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.

Eligibility

Inclusion Criteria:

* Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.
* Recent ACS within 7 days prior to enrollment, defined by all of the following:
* Clinical presentation consistent with acute coronary syndrome.
* Elevated high-sensitivity cardiac troponin above the 99th percentile.
* Presence or absence of persistent ST-segment elevation.
* Coronary artery ectasia in the culprit coronary artery, defined by all of the following:
* The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA).
* Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow.
* Hospital admission lasting more than 24 hours.
* Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted.
* Ability and willingness to provide written informed consent and to participate in the study.

Exclusion Criteria:

* Pregnant women.
* Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.
* Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²).
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² at hospital discharge.
* History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding.
* Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \<30% plus at least one of the following:
* More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or
* NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.

Conditions5

Interventions3

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