Carrié Didier, Lefevre Thierry, Cherradi Rhizlan, Dumas Pierre, Elbaz Meyer, Finet Gérard, Puel Jacques, Morice Marie Claude
Cardiology Department, Rangueil Hospital, Toulouse, France.
J Interv Cardiol. 2007 Oct;20(5):381-8. doi: 10.1111/j.1540-8183.2007.00281.x.
To compare the volume of in-stent neointimal proliferation, assessed by intravascular ultrasound (IVUS), at 6-month follow-up after implantation of a coronary Carbofilm-coated stent (Tecnic Carbostent, Sorin Biomedica Cardio, Saluggia, Italy) versus a conventional 316 L stent (Rx Multi-Link Penta, Abbott Laboratories, Abbott Park, IL).
Many trials suggest that stent characteristics and coating could be important determinants of restenosis.
From October 2004 to May 2005, 63 patients were randomized to Tecnic (T, n = 30) or Penta (P, n = 33). The primary end-point was in-stent volume of neointimal hyperplasia (NIH) measured by IVUS at 6 months. The secondary end-points included binary restenosis, minimal luminal diameter (MLD), target lesion revascularization, and major adverse cardiac events.
There were no significant differences between T and P as to mean age, male gender, clinical status, complexity of the lesion, lesion length, reference vessel diameter before percutaneous coronary intervention (PCI), MLD pre-PCI, and stent-to-artery ratio. However, MLD poststenting was greater in P group than T group (2.81 +/- 0.45 mm vs. 2.49 +/- 0.33 mm, P < 0.002). At 6 months, angiographic late lumen loss (0.61 +/- 0.51 mm vs. 0.92 +/- 0.61 mm, P < 0.043), in-stent obstruction (25.86 +/- 16.48% vs. 38.33 +/- 19.56%, P = 0.021), and in-stent late loss volume (31.62 +/- 29.75 mm(3) vs. 57.28 +/- 37.16 mm(3), P = 0.016) were significantly lower in T group than in P group.
Penta stent appears to offer a better deployment and a larger MLD post-PCI than Carbofilm-coated stent. However, a thicker NIH was observed on Penta stent at 6-month follow-up, when compared to Tecnic.
通过血管内超声（IVUS）评估，比较冠状动脉碳膜涂层支架（Tecnic Carbostent，索林生物医学心脏公司，意大利萨卢贾）与传统316L支架（Rx Multi-Link Penta，雅培实验室，美国伊利诺伊州雅培公园）植入后6个月随访时支架内新生内膜增生的体积。
许多试验表明，支架特性和涂层可能是再狭窄的重要决定因素。
2004年10月至2005年5月，63例患者被随机分为Tecnic组（T组，n = 30）或Penta组（P组，n = 33）。主要终点是6个月时通过IVUS测量的支架内新生内膜增生（NIH）体积。次要终点包括二元再狭窄、最小管腔直径（MLD）、靶病变血管重建和主要不良心脏事件。
T组和P组在平均年龄、男性性别、临床状态、病变复杂性、病变长度、经皮冠状动脉介入治疗（PCI）前的参考血管直径、PCI前的MLD以及支架与动脉比率方面无显著差异。然而，P组支架置入后的MLD大于T组（2.81±0.45mm对2.49±0.33mm，P < 0.002）。6个月时，T组的血管造影晚期管腔丢失（0.61±0.51mm对0.92±0.61mm，P < 0.043）、支架内阻塞（25.86±16.48%对38.33±19.56%，P = 0.021）和支架内晚期丢失体积（31.62±29.75mm³对57.28±37.16mm³，P = 0.016）均显著低于P组。
与碳膜涂层支架相比，Penta支架似乎能提供更好的展开效果和PCI后更大的MLD。然而，在6个月随访时，与Tecnic支架相比，Penta支架上观察到更厚的NIH。
