依维莫司洗脱生物可吸收支架与依维莫司洗脱支架的长期临床结果：AIDA 随机临床试验的最终 5 年结果。
Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial.
机构信息
Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands.
Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.
出版信息
EuroIntervention. 2022 Mar 18;17(16):1340-1347. doi: 10.4244/EIJ-D-21-00419.
BACKGROUND
Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce.
AIMS
This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group.
METHODS
AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT.
RESULTS
Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86).
CONCLUSIONS
The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical Trial Registration ClinicalTrials.gov: NCT01858077.
背景
生物可吸收血管支架（BVS）相关事件在 1 至 3 年内报告 - 这是支架生物吸收的活跃时期。在此时间点之后，关于 Absorb BVS 在日常临床实践中的表现的数据很少。
目的
本报告旨在提供 Absorb BVS 的最终五年临床随访结果，与 XIENCE 依维莫司洗脱支架（EES）进行比较。此外，我们评估了延长双联抗血小板治疗（DAPT）对支架组事件的影响。
方法
AIDA 是一项多中心、研究者发起的、非劣效性试验，共纳入 1845 名未经选择的冠心病患者，随机分配至 Absorb BVS（n=924）或 XIENCE EES（n=921）组。主要终点为靶血管失败（TVF），包括心脏死亡、靶血管心肌梗死或靶血管血运重建的复合终点。支架血栓病例与对照组相匹配，并进行了延长 DAPT 的效果检测。
结果
在长达五年的随访中，Absorb BVS（17.7%）与 XIENCE EES（16.1%）组之间 TVF 无差异（风险比[HR]1.31，95%置信区间[CI]：0.90-1.41；p=0.302）。支架组有 43 例（4.8%）发生明确或可能的器械血栓（DT），而支架组有 13 例（1.5%）（HR 3.32，95%CI：1.78-6.17；p<0.001）。Absorb 组在 3 至 4 年期间发生 6 次 DT，在 XIENCE 组发生 3 次。在 4 至 5 年期间，发病率分别为 3 次和 2 次。支架组的 3 例 DT 中，有 2 例发生在 XIENCE EES 治疗的病变中。在整个五年随访期间，DAPT 组支架血栓的优势比为 0.36（95%CI：0.15-0.86）。
结论
在常规 PCI 中，Absorb BVS 晚期不良事件（尤其是器械血栓）的风险持续增加，直至 4 年，此后似乎趋于稳定。
临床试验注册
ClinicalTrials.gov：NCT01858077。
Zotero 插件