ISSN: 0300-8932 Factor de impacto 2023 7,2
Vol. 7. Núm. E.
Páginas 29E-40E (Julio 2007)

Stents recubiertos
Stents recubiertos de fármacos para el tratamiento de lesiones complejas: enfoque sobre las lesiones largas y los pequeños vasos

Drug-Eluting Stents in the Treatment of Complex Lesions: Focus on Long Lesions and Small Vessels

Eugenia NikolskyGregg W. Stone¿

Opciones

Los stents recubiertos de fármacos (SRF) permiten el aporte intravascular local de elevadas concentraciones de un agente antiproliferativo en el lugar de la lesión, para inhibir la neoproliferación excesiva de la íntima, al mismo tiempo que se minimizan los efectos secundarios sistémicos del fármaco. Los ensayos fundamentales SIRIUS y TAXUS IV, multicéntricos, prospectivos, de distribución aleatoria y a gran escala, aportaron pruebas convincentes de que los SRF disminuyen de manera significativa la reestenosis y los fenómenos clínicos que la acompañan, en comparación con los stents de metal desnudo (SMD), después del implante en lesiones relativamente simples y moderadamente complejas en las arterias coronarias nativas. Otros estudios posteriores se han centrado en valorar la seguridad y la eficacia de los SRF en lesiones más complejas, incluidas las lesiones en los vasos de pequeño calibre y las lesiones largas, ambas con unas tasas de reestenosis más elevadas que las lesiones no complejas cuando se tratan mediante angioplastia con balón o SMD. En la presente revisión se resumen las pruebas actuales, obtenidas en ensayos de distribución aleatoria, registros prospectivos y estudios de observación, sobre la seguridad y la eficacia de los stents recubiertos de paclitaxel o sirolimus en las lesiones complejas, excluidas o poco representativas en los principales ensayos anteriores, y se enfoca sobre el tratamiento de las lesiones largas (incluidas las que requieren stents múltiples) y las localizadas en los vasos de pequeño calibre.

