Guideline:
Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents
Bibliographic Source(s)
- Grines CL Bonow RO Casey DE Jr Gardner TJ Lockhart PB Moliterno DJ O'Gara P Whitlow P American Heart Association American College of Cardiology Society for Cardiovascular Angiography and Interventions American College of Surgeons American Dental Association American College of Physicians. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association American College of Cardiology Society for Cardiovascular Angiography [trunc]. Circulation 2007 Feb 13;115(6):813-8. [36 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Counseling
Management
Prevention
Intended Users
Dentists
Health Care Providers
Patients
Physicians
Guideline Objective(s)
To emphasize the potential complications of premature discontinuation of thienopyridine therapy and to address potential strategies to minimize this occurrence
Target Population
Patients who have received coronary artery stents within the past year
Interventions and Practices Considered
- Continuation of dual antiplatelet therapy (aspirin thienopyridines) for 12 months after placement of drug-eluting stents
- Education of patients and healthcare providers about hazards of premature discontinuation of antiplatelet therapy
- Deference of elective procedures with significant risk of bleedings
- Continuation of aspirin if thienopyridine therapy is discontinued
Major Outcomes Considered
- Rates of stent thrombosis myocardial infarction (MI) and death
- Ratio of death to nonfatal MI
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Not stated
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
The cost of clopidogrel (approximately $4 daily) has been cited as one reason patients discontinue (or do not renew) their therapy. It is unclear whether the introduction of modestly lower-cost generic clopidogrel will significantly affect this issue.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on December 21 2006 by the American College of Cardiology on December 28 2006 by the Society for Cardiovascular Angiography and Interventions on December 20 2006 by the American College of Surgeons on December 16 2006 and by the American Dental Association on December 17 2006.
Major Recommendations
Thienopyridine therapy in combination with aspirin has become the mainstay antiplatelet treatment strategy for the prevention of stent thrombosis. Premature discontinuation of antiplatelet therapy markedly increases the risk of stent thrombosis a catastrophic event that frequently leads to myocardial infarction (MI) and/or death. Factors contributing to premature cessation of thienopyridine therapy include drug cost physician/dentist instructions to patients to discontinue therapy before procedures and inadequate patient education and understanding about the importance of continuing therapy.
To eliminate premature discontinuation of thienopyridine therapy the advisory group gives the following recommendations:
- Before implantation of a stent the physician should discuss the need for dual antiplatelet therapy. In patients not expected to comply with 12 months of thienopyridine therapy whether for economic or other reasons strong consideration should be given to avoiding a drug-eluting stent (DES).
- In patients who are undergoing preparation for percutaneous coronary intervention and are likely to require invasive or surgical procedures within the next 12 months consideration should be given to implantation of a bare-metal stent or performance of balloon angioplasty with provisional stent implantation instead of the routine use of a DES.
- A greater effort by healthcare professionals must be made before patient discharge to ensure patients are properly and thoroughly educated about the reasons they are prescribed thienopyridines and the significant risks associated with prematurely discontinuing such therapy.
- Patients should be specifically instructed before hospital discharge to contact their treating cardiologist before stopping any antiplatelet therapy even if instructed to stop such therapy by another healthcare provider.
- Healthcare providers who perform invasive or surgical procedures and are concerned about periprocedural and postprocedural bleeding must be made aware of the potentially catastrophic risks of premature discontinuation of thienopyridine therapy. Such professionals who perform these procedures should contact the patient's cardiologist if issues regarding the patient's antiplatelet therapy are unclear to discuss optimal patient management strategy.
- Elective procedures for which there is significant risk of perioperative or postoperative bleeding should be deferred until patients have completed an appropriate course of thienopyridine therapy (12 months after DES implantation if they are not at high risk of bleeding and a minimum of 1 month for bare-metal stent implantation).
- For patients treated with DES who are to undergo subsequent procedures that mandate discontinuation of thienopyridine therapy aspirin should be continued if at all possible and the thienopyridine restarted as soon as possible after the procedure because of concerns about late-stent thrombosis.
- The healthcare industry insurers the US Congress and the pharmaceutical industry should ensure that issues such as drug cost do not cause patients to prematurely discontinue thienopyridine therapy and to thus incur catastrophic cardiovascular complications.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is not specifically stated for each recommendation.
Potential Benefits
Prevention of stent thrombosis and associated myocardial infarction and death
Potential Harms
- Dual antiplatelet therapy is not without risk. Like all antithrombotic agents both aspirin and clopidogrel increase the risk of bleeding compared with placebo. When compared with aspirin clopidogrel may be associated with lower risk of gastrointestinal bleeding. However when clopidogrel was combined with aspirin and administered for prolonged duration (up to 28 months) randomized trials demonstrated an absolute increase (ranging from 0.4% to 1.0%) in major bleeding compared with aspirin alone.
