Atherothrombosis

Myocardial infarction (MI), commonly known as a heart attack, occurs when the blood supply to part of the heart muscle is severely reduced or stopped because of blockage of one or more of the coronary arteries. Thrombosis is a major cause of MI. Occlusion of the artery due to a large atherosclerotic lesion or plaque rupture results in an MI. 9

Each year in the U.S., approximately 1.2 million people experience an MI; and as many as 500,000 of these are recurrent. 18 Within 6 years of having a first MI, a second infarction will occur in 18% of men and 35% of women, and 8% of men and 11% of women will suffer a stroke. 4

Of the deaths reported within one year after the first MI, approximately 25% occurred within the first 48 hours, and more than half occurred within the first month. 16

Almost half of men and women <65 who have a heart attack will die within 8 years. 16

Risk factors for coronary heart disease (CHD) or MI include: 6

  • Hypertension
  • Hypercholesterolemia
  • Diabetes mellitus
  • Obesity
  • Physical inactivity
  • Increasing age (more than 83 percent of people who die of coronary heart disease are 65 or older )
  • Gender (men are more likely to have an MI than women, and men have MIs earlier in life)
  • Heredity (the risk of MI is higher in people who have a parent who had an MI)
  • Cigarette smoking

The most common warning signs of an MI include: 3

  • Uncomfortable pressure, squeezing, fullness, or pain in the center of the chest that lasts for longer than a few minutes, or goes away and then comes back
  • Pain that travels to the shoulders, neck, or arms
  • Shortness of breath
  • Sweating, nausea, lightheadedness, or fainting
Indications
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Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

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Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

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Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Important Risk Information 18
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PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)

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The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo
plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)

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As part of the worldwide post–marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)

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In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)