[Two-year clinical follow-up in 200 patients receiving sirolimus-eluting stents in lesions at a high risk of restenosis].
OBJECTIVE
Sirolimus-eluting stents (SESs) have been shown to reduce the rate of restenosis significantly in all types of coronary lesion. However, reports of late cases of thrombosis and restenosis have raised questions about long-term outcome in patients treated with these stents. Our aim was to evaluate long-term outcome in patients undergoing SES placement in lesions at a high risk of restenosis.


METHODS
Since SESs became available, we have used them to treat lesions at risk of restenosis. We studied clinical outcomes in consecutive patients treated with SESs who were followed up for more than 2 years.


RESULTS
The study included 200 patients (age 60[11] years, 22% diabetics) who were treated between June 2002 and April 2003 for 309 lesions: 16% were total occlusions, 16.8% in-stent restenoses, 28% diffuse lesions, and 30% small-vessel lesions. The total stent length per patient was 29 (16) mm and the mean diameter was 2.78 (0.27) mm. In a mean clinical follow-up period of 29 (3.2) months (range 24-34 months), there were four deaths, two (1%) of which were cardiac, four (2%) non-fatal infarctions, four (2%) in-stent thromboses (all occurred late, at 3, 7, 26 and 31 months), four (2%) cases requiring target lesion revascularization (at 3, 5, 14 and 15 months), and six (3%) requiring revascularization of a new lesion.


CONCLUSIONS
Long-term follow-up of patients undergoing SES placement in lesions at a high risk of restenosis revealed a very low restenosis rate. However, the incidence of late thrombosis appeared to be elevated and warrants further evaluation in larger studies.
de la Torre-Hernández
José M
JM
Unidad de Hemodinámica y Cardiología Intervencionista, Hospital Universitario Marqués de Valdecilla, Santander, España. hemodinamica@humv.es
Sainz-Laso
Fermín
F
Llano-Cardenal
Miguel
M
Ruiz-Lera
Marta
M
Fernández-Friera
Leticia
L
Rodríguez-Friera
Leticia
L
Burgos
Virginia
V
Zueco
Javier
J
Figueroa
Alvaro
A
Colman
Thierry
T
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000517:prevention & control*; D003627:Data Interpretation, Statistical; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus