Intravascular Gamma Radiation for In-Stent Restenosis in Saphenous-Vein Bypass Grafts
Ron Waksman, M.D., Andrew E. Ajani, M.D., R. Larry White, M.D., Rosanna C. Chan, M.D., Lowell F. Satler, M.D., Kenneth M. Kent, M.D., Augusto D. Pichard, M.D., Ellen E. Pinnow, M.S., Anh B. Bui, M.D., Steven Ramee, M.D., Paul Teirstein, M.D., and Joseph Lindsay, M.D.
Background Intracoronary radiation therapy is effective in reducingthe recurrence of in-stent stenosis in native coronary arteries.We examined the effects of intravascular gamma radiation inpatients with in-stent restenosis of saphenous-vein bypass grafts.
Methods A total of 120 patients with in-stent restenosis insaphenous-vein grafts, the majority of whom had diffuse lesions,underwent balloon angioplasty, atherectomy, additional stenting,or a combination of these procedures. If the intervention wassuccessful, the patients were randomly assigned in a double-blindfashion to intravascular treatment with a ribbon containingeither iridium-192 or nonradioactive seeds. The prescribed dose,delivered at a distance of 2 mm from the source, was 14 to 15Gy in vessels that were 2.5 to 4.0 mm in diameter and 18 Gyin vessels with a diameter that exceeded 4.0 mm. The primaryend points were death from cardiac causes, Q-wave myocardialinfarction, revascularization of the target vessel, and a compositeof these events at 12 months.
Results Revascularization and radiation therapy were successfullyaccomplished in all patients. At six months, the restenosisrate was lower in the 60 patients assigned to the iridium-192group than in the 60 assigned to the placebo group (21 percentvs. 44 percent, P=0.005). At 12 months, the rate of revascularizationof the target lesion was 70 percent lower in the iridium-192group than in the placebo group (17 percent vs. 57 percent,P<0.001), and the rate of major cardiac events was 49 percentlower (32 percent vs. 63 percent, P<0.001).
Conclusions The results of our study support the use of gamma-radiationtherapy for the treatment of in-stent restenosis in patientswith bypass grafts.
Source Information
From Washington Hospital Center and the Washington Cancer Institute at Washington Hospital Center, Washington, D.C. (R.W., A.E.A., R.L.W., R.C.C., L.F.S., K.M.K., A.D.P., E.E.P., A.B.B., J.L.); the Oschner Clinic, New Orleans (S.R.); and the Scripps Clinic, San Diego, Calif. (P.T.).
Address reprint requests to Dr. Waksman at the Division of Cardiology, Washington Hospital Center, 110 Irving St., NW, Suite 4B-1, Washington, DC 20010, or at ron.waksman{at}medstar.net.
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