摘要
Background and aims Tenecteplase(TNK)offers logistical advantages in stroke thrombolytic therapy with its single bolus administration compared with alteplase.We aim to investigate the real-world evidence regarding its safety and effectiveness in China.Methods We conducted a retrospective study on patients receiving alteplase or TNK for acute ischaemic stroke(AIS)within 4.5 hours of onset between 1 March 2019 and 1 October 2023,from 18 stroke centres in China.Using propensity score matching(PSM),TNK-treated patients were matched 1:1 with alteplase-treated patients.The primary outcome was the rate of symptomatic intracranial haemorrhage(sICH)within 72 hours post-thrombolysis.Secondary outcomes comprised the rate of parenchymal haemorrhage type 2,any intracranial haemorrhage,any systematic bleeding and mortality at 90 days,as well as 24-hour National Institutes of Health Stroke Scale(NIHSS),early neurological improvement at 24 hours,modified Rankin Scale(mRS)shift,percentage of mRS 0-1 and mRS 0-2 at 90 days.Results We identified 1113 patients with AIS who received TNK and 2360 patients who received alteplase.Following PSM,1113 TNK-treated patients with AIS were matched to 1113 patients treated with alteplase.No significant differences were observed in rates of sICH(1.8%vs 1.98%,p=0.864)or other safety outcomes.Moreover,TNK-treated patients demonstrated a lower rate of any intracranial haemorrhage(OR:0.51,95%CI:0.31 to 0.86,p=0.012).A higher proportion of patients achieving early neurological improvement at 24 hours(OR:1.76,95%CI:1.48 to 2.09,p=0.000),better 90-day mRS(OR:0.67,95%CI:0.57 to 0.79,p=0.000)as well as higher percentages of 90-day mRS 0-1(OR:1.27,95%CI:1.05 to 1.54,p=0.012)and mRS 0-2(OR:1.41,95%CI:1.14 to 1.75,p=0.001)compared with alteplase.Conclusions Thrombolysis with TNK is not associated with an increased risk of sICH,and may result in better early neurological improvement and 90-day functional outcomes compared with alteplase in patients with AIS.
基金
National Natural Science Foundation of China(82271352)
the Science and Technology Commission of Shanghai Municipality(20Z11900802)
the Shanghai Municipal Health Commission(2022XD022).
