Intracoronary radiation with gamma wire inhibits recurrent in-stent restenosis.
To study the safety and efficacy of intracoronary gamma radiation delivered via a new high-activity (192)Ir source wire for the treatment of in-stent restenosis. In-stent restenosis results from neointimal tissue proliferation especially in its diffused form and presents a therapeutic challenge. Gamma radiation has been shown to decrease neointima formation within stents in animal models and in initial clinical trials. A total of 26 patients with in-stent restenosis underwent successful intervention and was treated with open-label (192)Ir using a high-activity line source. The specific activity of the source wire was 372+/-51 mCi, and the dwell time was 10.8+/-1.9 min. Primary endpoints were freedom from death, myocardial infraction (MI), and repeat target lesion revascularization (TLR) at 6 months. Secondary endpoints included angiographic restenosis and intravascular ultrasound (IVUS) neointimal hyperplasia. Procedural success was high (96.2%), and in-hospital and 30-day complications were low with no deaths, MI, or requirement for repeat revascularization. At 6 months, event-free survival was 85%: one patient required repeat PTCA, one underwent bypass surgery, and two had an MI. Baseline lesion length measured 15.77 mm. Follow-up angiography was available in 21/25 (84%) patients. The binary restenosis rates were 19.0% (4/21) in-stent and 23.8% (5/21) in-lesion. Follow-up IVUS was available in 20/25 patients. There was no increase in intimal hyperplasia from postintervention to follow-up (3.11.8 vs. 3.41.8 mm(2); P=.32). Eight patients had a reduction of neointimal intimal tissue at follow-up. These results indicate that intracoronary gamma radiation with the Angiorad source wire is safe and effective in preventing in-stent restenosis.
Waksman
R
R
Washington Hospital Center, 110 Irving Street North West, Suite 4B-1, Washington, DC 20010, USA. rxw8@mhg.edu
Bhargava
B
B
Chan
R C
RC
Sherman
W
W
Pisch
J
J
Mintz
G S
GS
Lansky
A J
AJ
Ahmed
J
J
Ricci
N A
NA
Liprie
S F
SF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D001918:Brachytherapy / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis / Q000532:radiotherapy*; D004867:Equipment Design; D005260:Female; D005720:Gamma Rays; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000532:radiotherapy*; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D012008:Recurrence; D015607:Stents; D018084:Ultrasonography, Interventional
D007496:Iridium Radioisotopes