Hierarchical composite outcomes in acute ischaemic stroke with large infarct: a win ratio analysis of the TENSION trial.
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Ciobanu-Caraus Olga, Heesen Philip, Hill Michael D, Bonekamp Susanne, Fiehler Jens, Aamodt Anne Hege, Fuentes Blanca, Gizewski Elke R, Krajina Antonin, Pierot Laurent, Simonsen Claus Z, Zeleňák Kamil, Blauenfeldt Rolf A, Cheng Bastian, Denis Angélique, Deutschmann Hannes, Dorn Franziska, Flottmann Fabian, Gellißen Susanne, Gerber Johannes C, Goyal Mayank, Haring Jozef, Herweh Christian, Hopf-Jensen Silke, Hua Vi Tuan, Jensen Märit, Kastrup Andreas, Keil Christiane Fee, Klepanec Andrej, Kurča Egon, Mikkelsen Ronni, Müller-Hülsbeck Stefan, Münnich Nico, Pagano Paolo, Papanagiotou Panagiotis, Petzold Gabor C, Pham Mirko, Puetz Volker, Raupach Jan, Reimann Gernot, Ringleb Peter Arthur, Schell Maximilian, Schlemm Eckhard, Schönenberger Silvia, Tennøe Bjørn, Ulfert Christian, Vališ Kateřina, Vítková Eva, Vollherbst Dominik F, Wick Wolfgang, Thomalla Götz, Möhlenbruch Markus, Bendszus Martin, TENSION Investigators
Аннотация
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.