were consistent across prespecified subgroups, including both sexes, age ≤ 80 years, baseline mRS 0–1, conscious patients, ASPECTS 5 and M1 occlusions. Discussion: The WR provides an informative complement to conventional mRS-based analyses in acute ischaemic stroke trials. Our hierarchical composite outcome analysis demonstrated how ordering of hierarchical components affects the resulting estimates, with the predominant treatment effect in TENSION being driven by improved survival. Conclusion: These findings support the complementary use of hierarchical composite outcomes in future neurointerventional trials.
AB - Introduction: Traditional endpoints in acute ischaemic stroke trials, most commonly the mRS, incompletely capture the full spectrum of patient outcomes. The win ratio (WR) is a hierarchically structured composite outcome measure that prioritises endpoints according to clinical importance. In this study, we applied win statistics to investigate which components drive the overall treatment effect. Patients and methods: Of 253 patients in the TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) trial, 125 were randomised to EVT + BMT and 128 to BMT alone. Endpoints were ranked hierarchically: (1) time to death, (2) mRS at 12 months, (3) occurrence of any serious adverse event and (4) EuroQOL 5-dimension scores at 12 months. Outcomes were analysed using win statistics. Results: The overall WR was 1.61 (95% CI, 1.19–2.18; P = .002), indicating a relative frequency of wins for EVT + BMT of approximately 60% among untied pairwise comparisons. The win difference was 22.8% (95% CI, 8.3%–36.3%; P = .002), of which 15.7% were attributable to survival. Win ratios were consistent across prespecified subgroups, including both sexes, age ≤ 80 years, baseline mRS 0–1, conscious patients, ASPECTS 5 and M1 occlusions. Discussion: The WR provides an informative complement to conventional mRS-based analyses in acute ischaemic stroke trials. Our hierarchical composite outcome analysis demonstrated how ordering of hierarchical components affects the resulting estimates, with the predominant treatment effect in TENSION being driven by improved survival. Conclusion: These findings support the complementary use of hierarchical composite outcomes in future neurointerventional trials.
KW - acute ischaemic stroke
KW - large infarct
KW - win ratio
UR - https://www.scopus.com/pages/publications/105042183240
U2 - 10.1093/esj/aakag063
DO - 10.1093/esj/aakag063
M3 - Artículo
AN - SCOPUS:105042183240
SN - 2396-9873
VL - 11
JO - European Stroke Journal
JF - European Stroke Journal
IS - 6
M1 - aakag063
ER -