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.
OBJECTIVE
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.
Liistro
Francesco
F
Cardiovascular Department, San Donato Hospital, Arezzo, Italy. francescoliistro@hotmail.com <francescoliistro@hotmail.com>
Fineschi
Massimo
M
Grotti
Simone
S
Angioli
Paolo
P
Carrera
Arcangelo
A
Ducci
Kenneth
K
Gori
Tommaso
T
Falsini
Giovanni
G
Pierli
Carlo
C
Bolognese
Leonardo
L
D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D003404:Creatinine / Q000032:analysis; D003920:Diabetes Mellitus / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D013318:Stroke Volume; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D003404:Creatinine; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus