(Circulation. 2000;101:e9017.)
© 2000 American Heart Association, Inc.
Cardiovascular News |
From St Lukes Episcopal Hospital, Texas Heart Institute, Baylor College of Medicine, The University of Texas Health Science Center at Houston.
The following studies were presented at the 11th Annual Symposium on Transcatheter Cardiovascular Therapeutics, September 2226, 1999, in Washington, DC.
Radiation Therapy for In-Stent Restenosis
GAMMA 1
The Presenter: Martin Leon,
Cardiology Research Foundation, Washington Heart
Center, Washington, DC.
The Study: A multicenter, randomized, prospective, placebo-controlled study of radiation therapy for in-stent restenosis. A total of 252 patients with in-stent restenosis in native coronary arteries were randomized to receive adjunctive radiation therapy with an Ir192 gamma source (n=131) or sham placebo treatment (n=121) after percutaneous therapy (at the discretion of the operator). Dosimetry was guided by intraprocedural intravascular ultrasound (IVUS) measurements. All patients received aspirin and ticlopidine for 8 weeks. Follow-up angiography was performed at 6 months, with measurement of both in-lesion and in-stent minimum lumen diameter (MLD). The primary end point of the study was the cumulative incidence of adverse clinical events (death, myocardial infarction [MI], or target lesion revascularization) at 9 months.
Results: More than 80% of the patients received additional
adjunctive stents as part of their therapy. In-hospital outcomes were
similar between groups. The primary end point was significantly reduced
in the radiation therapy group (28.2% versus 43.8% in the sham
treatment group); this was largely driven by a dramatic reduction in
the need for target vessel revascularization.
However, the composite incidence of death or MI tended to be somewhat
higher in the radiation therapy group (16% versus 8% in the sham
treatment group), and there was a significant increase in the incidence
of late stent closure in the radiation therapy group (6.1% versus
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