Background This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Methods Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. Results There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. Conclusion The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

中文翻译：

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比较两种牛心包瓣膜一年血流动力学的对照试验

背景 这项随机对照试验旨在比较使用最近推出的（AVALUS 组）和全球使用的（CEPME 组）牛心包生物假体进行主动脉瓣置换术 (AVR) 后 1 年的血流动力学表现和临床结果。方法 根据非劣效性设计对患者进行筛选，每组纳入 70 名患者。该试验的主要终点是手术后 1 年的主动脉瓣平均压力梯度 (AVMPG)。92.1% 的研究患者（140 名患者中的 129 名）获得了一年的超声心动图数据。结果 各组之间的基线特征（包括性别和体表面积（1.64 ± 0.18 vs. 1.65 ± 0.15 m2））没有差异。AVALUS 组和 CEPME 组的 1 年超声心动图 AVMPG 分别为 14.0 ± 4.3 和 13.9 ± 5.1 mmHg（非劣效性 p 值为 0.0004）。在针对各个假体尺寸的亚组分析中，AVALUS 组中 19 毫米假体的 AVMPG 显着低于 CEPME 组（14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg，p = 0.012），而两组之间的其他尺寸没有显着差异。所有患者的有效孔口面积（1.49 ± 0.40 vs. 1.53 ± 0.38 cm2，p = 0.500）或有效孔口面积指数（0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2，p = 0.570）均无显着差异，或在 19 毫米假体的亚组分析中。两组之间的 1 年临床结果没有差异。结论 AVALUS 组的 1 年血流动力学和临床结果不劣于 CEPME 组 (NCT03796442)。