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JACC Cardiovasc Interv. 2011 Mar;4(3):300-9. doi: 10.1016/j.jcin.2010.11.013.

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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  • 1Department of Medicine, Division of Cardiology, Columbia University, Medical Center/New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York 10022, USA. gs2184@columbia.edu

Abstract

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 [CI]: 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% CI: 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.

Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PMID:
21435608
[PubMed - indexed for MEDLINE]
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