Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis: The TENET Randomized Clinical Trial.
Summary
In 83 patients with obstructive mechanical prosthetic valve thrombosis, tenecteplase achieved higher complete thrombolytic success (97.5% vs 81.5%) and shorter hospital stay (median 4.1 vs 6.5 days) than alteplase, with similar adverse event rates.
Key Findings
- Complete thrombolytic success: 97.5% with tenecteplase vs 81.5% with alteplase (RR 1.18; 95% CI 1.03–1.39; P=.02 for noninferiority).
- Shorter hospital stay with tenecteplase (median 4.1 vs 6.5 days; P<.001).
- Similar rates of major and minor adverse events between groups.
Clinical Implications
Tenecteplase can be considered a front-line thrombolytic for obstructive mechanical valve thrombosis, potentially reducing hospital LOS and streamlining care, especially where infusion infrastructure is limited.
Why It Matters
This is the first randomized comparison in mechanical valve thrombosis, suggesting a simpler bolus regimen (tenecteplase) may improve efficacy and efficiency over standard alteplase infusions.
Limitations
- Single-center, open-label trial with modest sample size
- Short-term outcomes; no long-term follow-up on valve function or recurrence
Future Directions
Multicenter trials to confirm efficacy and safety, define optimal dosing in diverse valve positions, and assess long-term outcomes and cost-effectiveness.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized clinical trial comparing thrombolytics
- Study Design
- OTHER