Triple Versus Dual Lipid-Lowering Therapy in Acute Coronary Syndrome: The ES-BempedACS Randomized Clinical Trial
Sergio Raposeiras‐Roubín, Emad Abu Assi, César Jiménez Méndez, Ester Mínguez de la Guía, Jose-Ángel Pérez-Rivera, Marta Marcos Mangas, Ana Ayesta, Aitor Uribarri, Pablo Jorge‐Pérez, Pablo Antúnez‐Muiños, Clara Bonanad Lozano, Anna Carrasquer, Ana Viana‐Tejedor, Pablo Domínguez Erquicia, Alberto Villar Ruiz, Macarena López Vázquez, Lara Aguilar‐Iglesias, Alberto Alén Andrémar, María Vidal‐Burdeus, Marta María Martín Cabeza, María Cristina González Cambeiro, Daznia Bompart, Juan Carlos Gómez-Polo, Marina García, Ana Merino‐Merino, José Rozado, José Antonio Panera de la Mano, F Martinez, Ester Sánchez Corral, Ana Isabel Santos Sanchez, Ángel Víctor Hernández Martos, Andrés Antelo Abejón, Andrés Íñiguez, Miguel Corbí‐Pascual, Albert Ariza‐Solé
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.