Angiorad Radiation Therapy for In-Stent Restenosis Trial In Coronaries - ARTISTIC

Description:

Gamma radiation to prevent instent restenosis of native coronary arteries

Hypothesis:

Gamma radiation will be safe and efficacious in inhibiting endothelial proliferation and decrease the incidence of recurrent in-stent restenosis.

Study Design

Study Design:

Patients Enrolled: 290
Mean Follow Up: 6 months

Patient Populations:

Stable or unstable angina with objective evidence of ischemia Single in-stent restenosis lesion Refernce vessel diameter betweeen 2.5 mm and 5.0 mm Lesion <25 mm

Primary Endpoints:

Clinical: MACE and target vessel failure at 6 months Angiographic: Binary restenosis at 6 months

Drug/Procedures Used:

Patients with in-stent restenosis of a native coronary artery are randomized to administration of gamma radiation or no adjunctive therapy after catheter baseed intervention. Intravascular ultrasound was not used for dosimetry. Doses of 12, 15, or 18 Gy are administered using an Ir125 source.

Principal Findings:

In preliminary verbal report of 26 patients, there was a 96% technical success rate. There were no in-hospital or 30-day major adverse cardiac events. At 6 months, the rate of major adverse cardiac events (MACE) was 15%. The restenosis rate was 9.5% for in-stent restenosis and 14% in-lesion restenosis.

Interpretation:

Conclusions from this study are pending report of final results with a larger number of patients.

References:

Ronald Waksman, MD. Washington Hospital Center. Verbal Report to Transcatheter Therapeutics.

Durairaj A, Faxon DP. The ARTISTIC and ARREST trials. J Invasive Cardiol 2000 Jan;12(1):44-9.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Gamma Rays, Stents


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