Tenecteplase Noninferior to Alteplase for Mechanical Prosthetic Heart Valve Thrombosis: TENET Trial Suggests
India: A new randomized clinical trial from the All India Institute of Medical Sciences (AIIMS), New Delhi, has reported encouraging results on the use of tenecteplase for treating obstructive mechanical prosthetic heart valve thrombosis (PVT).
Published in JAMA Cardiology, the TENET trial, led by Dr. Gautam Sharma and colleagues, evaluated whether a single intravenous bolus of tenecteplase could match the safety and efficacy of the standard low-dose, slow-infusion alteplase regimen.
Thrombolytic therapy with alteplase is widely used for symptomatic PVT, but evidence comparing it directly with tenecteplase has been scarce. The study aimed to fill that gap by assessing whether the easier-to-administer bolus dose of tenecteplase could offer similar or improved outcomes.
The open-label, parallel-group noninferiority trial enrolled 83 adults who presented with obstructive PVT between October 2022 and August 2024 at a tertiary cardiac care centre in India. Participants were randomly assigned to receive either weight-based bolus tenecteplase (n = 40) or the standard slow-infusion alteplase protocol (n = 43). The primary outcomes were complete thrombolytic success and the incidence of major complications.
The study led to the following findings:
- Complete thrombolytic success was achieved in 97.5% of patients receiving tenecteplase, compared with 81.5% in the alteplase group, demonstrating noninferiority (risk ratio: 1.18).
- Most patients in the tenecteplase group achieved complete thrombolysis with the first administered dose, indicating faster therapeutic action.
- Median hospital stay was shorter for tenecteplase-treated patients (4.1 days) compared with those receiving alteplase (6.5 days).
- Rates of major and minor adverse events were similar between the tenecteplase and alteplase groups.
- Tenecteplase’s single-bolus administration and strong efficacy suggest it is a practical, patient-friendly alternative in emergency settings.
The authors acknowledge that the open-label design and the relatively young study population may limit the generalizability of the findings. Patients with severe heart failure or cardiogenic shock were not included, and long-term outcomes could not be assessed. Therefore, further research is needed to determine how these results translate to older or higher-risk populations.
“The TENET randomized clinical trial provides strong evidence that tenecteplase is a safe, effective, and more convenient alternative to alteplase for treating obstructive mechanical prosthetic valve thrombosis. With higher rates of complete thrombolytic success, faster response to the first dose, and shorter hospital stays, tenecteplase may offer substantial clinical advantages, particularly in urgent care settings,” the authors wrote. They added that future studies involving broader patient populations and longer follow-up periods are needed to further clarify its role in routine clinical practice.
Reference:
Sharma G, Akkineni KP, Makkar N, et al. Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis: The TENET Randomized Clinical Trial. JAMA Cardiol. Published online December 03, 2025. doi:10.1001/jamacardio.2025.4369
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