Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, USA.
Am J Cardiol. 2012 Apr 1;109(7):932-40. doi: 10.1016/j.amjcard.2011.11.021. Epub 2012 Jan 3.
The use of drug-eluting stents (DESs) in primary percutaneous coronary intervention (PPCI) has shown early benefit over bare-metal stents (BMSs) in decreasing adverse cardiac events. However, there are concerns regarding the increased risk of late and very late stent thrombosis (ST) after DES use. With the paucity of ST events individual trials may have been underpowered to detect significant differences. We sought to perform a meta-analysis to evaluate the available literature examining the outcomes of DESs and BMSs in PPCI after ≥3 years of follow-up. We analyzed 8 randomized clinical trials (RCTs) and 5 observational studies comparing DESs to BMSs in PPCI. Clinical end-point data were analyzed for RCTs and observational studies separately using random-effect models. RCTs included 5,797 patients in whom first-generation DESs (sirolimus- or paclitaxel-eluting stents) were compared to BMS control arms. Patients receiving DESs had a significantly lower risk of target lesion revascularization (odds ratio [OR] 0.48, confidence interval [CI] 0.37 to 0.61), target vessel revascularization (OR 0.53, CI 0.42 to 0.66), and accordingly major adverse cardiac events (OR 0.69; CI 0.56 to 0.84). Incidence of ST was not different between groups (OR 1.02, CI 0.76 to 1.37). There was no significant difference in mortality (OR 0.88, CI 0.68 to 1.12) or recurrent myocardial infarction (OR 0.97; CI 0.61 to 1.54). Among observational studies (n = 4,650) fewer studies reported on target lesion revascularization and target vessel revascularization, but the trend remained in favor of DESs. A small but statistically significant increase in ST was noted with DES use (OR 1.62, CI 1.18 to 2.21) at ≥3 years of follow up, without evidence of recurrent myocardial infarction. Those receiving DESs had a significantly lower mortality compared to those receiving BMSs (OR, 0.65, 95% CI 0.53 to 0.80, p <0.001). In conclusion, this meta-analysis of RCTs examining the long-term outcomes of first-generation DESs versus BMSs in PPCI, DES use resulted in decreased repeat revascularization with no increase in ST, mortality, or recurrent myocardial infarction.
药物洗脱支架（DES）在经皮冠状动脉介入治疗（PPCI）中的应用，与裸金属支架（BMS）相比，在降低不良心脏事件方面显示出早期获益。然而，人们担心在使用 DES 后，晚期和极晚期支架血栓形成（ST）的风险增加。由于 ST 事件的数量较少，个别试验可能没有足够的能力来检测到显著的差异。我们试图进行一项荟萃分析，以评估现有的文献，研究 DES 和 BMS 在 PPCI 中的结果，随访时间≥3 年。我们分析了 8 项随机临床试验（RCT）和 5 项观察性研究，比较了 PPCI 中 DES 和 BMS 的结果。使用随机效应模型分别对 RCT 和观察性研究的临床终点数据进行分析。RCT 纳入了 5797 例患者，其中第一代 DES（西罗莫司或紫杉醇洗脱支架）与 BMS 对照组进行了比较。接受 DES 的患者靶病变血运重建（比值比 [OR] 0.48，置信区间 [CI] 0.37 至 0.61）、靶血管血运重建（OR 0.53，CI 0.42 至 0.66）的风险显著降低，相应的主要不良心脏事件（OR 0.69；CI 0.56 至 0.84）。两组 ST 发生率无差异（OR 1.02，CI 0.76 至 1.37）。死亡率（OR 0.88，CI 0.68 至 1.12）或复发性心肌梗死（OR 0.97；CI 0.61 至 1.54）无显著差异。在观察性研究（n=4650）中，较少的研究报告了靶病变血运重建和靶血管血运重建，但DES 的趋势仍然有利。在≥3 年的随访中，DES 使用率略有但统计学上显著增加 ST（OR 1.62，CI 1.18 至 2.21），但无复发性心肌梗死的证据。与接受 BMS 治疗的患者相比，接受 DES 治疗的患者死亡率显著降低（OR，0.65，95%CI 0.53 至 0.80，p<0.001）。总之，这项对第一代 DES 与 BMS 在 PPCI 中长期结果的 RCT 荟萃分析显示，DES 的使用降低了重复血运重建的风险，而 ST、死亡率或复发性心肌梗死没有增加。
