Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.
OBJECTIVE
This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world.


METHODS
From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure.


RESULTS
Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%).


CONCLUSIONS
Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.
Tamburino
Corrado
C
Ferrarotto Hospital, Cardiology Division, University of Catania, Italy. tambucor@unict.it
Ciriminna
Saverio
S
Barbagallo
Rossella
R
Galassi
Alfredo Ruggero
AR
Ussia
Gianpaolo
G
Capranzano
Piera
P
Tagliareni
Francesco
F
Tolaro
Salvatore
S
Nicosia
Antonino
A
Stabile
Amerigo
A
Grassi
Rosario
R
Fiscella
Antonio
A
Patti
Aldo
A
Saccone
Giovanni
G
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D003925:Diabetic Angiopathies / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D012042:Registries; D012802:Sicily; D020123:Sirolimus
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus