Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis: The TENET Randomized Clinical Trial.

Abstract

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. To assess the relative safety and efficacy of tenecteplase compared with standard infusions of alteplase in patients with PVT. 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. Patients received thrombolytic therapy with a low-dose slow infusion alteplase or weight-based bolus doses of tenecteplase. The primary outcomes were to determine the rates of complete thrombolytic success and the incidence of major complications. 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. 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. Clinical Trials Registry of India: CTRI/2022/10/046127.