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Optimizing lipid-lowering therapy for acute coronary syndrome using a decision support system: insights from a cluster randomized trial

Title: Optimizing lipid-lowering therapy for acute coronary syndrome using a decision support system: insights from a cluster randomized trial
Authors: Stevens, Christophe A T; Smith, Jessica; Brandts, Julia; Barkas, Fotios; Morales, Maria Moreno; Janani, Leila; Kiru, Gaia; Kaza, Nandita; Cornelius, Victoria; Poulter, Neil R; Khunti, Kamlesh; McEvoy, John William; Zambon, Alberto; Lopez-sendon, Jose L; Connolly, Derek; Hazell, Lorna; Ray, Kausik K; null, null; Wright, Annie; Britten, Eloise; Frost, Felicia; Lala, Francesco; Dao, Jonathan; Danois, Karen; Feng, Lisa; Das, Nayan; Anwar, Safa; Toopchiani, Sima; Das, Smita; Amiridis, Stephanie; Kakarla, Vanaja; Abdat, Yasmin; Sharma, Vinoda; Elorz, Christina; Moriarty, Andrew; Zaman, Afzar; Balakrishnan-Nair, Satheesh; Al-Lamee, Rasha; Sheikh, Azeem; Alama, Mohamed; Hunter, George; Ripley, David; Kodoth, Vivek; McKenzie, Daniel; Martins, Joe; Hossain, Rashed; Agrawal, Sharad; Routledge, Helen; Dhamrait, Sukhbir; Brunetti, Natale; Navazio, Alessandro; Casella, Gianni; Calabrò, Paolo; Andò, Giuseppe; Fresco, Claudio; Della Bona, Roberta; Borin, Andrea; De Caterina, Raffaele; Sciahbasi, Alessandro; Boriani, Giuseppe; Peteiro, Jesús; Juanatey, Jose Ramón González; Tuñón, José; Sellés, Manuel Martínez; Unzué, Leire; Arellano, Carlos; Aguilera, Jose Lopez; Sionis, Alessandro; Martín, Roberto; Moreno, Raul; Villanueva, Alejandro; Lozano, Jordi; Pascual, Domingo; Cortés, Francisco Javier
Contributors: Stevens, Christophe A T; Smith, Jessica; Brandts, Julia; Barkas, Fotio; Morales, Maria Moreno; Janani, Leila; Kiru, Gaia; Kaza, Nandita; Cornelius, Victoria; Poulter, Neil R; Khunti, Kamlesh; Mcevoy, John William; Zambon, Alberto; Lopez-sendon, Jose L; Connolly, Derek; Hazell, Lorna; Ray, Kausik K; Null, Null; Wright, Annie; Britten, Eloise; Frost, Felicia; Lala, Francesco; Dao, Jonathan; Danois, Karen; Feng, Lisa; Das, Nayan; Anwar, Safa; Toopchiani, Sima; Das, Smita; Amiridis, Stephanie; Kakarla, Vanaja; Abdat, Yasmin; Sharma, Vinoda; Elorz, Christina; Moriarty, Andrew; Zaman, Afzar; Balakrishnan-Nair, Satheesh; Al-Lamee, Rasha; Sheikh, Azeem; Alama, Mohamed; Hunter, George; Ripley, David; Kodoth, Vivek; Mckenzie, Daniel; Martins, Joe; Hossain, Rashed; Agrawal, Sharad; Routledge, Helen; Dhamrait, Sukhbir; Brunetti, Natale; Navazio, Alessandro; Casella, Gianni; Calabrò, Paolo; Andò, Giuseppe; Fresco, Claudio; Della Bona, Roberta; Borin, Andrea; De Caterina, Raffaele; Sciahbasi, Alessandro; Boriani, Giuseppe; Peteiro, Jesú; Juanatey, Jose Ramón González; Tuñón, José; Sellés, Manuel Martínez; Unzué, Leire; Arellano, Carlo; Aguilera, Jose Lopez; Sionis, Alessandro; Martín, Roberto; Moreno, Raul; Villanueva, Alejandro; Lozano, Jordi; Pascual, Domingo; Cortés, Francisco Javier
Publisher Information: OXFORD UNIV PRESS
Publication Year: 2026
Collection: Padua Research Archive (IRIS - Università degli Studi di Padova)
Subject Terms: Lipid-lowering therapies; Acute coronary syndrome (ACS); Implementation; Digital tools; Randomized controlled trial; Precision medicine
Description: Aims Lipid-lowering therapy (LLT) after acute coronary syndrome (ACS) typically follows stepwise intensification, delaying use of combination therapies and low-density lipoprotein cholesterol (LDL-C) goal attainment. We assessed whether access to a decision support system (DSS) altered the intensity of LLT prescribing vs. standard-of-care (SoC). Methods and results Pragmatic, multinational, parallel 1:1 cluster-randomized controlled trial of ACS patients comparing mandatory access to a DSS (providing estimates of cardiovascular events and benefits from different LLT scenarios) to SoC. The primary endpoint was the proportion receiving intensified monotherapy or initiated/escalated combination LLT by Week 16 compared to pre-admission LLT; secondary endpoints included individual components of the primary endpoint, proportions at goal (LDL-C < 1.4 mmol/L), and timing of LLT escalations. 42 sites from UK, Italy, and Spain were randomized, enrolling 1139 participants, 79% male, median age 62 years (IQR: 55, 69), 84% without prior CVD, 69% LLT-naïve at admission, and median admission LDL-C 3.0 mmol/L (IQR: 2.46, 3.75). The primary endpoint was met in 71.7% (DSS) vs. 65.7% (SoC) and risk ratio (RR) 1.11 (95%CI:0.92–1.33, P = 0.29). Intensification of monotherapy occurred in 9.0% vs. 13.1% (RR: 0.68, 95%CI: 0.46– 1.00), combination LLT in 61.6% vs. 50.6% (RR: 1.35, 95%CI: 0.93–1.98). LDL-C goal achievement was 54.8% vs. 50.3% (RR 1.06, 95%CI: 0.88–1.28), with LLT escalation before discharge in 64.8% vs. 60.7%. Conclusion Access to a DSS, in hospitals managing ACS, did not improve LLT intensification within 16 weeks or LDL-C goal attainment but revealed a favourable trend towards earlier combination LLT use, which merits larger, longer studies in other settings. Lay Summary The ZODIAC trial investigated whether a computer-based decision support system (DSS) could assist doctors over 16 weeks in selecting treatments more effective at lowering cholesterol for patients who suffered a heart attack within the last 72 h, ...
Document Type: article in journal/newspaper
File Description: ELETTRONICO
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/41624559; volume:7; issue:2; firstpage:1; lastpage:12; numberofpages:12; journal:EUROPEAN HEART JOURNAL. DIGITAL HEALTH; https://hdl.handle.net/11577/3583023
DOI: 10.1093/ehjdh/ztaf135
Availability: https://hdl.handle.net/11577/3583023; https://doi.org/10.1093/ehjdh/ztaf135
Rights: info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by/4.0/
Accession Number: edsbas.DA24FF1B
Database: BASE