Kang Si-Hyuck, Park Keun Ho, Ahn Hyo-Suk, Park Kyung Woo, Hong Young Joon, Koo Bon-Kwon, Jeong Myung Ho, Kim Hyo-Soo
Cardiovascular Centre, Seoul National University Hospital, Seoul, South Korea.
EuroIntervention. 2014 May;10(1):74-82. doi: 10.4244/EIJV10I1A13.
Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status.
Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI.
Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.
糖尿病患者经皮冠状动脉介入治疗(PCI)后发生不良事件的风险较高。本研究旨在根据糖尿病状态阐明依维莫司洗脱支架(EES)与西罗莫司洗脱支架(SES)的相对疗效。
将EXCELLENT随机试验和注册研究的数据以符合方案分析的方式进行汇总。主要终点为靶病变失败(TLF),这是一个综合了心源性死亡、靶血管相关心肌梗死或靶血管血运重建的指标。在总共6524例患者中,2404例(36.8%)患有糖尿病。糖尿病患者PCI术后的TLF发生率较高,这主要是由心源性死亡和心肌梗死的差异所致,而再次血运重建率和支架血栓形成率并无显著差异。在按糖尿病状态分层的每个亚组中,接受EES治疗的患者与接受SES治疗的患者的TLF发生率相似(交互作用p = 0.384)。此外,对于任何预先指定的临床终点均未发现显著的交互作用。治疗权重逆概率分析的结果证实了这一结果(交互作用p = 0.329)。我们还发现,胰岛素依赖型糖尿病使接受PCI治疗的患者发生TLF的风险更高。
尽管药物洗脱支架技术最近取得了进展,但糖尿病患者PCI术后发生不良临床事件的风险仍高于非糖尿病患者。就PCI术后的临床结局而言,患者接受EES还是SES治疗与糖尿病状态之间没有显著的交互作用。