Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions.

BACKGROUND Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. METHODS AND RESULTS In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. CONCLUSIONS In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.