Department of Cardiology, Academic Medical Center, Universiteit van Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Netherlands.
Department of Interventional Cardiology, 's-Gravendijkwal 230, 3015 CE Rotterdam, Netherlands.
Eur Heart J. 2017 Sep 1;38(33):2559-2566. doi: 10.1093/eurheartj/ehx155.
To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions.
A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n = 1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95%CI 1.37-6.26, P = 0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95%CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95%CI: 0.2-1.6) EES; OR 3.04; 95%CI 1.2-7.68, P = 0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95%CI 0.90-2.42, P = 0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death.
Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT.
比较经皮冠状动脉介入治疗后生物可吸收血管支架(BVS)与依维莫司洗脱支架(EES)的长期安全性和疗效。
对比较 BVS 和 EES 治疗患者 24 个月以上临床结局的随机临床试验进行了系统评价和荟萃分析。采用 Knapp-Hartung 法调整随机效应模型计算比值比(OR)和 95%置信区间(CI)。主要安全性终点为明确/可能的器械血栓形成(DT)风险。主要疗效终点为靶病变失败(TLF)风险。纳入了 5 项随机临床试验(n=1730)。与 EES 相比,接受 Absorb BVS 治疗的患者发生明确/可能 DT 的风险更高(OR 2.93,95%CI 1.37-6.26,P=0.01)。非常晚期 DT(VLDT)发生于 13 例患者中[12/996(1.4%,95%CI:0.08-2.5)Absorb BVS 比 1/701(0.5%,95%CI:0.2-1.6)EES;OR 3.04;95%CI 1.2-7.68,P=0.03],BVS 组 92%的 VLDT 发生在无双联抗血小板治疗(DAPT)的情况下。与 EES 相比,接受 Absorb BVS 治疗的患者 TLF 风险呈上升趋势(OR 1.48,95%CI 0.90-2.42,P=0.09),这主要是由于靶血管心肌梗死和缺血驱动的靶病变血运重建风险较高所致。两组间心脏死亡风险无差异。
与 EES 相比,Absorb BVS 的使用与更高的 DT 发生率和更高的 TLF 风险趋势相关。VLDT 发生率为 1.4%,这些事件多数发生在无 DAPT 的情况下。