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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
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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

Gregg W. Stone, Sheldon Goldberg, Charles O'Shaughnessy, Mark Midei, Robert M. Siegel, Ecaterina Cristea, George Dangas, Alexandra J. Lansky and Roxana Mehran
JACC. Cardiovascular interventions, v 4(3), pp 300-309
01 Mar 2011
DOI: https://doi.org/10.1016/j.jcin.2010.11.013
PMID: 21435608
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1016/j.jcin.2010.11.013View
Published, Version of Record (VoR)Open Access (Publisher-Specific),  Open

Abstract

Cardiac & Cardiovascular Systems Cardiovascular System & Cardiology Life Sciences & Biomedicine Science & Technology
Objectives We sought to evaluate the utility of the JOSTENT polytetrafluoroethylene (PTFE) stent-graft (Jomed GmbH, Rangendingen, Germany) in patients with diseased saphenous vein grafts (SVGs) undergoing percutaneous coronary intervention (PCI). Background Prior trials of the JOSTENT stent-graft did not mandate high-pressure implantation or prolonged dual antiplatelet therapy, and were limited by short-term follow-up. Methods A total of 243 patients at 47 centers with 1 to 2 discrete lesions in SVGs were prospectively randomized to JOSTENT implantation (>= 18 atm.) versus bare-metal stents (BMS). The JOSTENT patients were treated with aspirin indefinitely and clopidogrel for >= 8 months. Routine angiographic follow-up was performed at 8 months, and all patients were followed for 5 years. Results The primary end point of in-lesion binary restenosis occurred in 31.8% of lesions treated with the JOSTENT versus 28.4% of lesions treated with BMS (relative risk: 1.12, 95% confidence interval [Cl]: 0.72 to 1.75, p = 0.63). At 9 months, the major secondary end point of target vessel failure (death, myocardial infarction, or clinically driven target vessel revascularization) occurred in 32.2% of patients treated with the JOSTENT versus 22.1% of patients treated with BMS (hazard ratio: 1.54, 95% CI: 0.94 to 2.53, p = 0.08). During long-term follow-up, significantly more events accrued in the JOSTENT arm such that by 5 years target vessel failure had occurred in 68.3% of JOSTENT patients versus 51.8% of BMS patients (hazard ratio: 1.59, 95% Cl: 1.13 to 2.23, p = 0.007). Conclusions The long-term prognosis for diseased SVGs requiring PCI is dismal. The JOSTENT PTFE stent-graft results in inferior outcomes compared with BMS, despite high-pressure implantation and prolonged dual antiplatelet therapy, a finding that becomes more evident with longer-term follow-up. (J Am Coll Cardiol Intv 2011;4:300-9) (C) 2011 by the American College of Cardiology Foundation

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Cardiac & Cardiovascular Systems
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