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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 .
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Intervention_Physical
Primary stenting
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Intervention_Surgical
Primary intracoronary stent placement
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Intervention_Physical
conventional balloon angioplasty .
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Intervention_Physical
balloon angioplasty
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Intervention_Surgical
stent implantation
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Intervention_Control
conventional
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Intervention_Surgical
stented
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Intervention_Surgical
stented
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Intervention_Control
conventional
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Intervention_Surgical
stenting
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Intervention_Physical
balloon angioplasty alone
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Outcome_Physical
mean minimal luminal diameter
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Outcome_Physical
mean minimal luminal diameter
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Outcome_Physical
mean diameter stenosis
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Outcome_Physical
Binary angiographic restenosis
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Outcome_Other
reocclusion rates
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Outcome_Other
rate of target lesion revascularization
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Outcome_Physical
target lesion revascularization
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Outcome_Physical
restenosis rate
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Participant_Condition
chronic total occlusions
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Participant_Sample-size
200