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

详细信息    查看全文

• 作者：Gregg W. Stone ; MD^?/sup> ; ^{gs2184@columbia.edu} ; Sheldon Goldberg ; MD^&dagger ; ; Charles O'Shaughnessy ; MD^&Dagger ; ; Mark Midei ; MD^§ ; ; Robert M. Siegel ; MD^?/sup> ; Ecaterina Cristea ; MD^?/sup> ; George Dangas ; MD^?/sup> ; Alexandra J. Lansky ; MD^?/sup> ; Roxana Mehran ; MD^?/sup>
• 关键词：bypass graft ; coronary artery disease ; stent
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2011
• 出版时间：March 2011
• 年：2011
• 卷：4
• 期：3
• 页码：300-309
• 全文大小：527 K

文摘

| Figures/TablesFigures/Tables | ReferencesReferences

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 (?8 atm.) versus bare-metal stents (BMS). The JOSTENT patients were treated with aspirin indefinitely and clopidogrel for ? 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.