The Proliferation REduction with Vascular ENergy Trial (PREVENT)

PREVENT was the first prospective, randomized placebo-controlled study of intracoronary beta radiotherapy with (32)P. A total of 105 patients with de novo or restenotic lesions, treated by stenting or balloon angioplasty, received 0 (control), 16, 20, or 24 Gy to a depth of 1 mm beyond the lumen surface. Rates of restenosis (50% diameter stenosis or more) were significantly lower in radiotherapy patients at the target site (8% compared with 39%, P = 0.012) and at the target site plus adjacent segments (22% compared with 50%, P = 0.018). Stenosis adjacent to the target site and late thrombotic events reduced the overall clinical benefit of radiotherapy.