Safety, Functional Disability, Healthcare Utilization, and Quality-of-Life Outcomes in Elderly Receiving Alteplase and Tenecteplase: A Secondary Analysis From the AcT Trial.
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Singh Nishita, Bala Fouzi, Ademola Ayoola, Almekhlafi Mohammed, Coutts Shelagh B, Deschaintre Yan, Khosravani Houman, Buck Brian H, Appireddy Ramana, Moreau Francois, Gubitz Gord, Tkach Aleksander, Catanese Luciana, Dowlatshahi Dar, Medvedev George, Mandzia Jennifer, Pikula Aleksandra, Shankar Jai Jai, Poppe Alexandre Y, Williams Heather, Field Thalia S, Manosalva Alejandro, Siddiqui Muzaffar, Zafar Atif, Imoukhoude Oje, Hunter Gary, Shamy Michel, Demchuk Andrew, Swartz Richard H, Hill Michael D, Sajobi Tolulope T, Menon Bijoy K, Ganesh Aravind
Аннотация
METHODS: Data are from patients included in AcT (Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke), a pragmatic, registry-linked, phase 3 randomized controlled trial comparing TNK with alteplase. Outcomes included functional disability (per 90-day modified Rankin Scale), safety (24-hour symptomatic intracerebral hemorrhage, 90-day mortality rates), health care utilization (discharge destination, length of stay, thrombectomy rate), and quality of life measures (EQ-5D-5L [EuroQol 5-Dimension 5-Level Scale]). With an a priori plan, patients aged <80 years were compared with those ≥80 years at symptom onset. Mixed effects Poisson regression was used to assess (1) the association of age with outcomes and (2) if these associations were modified by thrombolytic administered (TNK versus alteplase), after adjusting for sex, and baseline stroke severity.
RESULTS: Of the 1577 patients, 1034 (65.6%; 520: TNK and 514: alteplase) were <80 years and 543 (34.4%; 286: TNK and 257: alteplase) were ≥80 years of age. Baseline characteristics in the 2 groups were similar except for sex 40% female in <80 years group versus 62.8% female in ≥80 years. There was no difference in rates of symptomatic intracranial hemorrhage (3.5% versus 3.1%). Patients in the ≥80 years group had significantly lower rates of excellent functional outcome, return to baseline status, higher mortality, and lower quality-of-life outcomes as compared with the <80 years group. Length of hospital stay was similar between the 2 groups but, patients in the ≥80 years age group had significantly lower rates of endovascular treatment utilization. Type of thrombolytic agent (TNK versus alteplase) did not modify the association between age and primary clinical outcome (Pinteraction=0.22).
CONCLUSIONS: Similar to alteplase, increasing age was associated with poorer functional outcomes with TNK. Rates of angiographic and bleeding outcomes were similar between patients <80 and ≥80 years.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03889249.