Catheter-based radiotherapy to inhibit restenosis after coronary stenting.

Abstract

BACKGROUND:

In animal models of coronary restenosis, intracoronary radiotherapy has been shown to reduce the intimal hyperplasia that is a part of restenosis. We studied the safety and efficacy of catheter-based intracoronary gamma radiation plus stenting to reduce coronary restenosis in patients with previous restenosis.

METHODS:

Patients with restenosis underwent coronary stenting, as required, and balloon dilation and were then randomly assigned to receive catheter-based irradiation with iridium-192 or placebo. Clinical follow-up was performed, with quantitative coronary angiographic and intravascular ultrasonographic measurements at six months.

RESULTS:

Fifty-five patients were enrolled; 26 were assigned to the iridium-192 group and 29 to the placebo group. Angiographic studies were performed in 53 patients (96 percent) at a mean (+/-SD) of 6.7+/-2.2 months. The mean minimal luminal diameter at follow-up was larger in the iridium-192 group than in the placebo group (2.43+/-0.78 mm vs. 1.85+/-0.89 mm, P=0.02). Late luminal loss was significantly lower in the iridium-192 group than in the placebo group (0.38+/-1.06 mm vs. 1.03+/-0.97 mm, P=0.03). Angiographically identified restenosis (stenosis of 50 percent or more of the luminal diameter at follow-up) occurred in 17 percent of the patients in the iridium-192 group, as compared with 54 percent of those in the placebo group (P= 0.01). There were no apparent complications of the treatment.

CONCLUSIONS:

In this preliminary, short-term study of patients with previous coronary restenosis, coronary stenting followed by catheter-based intracoronary radiotherapy substantially reduced the rate of subsequent restenosis.

• Authors: P S Teirstein, V Massullo, S Jani, J J Popma, G S Mintz, R J Russo, R A Schatz, E M Guarneri, S Steuterman, N B Morris, M B Leon, P Tripuraneni
• Journal: The New England journal of medicine (N Engl J Med) Vol. 336 Issue 24 Pg. 1697-703 (Jun 12 1997) ISSN: 0028-4793 [Print] United States
• PMID: 9180087 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Iridium Radioisotopes

Topics

• Aged
• Angioplasty, Balloon, Coronary
• Cardiac Catheterization
• Combined Modality Therapy
• Coronary Angiography
• Coronary Disease (prevention & control, radiotherapy, therapy)
• Coronary Vessels (diagnostic imaging, pathology)
• Disease-Free Survival
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Iridium Radioisotopes (therapeutic use)
• Male
• Recurrence
• Stents
• Treatment Outcome
• Ultrasonography, Interventional