Five-year clinical follow-up after intracoronary radiation: Results of a randomized clinical trial

• Published in: Circulation (New York, N.Y.) Vol. 105; no. 23; pp. 2737 - 2740
• Main Authors: GRISE, Mark A, MASSULLO, Vincent, TRIPURANENI, Prabhakar, TEIRSTEIN, Paul S, JANI, Shirish, POPMA, Jeffrey J, RUSSO, Robert J, SCHATZ, Richard A, GUARNERI, Erminia M, STEUTERMAN, Stephen, CLOUTIER, David A, LEON, Martin B
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 11.06.2002; American Heart Association, Inc
• Subjects: Aged; Biological and medical sciences; Brachytherapy; Cardiac Catheterization; Coronary Angiography; Coronary Circulation; Coronary Restenosis - blood; Coronary Restenosis - diagnosis; Coronary Restenosis - radiotherapy; Disease-Free Survival; Diseases of the cardiovascular system; Double-Blind Method; Female; Follow-Up Studies; Gamma Rays; Humans; Iridium Radioisotopes - administration & dosage; Iridium Radioisotopes - therapeutic use; Male; Medical sciences; Neovascularization, Pathologic; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents - adverse effects; Treatment Outcome; Human; Restenosis; Endoprosthesis; Gamma irradiation; Prognosis; Treatment; Follow up study; Coronary artery; Instrumentation therapy; Controlled therapeutic trial; Instrumental dilatation; Survival
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/01.CIR.0000018126.87045.E0

Several clinical trials indicate that intracoronary radiation is safe and effective for treatment of restenotic coronary arteries. We previously reported 6-month and 3-year clinical and angiographic follow-up demonstrating significant decreases in target lesion revascularization (TLR) and angiographic restenosis after gamma radiation of restenotic lesions. The objective of this study was to document the clinical outcome 5 years after treatment of restenotic coronary arteries with catheter-based iridium-192 (192Ir). A double-blind, randomized trail compared 192Ir to placebo sources in patients with restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to 192Ir and 29 to placebo. At 5-year follow-up, TLR was significantly lower in the 192Ir group (23.1% versus 48.3%; P=0.05). There were 2 TLRs between years 3 and 5 in patients in the 192Ir group and none in patients in the placebo group. The 5-year event-free survival rate (freedom from death, myocardial infarction, or TLR) was greater in 192Ir-treated patients (61.5% versus 34.5%; P=0.02). Despite apparent mitigation of efficacy over time, there remains a significant reduction in TLR at 5 years and an improvement in event-free survival in patients treated with intracoronary 192Ir. The early clinical benefits after intracoronary gamma radiation with 192Ir seem durable at 5-year clinical follow-up.