Clinical trials have demonstrated the efficacy and safety of mitral transcatheter edge-to-edge repair (M-TEER) for selected patients with severe mitral regurgitation. However, the generalizability of trial results to real-world patients remains uncertain. The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER. Using the National Inpatient Sample database years 2016-2020, M-TEER admissions were identified and categorized into trial participants vs none. We also identified a cohort of trial noneligible patients based on clinical exclusion criteria from pivotal trials. Multivariate regression analysis was performed to compare in-hospital outcomes. The primary outcome was in-hospital mortality, and secondary outcomes included in-hospital complications, length of stay, and hospitalization cost. Among 38,770 M-TEER admissions from 2016 to 2020, 11,450 (29.5%) were trial participants, 22,975 (59.3%) were eligible nonparticipants, and 2,960 (7.6%) were noneligible. Baseline characteristics and comorbidity profiles were mostly similar between trial participants vs eligible nonparticipants. In-hospital mortality (adjusted OR [aOR]: 0.98; 95% CI: 0.60-1.62), cardiogenic shock (aOR: 1.06; 95% CI: 0.80-1.42), mechanical circulatory support (aOR: 0.91; 95% CI: 0.58-1.41), mechanical ventilation (aOR: 1.03; 95% CI: 0.74-1.42), and conversion to mitral valve surgery (aOR: 1.08; 95% CI: 0.57-2.03) were not different between both groups. Conversely, M-TEER for noneligible patients was associated with higher rates of mortality (aOR: 6.27; 95% CI: 3.75-10.45) and complications. The majority of real-world M-TEER patients would have been eligible for clinical trial participation and had comparable clinical profiles and in-hospital outcomes to trial participants. However, noneligible patients had worse in-hospital outcomes compared with trial participants.

中文翻译：

---

临床试验参与状态与二尖瓣经导管边对边修复结果之间的关联

临床试验已证明二尖瓣经导管边对边修复术 (M-TEER) 对于选定的严重二尖瓣反流患者的有效性和安全性。然而，试验结果对现实世界患者的普遍适用性仍不确定。作者旨在比较接受 M-TEER 的试验参与者和非参与者的基线特征和院内结果。使用 2016-2020 年国家住院患者样本数据库，确定了 M-TEER 入院情况，并将其分为试验参与者与无参与者。我们还根据关键试验的临床排除标准确定了一组不符合试验资格的患者。进行多变量回归分析来比较院内结果。主要结局是院内死亡率，次要结局包括院内并发症、住院时间和住院费用。在 2016 年至 2020 年 38,770 名 M-TEER 入院患者中，11,450 名（29.5%）为试验参与者，22,975 名（59.3%）为合格非参与者，2,960 名（7.6%）为不合格。试验参与者与符合条件的非参与者之间的基线特征和合并症概况大多相似。院内死亡率（调整后 OR [aOR]：0.98；95% CI：0.60-1.62）、心源性休克（aOR：1.06；95% CI：0.80-1.42）、机械循环支持（aOR：0.91；95% CI：两组之间的机械通气（aOR：1.03；95% CI：0.74-1.42）和转二尖瓣手术（aOR：1.08；95% CI：0.57-2.03）没有差异。相反，对于不符合条件的患者，M-TEER 与较高的死亡率（aOR：6.27；95% CI：3.75-10.45）和并发症相关。现实世界中的大多数 M-TEER 患者都有资格参加临床试验，并且与试验参与者具有可比的临床特征和院内结果。然而，与试验参与者相比，不符合条件的患者的院内结果更差。