Department of Cardiology, Hôpital Cochin, AP-HP, Paris, France; Université Paris Descartes, Faculté de Médecine, Paris, France.
Department of Medicine, McGill University Health Center, Montréal, Canada.
Int J Cardiol. 2019 Mar 1;278:51-56. doi: 10.1016/j.ijcard.2018.11.113. Epub 2018 Nov 23.
Despite similar efficacy and safety profile in pilot studies, bioresorbable polymer drug-eluting stents (BP-DES) could have potential benefit over latest generation durable polymer (DP)-DES by facilitating vessel healing, therefore reducing inflammation and neoatherosclerosis leading to enhanced clinical safety. Therefore, we sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of everolimus-eluting BP-DES (BP-EES) to second-generation DP-DES.
We conducted a systematic review and meta-analysis to examine the safety and efficacy of BP-EES in patients treated for coronary artery disease. We searched PubMed, Scopus, and the Cochrane Library through February 2018 for RCTs that included outcome data on BP-EES. We identified four eligible studies, which included a total of 4631 patients. Three studies reported a follow-up of one year and one study of five years. The BP-EES group, included 2315 patients and the DP-DES group included 2316 patients (1143 treated with DP-EES and 1173 treated with zotarolimus eluting DP-DES). Patient's characteristics were comparable between the two groups except for higher prevalence of prior MI in the DP-DES group (25.7 vs 22.5%, respectively, p = 0.001). Procedural characteristics were comparable among groups except for slightly longer lesions in the BP-EES group compared to the DP-DES group (mean 15.1 vs 14.9 mm, p = 0.04). No significant differences were observed for cardiac mortality (p = 0.72), occurrence of MI (p = 0.64), any TLR (p = 0.93), ST (p = 0.85) or major adverse cardiac events (p = 0.43).
Overall, based on the available data BP-EES had similar one-year outcomes to contemporary DP-DES. Whether these devices could enhance clinical safety remains to be evaluated at longer follow-up.
尽管在试点研究中具有相似的疗效和安全性,生物可吸收聚合物药物洗脱支架(BP-DES)通过促进血管愈合,从而减少炎症和新生动脉粥样硬化,可能比最新一代的耐用聚合物(DP)-DES 具有潜在的优势,从而提高临床安全性。因此,我们旨在对比较依维莫司洗脱 BP-DES(BP-EES)与第二代 DP-DES 的安全性和疗效的随机临床试验(RCT)进行荟萃分析。
我们进行了系统评价和荟萃分析,以检查用于治疗冠状动脉疾病的 BP-EES 的安全性和疗效。我们通过 2018 年 2 月检索 PubMed、Scopus 和 Cochrane 图书馆,以查找包括 BP-EES 结果数据的 RCT。我们确定了四项符合条件的研究,其中包括 4631 名患者。三项研究报告了一年的随访结果,一项研究报告了五年的随访结果。BP-EES 组包括 2315 名患者,DP-DES 组包括 2316 名患者(1143 名接受 DP-EES 治疗,1173 名接受佐他莫司洗脱 DP-DES 治疗)。两组患者的特征相似,除了 DP-DES 组中先前发生心肌梗死的比例较高(分别为 25.7%和 22.5%,p=0.001)。各组间的操作特点相似,除了 BP-EES 组的病变稍长于 DP-DES 组(平均 15.1 毫米比 14.9 毫米,p=0.04)。在心脏死亡率(p=0.72)、心肌梗死的发生(p=0.64)、任何 TLR(p=0.93)、支架血栓形成(p=0.85)或主要不良心脏事件(p=0.43)方面,均无显著差异。
总体而言,根据现有数据,BP-EES 在一年时的结果与当代 DP-DES 相似。这些设备是否能提高临床安全性仍需在更长的随访中进行评估。