Department of Error (DOI:10.1016/S0140-6736(08)60922-8);Appropriate use of drug-eluting stents: balancing the reduction in restenosis with the concern of late thrombosis

The Lancet

Volumn 371, Issue 9630, 2008, Pages 2134-2143

  Bavry, Anthony A ^a   Bhatt, Deepak L ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ADENOSINE DIPHOSPHATE; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; EPTIFIBATIDE; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; PACLITAXEL; RAPAMYCIN; TIROFIBAN;

ANTICOAGULANT THERAPY; BLEEDING; CATHETERIZATION; DATA ANALYSIS; DRUG ELUTING STENT; DRUG WITHDRAWAL; ELECTIVE SURGERY; FOLLOW UP; HUMAN; INTERMETHOD COMPARISON; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; MORTALITY; PACLITAXEL ELUTING STENT; PATIENT ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; RESTENOSIS; REVASCULARIZATION; REVIEW; RISK REDUCTION; SAFETY; SIROLIMUS ELUTING STENT; SYSTEMATIC REVIEW; THROMBOSIS; TREATMENT PLANNING;

EID: 45249091884     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(08)61234-9     Document Type: Erratum

References (94)

1. Kandzari D., Roe M., Ohman E., et al. Frequency, predictors, and outcomes of drug-eluting stent utilization in patients with high-risk non-ST-segment elevation acute coronary syndromes. Am J Cardiol 96 (2005) 750-755
2. Babapulle M., Joseph L., Bélisle P., Brophy J., and Eisenberg M. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 364 (2004) 583-591
3. Bavry A., Kumbhani D., Helton T., Borek P., Mood G., and Bhatt D. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med 119 (2006) 1056-1061
4. US Food and Drug Administration. Update to FDA statement on coronary drug-eluting stents. http://www.fda.gov/cdrh/news/010407.html (accessed June 6, 2008).
5. Bavry A., Kumbhani D., Helton T., and Bhatt D. 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 45 (2005) 941-946
6. Bavry A., Kumbhani D., Helton T., and Bhatt D. Risk of thrombosis with the use of sirolimus-eluting stents for percutaneous coronary intervention (from registry and clinical trial data). Am J Cardiol 95 (2005) 1469-1472
7. Moreno R., Fernandez C., Hernandez R., et al. Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies. J Am Coll Cardiol 45 (2005) 954-959
8. Katritsis D., Karvouni E., and Ioannidis J. Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol 95 (2005) 640-643
9. Shafiq N., Malhotra S., Pandhi P., Grover A., and Uboweja A. A meta-analysis of clinical trials of paclitaxel- and sirolimus-eluting stents in patients with obstructive coronary artery disease. Br J Clin Pharmacol 59 (2005) 94-101
10. Pasceri V., Patti G., Speciale G., Pristipino C., Richichi G., and Di Sciascio G. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. Am Heart J 153 (2007) 749-754
11. Kereiakes D., Wang H., Popma J., et al. Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials. J Am Coll Cardiol 48 (2006) 21-31
12. Kittleson M., Needham D., Kim S., Ravindran B., Solomon S., and Guallar E. The efficacy of sirolimus- and paclitaxel-eluting stents: a meta-analysis of randomized controlled trials. Can J Cardiol 21 (2005) 581-587
13. Indolfi C., Pavia M., and Angelillo I. Drug-eluting stents versus bare metal stents in percutaneous coronary interventions (a meta-analysis). Am J Cardiol 95 (2005) 1146-1152
14. Roiron C., Sanchez P., Bouzamondo A., Lechat P., and Montalescot G. Drug eluting stents: an updated meta-analysis of randomised controlled trials. Heart 92 (2006) 641-649
15. Lord S., Howard K., Allen F., et al. A systematic review and economic analysis of drug-eluting coronary stents available in Australia. Med J Aust 183 (2005) 464-471
16. Stettler C., Allemann S., Egger M., Windecker S., Meir M., and Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart 92 (2006) 650-657
17. Sidhu S., Shafiq N., Malhotra S., Pandhi P., and Grover A. A meta-analysis of trials comparing Cypher and Taxus stents in patients with obstructive coronary artery disease. Br J Clin Pharmacol 61 (2006) 720-726
