Antiplatelet therapy to support PCI

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Aysha Anwar, M.B.B.S[2]

Overview

2011 AHA guidelines recommend the use of antiplatelet therapy aspirin (Level of Evidence: B) and P2Y12 receptor inhibitor (clopidogrel, prasugrel and ticagrelor) (Level of Evidence: A) to support PCI in patients with ACS. Few randomised trials have been conducted showing comparison of clopidogrel with aspirin and other P2Y12 inhibitors (prasugrel and ticagrelor) in terms of clinical benefit and risk of bleeding when given in patients undergoing PCI.[1][2][3][4][5] However, there is limited data comparing new P2Y12 receptor inhibitors (prasugrel and ticagrelor) for downstream and upstream therapy in patients undergoing PCI with non ST elevation MI in terms of clinical benefit and adverse effects. Hence, a new large scale randomised open label trial called DUBIUS is in process in Italy comparing two new P2Y12 inhibitors prasugrel and ticagrelor for pretreatment in patients with non ST elevation MI undergoing PCI.

Antiplatelet Therapy to Support PCI

2011 AHA guidelines recommend the use of antiplatelet therapy aspirin (Level of Evidence: B) and P2Y12 receptor inhibitor (clopidogrel, prasugrel and ticagrelor) (Level of Evidence: A) to support PCI in patients with ACS. Few randomised trials have been conducted showing comparison of clopidogrel with aspirin and other P2Y12 inhibitors (prasugrel and ticagrelor) in terms of clinical benefit and risk of bleeding when given in patients undergoing PCI.[1][2][3][4][5] However, there is limited data comparing new P2Y12 receptor inhibitors (prasugrel and ticagrelor) for downstream and upstream therapy in patients undergoing PCI with non ST elevation MI in terms of clinical benefit and adverse effects. Hence, a new large scale randomised open label trial called DUBIUS is in process in Italy comparing two new P2Y12 inhibitors prasugrel and ticagrelor for pretreatment in patients with non ST elevation MI undergoing PCI. It is a trial designed for superiority comparing downstream therapy over upstream therapy in terms of NACE ( net adverse cardic effect) and risk of major bleeding(BARC 3, 4 and 5). Another endpoint considered in the trial is non inferiority comparison between prasugrel and ticagrelor in terms of potency of the drug for clinical benefit and NACE.

2011 ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention (DO NOT EDIT)[6]

Oral Antiplatelet Therapy (DO NOT EDIT)[6]

Class I
"1. Patients already taking daily aspirin therapy should take 81 mg to 325 mg before PCI.[7][8][9] (Level of Evidence: B)"
"2. Patients not on aspirin therapy should be given non-enteric aspirin 325 mg before PCI.[7][9] (Level of Evidence: B)"
"3. After PCI, use of aspirin should be continued indefinitely.[10][11][12][13] (Level of Evidence: A)"
"4. A loading dose of a P2Y12 receptor inhibitor should be given to patients undergoing PCI with stenting.[1][2][3][4][5] (Level of Evidence: A) Options include:
a. Clopidogrel 600 mg (ACS and non-ACS patients).[1][2][3](Level of Evidence: B)
b. Prasugrel 60 mg (ACS patients).[4] (Level of Evidence: B)
c. Ticagrelor 180 mg (ACS patients).[5] (Level of Evidence: B)"
"5. The loading dose of clopidogrel for patients undergoing PCI after fibrinolytic therapy should be 300 mg within 24 hours and 600 mg more than 24 hours after receiving fibrinolytic therapy.[2][14] (Level of Evidence: C)"
"6. Patients should be counseled on the need for and risks of dual antiplatelet therapy (DAPT) before placement of intra-coronary stents, especially drug eluting stents (DES), and alternative therapies should be pursued if patients are unwilling or unable to comply with the recommended duration of dual antiplatelet therapy.[15] (Level of Evidence: C)"
"7. The duration of P2Y12 receptor inhibitor therapy after stent implantation should generally be as follows:
a. In patients receiving a stent (bare metal stent (BMS) or drug eluting stent (DES)) during PCI for ACS, P2Y12 receptor inhibitor therapy should be given for at least 12 months. Options include clopidogrel 75 mg daily [16],prasugrel 10 mg daily [4], and ticagrelor 90 mg twice daily.[5] (Level of Evidence: B)
b. In patients receiving drug eluting stent (DES) for a non-ACS indication, clopidogrel 75 mg daily should be given for at least 12 months if patients are not at high risk of bleeding.[15][17][18] (Level of Evidence: B)
c. In patients receiving bare metal stent (BMS) for a non-ACS indication, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks).[15][19] (Level of Evidence: B)"
Class III (Harm)
"1. Prasugrel should not be administered to patients with a prior history of stroke or transient ischemic attack.[4] (Level of Evidence: B)"
Class IIa
"1. After PCI, it is reasonable to use aspirin 81 mg per day in preference to higher maintenance doses.[8][20][21][22][23] (Level of Evidence: B)"
"2. If the risk of morbidity from bleeding outweighs the anticipated benefit afforded by a recommended duration of P2Y12 receptor inhibitor therapy after stent implantation, earlier discontinuation (e.g.,less than 12 months) of P2Y12 receptor inhibitor therapy is reasonable. (Level of Evidence: C)"
Class IIb
"1. Continuation of dual antiplatelet therapy (DAPT) beyond 12 months may be considered in patients undergoing drug eluting stent (DES) implantation.[4][5] (Level of Evidence: C)"

