New York University School of Medicine (S.B., F.F.).
Mt. Sinai Beth Israel Medical Center, New York, NY (B.T., N.P.).
Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456.
Contemporary second-generation drug-eluting stents (DES) have superior efficacy and safety in comparison with early-generation stents in patients undergoing percutaneous coronary intervention, in part, related to their thinner struts. Whether newer-generation ultrathin DES further improve clinical outcomes in comparison with older second-generation thicker strut DES is unknown.
We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for randomized clinical trials that compared newer-generation ultrathin strut DES (defined as strut thickness <70 µm) versus thicker strut second-generation DES and reported clinical outcomes. The primary outcome was target lesion failure (composite of cardiovascular death, target vessel myocardial infarction or ischemia-driven target lesion revascularization) evaluated at 1-year follow-up. Tests for subgroup effects based on the ultrathin strut DES type and the comparator DES type were performed by using meta-regression analysis.
We identified 10 trials that randomly assigned 11 658 patients and evaluated 3 newer-generation ultrathin strut DES: Orsiro stent (60 μm), MiStent (64 μm), and BioMime (65 µm). In comparison with thicker strut second-generation DES, newer-generation ultrathin strut DES were associated with a 16% reduction in target lesion failure (relative risk, 0.84; 95% CI, 0.72-0.99) driven by less myocardial infarction (relative risk, 0.80; 95% CI, 0.65-0.99). Ultrathin strut DES were also associated with qualitatively lower rates of any stent thrombosis (relative risk, 0.72; 95% CI, 0.51-1.01). Tests for subgroup effects based on the ultrathin strut DES type ( P=0.58) and the comparator DES type ( P=0.98) were not significant, suggesting consistent outcomes across the 3 ultrathin strut DES and with the different DES comparators.
In patients undergoing percutaneous coronary intervention, newer-generation ultrathin strut DES further improve 1-year clinical outcomes in comparison with contemporary thicker strut second-generation DES.
与早期支架相比，当代第二代药物洗脱支架（DES）在经皮冠状动脉介入治疗患者中具有更好的疗效和安全性，部分原因是其支架较薄。新一代超薄 DES 是否比旧的第二代厚支架 DES 进一步改善临床结局尚不清楚。
我们在 PubMed、Embase 和 Cochrane 对照试验中心注册数据库中检索了比较新一代超薄支架（定义为支架厚度＜70μm）与较厚第二代支架并报告临床结局的随机临床试验。主要结局是 1 年随访时的靶病变失败（心血管死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的复合终点）。通过使用 meta 回归分析，对基于超薄支架 DES 类型和比较 DES 类型的亚组效应进行了检验。
我们确定了 10 项试验，共纳入 11658 例患者，评估了 3 种新一代超薄支架：Orsiro 支架（60μm）、MiStent（64μm）和 BioMime（65μm）。与较厚的第二代 DES 相比，新一代超薄支架与靶病变失败率降低 16%相关（相对风险，0.84；95%CI，0.72-0.99），这主要是由于心肌梗死减少（相对风险，0.80；95%CI，0.65-0.99）。超薄支架血栓形成的发生率也较低（相对风险，0.72；95%CI，0.51-1.01）。基于超薄支架类型（ P=0.58）和比较 DES 类型（ P=0.98）的亚组效应检验无统计学意义，提示 3 种超薄支架和不同 DES 比较之间的结果一致。
在经皮冠状动脉介入治疗患者中，与当代较厚的第二代支架相比，新一代超薄支架可进一步改善 1 年临床结局。
