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Previous Volume 344:250-256 January 25, 2001 Number 4 Next

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ABSTRACT

Background Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis.

Methods Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo).

Results The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral antiplatelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment.

Conclusions Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis.

Source Information

From the Cardiovascular Research Foundation, Lenox Hill Hospital, New York (M.B.L., J.W.M., A.J.L.); the Scripps Clinic, La Jolla, Calif. (P.S.T., P.T., S.J.); Cornell–New York Hospital, New York (S.C.W.); the Texas Heart Institute, Houston (D.F.); the Cleveland Clinic, Cleveland (S.E.); the Mayo Clinic, Rochester, Minn. (D.R.H.); Christ Hospital, Cincinnati (D.K.); and Brigham and Women's Hospital, Boston (R.E.K.).

Address reprint requests to Dr. Leon at the Cardiovascular Research Foundation, 130 E. 77th St., 9 Blackhall, New York, NY 10021, or at mleon{at}crf.org.

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