Hausleiter Jörg, Kastrati Adnan, Mehilli Julinda, Schühlen Helmut, Pache Jürgen, Dotzer Franz, Sattelberger Ulrich, Dirschinger Josef, Schömig Albert
Deutsches Herzzentrum and Medizinische Klinik des Klinikums rechts der Isar, Technische Universität, Munich, Germany.
Am Heart J. 2003 Nov;146(5):882-6. doi: 10.1016/S0002-8703(03)00435-6.
A number of stent-versus-stent trials have not been able to disclose differences in stent performance. It has been hypothesized that the selection of patient subsets with simple lesion morphologies may have masked differences among the stent designs under testing. The randomized Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) trial has shown that a reduced stent strut thickness is associated with a reduced risk for restenosis. The rationale of this study was to investigate the role of lesion complexity on the capacity of a stent-versus-stent trial to distinguish between superior and inferior stents.
In the ISAR-STEREO trial, 651 patients were randomly assigned to receive either a thin-strut (n = 326) or a thick-strut stent (n = 325) with a comparable stent design. Restenosis, defined as a > or =50% diameter stenosis at follow-up angiography, was analyzed according to the lesion complexity, which was assessed with the use of the American College of Cardiology/American Heart Association classification system.
The restenosis rate did not differ between stent designs in patients with noncomplex lesions (type A or B(1); restenosis rate: 16.7% vs 16.7%, P = 1.0 for thin-strut vs thick-strut stents). In patients with complex lesions (type B2 or C), there was a significant reduction in restenosis in the thin-strut stent group (restenosis rate: 14.5% vs 29.0%; P <.01 for thin-strut vs thick-strut stents).
The results of this study suggest that the potential to detect differences in the risk for restenosis in stent-versus-stent trials is strongly dependent on the inclusion of patients with complex lesions. These findings may be relevant when planning new stent-versus-stent trials.
多项支架对比支架试验未能揭示支架性能的差异。有假设认为，选择病变形态简单的患者亚组可能掩盖了正在测试的支架设计之间的差异。随机冠状动脉内支架置入术及血管造影结果支架支柱厚度对再狭窄结局的影响（ISAR-STEREO）试验表明，支架支柱厚度减小与再狭窄风险降低相关。本研究的目的是探讨病变复杂性在支架对比支架试验区分优、劣支架能力方面的作用。
在ISAR-STEREO试验中，651例患者被随机分配接受支架设计相当的薄支柱支架（n = 326）或厚支柱支架（n = 325）。根据病变复杂性分析再狭窄情况，病变复杂性采用美国心脏病学会/美国心脏协会分类系统进行评估，再狭窄定义为随访血管造影时直径狭窄≥50%。
非复杂病变（A或B1型）患者中，不同支架设计的再狭窄率无差异（再狭窄率：薄支柱支架为16.7%，厚支柱支架为16.7%，P = 1.0）。在复杂病变（B2或C型）患者中，薄支柱支架组的再狭窄率显著降低（再狭窄率：薄支柱支架为14.5%，厚支柱支架为29.0%；薄支柱支架与厚支柱支架相比，P <.01）。
本研究结果表明，支架对比支架试验检测再狭窄风险差异的潜力很大程度上取决于纳入复杂病变患者。这些发现可能对规划新的支架对比支架试验具有参考意义。
