Institut Cardiovasculaire Paris Sud, Massy/Quincy, France.
Circ Cardiovasc Interv. 2009 Jun;2(3):188-95. doi: 10.1161/CIRCINTERVENTIONS.108.823443. Epub 2009 May 8.
The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.
We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.
The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.
新研发的 Nobori 冠状动脉支架，其表面涂有生物可降解聚合物聚乳酸和抗增殖药物比伐卢定，具有抑制新生内膜形成的潜力，从而降低再狭窄的发生率。
我们在欧洲、亚洲和澳大利亚的 29 个中心进行了一项随机（2:1）对照试验，比较了 Nobori 载比伐卢定的生物可降解支架和紫杉醇洗脱支架 Taxus Liberté，共纳入 243 例患者（153 例 Nobori 和 90 例 Taxus）。入组患者为病变局限于 2 根以内的原生冠状动脉，且未经治疗的患者。主要终点为 9 个月时的支架内晚期管腔丢失，次要终点包括其他定量冠状动脉造影参数，如节段晚期管腔丢失和再狭窄率以及关键的血管内超声参数。临床次要终点包括支架血栓形成和主要不良心脏事件的复合终点，包括死亡、心肌梗死和靶血管血运重建。9 个月时， Nobori 组的支架内晚期管腔丢失显著低于 Taxus 组（0.11+/-0.30mm 比 0.32+/-0.50mm），达到了 Nobori 支架与 Taxus Liberté 支架非劣效性的主要假设（P<0.001）和优效性的次要假设（P=0.001）。这一发现通过 Taxus 组的二元再狭窄率从 6.2%显著降低至 Nobori 组的 0.7%（P=0.02）和通过血管内超声检测到的新生内膜体积阻塞率从 Taxus 组的 5.5+/-7.2%降低至 Nobori 组的 1.8+/-5.2%（P=0.01）得到证实。 Nobori 组的主要不良心脏事件发生率为 4.6%，Taxus 组为 5.6%。 Nobori 组的支架血栓形成率为 0%，Taxus 组为 4.4%。
NOBORI 1 临床试验证实了其主要假设—— Nobori 载比伐卢定的生物可降解支架与 Taxus Liberté 支架在减少新生内膜增殖方面非劣效。在研究人群中，两种支架的主要不良心脏事件发生率均较低。
