Triple Versus Dual Lipid-Lowering Therapy in Acute Coronary Syndrome: The ES-BempedACS Randomized Clinical Trial
Abstract
BACKGROUND: Current guidelines recommend a stepwise strategy to achieve low-density lipoprotein cholesterol (LDL-C) goals after acute coronary syndrome (ACS). Earlier intensive strategies based on a combination of lipid-lowering therapies (LLTs) could be useful from the onset of ACS. However, the role of bempedoic acid in ACS, particularly when combined with high-intensity statins and ezetimibe, remains uncertain. The aim of ES-BempedACS (Efficacy and Security of Bempedoic Acid in Acute Coronary Syndrome) was to compare the efficacy and safety of triple LLT (high-dose, high-intensity statin+ezetimibe+bempedoic acid) versus standard of care (high-dose, high-intensity statin+ezetimibe) after ACS. METHODS: ES-BempedACS is a multicenter, independent, pragmatic, prospective, randomized, open, blinded end point controlled trial conducted in 12 Spanish hospitals between November 2023 and October 2024. The primary end point was the proportion of patients achieving LDL-C <55 mg/dL (<1.4 mmol/L) at 8 weeks after ACS, comparing triple LLT with standard of care. RESULTS: A total of 206 patients (59.5±10.9 years of age [mean±SD]; 21.4% women) were randomized within the first 72 hours of ACS to triple LLT or standard therapy of high-intensity statin+ezetimibe (ie, dual LLT). The baseline LDL-C level was 133.6±28.8 mg/dL. After 8 weeks, the LDL-C level was reduced to <55 mg/dL in 59.4% of patients in the triple LLT group compared with 53.1% in the control group (dual LLT; P =0.376). The percentage change in LDL-C level was 57.5±17.8% and 56.9±18.5% in the triple and dual LLT groups, respectively ( P =0.823). Triple versus dual LLT showed similar results in reduction of non–high-density lipoprotein cholesterol levels (49.0±25.4 in triple LLT versus 49.1±31.2 in dual LLT; P =0.970) and triglyceride levels (14.9±36.9 in triple LLT versus 16.8±36.0 in dual LLT;) P =0.718), without differences in adverse events. CONCLUSIONS: Both dual and triple LLT after ACS allow for high rates (>50%) of adequate LDL-C control (<55 mg/dL) at 8 weeks. Adding bempedoic acid to statin–ezetimibe therapy in the setting of ACS is safe but failed to improve the percentage of patients achieving the LDL-C goal (<55 mg/dL) at 8 weeks. Larger, randomized studies are needed to confirm our findings. REGISTRATION: URL: https://www.clinicaltrialsregister.eu ; Unique identifier: 2021-006550-31.
Article Details
Authors (35)
Sergio Raposeiras-Roubín
Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid
Emad Abu Assi
Povisa Hospital, Vigo, Spain (E.A.A.)
César Jiménez Méndez
Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain (C.J.M., A.V.R., M.T.G.G., J.A.P.d.l.M.)
Ester Mínguez de la Guía
Cardiology Department, University Hospital of Albacete, Spain (E.M.d.l.G., M.L.V., F.S.M., M.C.-P.)
José Ángel Pérez Rivera
Cardiology Department, University Hospital of Burgos, Spain (J.Á.P.R., L.A.I., A.M.M., E.S.C., I.S.S.)
Marta Marcos Mangas
Cardiology Department, Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain (M.M.M., Á.V.H.-M., A.A.-S.)
Ana Ayesta
Cardiology Department, University Hospital Central de Asturias, Oviedo, Spain (A.A., A.A. Andrémar, J.R.)
Aitor Uribarri
Cardiology Department, Hospital Universitari Vall d’Hebron, Barcelona, Spain (A.U., M.V.-B.).
Pablo Jorge Pérez
Cardiology Department, University Hospital of Canarias, Tenerife, Spain (P.J.P., M.M.M.C.)
