Prospective native coronary artery stenosis treated with sirolimus-eluting stent (ONASSIS) registry--acute results and mid-term outcomes: a single-center experience.
BACKGROUND
Encouraging results with the use of the sirolimus-eluting stent (SES) have been recently presented in several multi-center trials. In the present study, the short- and mid-term clinical outcomes of the SES in everyday clinical practice of interventional cardiology were compared with a strategy using conventional bare metal stents.


METHODS
In a total of 530 consecutive patients (males 86%, mean age 61 +/- 10 years) who had been treated with a SES were compared with a control group of 398 patients (males 87%, mean age 59 +/- 11 years) treated with a bare metal stent before the use of SES. In-hospital results and clinical outcomes during follow-up (11.22 +/- 3.4 versus 11.41 +/- 3.1 months) were obtained.


RESULTS
Patients treated with SES had more risk factors for coronary artery disease or multivessel disease compared to those with treated bare metal stent. The clinical success rate was 99.6% in the SES group and 98.5% in the bare metal stent group (p = ns), and non-Q-wave myocardial infarction (MI) occurred in 5.7% and 4.0% of patients, respectively. The incidence of death or MI during follow-up was not different (1.1% versus 1.3% and 0.8% versus 1.8%; p = ns). Percutaneous or surgical revascularization for target lesion restenosis was required in 2.1% of patients treated with SES and in 10.1% of those with bare metal stents (p < 0.001), and the event-free survival from death, cerebrovascular accident, MI or any percutaneous or surgical revascularization was 93.13% and 83.63%, respectively (p < 0.01).


CONCLUSIONS
The implantation of the SES is associated with excellent in-hospital and mid-term results, mainly because of dramatic reductions in the need for repeat revascularization, despite a higher risk factor profile and more complex lesion characteristics.
Voudris
Vassilis
V
1st Cardiology Department, Onassis Cardiac Surgery Center, 356 Sygrou av., 176 74. Athens, Greece. vvoudris@otenet.gr
Alexopoulos
Elias
E
Karyofillis
Panagiotis
P
Malakos
John
J
Manginas
Athanasios
A
Spargias
Constantinos
C
Pavlides
Gregory
G
Patsilinakos
Sotirios
S
Anyfantakis
Alexandros
A
Cokkinos
Dennis V
DV
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000706:statistics & numerical data; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000627:therapeutic use*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus