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急性冠状动脉综合征患者中依维莫司洗脱生物可吸收血管支架与依维莫司洗脱金属支架治疗结局的荟萃分析比较。

Meta-Analysis Comparing Outcomes After Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents in Patients with Acute Coronary Syndromes.

机构信息

Department of Cardiology, San Giovanni di Dio e Ruggi d'Aragona University Hospital, Salerno, Italy.

Division of Cardiology, S. Maria della Pietà Hospital, Nola, Italy.

出版信息

Am J Cardiol. 2018 Jul 1;122(1):61-68. doi: 10.1016/j.amjcard.2018.03.003. Epub 2018 Mar 27.

Abstract

Acute coronary syndromes (ACS) may represent an intriguing clinical scenario for implantation of bioresorbable vascular scaffold (BRS). Nevertheless, the knowledge about the performance of these devices in patients with ACS is limited. Therefore, we performed a meta-analysis of clinical studies aiming to assess the safety and efficacy of everolimus-eluting-BRS versus everolimus-eluting-metallic stents (EES) in ACS patients undergoing percutaneous coronary intervention. Six studies enrolling 2,318 patients were included and analyzed for the risk of primary safety outcome (stent or scaffold thrombosis [ST/ScT]), primary efficacy outcome (target lesion revascularisation [TLR]), and secondary outcomes (myocardial infarction, cardiac death, all-cause death). Median follow-up was 9.5 (6 to 19.5) months. Patients treated with BRS had a significantly higher risk of definite ST/ScT compared with those receiving EES (2.3% vs 1.08%, odds ratio [OR] 2.22, 95% confidence interval [CI] 1.10 to 4.45, p = 0.03, I2 = 0%). Similarly, the risk of TLR was significantly higher in the BRS compared with EES group (3.5% vs 2.5%, OR 1.79, 95% CI 1.02 to 3.16, p = 0.04, I2 = 0%). When TLRs due to thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR 1.19, 95% CI 0.48 to 2.98, p = 0.71, I2 = 25%). Risk for secondary endpoints did not differ between the 2 groups. Results were confirmed when clinical and procedural variables were tested as potential effect modifiers in the meta-regression analysis for both primary endpoints. In conclusion, compared with those receiving EES, patients with ACS treated with BRS had increased risk of definite device thrombosis and TLR at mid-term follow-up.

摘要

急性冠状动脉综合征(ACS)可能为生物可吸收血管支架(BRS)的植入提供了一个有趣的临床场景。然而,目前对于 ACS 患者使用这些器械的性能知之甚少。因此,我们进行了一项荟萃分析,旨在评估经皮冠状动脉介入治疗中,与依维莫司洗脱金属支架(EES)相比,依维莫司洗脱 BRS 的安全性和有效性。共纳入了 6 项纳入 2318 例患者的研究,对主要安全性结局(支架或支架血栓形成[ST/ScT])、主要疗效结局(靶病变血运重建[TLR])和次要结局(心肌梗死、心脏死亡、全因死亡)的风险进行了分析。中位随访时间为 9.5(6 至 19.5)个月。与接受 EES 治疗的患者相比,接受 BRS 治疗的患者 ST/ScT 的明确风险显著更高(2.3%比 1.08%,比值比[OR] 2.22,95%置信区间[CI] 1.10 至 4.45,p=0.03,I2=0%)。同样,BRS 组 TLR 的风险也显著高于 EES 组(3.5%比 2.5%,OR 1.79,95% CI 1.02 至 3.16,p=0.04,I2=0%)。当排除因血栓形成导致的 TLR 后,两组间的风险估计差异不再显著(OR 1.19,95% CI 0.48 至 2.98,p=0.71,I2=25%)。两组间次要终点的风险无差异。当在荟萃回归分析中对主要终点的临床和程序变量进行测试时,结果得到了证实。结论:与接受 EES 治疗的患者相比,ACS 患者接受 BRS 治疗后,中期随访时明确的器械血栓形成和 TLR 的风险增加。

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