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Scripps Coronary Radiation to Inhibit Proliferation Post Stenting III - SCRIPPS III
Description:
Registry to monitor occurence of stent thrombosis in patients who underwent stenting and irradiation with Ir-192 source.
Hypothesis:
Longer term anti-platelet therapy may be necessary after stenting and beta-radiation brachytherapy to prevent late stent thrombosis.
Study Design
Study Design:
Patients Enrolled: 500
Patient Populations:
Restenotic lesions within a stented area of a native coronary or bypass graft Reference vessel 2.75-4.0 mm Lesion length <81 mm
Primary Endpoints:
stent thrombosis mortality
Drug/Procedures Used:
Patients who underwent brachytherapy with a 14 Gy fixed dose of beta-radiation: Clopidigrel x 6 months Clopidigrel x 12 months if receiving a new stent at the time of irradiation
Principal Findings:
Of the patients in these registries, 25 percent in SCRIPPS-III and 29 percent in WRIST-Plus received new stents at the time of brachytherapy. Although all patients in these registries received antiplatelet drugs for at least 6 months, patients in the SCRIPPS-III registry who received new stents received antiplatelet therapy for 12 months. At the time of the review of the Checkmate device for premarketing approval, there were 534 patients registered in the two studies, of whom 206 had been followed for 210 days. Late thrombosis occurred in only three patients. In the combined population of these registries, thrombosis-free survival was 99 percent.
Interpretation:
No placebo group was available for comparison, and it is hard to draw conclusions regarding efficacy from this registry experience.
References:
New England Journal of Medicine 2001;344:297-99. (editorial) J Am Coll Cardiol 2001; 37 (Suppl A):60A (abstract)
Keywords: Beta Particles, Platelet Aggregation Inhibitors, Thrombosis, Coronary Disease, Blood Platelets, Iridium Radioisotopes, Brachytherapy, Stents
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