18. Kastrati A., Dibra A., Eberle S., et al. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA 294 (2005) 819-825
19. Biondi-Zoccai G., Lotrionte M., Abbate A., et al. Direct and indirect comparison meta-analysis demonstrates the superiority of sirolimus- versus paclitaxel-eluting stents across 5854 patients. Int J Cardiol 114 (2007) 104-105
20. Kandzari D., and Leon M. Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent. J Interv Cardiol 19 (2006) 405-413
21. Biondi-Zoccai G., Agostoni P., Abbate A., et al. Adjusted indirect comparison of intracoronary drug-eluting stents: evidence from a metaanalysis of randomized bare-metal-stent-controlled trials. Int J Cardiol 100 (2005) 119-123
22. Dibra A., Kastrati A., Alfonso F., et al. Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol 49 (2007) 616-623
23. Lasala J., Stone G., Dawkins K., et al. An overview of the TAXUS Express, paclitaxel-eluting stent clinical trial program. J Interv Cardiol 19 (2006) 422-431
24. Stettler C., Wandel S., Allemann S., et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370 (2007) 937-948
25. Stone G., Moses J., Ellis S., et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 356 (2007) 998-1008
26. Kastrati A., Mehilli J., Pache J., et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356 (2007) 1030-1039
27. Mauri L., Hsieh W., Massaro J., Ho K., D'Agostino R., and Cutlip D. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 356 (2007) 1020-1029
28. Spaulding C., Daemen J., Boersma E., Cutlip D., and Serruys P. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356 (2007) 989-997
29. Holmes Jr. D., Moses J., Schofer J., Morice M., Schampaert E., and Leon M. Cause of death with bare metal and sirolimus-eluting stents. Eur Heart J 27 (2006) 2815-2822
30. Ellis S., Colombo A., Grube E., et al. Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent. J Am Coll Cardiol 49 (2007) 1043-1051
31. Schampaert E., Moses J., Schofer J., et al. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularzations and stent thromboses. Am J Cardiol 98 (2006) 36-41
32. Nordmann A., Briel M., and Bucher H. Mortality in randomized controlled trials comparing drug-eluting vs bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 27 (2006) 2784-2814
33. Chen M., John J., Chew D., Lee D., Ellis S., and Bhatt D. Bare metal stent restenosis is not a benign clinical entity. Am Heart J 151 (2006) 1260-1264
34. Stone G., Ellis S., Colombo A., et al. Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 115 (2007) 2842-2847
35. Bavry A., and Bhatt D. Drug-eluting stents: dual anti-platelet therapy for every survivor?. Circulation 116 (2007) 696-699
36. Boden W., O'Rouke R., Teo K., et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 356 (2007) 1503-1516
37. Hochman J., Lamas G., Buller C., et al. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med 355 (2006) 2395-2407
38. Iakovou I., Schmidt T., Bonizzoni E., et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293 (2005) 2126-2130
39. Park D., Park S., Park K., et al. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. Am J Cardiol 98 (2006) 352-356
40. Artang R., and Dieter R. Analysis of 36 reported cases of late thrombosis in drug-eluting stents placed in coronary arteries. Am J Cardiol 99 (2007) 1039-1043
41. Buonamici P., Marcucci R., Migliorini A., et al. Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis. J Am Coll Cardiol 49 (2007) 2312-2317
42. Spertus J., 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 113 (2006) 2803-2809
43. Bavry A., and Bhatt D. Acute myocardial infarction and drug eluting stents: a green light for their use or time for measured restraint?. Am Heart J 153 (2007) 719-721
44. Helton T., Bavry A., Kumbhani D., Duggal S., Roukoz H., and Bhatt D. Incremental effect of clopidogrel on important outcomes in patients with cardiovascular disease: a meta-analysis of randomized trials. Am J Cardiovasc Drugs 7 (2007) 289-297
45. Orford J., Fasseas P., Melby S., et al. Safety and efficacy of aspirin, clopidogrel, and warfarin after coronary stent placement in patients with an indication for anticoagulation. Am Heart J 147 (2004) 463-467
46. McFalls E., Ward H., Moritz T., et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med 351 (2004) 2795-2804
47. Poldermans D., Schouten O., Vidakovic R., et al. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V pilot study. J Am Coll Cardiol 49 (2007) 1763-1769
48. Berger P., Bell M., Hasdai D., Grill D., Melby S., and Holmes Jr. D. Safety and efficacy of ticlopidine for only 2 weeks after successful intracoronary stent placement. Circulation 99 (1999) 248-253
49. Kaluza G., Joseph J., Lee J., Raizner M., and Raizner A. Catastrophic outcomes of noncardiac surgery soon after coronary stenting. J Am Coll Cardiol 35 (2000) 1288-1294
50. Dacey L., Munoz J., Johnson E., et al. Effect of preoperative aspirin use on mortality in coronary artery bypass grafting patients. Ann Thorac Surg 70 (2000) 1986-1990
51. Bhatt D., and Topol E. Current role of platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes. JAMA 284 (2000) 1549-1558
52. Rabbat M., Bavry A., Bhatt D., and Ellis S. Understanding and minimizing late thrombosis of drug eluting stents. Clev Clinic J Med 74 (2007) 129-136
53. Nayak A., Kawamura A., Nesto R., et al. Myocardial infarction as a presentation of clinical in-stent restenosis. Circulation 70 (2006) 1026-1029
54. Assali A., Moustapha A., Sdringola S., et al. Acute coronary syndrome may occur with in-stent restenosis and is associated with adverse outcomes (the PRESTO trial). Am J Cardiol 98 (2006) 729-733
55. Schuhlen H., Kastrati A., Mehilli J., et al. Restenosis detected by routine angiographic follow-up and late mortality after coronary stent placement. Am Heart J 147 (2004) 317-322
56. Van Belle E., Ketelers R., Bauters C., et al. Patency of percutaneous transluminal coronary angioplasty sites at 6-month angiographic follow-up: a key determinant of survival in diabetics after coronary balloon angioplasty. Circulation 103 (2001) 1218-1224
57. Yang E., Gumina R., Lennon R., Holmes Jr. D., Rihal C., and Singh M. Emergency coronary artery bypass surgery for percutaneous coronary interventions: changes in the incidence, clinical characteristics, and indications from 1979 to 2003. J Am Coll Cardiol 46 (2005) 2004-2009
58. Hoffman S., TenBrook J., Wolf M., Pauker S., Salem D., and Wong J. A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: one- to eight-year outcomes. J Am Coll Cardiol 41 (2003) 1293-1304
59. Kastrati A., Schomig A., Elezi S., et al. Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 30 (1997) 1428-1436
60. Mathew V., Gersh B., Williams B., et al. Outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention in the current era: a report from the prevention of restenosis with tranilast and its outcomes (PRESTO) trial. Circulation 109 (2004) 476-480
61. BARI investigators. Influence of diabetes on 5-year mortality and morbidity in a randomized trial comparing CABG and PTCA in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 96 (1997) 1761-1769
62. Elezi S., Kastrati A., Pache J., et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 32 (1998) 1866-1873
63. Kastrati A., Mehilli J., Dirschinger J., et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation 103 (2001) 2816-2821
64. Briguori C., Sarais C., Pagnotta P., et al. In-stent restenosis in small coronary arteries: impact of strut thickness. J Am Coll Cardiol 40 (2002) 403-409
65. Pache J., Dibra A., Mehilli J., Dirschinger J., Schomig A., and Kastrati A. Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial. Eur Heart J 26 (2005) 1262-1268
66. Lee C., Suh J., Lee S., et al. Factors predictive of cardiac events and restenosis after sirolimus-eluting stent implantation in small coronary arteries. Catheter Cardiovasc Interv 69 (2007) 821-825
67. Tung R., Kaul S., Diamond G., and Shah P. Narrative review: drug-eluting stents for the management of restenosis-a critical appraisal of the evidence. Ann Intern Med 144 (2006) 913-919
