SPC365

Exploratory analysis of clinical outcomes in patients with secondary mitral regurgitation: the impact of COAPT trial criteria

Session: Sessão de Posters 54 - Intervenção valvular mitral
Speaker: Francisco Barbas de Albuquerque

Congress: CPC 2024
Topic: H. Interventional Cardiology and Cardiovascular Surgery
Theme: 25. Interventional Cardiology
Subtheme: 25.3 Non-coronary Cardiac Intervention
Session Type: Cartazes
FP Number: ---
Authors: Francisco Barbas De Albuquerque; Miguel Abrantes Figueiredo; Vera Ferreira; António Fiarresga; Rúben Ramos; João Pedro Reis; Ana Teresa Timóteo; Pedro Rio; Ana Galrinho; Luísa Moura Branco; Rui Ferreira; Duarte Cacela

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif"><strong>Background</strong></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">Mitral regurgitation (MR) is a common valvulopathy associated with poor prognosis. The COAPT-trial had a pivotal role for defining which patients would benefit the most from mitral transcatheter edge-to-edge repair (TEER) in patients with severe functional MR comparing to medical therapy alone. Nevertheless, in the real word setting some patients are submitted to mitral TEER despite not fulfilling the COAPT trial inclusion/exclusion criteria.</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif"><strong>Aim</strong></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">To perform an exploratory analysis of clinical outcomes in patients with severe functional MR submitted to MitraClip &reg; that did not fulfill the COAPT trial criteria versus those who did.</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif"><strong>Methods</strong></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">Single-center prospective registry analysis of patients with severe MR that were submitted to mitral TEER between 2013 and 2023. Functional MR patients were selected for the exploratory analysis. Patients that fulfilled all COAPT trial criteria were considered in COAPT-group. Patients were considered in the non-COAPT group if any of the following verified: left ventricle (LV) ejection fraction (EF) &lt; 20%, end-systolic LV diameter (ESLVD) &gt; 70 mm and systolic pulmonary artery pressure (SPAP) &gt; 70 mmHg. </span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">Clinical outcomes of interest were the composite of all-cause mortality or heart failure (HF) hospitalization (HFH) at 1 year and all-cause mortality at the median total follow-up time. Kaplan-Meier survival curves were calculated using log-rank test. Cox regression was used to assess differences in the two groups. &nbsp;A <em>p</em> value &le; 0.05 was considered significant.</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif"><strong>Results</strong></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">From a total of 76 MitraClip &reg; implanted during the study period, 57 were implanted in functional MR. Of these, 49 patients were in the COAPT-group and 8 in the non-COAPT group. Figure 1 depicts the baseline and echocardiographic characteristics of subgroups. Most characteristics are balanced. Of note, patients in non-COAPT group had higher LVESD (p=0.013) and PSAP (p=0.003) and a lower TAPSE (p=0.002) comparing to COAPT group.</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">At 1 year follow-up, the composite endpoint of all-cause mortality or heart failure (HF) hospitalization (HFH) rate was 26.5% (n=13) in COAPT-group versus 37.5% (n=3) in non-COAPT group [HR=0.55, 95% CI (0.16-1.9), p=0.35] (Figure 1.)</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">During a median total follow-up time of 2.1 year per patient, the all-cause mortality rate was 30.6% (n=15) in COAPT-group versus 50% (n=4) in non-COAPT group [HR=0.54, 95% CI (0.18-1.6), p=0.26] (Figure 1).</span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif"><strong>Conclusion</strong></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Aptos,sans-serif">In a real-world patient setting of severe functional MR that were implanted MitraClip &reg;, patients that would be formally excluded from COAPT-trial had similar clinical outcomes at 1 year than those who fulfilled the criteria. At longer-term follow-up of 2.1-year, similar all-cause mortality rates were observed between groups. This provides valuable insights regarding the tailored and personalized decision-making process when considering patients for mitral TEER.</span></span></p>