Division of Cardiology, Cardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo, Italy.
Circulation. 2011 Jan 25;123(3):274-81. doi: 10.1161/CIRCULATIONAHA.110.963181. Epub 2011 Jan 10.
The safety of drug-eluting stents in ST-segment elevation myocardial infarction (STEMI) continues to be debated. Pathological studies have demonstrated an association between uncovered struts and subsequent stent thrombosis. Optical coherence tomography can detect stent strut coverage in vivo on a micron-scale level. We therefore used optical coherence tomography to examine strut coverage in patients with STEMI treated with paclitaxel-eluting stents (PES) and bare metal stents (BMS).
In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with STEMI were randomized 3:1 to PES or BMS implantation. In a formal substudy, optical coherence tomography at 13 months was performed in 118 consecutive randomized patients (89 PES, 29 BMS) in whom 188 stents were assessed (146 PES and 42 BMS). A total of 44 139 stent struts were analyzed by an independent core laboratory blinded to stent assignment. The primary prespecified end point, the percentage of uncovered stent struts per lesion at follow-up, was 1.1 ± 2.5% in BMS lesions versus 5.7 ± 7.0% in PES lesions (P < 0.0001). Malapposed struts were observed in 0.1 ± 0.2% of BMS lesions versus 0.9 ± 2.1% of PES lesions (P = 0.0003). Percentage net volume obstruction was 36.0 ± 15.4% with BMS and 19.2 ± 11.3% with PES (P < 0.0001).
In patients with STEMI undergoing primary percutaneous coronary intervention, implantation of PES as compared with BMS significantly reduces neointimal hyperplasia but results in higher rates of uncovered and malapposed stent struts as assessed by optical coherence tomography at 13-month follow-up. Further studies are required to determine the clinical significance of these findings.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.
药物洗脱支架在 ST 段抬高型心肌梗死（STEMI）中的安全性仍存在争议。病理学研究表明，uncovered struts 与随后的支架血栓形成之间存在关联。光学相干断层扫描（OCT）可在微米级水平上检测体内支架的支架覆盖率。因此，我们使用 OCT 检查了紫杉醇洗脱支架（PES）和裸金属支架（BMS）治疗 STEMI 患者的支架覆盖率。
在 Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction（HORIZONS-AMI）试验中，STEMI 患者按 3:1 随机分组接受 PES 或 BMS 植入。在一项正式的亚研究中，对 118 例连续随机患者（89 例 PES，29 例 BMS）进行了 13 个月的 OCT 检查，共评估了 188 个支架（146 个 PES 和 42 个 BMS）。一个独立的核心实验室对支架分配情况进行了盲法分析，共分析了 44139 个支架的支架覆盖率。主要预设终点为随访时每个病变未覆盖的支架覆盖率，BMS 病变为 1.1±2.5%，PES 病变为 5.7±7.0%（P<0.0001）。BMS 病变中 malapposed struts 的发生率为 0.1±0.2%，PES 病变中为 0.9±2.1%（P=0.0003）。BMS 的净体积阻塞率为 36.0±15.4%，PES 为 19.2±11.3%（P<0.0001）。
在接受直接经皮冠状动脉介入治疗的 STEMI 患者中，与 BMS 相比，PES 的植入显著减少了新生内膜增生，但在 13 个月的随访时，OCT 检查显示未覆盖和 malapposed 的支架覆盖率更高。需要进一步的研究来确定这些发现的临床意义。
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