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CLINICAL RESEARCH

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

The TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry

Francesco Liistro, MD^_*,_*, Massimo Fineschi, MD, Paolo Angioli, MD^_*, Giuseppe Sinicropi, MD, Giovanni Falsini, MD^_*, Tommaso Gori, MD, Kenneth Ducci, MD^_*, Achille Bravi, MD and Leonardo Bolognese, MD^_*

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

Manuscript received December 19, 2005; revised manuscript received March 13, 2006, accepted March 21, 2006.

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

OBJECTIVES: This study sought to evaluate the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis (ISR) in consecutive unselected patients undergoing coronary intervention in a real-world scenario.

BACKGROUND: Restenosis after bare metal stenting is characterized by a high rate of re-restenosis once treated with repeated percutaneous coronary intervention.

METHODS: The study was designed as a prospective two-center registry. We enrolled 244 patients with ISR in a native coronary artery or saphenous vein graft who had clinical indication for repeat intervention.

RESULTS: Sirolimus stent implantation was successful in all lesions. At 9-month follow-up, death occurred in 4 (1.6%) patients, myocardial infarction in 4 (1.6%), and ischemia-driven target lesion revascularization (TLR) in 12 (4.9%), for a cumulative event-free survival of 227 (93%). Although 9-month follow-up angiography was planned in all patients, only 150 (62%) patients completed it, and restenosis was present in 13 (8.7%) patients. Diabetes and non–ST-segment elevation acute coronary syndrome at presentation were the only independent predictors of freedom from ischemia-driven TLR and major adverse cardiac events.

CONCLUSIONS: Sirolimus stent implantation for the treatment of ISR is effective and safe. In diabetic patients and in those with acute coronary syndrome, the higher rate of recurrence requires further evaluation.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   ISR = in-stent restenosis   MACE = major adverse cardiac event   MI = myocardial infarction   NSTEACS = non–ST-segment elevation acute coronary syndrome   OR = odds ratio   PCI = percutaneous coronary intervention   SES = sirolimus-eluting stent(s)   TIMI = Thrombolysis In Myocardial Infarction   TLR = target lesion revascularization

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