The safety and efficacy of aspirin and clopidogrel as a combination treatment in patients with coronary heart disease

Expert Opinion on Drug Safety

Volumn 5, Issue 6, 2006, Pages 815-826

  Coole, Glen E ^a   Goldschmidt Clermont, Pascal J ^b  

^a OHIO STATE UNIVERSITY   (United States)

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Aspirin; Atherothrombosis; Blood platelet; Clopidogrel; Coronary artery disease

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; HEPARIN; METAL; PACLITAXEL; PHENPROCOUMON; PLACEBO; RAPAMYCIN; TICLOPIDINE;

ATHEROSCLEROTIC PLAQUE; BLEEDING; BLEEDING TENDENCY; BLOOD VESSEL INJURY; BRAIN HEMORRHAGE; CLINICAL PRACTICE; CLINICAL TRIAL; CORONARY ARTERY ATHEROSCLEROSIS; CORONARY STENT; DIARRHEA; DRUG ACTIVITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELUTING STENT; DRUG ERUPTION; DRUG FATALITY; DRUG MECHANISM; DRUG POTENTIATION; DRUG SAFETY; DRUG USE; EQUIPMENT DESIGN; HEALTH CARE COST; HEART INFARCTION; HEART REINFARCTION; HUMAN; ISCHEMIC HEART DISEASE; LOW DRUG DOSE; META ANALYSIS; NEUTROPENIA; PATIENT CARE; PERCUTANEOUS CORONARY INTERVENTION; REVIEW; SYSTEMATIC REVIEW; THROMBOSIS; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS;

ASPIRIN; CORONARY DISEASE; DRUG THERAPY, COMBINATION; HUMANS; PLATELET AGGREGATION INHIBITORS; TICLOPIDINE;

EID: 33750555770     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.5.6.815     Document Type: Review

References (82)

