Three-year follow-up after intracoronary gamma radiation therapy for in-stent restenosis. Original WRIST. Washington Radiation for In-Stent Restenosis Trial.
BACKGROUND
The Washington Radiation for In-Stent Restenosis Trial (WRIST) is a double-blinded randomized study evaluating the effects of intracoronary radiation therapy (IRT) in patients with in-stent restenosis (ISR).


METHODS
One hundred and thirty patients with ISR (100 native coronary and 30 vein grafts) underwent PTCA, laser ablation, rotational atherectomy, and/or additional stenting (36% of lesions). Patients were randomized to either Iridium-192 IRT or placebo, with a prescribed dose of 15 Gy to a 2-mm radial distance from the center of the source.


RESULTS
Angiographic restenosis (27% vs. 56%, P=.002) and target vessel revascularization (TVR; 26% vs. 66%, P<.001) were dramatically reduced at 6 months in IRT patients. Between 6 and 36 months, IRT compared to placebo patients had more target lesion revascularization (TLR; IRT=17% vs. placebo=2%, P=.002) and TVR (IRT=17% vs. placebo=3%, P=.009). At 3 years, the major adverse cardiac event (MACE) rate was significantly reduced with IRT (39% vs. 65%, P=.003).


CONCLUSIONS
In WRIST, patients with ISR treated with IRT using 192Ir had a marked reduction in the need for repeat target lesion and vessel revascularization at 6 months, with the clinical benefit maintained at 3 years.
Ajani
A E
AE
Washington Hospital Center and Washington Cancer Institute at the Washington Hospital Center, Washington, DC 20010, USA.
Waksman
R
R
Sharma
A K
AK
Cha
D H
DH
Cheneau
E
E
White
R L
RL
Canos
D
D
Pichard
A D
AD
Satler
L F
LF
Kent
K M
KM
Pinnow
E
E
Lindsay
J
J
D001918:Brachytherapy; D023903:Coronary Restenosis / Q000532:radiotherapy*; D023921:Coronary Stenosis / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D015607:Stents; D013997:Time Factors
D007496:Iridium Radioisotopes