Stent thrombosis in randomized clinical trials of drug-eluting stents

New England Journal of Medicine

Volumn 356, Issue 10, 2007, Pages 1020-1029

  Mauri, Laura ^a,b,d   Hsieh, Wen Hua ^b   Massaro, Joseph M ^b,e   Ho, Kalon K L ^b,c,d   D'Agostino, Ralph ^b,e   Cutlip, Donald E ^b,c,d  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^c BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTITHROMBOCYTIC AGENT; PACLITAXEL; RAPAMYCIN;

ADULT; AGED; ARTICLE; BRACHYTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY STENT; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HUMAN; INCIDENCE; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MEDICAL SOCIETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOSIS;

EID: 33847705701     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa067731     Document Type: Article

References (30)

1. 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;331:496-501.
2. 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;331:489-95.
3. Williams DO, Holubkov R, Yeh W, et al. Percutaneous coronary intervention in the current era compared with 1985-1986: the National Heart, Lung, and Blood Institute Registries. Circulation 2000;102:2945-51.
4. 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;349:1315-23.
5. 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;350:221-31.
6. 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;103:1967-71.
7. Stone GW, Ellis SG, Cox DA, et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 2004;109:1942-7.
8. Holmes DR Jr, Leon MB, Moses JW, et al. 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;109:634-40.
9. 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 2005;45:954-9.
10. Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005;45:2088-92.
11. Pfisterer M, Brunner-La Rocca HP, Buser PT, 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 2006;48:2584-91.
12. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxeleluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet (in press).
13. Camenzind E, Steg G, Wijns W. Safety of drug-eluting stents: a meta-analysis of 1st generation DES programs. European Society of Cardiology 2006 Hot Line session. (Accessed February 9, 2007, at http://www.escardio.org/ knowledge/congresses/CongressReports/hotlinesandctus/707009_Camenzind.htm.)
14. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a metaanalysis. Eur Heart J 2006;27:2784-814.
15. Food and Drug Administration. Circulatory System Devices Panel Meeting. (Accessed February 9, 2007, at http://www.fda.gov/ohrms/dockets/ac/cdrh06. html#circulatory.)
16. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-80.
17. Schampaert E, Cohen EA, Schluter 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;43:1110-5.
18. Schofer J, Schluter M, Gershlick 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;362:1093-9.
19. Grube E, Silber S, Hauptmann KE, et al. 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.
20. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788-94.
21. 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;294:1215-23.
22. Lin DY, Wei LJ, Ying Z. Checking the Cox model with cumulative sums of Martingale-based residuals. Biometrika 1993; 80:557-72.
23. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
24. Waksman R, Bhargava B, Mintz GS, et al. Late total occlusion after intracoronary brachytherapy for patients with in-stent restenosis. J Am Coll Cardiol 2000;36:65-8.
25. Popma JJ, Suntharalingam M, Lansky AJ, et al. Randomized trial of 90Sr/90Y beta-radiation versus placebo control for treatment of in-stent restenosis. Circulation 2002;106:1090-6.
26. Stone GW, Ellis SG, O'Shaughnessy CD, et al. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 2006;295:1253-63.
27. Holmes DR Jr, Teirstein P, Satler L, et al. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA 2006;295:1264-73.
28. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007;297:159-68.
29. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126-30.
30. Mak KH, Belli G, Ellis SG, Moliterno DJ. Subacute stent thrombosis: evolving issues and current concepts. J Am Coll Cardiol 1996;27:494-503.