(Circulation. 2000;101:2165.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Intracoronary 
-Radiation Therapy After Angioplasty Inhibits Recurrence in Patients With In-Stent Restenosis
From the Cardiology Research Foundation, Division of Cardiology (R.W., G.S.M., R.M., A.J.L., M.B.L., L.F.S., L.G., B.B., K.M.K., A.D.P.), and the Washington Cancer Institute (R.L.W., R.C.C., B.G.B.), Washington Hospital Center, Washington DC; The Interventional Cardiology Department Thoraxcenter (P.W.S.), Erasmus University, Rotterdam, the Netherlands; and the Intravascular Ultrasound Core Laboratories (P.F.), Stanford University, Calif.
Background—Treatment of in-stent
restenosis presents a critical limitation of
intracoronary stent implantation. Ionizing radiation has been
shown to decrease neointimal formation within stents in
animal models and in initial clinical trials. We studied the effects of
intracoronary 
-radiation therapy versus placebo on the
clinical and angiographic outcomes of patients with in-stent
restenosis.
Methods and Results—One hundred thirty patients with in-stent
restenosis underwent successful coronary intervention
and were then blindly randomized to receive either
intracoronary -radiation with 192Ir (15 Gy) or
placebo. Four independent core laboratories blinded to the treatment
protocol analyzed the angiographic and intravascular ultrasound
end points of restenosis. Procedural success and in-hospital
and 30-day complications were similar among the groups. At 6 months,
patients assigned to radiation therapy required less target lesion
revascularization and target vessel
revascularization (9 [13.8%] and 17 [26.2%],
respectively) compared with patients assigned to placebo (41 [63.1%,
P=0.0001] and 44 [67.7%, P=0.0001],
respectively). Binary angiographic restenosis was lower in the
irradiated group (19% versus 58% for placebo,
P=0.001). Freedom from major cardiac events was lower in
the radiation group (29.2% versus 67.7% for placebo,
P<0.001).
Conclusions—Intracoronary -radiation used as adjunct
therapy for patients with in-stent restenosis significantly
reduces both angiographic and clinical restenosis.
Key Words: restenosis • angioplasty • revascularization • radioisotopes
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