A Randomized Controlled Trial of a Paclitaxel-Eluting Stent Versus a Similar Bare-Metal Stent in Saphenous Vein Graft Lesions The SOS (Stenting Of Saphenous Vein Grafts) Trial

被引:158
作者
Brilakis, Emmanouil S. [1 ,2 ]
Lichtenwalter, Christopher [1 ,2 ]
de Lemos, James A. [1 ,2 ]
Roesle, Michele [1 ]
Obel, Owen [1 ,2 ]
Haagen, Donald [1 ]
Saeed, Bilal [3 ]
Gadiparthi, Chiranjeevi [1 ,2 ]
Bissett, Joseph K. [4 ,5 ]
Sachdeva, Rajesh [4 ,5 ]
Voudris, Vassilios V. [6 ]
Karyofillis, Panagiotis [6 ]
Kar, Biswajit [7 ]
Rossen, James [8 ]
Fasseas, Panayotis [9 ]
Berger, Peter [10 ]
Banerjee, Subhash [1 ,2 ]
机构
[1] Vet Affairs N Texas Healtchcare Syst, Dallas, TX USA
[2] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA
[3] Univ Toledo, Dept Internal Med, Toledo, OH 43606 USA
[4] Cent Arkansas Vet Hlthcare Syst, Little Rock, AR USA
[5] Univ Arkansas Med Sci, Little Rock, AR USA
[6] Onassis Cariac Surg Ctr, Athens, Greece
[7] Michael E DeBakey VA Med Ctr, Houston, TX USA
[8] Iowa City Vet Affairs Med Ctr, Iowa City, IA USA
[9] Wheaton Franciscan Med Grp, Racine, WI USA
[10] Weis Ctr Res, Geisinger Clin, Danville, PA 17822 USA
关键词
bare-metal stents; coronary artery bypass graft surgery; drug-eluting stents; outcomes; percutaneous coronary intervention; saphenous vein grafts; FOLLOW-UP; OUTCOMES; IMPLANTATION;
D O I
10.1016/j.jacc.2008.11.029
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions. Background There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs. Methods Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure. Results Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27). Conclusions In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS. (The SOS [Stenting of Saphenous Vein Grafts] Randomized-Controlled Trial; NCT00247208) (J Am Coll Cardiol 2009; 53: 919-28) (C) 2009 by the American College of Cardiology Foundation
引用
收藏
页码:919 / 928
页数:10
相关论文
共 25 条
[1]   Myocardial infarction redefined -: A consensus Document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction [J].
Alpert, JS ;
Antman, E ;
Apple, F ;
Armstrong, PW ;
Bassand, JP ;
de Luna, AB ;
Beller, G ;
Breithardt, G ;
Chaitman, BR ;
Clemmensen, P ;
Falk, E ;
Fishbein, MC ;
Galvani, M ;
Garson, A ;
Grines, C ;
Hamm, C ;
Jaffe, A ;
Katus, H ;
Kjekshus, J ;
Klein, W ;
Klootwijk, P ;
Lenfant, C ;
Levy, D ;
Levy, RI ;
Luepker, R ;
Marcus, F ;
Näslund, U ;
Ohman, M ;
Pahlm, O ;
Poole-Wilson, P ;
Popp, R ;
Alto, P ;
Pyörälä, K ;
Ravkilde, J ;
Rehnquist, N ;
Roberts, W ;
Roberts, R ;
Roelandt, J ;
Rydén, L ;
Sans, S ;
Simoons, ML ;
Thygesen, K ;
Tunstall-Pedoe, H ;
Underwood, R ;
Uretsky, BF ;
Van de Werf, F ;
Voipio-Pulkki, LM ;
Wagner, G ;
Wallentin, L ;
Wijns, W .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2000, 36 (03) :959-969
[2]  
American College of Cardiology, 2006, J Am Coll Cardiol, V48, pe1, DOI 10.1016/j.jacc.2006.05.021
[3]   Late outcomes of drug-eluting versus bare meta stents in saphenous vein grafts: Propensity score analysis [J].
Applegate, Robert J. ;
Sacrinty, Matthew ;
Kutcher, Michael ;
Santos, Renato ;
Gandhi, Sanjay ;
Little, William .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2008, 72 (01) :7-12
[4]   Percutaneous intervention on the saphenous vein bypass grafts - Long-term outcomes [J].
Bansal, Darpan ;
Muppidi, Raghu ;
Singla, Sandeep ;
Sukhija, Rishi ;
Zarich, Stuart ;
Mehta, Jawahar L. ;
Sachdeva, Rajesh .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2008, 71 (01) :58-61
[5]   Should Bare Metal or Drug-Eluting Stents Be Used During PCI of Saphenous Vein Graft Lesions: Waiting For Godot? [J].
Brilakis, Emmanouil S. ;
Berger, Peter B. .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2008, 72 (06) :815-818
[6]   Use of drug-eluting stents in saphenous vein aortocoronary bypass graft lesions: A critical appraisal [J].
Brilakis, Emmanouil S. ;
Saeed, Bilal ;
Banerjee, Subhash .
JOURNAL OF INTERVENTIONAL CARDIOLOGY, 2008, 21 (02) :151-157
[7]  
Brodie BR, 2008, JACC-CARDIOVASC INTE, V1, P405, DOI 10.1016/j.jcin.2008.06.005
[8]   Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention [J].
Chu, WW ;
Rha, SW ;
Kuchulakanti, PK ;
Cheneau, E ;
Torguson, R ;
Pinnow, E ;
Alexieva-Fournadjiev, J ;
Pichard, AD ;
Satler, LF ;
Kent, KM ;
Lindsay, J ;
Waksman, R .
AMERICAN JOURNAL OF CARDIOLOGY, 2006, 97 (01) :34-37
[9]   Saphenous vein graft stenting and major adverse cardiac events - A predictive model derived from a pooled analysis of 3958 patients [J].
Coolong, Alanna ;
Baim, Donald S. ;
Kuntz, Richard E. ;
O'Malley, A. James ;
Marulkar, Sachin ;
Cutlip, Donald E. ;
Popma, Jeffrey J. ;
Mauri, Laura .
CIRCULATION, 2008, 117 (06) :790-797
[10]   Clinical end points in coronary stent trials - A case for standardized definitions [J].
Cutlip, Donald E. ;
Windecker, Stephan ;
Mehran, Roxana ;
Boam, Ashley ;
Cohen, David J. ;
van Es, Gerrit-Anne ;
Steg, P. Gabriel ;
Morel, Marie-angele ;
Mauri, Laura ;
Vranckx, Pascal ;
McFadden, Eugene ;
Lansky, Alexandra ;
Hamon, Martial ;
Krucoff, Mitchell W. ;
Serruys, Patrick W. .
CIRCULATION, 2007, 115 (17) :2344-2351