Tijssen Ruben Y G, van der Schaaf Rene J, Kraak Robin P, Vink Maarten A, Hofma Sjoerd H, Arkenbout E Karin, Weevers Auke P J D, Kerkmeijer Laura S M, Onuma Yoshinobu, Serruys Patrick W, Beijk Marcel A M, Koch Karel T, Baan Jan, Vis M Marije, Piek Jan J, Tijssen Jan G P, Henriques Jose P S, de Winter Robbert J, Wykrzykowska Joanna J
Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.
The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Catheter Cardiovasc Interv. 2020 Jan;95(1):89-96. doi: 10.1002/ccd.28193. Epub 2019 Apr 9.
Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS.
We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17).
In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.
急性冠状动脉综合征(ACS)患者可能代表一个特定亚组,在经皮冠状动脉介入治疗(PCI)中,与使用金属药物洗脱支架的传统治疗相比,植入生物可吸收支架可能会带来更好的结果。在这项阿姆斯特丹研究者发起的全入组Absorb策略(AIDA)试验的预设亚组分析中,我们评估了Absorb生物可吸收血管支架(BVS)与Xience依维莫司洗脱支架(EES)治疗的有或无ACS患者的临床结局。
我们根据ACS或非ACS的临床表现对AIDA患者进行分类。在ACS患者中,使用Absorb BVS或Xience EES治疗后,2年主要终点靶血管失败(TVF)率相似(分别为10.2%和9.0%;P = 0.49),在非ACS患者中也相似(分别为11.7%和10.7%;P = 0.67)。与Xience EES相比,Absorb BVS在ACS患者(分别为4.3%和1.7%,P = 0.03)以及非ACS患者(分别为2.4%和0.2%;P = 0.002)中发生明确或可能的器械血栓形成更为频繁。对于TVF(P = 0.80)以及明确或可能的器械血栓形成终点(P = 0.17),临床表现与随机分配的器械类型之间没有统计学上的显著交互作用。
在AIDA试验中,Absorb BVS与Xience EES进行PCI的2年结局在ACS和非ACS患者中是一致的:TVF率相似,且Absorb BVS与Xience EES相比,明确或可能的支架血栓形成率持续更高。临床表现与随机分配的器械类型之间没有统计学上的显著交互作用。