Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia

Summary

Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain. Dual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy. The OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.

Timeline

Start

2026-02-11

Primary completion

2029-06

Completion

2029-06

Publications

• Background Solis-Jimenez F, Esparza XL, Guzman-Solorzano HP, Villalobos-Pedroza M, Morales-Villamil LA, Diaz-Herrera BA, Hernandez-Pastrana S, Gopar-Nieto R, Arias-Sanchez EA, Marroquin-Donday LA, Jimenez-Rodriguez GM, Sierra-Lara D, Araiza-Garaygordobil D, Arias-Mendoza A. Anticoagulant versus Antiplatelet Therapy After Acute Coronary Syndromes in Patients with Coronary Artery Ectasia: A Retrospective Cohort Study. Cardiovasc Drugs Ther. 2026 Jun;40(3):1021-1033. doi: 10.1007/s10557-025-07784-0. Epub 2025 Sep 24.
• Background Araiza-Garaygordobil D, Gopar-Nieto R, Sierra-Lara Martinez JD, Mullasari AS, Belderrain-Morales N, Najera-Rojas NA, Diaz-Herrera BA, Sarabia-Chao V, Alfaro-Ponce DL, Briseno-De la Cruz JL, Ruiz-Beltran M, Martinez-Rios MA, Pina-Reyna Y, Latapi-Ruiz Esparza X, Grimaldo-Gomez FA, Cortina-De la Rosa E, Romero-Arroyo MO, Sierra-Gonzalez de Cossio A, Gonzalez-Pacheco H, Arias-Mendoza A. A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia. Am Heart J. 2025 Mar;281:103-111. doi: 10.1016/j.ahj.2024.11.012. Epub 2024 Nov 29.
• Background Doi T, Kataoka Y, Noguchi T, Shibata T, Nakashima T, Kawakami S, Nakao K, Fujino M, Nagai T, Kanaya T, Tahara Y, Asaumi Y, Tsuda E, Nakai M, Nishimura K, Anzai T, Kusano K, Shimokawa H, Goto Y, Yasuda S. Coronary Artery Ectasia Predicts Future Cardiac Events in Patients With Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2017 Dec;37(12):2350-2355. doi: 10.1161/ATVBAHA.117.309683. Epub 2017 Oct 19.
• Background Iwanczyk S, Lehmann T, Cieslewicz A, Malesza K, Wozniak P, Hertel A, Krupka G, Jagodzinski PP, Grygier M, Lesiak M, Araszkiewicz A. Circulating miRNA-451a and miRNA-328-3p as Potential Markers of Coronary Artery Aneurysmal Disease. Int J Mol Sci. 2023 Mar 18;24(6):5817. doi: 10.3390/ijms24065817.
• Background Lu TP, Chuang NC, Cheng CY, Hsu CA, Wang YC, Lin YH, Lee JK, Wu CK, Hwang JJ, Lin LY, Yeh SS, Chien KL, Juang JJ. Genome-wide methylation profiles in coronary artery ectasia. Clin Sci (Lond). 2017 Apr 1;131(7):583-594. doi: 10.1042/CS20160821. Epub 2017 Jan 31.
• Background Dogan A, Tunc B, Ergene O, Ozaydin M, Nazli C, Altinbas A, Gedikli O. Evaluation of overall fibrinolytic activity in patients with coronary artery ectasia: global fibrinolytic capacity. Int J Cardiovasc Imaging. 2003 Dec;19(6):465-71. doi: 10.1023/b:caim.0000004339.30038.8d.
• Background Nunez-Gil IJ, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodriguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, de la Torre Hernandez JM, Pascual I, Liebetrau C, Camacho B, Pavani M, Albistur J, Latini RA, Varbella F, Jimenez-Diaz VA, Piraino D, Mancone M, Alfonso F, Linares JA, Rodriguez-Olivares R, Jimenez Mazuecos JM, Palazuelos Molinero J, Sanchez-Grande Flecha A, Gomez-Hospital JA, Ielasi A, Lozano I, Omede P, Bagur R, Ugo F, Medda M, Louka BF, Kala P, Escaned J, Bautista D, Feltes G, Salinas P, Alkhouli M, Macaya C, Fernandez-Ortiz A; CAAR investigators. Coronary artery aneurysms, insights from the international coronary artery aneurysm registry (CAAR). Int J Cardiol. 2020 Jan 15;299:49-55. doi: 10.1016/j.ijcard.2019.05.067. Epub 2019 Jul 19.
• Background Gunasekaran P, Stanojevic D, Drees T, Fritzlen J, Haghnegahdar M, McCullough M, Barua R, Mehta A, Hockstad E, Wiley M, Earnest M, Tadros P, Genton R, Gupta K. Prognostic significance, angiographic characteristics and impact of antithrombotic and anticoagulant therapy on outcomes in high versus low grade coronary artery ectasia: A long-term follow-up study. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1219-1227. doi: 10.1002/ccd.27929. Epub 2018 Nov 4.
• Background Bogana Shanmugam V, Psaltis PJ, T L Wong D, T Meredith I, Malaiapan Y, Ahmar W. Outcomes After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Caused by Ectatic Infarct Related Arteries. Heart Lung Circ. 2017 Oct;26(10):1059-1068. doi: 10.1016/j.hlc.2016.12.006. Epub 2017 Feb 7.
• Background Yip HK, Chen MC, Wu CJ, Hang CL, Hsieh KY, Fang CY, Yeh KH, Fu M. Clinical features and outcome of coronary artery aneurysm in patients with acute myocardial infarction undergoing a primary percutaneous coronary intervention. Cardiology. 2002;98(3):132-40. doi: 10.1159/000066322.
• Background Hartnell GG, Parnell BM, Pridie RB. Coronary artery ectasia. Its prevalence and clinical significance in 4993 patients. Br Heart J. 1985 Oct;54(4):392-5. doi: 10.1136/hrt.54.4.392.
• Background Markis JE, Joffe CD, Cohn PF, Feen DJ, Herman MV, Gorlin R. Clinical significance of coronary arterial ectasia. Am J Cardiol. 1976 Feb;37(2):217-22. doi: 10.1016/0002-9149(76)90315-5.
• Background Swaye PS, Fisher LD, Litwin P, Vignola PA, Judkins MP, Kemp HG, Mudd JG, Gosselin AJ. Aneurysmal coronary artery disease. Circulation. 1983 Jan;67(1):134-8. doi: 10.1161/01.cir.67.1.134.

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Indications