Key result
TEER does not increase worsening renal function vs GDMT alone and maintains its treatment benefits.
Why the study?
The incidence and prognostic implications of worsening renal function after mitral valve transcatheter edge-to-edge repair in patients with heart failure were unknown.
Does transcatheter edge-to-edge repair (TEER) increase the risk of worsening renal function at 30 days, and does worsening renal function attenuate the clinical benefits of TEER in patients with heart failure and secondary mitral regurgitation?
RCT (n=614)
Does transcatheter edge-to-edge repair (TEER) increase the risk of worsening renal function at 30 days, and does worsening renal function attenuate the clinical benefits of TEER in patients with heart failure and secondary mitral regurgitation?
Absolute Event Rate: 9.7% vs 13.1%
p-value: p=0.23
TEER does not increase the risk of 30-day worsening renal function compared to medical therapy alone, and its benefits in reducing mortality and heart failure hospitalization are maintained even in patients who develop worsening renal function.
TEER remains appropriate in HF with severe secondary MR despite renal vulnerability; confirms WRF does not modify treatment benefit.
Background The incidence and implications of worsening renal function (WRF) after mitral valve transcatheter edge‐to‐edge repair (TEER) in patients with heart failure (HF) are unknown. Therefore, the aim of this study was to determine the proportion of patients with HF and secondary mitral regurgitation who develop persistent WRF within 30 days following TEER, and whether this development portends a worse prognosis. Methods and Results In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, 614 patients with HF and severe secondary mitral regurgitation were randomized to TEER with the MitraClip plus guideline‐directed medical therapy (GDMT) versus GDMT alone. WRF was defined as serum creatinine increase ≥1.5× or ≥0.3 mg/dL from baseline persisting to day 30 or requiring renal replacement therapy. All‐cause death and HF hospitalization rates between 30 days and 2 years were compared in patients with and without WRF. WRF at 30 days was present in 11.3% of patients (9.7% in the TEER plus GDMT group and 13.1% in the GDMT alone group; P =0.23). WRF was associated with all‐cause death (hazard ratio [HR], 1.98 [95% CI, 1.3–3.03]; P =0.001) but not HF hospitalization (HR, 1.47 [ 95% CI, 0.97–2.24]; P =0.07) between 30 days and 2 years. Compared with GDMT alone, TEER reduced both death and HF hospitalization consistently in patients with and without WRF ( P interaction =0.53 and 0.57, respectively). Conclusions Among patients with HF and severe secondary mitral regurgitation, the incidence of WRF at 30 days was not increased after TEER compared with GDMT alone. WRF was associated with greater 2‐year mortality but did not attenuate the treatment benefits of TEER in reducing death and HF hospitalization compared with GDMT alone. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01626079.
No takes yet. Share an insight, caveat, or question.
Kong et al. (2023) conducted an RCT in Heart failure and severe secondary mitral regurgitation (n=614). Transcatheter edge-to-edge repair (TEER) with MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone was evaluated on Worsening renal function (WRF) at 30 days (p=0.23). TEER did not increase the incidence of worsening renal function at 30 days compared with GDMT alone (9.7% vs 13.1%; P=0.23), and WRF did not attenuate the treatment benefits of TEER.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: