Ospedale Maggiore Policlinico, Milan, Italy.
EuroIntervention. 2012 May 15;8(1):109-16. doi: 10.4244/EIJV8I1A17.
Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting.
A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5).
The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions.
先前针对已批准适应证（适应证内）的研究显示 Nobori DES 的安全性和疗效良好。我们进行了一项前瞻性、多中心研究，以验证该支架在真实环境中的临床性能。
共有 3067 例连续接受 Nobori DES 经皮冠状动脉介入治疗的患者被纳入 NOBORI 2 注册研究。在 1 年和 2 年时，分别有 97%和 95%的患者可进行随访。靶病变失败（TLF）、心源性死亡、心肌梗死和靶病变血运重建的发生率分别为：1 年时为 3.9%、1.2%、1.9%和 2.2%，2 年时为 5.1%、1.6%、2.4%和 3.0%。总体而言，2242 例（73%）患者至少接受了一种适应证外治疗。在比较适应证内和适应证外组时，结果为：1 年时 TLF 为 4.5% vs. 2.2%，p=0.003，2 年时为 5.9% vs. 2.8%，p=0.001。支架血栓形成率分别为 0.68%和 0.80%，1 年和 2 年时在适应证内和适应证外组之间无差异（0.76% vs. 0.48%，p=0.6 和 0.89% vs. 0.61%，p=0.5）。
在低风险患者中观察到的有希望的结果可以在日常实践中复制。正如预期的那样，在适应证外，不良事件的发生率更高。然而，我们的结果表明，该支架系统在具有显著合并症和/或复杂病变的高危患者中具有良好和持续的性能。
