Love in Vain?

HomeCirculation: Cardiovascular InterventionsVol. 11, No. 11Love in Vain? Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBLove in Vain?Drug-Eluting Stents and the Saphenous Bypass Vein Michael P. Savage, MD and David L. Fischman, MD Michael P. SavageMichael P. Savage Michael P. Savage, MD, Jefferson Angioplasty Center, Suite 6210, Gibbon Bldg, 111 S 11th St, Philadelphia, PA 19107. Email E-mail Address: [email protected] Department of Medicine (Cardiology), Thomas Jefferson University Hospital, Philadelphia, PA. and David L. FischmanDavid L. Fischman Department of Medicine (Cardiology), Thomas Jefferson University Hospital, Philadelphia, PA. Originally published16 Nov 2018https://doi.org/10.1161/CIRCINTERVENTIONS.118.007458Circulation: Cardiovascular Interventions. 2018;11:e007458This article is a commentary on the followingDrug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft InterventionSee Article by Patel et alTo paraphrase Mark Twain, the demise of the saphenous vein bypass graft has been greatly exaggerated. Despite a 30% decline during the past decade, coronary artery bypass grafting (CABG) remains one of the most commonly performed surgical procedures with ≈400 000 operations performed annually in the United States alone.1 Compared with percutaneous coronary intervention, CABG provides superior outcomes to many patients, especially those with diabetes mellitus, poor left ventricular function, and complex multivessel coronary artery disease. Present guidelines confer CABG a class I recommendation for patients with unprotected left main disease, 3-vessel coronary artery disease, 2-vessel coronary artery disease with involvement of the proximal left anterior descending coronary artery, and for those with unacceptable angina despite optimized medical therapy.2The saphenous vein remains the most commonly used conduit for CABG. Patients undergoing CABG typically have 3 or 4 vessels grafted. Although use of the left internal mammary artery to bypass the left anterior descending is standard, the remaining vessels are most often bypassed with a saphenous vein graft (SVG). Despite the apparent benefits of arterial grafts, only 10% of patients undergoing CABG receive >1 arterial graft.3 Although the saphenous vein has a short-term procedural advantage in that it can be harvested to provide multiple bypasses, there is a distinct long-term disadvantage because of accelerated atherosclerosis. Within the first decade from surgery, most SVG will be occluded or have severe atherosclerotic disease.4,5 Although aspirin and statins have been shown to help prevent SVG disease, failure to maintain these simple therapies long-term is not uncommon and contributes to the problem of late graft attrition. In one series of 381 patients referred for coronary angiography on average more than 10 years after CABG, only 52% of patients had continued taking both aspirin and a statin.6Revascularization of patients with SVG disease is problematic.7,8 Reoperation is associated with a heightened risk of morbidity and mortality, and percutaneous coronary intervention is often the preferred option. However, percutaneous coronary intervention of aged SVG is also a high-risk endeavor with early postprocedural complications of distal embolization, no-reflow, and myocardial infarction, as well as common late complications of restenosis and graft closure. Accordingly, when faced with the presence of SVG disease, the feasibility of revascularizing the native vessel should be considered first, particularly if the graft has diffuse degenerative disease. Intervention on the native coronary artery may also be difficult in this setting because of chronic total occlusion or complex disease and may necessitate referral to centers proficient in advanced techniques.The preeminent role of coronary stenting in the treatment of SVG disease was established by the SAVED trial (Saphenous Vein De Novo).9 In this prospective trial, 220 patients with de novo SVG lesions were randomized to either balloon angioplasty or bare-metal stent (BMS) placement. Compared with balloon angioplasty, stenting resulted in improved procedural outcomes and superior angiographic results at 6-month follow-up.Freedom from a major cardiac event at 240 days (death, myocardial infarction, repeat CABG, or target lesion revascularization [TLR]) was significantly higher in the stent group (73% versus 58%; P=0.03). Nevertheless, despite these improved outcomes, BMS was associated with a relatively high rate (37%) of angiographic restenosis. With the advent of drug-eluting stents (DES), it was hoped that clinical outcomes could be further improved by reducing restenosis.The literature on the efficacy of DES in vein grafts has been a veritable roller coaster ride. Initially, the results of small randomized trials of first-generation DES were promising. The RRISC trial (Reduction of Restenosis in Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; n=75) and SOS trial (Stenting of Saphenous Vein Grafts; n=80) demonstrated less restenosis and fewer TLR during the first year with DES.10,11 However, a subsequent analysis from the RRISC trial, which assessed late clinical outcomes at a mean of 32 months post-procedure, found that the earlier reduction in TLR with DES at 6 months was lost at longer term follow-up.12 In addition, late mortality was significantly higher in the DES group than in the BMS group.An upswing in the enthusiasm for DES in SVG was created by the initial publication of the ISAR-CABG trial (Efficacy Study of Drug-Eluting and Bare Metal Stents in Bypass Graft Lesions).13 This was a larger randomized trial of 610 patients whose primary end point was the combined incidence of death, myocardial infarction, and TLR at 1 year. The primary end point was significantly reduced by DES (15% versus 22%; P=0.02), driven mostly by a reduction in TLR (7% versus 13%; P=0.01).Recently, the 5-year outcomes from the ISAR-CABG trial have been published.14 The benefit of DES over BMS seen at 1 year was lost at 5 years because of higher attrition of efficacy in the DES group. At 5 years, TLR occurred in 25.5% of the BMS group and 33.1% of the DES group (P=0.27). There was a significant interaction between treatment effect and time. Although TLR was significantly lower in the DES group at 1 year, between 1 and 5 years, the opposite was true with TLR being 2-fold higher in the DES group. These results coupled with that of the DELAYED RRISC study (Death and Events at Long-Term Follow-Up Analysis: Extended Duration of the Reduction of Restenosis in Saphenous Vein Grafts With Cypher Stent) suggest a catchup phenomenon for DES in SVG whereby an early beneficial effect is lost because of an excess in later events (Figure).Download figureDownload PowerPointFigure. Catchup phenomenon of drug-eluting stents (DES) in saphenous vein grafts. At 6 and 12 mo, respectively, the RRISC (Reduction of Restenosis in Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent) and ISAR-CABG (Efficacy Study of Drug-Eluting and Bare Metal Stents in Bypass Graft Lesions) trials demonstrated significantly lower rates of target lesion revascularization (TLR) with drug-eluting stents. Subsequently, more revascularization events occurred with drug-eluting than bare-metal stents (BMS) so that on longer term follow-up, the benefit of drug-eluting stents disappeared.More sobering news for DES in SVG came with publication of the DIVA trial (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty), which enrolled 599 patients at 25 Veterans Administration centers.15 In contrast to prior SVG trials that utilized first-generation DES, the DIVA trial was unique in that mainly second-generation DES were used. At 12 months, the incidence of target vessel failure (cardiovascular death, myocardial infarction, or target vessel revascularization [TVR]) was similar in the DES and BMS groups (17% versus 19%; P=0.70). Similar results were observed during longer term follow-up at 2.7 years.Given the mixed results of DES trials in SVG, the updated meta-analysis by Patel et al16 in the current issue of Circulation: Cardiovascular Interventions is particularly timely. The authors identified 6 randomized trials involving 1582 patients. There were no statistically significant differences between DES and BMS for mortality, myocardial infarction, TVR, stent thrombosis, or composite major adverse cardiac events. The absence of a significant reduction in TVR is especially notable, although there was a trend toward lower TVR with DES (relative risk, 0.73; 95% CI, 0.48–1.11; P=0.14). The findings of this meta-analysis conflict with most prior meta-analyses, which reported that DES reduce TVR and major adverse cardiac events when used in SVG.17 What differentiates the current analysis from earlier publications is the inclusion not only of the DIVA trial but also the recent 5-year follow-up of ISAR-CABG. The negative results of these 2 largest SVG trials factored heavily into the findings of the updated meta-analysis.Why are DES so much less effective in SVG than in native coronary arteries? The answer likely relates to the differences in biology of veins and arteries. Designed to function in a low-pressure milieu, veins have much thinner walls owing to a sparse tunica media containing much less smooth muscle than arteries. Accordingly, the processes leading to restenosis and the biological effects of antiproliferative agents are likely different in SVG. In contrast to restenosis in coronary arteries, which is mainly because of smooth muscle cell proliferation and neointima formation, restenosis of SVG stents occurs later and more often involves neoatherosclerosis, inflammation, and thrombosis.18 Compared with BMS, the pathology of DES in SVG is characterized by delayed healing with increased peristent fibrin deposition, less endothelialization, more