Red Cross Hospital Cardiology Center, Frankfurt, Germany.
Clin Cardiol. 2010 Apr;33(4):E33-8. doi: 10.1002/clc.20483.
Previously the polymer-free sirolimus-eluting YUKON-Choice stent (A) has demonstrated noninferiority compared to the polymer-based paclitaxel-eluting TAXUS stent (B). To test for long-term equivalency in unselected real-world coronary lesions of various complexities, we retrospectively compared both stents.
A total of 410 patients with symptomatic coronary artery disease (CAD) were treated with stent A (n = 205) or stent B (n = 205). Baseline clinical characteristics, lesion location, and length and the number of stents implanted per lesion were equally distributed. Clinical follow-up with assessment of major adverse cardiac events (MACE) and noncardiac deaths was obtained at 9 and 12 months.
Nominal stent diameter and nominal length of the stented segment were without differences between the groups. The incidence of MACE after 12 months was significantly higher in group A (35.1%) compared to group B (16.6%, P = .001). This was mainly due to increased rates of target-lesion revascularizations in group A (13.7%) vs group B (4.4%, P = .005). No significant differences in target-vessel revascularizations and non-target-vessel revascularizations were observed. In group B, 1 stent thrombosis was documented (0.5%) vs none in group A (P > .05); in each group 1 myocardial infarction (MI), but no cardiac deaths occurred; 3 noncardiac deaths in group A (1.5%) vs 7 in group B (3.4%) were observed (P = .3).
In contrast to our previous findings indicating no differences in MACE between patients treated with the polymer-free sirolimus-eluting YUKON-Choice stent and the polymer-based paclitaxel-eluting TAXUS stent at 6 months, we herewith show that 12 months after percutaneous coronary intervention (PCI) of real-world coronary lesions the YUKON stent appears to be inferior due to increased target-lesion revascularization (TLR) rates as a consequence of delayed restenosis.
先前的无聚合物西罗莫司洗脱 Yukon-Choice 支架（A）与基于聚合物的紫杉醇洗脱 Taxus 支架（B）相比，已被证明非劣效性。为了在各种复杂程度的未经选择的真实冠状动脉病变中测试长期等效性，我们回顾性地比较了这两种支架。
共有 410 例有症状的冠状动脉疾病（CAD）患者接受支架 A（n=205）或支架 B（n=205）治疗。基线临床特征、病变位置、植入每个病变的支架数量和长度均均匀分布。在 9 和 12 个月时获得了主要不良心脏事件（MACE）和非心脏死亡的临床随访评估。
两组支架的名义支架直径和支架段的名义长度无差异。A 组 12 个月时 MACE 的发生率明显高于 B 组（35.1%比 16.6%，P=0.001）。这主要是由于 A 组（13.7%）的靶病变血运重建率高于 B 组（4.4%，P=0.005）。两组之间的靶血管血运重建和非靶血管血运重建率无显著差异。B 组发生 1 例支架血栓形成（0.5%），而 A 组无（P＞0.05）；两组各发生 1 例心肌梗死（MI），但无心脏死亡；A 组发生 3 例非心脏死亡（1.5%），B 组发生 7 例（3.4%）（P=0.3）。
与我们之前的研究结果相反，即与聚合物洗脱紫杉醇 Taxus 支架相比，6 个月时接受无聚合物西罗莫司洗脱 Yukon-Choice 支架治疗的患者在 MACE 方面没有差异，我们发现，在真实冠状动脉病变经皮冠状动脉介入治疗（PCI）后 12 个月，Yukon 支架由于延迟再狭窄导致靶病变血运重建（TLR）率增加，因此效果较差。
