Inhibition of Restenosis With b-Emitting Radiotherapy.pdfVIP

Clinical Investigation and Reports Inhibition of Restenosis With -Emitting Radiotherapy Report of the Proliferation Reduction With Vascular Energy Trial (PREVENT) Albert E. Raizner, MD; Stephen N. Oesterle, MD; Ron Waksman, MD; Patrick W. Serruys, MD, PhD; Antonio Colombo, MD; Yean-Leng Lim, MD; Alan C. Yeung, MD; Wim J. van der Giessen, MD, PhD; Lynn Vandertie, MS; Joseph K. Chiu, MD; Larry R. White, PhD; Peter J. Fitzgerald, MD, PhD; Grzegorz L. Kałuz˙a, MD, PhD; Nadir M. Ali, MD Background—Intracoronary - and -radiation have reduced restenosis in animal models. In the clinical setting, the effectiveness of -emitters has not been studied in a broad spectrum of patients, particularly those receiving stents. Methods and Results—A prospective, randomized, sham-controlled study of intracoronary radiotherapy with the -emitting 32P source wire, using a centering catheter and automated source delivery unit, was conducted. A total of 105 patients with de novo (70%) or restenotic (30%) lesions who were treated by stenting (61%) or balloon angioplasty (39%) received 0 (control), 16, 20, or 24 Gy to a depth of 1 mm in the artery wall. Angiography at 6 months showed a target site late loss index of 11 36% in radiotherapy patients versus 5530% in controls (P 0.0001). A low late loss index was seen in stented and balloon-treated patients and was similar across the 16, 20, and 24 Gy radiotherapy groups. Restenosis (50%) rates were significantly lower in radiotherapy patients at the target site (8% versus 39%; P 0.012) and at target site plus adjacent segments (22% versus 50%; P 0.018). Target lesion revascularization was needed in 5 radiotherapy patients (6%) and 6 controls (24%; P 0.05). Stenosis adjacent to the target site and