Dual Antiplatelet Therapy Compliance and Stent Thrombosis (DO NOT EDIT) [6]

Class III (Harm)

"1. PCI with coronary stenting (BMS or DES) should not be performed if the patient is not likely to be able to tolerate and comply with dual antiplatelet therapy (DAPT) for the appropriate duration of treatment based on the type of stent implanted. [15][24][25][26](Level of Evidence: B)"

References

  1. ↑ 1.0 1.1 1.2 1.3 Gurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US (2005). "Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study". Circulation. 111 (9): 1153–9. doi:10.1161/01.CIR.0000157138.02645.11. PMID 15738352. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  2. ↑ 2.0 2.1 2.2 2.3 2.4 Sabatine MS, Cannon CP, Gibson CM, López-Sendón JL, Montalescot G, Theroux P, Lewis BS, Murphy SA, McCabe CH, Braunwald E (2005). "Effect of clopidogrel pretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics: the PCI-CLARITY study". JAMA : the Journal of the American Medical Association. 294 (10): 1224–32. doi:10.1001/jama.294.10.1224. PMID 16143698. Unknown parameter |month= ignored (help); |access-date= requires |url= (help)
  3. ↑ 3.0 3.1 3.2 3.3 van der Heijden DJ, Westendorp IC, Riezebos RK, Kiemeneij F, Slagboom T, van der Wieken LR, Laarman GJ (2004). "Lack of efficacy of clopidogrel pre-treatment in the prevention of myocardial damage after elective stent implantation". Journal of the American College of Cardiology. 44 (1): 20–4. doi:10.1016/j.jacc.2004.02.056. PMID 15234399. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  4. ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM (2007). "Prasugrel versus clopidogrel in patients with acute coronary syndromes". The New England Journal of Medicine. 357 (20): 2001–15. doi:10.1056/NEJMoa0706482. PMID 17982182. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  5. ↑ 5.0 5.1 5.2 5.3 5.4 5.5 Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Freij A, Thorsén M (2009). "Ticagrelor versus clopidogrel in patients with acute coronary syndromes". The New England Journal of Medicine. 361 (11): 1045–57. doi:10.1056/NEJMoa0904327. PMID 19717846. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  6. ↑ 6.0 6.1 6.2 Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH (2011). "2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: Executive Summary A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions" (PDF). Journal of the American College of Cardiology. 58 (24): 2550–83. doi:10.1016/j.jacc.2011.08.006. PMID 22070837. Retrieved 2011-12-08. Text "PDF" ignored (help); Unknown parameter |month= ignored (help)
  7. ↑ 7.0 7.1 Barnathan ES, Schwartz JS, Taylor L, Laskey WK, Kleaveland JP, Kussmaul WG, Hirshfeld JW (1987). "Aspirin and dipyridamole in the prevention of acute coronary thrombosis complicating coronary angioplasty". Circulation. 76 (1): 125–34. PMID 2954724. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  8. ↑ 8.0 8.1 Jolly SS, Pogue J, Haladyn K, Peters RJ, Fox KA, Avezum A, Gersh BJ, Rupprecht HJ, Yusuf S, Mehta SR (2009). "Effects of aspirin dose on ischaemic events and bleeding after percutaneous coronary intervention: insights from the PCI-CURE study". European Heart Journal. 30 (8): 900–7. doi:10.1093/eurheartj/ehn417. PMID 18819961. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  9. ↑ 9.0 9.1 Popma JJ, Berger P, Ohman EM, Harrington RA, Grines C, Weitz JI (2004). "Antithrombotic therapy during percutaneous coronary intervention: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy". Chest. 126 (3 Suppl): 576S–599S. doi:10.1378/chest.126.3_suppl.576S. PMID 15383485. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  10. ↑ Schömig A, Neumann FJ, Kastrati A, Schühlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K (1996). "A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents". The New England Journal of Medicine. 334 (17): 1084–9. doi:10.1056/NEJM199604253341702. PMID 8598866. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  11. ↑ "Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients". BMJ (Clinical Research Ed.). 324 (7329): 71–86. 2002. PMC 64503. PMID 11786451. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  12. ↑ Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A (2009). "Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials". Lancet. 373 (9678): 1849–60. doi:10.1016/S0140-6736(09)60503-1. PMC 2715005. PMID 19482214. