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.
Rahel
Braim M
BM
Department of Interventional Cardiology-OLVG, St Antonius Hospital Nieuwegein and Amsterdam, Nieuwegein, The Netherlands.
Laarman
Gert J
GJ
Suttorp
Maarten J
MJ
D000800:Angioplasty, Balloon / Q000379:methods; D002908:Chronic Disease; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003692:Delayed-Action Preparations; D005500:Follow-Up Studies; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000145:classification*
D003692:Delayed-Action Preparations; D020123:Sirolimus