Ke Junsong, Zhang Hongyu, Huang Jun, Lv Ping, Yan Jumei
Department of Cardiology, The First Affiliated Hospital of Nanchang University, Nanchang.
Department of Cardiology, The Jiujiang First People's Hospital, Jiujiang, China.
Medicine (Baltimore). 2020 Mar;99(10):e19458. doi: 10.1097/MD.0000000000019458.
Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes.
We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.
Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups.
At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.
依维莫司洗脱生物可吸收血管支架(BVS)具有支架吸收和血管功能恢复的特点,是冠状动脉疾病治疗领域的最新创新。这一新概念已成为介入心脏病学领域的热门话题。目前,关于BVS在急性冠状动脉综合征中的中期临床结果的数据稀缺。本系统评价和荟萃分析的目的是比较BVS和第二代药物洗脱支架(DES)在治疗急性冠状动脉综合征中的中期结果数据。
我们检索了PubMed、Embase、Cochrane图书馆、Web of Science以及相关网站,以查找随访时间≥1年的研究,这些研究比较了急性冠状动脉综合征患者接受BVS与第二代DES的经皮冠状动脉介入治疗。按照Cochrane干预措施系统评价手册5.1.0的标准,使用RevMan软件进行荟萃分析。
纳入了5项研究,其中2项随机对照试验和3项观察性研究,共有1758例患者(BVS组917例;DES组841例),中位随访时间为24个月。与DES相比,BVS导致更高的靶病变血运重建(TLR)率(比值比[OR],2.20;95%置信区间[CI],1.12 - 3.64;P = 0.02)和支架/支架内血栓形成(ST/ScT)率(OR = 2.35,95% CI:1.13 - 4.89,P = 0.02)。排除因器械血栓形成导致的TLR后,两组之间的风险估计差异不再显著(OR:1.67,95% CI:0.73 - 3.82,P = 0.22)。全因死亡风险(OR = 1.32,95% CI:0.61 - 2.88,P = 0.48)、心源性死亡风险(OR = 1.29,95% CI:0.58 - 2.86,P = 0.52)、靶血管心肌梗死风险(OR = 1.50,95% CI:0.86 - 2.61,P = 0.15)和靶病变失败风险(OR = 1.34,95% CI:0.76 - 2.35,P = 0.31)在BVS组和DES组之间没有差异。
在中期随访中,急性冠状动脉综合征患者中,BVS发生TLR和ST/ScT的风险高于第二代DES。ST/ScT是表明BVS相对于DES安全性和有效性降低的关键因素。