Article Impact Level: HIGH Data Quality: STRONG Summary of Clinical Cardiology, 46(7), 777–784. https://doi.org/10.1002/clc.24025 Dr. Xiaoxuan Gong et al.
Points
- The OPTIMA-4 trial focuses on ACS patients with concomitant atrial fibrillation, aiming to determine the best dual antithrombotic regimen post-new-generation DES implantation.
- The primary hypothesis being tested is whether clopidogrel combined with dabigatran is as effective and safer than ticagrelor for these patients, with an enrollment of 1472 eligible participants.
- Patient eligibility is defined by low-to-moderate bleeding risk (HAS-BLED score ≤ 2) and a need for anticoagulation therapy (CHA2DS2-VASc score ≥ 2).
- Primary endpoints encompass a composite of cardiovascular events for efficacy and significant bleeding or clinically relevant nonmajor bleeding for safety, following a 12-month treatment regimen.
- The trial initiated its first enrollment in March 2018, with an anticipated completion date for patient recruitment by December 31, 2024, providing valuable data to guide clinical practice for this specific patient group.
Summary
The “OPtimal management of anTIthroMbotic Agents (OPTIMA)-4” trial aims to address a critical challenge in the treatment of acute coronary syndrome (ACS) patients. Approximately 5%–15% of ACS patients undergoing stent implantation also present with concomitant atrial fibrillation, necessitating antiplatelet and anticoagulant therapies. However, the optimal antithrombotic regimen for this specific patient group remains uncertain.
The primary hypothesis being tested in this multicenter randomized controlled trial is whether clopidogrel, when combined with dabigatran, is not only comparable in efficacy but also superior in safety to ticagrelor for these patients following the implantation of new-generation drug-eluting stents (DES). To gather data for this study, ACS patients with a low-to-moderate risk of bleeding (defined as a HAS-BLED score ≤ 2) who require anticoagulation therapy (CHA2DS2-VASc score ≥ 2) will be recruited. A total of 1472 eligible patients will be randomly assigned to receive a 12-month dual antithrombotic treatment regimen. This regimen will consist of either clopidogrel 75 mg daily or ticagrelor 90 mg twice daily in combination with dabigatran 110 mg twice daily.
The trial’s primary endpoints include both efficacy and safety measures. The primary efficacy endpoint is a composite outcome that comprises cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systemic thromboembolism. Meanwhile, the primary safety endpoint focuses on major or clinically relevant nonmajor bleeding, as defined by the International Society of Thrombosis and Hemostasis. Notably, the first enrollment for the OPTIMA-4 trial commenced on March 12, 2018, with the expectation of completing patient recruitment before December 31, 2024.
In conclusion, the OPTIMA-4 trial addresses a critical clinical question by assessing dual antithrombotic regimens’ comparative effectiveness and safety for ACS patients with concomitant nonvalvular atrial fibrillation following new-generation DES implantation. With its rigorous methodology and substantial patient enrollment, this research initiative is poised to provide valuable data to guide clinical decision-making in this specific patient population.
Link to the article: https://onlinelibrary.wiley.com/doi/10.1002/clc.24025
References Gong, X., Hua, R., Bai, J., Wu, T., Wang, Q., Zhang, J., Zhang, W., Ying, L., Ke, Y., Wang, X., Zhang, X., Liu, K., Chen, Y., Zhang, B., Dong, P., Xiao, J., Li, C., Zhu, L., & Li, C. (2023). Rationale and design of the optimal antithrombotic treatment for acute coronary syndrome patients with concomitant atrial fibrillation and implanted with new‐generation drug‐eluting stent: OPtimal management of anTIthroMbotic Agents (Optima)‐4 trial. Clinical Cardiology, 46(7), 777–784. https://doi.org/10.1002/clc.24025
