Meta-analysis shows similar risk of thrombosis after drug-eluting stent, bare-metal stent, or angioplasty

Endothelium: Journal of Endothelial Cell Research

Volumn 15, Issue 1-2, 2008, Pages 93-100

  Fuchs, Alexandra Theresia ^a   Kuehnl, Andreas ^b   Pelisek, Jaroslav ^b   Rolland, Pierre Henri ^c   Mekkaoui, Choukri ^c   Netz, Heinrich ^a   Nikol, Sigrid ^b  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b UNIVERSITY OF MÜNSTER   (Germany)

^c AIX MARSEILLE UNIVERSITY   (France)

Author keywords

Bare Metal Stents; Drug Eluting Stents; Meta Analysis; Stent Thrombosis

Indexed keywords

ANTITHROMBOCYTIC AGENT; EVEROLIMUS; PACLITAXEL; RAPAMYCIN; ZOTAROLIMUS;

ARTICLE; BARE METAL STENT; CALCULATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CORONARY STENT; DRUG ELUTING STENT; FOLLOW UP; HUMAN; INCIDENCE; ISCHEMIC HEART DISEASE; META ANALYSIS; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; RESTENOSIS; RISK ASSESSMENT; SYSTEMATIC REVIEW; THROMBOSIS;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CONFIDENCE INTERVALS; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INCIDENCE; MALE; MIDDLE AGED; ODDS RATIO; PACLITAXEL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; SIROLIMUS; STENTS; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 46049121146     PISSN: 10623329     EISSN: 10292373     Source Type: Journal    
DOI: 10.1080/10623320802092534     Document Type: Article

References (59)

