Suk Ho Sohn, Yoonjin Kang, Ji Seong Kim, Jae Woong Choi, Jae Hang Lee, Jun Sung Kim, Cheong Lim, Ho Young Hwang
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引用次数: 0
Abstract
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).
背景：这项随机对照试验旨在比较主动脉瓣置换术（AVR）后1年的血液动力学表现和临床结果，使用最近引入的（AVALUS组）和世界范围内使用的（CEPME组）牛心包生物瓣膜。方法：根据非劣效性设计，对患者进行筛选，每组70名患者。试验的主要终点是术后1年主动脉瓣的平均压力梯度（AVMPG）。一年的超声心动图数据来自92.1%（140名患者中的129名）的研究患者。结果：两组在基线特征，包括性别和体表面积方面没有差异（1.64±0.18 vs 1.65±0.15m2）。AVALUS组和CEPME组1年超声心动图上的AVMPG分别为14.0±4.3 mmHg和13.9±5.1 mmHg（非劣效性P=0.004）。在假体尺寸的亚组分析中，AVALUS中19mm假体的AVMPG显著低于CEPME组（14.0±4.3mmHg vs 20.0±4.7mmHg，P=0.012），而其他尺寸的那些在两组之间没有显著差异。所有患者的有效孔口面积（1.49±0.40 cm2 vs 1.53±0.38 cm2，P=.500）或有效孔口面积指数（0.91±0.22 cm2/m2 vs 0.93±0.23 cm2/cm2，P=.570）或19mm假体的亚组分析均无显著差异。两组之间的1年临床结果没有差异。结论：AVALUS组的1年血液动力学和临床结果不劣于CEPME组。（nct3796442）。
期刊介绍：
The Thoracic and Cardiovascular Surgeon publishes articles of the highest standard from internationally recognized thoracic and cardiovascular surgeons, cardiologists, anesthesiologists, physiologists, and pathologists. This journal is an essential resource for anyone working in this field.
Original articles, short communications, reviews and important meeting announcements keep you abreast of key clinical advances, as well as providing the theoretical background of cardiovascular and thoracic surgery. Case reports are published in our Open Access companion journal The Thoracic and Cardiovascular Surgeon Reports.
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