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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Long-Term Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis

Results of the TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry at 4 Years

Francesco Liistro, MD^_*,_*, Massimo Fineschi, MD, Simone Grotti, MD^_*, Paolo Angioli, MD^_*, Arcangelo Carrera, MD, Kenneth Ducci, MD^_*, Tommaso Gori, MD, Giovanni Falsini, MD^_*, Carlo Pierli, MD and Leonardo Bolognese, MD^_*

^_* Cardiovascular Department, San Donato Hospital, Arezzo, Italy
Cardiovascular Department, Le Scotte Hospital, Siena, Italy

Manuscript received June 26, 2009; revised manuscript received August 24, 2009, accepted August 24, 2009.

^_* Reprint requests and correspondence: Dr. Francesco Liistro, Department of Cardiovascular Disease, San Donato Hospital, Via Peitro Nenni 22, 52100 Arezzo, Italy (Email: francescoliistro{at}hotmail.com).

Objectives: The aim of this study was to evaluate the long-term clinical outcome of the efficacy and safety of sirolimus-eluting stents (SES) for in-stent restenosis (ISR) in the TRUE (Tuscany Registry of Unselected In-Stent Restenosis) database.

Background: The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis <1%) at 9 months. Clinical outcome at 4 years is reported.

Methods: A total of 244 patients with ISR who were treated with SES implantation represent the study population. The incidence of major adverse cardiac events was collected at 4 years.

Results: At 4-year follow-up, overall mortality was 9.8% (24 patients). Cardiac death occurred in 11 (4.5%), nonfatal myocardial infarction in 8 (3.2%), and TLR in 27 (11.1%) patients for a cumulative event-free survival rate of 80.3%. Definite stent thrombosis occurred in 5 (2%) patients and possible stent thrombosis in 2 (0.8%). Diabetes remained an independent negative predictor of freedom from TLR (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.20 to 0.71, p = 0.002) and major adverse cardiac events (OR: 0.38; 95% CI: 0.20 to 0.71, p = 0.002).

Conclusions: The clinical benefit of SES implantation for bare-metal stent ISR is maintained at 4 years with a low TLR rate and an overall incidence of stent thrombosis of 0.7% per year.

Key Words: sirolimus-eluting stent • in-stent restenosis • long-term clinical outcome • late stent thrombosis

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   IDTLR = ischemia-driven target lesion revascularization   ISR = in-stent restenosis   MACE = major adverse cardiac events   OR = odds ratio   SES = sirolimus-eluting stent(s)   ST = stent thrombosis   TLR = target lesion revascularization

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