Palabras clave

Stent
Lesión
Coronariopatía
Reestenosis
Pronóstico
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Bibliografía
[1.]
A.R. Gruentzig.
Transluminal dilatation of coronary artery stenosis [letter].
Lancet, (1978), 1 pp. 263
[2.]
American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association; 2002.
[3.]
D.O. Williams, J.D. Abbott, K.E. Kip.
Outcomes of 6906 Patients Undergoing Percutaneous Coronary Intervention in the Era of Drug-Eluting Stents. Report of the DEScover Registry.
Circulation, (2006), 114 pp. 2154-2162
[4.]
M.C. Morice, P.W. Serruys, J.E. Sousa, J. Fajadet, E. Ban Hayashi, M. Perin, RAVEL Study Group, et al.
Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.
N Engl J Med, (2002), 346 pp. 1773-1780
[5.]
A. Colombo, J. Drzewiecki, A. Banning, E. Grube, K. Hauptmann, S. Silber, et al.
TAXUS II Study Group Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.
Circulation, (2003), 108 pp. 788-794
[6.]
J.W. Moses, M.B. Leon, J.J. Popma, P.J. Fitzgerald, D.R. Holmes, C. O'Shaughnessy, et al.
SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.
N Engl J Med, (2003), 349 pp. 1315-1323
[7.]
G.W. Stone, S.G. Ellis, D.A. Cox, J. Hermiller, C. O'Shaughnessy, J.T. Mann, TAXUS-IV Investigators, et al.
A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.
N Engl J Med, (2004), 350 pp. 221-231
[8.]
S.V. Rao, R.E. Shaw, R.G. Brindis, L.W. Klein, W.S. Weintraub, E.D. Peterson, et al.
On-versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]).
Am J Cardiol, (2006), 97 pp. 1478-1481
[9.]
S. Elezi, A. Kastrati, F.J. Neumann, M. Hadamitzky, J. Dirschinger, A. Schomig.
Vessel size and long-term outcome after coronary stent placement.
Circulation, (1998), 98 pp. 1875-1880
[10.]
H. Schunkert, L. Harrell, I.F. Palacios.
Implications of small reference vessel diameter in patients undergoing percutaneous coronary revascularization.
J Am Coll Cardiol, (1999), 34 pp. 40-48
[11.]
A. Kastrati, A. Schoming, J. Dirshinger, J. Mehilli, F. Dotzer, N. Von Welser, ISAR-SMART Study Investigators, et al.
A randomized trial comparing stenting with balloon angioplasty in small vessels in patients with symptomatic coronary artery disease: Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries.
Circulation, (2000), 102 pp. 2593-2598
[12.]
S.W. Park, C.W. Lee, M.K. Hong, J.J. Kim, G.Y. Cho, D.Y. Nah, et al.
Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries.
Eur Heart J, (2000), 21 pp. 1785-1789
[13.]
S. Doucet, M.J. Schalij, M.C. Vrolix, D. Hilton, P. Chenu, B. De Bruyne, et al.
Stent placement to prevent restenosis after angioplasty in small coronary arteries.
Circulation, (2001), 104 pp. 2029-2033
[14.]
J. Schofer, M. Schluter, A.H. Gershlick, W. Wijns, E. Garcia, E. Schampaert, E-SIRIUS Investigators, 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 pp. 1093-1099
[15.]
E. Schampaert, E.A. Cohen, M. Schluter, F. Reeves, M. Traboulsi, L.M. Title, C-SIRIUS Investigators, 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 pp. 1110-1115
[16.]
D. Ardissino, C. Cavallini, E. Bramucci, C. Indolfi, A. Marzocchi, A. Manari, SES-SMART Investigators, et al.
Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial.
JAMA, (2004), 292 pp. 2727-2734
[17.]
G.W. Stone, S.G. Ellis, L. Cannon, J.T. Mann, J.D. Greenberg, D. Spriggs, TAXUS V Investigators, 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 pp. 1215-1223
[18.]
Sousa JE. SVELTE: Study in Patients with De Novo Coronary Artery Lesions in Small Vessels Treated With the Cypher Stent. EuroPCR 2004, the Paris Course on Revascularization.
[19.]
J.W. Moses, E. Nikolsky, R. Mehran, P.A. Cambier, W.B. Bachinsky, F. Leya, For the SIRIUS 2.25 Investigators, et al.
Safety and Efficacy of the 2.25 mm Sirolimus-Eluting BX Velocity™ Stent in the Treatment of Patients with De Novo Native Coronary Artery Lesions: the SIRIUS 2.25 Trial.
Am J Cardiol, (2006), 98 pp. 1455-1460
[20.]
J.W. Hirshfeld Jr, J.S. Schwartz, R. Jugo, R.G. MacDonald, S. Goldberg, M.P. Savage, et al.
Restenosis after coronary angioplasty: a multivariate statistical model to relate lesion and procedure variables to restenosis. The M-HEART Investigators.
J Am Coll Cardiol, (1991), 18 pp. 647-656
[21.]
A. Kastrati, S. Elezi, J. Dirschinger, M. Hadamitzky, F.J. Neumann, A. Schomig.
Influence of lesion length on restenosis after coronary stent placement.
Am J Cardiol, (1999), 83 pp. 1617-1622
[22.]
D. Antoniucci, R. Valenti, G.M. Santoro, L. Bolognese, M. Trapani, G. Cerisano, et al.
Restenosis after coronary stenting in current clinical practice.
Am Heart J, (1998), 135 pp. 510-518
[23.]
K.D. Dawkins, E. Grube, G. Guagliumi, A.P. Banning, K. Zmudka, A. Colombo, TAXUS VI Investigators, et al.
Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of omplex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice.
Circulation, (2005), 112 pp. 3306-3313
[24.]
J. Waugh, A.J. Wagstaff.
The paclitaxel (TAXUS)-eluting stent: a review of its use in the management of de novo coronary artery lesions.
Am J Cardiovasc Drugs, (2004), 4 pp. 257-268
[25.]
H. Kelbaek, L. Thuesen, S. Helqvist, L. Klovgaard, E. Jorgensen, S. Aljabbari, SCANDSTENT Investigators, et al.
The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial.
J Am Coll Cardiol, (2006), 47 pp. 449-455
[26.]
E. Tsagalou, A. Chieffo, I. Iakovou, L. Ge, G.M. Sangiorgi, N. Corvaja, et al.
Multiple overlapping drug-eluting stents to treat diffuse disease of the left anterior descending coronary artery.
J Am Coll Cardiol, (2005), 45 pp. 1570-1573
[27.]
M. Degertekin, C.A. Arampatzis, P.A. Lemos, F. Saia, A. Hoye, J. Daemen, et al.
Very long sirolimus-eluting stent implantation for de novo coronary lesions.
Am J Cardiol, (2004), 93 pp. 826-829
[28.]
W.W. Chu, P.K. Kuchulakanti, R. Torguson, B. Wang, L.C. Clavijo, W.O. Suddath, et al.
Impact of overlapping drug-eluting stents in patients undergoing percutaneous coronary intervention.
Catheter Cardiovasc Interv, (2006), 67 pp. 595-599
[29.]
W.W. Chu, P.K. Kuchulakanti, R. Torguson, B. Wang, L.C. Clavijo, W.O. Suddath, et al.
Impact of three or more sirolimus-eluting stents versus paclitaxel-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention.
Catheter Cardiovasc Interv, (2006), 68 pp. 62-66
[30.]
Moses JW. Direct Stenting Using the Sirolimus-Eluting Bx VELOCITY Stent (DIRECT). Presented at American College of Cardiology Annual Scientific Session 2004, New Orleans, LA. Disponible en: http://www.medscape.com/viewarticle/471804.
[31.]
D.J. Kereiakes, H. Wang, J.J. Popma, R.E. Kuntz, D.J. Donohoe, J. Schofer, et al.
Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials.
J Am Coll Cardiol, (2006), 48 pp. 21-31
[32.]
C.W. Lee, K.H. Park, Y.H. Kim, M.K. Hong, J.J. Kim, S.W. Park, et al.
Clinical and angiographic outcomes after placement of multiple overlapping drug-eluting stents in diffuse coronary lesions.
Am J Cardiol, (2006), 98 pp. 918-922
[33.]
J. Aoki, A.T. Ong, G.A. Rodríguez Granillo, E.P. McFadden, C.A. Van Mieghem, M. Valgimigli, et al.
«Full metal jacket» (stented length ≥ 64 mm) using drug-eluting stents for de novo coronary artery lesions.
Am Heart J, (2005), 150 pp. 994-999
[34.]
P. Urban, A.H. Gershlick, G. Guagliumi, P. Guyon, C. Lotan, J. Schofer, e-Cypher Investigators, et al.
Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry.
Circulation, (2006), 113 pp. 1434-1441
[35.]
A. Abizaid, C. Chan, Y.T. Lim, U. Kaul, N. Sinha, T. Patel, WISDOM Investigators, et al.
Twelve-month outcomes with a paclitaxel-eluting stent transitioning from controlled trials to clinical practice (the WISDOM Registry).
Am J Cardiol, (2006), 98 pp. 1028-1032
[36.]
Lasala JM. Novel insight into drug-eluting stent practice: 1-year outcomes for ARRIVE 1, a Prospective, Multicenter US Registry Capturing Consecutive Patients Treated with the TAXUS Paclitaxel-Eluting Stent System. Paper presented at: American Heart Association Scientific Sessions; November 15, 2005; Dallas, Texas.
[37.]
K. Niemela, B. Chevalier, H. Stoerger, L. Bilodeau, F. Brito, M. Russell.
Taxus Express stent usage patterns and clinical outcomes: twelve-month results from the European subset of the Global Milestone-II Registry.
J Am Coll Cardiol, (2005), 45 pp. 50A
[38.]
M.E. Russell, M.I. Friedman, S.R. Mascioli, L.E. Stolz.
Off-label use: an industry perspective on expanding use beyond approved indications.
J Interven Cardiol, (2006), 19 pp. 432-438
[39.]
J. Hausleiter, A. Kastrati, J. Mehilli, F. Dotzer, H. Schuhlen, J. Dirschinger, ISAR-SMART Trail investigators, et al.
Comparative analysis of stent placement versus balloon angioplasty in small coronary arteries with long narrowings (the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries [ISAR-SMART] Trial.
Am J Cardiol, (2002), 89 pp. 58-60
[40.]
M.C. Morice, A. Colombo, B. Meier, P. Serruys, C. Tamburino, G. Guagliumi, REALITY Trial Investigators, et al.
Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial.
JAMA, (2006), 295 pp. 895-904
[41.]
Y.H. Kim, S.W. Park, S.W. Lee, D.W. Park, S.C. Yun, C.W. Lee, et al.
Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent for Patients With Long Coronary Artery Disease.
Circulation, (2006), 114 pp. 2148-2153
[42.]
K.H. Park, S.W. Park, M.K. Hong, Y.H. Kim, B.K. Lee, D.W. Park, et al.
Comparison of the effectiveness of sirolimus- and paclitaxel-eluting stents for small coronary artery lesions.
Catheter Cardiovasc Interv, (2006), 67 pp. 589-594
[43.]
Y.H. Kim, S.W. Park, C.W. Lee, M.K. Hong, H.C. Gwon, Y. Jang, et al.
Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions.
Catheter Cardiovasc Interv, (2006), 67 pp. 181-187
[44.]
G.A. Rodríguez-Granillo, M. Valgimigli, H.M. García-García, A.T. Ong, J. Aoki, C.A. Van Mieghem, et al.
One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries.
J Invasive Cardiol, (2005), 17 pp. 409-412
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