1. AMERICAN HEART ASSOCIATION: Heart Disease and Stroke Statistics-2006 Update. American Heart Association, Dallas, Texas, USA (2006).
2. DUVALL WL, VORCHHEIMER DA: Multi-bed vascular disease and atherothrombosis: scope of the problem. J. Thromb. Thrombolysis (2004) 17(1):51-61.
3. FITZGERALD DJ, ROY L, CATELLA F, FITZGERALD GA: Platelet activation in unstable coronary disease. N. Engl. J. Med. (1986) 315(16):983-989.
4. FUSTER V, BADIMON L, BADIMON JJ et al.: The pathogenesis of coronary disease and the acute coronary syndromes. N. Engl. J. Med. (1992) 326(4):242-250.
5. LEWIS HD, DAVIS JW, ARCHIBALD DG et al.: Protective effects of aspirin against acute myocardial infarction and death in men with unstable angina. Results of a Veterans Administration Cooperative Study. N. Engl. J. Med. (1983) 309(7):396-403.
6. CAIRNS JA, GENT M, SINGER J et al.: Aspirin, sulfinpyrazone, or both in unstable angina. Results of a Canadian multicenter trial. N. Engl. J. Med. (1985) 313(22):1369-1375.
7. PETO R, GRAY R, COLLINS R et al.: Randomised trial of prophylactic daily aspirin in British male doctors. Br. Med. J. (Clin. Res. Ed.) (1988) 296(6618):313-316.
8. ISIS-2 (SECOND INTERNATIONAL STUDY OF INFARCT SURVIVAL) COLLABORATIVE GROUP: Randomised trial of intravenous streptokinase, aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet (1988) 2(8609):349-360.
9. THÉROUX P, OUIMET H, MCCANS J et al.: Aspirin, heparin, or both to treat acute unstable angina. N. Engl. J. Med. (1988) 319(17):1105-1111.
10. THE STEERING COMMITTEE OF THE PHYSICIANS' HEALTH STUDY RESEARCH GROUP: Final report on the aspirin component of the ongoing Physicians' Health Study. N. Engl. J. Med. (1989) 321(3):129-135.
11. HASS WK, EASTON JD, ADAMS HP et al.: A randomized trial comparing ticlopidine hydrochloride with aspirin for the prevention of stroke in high-risk patients. Ticlopidine Aspirin Stroke Study Group. N. Engl. J. Med. (1989) 321(8):501-507.
12. THE RISC GROUP (1990): Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease. Lancet (1990) 336(8719):827-830.
13. ANTIPLATELET TRIALISTS' COLLABORATION: Collaborative overview of randomised trials of antiplatelet treatment. Part 1: Prevention of vascular death, myocardial infarction, and stroke by prolonged antiplatelet therapy in different categories of patients. Br. Med. J. (1994) 308(6921):81-106.
14. CAPRIE STEERING COMMITTEE: A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischemic events (CAPRIE). Lancet (1996) 348(9038):1329-1339.
15. THE CLOPIDOGREL IN UNSTABLE ANGINA TO PREVENT RECURRENT EVENTS TRIAL INVESTIGATORS: Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without st-segment elevation. N. Engl. J. Med. (2001) 345(7):494-502.
16. ROTH GJ, MAJERUS PW: The mechanism of the effect of aspirin on human platelets. Acetylation of a particulate fraction protein. J. Clin. Invest. (1975) 56(3):624-632.
17. HERBERT JM, FREHEL D, VALLEE E et al.: Clopidogrel, a novel antiplatelet and antithrombotic agent. Cardiovasc. Drug Rev. (1993) 11:180-198.
18. QUINN MJ, FITZGERALD DJ: Ticlopidine and clopidogrel. Circulation (1999) 100(15):1662-1666.
19. BORN GV, COLLINS R: Aspirin versus clopidogrel: the wrong question? Lancet (1997) 349(9054):806-807.
20. HERBERT JM, BERNAT A, SAMAMA M, MAFFRAND JP: The antiaggregating and antithrombotic activity of ticlopidine is potentiated by aspirin in the rat. Thromb. Haemost. (1996) 76(1):94-98.
21. HERBERT JM, DOL F, BERNAT A, FALOTICO R, LALE A, SAVI P: The antiaggregating and antithrombotic activity of clopidogrel is potentiated by aspirin in several experimental models in the rabbit. Thromb. Haemost. (1998) 80(3):512-518.
22. HARKER LA, MARZEK LA, KELLY AB et al.: Clopidogrel inhibition of stent, graft and vascular thrombogenesis with antithrombotic enhancement by aspirin in nonhuman primates. Circulation (1998) 98(22):2461-2469.
23. MOSHFEGH K, REDONDO K, JULMY F et al.: Antiplatelet effects of clopidogrel compared with aspirin after myocardial infarction: enhanced inhibitory effects of combination therapy. J. Am. Coll. Cardiol. (2000) 36(3):699-705.
24. CADROY Y,BOSSAVY J-P, THALAMAS C, SAGNARD L, SAKARIASSEN K, BONEU B: Early potent antithrombotic effect with combined aspirin and a loading dose of clopidogrel on experimental arterial thrombogenesis in humans. Circulation (2000) 101(24):2823-2828.
25. GRAU AJ, REINERS S, LICHY C, BUGGLE F, RUF A: Platelet function under aspirin, clopidogrel, and both after ischemic stroke. A case-crossover study. Stroke (2003) 34(4):849-855.
26. SEREBRUANY VL, MALININ AI, JEROME SD et al.: Effects of clopidogrel and aspirin combination versus aspirin alone on platelet aggregation and major receptor expression in patients with heart failure: the Plavix use for treatment of congestive heart failure (PLUTO-CHF) trial. Am. Heart J. (2003) 146(4):713-720.
