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Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents

Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents.

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Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents

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  1. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents 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 and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians Cindy L. Grines; Robert O. Bonow; Donald E. Casey, Jr.; Timothy J. Gardner; Peter B. Lockhart; David J. Moliterno; Patrick O’Gara; and Patrick Whitlow Published in Circulation January 15, 2007

  2. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Background • The combination of thienopyridine and aspirin therapy have been shown to dramatically reduce the incidence of early major adverse cardiac events after bare metal stent (BMS) placement compared with aspirin (ASA) alone or in combination with warfarin. • It is known that thienopyridine therapy plus ASA for up to 1 year after non-ST-segment elevation ACS decreases the incidence of ischemic cardiovascular events. Grines CL, et al. Circulation. 2007 Jan:1-6.

  3. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Background • Thienopyridine treatment in combination with ASA therapy is recommended by the ACC/AHA practice guidelines for the treatment of patients undergoing PCI and for the medical treatment of patients with non-ST segment elevation ACS. • The leading adverse event associated with early antiplatelet discontinuation is stent thrombosis, and the majority of these events lead to acute MI or death. Grines CL, et al. Circulation. 2007 Jan:1-6.

  4. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Background • The AHA working with the ACC, the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Physicians, the American College of Surgeons, and the American Dental Association, commissioned this advisory to emphasize the potential complications of premature discontinuation of thienopyridine therapy and to address potential strategies to minimize this occurrence. Grines CL, et al. Circulation. 2007 Jan:1-6.

  5. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Background After BMS Placement, ASA Plus Thienopyridine Reduces Cardiac Events Compared with ASA Alone or with Oral Antithrombins MACE indicates major adverse cardiovascular events; Pts, patients; ASA, aspirin; ISAR, Intracoronary Stenting and Antithrombotic Regimen trial; FANTASTIC, Full ANTicoagulation versus Aspirin TIClopidine after stent implantation; STARS, STent Anticoagulation Regimen Study; and MATTIS, Multicenter Aspirin and Ticlopidine Trial after Intracoronary Stenting. *Cardiac death, acute MI, or repeat TVR at 30 days (except for the FANTASTIC study). †Death, MI, or stent occlusion at 6 weeks. Adapted from ten Berg et al. Grines CL, et al. Circulation. 2007 Jan:1-6.

  6. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Current Recommendations • The current ACC/AHA/SCAI recommendations for the prevention of stent thrombosis after coronary stent implantation state: • At the minimum, patients should be treated with 75 mg clopidogrel and ASA 325mg for 1 month after BMS implantation, 3 months after sirolimus DES implantation, 6 months after paclitaxel DES implantation, and ideally, up to 12 months if they are not at a high-risk for bleeding. Grines CL, et al. Circulation. 2007 Jan:1-6.

  7. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Current Recommendations (cont.) • The current recommendations were based on the antiplatelet regimen used in trials that were conducted to obtain U.S. Food and Drug Administration approval (low-risk lesions in low-risk patients) and the anticipated time it takes for the metal stent struts to become adequately endothelialized to reduce the risk of stent thrombosis. Grines CL, et al. Circulation. 2007 Jan:1-6.

  8. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need For New Recommendations • However, DESs are now being used in high-risk lesions, and reports have suggested that they may be associated with delayed (or absent) endothelialization, localized hypersensitivity reactions, and late stent thrombosis. Grines CL, et al. Circulation. 2007 Jan:1-6.

  9. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Stent Thrombosis • Stent thrombosis most commonly occurs in the first month after stent implantation and referred to as “subacute stent thrombosis” • Many cases of “late-stent thrombosis”, occurring months or years after stent implantation, have been reported – especially in patients treated with DES • Stent thrombosis often results in life-threatening complications Grines CL, et al. Circulation. 2007 Jan:1-6.

  10. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Stent Thrombosis (cont.) • The incidence of death or MI associated with angiographically documented stent thrombosis was 64.4% in a pooled analysis of 6 trials and registries from the 1990s. • Mortality rates due to presumed or documented stent thrombosis range from 20% to 45%. Grines CL, et al. Circulation. 2007 Jan:1-6.

  11. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Stent Thrombosis in DES • The average reported occurrence of subacute stent thrombosis is 1% and the timing of thrombosis seems to be delayed in DES. • Late stent thrombosis was not readily apparent in BMS but was reported to occur in 0.19% of patients in a large DES registry. Grines CL, et al. Circulation. 2007 Jan:1-6.

  12. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations Predictors of DES Thrombosis: Considerations for Prolonged Dual Antiplatelet Therapy Reference/Presentation Location

  13. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: FDA Advisory Panel Meeting • A panel convened by the FDA concluded that there appears to be an excess of late stent thrombosis with DES; however, the magnitude is uncertain and the off-label use of DES, as with BMS, is associated with increased risk when compared with on-label use. Grines CL, et al. Circulation. 2007 Jan:1-6.

  14. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: FDA Advisory Panel Meeting (cont.) • In the future, DES studies should have: • Longer follow-up • Greater number of patients enrolled • Stent thrombosis as study endpoint • Concurred with joint clinical practice guideline recommendation: 12 months of antiplatelet therapy after placement of DES in patients who are not at high risk for bleeding. Grines CL, et al. Circulation. 2007 Jan:1-6.

