COMFORTABLE AMI 试验的 5 年临床结果和冠状动脉影像学研究：急性 ST 段抬高型心肌梗死患者中，载药涂层生物可降解聚合物支架与金属裸支架的随机对照比较。
Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction.
机构信息
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.
Department of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.
出版信息
Eur Heart J. 2019 Jun 21;40(24):1909-1919. doi: 10.1093/eurheartj/ehz074.
AIMS
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.
METHODS AND RESULTS
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).
CONCLUSION
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.
CLINICAL TRIAL REGISTRATION
http://www.clinicaltrials.gov. Unique identifier: NCT00962416.
目的
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。
方法和结果
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）。
结论
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。
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