Abstract
Purpose
Methods
Results
Conclusions
Keywords
- •Stent thrombosis is a serious and often fatal event.
- •The association between drug-eluting stents and thrombosis remains controversial.
- •Compared with bare metal stents, drug-eluting stents appear to increase slightly the risk for late thrombosis.
Methods
Literature Review
Selection Criteria
Endpoints/Data Abstraction
Statistical Analysis
Results
Duration of Dual AntiPlatelet Therapy and Duration of Clinical Follow-Up
SIRIUS, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756655. Accessed November 15, 2005.
E-SIRIUS, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814895. Accessed November 15, 2005.
RAVEL, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=823586. Accessed November 15, 2005.
RAVEL, 4 year follow-up. Available at: http://www.tctmd.com/csportal/ShowBinary/BEA%20Repository/TCTMD%20Portal/EPSlidePresPoolNew/2005/Slides_May05/RAVEL_Sousa_PCR05//pdfFile. Accessed November 15, 2005.
SCANDSTENT. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756734. Accessed November 15, 2005.
DIABETES. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814709. Accessed November 15, 2005.
TAXUS I, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880407. Accessed November 15, 2005.
TAXUS II, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=812016. Accessed November 15, 2005.
TAXUS IV, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814047. Accessed November 15, 2005.
TAXUS VI, 30 day follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880460. Accessed November 15, 2005.
TAXUS VI, 9 month follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/descoe?_nfpb=true&_pageLabel=DESCenterContent&hdCon=958541. Accessed November 15, 2005.
TAXUS VI, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1256014. Accessed November 15, 2005.
DIABETES. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814709. Accessed November 15, 2005.
Trial Name | SES n=1587 | BMS n=1575 | Duration of Clopidogrel | Clinical Follow-up | Early Events | Late Events (>30 Days) |
---|---|---|---|---|---|---|
SIRIUS 9 , 10 , 11 SIRIUS, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756655. Accessed November 15, 2005. | 533 | 525 | 3 | 36 | 1/1 | 3/3 |
E-SIRIUS 12 , 13 E-SIRIUS, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814895. Accessed November 15, 2005. | 175 | 177 | 2 | 24 | 2/0 | 1/0 |
C-SIRIUS 14 | 50 | 50 | 2 | 9 | 1/0 | 0/1 |
RAVEL 15 , 16 , RAVEL, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=823586. Accessed November 15, 2005. 17 RAVEL, 4 year follow-up. Available at: http://www.tctmd.com/csportal/ShowBinary/BEA%20Repository/TCTMD%20Portal/EPSlidePresPoolNew/2005/Slides_May05/RAVEL_Sousa_PCR05//pdfFile. Accessed November 15, 2005. | 120 | 118 | 2 | 48 | 0/0 | 0/0 |
SES-SMART 18 | 129 | 128 | 2 | 8 | 1/1 | 0/3 |
SCANDSTENT 19 SCANDSTENT. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756734. Accessed November 15, 2005. | 163 | 159 | NA | 8 | 1/5 | 0/0 |
DIABETES 20 DIABETES. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814709. Accessed November 15, 2005. | 80 | 80 | 12 | 9 | 0/0 | 0/0 |
Pache et al 21 | 250 | 250 | 6 | 12 | 1/1 | 1/0 |
STRATEGY 22 | 87 | 88 | 3 | 8 | 0/2 | 0/0 |
Incidence (per 1000) | 4.2/3.5 | 3.5/4.9 |
Trial Name | PES n = 1755 | BMS n = 1758 | Duration of Clopidogrel | Clinical Follow-up | Early Events | Late Events (≥30 Days) |
---|---|---|---|---|---|---|
TAXUS–I 23 , 24 TAXUS I, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880407. Accessed November 15, 2005. | 31 | 30 | 6 | 24 | 0/0 | 0/0 |
TAXUS–II 25 , 26 TAXUS II, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=812016. Accessed November 15, 2005. | 266 | 270 | 6 | 24 | 1/0 | 5/0 |
TAXUS–IV 27 , 28 , 29 TAXUS IV, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814047. Accessed November 15, 2005. | 662 | 652 | 6 | 24 | 2/4 | 5/1 |
TAXUS–V 30 | 577 | 579 | 6 | 9 | 4/4 | 0/1 |
TAXUS–VI 31 , TAXUS VI, 30 day follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880460. Accessed November 15, 2005. 32 , TAXUS VI, 9 month follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/descoe?_nfpb=true&_pageLabel=DESCenterContent&hdCon=958541. Accessed November 15, 2005. 33 TAXUS VI, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1256014. Accessed November 15, 2005. | 219 | 227 | 6 | 24 | 1/3 | 1/0 |
Incidence (per 1000 patients) | 4.6/6.3 | 6.3/1.1 |
Overall Risk of Thrombotic Events
Risk of Early Thrombotic Events
Risk of Late Thrombotic Events




Discussion
References
- FDA public health notification: Information for physicians on sub-acute thromboses (SAT) and hypersensitivity reactions with use of the Cordis Cypher coronary stent. 2003 (Issued October 29. Available at: http://www.fda.gov/cdrh/safety/cypher.html. Accessed November 15, 2005.)
