We have located links that may give you full text access.
Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair.
JACC. Cardiovascular Interventions 2024 Februrary 27
BACKGROUND: 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.
OBJECTIVES: The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVES: The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
Full text links
Related Resources
Trending Papers
Autoimmune Hemolytic Anemias: Classifications, Pathophysiology, Diagnoses and Management.International Journal of Molecular Sciences 2024 April 13
Executive Summary: State-of-the-Art Review: Unintended Consequences: Risk of Opportunistic Infections Associated with Long-term Glucocorticoid Therapies in Adults.Clinical Infectious Diseases 2024 April 11
Clinical practice guidelines on the management of status epilepticus in adults: A systematic review.Epilepsia 2024 April 13
Finerenone: From the Mechanism of Action to Clinical Use in Kidney Disease.Pharmaceuticals 2024 March 27
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app