Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.
Department of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.
Eur Heart J. 2019 Jun 21;40(24):1909-1919. doi: 10.1093/eurheartj/ehz074.
The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.
We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25-0.66, P < 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P < 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES: -0.63 mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11 mm2, 95% CI: -2.27 to 0.04, P = 0.07).
Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type.
http://www.clinicaltrials.gov. Unique identifier: NCT00962416.
在 ST 段抬高型心肌梗死（STEMI）患者中，与金属裸支架（BMS）相比，具有生物可降解聚合物的生物可吸收支架（BES）的长期结果仍不清楚。
我们对随机 COMFORTABLE AMI 试验中纳入的 1157 例患者（BES：N=575 例和 BMS：N=582 例）进行了 5 年的临床随访。在基线和 13 个月的随访时，对 103 例患者的支架节段进行了血管内超声（IVUS）和光学相干断层扫描（OCT）的连续冠状动脉成像分析。5 年后，BES 降低了主要不良心脏事件（MACE）的风险[危险比（HR）0.56，95%置信区间（CI）：0.39-0.79，P=0.001]，这主要归因于靶血管相关再梗死（HR 0.44，95%CI：0.22-0.87，P=0.02）和缺血驱动的靶病变血运重建（HR 0.41，95%CI：0.25-0.66，P<0.001）的风险降低。记录到明确的支架血栓（ST）分别为 2.2%和 3.9%（HR 0.57，95%CI：0.28-1.16，P=0.12），但极晚期明确 ST 的发生率无差异（1.3% vs. 1.6%，P=0.77）。OCT 显示在随访时支架贴壁不良的发生率没有差异（BES 0.08% vs. BMS 0.02%，P=0.10）。未覆盖的支架支柱很少观察到，但在 BES 中更为常见（2.1% vs. 0.15%，P<0.001）。在 IVUS 分析中，两组均未出现正性重构（BES 组的外部弹性膜面积变化为-0.63mm2，95%CI：-1.44 至 0.39；BMS 组为-1.11mm2，95%CI：-2.27 至 0.04，P=0.07）。
与 BMS 相比，在接受直接经皮冠状动脉介入治疗的 STEMI 患者中，植入生物可降解聚合物涂层的 BES 可降低 5 年时的 MACE 发生率。在 13 个月时，无论支架类型如何，治疗罪犯病变的血管愈合几乎完全。
