Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.
BACKGROUND
Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based (192)Ir.


RESULTS
A double-blind, randomized trial compared (192)Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to (192)Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the (192)Ir group (15. 4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in (192)Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49+/-0.81 to 2.12+/-0.73 mm in (192)Ir patients but was unchanged in placebo patients.


CONCLUSIONS
The early clinical benefits observed after treatment of coronary restenosis with (192)Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in (192)Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the (192)Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.
Teirstein
P S
PS
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA 92037, USA.
Massullo
V
V
Jani
S
S
Popma
J J
JJ
Russo
R J
RJ
Schatz
R A
RA
Guarneri
E M
EM
Steuterman
S
S
Sirkin
K
K
Cloutier
D A
DA
Leon
M B
MB
Tripuraneni
P
P
D000368:Aged; D000800:Angioplasty, Balloon; D001918:Brachytherapy / Q000401:mortality; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000532:radiotherapy* / Q000628:therapy; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use*; D008297:Male; D009203:Myocardial Infarction / Q000601:surgery / Q000628:therapy; D010919:Placebos; D012008:Recurrence; D015607:Stents; D016019:Survival Analysis
D007496:Iridium Radioisotopes; D010919:Placebos