[Two-year clinical follow-up in 200 patients receiving sirolimus-eluting stents in lesions at a high risk of restenosis]. / Seguimiento clínico a 2 años de 200 pacientes tratados con stent liberador de rapamicina en lesiones de alto riesgo de reestenosis.

INTRODUCTION AND OBJECTIVES: 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. PATIENTS AND METHOD: 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.

Seguimiento clínico a 2 años de 200 pacientes tratados con stent liberador de rapamicina en lesiones de alto riesgo de reestenosis / Two-year clinical follow-up in 200 patients receiving sirolimus-eluting stents in lesions at a high risk of restenosis

Introducción y objetivos. Los stents de rapamicina (SR) han demostrado reducir la tasa de reestenosis en múltiples estudios, pero se han descrito algunos casos de reestenosis y trombosis tardías que proyectan dudas sobre sus resultados a largo plazo (> 2 años). Nos planteamos estudiar retrospectivamente la evolución a largo plazo de pacientes tratados con SR en lesiones de alto riesgo de reestenosis. Pacientes y método. Desde su introducción, hemos utilizado SR en los casos con lesiones de mayor riesgo de reestenosis. Estudiamos la evolución clínica de los pacientes en los que se implantaron SR y que cuentan con un seguimiento clínico superior a 2 años. Resultados. Se estudió a 200 pacientes (edad 60 ± 11 años, un 22% diabéticos) tratados entre junio de 2002 y abril de 2003 en 309 lesiones: un 16%, oclusiones totales; un 16,8%, reestenosis intra-stent; un 28%, difusas, y un 30%, en vaso pequeño. La longitud total de stent por paciente fue de 29 ± 16 mm y el diámetro del stent, de 2,78 ± 0,27 mm. En el seguimiento clínico de 29 ± 3,2 meses se produjeron los siguientes eventos: 4 muertes, de las que 2 (1%) fueron cardiacas; 4 infartos (2%); 4 trombosis de stent documentadas (2%), todas tardías a los 3, 7, 26 y 31 meses; 4 casos (2%) de revascularización por reestenosis del segmento tratado a los 3, 5, 14 y 15 meses, y 6 casos (3%) de revascularización de otra lesión. Conclusiones. La evolución a largo plazo de los pacientes con SR en lesiones de alto riesgo reestenótico muestra una tasa de reestenosis clínica muy baja. La incidencia de trombosis tardía parece resultar algo elevada y debería ser evaluada en series más amplias

Introduction and objectives. 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. Patients and method. 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