PLAVIX in Treatment Guidelines

ACC/AHA UA/NSTEMI Guidelines


Guidelines supporting discharge therapy in unstable angina (UA)/non-ST segment elevation MI (NSTEMI)
Patient Type Guidelines Evidence Basis* Recommendation
UA/NSTEMI: treated medically without receiving a stent after PCI ACC/AHA§ 2007 Guidelines for the Management of Patients with UA/NSTEMI ‡
Class IA Clopidogrel once daily for at least 1 month
Class IB Clopidogrel ideally up to 1 year
Class IA Aspirin indefinitely
UA/NSTEMI: receiving PCI with bare-metal stent  
Class IA Clopidogrel daily for at least 1 month (unless patient is at increased risk for bleeding, then it should be given for a minimum of 2 weeks)
Class IB Clopidogrel ideally up to 1 year
Class IA Aspirin for at least 1 month and then indefinitely
Post-CABG patients   Class IC Medical treatment post-CABG should follow the same recommendations for non-post-CABG patients
Acute Care
UA/NSTEMI: treated medically without stent 		  Class IA Clopidogrel added to aspirin as soon as possible after admission
Class IA Clopidogrel for at least 1 month added to aspirin
Class IB Clopidogrel ideally up to 1 year added to aspirin

In patients taking clopidogrel bisulfate in whom elective coronary artery bypass graft (CABG) is planned, the drug should be withheld for 5 to 7 days prior to surgery. For aspirin-allergic or clopidogrel-allergic patients, please refer to full text guidelines.9

*Please see the definitions for classifications and Levels of Evidence below.

§ACC/AHA=American College of Cardiology/American Heart Association.

‡These do not represent the complete ACC/AHA 2007 guideline recommendations. Please visit http://www.acc.org to access the complete recommendations.


ACC/AHA UA/NSTEMI Classification of Recommendations and Levels of Evidence9*
Class Level of Evidence
Class I Procedure/treatment SHOULD be performed/administered.
Class IA Recommendation that procedure/treatment is useful/effective and there is sufficient evidence from multiple randomized trials or meta-analyses.
Class IB Recommendation that procedure/treatment is useful/effective and there is limited evidence from single randomized trial or nonrandomized studies.
Class IC Recommendation that procedure/treatment is useful/effective and evidence is only expert opinion, case studies, or standard of care.
Level A Multiple (3-5) population risk strata evaluated (general consistency of direction and magnitude of effect).
Level B Limited (2-3) population risk strata evaluated.
Level C Very limited (1-2) population risk strata evaluated.

*These do not represent the complete guideline definitions. Please refer to the full text of each guideline for all classifications and Levels of Evidence.

WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS

The effectiveness of PLAVIX is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 (See WARNINGS and PRECAUTIONS: Drug Interactions.*). PLAVIX at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with PLAVIX at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy (See Clinical Pharmacology.*). Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers (See Dosage and Administration.*).

Important Safety Information

CONTRAINDICATIONS

PLAVIX is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

PLAVIX is contraindicated in patients with hypersensitivity (eg, anaphylaxis) to clopidogrel or any component of the product. (See Adverse Reactions.*)

WARNINGS AND PRECAUTIONS

Avoid concomitant use of PLAVIX and drugs that inhibit CYP2C19 activity. Co-administration of PLAVIX with omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of PLAVIX if given concomitantly or if given 12 hours apart. (See Drug Interactions.*)

Thienopyridines, including PLAVIX, increase the risk of bleeding. If a patient is to undergo surgery and an antiplatelet effect is not desired, discontinue PLAVIX 5 days prior to surgery.

Avoid lapses in therapy, and if PLAVIX must be temporarily discontinued, restart as soon as possible. Premature discontinuation of PLAVIX may increase the risk of cardiovascular events.

In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the combination of aspirin and PLAVIX has not been shown to be more effective than PLAVIX alone, but the combination has been shown to increase major bleeding.

TTP, sometimes fatal, has been reported following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange).

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.

DRUG INTERACTIONS

Co-administering warfarin with PLAVIX increases the risk of bleeding.

Co-administration of PLAVIX and NSAIDs increases the risk of gastrointestinal bleeding.

USE IN SPECIFIC POPULATIONS

Nursing mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother.

*Please See the Full PLAVIX Prescribing Information, Including BOXED WARNING

Indications

Acute coronary syndrome (ACS)

For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, PLAVIX has been shown to decrease the rate of a combined end point of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia.

For patients with ST-elevation myocardial infarction (STEMI), PLAVIX has been shown to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.

The optimal duration of PLAVIX therapy in ACS is unknown.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown 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.