- Stent thrombosis after successful sirolimus-eluting stent implantation.Circulation. 2004; 109: 1930-1932
- What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?.J Am Coll Cardiol. 2005; 45: 941-946
- Risk of thrombosis with the use of sirolimus-eluting stents for percutaneous coronary intervention (from registry and clinical trial data).Am J Cardiol. 2005; 95: 1469-1472
- A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents.Lancet. 2004; 364: 583-591
- Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies.J Am Coll Cardiol. 2005; 45: 954-959
- Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation.J Am Coll Cardiol. 2005; 45: 947-953
- Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy.Lancet. 2004; 364: 1519-1521
- Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323
- Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis.Circulation. 2004; 109: 634-640
SIRIUS, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756655. Accessed November 15, 2005.
- 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: 1093-1099
E-SIRIUS, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814895. Accessed November 15, 2005.
- 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: 1110-1115
- A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med. 2002; 346: 1773-1780
RAVEL, 3 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=823586. Accessed November 15, 2005.
RAVEL, 4 year follow-up. Available at: http://www.tctmd.com/csportal/ShowBinary/BEA%20Repository/TCTMD%20Portal/EPSlidePresPoolNew/2005/Slides_May05/RAVEL_Sousa_PCR05//pdfFile. Accessed November 15, 2005.
- Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial.JAMA. 2004; 292: 2727-2734
SCANDSTENT. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=756734. Accessed November 15, 2005.
DIABETES. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814709. Accessed November 15, 2005.
- Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial.Eur Heart J. 2005; 26: 1262-1268
- Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial.JAMA. 2005; 293: 2109-2117
- TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.Circulation. 2003; 107: 38-42
TAXUS I, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880407. Accessed November 15, 2005.
- Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.Circulation. 2003; 108: 788-794
TAXUS II, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=812016. Accessed November 15, 2005.
- A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231
- One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial.Circulation. 2004; 109: 1942-1947
TAXUS IV, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=814047. Accessed November 15, 2005.
- 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: 1215-1223
TAXUS VI, 30 day follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=880460. Accessed November 15, 2005.
TAXUS VI, 9 month follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/descoe?_nfpb=true&_pageLabel=DESCenterContent&hdCon=958541. Accessed November 15, 2005.
TAXUS VI, 2 year follow-up. Available at: http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1256014. Accessed November 15, 2005.
- Meta-analysis of randomized and registry comparisons of ticlopidine with clopidogrel after stenting.J Am Coll Cardiol. 2002; 39: 9-14
- Coronary syndromes following aspirin withdrawal: a special risk for late stent thrombosis.J Am Coll Cardiol. 2005; 45: 456-459
- Impact of prior use or recent withdrawal of oral antiplatelet agents on acute coronary syndromes.Circulation. 2004; 110: 2361-2367
- 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
- Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial.JAMA. 2002; 288: 2411-2420