Advertisement

Percutaneous Coronary Intervention With Second-Generation Paclitaxel-Eluting Stents Versus Everolimus-Eluting Stents in United States Contemporary Practice (REWARDS TLX Trial)

      Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs.
      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

        • Turco M.A.
        • Ormiston J.A.
        • Popma J.J.
        • Mandinov L.
        • O'Shaughnessy C.D.
        • Mann T.
        • McGarry T.F.
        • Wu C.J.
        • Chan C.
        • Webster M.W.
        • Hall J.J.
        • Mishkel G.J.
        • Cannon L.A.
        • Baim D.S.
        • Koglin J.
        Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.
        J Am Coll Cardiol. 2007; 49: 1676-1683
        • Stone G.W.
        • Midei M.
        • Newman W.
        • Sanz M.
        • Hermiller J.B.
        • Williams J.
        • Farhat N.
        • Mahaffey K.W.
        • Cutlip D.E.
        • Fitzgerald P.J.
        • Sood P.
        • Su X.
        • Lansky A.J.
        • SPIRIT III Investigators
        Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial.
        JAMA. 2008; 299: 1903-1913
        • 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 stents in coronary artery disease.
        N Engl J Med. 2010; 362: 1663-1674
        • Kedhi E.
        • Joesoef K.S.
        • McFadden E.
        • Wassing J.
        • van Mieghem C.
        • Goedhart D.
        • Smits P.C.
        Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.
        Lancet. 2010; 375: 201-209
        • Smits P.C.
        • Kedhi E.
        • Royaards K.J.
        • Joesoef K.S.
        • Wassing J.
        • Rademaker-Havinga T.A.
        • McFadden E.
        2-Year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice.
        J Am Coll Cardiol. 2011; 58: 11-18
        • Silber S.
        • Windecker S.
        • Vranckx P.
        • Serruys P.W.
        • RESOLUTE All Comers investigators
        Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial.
        Lancet. 2011; 377: 1241-1247
        • Stone G.W.
        • Lansky A.J.
        • Pocock S.J.
        • Gersh B.J.
        • Dangas G.
        • Wong S.C.
        • Witzenbichler B.
        • Guagliumi G.
        • Peruga J.Z.
        • Brodie B.R.
        • Dudek D.
        • Möckel M.
        • Ochala A.
        • Kellock A.
        • Parise H.
        • Mehran R.
        • HORIZONS-AMI Trial Investigators
        Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction.
        N Engl J Med. 2009; 360: 1946-1959
        • Roy P.
        • Steinberg D.H.
        • Sushinsky S.J.
        • Okabe T.
        • Pinto Slottow T.L.
        • Kaneshige K.
        • Xue Z.
        • Satler L.F.
        • Kent K.M.
        • Suddath W.O.
        • Pichard A.D.
        • Weissman N.J.
        • Lindsay J.
        • Waksman R.
        The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents.
        Eur Heart J. 2008; 29: 1851-1857
        • Kereiakes D.J.
        • Cutlip D.E.
        • Applegate R.J.
        • Wang J.
        • Yaqub M.
        • Sood P.
        • Su X.
        • Su G.
        • Farhat N.
        • Rizvi A.
        • Simonton C.A.
        • Sudhir K.
        • Stone G.W.
        Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System).
        J Am Coll Cardiol. 2010; 56: 2084-2089