Biodegradable Polymer-based, Polymer-free, Cypher Comparable

　　生物可降解支架和无载体雷帕霉素支架一年资料显示：其安全性与Cypher支架相似。这项对比试验结果显示：上述支架至少与Cypher支架一样有效。来自德国慕尼黑的Julinda Mehilli医生说道：“我们还在继续研究无多聚物载体的支架与提高远期临床效果是否有关。”

　　ISAR-TEST-3试验

　　ISAR-TEST-3试验分别比较了生物可降解支架，无载体雷帕霉素支架与Cypher支架抗再狭窄效果，三种支架的晚期管腔丢失率具有可比性（P<0.001，非劣效性比较）

　　生物可降解支架，无载体雷帕霉素支架和Cypher支架造影再狭窄分别为9% ，16.9%和10.8%；临床再狭窄分别为5.9%，12.9%, 和 7.9%，均无统计学差别。明确的/可能的支架内血栓发生率在生物可降解支架，无载体雷帕霉素支架和Cypher支架组分别为：1%，1.5% 和 2%。

　　Jeffrey Popma医生评价说：ISAR-TEST-3 试验是一个很重要的研究，有较高的造影随访率，支架晚期管腔丢失能很好的反映支架内内膜增生程度，是一个很恰当的终点指标。我们有必要进行大规模临床试验对生物可降解支架和无载体雷帕霉素支架系统的安全性和有效性进行检验。

　　（阜外心血管病医院 陈俊 高立建 编译）

Biodegradable Polymer-based, Polymer-free, Cypher Comparable

Biodegradable polymer-based and polymer-free rapamycin-eluting stents have a 1-year safety profile similar to that of the Cypher stent. In a comparison trial, both the biodegradable, polymer-based, and polymer-free, rapamycin-eluting stents were found to be at least as effective as Cypher.

“It remains to be investigated whether the absence of a permanent polymer is associated with an improved outcome at longer term,” said Julinda Mehilli, MD, of Technische Universitat in Munich, Germany.

ISAR-TEST-3

In the ISAR-TEST-3 trial a comparison of the antirestenotic efficacy of biodegradable polymer based and polymer-free rapamycineluting stents vs. the Cypher (Cordis, Johnson & Johnson) stent, researchers reported comparable rates of late lumen loss in all three stents (P <0 .001for non-inferiority, Figure).

Angiographic restenosis was 9% and clinical restenosis was 5.9% for the biodegradable stent; 16.9% and 12.9%, respectively, for the polymer-free stent; and10.8% and 7.9%, respectively, for the Cypher stent these differences were not statistically significant.

Four patients in each group died (P = .70). Definite/probably/possible stent thrombosis occurred in 1% of patients treated with the biodegradable polymer-based stent; 1.5% of patients treated with the polymer-free stent; and 2% of patients treated with the Cypher.

Jeffrey Popma, MD, said ISARTEST-3 was an important study, with good angiographic follow-up. In-stent late loss was suitable as an endpoint, he said, and was the best measure for the degree of intimal hyperplasia within the stent. He said larger clinical studies examining safety and clinical efficacy are warranted for both biodegradable and polymer-free rapamycin-eluting stent systems.