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Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis: The TENET Randomized Clinical Trial
Gautam Sharma1, Krishna Prasad Akkineni1, Nayani Makkar1
1Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India.
Importance:
For patients presenting with symptomatic prosthetic valve thrombosis (PVT) after mechanical heart valve replacement, thrombolytic therapy with alteplase is accepted as a first-line therapeutic alternative. The utility of tenecteplase compared with conventional regimens remains unstudied, to the authors' knowledge, in this patient population.
Objective:
To assess the relative safety and efficacy of tenecteplase compared with standard infusions of alteplase in patients with PVT.
Design, Setting And Participants:
This was an open-label, parallel-group, non-inferiority randomized clinical trial among consecutive adult patients presenting with obstructive PVT of a mechanical prosthetic valve over the study period from October 2022 to August 2024 to a single tertiary care center in India.
Interventions:
Patients received thrombolytic therapy with a low-dose slow infusion alteplase or weight-based bolus doses of tenecteplase.
Main Outcomes And Measures:
The primary outcomes were to determine the rates of complete thrombolytic success and the incidence of major complications.
Results:
A total of 83 patients (mean [SD] age, 39.6 [12.4] years, 42 male [50.6%]) were randomized to receive alteplase (n = 43) or tenecteplase (n = 40). The rates of the primary efficacy end point (complete thrombolytic success) were significantly higher (risk ratio, 1.18; 95% CI, 1.03-1.39; P = .02 for noninferiority) in the tenecteplase group (39 patients [97.5%]) compared with the alteplase group (35 patients [81.5%]). Additionally, patients treated with tenecteplase had higher rates of complete success with the first administered dose and a shorter duration of hospital stay (median [IQR], 4.1 [3.2-5.1] days vs 6.5 [4.3-9.2] days; P < .001). The rates of major and minor adverse events were similar.
Conclusions And Relevance:
Tenecteplase may be a safe and effective alternative to alteplase in patients presenting with obstructive PVT. Patients treated with tenecteplase in our study had higher rates of complete thrombolytic success and a shorter duration of hospital stay. Furthermore, the relative ease of drug administration with tenecteplase may translate to greater clinical benefit in a real-world setting.
Trial Registration:
Clinical Trials Registry of India: CTRI/2022/10/046127.