Pablo José Antúnez Muinos
Cardiology Department, University Hospital Montecelo, Pontevedra, Spain (P.J.A.M., M.C.G.C.)
Clara Bonanad Lozano
Cardiology Department, University Clinical Hospital of Valencia and INCLIVA Health Research Institute, Spain (C.B.L., D.B.)
Anna Carrasquer
Hospital Universitari Joan XXIII, Tarragona, Spain
Ana Viana-Tejedor
Cardiology Department, University Hospital Joan XXIII of Tarragona, Spain (A.C.)
Pablo Domínguez Erquicia
Cardiology Department, University Hospital Álvaro Cunqueiro and Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain (S.R.R., P.D.E., A.A. Abejón, A.I.R.)
Alberto Villar Ruiz
Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain (C.J.M., A.V.R., M.T.G.G., J.A.P.d.l.M.)
Macarena López Vázquez
Cardiology Department, University Hospital of Albacete, Spain (E.M.d.l.G., M.L.V., F.S.M., M.C.-P.)
Lara Aguilar Iglesias
Cardiology Department, University Hospital of Burgos, Spain (J.Á.P.R., L.A.I., A.M.M., E.S.C., I.S.S.)
Alberto Alén Andrémar
Cardiology Department, University Hospital Álvaro Cunqueiro and Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain (S.R.R., P.D.E., A.A. Abejón, A.I.R.)
Maria Vidal Burdeus
Cardiology Department, University Hospital Vall D’Hebron, Barcelona, Spain (A.U., M.V.B.)
Marta Maria Martin Cabeza
Cardiology Department, University Hospital of Canarias, Tenerife, Spain (P.J.P., M.M.M.C.)
María Cristina González Cambeiro
Cardiology Department, University Hospital Montecelo, Pontevedra, Spain (P.J.A.M., M.C.G.C.)
Daznia Bompart
Cardiology Department, University Clinical Hospital of Valencia and INCLIVA Health Research Institute, Spain (C.B.L., D.B.)
Juan Carlos Gómez Polo
Cardiology Department, University Clinical Hospital San Carlos, Madrid, Spain (A.V.-T., J.C.G.P.).
Marina Teresa García García
Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain (C.J.M., A.V.R., M.T.G.G., J.A.P.d.l.M.)
Ana Merino Merino
Cardiology Department, University Hospital of Burgos, Spain (J.Á.P.R., L.A.I., A.M.M., E.S.C., I.S.S.)
José Rozado
Cardiology Department, University Hospital Central de Asturias, Oviedo, Spain (A.A., A.A. Andrémar, J.R.)
José Antonio Panera de la Mano
Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain (C.J.M., A.V.R., M.T.G.G., J.A.P.d.l.M.)
Francisco Salmerón Martínez
Cardiology Department, University Hospital of Albacete, Spain (E.M.d.l.G., M.L.V., F.S.M., M.C.-P.)
Ester Sánchez Corral
Cardiology Department, University Hospital of Burgos, Spain (J.Á.P.R., L.A.I., A.M.M., E.S.C., I.S.S.)
Isabel Santos Sánchez
Cardiology Department, University Hospital of Burgos, Spain (J.Á.P.R., L.A.I., A.M.M., E.S.C., I.S.S.)
Ángel Víctor Hernández-Martos
Cardiology Department, Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain (M.M.M., Á.V.H.-M., A.A.-S.)
Andrés Antelo Abejón
Cardiology Department, University Hospital Álvaro Cunqueiro and Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain (S.R.R., P.D.E., A.A. Abejón, A.I.R.)
Andrés Iñiguez Romo
Cardiology Department, University Hospital Álvaro Cunqueiro and Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain (S.R.R., P.D.E., A.A. Abejón, A.I.R.)
Miguel Corbi-Pascual
Cardiology Department, University Hospital of Albacete, Spain (E.M.d.l.G., M.L.V., F.S.M., M.C.-P.)
Albert Ariza-Solé
Cardiology Department, Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain (M.M.M., Á.V.H.-M., A.A.-S.)