uncovered stent struts, and late stent thrombosis.19 These effects may account for the late catchup phenomenon observed clinically with DES.Does the report by Patel indicate that use of DES in SVG should be abandoned? We think not. A reassuring aspect of the meta-analysis was the safety of DES with respect to mortality and stent thrombosis. TLR seems to be reduced by DES at least early on (and the longer term trend still favors DES albeit not statistically significant). What this analysis highlights is that there is more work to be done in the management of SVG disease. We must continue to explore novel strategies. One possible approach would be the use of more potent or prolonged antiplatelet regimens.20 Development of DES, which promotes more rapid healing, would be another attractive option. Finally, if the current disappointing results of SVG intervention encourage our surgical colleagues to use more arterial bypass conduits, that would not be a bad thing. After all, the most effective way to prevent bypass graft disease of the saphenous vein is to leave it in the leg.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circinterventionsMichael P. Savage, MD, Jefferson Angioplasty Center, Suite 6210, Gibbon Bldg, 111 S 11th St, Philadelphia, PA 19107. Email michael.[email protected]eduReferences1. Alexander JH, Smith PK. Coronary-artery bypass grafting.N Engl J Med. 2016; 374:1954–1964. doi: 10.1056/NEJMra1406944CrossrefMedlineGoogle Scholar2. Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines.Circulation. 2011; 124:e652–e735. doi: 10.1161/CIR.0b013e31823c074eLinkGoogle Scholar3. Gaudino M, Benedetto U, Fremes S, Biondi-Zoccai G, Sedrakyan A, Puskas JD, Angelini GD, Buxton B, Frati G, Hare DL, Hayward P, Nasso G, Moat N, Peric M, Yoo KJ, Speziale G, Girardi LN, Taggart DP; RADIAL Investigators. 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Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G; DELAYED RRISC (Death and Events at Long-Term Follow-Up Analysis: Extended Duration of the Reduction of Restenosis in Saphenous Vein Grafts With Cypher Stent) Investigators. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC trial.J Am Coll Cardiol. 2007; 50:261–267. doi: 10.1016/j.jacc.2007.05.010CrossrefMedlineGoogle Scholar13. Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schömig A, Kastrati A; Is Drug-Eluting-Stenting Associated With Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. 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Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.Lancet. 2018; 391:1997–2007. doi: 10.1016/S0140-6736(18)30801-8CrossrefMedlineGoogle Scholar16. Patel NJ, Bavishi C, Atti V, Tripathi A, Nalluri N, Cohen MG, Kini AS, Sharma SK, Dangas G, Bhatt DL. Drug-eluting stents versus bare-metal stents in saphenous vein graft intervention: an updated meta-analysis of randomized controlled trials.Circ Cardiovasc Interv. 2018; 11:e007045. doi: 10.1161/CIRCINTERVENTIONS.118.007045LinkGoogle Scholar17. Shah R, Jovin IS, Latham SB, Hesterberg K, Heckle MR, Rashid A, Vetrovec GW. A comprehensive meta-analysis of randomized controlled trials comparing drug-eluting stents with bare-metal stents in saphenous vein graft interventions [published online July 26, 2018].Catheter Cardiovasc Interv. doi: 10.1002/ccd.27687Google Scholar18. Depre C, Havaux X, Wijns W. Pathology of restenosis in saphenous bypass grafts after long-term stent implantation.Am J Clin Pathol. 1998; 110:378–384.CrossrefMedlineGoogle Scholar19. Yazdani SK, Farb A, Nakano M, Vorpahl M, Ladich E, Finn AV, Kolodgie FD, Virmani R. Pathology of drug-eluting versus bare-metal stents in saphenous vein bypass graft lesions.JACC Cardiovasc Interv. 2012; 5:666–674. doi: 10.1016/j.jcin.2011.12.017CrossrefMedlineGoogle Scholar20. Redfors B, Généreux P, Witzenbichler B, McAndrewT , Diamond J, Huang X, Maehara A, Weisz G, Mehran R, Kirtane AJ, Stone GW. Percutaneous coronary intervention of saphenous vein graft.Circ Cardiovasc Interv. 2017; 10:e004953. doi: 10.1161/CIRCINTERVENTIONS.117.004953LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Nardone E, Madsen B, McCarey M, Fischman D, Ruggiero N, Walinsky P, Vishnevsky A and Savage M (2021) Percutaneous coronary intervention of totally occluded coronary venous bypass grafts: An exercise in futility?, World Journal of Cardiology, 10.4330/wjc.v13.i9.493, 13:9, (493-502), Online publication date: 26-Sep-2021. Related articlesDrug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft InterventionNileshkumar J. Patel, et al. Circulation: Cardiovascular Interventions. 2018;11 November 2018Vol 11, Issue 11 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007458PMID: 30571218 Originally publishedNovember 16, 2018 Keywordsaspirindrug-eluting stentspercutaneous coronary interventioncoronary artery bypass surgerycoronary stentsEditorialsPDF download Advertisement SubjectsStent

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.