BACKGROUND: Radioactive stents with an activity of 0.75 to 12 microCi have shown >40% edge restenosis due to neointimal hyperplasia and negative remodeling. This trial evaluated whether radioactive Cold Ends stents might resolve edge restenosis by preventing remodeling at the injured extremities. METHODS AND RESULTS: The 25-mm long (15-mm radioactive center and 5-mm nonradioactive ends) Cold Ends stents had an activity of 3 to 12 microCi at implantation. Forty-three stents were implanted in 43 patients with de novo native coronary artery disease. Two procedural, 1 subacute, and 1 late stent thrombosis occurred. A restenosis rate of 22% was observed with a shift of the restenosis, usually occurring at the stent edges of radioactive stents, into the Cold Ends stents. The most severe restenosis occurred at the transition zone from radioactive to nonradioactive segments, a region located in dose fall-off. CONCLUSION: Cold Ends stents did not resolve edge restenosis.

*Coronary Angiography, Adult, Aged, Aged, 80 and over, Angina Pectoris/etiology, Blood Vessel Prosthesis Implantation/*adverse effects, Brachytherapy/*instrumentation/methods, Coronary Arteriosclerosis/drug therapy/*surgery, Coronary Thrombosis/etiology, Dose-Response Relationship, Radiation, Female, Fibrinolytic Agents/therapeutic use, Follow-Up Studies, Graft Occlusion, Vascular/diagnosis/*etiology/prevention & control, Humans, Male, Middle aged, Phosphorus Radioisotopes/therapeutic use, Platelet Aggregation Inhibitors/therapeutic use, Stents/*adverse effects, Treatment Outcome,
Circulation (Baltimore)
Erasmus MC: University Medical Center Rotterdam

Wardeh, A.J, Colombo, A, Albiero, R, Kay, I.P, Knook, A.H.M, Wijns, W, … van der Giessen, W.J. (2002). Angiographical follow-up after radioactive "Cold Ends" stent implantation: a multicenter trial. Circulation (Baltimore), 105(5), 550–553. doi:10.1161/hc0502.104539