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Tenecteplase in Acute Ischemic Cerebrovascular Events 

Compared with alteplase at 53 Chinese facilities, tenecteplase was noninferior in a trial of people with acute ischemic stroke who were eligible for standard intravenous thrombolysis but ineligible for or refused endovascular thrombectomy.

Study participants were prospectively randomized to open-label intravenous tenecteplase or alteplase within 4.5 hours of stroke. Inclusion criteria included a modified Rankin Scale (mRS) score of no more than 1 before enrollment and an NIH Stroke Scale score of 5–25. Clinicians evaluating outcomes were masked to treatment type when they evaluated participants based on a primary efficacy outcome of the proportion of participants with an mRS score of 0–1 at 90 days and a primary safety outcome of symptomatic intracranial hemorrhage within 36 hours.

“Between June 12, 2021, and May 29, 2022, 1,430 participants were enrolled and randomly assigned to tenecteplase (n = 716) or alteplase (n = 714),” the authors write. “Six patients assigned to tenecteplase and seven to alteplase did not receive study product, and five participants in the tenecteplase group and 11 in the alteplase group were lost to follow-up at 90 days. The primary outcome in the modified intention-to-treat population occurred in 439 (62%) of 705 in the tenecteplase group versus 405 (58%) of 696 in the alteplase group (RR 1.07, 95% CI 0.98–1.16). The lower limit of the RR’s 95% CI was greater than the non-inferiority margin. Symptomatic intracranial haemorrhage within 36 h was observed in 15 (2%) of 711 in the tenecteplase group and 13 (2%) of 706 in the alteplase group (RR 1.18, 95% CI 0.56–2.50). Mortality within 90 days occurred in 46 (7%) individuals in the tenecteplase group versus 35 (5%) in the alteplase group (RR 1.31, 95% CI 0.86–2.01).”

Source: Lancet