Department of Cardiology New Haven, Yale School of Medicine, New Haven, Connecticut, USA.
Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, Connecticut, USA.
Catheter Cardiovasc Interv. 2022 Feb;99(3):563-574. doi: 10.1002/ccd.29866. Epub 2021 Jul 8.
Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease.
Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown.
PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial.
We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05).
In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.
确定超薄药物洗脱支架对冠状动脉疾病长期结局的影响。
虽然第二代药物洗脱支架（DES）优于第一代 DES，但不良结局的持续存在导致设计不断改进。超薄第二代 DES 在 1 年随访时显示出改善结局的效果。超过 1 年，其效果仍未知。
使用 PubMed、Embase 和 Cochrane 数据库搜索比较超薄（定义为 <70μm）和标准厚度第二代 DES 的随机对照试验。根据 PROSPERO 方案（CRD42020185374）选择研究。使用随机效应模型（Mantel-Haenszel）对随机对照试验的数据进行汇总。主要结局是 2 年时的靶病变失败（TLF），由心脏死亡、靶血管心肌梗死和缺血驱动的靶血管血运重建组成。次要结局包括 3 年和 5 年时的 TLF、TLF 的组成部分以及确定或可能的支架血栓形成。两组之间的结局差异以每个试验的风险比（RR）及其相应的 95%置信区间（CI）表示，呈森林图形式呈现。
我们从 10 项试验中确定了 18 项出版物，共纳入 14649 名患者。在 2 年时，使用超薄 DES 可使 TLF 降低 12%（RR，0.88；95%CI，0.78-0.99；p<0.05）。在 3 年时，使用超薄 DES 可使 TLF 降低 19%（RR，0.79；95%CI，0.64-0.98；p<0.05）。
在接受经皮冠状动脉介入治疗的患者中，超薄 DES 可改善长期临床结局。
