Advertisement

Everolimus-Eluting Versus Paclitaxel-Eluting Stents for Treatment of Bare Metal Stent Restenosis

      First-generation drug-eluting stents have been proved to be very effective for the treatment of bare metal stent in-stent restenosis (BMS ISR). The efficacy of second-generation drug-eluting stents in this setting remains less well defined. The present study compared the long-term clinical outcome after treatment of BMS ISR using the second-generation everolimus-eluting stent (EES) to that after treatment using the paclitaxel-eluting stent (PES). A total of 174 patients with BMS ISR underwent percutaneous coronary intervention using a PES (95 patients) or an EES (79 patients) from 2003 to 2010. The patients in the PES and EES groups were followed up for 42.2 ± 22.2 and 18.3 ± 8.2 months, respectively. The primary end point of the study was survival free of major adverse cardiac events at 1 year. The secondary end points were survival free of the need for revascularization of the target lesion and definite stent thrombosis. The baseline clinical and angiographic parameters were comparable between the 2 groups. The freedom from major adverse cardiac event rate at 1 year of follow-up was 4.5% and 13.6% (p = 0.0663) for the EES and PES groups, respectively. The target lesion revascularization (TLR) rates were greater in the PES group at 1 year of follow-up compared to the EES group (1% vs 11.5%, p = 0.0193). The rate of myocardial infarction, death, and definite stent thrombosis for the EES and PES groups at 1 year of follow-up was 0% versus 4.2% (p = 0.0984), 3% versus 2.1% (p = 0.6855), and 0% versus 2.1% (p = 0.2382), respectively. The use of a PES for treatment of ISR was the only independent predictor of recurrent TLR at 1 year of follow-up (odds ratios 1.11, 95% confidence interval 1.05 to 1.18; p = 0.0193). During the complete follow-up period, the rates of TLR, myocardial infarction, death, major adverse cardiac events, and definite stent thrombosis were not different between the 2 treatment groups. In conclusion, EES resulted in reduced rates of TLR at 1 year of follow-up compared to PES when used for treatment of BMS ISR. However, at long-term follow-up, the event rates between EES and PES were comparable after treatment of BMS ISR.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Yokoi H.
        • Kimura T.
        • Nakagawa Y.
        • Nosaka H.
        • Nobuyoshi M.
        Long-term clinical and quantitative angiographic follow-up after the Palmaz-Schatz Stent restenosis.
        J Am Coll Cardiol. 1996; 27: 224A-225A
        • Morice M.C.
        • Serruys P.W.
        • Sousa J.E.
        • Fajadet J.
        • Ban Hayashi E.
        • Perin M.
        • Colombo A.
        • Schuler G.
        • Barragan P.
        • Guagliumi G.
        • Molnàr F.
        • Falotico R.
        • RAVEL Study Group
        A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.
        N Engl J Med. 2002; 346: 1773-1880
        • 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.
        • Russell M.E.
        • Taxus-IV Investigators
        A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.
        N Engl J Med. 2004; 350: 221-231
        • Alfonso F.
        • Pérez-Vizcayno M.J.
        • Hernandez R.
        • Bethencourt A.
        • Martí V.
        • López-Mínguez J.R.
        • Angel J.
        • Mantilla R.
        • Morís C.
        • Cequier A.
        • Sabaté M.
        • Escaned J.
        • Moreno R.
        • Bañuelos C.
        • Suárez A.
        • Macaya C.
        • RIBS-II Investigators
        A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial.
        J Am Coll Cardiol. 2006; 47: 2152-2160
        • Holmes Jr, D.R.
        • Teirstein P.
        • Satler L.
        • Sketch M.
        • O'Malley J.
        • Popma J.J.
        • Kuntz R.E.
        • Fitzgerald P.J.
        • Wang H.
        • Caramanica E.
        • Cohen S.A.
        • SISR Investigators
        Sirolimus-eluting stents vs. vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial.
        JAMA. 2006; 295: 1264-1273
        • Radke P.W.
        • Kobella S.
        • Kaiser A.
        • Franke A.
        • Schubert D.
        • Grube E.
        • Hanrath P.
        • Hoffmann R.
        Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary beta-radiation therapy.
        Eur Heart J. 2004; 25: 920-925
        • Stone G.W.
        • Rizvi A.
