PDF(Pubmed)
Abstract：
UNASSIGNED: The use of transcatheter aortic valve implantation (TAVI) in patients with aortic valve disease excluded from clinical trials has increased with no large-scale data on its safety.
UNASSIGNED: The purpose of this study was to assess the trend of utilization and adjusted outcomes of TAVI in clinical trials excluded (CTE) vs clinical trials included TAVI (CTI-TAVI) patients.
UNASSIGNED: We used the National Readmission Database (2015-2019) to identify 15 CTE-TAVI conditions. A propensity score-matched analysis was used to calculate the adjusted odds ratio (aOR) of net adverse clinical events (composite of mortality, stroke, and major bleeding) in patients undergoing CTE-TAVI vs CTI-TAVI.
UNASSIGNED: Among the 223,238 patients undergoing TAVI, CTE-TAVI was used in 41,408 patients (18.5%). The yearly trend showed a steep increase in CTE-TAVI utilization (P = 0.026). At index admission, the adjusted odds of net adverse clinical events (aOR: 1.83, 95% CI: 1.73-1.95) and its components, including mortality (aOR: 2.94, 95% CI: 2.66-3.24), stroke (aOR: 1.20, 95% CI: 1.07-1.34), and major bleeding (aOR: 1.49, 95% CI: 1.36-1.63) were significantly higher in CTE-TAVI compared with CTI-TAVI. Among the individual contraindications to clinical trial enrollment in the CTE-TAVI, patients with bicuspid aortic valve, leukopenia, and peptic ulcer disease appeared to have similar outcomes compared with CTI-TAVI, while patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy had a higher readmission rate at 30 and 180 days.
UNASSIGNED: CTE-TAVI utilization has increased significantly over the 4-year study period. Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.
UNASSIGNED: The purpose of this study was to assess the trend of utilization and adjusted outcomes of TAVI in clinical trials excluded (CTE) vs clinical trials included TAVI (CTI-TAVI) patients.
UNASSIGNED: We used the National Readmission Database (2015-2019) to identify 15 CTE-TAVI conditions. A propensity score-matched analysis was used to calculate the adjusted odds ratio (aOR) of net adverse clinical events (composite of mortality, stroke, and major bleeding) in patients undergoing CTE-TAVI vs CTI-TAVI.
UNASSIGNED: Among the 223,238 patients undergoing TAVI, CTE-TAVI was used in 41,408 patients (18.5%). The yearly trend showed a steep increase in CTE-TAVI utilization (P = 0.026). At index admission, the adjusted odds of net adverse clinical events (aOR: 1.83, 95% CI: 1.73-1.95) and its components, including mortality (aOR: 2.94, 95% CI: 2.66-3.24), stroke (aOR: 1.20, 95% CI: 1.07-1.34), and major bleeding (aOR: 1.49, 95% CI: 1.36-1.63) were significantly higher in CTE-TAVI compared with CTI-TAVI. Among the individual contraindications to clinical trial enrollment in the CTE-TAVI, patients with bicuspid aortic valve, leukopenia, and peptic ulcer disease appeared to have similar outcomes compared with CTI-TAVI, while patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy had a higher readmission rate at 30 and 180 days.
UNASSIGNED: CTE-TAVI utilization has increased significantly over the 4-year study period. Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.
摘要：
■在被排除在临床试验之外的主动脉瓣疾病患者中，经导管主动脉瓣植入（TAVI）的使用有所增加，而没有关于其安全性的大规模数据。
本研究的目的是评估排除的临床试验（CTE）与包括TAVI（CTI-TAVI）患者的临床试验中TAVI的利用趋势和调整结果。
■我们使用国家再录取数据库（2015-2019年）确定了15种CTE-TAVI条件。倾向评分匹配分析用于计算净不良临床事件的调整比值比(aOR)(复合死亡率,中风,和大出血）在接受CTE-TAVI和CTI-TAVI的患者中。
■在223,238名接受TAVI的患者中，CTE-TAVI用于41,408例患者（18.5%）。CTE-TAVI利用率呈逐年上升趋势(P=0.026)。在索引录取时，净不良临床事件的校正几率(AOR：1.83，95%CI：1.73-1.95)及其组成部分，包括死亡率（AOR：2.94，95%CI：2.66-3.24），中风(AOR：1.20，95%CI：1.07-1.34)，与CTI-TAVI相比，CTE-TAVI中的大出血（aOR：1.49，95％CI：1.36-1.63）显着升高。在CTE-TAVI临床试验招募的个人禁忌症中，患有二叶主动脉瓣的患者，白细胞减少症,与CTI-TAVI相比，消化性溃疡似乎有相似的结果，而终末期肾病患者，生物人工主动脉瓣,凝血病在30天和180天的再入院率较高。
■CTE-TAVI利用率在4年的研究期间显著增加。接受CTE-TAVI的患者死亡的可能性更高，中风,和出血比那些接受CTI-TAVI。
本研究的目的是评估排除的临床试验（CTE）与包括TAVI（CTI-TAVI）患者的临床试验中TAVI的利用趋势和调整结果。
■我们使用国家再录取数据库（2015-2019年）确定了15种CTE-TAVI条件。倾向评分匹配分析用于计算净不良临床事件的调整比值比(aOR)(复合死亡率,中风,和大出血）在接受CTE-TAVI和CTI-TAVI的患者中。
■在223,238名接受TAVI的患者中，CTE-TAVI用于41,408例患者（18.5%）。CTE-TAVI利用率呈逐年上升趋势(P=0.026)。在索引录取时，净不良临床事件的校正几率(AOR：1.83，95%CI：1.73-1.95)及其组成部分，包括死亡率（AOR：2.94，95%CI：2.66-3.24），中风(AOR：1.20，95%CI：1.07-1.34)，与CTI-TAVI相比，CTE-TAVI中的大出血（aOR：1.49，95％CI：1.36-1.63）显着升高。在CTE-TAVI临床试验招募的个人禁忌症中，患有二叶主动脉瓣的患者，白细胞减少症,与CTI-TAVI相比，消化性溃疡似乎有相似的结果，而终末期肾病患者，生物人工主动脉瓣,凝血病在30天和180天的再入院率较高。
■CTE-TAVI利用率在4年的研究期间显著增加。接受CTE-TAVI的患者死亡的可能性更高，中风,和出血比那些接受CTI-TAVI。
