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Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation
Quick Takes
- The COAPT-PAS was initiated in 2019 after two randomized controlled trials (RCTs) evaluating the role of transcatheter edge-to-edge repair (TEER; MitraClip) for secondary mitral regurgitation (SMR) showed discordant results (COAPT-RCT and MITRA-FR-RCT).
- The 5,000 patients in the current COAPT-PAS had more comorbidities, more functional limitations related to severe heart failure, and were on less guideline-directed medical therapy compared to patients enrolled in the RCTs.
- There were high implant rates, MR reduction of ≤2 (91%), QoL improvements, as well as low clinical event rates among patients undergoing MitraClip for SMR.
Study Questions:
What is the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR) in clinical practice?
Methods:
The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) Post-Approval Study (COAPT-PAS) is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 US centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019–2020. One-year outcomes from the COAPT-PAS full cohort, and COAPT-like and MITRA-FR-like subgroups who met randomized controlled trial (RCT) inclusion/exclusion criteria are reported.
Results:
Patients in the COAPT-PAS had more comorbidities, more severe heart failure (HF) and functional limitations, and less guideline-directed medical therapy (GDMT) than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR-like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, similar and durable reduction of MR to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), large improvement in quality of life (QoL) at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR-like), faster procedure times, similar or lower clinical event rates compared to the RCTs’ MitraClip arms, and lower clinical event rates than the RCTs’ GDMT-only arms. One-year HF hospitalizations were 18.9% in COAPT-PAS, 19.7% in COAPT-like compared to 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR-like compared to 47.4% in MITRA-FR-RCT.
Conclusions:
This large, contemporary real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR-RCT inclusion/exclusion criteria and patients excluded from the RCTs.
Perspective:
The COAPT-PAS was initiated in 2019 after two RCTs evaluating the role of transcatheter edge-to-edge repair (TEER; MitraClip) for SMR showed discordant results (COAPT-RCT and MITRA-FR-RCT). COAPT-PAS represents the largest observational study to assess the role of MitraClip for SMR. The 5,000 patients in the current COAPT-PAS had more comorbidities, more functional limitations related to severe HF, and were on less GDMT compared to patients enrolled in the RCT. There were high implant rates, MR reduction of ≤2 (91%), QoL improvements, as well as low clinical event rates. Reasons for discrepant RCT findings remain unresolved by the current study; however, findings provide reassurance regarding use of MitraClip for SMR in contemporary clinical practice.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Heart Failure, Mitral Valve Insufficiency, STS/ACC TVT Registry
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