27. SEREBRUANY VL, MALININ AI, ZIAI W et al.: Effects of clopidogrel and aspirin in combination versus aspirin alone on platelet activation and major receptor expression in patients after recent ischemic stroke. For the Plavix use for treatment of stroke (PLUTO-Stroke) trial. Stroke (2005) 36(10):2289-2292.
28. COOKE GE, LIU-STRATTON Y, FERKETICH AK et al.: Effect of platelet antigen polymorphism on platelet inhibition by aspirin, clopidogrel, or their combination. J. Am. Coll. Cardiol. (2006) 47(3):541-546.
29. GRUNTZIG AR, SENNING A, SIEGENTHALER WE: Nonoperative dilation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N. Engl. J. Med. (1979) 301(2):61-68.
30. SIGWART U, PUEL J, MIRKOVITCH V, JOFFRE F, KAPPENBERGER L: Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N. Engl. J. Med. (1987) 316(12):701-706.
31. SERRUYS PW, DE JAEGERE P, KIEMENEIJ F et al.: Angiographic follow-up after placement of a self-expanding coronary-artery stent. N. Engl. J. Med. (1991) 321(1):13-17.
32. SCHATZ RA, BAIM DS, LEON M et al.: Clinical experience with the Palmaz-Schatz coronary stent: initial results of a multicenter study. Circulation (1991) 83(1):148-161.
33. SERRUYS PW, DE JAEGERE P, KIEMENEIJ F et al.: A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N. Engl. J. Med. (1994) 331(8):489-495.
34. FISCHMAN DL, LEON MB, BAIM DS et al.: A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N. Engl. J. Med. (1994) 331(8):496-501.
35. ERBEL R, HAUDE M, HÖPP HW et al.: Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. N. Engl. J. Med. (1998) 339(23):1672-1678.
36. SCHÖMIG A, KASTRETI A, MUDRA H et al.: Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure. Circulation (1994) 90(6):2716-2724.
37. SCHÖMIG A, NEUMANN F-J, KASTRETI A et al.: A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N. Engl. J. Med. (1996) 334(17):1084-1089.
38. HALL P, NAKAMURA S, MAIELLO L et al.: A randomized comparison of combined ticlopidine and aspirin therapy versus aspirin therapy alone after successful intravascular ultrasound-guided stent implantation. Circulation (1996) 93(2):215-222.
39. KARRILLON GI, MORICE MC, BENEVENISTE E et al.: Intracoronary stent implantation without ultrasound guidance and with replacement of conventional anticoagulation by antiplatelet therapy:30-day clinical outcome of the French Multicenter Registry. Circulation (1996) 94(7):1519-1527.
40. ALBIERO R, HALL P, ITOH A et al.: Results of a consecutive series of patients receiving only antiplatelet therapy after optimized stent implantation: comparison of aspirin alone versus combined ticlopidine and aspirin therapy. Circulation (1997) 95(5):1145-1156.
41. LEON MB, BAIM DS, POPMA JJ et al.: A clinical trial comparing three anti-thrombotic-drug regimens after coronary-artery stenting. N. Engl. J. Med. (1998) 339(23):1665-1671.
42. RUPPRECHT HJ, DARIUS H, BORKOWSKI U et al.: Comparison of antiplatelet effects of aspirin, ticlopidine, or their combination after stent implantation. Circulation (1998) 97(11):1046-1052.
43. BERTRAND ME, LEGRAND V, BOLAND J et al.: Randomized Multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting: the Full Anticoagulation Versus Aspirin and Ticlopidine (FANTASTIC) Study. Circulation (1998) 98(16):1597-1603.
44. URBAN P, MACAYA C, RUPPRECHT HJ et al.: Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the Multicenter Aspirin and Ticlopidine Trial after Intracoronary Stenting (MATTIS). Circulation (1998) 98(20):2126-2132.
45. BHATT DL, BERTRAND ME, BERGER PB et al.: Meta-analysis of randomized and registry comparisons of ticlopidine with clopidogrel after stenting. J. Am. Coll. Cardiol. (2002) 39(1):9-14.
46. 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(1):6-12.
47. CUTLIP DE, BAIM DS, HO KKL et al.: Stent thrombosis in the modern era. A pooled analysis of multicenter coronary stent clinical trials. Circulation (2001) 103(15):1967-1971.
48. CHENEAU E, LEBORGNE L, MINTZ GS et al.: Predictors of subacute stent thrombosis. Results of a systematic intravascular ultrasound study. Circulation (2003) 108(1):43-47.
49. BENNETT CL, CONNERS JM, CARWILE JM et al.: Thrombotic thrombocytopenic purpura associated with clopidogrel. N. Engl. J. Med. (2000) 342(24):1773-1777.
50. MOUSSA I, OETGEN M, ROUBIN G et al.: Effectiveness of clopidogrel and aspirin versus ticlopidine and aspirin in preventing stent thrombosis after coronary stent implantation. Circulation (1999) 99(18):2364-2366.
51. MÜLLER C, BÜTTNER HJ, PETERSEN J, ROSKAMM H: A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after the placement of coronary-artery stents. Circulation (2000) 101(6):590-593.
52. BERTRAND ME, RUPPRECHT H-J, URBAN P, GERSHLICK AH: Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting. Circulation (2000) 102(6):624-629.
53. GASPOZ J-M, COXSON PG, GOLDMAN PA et al.: Cost effectiveness of aspirin, clopidogrel, or both for secondary prevention of coronary heart disease. N. Engl. J. Med. (2002) 346(23):1800-1806.
