摘要
Context: Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated. Objective: To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent. Design, Setting, and Patients: This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003. Intervention: Patients were randomly assigned to receive a sirolimuseluting stent(129 patients)or an uncoated stent having an identical architecture and radiographic appearance(128 patients). Main Outcome Measures: The primary end point was the 8-month binary insegment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events. Results: The mean(SD)reference diameter of the treated segment was 2.2(0.28)mm; the lesion length, 11.84(6.15)mm. After 8 months, the binary in-segment restenosis rate was 53.1%(60/113)in the patients receiving an uncoated stent and 9.8%(12/123)-in those receiving a sirolimus-eluting stent(relative risk [RR], 0.18; 95%confidence interval [CI], 0.10-0.32; P< .001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events(12/129[9.3%] vs 40/128[31.3%]; RR, 0.30; 95%CI, 0.15-0.55; P< .001)mainly because of a reduction in target lesion revascularization(9/129[7%] vs 27/128[21.1%]; RR, 0.33; 95%CI, 0.140.70; P=.002)and myocardial infarction(2/129 [1.6%] vs 10/129[7.8%]; RR, 0.20; 95%CI, 0.01-0.93; P=.04). Conclusion: The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.
Context: Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated. Objective: To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent. Design, Setting, and Patients: This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003. Intervention: Patients were randomly assigned to receive a sirolimuseluting stent(129 patients)or an uncoated stent having an identical architecture and radiographic appearance(128 patients). Main Outcome Measures: The primary end point was the 8-month binary insegment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events. Results: The mean(SD)reference diameter of the treated segment was 2.2(0.28)mm; the lesion length, 11.84(6.15)mm. After 8 months, the binary in-segment restenosis rate was 53.1%(60/113)in the patients receiving an uncoated stent and 9.8%(12/123)-in those receiving a sirolimus-eluting stent(relative risk [RR], 0.18; 95%confidence interval [CI], 0.10-0.32; P< .001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events(12/129[9.3%] vs 40/128[31.3%]; RR, 0.30; 95%CI, 0.15-0.55; P< .001)mainly because of a reduction in target lesion revascularization(9/129[7%] vs 27/128[21.1%]; RR, 0.33; 95%CI, 0.140.70; P=.002)and myocardial infarction(2/129 [1.6%] vs 10/129[7.8%]; RR, 0.20; 95%CI, 0.01-0.93; P=.04). Conclusion: The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.
