Key result
TEER plus GDMT cuts 2-year HFH ~49% vs. GDMT alone.
Why the study?
The impact of transcatheter edge-to-edge repair on the rate and prognostic impact of fatal and nonfatal hospitalizations in patients with heart failure and severe secondary mitral regurgitation was unknown.
Does transcatheter edge-to-edge repair (TEER) reduce fatal and nonfatal hospitalizations in patients with heart failure and severe secondary mitral regurgitation?
RCT (n=614)
randomized
Does transcatheter edge-to-edge repair (TEER) reduce fatal and nonfatal hospitalizations in patients with heart failure and severe secondary mitral regurgitation?
Hazard Ratio: 0.51 (95% CI 0.39–0.66)
Absolute Event Rate: 34.8% vs 56.4%
In patients with heart failure and severe secondary mitral regurgitation, TEER significantly reduces fatal and nonfatal hospitalizations and increases time alive and out of the hospital compared to GDMT alone.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Among patients with heart failure, it has previously been shown that rehospitalisation events are associated with increased risk of morbidity mortality and healthcare costs.”
“This is really the first therapy that's been shown to improve the prognosis in high-risk patients with secondary mitral regurgitation due to underlying left ventricular dysfunction.”
“Would MitraClip be of benefit in patients that have significant MR but who are asymptomatic or don't have much symptoms? In one sense, we see that reducing the severity of secondary MR in these patients reduces clinical endpoints regardless of symptoms. That underscores the pathophysiological role of significant secondary MR in patients with heart failure.”
Supports TEER over GDMT to reduce HF hospitalizations; extends RCT evidence to 2-year outcomes in severe secondary MR.
BACKGROUND The impact of transcatheter edge-to-edge repair (TEER) on the rate and prognostic impact of hospitalizations in patients with heart failure (HF) and severe secondary mitral regurgitation is unknown. OBJECTIVES This study sought to evaluate the effect of the MitraClip percutaneous edge-to edge repair system on fatal and nonfatal hospitalizations and their relationship with mortality in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS Patients with HF (n = 614) with severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) versus GDMT alone. Hospitalizations were classified as fatal if death occurred during that hospitalization or nonfatal if the patient was discharged alive. RESULTS At 2 years, TEER treatment, compared with GDMT alone, resulted in lower time-to-first-event rates of any heart failure hospitalization (HFH) (34.8% vs 56.4%; HR: 0.51; 95% CI: 0.39-0.66) and fatal HFH (6.5% vs 12.6%; HR: 0.47; 95% CI: 0.26-0.85). TEER also resulted in lower rates of all-cause nonfatal and fatal hospitalizations. During the 2-year follow-up period, patients who underwent TEER spent an average of 2 more months alive and out of the hospital than did patients treated with GDMT alone (581 ± 27 days vs 519 ± 26 days; P = 0.002). All HFHs (adjusted HR: 6.37; 95% CI: 4.63-8.78) and nonfatal HFHs (adjusted HR: 1.78; 95% CI: 1.27-2.49) were consistently independently associated with increased 2-year mortality in both the TEER and GDMT groups (Pinteraction = 0.34 and 0.39, respectively). CONCLUSIONS In the COAPT trial, compared with GDMT alone, patients with HF and severe secondary mitral regurgitation undergoing TEER with the percutaneous edge-to edge repair system had lower 2-year rates of fatal and nonfatal all-cause hospitalizations and HFH and spent more time alive and out of the hospital. HFHs were strongly associated with mortality, irrespective of treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079).
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Giustino et al. (2022) conducted an RCT in heart failure and severe secondary mitral regurgitation (n=614). transcatheter edge-to-edge repair (TEER) plus GDMT vs. GDMT alone was evaluated on any heart failure hospitalization (HFH) (HR 0.51, 95% CI 0.39-0.66). Transcatheter edge-to-edge repair plus GDMT reduced the 2-year rate of any heart failure hospitalization compared to GDMT alone (34.8% vs 56.4%; HR 0.51; 95% CI 0.39-0.66).