54. STEINHUBL SR, BERGER PB, MANN JT et al.: Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention. JAMA (2002) 288(19):2411-2420.
55. HOFFMAN R, MINTZ GS, DUSSAILLANT GR et al.: Patterns and Mechanisms of in-stent restenosis. A serial intravascular ultrasound study. Circulation (1996) 94(6):1247-1254.
56. MORICE M-C, SERRUYS PW, SOUSA E et al.: A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. (2002) 346(23):1773-1780.
57. PARK S-J, SHIM WH, HO DS et al.: A paclitaxel-eluting stent for the prevention of coronary restenosis. N. Engl. J. Med. (2003) 348(16):1537-1545.
58. MOSES JW, LEON MB, POPMA JJ et al.: Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. (2003) 349(14):1315-1323.
59. SCHOFER J, SCHLÜTER M, GERSHLIBK AH et al.: Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet (2003) 362(9390):1093-1099.
60. GRUBE E, SILBER E, HAUPTMANN KE et al.: Six- and twelve-month results from a randomized, double-blind trial on a slow-released paclitaxel-eluting stent for de novo coronary lesions. Circulation (2003) 107(1):28-42.
61. COLOMBO A, DRZEWIECKI J, BANNING A et al.: Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents coronary artery lesions. Circulation (2003) 108(7):788-794.
62. SCHAMPAERT E, COHEN EA, SCHLÜTER M et al.: The canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J. Am. Coll. Cardiol. (2004) 43(6):1110-1115.
63. GERSHLICK A, DE SCHEERDER I, BHEVALIER B et al.: Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent. The European Evaluation of Paclitaxel Eluting Stent (ELUTES) trial. Circulation (2004) 109(4):487-493.
64. STONE GW, ELLIS SG, COX DA et al.: A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N. Engl. J. Med. (2004) 350(3):221-231.
65. ARDISSINO D, CAVALLINI C, BRAMUCCI E et al.: Sirolimus-eluting versus uncoated stents for prevention of restenosis in small coronary arteries. a randomized trial. JAMA (2004) 292(22):2727-2734.
66. STONE GW, ELLIS SG, CANNON L et al.: Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease. A randomized controlled trial. JAMA (2005) 294(10):1215-1223.
67. JEREMIAS A, SYLVIA B, BRIDGES J et al.: Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation (2004) 109(16):1930-1932.
68. MCFADDEN EP, STABILE E, REGAR E et al.: Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet (2004) 364(9444):1519-1521.
69. BAVRY AA, KUMBHANI DJ, HELTON TJ, BHATT DL: What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention? A meta-analysis. J. Am. Coll. Cardiol. (2005) 45(6):941-946.
70. IAKOVOU I, SCHMIDT T, BONIZZONI E et al.: Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA (2005) 293(17):2126-2130.
71. ONG ATL, MCFADDEN EP, REGAR E, DE JAEGERE PPT, VAN DOMBURG RT, SERRUYS PW: Late angiographic stent thrombosis (last) events with drug-eluting stents. J. Am. Coll. Cardiol. (2005) 45(12):2088-2092.
72. PFISTERER ME, KAISER CA, BADER F, BRUNNER-LA ROCCA HP, BONETTI PO, BUSER PT: Late clinical events related to late stent thrombosis after stopping clopidogrel: prospective randomized comparison between drug-eluting versus bare-metal stenting. Program and abstracts from the American College of Cardiology 55th Annual Scientific Session. 11 - 14 March, Atlanta, GA, USA (2006): Abstract 411-422.
73. BABAPULLE MN, JOSEPH L, BÉLISLE P, BROPHY JM, EISENBERG MJ: A hierarchical Bayesian met-analysis of randomized clinical trials of drug-eluting stents. Lancet (2004) 364(9434):581-583.
74. MEHTA SR, YUSUF S, PETERS RJG et al.: 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(9281):527-533.
75. STABLES RH: Clopidogrel in invasive management of non-ST-elevation ACS. Lancet (2001) 358(9281):520-521.
76. SABATINE MS, CANNNN CP, GIBSON CM et al.: Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with st-segment elevation. N. Engl. J. Med. (2005) 352(12):1178-1189.
77. COMMIT (CLOPIDOGREL AND METOPROLOL IN MYOCARDIAL INFARCTION TRIAL) COLLABORATIVE GROUP: Addition of clopidogrel to aspirin in 45852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet (2005) 366(9497):1607-1621.
78. BHATT DL, FOX KAA, HACKE W et al.: Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N. Engl. J. Med. (2006) 354(16):1706-1717.
79. STONE GW, ARONOW HD: Long-term care after percutaneous coronary intervention: focus on the role of antiplatelet therapy. Mayo Clin. Proc. (2006) 81(5):641-652.
80. GOLDSCHMIDT-CLERMONT PJ, COOKE GE, EATON GM, BINKLEY PF: PlA2, a variant of GPIIIa implicated in coronary thromboembolic complications. J. Am. Coll. Cardiol. (2000) 36(1):90-93.
81. KASTRATI A, MEHILLI J, SCHÜHLEN H et al.: A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N. Engl. J. Med. (2004) 350(3):232-238.
82. PATTI G, COLONNA G, PASCERI V, PEPE LL, MONTINARO A, DI SCIASCIO G: Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention. Results of the ARMYDA-2 (Antiplatelet therapy for Reduction of Myocardial Damage during Angioplasty) study. Circulation (2005) 111(16):2099-2106.