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(Circulation. 2004;109:340-344.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Five-Year Follow-Up After Intracoronary Gamma Radiation Therapy for In-Stent Restenosis

Ron Waksman, MD; Andrew E. Ajani, MD; R. Lawrence White, MD; Rosanna Chan, MD; Bill Bass, PhD; Augusto D. Pichard, MD; Lowell F. Satler, MD; Kenneth M. Kent, MD; Rebecca Torguson, BS; Regina Deible, RN; Ellen Pinnow, MS; Joseph Lindsay, MD

From Washington Hospital Center and Washington Cancer Institute at the Washington Hospital Center, Washington, DC.

Correspondence to Ron Waksman, MD, Washington Hospital Center, 110 Irving St NW, Suite 4B-1, Washington, DC 20010. E-mail ron.waksman{at}medstar.net

Received March 19, 2003; de novo received August 11, 2003; revision received October 10, 2003; accepted October 13, 2003.

Background— The Washington Radiation for In-Stent Restenosis Trial is a double-blinded randomized study evaluating the effects of intracoronary radiation therapy (IRT) in patients with in-stent restenosis (ISR).

Methods and Results— One hundred thirty patients with ISR (100 native coronary and 30 vein grafts) underwent percutaneous transluminal coronary angioplasty, laser ablation, rotational atherectomy, or additional stenting (36% of lesions). Patients were randomized to either 192-Iridium IRT or placebo, with a prescribed dose of 15 Gy to a 2-mm radial distance from the center of the source. Angiographic restenosis (27% versus 56%, P=0.002) and target vessel revascularization (26% versus 68%, P<0.001) were reduced at 6 months in patients treated with IRT. Between 6 and 60 months, patients treated with IRT compared with placebo had more target lesion revascularization (IRT, 21.6% versus placebo, 4.7%; P=0.04) and target vessel revascularization (IRT, 21.5% versus placebo, 6.1%; P=0.03). At 5 years, the major adverse cardiac event rate was significantly reduced with IRT (46.2% versus 69.2%, P=0.008).

Conclusions— In the Washington Radiation for In-Stent Restenosis Trial, patients with ISR treated with IRT using 192-Iridium had a reduction in the need for repeat target lesion and vessel revascularization at 6 months and 5 years.

Key Words: restenosis • angioplasty • revascularization • radioisotopes

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