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(Circulation. 2002;105:2737.)
© 2002 American Heart Association, Inc.

Clinical Investigation and Reports

Five-Year Clinical Follow-Up After Intracoronary Radiation

Results of a Randomized Clinical Trial

Mark A. Grise, MD; Vincent Massullo, MD; Shirish Jani, PhD; Jeffrey J. Popma, MD; Robert J. Russo, MD, PhD; Richard A. Schatz, MD; Erminia M. Guarneri, MD; Stephen Steuterman, MS; David A. Cloutier, BS; Martin B. Leon, MD; Prabhakar Tripuraneni, MD; Paul S. Teirstein, MD

From the Division of Cardiovascular Diseases (M.A.G., R.J.R., R.A.S., E.M.G., S.S., D.A.C., P.S.T.) and Division of Radiation Oncology (V.M., S.J., P.T.), Scripps Clinic, La Jolla, Calif; Division of Cardiology (J.J.P.), Brigham and Women’s Hospital, Boston, Mass; and Division of Cardiology (M.B.L.), Lenox Hill, New York, NY.

Correspondence to Paul S. Teirstein, MD, Division of Cardiovascular Diseases, Scripps Clinic, 10666 North Torrey Pines Rd, La Jolla, CA 92037. E-mail Radman{at}scrippsclinic.com

Background— 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 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).

Methods and Results— 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).

Conclusions— 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 radiation with ¹⁹²Ir seem durable at 5-year clinical follow-up.

Key Words: restenosis • angioplasty • stents • radioisotopes

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