Service de Cardiologie, Centre Hospitalier Universitaire Rangueil, Toulouse, France.
J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25.
This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention.
Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain.
Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté stents. Primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound was performed in 20% of the patients. All patients will be clinically followed up to 5 years.
Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberté stents. In-stent LLL was significantly lower in Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority <0.0001, p superiority <0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups.
The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus Carbostent and Taxus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions [NEXT]; NCT01373502).
本研究旨在证明无聚合物阿米利姆斯洗脱支架（Cre8，CID，Saluggia，意大利）与永久性聚合物紫杉醇洗脱支架（Taxus Liberté，波士顿科学，马萨诸塞州Natick）在经皮冠状动脉介入治疗中的非劣效性。
尽管药物洗脱支架的疗效已经得到充分证实，但风险效益平衡仍不理想，聚合物的安全性仍不确定。
接受经皮冠状动脉介入治疗的新发病变患者以 1:1 的比例随机分配至 Cre8 或 Taxus Liberté 支架组。主要终点是 6 个月时非劣效性范围内的支架内晚期管腔丢失（LLL）。20%的患者进行了 6 个月的血管内超声检查。所有患者将进行 5 年的临床随访。
在纳入的 323 例患者中，162 例接受 Cre8 支架治疗，161 例接受 Taxus Liberté 支架治疗。Cre8 组的支架内 LLL 明显较低（0.14±0.36mm 比 0.34±0.40mm，p 非劣效性<0.0001，p 优越性<0.0001）。两组 12 个月时的临床终点（心源性死亡、心肌梗死、靶病变血运重建和支架血栓形成）无显著差异。
在新发病变中，Cre8 支架在 6 个月时的支架内 LLL 明显低于 Taxus Liberté 支架，且 12 个月时的临床安全性和疗效结果有改善趋势。（国际随机比较 DES Limus Carbostent 与 Taxus 药物洗脱支架在治疗新发冠状动脉病变中的疗效[NEXT]；NCT01373502）。