  15. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: FDA Advisory Panel Meeting (cont.) • The panel also agreed that a large randomized clinical trial looking specifically at appropriate duration of dual antiplatelet therapy is needed. Grines CL, et al. Circulation. 2007 Jan:1-6.

  16. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Premature Thienopyridine Discontinuation and Stent Thrombosis • The leading independent predictor for stent thrombosis in multivariate analyses is premature discontinuation of thienopyridine therapy • In a large observational cohort study of patients treated with DES, stent thrombosis occurred in 29% of patients in whom antiplatelet therapy was discontinued prematurely. Grines CL, et al. Circulation. 2007 Jan:1-6.

  17. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Stent Thrombosis After Noncardiac Surgery • Several reports have described incidents of stent thrombosis that occurred after the discontinuation of antiplatelet therapy for noncardiac surgery among patients recently treated with coronary stents. • Kaluza et al reported on 40 patients treated with BMS who underwent noncardiac surgery within 6 weeks of stent implantation. Seven patients had an MI, of which 6 were fatal. Grines CL, et al. Circulation. 2007 Jan:1-6.

  18. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Stent Thrombosis After Noncardiac Surgery • Stent thrombosis was presumed to be the cause of all MIs and in 5 of the 7 cases thienopyridine therapy was withheld before surgery. • In a similar analysis of 47 patients who underwent noncardiac surgery within 90 days of BMS implantation, 6 of the 7 patients in whom thienopyridine therapy was discontinued died, likely due to stent thrombosis. Grines CL, et al. Circulation. 2007 Jan:1-6.

  19. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Factors Related to Premature Cessation of Thienopyridine Therapy • Premature discontinuation of antiplatelet therapy may occur for many reasons: • Cost of clopidogrel may discourage prescription renewal (~$4 daily) • Older age • Not referred for cardiac rehabilitation • Did not finish high school • Not seeking health care due to cost • Not receiving discharge instructions for medication use • Greater likelihood of having preexistent CV disease or anemia • Not being married Grines CL, et al. Circulation. 2007 Jan:1-6.

  20. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Factors Related to Premature Cessation of Thienopyridine Therapy (cont.) • Antiplatelet therapy may be stopped at the instruction of physicians, dentists, and other healthcare providers who are to perform an invasive or surgical procedure on the patient because of misguided concerns about excessive procedure-related bleeding. • Many of these procedures (e.g., minor surgery, teeth cleaning, and tooth extraction) can likely be performed at no or only minor risk of bleeding or could be delayed until the prescribed antiplatelet regimen is completed. Grines CL, et al. Circulation. 2007 Jan:1-6.

  21. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Factors Related to Premature Cessation of Thienopyridine Therapy (cont.) • Although there is a long standing concern on the part of dental practitioners about the possibility of prolonged bleeding during and after invasive dental procedures on patients receiving antiplatelet therapy, a recent prospective study of single tooth extractions on patients randomized to ASA versus a placebo failed to show a statistically significant difference in postoperative bleeding. Grines CL, et al. Circulation. 2007 Jan:1-6.

  22. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Summary • 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 MI and/or death. • Premature cessation of thienopyridine therapy should be eliminated. Reference/Presentation Location

  23. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Advisory Group’s Recommendations • Physicians should discuss thienopyridine therapy with patients before stent implantation. In patients not expected to comply with 12 months of treatment, strong consideration should be given to avoiding DES. • In patients preparing for PCI and likely to require invasive or surgical procedures within 12 months, consideration should be given to BMS or balloon angioplasty instead of DES. Reference/Presentation Location

  24. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Advisory Group’s Recommendations • Before patient discharge, more effort towards the education of patients about thienopyridines and associated risks should be made by healthcare professionals. • Before patient discharge, patients should be specifically instructed to contact their treating cardiologist before stopping any antiplatelet therapy. Reference/Presentation Location

  25. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Advisory Group’s Recommendations • Healthcare providers who perform invasive or surgical procedures with risk of peri- and post-procedural bleeding must be made aware of the dangers of premature therapy discontinuation. These providers should contact the patient’s cardiologist if issues are unclear. • Elective procedures for which there is significant risk of peri- or post-operative bleeding should be deferred until patients have completed an appropriate course of thienopyridine therapy. Reference/Presentation Location

  26. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Advisory Group’s Recommendations • For DES patients who are to undergo subsequent procedures that require discontinuation of thienopyridine therapy, aspirin should be continued if at all possible and thienopyridine restarted as soon as possible. • The healthcare and pharmaceutical industries, insurers, and the US congress should ensure that drug cost doesn’t cause patients to discontinue antiplatelet therapy too soon, thus incurring severe cardiovascular complications. Grines CL, et al. Circulation. 2007 Jan:1-6.

  27. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Disclosures Writing Group Disclosures Grines CL, et al. Circulation. 2007 Jan:1-6.

  28. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Disclosures Writing Group Disclosures Grines CL, et al. Circulation. 2007 Jan:1-6.

  29. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Disclosures Reviewer Disclosures Grines CL, et al. Circulation. 2007 Jan:1-6.

  30. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents: Need for New Recommendations: Disclosures • 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 this definition. Grines CL, et al. Circulation. 2007 Jan:1-6.

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