Oral antiplatelet therapy after drug-eluting stent implantation: Adherence and side-effects

Journal of Cardiovascular Medicine

Volumn 14, Issue 2, 2013, Pages 81-90

  Rossini, Roberta ^a   Baroni, Matteo ^b   Musumeci, Giuseppe ^a   Gavazzi, Antonello ^a  

^a OSPEDALI RIUNITI   (Italy)

^b OSPEDALE NIGUARDA CA GRANDA   (Italy)

Author keywords

adherence; antiplatelet therapy; bleeding; drug eluting stent; prognosis

Indexed keywords

CLOPIDOGREL; LANSOPRAZOLE; OMEPRAZOLE; PRASUGREL; TICAGRELOR;

ANTICOAGULANT THERAPY; BLOOD CLOT LYSIS; CARDIOVASCULAR MORTALITY; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DRUG ANTAGONISM; DRUG EFFECT; DRUG EFFICACY; DRUG ELUTING STENT; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; HUMAN; INCIDENCE; ISCHEMIA; MEDICAL DECISION MAKING; META ANALYSIS (TOPIC); MOTIVATION; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT COMPLIANCE; PRACTICE GUIDELINE; PREMATURE ANTIPLATELET THERAPY DISCONTINUATION; PROGNOSIS; REVASCULARIZATION; REVIEW; STENT THROMBOSIS; TREATMENT DURATION; TREATMENT REFUSAL; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, ORAL; CORONARY RESTENOSIS; CORONARY THROMBOSIS; DRUG-ELUTING STENTS; HUMANS; INCIDENCE; MEDICATION ADHERENCE; PLATELET AGGREGATION INHIBITORS; POSTOPERATIVE CARE; POSTOPERATIVE HEMORRHAGE; PROGNOSIS;

EID: 84873090707     PISSN: 15582027     EISSN: 15582035     Source Type: Journal    
DOI: 10.2459/JCM.0b013e328356a545     Document Type: Review

References (82)

1. Schomig A, Neumann FJ, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronaryartery stents. N Engl J Med 1996; 334:1084-1089.
2. Moussa I, Di Mario C, Reimers B, Akiyama T, Tobis J, Colombo A. Subacute stent thrombosis in the era of intravascular ultrasound-guided coronary stenting without anticoagulation: frequency, predictors and clinical outcome. J Am Coll Cardiol 1997; 29:6-12.
3. Grines CL, Bonow RO, Casey DE Jr, et al., 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 and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians. Circulation 2007; 115:813-818.
4. Cutlip DE, Baim DS, Ho KK, et al. Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials. Circulation 2001; 103:1967-1971.
5. Spertus JA, Kettelkamp R, Vance C, et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation 2006; 113:2803-2809.
6. Pfisterer M, Brunner-LaRocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents. J Am Coll Cardiol 2006; 48:2584-2591.
7. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007; 297:159-168.
8. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation 2009; 119:3028-3035.
9. Delamater AM. Improving patient adherence. Clin Diabetes 2006; 24:71-77.
10. Heidenreich PA. Patient adherence: the next frontier in quality improvement. Am J Med 2004; 117:130-132.
11. Cuisset T, Frere C, Quilici J, et al. Aspirin noncompliance is the major cause of aspirin resistance in patients undergoing coronary stenting. Am Heart J 2009; 157:889-893.
12. Mehta SR, Yusuf S, Peters RJ, et al., Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358:527-533.
13. Wiviott SD, Braunwald E, McCabe CH, et al., TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357:2001-2015.
14. Wallentin L, Becker RC, Budaj A, et al., for PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361:1045-1057.
15. Baroletti S, Dell'Orfano H. Medication adherence in cardiovascular disease. Circulation 2010; 121:1455-1458.
16. Rossini R, Capodanno D, Lettieri C, et al. Prevalence, predictors, and longterm prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. Am J Cardiol 2011; 107:186-194.
17. Ferreira-González I, Marsal JR, Ribera A, et al. Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation. Circulation 2010; 122:1017-1025.
18. Savonitto S, Caracciolo M, Cattaneo M, De Servi S. Management of patients with recently implanted coronary stents on dual antiplatelet therapy who need to undergo major surgery. J Thromb Haemost 2011; 9:2133-2142.
19. Eagle KA, Berger PB, Calkins H, et al. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery: executive summary a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee to update the 1996 guidelines on perioperative cardiovascular evaluation for noncardiac surgery). Circulation 2002; 105:1257-1267.
20. Kaluza GL, Joseph J, Lee JR, Raizner ME, Raizner AE. Catastrophic outcomes of noncardiac surgery soon after coronary stenting. J Am Coll Cardiol 2000; 35:1288-1294.
21. Vicenzi MN, Meislitzer T, Heitzinger B, Halaj M, Fleisher LA, Metzler H. Coronary artery stenting and noncardiac surgery: a prospective outcome study. Br J Anaesth 2006; 96:686-693.
22. Wilson SH, Fasseas P, Orford J, et al. Clinical outcome of patients undergoing noncardiac surgery in the two months following coronary stenting. J Am Coll Cardiol 2003; 42:234-240.
23. Sharma AK, Ajani AE, Hamwi SM, et al. Major noncardiac surgery following coronary stenting: when is it safe to operate? Catheter Cardiovasc Interv 2004; 63:141-145.
24. Reddy PR, Vaitkus PT. Risks of noncardiac surgery after coronary stenting. Am J Cardiol 2005; 95:755-757.
25. Leibowitz D, Cohen M, Planer D, et al. Comparison of cardiovascular risk of noncardiac surgery following coronary angioplasty with versus without stenting. Am J Cardiol 2006; 97:1188-1191.
26. Compton PA, Zankar AA, Adesanya AO, Banerjee S, Brilakis ES. Risk of noncardiac surgery after coronary drug-eluting stent implantation. Am J Cardiol 2006; 98:1212-1213.
27. Schouten O, van Domburg RT, Bax JJ, et al. Noncardiac surgery after coronary stenting: early surgery and interruption of antiplatelet therapy are associated with an increase in major adverse cardiac events. J Am Coll Cardiol 2007; 49:122-124.
28. Chassot PG, Delabays A, Spahn DR. Perioperative antiplatelet therapy: the case for continuing therapy in patients at risk of myocardial infarction. Br J Anaesth 2007; 99:316-328.
29. Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention: cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation -review and meta-analysis. J Intern Med 2005; 257:399-414.
30. Cardiac Society of Australia and New Zealand. Guidelines for the management of antiplatelet therapy in patients with coronary stents undergoing noncardiac surgery. Heart Lung Circ 2010; 19:2-10.
