Article Impact Level: HIGH Data Quality: STRONG Summary of Journal of the American College of Cardiology, 82(13), 1281–1297. https://doi.org/10.1016/j.jacc.2023.07.015 Dr. Kashish Goel et al.
Points
- The COAPT-PAS study aimed to evaluate the safety and effectiveness of the MitraClip System in patients with secondary mitral regurgitation (SMR), addressing the debate about its real-world applicability.
- COAPT-PAS included 5,000 consecutive SMR patients, showing a high MitraClip implant rate (97.7%) and sustained reduction of mitral regurgitation to ≤2+ at one year.
- Patients in COAPT-PAS had more comorbidities, severe heart failure, and lower guideline-directed medical therapy compared to COAPT and MITRA-FR RCTs.
- Quality of life substantially improved in COAPT-PAS patients, with faster procedure times and clinical event rates comparable to or lower than RCTs’ MitraClip arms.
- Heart failure hospitalizations at one year were significantly reduced in COAPT-PAS, reinforcing the safety and effectiveness of the MitraClip System in SMR patients, including those excluded from the RCTs.
Summary
In a recent research paper, the authors delved into the ongoing debate surrounding the real-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT). This debate was primarily centered around concerns regarding patient selection and the contrasting findings of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT. To address these concerns, the COAPT-PAS (COAPT Post-Approval Study) was initiated to evaluate the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR).
The COAPT-PAS was a prospective, single-arm, observational study conducted on a cohort of 5,000 consecutive patients with SMR who underwent MitraClip treatment across 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The study’s results revealed several key findings: Patients in the COAPT-PAS cohort exhibited a higher prevalence of comorbidities, more severe heart failure, and more significant functional limitations while receiving less guideline-directed medical therapy than patients in the COAPT or MITRA-FR RCTs. Nevertheless, the patients in the COAPT-PAS cohort and subgroups resembling the COAPT and MITRA-FR RCTs demonstrated a high MitraClip implant rate, with 97.7% of patients receiving the implant. The reduction of mitral regurgitation to ≤2+ at the 1-year mark was notably sustained, with rates of 90.7% in the COAPT-PAS cohort, 89.7% in the COAPT-like subgroup (n = 991), and 86.6% in the MITRA-FR–like subgroup (n = 917).
Moreover, patients experienced a significant improvement in their quality of life at the 1-year follow-up, as measured by the Kansas City Cardiomyopathy Questionnaire, with increases of +29 in COAPT-PAS, +27 in COAPT-like and +33 in MITRA-FR–like subgroups. The procedure times were faster in the COAPT-PAS cohort. Importantly, clinical event rates in the COAPT-PAS cohort and subgroups were comparable to or lower than the MitraClip arms of the RCTs and notably lower than the guideline-directed medical therapy-only arms. One-year heart failure hospitalizations were notably reduced, standing at 18.9% in COAPT-PAS, 19.7% in the COAPT-like subgroup, in contrast to 24.9% in the COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR–like subgroup, compared with 47.4% in MITRA-FR-RCT.
In conclusion, this extensive real-world study provides substantial evidence affirming the safety and effectiveness of the MitraClip System in patients with SMR. These findings are particularly relevant for patients meeting the criteria of the COAPT and MITRA-FR RCTs and those excluded from these trials. The study underlines MitraClip’s potential to mitigate heart failure hospitalizations and highlights its superior performance compared to guideline-directed medical therapy in this patient population.
Link to the article: https://www.sciencedirect.com/science/article/abs/pii/S0735109723062903
References Goel, K., Lindenfeld, J., Makkar, R., Naik, H., Atmakuri, S., Mahoney, P., Morse, M. A., Thourani, V. H., Yadav, P., Batchelor, W., Rogers, J., Whisenant, B., Rinaldi, M., Hermiller, J., Lindman, B. R., & Barker, C. M. (2023). Transcatheter edge-to-edge repair in 5,000 patients with secondary mitral regurgitation. Journal of the American College of Cardiology, 82(13), 1281–1297. https://doi.org/10.1016/j.jacc.2023.07.015