1. Ardissino, D., Cavallini, C., Bramucci, E., Indolfi, C., Marzocchi, A., Manari, A., Angeloni, G., Carosio, G., Bonizzoni, E., Colusso, S., Repetto, M. and Merlini, P. A. (2004) Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: A randomized trial. Journal of the American Medical Association, 292, pp. 2727-2734.
2. Bavry, A. A. and Bhatt, D. L. (2007) Acute myocardial infarction and drug-eluting stents: A green light for their use or time for measured restraint?. American Heart Journal, 153, pp. 719-721.
3. Bavry, A. A., Kumbhani, D. J., Helton, T. J. and Bhatt, D. L. (2005) What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: A meta-analysis. Journal of the American College of Cardiology, 45, pp. 941-946.
4. Bavry, A. A., Kumbhani, D. J., Helton, T. J., Borek, P. P., Mood, G. R. and Bhatt, D. L. (2006) Late thrombosis of drug-eluting stents: A meta-analysis of randomized clinical trials. American Journal of Medicine, 119, pp. 1056-1061.
5. Carlsson, J., von Wagenheim, B., Linder, R., Anwari, T. M., Qvist, J., Petersson, I., Magounakis, T. and Lagerqvist, B. (2007) Is late stent thrombosis in drug-eluting stents a real clinical issue?: A single-center experience and review of the literature. Clinical Research in Cardiology, 96, pp. 86-93.
6. Colombo, A., Drzewiecki, J., Banning, A., Grube, E., Hauptmann, K., Silber, S., Dudek, D., Fort, S., Schiele, F., Zmudka, K., Guagliumi, G. and Russell, M. E. (2003) Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation, 108, pp. 788-794.
7. Costa, R. A., Lansky, A. J., Mintz, G. S., Mehran, R., Tsuchiya, Y., Negoita, M., Gilutz, Y., Nikolsky, E., Fahy, M., Pop, R., Cristea, E., Carlier, S., Dangas, G., Stone, G. W., Leon, M. B., Muller, R., Techen, G. and Grube, E. (2005) Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial). American Journal of Cardiology, 95, pp. 113-116.
8. Custodis, F., Scheller, B. and Laufs, U. (2006) [Stable coronary artery disease-case report]. Deutsch Medizinische Wochenschrift, 131, pp. 554-555.
9. Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G. A., Steg, P. G., Morel, M. A., Mauri, L., Vranckx, P., McFadden, E., Lansky, A., Hamon, M., Krucoff, M. W. and Serruys, P. W. (2007) Clinical end points in coronary stent trials: A case for standardized definitions. Circulation, 115, pp. 2344-2351.
10. Daemen, J., Wenaweser, P., Tsuchida, K., Abrecht, L., Vaina, S., Morger, C., Kukreja, N., Juni, P., Sianos, G., Hellige, G., Van Domburg, R. T., Hess, O. M., Boersma, E., Meier, B., Windecker, S. and Serruys, P. W. (2007) 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, pp. 667-678.
11. Dawkins, K. D., Grube, E., Guagliumi, G., Banning, A. P., Zmudka, K., Colombo, A., Thuesen, L., Hauptman, K., Marco, J., Wijns, W., Popma, J. J., Koglin, J. and Russell, M. E. (2005) Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: Support for the use of drug-eluting stents in contemporary clinical practice. Circulation, 112, pp. 3306-3313.
12. Egger, M., Davey, S. G., Schneider, M. and Minder, C. (1997) Bias in meta-analysis detected by a simple, graphical test. British Medical Journal, 315, pp. 629-634.
13. Egger, M. and Smith, G. D. (1997) Meta-analysis. Potentials and promise. British Medical Journal, 315, pp. 1371-1374.
14. Egger, M., Smith, G. D. and Phillips, A. N. (1997) Meta-analysis: Principles and procedures. British Medical Journal, 315, pp. 1533-1537.
15. Ellis, S. G., Colombo, A., Grube, E., Popma, J., Koglin, J., Dawkins, K. D. and Stone, G. W. (2007) Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: A TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years. Journal of the American College of Cardiology, 49, pp. 1043-1051.
16. Erbel, R., Haude, M., Hopp, H. W., Franzen, D., Rupprecht, H. J., Heublein, B., Fischer, K., de Jaegere, P., Serruys, P., Rutsch, W. and Probst, P. (1998) Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group. New England Journal of Medicine, 339, pp. 1672-1678.