        • Newman W.
        • Mastali K.
        • Wang J.C.
        • Caputo R.
        • Doostzadeh J.
        • Cao S.
        • Simonton C.A.
        • Sudhir K.
        • Lansky A.J.
        • Cutlip D.E.
        • Kereiakes D.J.
        • SPIRIT IV Investigators
        Everolimus-eluting versus paclitaxel-eluting stent in coronary artery disease.
        N Engl J Med. 2010; 362: 1728-1730
        • Mehran R.
        • Dangas G.
        • Abizaid A.S.
        • Mintz G.S.
        • Lansky A.J.
        • Satler L.F.
        • Pichard A.D.
        • Kent K.M.
        • Stone G.W.
        • Leon M.B.
        Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome.
        Circulation. 1999; 100: 1872-1878
        • Dussaillant G.R.
        • Mintz G.S.
        • Pichard A.D.
        • Kent K.M.
        • Satler L.F.
        • Popma J.J.
        • Wong S.C.
        • Leon M.B.
        Small stent size and intimal hyperplasia contribute to restenosis: a volumetric intravascular ultrasound analysis.
        J Am Coll Cardiol. 1995; 26: 720-724
        • Hoffmann R.
        • Mintz G.S.
        • Dussaillant G.R.
        • Popma J.J.
        • Pichard A.D.
        • Satler L.F.
        • Kent K.M.
        • Griffin J.
        • Leon M.B.
        Patterns and mechanisms of in-stent restenosis: a serial intravascular ultrasound study.
        Circulation. 1996; 94: 1247-1254
        • Dibra A.
        • Kastarati A.
        • Alfonso F.
        • Seyfarth M.
        • Pérez-Vizcayno M.J.
        • Mehilli J.
        • Schömig A.
        Effectiveness of drug eluting stents in patients with bare metal in stent restenosis—metaanalysis of randomized trials.
        J Am Coll Cardiol. 2007; 49: 616-623
        • Ellis S.G.
        • O'Shaughnessy C.D.
        • Martin S.L.
        • Kent K.
        • McGarry T.
        • Turco M.A.
        • Kereiakes D.J.
        • Popma J.J.
        • Friedman M.
        • Koglin J.
        • Stone G.W.
        • Taxus V ISR Investigators
        Two year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis.
        Eur Heart J. 2008; 29: 1625-1634
        • Kastrati A.
        • Dibra A.
        • Eberle S.
        • Mehilli J.
        • Suárez de Lezo J.
        • Goy J.J.
        • Ulm K.
        • Schömig A.
        Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial.
        JAMA. 2005; 293: 165-171
        • Saia F.
        • Lemos P.A.
        • Hoye A.
        • Sianos G.
        • Arampatzis C.A.
        • de Feyter P.J.
        • van der Giessen W.J.
        • Smits P.C.
        • van Domburg R.T.
        • Serruys P.W.
        Clinical outcomes for sirolimus-eluting stent implantation and vascular brachytherapy for the treatment of in-stent restenosis.
        Cathet Cardiovasc Intervent. 2004; 62: 283-288
        • Stone G.W.
        • Ellis S.G.
        • O'Shaughnessy C.D.
        • Martin S.L.
        • Satler L.
        • McGarry T.
        • Turco M.A.
        • Kereiakes D.J.
        • elley K.
        • Popma J.J.
        • Russell M.E.
        • Taxus V ISR Investigators
        Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare metal stents: the Taxus V ISR randomized trial.
        JAMA. 2006; 295 (L): 1253-1263
        • Liistro F.
        • Fineschi M.
        • Grotti S.
        • Angioli P.
        • Carrera A.
        • Ducci K.
        • Gori T.
        • Falsini G.
        • Pierli C.
        • Bolognese L.
        Long-term effectiveness and safety of sirolimus-eluting stent implantation for coronary in stent restenosis: results of the TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry at 4 years.
        J Am Coll Cardiol. 2010; 55: 613-616
        • Holmes Jr, D.R.
        • Teirstein P.S.
        • Satler L.
        • Sketch Jr, M.H.
        • Popma J.J.
        • Mauri L.
        • Wang H.P.
        • Schleckser P.A.
        • Cohen S.A.
        • SISR Investigators
        3-Year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial.
        JACC Intv. 2008; 1: 439-448