Schofer Joachim, Schlüter Michael, Gershlick Anthony H, Wijns William, Garcia Eulogio, Schampaert Erick, Breithardt Günter
Centre for Cardiology and Vascular Intervention, Othmarscher Kirchenweg 168, D-22763, Hamburg, Germany.
Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.
Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease. We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences.
We enrolled 352 patients in whom one coronary artery required treatment, with diameter 2.5-3.0 mm and lesion length 15-32 mm. We randomly assigned patients sirolimus-eluting stents (n=175) or bare-metal stents (control, n=177). At 8 months we assessed differences in minimum lumen diameter and binary restenosis within the lesion (restenosis of > or =50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Patients were also followed up for 9 months for major adverse cardiac events. Analysis was by intention to treat.
Stent implantation was successful in 100% of sirolimus-stent patients and 99.4% of controls. The mean diameter of treated coronary arteries was 2.55 mm (SD 0.37) and mean lesion length was 15.0 mm (6.0). Multiple stents were implanted in 170 (48%) patients. At 8 months, minimum lumen diameter was significantly higher with sirolimus-eluting stents than with control stents (2.22 vs 1.33 mm, p<0.0001). The rate of binary restenosis was significantly reduced with sirolimus-eluting stents compared with control stents (5.9 vs 42.3%, p=0.0001). Significantly fewer patients with sirolimus-eluting stents had major adverse cardiac events at 9 months than did controls (8.0 vs 22.6%, p=0.0002), due mainly to a lower need for target-lesion revascularisations (4.0 vs 20.9%, p<0.0001).
Sirolimus-eluting stents are better than bare-metal stents for treatment of single long atherosclerotic lesions in a coronary vessel smaller than 3 mm in diameter.
西罗莫司洗脱支架已被研发用于预防冠状动脉疾病治疗中的再狭窄。我们比较了使用西罗莫司洗脱支架与裸金属支架的再狭窄风险，以评估可能存在的差异。
我们纳入了352例需要治疗一条冠状动脉的患者，冠状动脉直径为2.5 - 3.0毫米，病变长度为15 - 32毫米。我们将患者随机分为西罗莫司洗脱支架组（n = 175）或裸金属支架组（对照组，n = 177）。在8个月时，我们评估了病变内最小管腔直径和二元再狭窄（直径狭窄≥50%，包括支架段近端和远端5毫米血管段）的差异。患者还被随访9个月以观察主要不良心脏事件。分析采用意向性治疗。
西罗莫司洗脱支架组100%的患者和对照组99.4%的患者成功植入支架。治疗的冠状动脉平均直径为2.55毫米（标准差0.37），平均病变长度为15.0毫米（6.0）。170例（48%）患者植入了多个支架。在8个月时，西罗莫司洗脱支架的最小管腔直径显著高于对照组支架（2.22对1.33毫米，p < 0.0001）。与对照组支架相比，西罗莫司洗脱支架的二元再狭窄率显著降低（5.9%对42.3%，p = 0.0001）。在9个月时，使用西罗莫司洗脱支架的患者发生主要不良心脏事件的人数显著少于对照组（8.0%对22.6%，p = 0.0002），主要原因是靶病变血管重建的需求较低（4.0%对20.9%，p < 0.0001）。
对于治疗直径小于3毫米的冠状动脉中单个长动脉粥样硬化病变，西罗莫司洗脱支架优于裸金属支架。
