This Article Figures Only Full Text Full Text (PDF) All Versions of this Article: j.jacc.2007.05.010v1 50/3/261    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Vermeersch, P. Search for Related Content PubMed PubMed Citation Articles by Vermeersch, P. Related Collections Related Article

EXPEDITED REVIEW

Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare-Metal Stents in Diseased Saphenous Vein Grafts

Results From the Randomized DELAYED RRISC Trial

Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium

Manuscript received April 2, 2007; revised manuscript received May 18, 2007, accepted May 21, 2007.

^_* Reprint requests and correspondence: Dr. Pierfrancesco Agostoni, Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Lindendreef 1, 2020 Antwerp, Belgium (Email: agostonipf{at}gmail.com).

Objectives: We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial.

Background: We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES.

Methods: A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization.

Results: Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively).

Conclusions: In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up.(RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263 [ClinicalTrials.gov] )

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   MI = myocardial infarction   SES = sirolimus-eluting stent(s)   SVG = saphenous vein graft(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

Related Article

"Crying Fire in a Theater" or a "Confirmatory Sighting?"

Stephen G. Ellis
J. Am. Coll. Cardiol. 2007 50: 268-269. [Full Text] [PDF]

This article has been cited by other articles:

				D. T. Ko, H. Guo, H. C. Wijeysundera, M. I. Zia, V. Dzavik, M. W. A. Chu, S. E. Fremes, E. A. Cohen, and J. V. Tu Long-Term Safety and Effectiveness of Drug-Eluting Stents for the Treatment of Saphenous Vein Grafts Disease: A Population-Based Study J. Am. Coll. Cardiol. Intv., September 1, 2011; 4(9): 965 - 973. [Abstract] [Full Text] [PDF]

				M. S. Lee, S.-J. Park, D. E. Kandzari, A. J. Kirtane, W. F. Fearon, E. S. Brilakis, P. Vermeersch, Y.-H. Kim, R. Waksman, J. Mehilli, et al. Saphenous Vein Graft Intervention J. Am. Coll. Cardiol. Intv., August 1, 2011; 4(8): 831 - 843. [Abstract] [Full Text] [PDF]

				K. M. Ziada, A. Abdel-Latif, and M. E. Wiisanen Reply J. Am. Coll. Cardiol. Intv., May 1, 2011; 4(5): 591 - 593. [Full Text] [PDF]

				Y. Rozenman Drug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft Interventions J. Am. Coll. Cardiol. Intv., May 1, 2011; 4(5): 590 - 591. [Full Text] [PDF]

				G. W. Stone, S. Goldberg, C. O'Shaughnessy, M. Midei, R. M. Siegel, E. Cristea, G. Dangas, A. J. Lansky, and R. Mehran 5-Year Follow-Up of Polytetrafluoroethylene-Covered Stents Compared With Bare-Metal Stents in Aortocoronary Saphenous Vein Grafts: The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial J. Am. Coll. Cardiol. Intv., March 1, 2011; 4(3): 300 - 309. [Abstract] [Full Text] [PDF]

				E. S. Brilakis, C. Lichtenwalter, A.-r. R. Abdel-karim, J. A. de Lemos, O. Obel, T. Addo, M. Roesle, D. Haagen, B. V. Rangan, B. Saeed, et al. Continued Benefit From Paclitaxel-Eluting Compared With Bare-Metal Stent Implantation in Saphenous Vein Graft Lesions During Long-Term Follow-Up of the SOS (Stenting of Saphenous Vein Grafts) Trial J. Am. Coll. Cardiol. Intv., February 1, 2011; 4(2): 176 - 182. [Abstract] [Full Text] [PDF]

				M. E. Wiisanen, A. Abdel-Latif, D. Mukherjee, and K. M. Ziada Drug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft Interventions: A Systematic Review and Meta-Analysis J. Am. Coll. Cardiol. Intv., December 1, 2010; 3(12): 1262 - 1273. [Abstract] [Full Text] [PDF]

				J.-M. Paradis, P. Belisle, L. Joseph, O. F. Bertrand, R. DeLarochelliere, J.-P. Dery, E. Larose, J. Rodes-Cabau, and S. Rinfret Drug-Eluting or Bare Metal Stents for the Treatment of Saphenous Vein Graft Disease: A Bayesian Meta-Analysis Circ Cardiovasc Interv, December 1, 2010; 3(6): 565 - 576. [Abstract] [Full Text] [PDF]

				E. S. Brilakis, T. Y. Wang, S. V. Rao, S. Banerjee, S. Goldman, K. Shunk, B. Kar, D. R. Holmes Jr, D. Dai, C. T. Chin, et al. Frequency and Predictors of Drug-Eluting Stent Use in Saphenous Vein Bypass Graft Percutaneous Coronary Interventions: A Report From the American College of Cardiology National Cardiovascular Data CathPCI Registry J. Am. Coll. Cardiol. Intv., October 1, 2010; 3(10): 1068 - 1073. [Abstract] [Full Text] [PDF]

				S. Garg and P. W. Serruys Coronary Stents: Current Status J. Am. Coll. Cardiol., August 31, 2010; 56(10_Suppl_S): S1 - S42. [Abstract] [Full Text] [PDF]

