BACKGROUND: Previous experimental studies with a new covered stent, the autologous venous graft-covered stent (AVGCS), have shown favorable results. The aim of this study was to evaluate the feasibility and safety of this new technique in human coronary arteries and to compare the long-term outcome with uncovered stents. METHODS AND RESULTS: A venous graft was removed from an upper limb. A conventional stent then was covered by the venous graft. Fifty-eight AVGCS were implanted in 56 patients, including 16 patients with acute coronary syndromes (ACS). Additionally, in 114 patients, 138 uncovered stents were implanted, serving as a control group, including 38 patients with ACS. The procedure was successful in all patients. Stent thrombosis was observed in 3 patients in the control group and in 1 patient with an AVGCS. There was a trend for the minimal luminal diameter to be greater in the AVGCS group at follow-up (P =.07), and statistical significance was observed in patients with ACS (P <.01). The target vessel revascularization and the restenosis rates were similar between the 2 groups. In patients with ACS, the restenosis rate was less (P <.04) and there was a trend for target vessel revascularization to be less in covered stents (P =.09). The event-free survival rate at 4 years was 85% in the AVGCS group versus 81% in the control group (P = not significant); in ACS it was 94% versus 78%, respectively (P = not significant). Stents covered by thicker venous grafts were associated with improved clinical outcome. CONCLUSIONS: Stents covered by autologous venous grafts may be safely prepared without complications. This technique may prove to be a useful means, especially in patients with ACS.
BACKGROUND: Previous experimental studies with a new covered stent, the autologous venous graft-covered stent (AVGCS), have shown favorable results. The aim of this study was to evaluate the feasibility and safety of this new technique in human coronary arteries and to compare the long-term outcome with uncovered stents. METHODS AND RESULTS: A venous graft was removed from an upper limb. A conventional stent then was covered by the venous graft. Fifty-eight AVGCS were implanted in 56 patients, including 16 patients with acute coronary syndromes (ACS). Additionally, in 114 patients, 138 uncovered stents were implanted, serving as a control group, including 38 patients with ACS. The procedure was successful in all patients. Stent thrombosis was observed in 3 patients in the control group and in 1 patient with an AVGCS. There was a trend for the minimal luminal diameter to be greater in the AVGCS group at follow-up (P =.07), and statistical significance was observed in patients with ACS (P <.01). The target vessel revascularization and the restenosis rates were similar between the 2 groups. In patients with ACS, the restenosis rate was less (P <.04) and there was a trend for target vessel revascularization to be less in covered stents (P =.09). The event-free survival rate at 4 years was 85% in the AVGCS group versus 81% in the control group (P = not significant); in ACS it was 94% versus 78%, respectively (P = not significant). Stents covered by thicker venous grafts were associated with improved clinical outcome. CONCLUSIONS: Stents covered by autologous venous grafts may be safely prepared without complications. This technique may prove to be a useful means, especially in patients with ACS.