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  13. ↑ Smith SC, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pasternak RC, Pearson T, Pfeffer MA, Taubert KA (2006). "AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute". Circulation. 113 (19): 2363–72. doi:10.1161/CIRCULATIONAHA.106.174516. PMID 16702489. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  14. ↑ Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS (2005). "Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial". Lancet. 366 (9497): 1607–21. doi:10.1016/S0140-6736(05)67660-X. PMID 16271642. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  15. ↑ 15.0 15.1 15.2 15.3 Grines CL, Bonow RO, Casey DE, Gardner TJ, Lockhart PB, Moliterno DJ, O'Gara P, Whitlow P (2007). "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". Journal of the American College of Cardiology. 49 (6): 734–9. doi:10.1016/j.jacc.2007.01.003. PMID 17291948. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  16. ↑ Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA (2001). "Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study". Lancet. 358 (9281): 527–33. PMID 11520521. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  17. ↑ Brar SS, Kim J, Brar SK, Zadegan R, Ree M, Liu IL, Mansukhani P, Aharonian V, Hyett R, Shen AY (2008). "Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions". Journal of the American College of Cardiology. 51 (23): 2220–7. doi:10.1016/j.jacc.2008.01.063. PMID 18534267. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  18. ↑ Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM (2007). "Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation". JAMA : the Journal of the American Medical Association. 297 (2): 159–68. doi:10.1001/jama.297.2.joc60179. PMID 17148711. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  19. ↑ Steinhubl SR, Berger PB, Mann JT, Fry ET, DeLago A, Wilmer C, Topol EJ (2002). "Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial". JAMA : the Journal of the American Medical Association. 288 (19): 2411–20. PMID 12435254. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  20. ↑ Patrono C, Baigent C, Hirsh J, Roth G (2008). "Antiplatelet drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)". Chest. 133 (6 Suppl): 199S–233S. doi:10.1378/chest.08-0672. PMID 18574266. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  21. ↑ Steinhubl SR, Bhatt DL, Brennan DM, Montalescot G, Hankey GJ, Eikelboom JW, Berger PB, Topol EJ (2009). "Aspirin to prevent cardiovascular disease: the association of aspirin dose and clopidogrel with thrombosis and bleeding". Annals of Internal Medicine. 150 (6): 379–86. PMID 19293071. Unknown parameter |month= ignored (help); |access-date= requires |url= (help)
  22. ↑ Serebruany VL, Steinhubl SR, Berger PB, Malinin AI, Baggish JS, Bhatt DL, Topol EJ (2005). "Analysis of risk of bleeding complications after different doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials". The American Journal of Cardiology. 95 (10): 1218–22. doi:10.1016/j.amjcard.2005.01.049. PMID 15877994. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  23. ↑ Peters RJ, Mehta SR, Fox KA, Zhao F, Lewis BS, Kopecky SL, Diaz R, Commerford PJ, Valentin V, Yusuf S (2003). "Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes: observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study". Circulation. 108 (14): 1682–7. doi:10.1161/01.CIR.0000091201.39590.CB. PMID 14504182. Retrieved 2011-12-13. Unknown parameter |month= ignored (help)
  24. ↑ Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE (1998). "A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators". The New England Journal of Medicine. 339 (23): 1665–71. doi:10.1056/NEJM199812033392303. PMID 9834303. Retrieved 2011-12-06. Unknown parameter |month= ignored (help)
  25. ↑ Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE (2007). "Stent thrombosis in randomized clinical trials of drug-eluting stents". The New England Journal of Medicine. 356 (10): 1020–9. doi:10.1056/NEJMoa067731. PMID 17296821. Retrieved 2011-12-06. Unknown parameter |month= ignored (help)
  26. ↑ McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW (2004). "Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy". Lancet. 364 (9444): 1519–21. doi:10.1016/S0140-6736(04)17275-9. PMID 15500897. Retrieved 2011-12-06.

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