| 539 | In combination with acetylsalicylic acid (ASA; 75mg to 100mg) for the prevention of stroke, myocardial infarction, and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with concomitant coronary artery disease (CAD) and peripheral artery disease (PAD) if the following conditions are met:
Patients with CAD are defined as having one or more of the following:
- myocardial infarction within the last 20 years
- multi-vessel coronary disease(i.e., stenosis of greater than or equal to 50% in two or more coronary arteries, or in one coronary territory if at least one other territory has been revascularized) with symptoms or history of stable or unstable angina.
- multi-vessel precutaneous coronary intervation
- multi-vessel coronary artery bypass graft surgery
- and meet at least one of the following criteria:
- aged 65 years or older, or
- aged younger than 65 years with documented atherosclerosis or revascularization involving at least two vascular beds (coronary and other vascular) or at least two additional risk factors (current smoker, diabetes mellitus, estimated glomerular filtration rate less than 60mL/min, heart failure, non-lacunar ischemic stroke 1 month or more ago).
Patients with PAD are defined as having one or more of the following:
- previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries
- previous limb or foot amputation for arterial vascular disease
- history of intermittent claudication and one or more of the following:
- an anklebrachial index less than 0.90, or
- significant peripheral artery stenosis (greater than or equal to 50%) documented by angiography or by duplex ultrasound
- previous carotid revascularization or asymptomatic carotid artery stenosis greater than or equal to 50%, as diagnosed by duplex ultrasound or angiography.
Exclusion Criteria
The Drug Product should not be reimbursed for patients who have CAD or PAD alone or in patients with any one of the following characteristics:
- at high risk of bleeding
- a history of stroke within one month of treatment initiation or any history of hemorrhagic or lacunar stroke
- severe heart failure with a known ejection fraction less than 30% or New York Heart Association class III or IV symptoms
- an estimated glomerular filtration rate less than 15mL/min require dual antiplatelet therapy, other non-ASA antiplatelet therapy, or oral anticoagulant therapy.
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