17. Fajadet, J., Wijns, W., Laarman, G. J., Kuck, K. H., Ormiston, J., Munzel, T., Popma, J. J., Fitzgerald, P. J., Bonan, R. and Kuntz, R. E. (2007) Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions. Clinical and angiographic results of the ENDEAVOR II Trial. Minerva Cardioangiology, 55, pp. 1-18.
18. Gershlick, A., De, S. I., Chevalier, B., Stephens-Lloyd, A., Camenzind, E., Vrints, C., Reifart, N., Missault, L., Goy, J. J., Brinker, J. A., Raizner, A. E., Urban, P. and Heldman, A. W. (2004) Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: The European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial. Circulation, 109, pp. 487-493.
19. Grines, C. L., Cox, D. A., Stone, G. W., Garcia, E., Mattos, L. A., Giambartolomei, A., Brodie, B. R., Madonna, O., Eijgelshoven, M., Lansky, A. J., O'Neill, W. W. and Morice, M. C. (1999) Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. New England Journal of Medicine, 341, pp. 1949-1956.
20. Grube, E., Silber, S., Hauptmann, K. E., Mueller, R., Buellesfeld, L., Gerckens, U. and Russell, M. E. (2003) 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, 107, pp. 38-42.
21. Hong, M. K., Mintz, G. S., Tinana, A., Lee, C. W., Kim, J. J., Fearnot, N. E., Park, S. W., Park, S. J. and Weissman, N. J. (2003) Impact of preinterventional arterial remodeling on neointimal hyperplasia after implantation of (non-polymer-encapsulated) paclitaxel-coated stents: A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT). Circulation, 108:11, pp. 1295-1298.
22. Iakovou, I., Schmidt, T., Bonizzoni, E., Ge, L., Sangiorgi, G. M., Stankovic, G., Airoldi, F., Chieffo, A., Montorfano, M., Carlino, M., Michev, I., Corvaja, N., Briguori, C., Gerckens, U., Grube, E. and Colombo, A. (2005) Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. Journal of the American Medical Association, 293, pp. 2126-2130.
23. Joner, M., Finn, A. V., Farb, A., Mont, E. K., Kolodgie, F. D., Ladich, E., Kutys, R., Skorija, K., Gold, H. K. and Virmani, R. (2006) Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. Journal of the American College of Cardiology, 48, p. 193.
24. Kaiser, C., Brunner-La Rocca, H.P., Buser, P. T., Bonetti, P. O., Osswald, S., Linka, A., Bernheim, A., Zutter, A., Zellweger, M., Grize, L. and Pfisterer, M. E. (2005) Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: Randomised Basel Stent Kosten Effektivitats Trial (BASKET). Lancet, 366, pp. 921-929.
25. Karvouni, E., Korovesis, S. and Katritsis, D. G. (2005) Very late thrombosis after implantation of sirolimus eluting stent. Heart, 91, p. e45.
26. Kastrati, A., Mehilli, J., Nekolla, S., Bollwein, H., Martinoff, S., Pache, J., Schuhlen, H., Seyfarth, M., Gawaz, M., Neumann, F. J., Dirschinger, J., Schwaiger, M. and Schomig, A. (2004) A randomized trial comparing myocardial salvage achieved by coronary stenting versus balloon angioplasty in patients with acute myocardial infarction considered ineligible for reperfusion therapy. Journal of the American College of Cardiology, 43, pp. 734-741.
27. Kastrati, A., Mehilli, J., Pache, J., Kaiser, C., Valgimigli, M., Kelbaek, H., Menichelli, M., Sabate, M., Suttorp, M. J., Baumgart, D., Seyfarth, M., Pfisterer, M. E. and Schomig, A. (2007) Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. New England Journal of Medicine, 356, pp. 1030-1103.
28. Kelbaek, H., Thuesen, L., Helqvist, S., Klovgaard, L., Jorgensen, E., Aljabbari, S., Saunamaki, K., Krusell, L. R., Jensen, G. V., Botker, H. E., Lassen, J. F., Andersen, H. R., Thayssen, P., Galloe, A. and van Weert, A. (2006) The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial. Journal of the American College of Cardiology, 47, pp. 449-455.
29. Lansky, A. J., Costa, R. A., Mintz, G. S., Tsuchiya, Y., Midei, M., Cox, D. A., O'Shaughnessy, C., Applegate, R. A., Cannon, L. A., Mooney, M., Farah, A., Tannenbaum, M. A., Yakubov, S., Kereiakes, D. J., Wong, S. C., Kaplan, B., Cristea, E., Stone, G. W., Leon, M. B., Knopf, W. D. and O'Neill, W. W. (2004) Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: Angiographic follow-up of the DELIVER clinical trial. Circulation, 109, pp. 1948-1954.
