5-year follow-up of XXXX -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.

@entity1 @entity583 @entity1397 @entity117 @entity736 @entity204
OBJECTIVES: We sought to evaluate the utility of the JOSTENT @entity736 ( @entity736 ) stent-graft (Jomed GmbH, Rangendingen, Germany) in @entity1 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 @entity1 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 @entity1 were treated with @entity117 indefinitely and @entity1397 for >= 8 months. Routine angiographic follow-up was performed at 8 months, and all @entity1 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 ( @entity204 , @entity583 , or clinically driven target vessel revascularization) occurred in 32.2% of @entity1 treated with the JOSTENT versus 22.1% of @entity1 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 @entity1 versus 51.8% of BMS @entity1 (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.
