This is the current release of the guideline.

Fatal and nonfatal ischemic complications in acute myocardial infarction and high-risk acute coronary syndromes (ACS)

Note: Acute coronary syndromes (ACS) are defined as unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI)

Evaluation
Management
Treatment

Cardiology
Family Practice
Internal Medicine
Surgery

Health Care Providers
Physicians

To review what is known and not known about percutaneous coronary intervention (PCI) in women and to put published data in context with contemporary coronary intervention

Women with acute myocardial infarction and high-risk acute coronary syndromes (ACS)

Note: Acute coronary syndrome (ACS) is defined as unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI)

Percutaneous Coronary Intervention (PCI)

Interventions

1. Stents (bare metal, drug-eluting)
2. Atherectomy
3. Distal protection during saphenous vein graft
4. Thrombectomy
5. Vascular brachytherapy
6. Balloon angioplasty

Pharmacotherapy

1. Antiplatelets
   • Aspirin
   • Thienopyridines (clopidogrel, ticlopidine)
2. Glycoproteins (GP) IIb/IIIa inhibitors
3. Antithrombin agents
   • Unfractionated heparin (UFH)
   • Low-molecular-weight heparin (LMWH)
   • Direct thrombin inhibitors

• Mortality, including in-hospital mortality
• Target vessel revascularization
• Incidence of major adverse cardiovascular events (MACE)
• Myocardial infarction
• Incidence of restenosis
• Incidence of ischemic and vascular complications (such as access-site hematomas, bleeding complications)

Searches of Electronic Databases

By searching MEDLINE from January 1988 through January 2005, the writing group identified 2,156 relevant publications. Of these publications, 142 were selected on the basis of the following criteria: sex-specific trials in interventional cardiology and pharmacotherapy, randomized clinical trials or large-scale registries of at least 250 consecutive patients, and review articles.

142

Expert Consensus

Not applicable

Systematic Review with Evidence Tables

Publications were reviewed and summarized by dedicated medical writers.

Expert Consensus

Publications were reviewed and summarized by dedicated medical writers (P.A.W., C.G.P.). The summary was used as the basis of a draft manuscript, which was written by the writing group chair. The manuscript was subsequently submitted for review to the entire writing group, and each member was assigned a specific section. Each section was reviewed by at least 2 group members, and the final document was fact-checked by the medical writers. The data presented are sex specific and consistent with relevant current American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Practice recommendations or trial results without supporting sex-specific data are specified. The writing group contacted the investigators of eligible studies that did not report findings separately by sex to obtain these data; these citations are marked with the symbol § in the original guideline document.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

The following tables summarize the findings for women drawn from the literature. See the original guideline document for detailed discussion of each intervention.

Table: Outcomes in Women by Device, Lesion Type, and Clinical Syndrome

*Optimal directional atherectomy indicates final residual stenosis <30% after intervention.

Note: This table summarizes the findings for women drawn from the literature review. It is not the intention of the writing group to provide formal treatment recommendations; rather this table should serve as a convenient point of reference. Refer to text in the original guideline document for discussion and citations.

Table: Pharmacotherapy in Women

This table summarizes the findings for women drawn from the literature review. It is not the intention of the writing group to provide formal treatment recommendations; rather, this table should serve as a convenient point of reference. Refer to text in the original guideline document for discussion and citations. When recommendations are provided, they are based on previously published American College of Cardiology/American Heart Association guidelines.

None provided

The type of evidence supporting the recommendations is not specifically stated.

Increased use of percutaneous coronary intervention and adjunctive pharmacotherapy may improve outcomes for women with high-risk acute coronary syndromes and ST-elevation myocardial infarction (STEMI).

• The adverse outcomes of women undergoing percutaneous coronary intervention (PCI), including the rates of short- and long-term mortality, nonfatal myocardial infarction (MI), and emergency coronary bypass surgery, have decreased significantly over time with contemporary interventional therapies. Nevertheless, women consistently tend to have worse clinical outcomes than those of men; most of these worse outcomes are explained by the higher risk profile of women.
• Although rarely used today, directional atherectomy is associated with lower procedural success and more bleeding complications in women than in men.
• Excimer laser angioplasty, rarely performed in the current percutaneous coronary intervention era, is associated with more coronary perforations in women, primarily attributed to women's smaller vessel sizes.
• Previous guidelines recommended that the thienopyridines (preferably clopidogrel) be substituted for aspirin only in aspirin-allergic patients (men or women) for secondary prevention. Given their comparable efficacy but increased rates of neutropenia, thrombotic thrombocytopenia, and aplastic anemia with ticlopidine, clopidogrel is used in most cases.
• Dual antiplatelet therapy is associated with increased bleeding risk as the dose of aspirin increases, and reducing the aspirin dose (75 to 100 mg/day) 1 month after percutaneous coronary intervention should be considered for patients who have not received a drug-eluting stent (DES).
• Clopidogrel administered before coronary artery bypass graft (CABG) has been associated with significant increase in perioperative bleeding, and should be discontinued 5 to 7 days before elective coronary artery bypass graft unless the urgency for revascularization outweighs the bleeding risk.

It is not the intention of the writing group to give specific treatment recommendations but rather to compile and collate the available sex-specific data on the safety and efficacy of interventional therapies in women.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness
Timeliness

Not applicable: The guideline was not adapted from another source.

2005 Feb 22

American Heart Association - Professional Association

American Heart Association

Not stated

Authors: Alexandra J. Lansky, MD, Chair; Judith S. Hochman, MD; Patricia A. Ward, MA; Gary S. Mintz, MD; Rosalind Fabunmi, PhD; Peter B. Berger, MD; Gishel New, MD; Cindy L. Grines, MD; Cody G. Pietras; Morton J. Kern, MD; Margaret Ferrell, MD; Martin B. Leon, MD; Roxana Mehran, MD; Christopher White, MD; Jennifer H. Mieres, MD; Jeffrey W. Moses, MD; Gregg W. Stone, MD; Alice K. Jacobs, MD

The American Heart Association (AHA) makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.

Table: Author Disclosures

This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all members of the writing group are required to complete and submit.

Table: Reviewer Disclosures

This table represents the relationships of peer reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit.

American College of Cardiology Foundation - Medical Specialty Society

This is the current release of the guideline.

None available

None available

This summary was completed by ECRI on May 18, 2005. This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on July 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Troponin-1 Immunoassay. This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection.