Importance Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, −∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, −10.1%; Farrington-Manning 97.5% CI, −∞ to −4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, −6.1%; 95% CI, −9.6% to −2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, −10.2%; 95% CI, −16.3% to −4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration ClinicalTrials.gov Identifier: NCT02202434

中文翻译：

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机械扩张与自扩张经导管主动脉瓣置换术对主动脉瓣狭窄高危患者死亡率和主要不良临床事件的影响

重要性 经导管主动脉瓣置换术 (TAVR) 是为选定的严重主动脉瓣狭窄患者建立的。然而，会发生诸如次优部署、传导障碍和瓣周漏等限制。目的 评估机械扩张瓣膜 (MEV) 在接受 TAVR 的主动脉瓣狭窄高危患者中是否不劣于经批准的自扩张瓣膜 (SEV)。设计、设置和参与者 REPRISE III 试验于 2014 年 9 月 22 日至 2015 年 12 月 24 日期间在北美、欧洲和澳大利亚的 55 个中心对 912 名高风险或极端风险以及严重、有症状的主动脉瓣狭窄患者进行了2017 年 3 月 8 日进行最终随访。 干预措施 参与者以 2:1 的比例随机接受 MEV（n = 607）或 SEV（n = 305）。主要结果和措施 主要安全性终点是 30 天复合全因死亡率、中风、危及生命或大出血、2/3 期急性肾损伤和主要血管并发症的非劣效性测试（边际，10.5% ）。主要有效性终点是经过非劣效性测试的全因死亡率、致残性卒中和中度或更大瓣周漏的 1 年复合终点（边际，9.5%）。如果满足非劣效性标准，则在完整分析数据集中测试 1 年中度或更大瓣周漏的次要终点的优效性。结果 在 912 名随机患者（平均年龄，82.8 [SD，7.3] 岁；463 [51%] 名女性；预测死亡风险，6.8%）中，874 名 (96%) 在 1 年时可评估。30 天时的主要安全性复合终点发生在 20 天。3% 的 MEV 患者和 17.2% 的 SEV 患者（差异，3.1%；Farrington-Manning 97.5% CI，-∞ 至 8.3%；非劣效性 P = .003）。1 年时，主要有效性复合终点发生在 MEV 的 15.4% 和 SEV 的 25.5%（差异，-10.1%；Farrington-Manning 97.5% CI，-∞ 至 -4.4%；非劣效性 P<.001 ）。MEV 中度或重度瓣周漏的 1 年发生率为 0.9%，SEV 为 6.8%（差异，-6.1%；95% CI，-9.6% 至 -2.6%；P < .001）。主要有效性的优势分析具有统计学意义（差异，-10.2%；95% CI，-16.3% 至 -4.0%；P < .001）。MEV 的新起搏器植入率（35.5% 对 19.6%；P < .001）和瓣膜血栓形成率（1.5% 对 0%）较高，但重复手术率（0.2% 对 2.0%）、瓣中瓣部署（0% vs 3.7%），和瓣膜错位（0% 对 2.7%）。结论和相关性 在主动脉瓣狭窄的高危患者中，与 SEV 相比，使用 MEV 不会导致主要安全性终点或主要有效性终点的较差结果。这些发现表明，MEV 可能是高危患者 TAVR 的有用补充。试验注册 ClinicalTrials.gov 标识符：NCT02202434