Background- The use of sirolimus- eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1- year incidence of major adverse cardiac events(MACE). T...Background- The use of sirolimus- eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1- year incidence of major adverse cardiac events(MACE). This analysis examined whether these beneficial effects persist over the longer term. Methods and Results- This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus- eluting versus conventional baremetal stents. Survival free from target lesion revascularization(TLR), target vessel failure(TVF), and MACE up to 3 years of follow- up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus- eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1- , 2- , and 3- year event- free survival rates were 99.2% , 96.5% , and 93.7% for TLR and 95.8% , 92.3% , and 87.9% for TVF, respectively, in the sirolimus- eluting stent group, versus 75.9% , 75.9% , and 75.0% for TLR and 71.2% , 69.4% , and 67.3% for TVF in the control group(P< 0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus- eluting stents versus 33.1% in patients assigned to bare- metal stents(P=0.002). One patient treated with a sirolimus- eluting stent died of a cardiac cause between 12 and 36 months. Conclusions- Treatment of de novo coronary stenosis with sirolimus- eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.展开更多
文摘Background- The use of sirolimus- eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1- year incidence of major adverse cardiac events(MACE). This analysis examined whether these beneficial effects persist over the longer term. Methods and Results- This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus- eluting versus conventional baremetal stents. Survival free from target lesion revascularization(TLR), target vessel failure(TVF), and MACE up to 3 years of follow- up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus- eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1- , 2- , and 3- year event- free survival rates were 99.2% , 96.5% , and 93.7% for TLR and 95.8% , 92.3% , and 87.9% for TVF, respectively, in the sirolimus- eluting stent group, versus 75.9% , 75.9% , and 75.0% for TLR and 71.2% , 69.4% , and 67.3% for TVF in the control group(P< 0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus- eluting stents versus 33.1% in patients assigned to bare- metal stents(P=0.002). One patient treated with a sirolimus- eluting stent died of a cardiac cause between 12 and 36 months. Conclusions- Treatment of de novo coronary stenosis with sirolimus- eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.
