Abstract: TH-PO1084
Influence of Impaired Renal Function on the Efficacy and Safety of Intravenous Thrombolytic Therapy with Tenecteplase vs. Alteplase in Patients with Acute Ischaemic Stroke
Session Information
- CKD Progression and Complications: Diagnosis, Prognosis, Risk Factors
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Wu, Yu, Beijing Tiantan Hospital, Beijing, China
- Zhou, Yilun, Beijing Tiantan Hospital, Beijing, China
Background
Data about intravenous thrombolysis (IVT) therapy among stroke patients with chronic kidney disease (CKD) are limited, especially for tenecteplase. We aimed to investigate the impact of renal dysfunction on efficacy and safety of tenecteplase versus alteplase in patients with acute ischemic stroke (AIS) based on the TRACE-2 trial.
Methods
A total of 1,412 thrombolysis-eligible patients with AIS were randomly assigned to intravenous tenecteplase or alteplase within 4.5 hours of symptom onset. Patients were categorized by their eGFR ≥90 (normal), 60-89 (mild CKD), and <60mL/min/1.73 m2 (moderate CKD). The primary efficacy outcome was the proportion of participants who had a mRS score of 0–1 at 90 days. The primary safety outcome was symptomatic intracranial haemorrhage (ICH) within 36 h.
Results
Patients across the renal function strata did not have a statistically significant difference in primary efficacy outcomes with tenecteplase therapy versus alteplase (normal: RR 1.07, 95% CI, 0.97-1.18; mild: RR 1.14, 95% CI, 0.95-1.37, moderate: RR 0.86, 95% CI, 0.59-1.27) with no significant interaction between renal dysfunction and treatment assignment (Pinteraction = 0.55). The safety outcomes including proportions of symptomatic ICH (Pinteraction = 0.55) or rates of mortality (Pinteraction = 0.65) were also not different between the two treatments based on renal function.
Conclusion
CKD did not modify the treatment effect of tenecteplase versus alteplase. IVT with tenecteplase for AIS had the same efficacy outcomes compared with alteplase without increasing ICH, mortality and other bleeding events in reduced renal function, thus these patients should not be excluded from tenecteplase treatment.
Efficacy outcomes at 3 months according to 3 eGFR category
| eGFR(mL/min/1.73m2) | Tenecteplase,% | Alteplase,% | Effect size | P value | Interaction P value | |
| mRS score 0-1 at 3 months | ≥90 | 302(65.51) | 293(61.17) | 1.07(0.97-1.18) | 0.53 | 0.55 |
| 60-89 | 114(58.76) | 86(51.5) | 1.14(0.95-1.37) | 0.13 | ||
| ＜60 | 21(46.67) | 26(52.0) | 0.86(0.59-1.27) | 0.74 | ||
| mRS score 0-2 at 3 months | 60-89 | 355(77.01) | 363(75.78) | 1.01(0.94-1.09) | 079 | 0.79 |
| ≥90 | 132(68.04) | 108(64.67) | 1.04(0.90-1.21) | 0.60 | ||
| ＜60 | 26(57.78) | 31(62) | 0.94(0.69-1.30) | 0.73 | ||
| mRS at 3 months | ≥90 | 1(0 to 2) | 1(0 to 2) | 1.12(0.89-1.41) | 0.34 | 0.63 |
| 60-89 | 1(0 to 3) | 1(0 to 3) | 1.16(0.81-1.68) | 0.42 | ||
| ＜60 | 2(1 to 4) | 1(0 to 4) | 0.82(0.40-1.68) | 0.59 |
Funding
- Government Support – Non-U.S.