30. Liistro, F. and Colombo, A. (2001) Late acute thrombosis after paclitaxel eluting stent implantation. Heart, 86, pp. 262-264.
31. Manjappa, N., Agarwal, A. and Cavusoglu, E. (2006) Very late bare-metal stent thrombosis. A case report and review of the literature. Journal of Invasive Cardiology, 18, pp. E203-E206.
32. McFadden, E. P., Stabile, E., Regar, E., Cheneau, E., Ong, A. T., Kinnaird, T., Suddath, W. O., Weissman, N. J., Torguson, R., Kent, K. M., Pichard, A. D., Satler, L. F., Waksman, R. and Serruys, P. W. (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet, 364, pp. 1519-1521.
33. Morice, M. C., Serruys, P. W., Sousa, J. E., Fajadet, J., Ban, H. E., Perin, M., Colombo, A., Schuler, G., Barragan, P., Guagliumi, G., Molnar, F. and Falotico, R. (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. New England Journal of Medicine, 346, pp. 1773-1780.
34. Moses, J. W., Leon, M. B., Popma, J. J., Fitzgerald, P. J., Holmes, D. R., O'Shaughnessy, C., Caputo, R. P., Kereiakes, D. J., Williams, D. O., Teirstein, P. S., Jaeger, J. L. and Kuntz, R. E. (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. New England Journal of Medicine, 349, pp. 1315-1323.
35. Ong, A. T., McFadden, Regar, E., de Jaegere, P. P., Van Domburg, R. T. and Serruys, P. W. (2005) Late angiographic stent thrombosis (LAST) events with drug-eluting stents. Journal of the American College of Cardiology, 45, pp. 2088-2092.
36. Pache, J., Dibra, A., Mehilli, J., Dirschinger, J., Schomig, A. and Kastrati, A. (2005) Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: A prospective, randomized trial. European Heart Journal, 26, pp. 1262-1268.
37. Pasceri, V., Patti, G., Speciale, G., Pristipino, C., Richichi, G. and Di Sciascio, G. (2007) Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. American Heart Journal, 153, pp. 749-754.
38. Pfisterer, M., Brunner-La Rocca, H.P., Buser, P. T., Rickenbacher, P., Hunziker, P., Mueller, C., Jeger, R., Bader, F., Osswald, S. and Kaiser, C. (2006) Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting versus bare-metal stents. Journal of American College of Cardiology, 48, pp. 2584-2591.
39. Rabbat, M. G., Bavry, A. A., Bhatt, D. L. and Ellis, S. G. (2007) Understanding and minimizing late thrombosis of drug-eluting stents. Cleveland Clinic Journal of Medicine, 74, pp. 129-136.
40. Sabate, M., Jimenez-Quevedo, P., Angiolillo, D. J., Gomez-Hospital, J. A., Alfonso, F., Hernandez-Antolin, R., Goicolea, J., Banuelos, C., Escaned, J., Moreno, R., Fernandez, C., Fernandez-Aviles, F. and Macaya, C. (2005) Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: The diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation, 112, pp. 2175-2183.
41. Saito, S., Hosokawa, G., Tanaka, S. and Nakamura, S. (1999) Primary stent implantation is superior to balloon angioplasty in acute myocardial infarction: Final results of the primary angioplasty versus stent implantation in acute myocardial infarction (PASTA) trial. PASTA Trial Investigators. Catheter Cardiovascular Intervention, 48, pp. 262-268.
42. Schampaert, E., Cohen, E. A., Schluter, M., Reeves, F., Traboulsi, M., Title, L. M., Kuntz, R. E. and Popma, J. J. (2004) 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). Journal of the American College of Cardiology, 43, pp. 1110-1115.
43. Scheller, B., Hehrlein, C., Bocksch, W., Rutsch, W., Haghi, D., Dietz, U., Bohm, M. and Speck, U. (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. New England Journal of Medicine, 355, pp. 2113-2124.
44. Scheller, B., Speck, U., Abramjuk, C., Bernhardt, U., Bohm, M. and Nickenig, G. (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation, 110, pp. 810-814.
45. Schofer, J., Schluter, M., Gershlick, A. H., Wijns, W., Garcia, E., Schampaert, E. and Breithardt, G. (2003) Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet, 362, pp. 1093-1099.