31. Brilakis ES, Banerjee S, Berger PB. Perioperative management of patients with coronary stents. J Am Coll Cardiol 2007; 49:2145-2150.
32. Riddell JW, Chiche L, Plaud B, Hamon M. Coronary stents and noncardiac surgery. Circulation 2007; 116:e378-e382.
33. Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 2002 guidelines on perioperative cardiovascular evaluation for noncardiac surgery). J Am Coll Cardiol 2007; 50:e159-e241.
34. Eagle KA, Guyton RA, Davidoff R, et al. ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee to update the 1999 guidelines for coronary artery bypass graft surgery). Circulation 2004; 110:1168-1176.
35. Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Noncardiac Surgery, European Society of Cardiology (ESC). Guidelines for preoperative cardiac risk assessment and peri-operative cardiac management in noncardiac surgery. Eur Heart J 2009; 30:2769-2812.
36. Douketis JD, Berger PB, Dunn AS, et al. The perioperative management of antithrombotic therapy. American College of Chest Physicians evidencebased clinical practice guidelines (8th edition). Chest 2008; 133:299-339.
37. Samama CM, Bastien O, Forestier F, et al., French Society of Anesthesiology, Intensive Care. Antiplatelet agents in the perioperative period: export recommendations of the French Society of Anesthesiology and Intensive Care (SFAR) 2001 -summary statement. Can J Anaesth 2002; 49:S26-35.
38. Collet JP, Montalescot G. Premature withdrawal and alternative therapies to dual oral antiplatelet therapy. Eur Heart J Suppl 2006; 8:G46-G52.
39. Korte W, Cattaneo M, Chassot PG, et al. Peri-operative management of antiplatelet therapy in patients with coronary artery disease. Joint position paper by members of the working group on perioperative haemostasis of the Society on Thrombosis and Haemostasis Research (GTH), the working group on Perioperative Coagulation of the Austrian Society for Anesthesiology, Resuscitation and Intensive Care (ÖGARI) and the Working Group Thrombosis of the European Society for Cardiology (ESC). Thromb Haemost 2011; 105:743-749.
40. Bollati M, Giraudi E, Moretti C, et al. Dual oral antiplatelet therapy and unplanned surgery: possible role for intravenous platelet glycoprotein receptor inhibitors. J Cardiovasc Med (Hagerstown) 2011; 12:673-674.
41. Rossini R, Bramucci E, Castiglioni B, et al. Coronary stenting and surgery: perioperative management of the antiplatelet therapy in patients undergoing surgery after coronary stent implantation.GItal Cardiol (Rome) 2012; 13:528-551.
42. Haas S. Rivaroxaban: an oral, direct factor Xa inhibitor -lessons from a broad clinical study program. Eur J Haematol 2009; 82:339-349.
43. Tsai TT, Ho PM, Xu S, et al. Increased risk of bleeding in patients on clopidogrel therapy after drug-eluting stents implantation: insights from the HMO Research Network-Stent Registry (HMORN-stent). Circ Cardiovasc Interv 2010; 3:230-235.
44. Latib A, Morici N, Cosgrave J, et al. Incidence of bleeding and compliance on prolonged dual antiplatelet therapy (aspirin + thienopyridine) following drug-eluting stent implantation. Am J Cardiol 2008; 102:1477-1481.
45. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011; 123:2736-2747.
46. Ndrepepa G, Schuster T, Hadamitzky M, et al. Validation of the bleeding academic research consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention. Circulation 2012; 125:1424-1431.
47. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114:774-882.
48. Feit F, Voeltz MD, Attubato MJ, et al. Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 trial. Am J Cardiol 2007; 100:1364-1369.
49. Manoukian SV, Feit F, Mehran R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol 2007; 49:1362-1368.
50. Alexander KP, Chen AY, Roe MT, et al., CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-STsegment elevation acute coronary syndromes. JAMA 2005; 294:3108-3116.
51. Ko DT, Yun L, Wijeysundera HC, et al. Incidence, predictors, and prognostic implications of hospitalization for late bleeding after percutaneous coronary intervention for patients older than 65 years. Circ Cardiovasc Interv 2010; 3:140-147.
52. Musumeci G, Rossini R, Lettieri C, et al. Prognostic implications of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation. Catheter Cardiovasc Interv 2011. doi: 10.1002/ccd.23337. [Epub ahead of print]
53. Moscucci M, Fox KA, Cannon CP, et al. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J 2003; 24:1815-1823.
54. Mehran R, Pocock SJ, Stone GW, et al. Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute coronary syndromes: a risk model from the ACUITY trial. Eur Heart J 2009; 30:1457-1466.
55. Mehran R, Pocock SJ, Nikolsky E, et al. A risk score to predict bleeding in patients with acute coronary syndromes. J Am Coll Cardiol 2010; 55:2556-2566.
