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  
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.

Important Risk Information

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.*)

The metabolism of PLAVIX can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19 (eg,omeprazole), causing reduced effectiveness. Avoid use of PLAVIX in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity. (See WARNINGS and PRECAUTIONS: Drug Interactions.*)

As part of the worldwide postmarketing 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.*)

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.*)

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.*)

*Please See the Full PLAVIX Prescribing Information

PLAVIX Indications

PLAVIX® (clopidigrel bisulfate) is indicated for the reduction of atherothrombotic events as follows:

–
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.

–
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.

–
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.