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TRUE

Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis

Issue: March 2010

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Trial was conducted to assess clinical outcome of the efficacy and safety of sirolimus-eluting stents for in-stent restenosis four years after implantation.

Design: prospective, single arm
Patients: 244
Centers: 2
Country: Italy

RESULTS: Overall mortality was 9.8%, with 11 patients experiencing cardiac death. Eight patients died from a cardiac event and 27 experienced target lesion revascularization. Cumulative event-free survival was 80.3%. Five patients experienced definite stent thrombosis (2%) and another two experienced possible stent thrombosis (0.8%). Diabetes was an independent negative predictor of freedom from target lesion revascularization (OR=0.38; 95% CI, 0.20-0.71; P=0.002).

Published in: J Am Coll Cardiol. 2010;55:613-616.

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