A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion.
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Ryan Stephen J, Jørstad Øystein Kalsnes, Skjelland Mona, Pesonen Maiju, Simonsen Claus Z, Bek Toke, Blauenfeldt Rolf Ankerlund, Ijäs Petra, Laitinen Arja, Khanevski Andrej, Krohn Jørgen, Rødahl Eyvind, Lemmens Robin, Demeestere Jelle, Cassiman Catherine, Nakstad Ingvild, Evensen Kristin, Sandell Tiril, Hamann Steffen, Truelsen Thomas C, Christensen Louisa M, Rosenbaum Sverre, Matijošaitis Vaidas, Žemaitienė Reda, Ellekjær Hanne, Almaas Erlend, Austeng Dordi, Mazya Michael V, Traïsk Frank, Ylikotila Pauli, Salmi Ulpu, Jenssen Kristian N, Lisether Håvard, Breivik Cathrine, Devik Kristina, Honningsvåg Lasse-Marius Elden, Valaikienė Jurgita, Cimbalas Andrius, Malmberg Vetle Nilsen, Anderson Espen, Roy Ansar, Skattør Thor Håkon, Kraglund Kristian Lundsgaard, Kefaloykos Christina, Olsen Inge Christoffer, Vanacker Peter, Strbian Daniel, Moe Morten C, Aamodt Anne Hege, TenCRAOS Investigators
Аннотация
METHODS: We conducted a phase 3, double-blind, double-dummy, randomized, controlled trial involving adults with acute, nonarteritic central retinal artery occlusion who had symptom onset within 4.5 hours before treatment. Patients were assigned, in a 1:1 ratio, to receive intravenous tenecteplase (at a dose of 0.25 mg per kilogram of body weight) and oral placebo or intravenous placebo and oral aspirin (at a dose of 300 mg). The primary end point was vision recovery, defined as a best corrected visual acuity (BCVA) in the affected eye at 30 days of up to 0.7 logMAR (logarithm of the minimum angle of resolution; equivalent to ≥20/100). Key secondary visual end points were a BCVA of up to 0.5 logMAR (equivalent to ≥20/63), mean improvement in BCVA, and perimetry score at 30 days. Key safety end points included symptomatic intracranial hemorrhage, major bleeding, and death.
RESULTS: A total of 78 patients at 16 sites in six countries underwent randomization, with 40 assigned to receive tenecteplase and 38 to receive aspirin. At 30 days, 8 patients (20%) in the tenecteplase group and 9 patients (24%) in the aspirin group had vision recovery (risk difference, -3.7 percentage points; 95% confidence interval, -22.0 to 14.7; P = 0.69). The outcomes with regard to the secondary visual end points did not differ substantially between the groups. There was a greater incidence of adverse events in the tenecteplase group, including one fatal intracranial hemorrhage.
CONCLUSIONS: Intravenous tenecteplase administered within 4.5 hours after onset of central retinal artery occlusion did not result in significantly greater vision recovery at 30 days than oral aspirin but was associated with serious safety concerns. (Funded by Oslo University Hospital and others; TenCRAOS ClinicalTrials.gov number, NCT04526951; EU Clinical Trials number, 2024-517606-29-00.).