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

The utility of tenecteplase compared with conventional regimens remains unstudied, to the authors' knowledge, in this patient population.

据作者所知，与传统方案相比，tenecteplase在这一患者群体中的效用尚未被研究。

Background

To assess the relative safety and efficacy of tenecteplase compared with standard infusions of alteplase in patients with PVT.

评估与标准输注阿替普酶相比，替奈普酶在PVT患者中的相对安全性和有效性。

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.

设计、设置和参与者：这是一项开放标签、平行组、非劣效性随机临床试验，研究对象为2022年10月至2024年8月期间在印度一家三级护理中心连续出现机械瓣膜性PVT的成年患者。

Methods

Patients received thrombolytic therapy with a low-dose slow infusion alteplase or weight-based bolus doses of tenecteplase.

患者接受了低剂量缓慢输注的阿替普酶或基于体重的冲击剂量的替奈普酶溶栓治疗。

main_outcomes_and_measures

The primary outcomes were to determine the rates of complete thrombolytic success and the incidenceof major complications.

主要结果是确定完全溶栓成功的比率和主要并发症的发生率。

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).

共有83名患者（平均年龄[标准差]为39.6[12.4]岁，42名男性[50.6%]）被随机分配接受阿替普酶（n = 43）或替奈普酶（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%]).

主要有效性终点（完全溶栓成功）的比率在替奈普酶组（39名患者[97.5%]）显著高于阿替普酶组（35名患者[81.5%]）（风险比，1.18；95%置信区间，1.03-1.39；P = .02，显示非劣效性）。

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).

此外，接受替奈普酶治疗的患者首次给药完全成功的比率更高，住院时间也更短（中位数[四分位数间距]，4.1 [3.2-5.1]天 vs 6.5 [4.3-9.2]天；P < .001）。

The rates of major and minor adverse events were similar.

主要和次要不良事件的发生率相似。

conclusions_and_relevance

Tenecteplase may be a safe and effective alternative to alteplase in patients presenting with obstructive PVT.

在出现梗阻性门静脉血栓（PVT）的患者中，替奈普酶可能是阿替普酶的安全有效替代品。

Patients treated with tenecteplase in our study had higher rates of complete thrombolytic success and a shorter duration of hospital stay.

在我们的研究中，接受替奈普酶治疗的患者完全溶栓成功率更高，住院时间也更短。

Furthermore, the relative ease of drug administration with tenecteplase may translate to greater clinical benefit in a real-world setting.

此外，替奈普酶的药物给药相对简便，可能在现实世界环境中转化为更大的临床益处。

trial_registration

Clinical Trials Registry of India: CTRI/2022/10/046127.

印度临床试验注册处：CTRI/2022/10/046127。