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.

Primary stenting of occluded native coronary arteries II--rationale and design of the PRISON II study: a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions.

Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of CTO. A total of 200 patients will be followed up for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate.

Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study.

BACKGROUND: Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions may decrease the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. METHODS: In a prospective, randomized trial, balloon angioplasty was compared with stent implantation for the treatment of chronic total occlusions. Patients were followed for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis was performed by an independent core lab. RESULTS: A total of 200 patients were enrolled. Baseline characteristics were evenly distributed. After the procedure the mean minimal luminal diameter in the conventional group was 2.34 +/- 0.46 mm versus 2.90 +/- 0.41 mm in the stented group (P <.0001). The 6-month angiographic follow-up showed a mean minimal luminal diameter of 1.57 +/- 0.74 mm in the conventional group versus 1.93 +/- 0.85 mm in the stented group (P =.009) and a mean diameter stenosis of 44.7% +/- 25.0% versus 35.5% +/- 26.5% (P =.036). Binary angiographic restenosis (>50% diameter stenosis) was seen in 33% in the conventional group versus 22% in the stented group (P =.137). The reocclusion rates were 7.3% and 8.2%, respectively (P = 1.00). At 12 month follow-up, the rate of target lesion revascularization was significantly higher in the conventional group (29% versus 13%, P <.0001). CONCLUSION: These data demonstrate that stenting of chronic total occlusions is superior to balloon angioplasty alone with a statistically significant reduction in the need for target lesion revascularization and a lower, but not significant, restenosis rate.