Randomized trial of 90Sr/90Y beta-radiation versus placebo control for treatment of in-stent restenosis.
BACKGROUND
After conventional treatment of in-stent restenosis, the incidence of recurrent clinical restenosis may approach 40%. We report the first multicenter, blinded, and randomized trial of intracoronary radiation with the use of a 90Sr/90Y beta-source for the treatment of in-stent restenosis.


RESULTS
After successful catheter-based treatment of in-stent restenosis, 476 patients were randomly assigned to receive an intracoronary catheter containing either 90Sr/90Y (n=244) or placebo (n=232) sources. The prescribed dose 2 mm from the center of the source was 18.4 Gy for vessels between 2.70 and 3.35 mm in diameter and 23.0 Gy for vessels between 3.36 and 4.0 mm. The primary end point, ie, clinically driven target-vessel revascularization by 8 months, was observed in 56 (26.8%) of the patients assigned to placebo and 39 (17.0%) of the patients assigned to radiation (P=0.015). The incidence of the composite including death, myocardial infarction, and target-vessel revascularization was observed in 60 (28.7%) of the patients assigned to placebo and 44 (19.1%) of the patients assigned to radiation (P=0.024). Binary 8-month angiographic restenosis (> or =50% diameter stenosis) within the entire segment treated with radiation was reduced from 45.2% in the placebo-treated patients to 28.8% in the 90Sr/90Y-treated patients (P=0.001). Stent thromboses occurred in 1 patient assigned to placebo <24 hours after the procedure and in 1 patient assigned to 90Sr/90Y at day 244.


CONCLUSIONS
The results of this study demonstrated that beta-radiation using 90Sr/90Y is both safe and effective for preventing recurrence in patients with in-stent restenosis.
Interventional Cardiology, Brigham and Women's Hospital, Boston, Mass 02115, USA. jpopma@partners.org
Jeffrey J
JJ
Popma
Mohan
M
Suntharalingam
Alexandra J
AJ
Lansky
Richard R
RR
Heuser
Burton
B
Speiser
Paul S
PS
Teirstein
Vincent
V
Massullo
Theodore
T
Bass
Randall
R
Henderson
Sigmund
S
Silber
Peter
P
von Rottkay
Raoul
R
Bonan
Kalon K L
KK
Ho
Alison
A
Osattin
Richard E
RE
Kuntz
D001610:Beta Particles / Q000009:adverse effects / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data*; D006328:Cardiac Catheterization; D002932:Cineangiography; D023903:Coronary Restenosis / Q000517:prevention & control / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D055502:Secondary Prevention; D015607:Stents / Q000009:adverse effects; D013326:Strontium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome; D014654:Vascular Patency / Q000528:radiation effects; D015021:Yttrium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*
D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes