Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization

Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia

As classified by Academic Research Consortium (ARC) (Circulation. 2007;115:2344-2351).

• Cardiac Death: Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease should be classified as cardiac.
• Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
• Cancer related death: death from cancer cause

As classified by Academic Research Consortium (ARC): However, the sensitivity is too high for the evaluation with Troponin of the peri-procedural MI, thus CKMB will be used.

Ischemic stroke is defined as acute onset of a neurological deficit that persists for at least 24 hours and is the result of a disturbance of the cerebral circulation due to ischemia. Deficits that last ≤ 24 hours are due to transient ischemic neurological attack and are not classified in this category.

The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

Critical limb ischemia is defined by chronic ischemic pain at rest and/or presence of ischemic skin lesions (gangrene or ulcerations).

• Cardiac Death: Any death due to proximate cardiac cause (e.g. myocardial infarction [MI], low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
• Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Bleeding/Hemorrhagic Complications will be evaluated using the Bleeding Academic Research Consortium (BARC) definition. Major bleeding is defined as BARC 3 or 5.

An unplanned hospitalization with heart failure. Heart failure is defined by the modified Framingham criteria as follow:

[Major Criteria] 1) Paroxysmal nocturnal dyspnea 2) Orthopnea 3) Neck-vein distension 4) Rales 5) Acute pulmonary edema [Minor Criteria]

• Ankle edema
• Dyspnea on exertion
• Pleural effusion
• Tachycardia (HR ≧ 120/min) * For establishing a definite diagnosis of heart failure, 2 Major criteria or 1 major and 2 minor criteria must be present concurrently

• Non-metastatic cancer (not present prior to randomization)
• Metastatic cancer (cancer that was metastatic at presentation, metastasis of a non-metastatic cancer presents at baseline, or blood cancer) Non-melanoma skin cancer was excluded cancer end points.

Cancer death is defined as death from cancer cause.

Composite of all-cause mortality, myocardial infarction, ischemic stroke, coronary revascularization, lower extremity revascularization, critical lower extremity ischemia, major bleeding, hospital admission for heart failure, cancer death