56. Valgimigli M, Campo G, Monti M, et al. Short versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation 2012; 125:2015-2026.
57. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357:2001-2015.
58. Park S-J, Park D-W, Kim Y-H, et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med 2010; 362:1374-1382.
59. Kandzari DE, Angiolillo DJ, Price MJ, Teirstein PS. Identifying the 'optimal' duration of dual antiplatelet therapy after drug-eluting stent revascularization. J Am Coll Cardiol Cardiovasc Interv 2009; 2:1279-1285.
60. Prasugrel (LY640315 CS-747) as an antithrombotic therapy in patients with acute coronary syndromes (ACS). NDA 22 NDA 22-307, EFFIENTTM (prasugrel). Presentation to the Cardiovascular and Renal Drugs Advisory Committee, 3 February 2009. Washington DC/Silver Spring, Maryland.
61. Husted S, Emanuelsson H, Heptinstall S, Sandset PM, Wickens M, Peters G. Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin. Eur Heart J 2006; 27:1038-1047.
62. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm263964.htm [Accessed 7 July 2012].
63. Held C, Asenblad N, Bassand JP, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes undergoing coronary artery bypass surgery: results from the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol 2011; 57:672-684.
64. Gilard M, Arnaud B, Le Gal G, Abgrall JF, Boschat J. Influence of omeprazol on the antiplatelet action of clopidogrel associated to aspirin. J Thromb Haemost 2006; 4:2508-2509.
65. Gilard M, Arnaud B, Cornily JC, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole Clopidogrel Aspirin) study. J Am Coll Cardiol 2008; 51:256-260.
66. Ho PM, Maddox TM, Wing L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009; 301:937-944.
67. Juurlink DN, Gomes T, Ko DT, et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. Can Med Assoc J 2009; 180:713-718.
68. Ortolani P, Marino M, Marzocchi A, et al. One-year clinical outcome in patients with acute coronary syndrome treated with concomitant use of clopidogrel and proton pump inhibitors: results from a regional cohort study. J Cardiovasc Med (Hagerstown) 2011 [Epub ahead of print].
69. O'Donoghue ML, Braunwalk E, Antman EM, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a protonpump inhibitor: an analysis of two randomised trials. Lancet 2009; 374:989-997.
70. Li XQ, Andersson TB, Ahlstrom M, Weidolf L. Comparison of inhibitory effects of the proton pump-inhibiting drugs omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on human cytochrome P450 activities. Drug Metab Dispos 2004; 32:821-827.
71. Sibbing D, Morath T, Stegherr J, et al. Impact of proton pump inhibitors on the antiplatelet effects of clopidogrel. Thromb Haemost 2009; 101:714-719.
72. Cuisset T, Frere C, Quilici J, et al. Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose the PACA (Proton Pump Inhibitors And Clopidogrel Association) prospective randomized study. J Am Coll Cardiol 2009; 54:1149-1153.
73. Bhatt DL, Cryer B, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010; 363:1909-1917.
74. Rossini R, Capodanno D, Musumeci G, et al. Safety of clopidogrel and proton pump inhibitors in patients undergoing drug-eluting stent implantation. Coron Artery Dis 2011; 22:199-205.
75. Rassen J, Choudhry N, Avorn J, Schneeweiss S. Proton pump inhibitors after percutaneous coronary intervention or acute cardiovascular outcomes and mortality in patients using clopidogrel with acute coronary syndrome. Circulation 2009; 120:2322-2329.
76. Stockl K, Le L, Zakharyan A, et al. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. Arch Intern Med 2010; 170:704-710.
77. Siller-Matula JM, Jilma B, Schrör K, Christ G, Huber K. Effect of proton pump inhibitors on clinical outcome in patients treated with clopidogrel: a systematic review and meta-analysis. J Thromb Haemost 2010; 8:2624-2641.
78. Kwok C, Loke Y. Meta-analysis: the effects of proton pump inhibitors on cardiovascular events and mortality in patients receiving clopidogrel. Aliment Pharmacol Ther 2010; 31:810-823.
79. Goodman SG, Clare R, Pieper KS, et al.; Platelet Inhibition and Patient Outcomes Trial Investigators. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation 2012; 125:978-986.
80. Mahaffey KW, Wojdyla DM, Carroll K, et al., PLATO Investigators. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation 2011; 124:544-554.
81. Petrilla AA, Benner JS, Battleman DS, Tierce JC, Hazard EH. Evidencebased interventions to improve compliance with antihypertensive and lipidlowering medications. Int J Clin Pract 2005; 59:1441-1451.
82. Fanikos J, Stevens LA, Labreche M, et al. Adherence to pharmacological thromboprophylaxis orders in hospitalized patients. Am J Med 2010; 123:536-541.