				J. M. Stolker, K. F. Kennedy, J. B. Lindsey, S. P. Marso, M. J. Pencina, D. E. Cutlip, L. Mauri, N. S. Kleiman, D. J. Cohen, and on behalf of the EVENT Investigators Predicting Restenosis of Drug-Eluting Stents Placed in Real-World Clinical Practice: Derivation and Validation of a Risk Model From the EVENT Registry Circ Cardiovasc Interv, August 1, 2010; 3(4): 327 - 334. [Abstract] [Full Text] [PDF]

				E. S. Brilakis, J. M. Lasala, D. A. Cox, P. B. Berger, T. S. Bowman, R. M. Starzyk, and K. D. Dawkins Outcomes After Implantation of the TAXUS Paclitaxel-Eluting Stent in Saphenous Vein Graft Lesions: Results From the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) Program J. Am. Coll. Cardiol. Intv., July 1, 2010; 3(7): 742 - 750. [Abstract] [Full Text] [PDF]

				A. Latib, L. Ferri, A. Ielasi, J. Cosgrave, C. Godino, E. Bonizzoni, E. Romagnoli, A. Chieffo, M. Valgimigli, C. Penzo, et al. Comparison of the Long-Term Safety and Efficacy of Drug-Eluting and Bare-Metal Stent Implantation in Saphenous Vein Grafts Circ Cardiovasc Interv, June 1, 2010; 3(3): 249 - 256. [Abstract] [Full Text] [PDF]

				J. Rodes-Cabau, O. F. Bertrand, E. Larose, J.-P. Dery, S. Rinfret, R. Bagur, G. Proulx, C. M. Nguyen, M. Cote, M.-C. Landcop, et al. Comparison of Plaque Sealing With Paclitaxel-Eluting Stents Versus Medical Therapy for the Treatment of Moderate Nonsignificant Saphenous Vein Graft Lesions: The Moderate VEin Graft LEsion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) Pilot Trial Circulation, November 17, 2009; 120(20): 1978 - 1986. [Abstract] [Full Text] [PDF]

				B. R. Brodie, H. Wilson, T. Stuckey, M. Nussbaum, S. Laurent, B. Bradshaw, A. Humphrey, C. Metzger, J. Hermiller, F. Krainin, et al. Outcomes With Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Graft Intervention: Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group J. Am. Coll. Cardiol. Intv., November 1, 2009; 2(11): 1105 - 1112. [Abstract] [Full Text] [PDF]

				J. S. Douglas Jr Are Our Patients Better Off With Drug-Eluting Stents in Saphenous Vein Grafts? J. Am. Coll. Cardiol. Intv., November 1, 2009; 2(11): 1113 - 1115. [Full Text] [PDF]

				J. Carlsson, S. K. James, J. Lindback, F. Schersten, T. Nilsson, U. Stenestrand, B. Lagerqvist, and for the SCAAR (Swedish Coronary Angiography and An Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria J. Am. Coll. Cardiol., April 21, 2009; 53(16): 1389 - 1398. [Abstract] [Full Text] [PDF]

				J. A. Bittl Drug-Eluting Stents for Saphenous Vein Graft Lesions: The Limits of Evidence J. Am. Coll. Cardiol., March 17, 2009; 53(11): 929 - 930. [Full Text] [PDF]

				E. S. Brilakis, C. Lichtenwalter, J. A. de Lemos, M. Roesle, O. Obel, D. Haagen, B. Saeed, C. Gadiparthi, J. K. Bissett, R. Sachdeva, et al. 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 J. Am. Coll. Cardiol., March 17, 2009; 53(11): 919 - 928. [Abstract] [Full Text] [PDF]

				B. R. Brodie, T. Stuckey, W. Downey, A. Humphrey, B. Bradshaw, C. Metzger, J. Hermiller, F. Krainin, S. Juk, B. Cheek, et al. Outcomes and Complications With Off-Label Use of Drug-Eluting Stents: Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group J. Am. Coll. Cardiol. Intv., August 1, 2008; 1(4): 405 - 414. [Abstract] [Full Text] [PDF]

				L. T. Newsome, M. A. Kutcher, and R. L. Royster Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention Anesth. Analg., August 1, 2008; 107(2): 552 - 569. [Abstract] [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., June 17, 2008; 51(24): 2355 - 2369. [Full Text] [PDF]

				D. Bansal, R. Sachdeva, and J. L. Mehta Percutaneous Intervention in Saphenous Vein Bypass Graft Disease: Case Against the Use of Drug-Eluting Stents J. Am. Coll. Cardiol., March 4, 2008; 51(9): 970 - 971. [Full Text] [PDF]

				P. Vermeersch, P. Agostoni, S. Verheye, P. Van den Heuvel, C. Convens, F. Van den Branden, and G. Van Langenhove Reply. J. Am. Coll. Cardiol., March 4, 2008; 51(9): 971 - 972. [Full Text] [PDF]

				N Melikian and W Wijns Drug-eluting stents: a critique Heart, February 1, 2008; 94(2): 145 - 152. [Abstract] [Full Text] [PDF]

				Increased Mortality with Sirolimus-Eluting Stents in Saphenous Vein Grafts? Journal Watch Cardiology, September 19, 2007; 2007(919): 1 - 1. [Full Text]

				S. G. Ellis "Crying Fire in a Theater" or a "Confirmatory Sighting?" J. Am. Coll. Cardiol., July 17, 2007; 50(3): 268 - 269. [Full Text] [PDF]