- The likelihood of increased bleeding and/or an increased requirement for blood transfusion in patients undergoing major noncardiac surgery can be inferred from reports of increased bleeding when cardiac surgery (including off-pump coronary bypass grafting) is undertaken in patients taking a thienopyridine drug. Independent documentation of the scope of this risk of increased bleeding during noncardiac surgery however is not available.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety
Timeliness
Bibliographic Source(s)
- Grines CL Bonow RO Casey DE Jr Gardner TJ Lockhart PB Moliterno DJ O'Gara P Whitlow P American Heart Association American College of Cardiology Society for Cardiovascular Angiography and Interventions American College of Surgeons American Dental Association American College of Physicians. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association American College of Cardiology Society for Cardiovascular Angiography [trunc]. Circulation 2007 Feb 13;115(6):813-8. [36 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Heart Association
Guideline Committee
American Heart Association
American College of Cardiology
Society for Cardiovascular Angiography and Interventions
American College of Surgeons
American Dental Association
(with representation from) American College of Physicians
Composition of Group that Authored the Guideline
Writing Committee Members: Cindy L. Grines MD FACC; Robert O. Bonow MD FAHA FACC; Donald E. Casey Jr MD MPH MBA FACP; Timothy J. Gardner MD FAHA FACC FACS; Peter B. Lockhart DDS FDS RCSEd; David J. Moliterno MD FAHA FSCAI FACC; Patrick O'Gara MD FAHA FACC; Patrick Whitlow MD FAHA FACC
Financial Disclosures/Conflicts of Interest
The American Heart Association the American College of Cardiology the Society for Cardiovascular Angiography and Interventions the American College of Surgeons and the American Dental Association make 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.
Writing Group Disclosures
| Writing Group Member | Organization Represented | Employment | Research Grant | Other Research Support | Speakers' Bureau/ Honoraria | Ownership Interest | Consultant/ Advisory Board | Other |
|---|---|---|---|---|---|---|---|---|
| Cindy L. Grines | AHA Representative | William Beaumont Hospital | None | None | None | None | None | None |
| Robert O. Bonow | AHA Representative | Northwestern University | None | None | None | None | None | None |
| Donald E. Casey Jr | ACP Representative | Atlantic Health | None | None | None | None | None | None |
| Timothy J. Gardner | ACS Representative | Christiana Care Health System | None | None | None | None | None | None |
| Peter B. Lockhart | ADA Representative | Carolinas Medical Center | None | None | None | None | None | None |
| David J. Moliterno | SCAI Representative | University of Kentucky | None | None | None | None | None | None |
| Patrick O'Gara | ACC Representative | Brigham and Women's Hospital | None | None | None | None | None | None |
| Patrick Whitlow | ACC Representative | Cleveland Clinic | None | None | None | None | ICON Interventional; Systems* Medlogics* | None |
AHA indicates American Heart Association; ACP American College of Physicians; ACS American College of Surgeons; ADA American Dental Association; SCAI Society for Cardiovascular Angiography and Interventions; and ACC American College of Cardiology.
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. A relationship is considered to be "significant" if (1) the person receives $10 000 or more during any 12-month period or 5% or more of the person's gross income; or (2) the person owns 5% or more of the voting stock or share of the entity or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be "modest" if it is less than "significant" under the preceding definition.
*Modest
Reviewer Disclosures
| Reviewer | Employment | Research Grant | Other Research Support | Speakers' Bureau/ Honoraria | Expert Witness | Ownership Interest | Consultant/ Advisory Board | Other |
|---|---|---|---|---|---|---|---|---|
| Elliott M. Antman | Brigham and Women's Hospital | Eli Lilly* | None | None | None | None | None | None |
| Gregory J. Dehmer | Texas A&M University College of Medicine and Scott & White Clinic | None | None | None | None | None | None | None |
| T. Bruce Ferguson | East Carolina University | None | None | None | None | None | None | None |
| Raymond J. Gibbons | Mayo Clinic | Radiant Medical** KAI Pharmaceuticals** TargeGen** TherOx** | None | None | None | None | Hawaii Biotech* TIMI 37A* | None |
| Arthur H. Jeske | University of Texas Health Science Center Houston | None | None | None | None | None | None | None |
| Vincenza Snow | American College of Physicians | None | None | None | None | None | None | None |
This table represents the relationships of 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. A relationship is considered to be "significant" if (1) the person receives $10 000 or more during any 12-month period or 5% or more of the person's gross income; or (2) the person owns 5% or more of the voting stock or share of the entity or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be "modest" if it is less than "significant" under the preceding definition.
*Modest
**Significant
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Heart Association Web site.
Print copies: Available from the American Heart Association Public Information 7272 Greenville Ave Dallas TX 75231-4596; Phone: 800-242-8721
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This summary was completed by ECRI Institute on January 9 2008. The information was verified by the guideline developer on February 12 2008.
COPYRIGHT STATEMENT
Copyright to the original guideline is owned by the American Heart Association Inc. (AHA). Reproduction of the AHA Guideline without permission is prohibited. Single reprint is available by calling 800-242-8721 (US only) or writing the American Heart Association Public Information 7272 Greenville Ave. Dallas TX 75231-4596. Ask for reprint No. 71-0276. To purchase additional reprints: up to 999 copies call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies call 410-528-4121 fax 410-528-4264 or email kgray@lww.com. To make photocopies for personal or educational use call the Copyright Clearance Center 978-750-8400.
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