68. Ellis S., Bajzer C., Bhatt D., et al. Real-world bare metal stenting: identification of patients at low or very low risk of 9-month coronary revascularization. Catheter Cardiovasc Interv 63 (2004) 135-140
69. Kandzari D., Tuttle R., Zidar J., and Jollis J. Temporal trends in target vessel revascularization in clinical practice: long-term outcomes following coronary stenting from the Duke Database for Cardiovascular Disease. J Invasive Cardiol 18 (2006) 398-402
70. Yock A., Isbill J., and King III S. Bare-metal stent outcomes in an unselected patient population. Clin Cardiol 29 (2006) 352-356
71. Bavry A., and Bhatt D. Bare metal stents: no longer passe?. J Invasive Cardiol 18 (2006) 403-404
72. Heller L., Shemwell K., and Hug K. Late stent thrombosis in the absence of prior intracoronary brachytherapy. Catheter Cardiovasc Interv 53 (2001) 23-28
73. Wang F., Stouffer G., Waxman S., and Uretsky B. Late coronary stent thrombosis: early vs. late stent thrombosis in the stent era. Catheter Cardiovasc Interv 55 (2002) 142-147
74. Joner M., Finn A., Farb A., et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48 (2006) 193-202
75. Virmani R., Guagliumi G., Farb A., et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious?. Circulation 109 (2004) 701-705
76. Togni M., Windecker S., Cocchia R., et al. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 46 (2005) 231-236
77. Pfisterer M., Brunner-La Rocca H., Buser P., et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 48 (2006) 2584-2591
78. Kuchulakanti P., Chu W., Torguson R., et al. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation 113 (2006) 1108-1113
79. Daemen J., Wenaweser P., Tsuchida K., et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 369 (2007) 667-678
80. Fujii K., Carlier S., Mintz G., et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 45 (2005) 995-998
81. Cook S., Wenaweser P., Togni M., et al. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation 115 (2007) 2426-2434
82. Bavry A., Chiu J., Jefferson B., et al. Development of coronary aneurysm after drug-eluting stent implantation. Ann Intern Med 6 (2007) 230-232
83. Mintz G., and Weissman N. Intravascular ultrasound in the drug-eluting stent era. J Am Coll Cardiol 48 (2006) 421-429
84. Airoldi F., Colombo A., Morici N., et al. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation 116 (2007) 745-754
85. Grines C., Bonow R., Casey D., et al. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents. J Am Coll Cardiol 49 (2007) 734-739
86. Steinhubl S., Berger P., Mann III J., et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 288 (2002) 2411-2420
87. Waksman R., Ajani A., Pinnow E., et al. Twelve versus six months of clopidogrel to reduce major cardiac events in patients undergoing gamma-radiation therapy for in-stent restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 versus WRIST PLUS. Circulation 106 (2002) 776-778
88. Waksman R., Ajani A., White R., et al. Prolonged antiplatelet therapy to prevent late thrombosis after intracoronary gamma-radiation in patients with in-stent restenosis: Washington Radiation for In-Stent Restenosis Trial plus 6 months of clopidogrel (WRIST PLUS). Circulation 103 (2001) 2332-2335
89. Eisenstein E., Anstrom K., Kong D., et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 297 (2007) 159-168
90. Lagerqvist B., James S., Stenestrand U., Lindback J., Nilsson T., and Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356 (2007) 1009-1019
91. Bhatt D., Flather M., Hacke W., et al. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol 49 (2007) 1982-1988
92. Beohar N., Davidson C., Kip K., et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 297 (2007) 1992-2000
93. Win H., Caldera A., Maresh K., et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA 297 (2007) 2001-2009
94. Dove J. President's page: drug-eluting stents in contemporary practice-a call for a real-world, open-entry, device-tracking registry. J Am Coll Cardiol 49 (2007) 2223-2226