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.