46. Sousa, J. E., Costa, M. A., Abizaid, A., Abizaid, A. S., Feres, F., Pinto, I. M., Seixas, A. C., Staico, R., Mattos, L. A., Sousa, A. G., Falotico, R., Jaeger, J., Popma, J. J. and Serruys, P. W. (2001) Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation, 103, pp. 192-195.
47. Spaulding, C., Daemen, J., Boersma, E., Cutlip, D. E. and Serruys, P. W. (2007) A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. New England Journal of Medicine, 356, pp. 989-997.
48. Spaulding, C., Henry, P., Teiger, E., Beatt, K., Bramucci, E., Carrie, D., Slama, M. S., Merkely, B., Erglis, A., Margheri, M., Varenne, O., Cebrian, A., Stoll, H. P., Snead, D. B. and Bode, C. (2006) Sirolimus-eluting versus uncoated stents in acute myocardial infarction. New England Journal of Medicine, 355, pp. 1093-1104.
49. Steinberg, D. H., Mishra, S., Javaid, A., Slottow, T. L., Buch, A. N., Roy, P., Okabe, T., Smith, K. A., Torguson, R., Xue, Z., Pichard, A. D., Satler, L. F., Kent, K. M., Suddath, W. O. and Waksman, R. (2007) Comparison of effectiveness of bare metal stents versus drug-eluting stents in large (> or = 3.5 mm) coronary arteries. American Journal of Cardiology, 99, pp. 599-602.
50. Stettler, C., Wandel, S., Allemann, S., Kastrati, A., Morice, M. C., Schomig, A., Pfisterer, M. E., Stone, G. W., Leon, M. B., de Lezo, J. S., Goy, J. J., Park, S. J., Sabate, M., Suttorp, M. J., Kelbaek, H., Spaulding, C., Menichelli, M., Vermeersch, P., Dirksen, M. T., Cervinka, P., Petronio, A. S., Nordmann, A. J., Diem, P., Meier, B., Zwahlen, M., Reichenbach, S., Trelle, S., Windecker, S. and Juni, P. (2007) Outcomes associated with drug-eluting and bare-metal stents: A collaborative network meta-analysis. Lancet, 370, pp. 937-948.
51. Stone, G. W., Ellis, S. G., Colombo, A., Dawkins, K. D., Grube, E., Cutlip, D. E., Friedman, M., Baim, D. S. and Koglin, J. (2007) Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation, 115, pp. 2842-2847.
52. Stone, G. W., Ellis, S. G., Cox, D. A., Hermiller, J., O'Shaughnessy, C., Mann, J. T., Turco, M., Caputo, R., Bergin, P., Greenberg, J., Popma, J. J. and Russell, M. E. (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. New England Journal of Medicine, 350, pp. 221-231.
53. Stone, G. W., Grines, C. L., Cox, D. A., Garcia, E., Tcheng, J. E., Griffin, J. J., Guagliumi, G., Stuckey, T., Turco, M., Carroll, J. D., Rutherford, B. D. and Lansky, A. J. (2002) Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. New England Journal of Medicine, 346, pp. 957-966.
54. Suryapranata, H., De Luca, G., 't Hof, A.W., Ottervanger, J. P., Hoorntje, J. C., Dambrink, J. H., Gosselink, A. T., Zijlstra, F. and de Boer, M. J. (2005) Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart, 91, pp. 641-645.
55. Suryapranata, H., 't Hof, A.W., Hoorntje, J. C., de Boer, M. J. and Zijlstra, F. (1998) Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation, 97, pp. 2502-2505.
56. Suttorp, M. J., Laarmann, G. J., Rahel, B. M., Kelder, J. C., Bosschaert, M. A., Kiemeneij, F., Ten Berg, J.M., Bal, E. T., Rensing, B. J., Eefting, F. D. and Mast, E. G. (2006) Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation, 114:9, pp. 921-928.
57. Svilaas, T., van der Horst, L. C. and Zijlstra, F. (2007) A quantitative estimate of bare-metal stenting compared with balloon angioplasty in patients with acute myocardial infarction: Angiographic measures in relation to clinical outcome. Heart, 93, pp. 792-800.
58. Virmani, R., Guagliumi, G., Farb, A., Musumeci, G., Grieco, N., Motta, T., Mihalcsik, L., Tespili, M., Valsecchi, O. and Kolodgie, F. D. (2004) Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: Should we be cautious?. Circulation, 109, pp. 701-705.
59. Wenaweser, P. and Hess, O. (2005) Stent thrombosis is associated with an impaired response to antiplatelet therapy. Journal of the American College of Cardiology, 46, pp. CS5-CS6.