Silber Sigmund, Hamburger Jaap, Grube Eberhard, Pfisterer Matthias, Belardi Jorge, Webb John, Zmudka Krzysztof, Nienaber Christoph, Hauptman Karl, Rutsch Wolfgang, Dawkins Keith, Drzewiecki Janusz, Koglin Jörg, Colombo Antonio
Cardiology Practice and Hospital, Munich, Germany.
Herz. 2004 Mar;29(2):171-80. doi: 10.1007/s00059-004-2575-3.
Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26).
In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 +/- 0.36 vs. 0.33 +/- 0.30 mm) or intravascular ultrasound-(IVUS-)measured volume obstruction (7.95 +/- 9.84% vs. 5.61 +/- 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 +/- 0.30 vs. 0.80 +/- 0.62 mm) or IVUS-measured volume obstruction (5.61 +/- 7.91% vs. 22.50 +/- 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent.
Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.
尽管直接冠状动脉支架置入术并不能改善血管造影结果，但它在减少手术时间、辐射暴露和成本方面具有意义。直接支架置入术的其他潜在优势可能是减少心肌缺血时间，这在高危患者中可能具有临床相关性。然而，随着药物洗脱支架的引入，人们担心直接支架置入术可能会损坏聚合物涂层并改变或降低程序性药物释放的效果。此外，还出现了对单个支架支柱未能最佳贴壁导致安全性的担忧。本文的目的是回顾性分析TAXUS-II试验（536例患者）中直接支架置入组和非直接支架置入组患者的数据。按照方案推荐进行预扩张，但不禁止直接支架置入：因此，49例患者进行了直接支架置入（TAXUS组23例，对照组26例）。
在TAXUS组中，预扩张患者和直接支架置入患者在6个月时的主要不良心脏事件（MACE；7.5%对4.3%）、分析节段的血管造影再狭窄（4.8%对4.3%）、晚期管腔丢失（0.28±0.36对0.33±0.30 mm）或血管内超声（IVUS）测量的容积阻塞（7.95±9.84%对5.61±7.91%）方面无显著差异。接受对照支架的患者情况相同。与直接支架置入对照组相比，TAXUS直接支架置入在6个月时分析节段的血管造影再狭窄（4.3%对30.8%）、晚期管腔丢失（0.33±0.30对0.80±0.62 mm）或IVUS测量的容积阻塞（5.61±7.91%对22.50±21.62%）方面保持了统计学上显著的积极效果。MACE从19.2%降至4.3%；由于患者数量较少，这一趋势未达到统计学显著性。预扩张后，TAXUS支架使所有参数均得到显著改善。
比较接受TAXUS支架且有或无预扩张的患者，6个月时在临床、血管造影或IVUS参数方面无差异。这表明使用基于聚合物的紫杉醇洗脱TAXUS支架进行直接支架置入术是可行、安全且同样有效的。有必要进行随机试验比较预扩张后支架置入与药物洗脱支架直接支架置入的效果。
