Interventional Cardiology Unit, San Raffaele Scientific Hospital, Milan, Italy.
EuroIntervention. 2014 Dec;10(8):916-23. doi: 10.4244/EIJY14M06_10.
To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. new-generation zotarolimus-eluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R.
All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia cross-sectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group.
In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis.
据我们所知，尚无研究比较过急性冠状动脉综合征（ACS）患者中依维莫司洗脱支架（EES）与新一代佐他莫司洗脱支架（ZES-R）的无覆盖支架梁比例。本研究旨在通过光学相干断层扫描（OCT）评估 ACS 患者接受药物洗脱支架（DES）治疗后，EES 与新一代 ZES-R 之间新生内膜覆盖的完整性。
所有符合条件的 ACS 患者均随机 1:1 接受 EES 或 ZES-R 治疗，这些患者因病变而被纳入意大利四个中心的临床治疗中。主要研究终点为 6 个月时 OCT 评估的无覆盖支架梁比例。次要终点为 OCT 评估的支架梁贴壁不良比例、新生内膜增生横截面面积（CSA）百分比和主要不良心脏事件（MACE）。共 60 例患者被随机分为 EES（n=29）或 ZES-R（n=31）组。两组间基线特征无差异。总体而言，31.7%为 STEMI，其中 68.4%为前壁心梗。其余患者包括 41.7% NSTEMI 和 26.7%肌钙蛋白阴性 ACS。每位患者平均治疗 1.3±0.6 个病变，平均每个病变植入 1.3±0.5 个支架。术后 30 天，1 例患者突然死亡。在 EES 组的 25 个病变和 ZES-R 组的 24 个病变中进行了 6 个月的 OCT 分析。两组间主要终点（无覆盖支架梁比例）无差异（EES 6.42%[3.27，9.57] vs. ZES-R 7.07%[3.22，10.92]；p=0.80）。此外，两组间支架梁贴壁不良比例也无差异，包括有覆盖的（EES 1.19%[0.34，2.04] vs. ZES-R 0.85%[0.40，1.30]；p=0.49）和无覆盖的（EES 1.06%[0.12，2.01] vs. ZES-R 0.24%[0.05，0.44]；p=0.09）。两组间新生内膜 CSA 百分比相似（EES 37.0%[18.6，55.3] vs. ZES-R 26.6%[18.4，34.8]；p=0.31）。在 6 个月的临床随访中，EES 组有 4 例 MACE，ZES-R 组有 1 例。
在我们的研究中，ACS 患者中，EES 和 ZES-R 在 6 个月的 OCT 分析中，支架梁贴壁不良和无覆盖的比例均较低。
