(Circulation. 2000;102:951.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Inhibition of Restenosis With ß-Emitting Radiotherapy
Report of the Proliferation Reduction With Vascular Energy Trial (PREVENT)
u
a, MD, PhDFrom Baylor College of Medicine, Houston, Tex (A.E.R., J.K.C., G.L.K., N.M.A.); Stanford University, Stanford, Calif (S.N.O., A.C.Y., P.J.F.); Washington Hospital Center, Washington, DC (R.W., L.R.W.); Thoraxcenter, Rotterdam, The Netherlands (P.W.S., W.J.v.d.G.); Centro Cuore Columbus, Milan, Italy (A.C.); National Heart Center, Singapore (Y.-L.L.); and Guidant Vascular Intervention, Santa Clara, Calif (L.V.).
Correspondence to Albert E. Raizner, MD, Director, Cardiac Catheterization Laboratories, The Methodist Hospital, 6535 Fannin, FB 1034, Houston, TX 77030. E-mail araizner{at}tmh.tmc.edu
Background—Intracoronary
- and ß-radiation have reduced restenosis in animal
models. In the clinical setting, the effectiveness of ß-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 ß-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 55±30% 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 late thrombotic events
reduced the overall clinical benefit of radiotherapy.
Conclusions—ß-radiotherapy with a centered 32P source is safe and highly effective in inhibiting restenosis at the target site after stent or balloon angioplasty. However, minimizing edge narrowing and late thrombotic events must be accomplished to maximize the clinical benefit of this modality.
Key Words: radiotherapy • radiation • restenosis • radioisotopes • stents • coronary disease
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|
|
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|
|
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|
|
|
|
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|
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|
|
|
|
|
|
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|
|
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|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
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|
|