长度≤18mm的小型与大型ABSORB生物可吸收血管支架的两年疗效与安全性：德国-奥地利ABSORB注册研究（GABI-R）的亚组分析
Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R).
作者信息
Zaczkiewicz Myron, Wein Bastian, Graf Matthias, Zimmermann Oliver, Kastner Johannes, Wöhrle Jochen, Thomas Riemer, Hamm Christian, Torzewski Jan
机构信息
Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
Department of Cardiology, University of Vienna Medical School, Vienna, Austria.
出版信息
Int J Cardiol Heart Vasc. 2020 Mar 20;27:100501. doi: 10.1016/j.ijcha.2020.100501. eCollection 2020 Apr.
AIMS
The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort.
METHODS AND RESULTS
We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05).
CONCLUSION
Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters.
CLINICAL TRIAL REGISTRATION
目的
由于支架内血栓形成（ScT）发生率较高以及支架技术所需的足够支架直径和长度，ABSO RB生物可吸收血管支架引发了安全担忧。较小的支架直径（SScD，2.5毫米）是很少被提及的主要不良心脏事件（MACE）预测因素。因此，我们在真实世界的GABI - R队列中评估了≤18毫米器械长度的较小支架直径（SScD）与较大支架直径（LScD，≥3毫米）对2年结局的影响。
方法与结果
我们比较了器械长度≤18毫米的植入LScD（1341例患者）与SScD（444例患者）的患者。LScD患者更常表现为ST段抬高型心肌梗死（35.8%对20.6%，p<0.0001）和单支血管病变（50.6%对36.5%，p<0.0001）。经过24个月的随访，MACE（9.66%对12.31%，p = 0.14）或明确/可能的ScT（2.47%对2.82%，p = 0.71）方面没有差异。尽管靶病变血运重建（TLR）没有差异（5.81%对7.71%，p = 0.18），但SScD组靶血管血运重建（TVR）的需求更高（11.57%对7.51%，p<0.05）。
结论
与LScD相比，器械长度≤18毫米的SScD在MACE和ScT方面显示出相当的安全性，在TLR方面显示出相当的疗效。可吸收支架技术不应局限于大血管直径。
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