Bundhun Pravesh Kumar, Bhurtu Akash, Soogund Mohammad Zafooruddin Sani, Long Man-Yun
Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, P. R. China.
Guangxi Medical University, Nanning, Guangxi, 530021, P. R. China.
PLoS One. 2016 Apr 25;11(4):e0154064. doi: 10.1371/journal.pone.0154064. eCollection 2016.
Several studies have shown Drug Eluting Stents (DES) to be better compared to Bare Metal Stents (BMS) in patients with type 2 Diabetes Mellitus (T2DM). Since, the adverse clinical outcomes in patients with Insulin-Treated Type 2 Diabetes Mellitus (ITDM) implanted with DES and BMS have not been previously studied, we aim to compare the clinical outcomes in similar patients with cardiovascular diseases, treated with DES and BMS.
Randomized Controlled Trials (RCTs) comparing patients treated with DES and BMS were searched from PubMed and EMBASE databases. Outcome data for the patients with ITDM were carefully extracted. Major Adverse Cardiac Events (MACEs), mortality, Target Vessel Revascularization (TVR), Target Lesion Revascularization (TLR), Myocardial Infarction (MI) and Stent Thrombosis (ST) were considered as the clinical endpoints for this analysis. Odds ratios (OR) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software.
Ten RCTs consisting of 830 patients with ITDM (477 patients in the DES group and 353 patients in the BMS group) from a total number of 9,141 patients were included in this analysis. During a follow-up period from one month to one year, MACEs were not increased with the use of DES in these patients with ITDM. At 9 months, MACEs were significantly lower in the DES group with OR: 0.40, 95% CI: 0.23-0.72; P = 0.002 with no increase in mortality. TVR and TLR also favored the DES group with OR: 0.44, 95% CI: 0.22-0.88, P = 0.02 and OR: 0.28, 95% CI: 0.14-0.53; P = 0.0001 respectively at 9 months, and OR: 0.46, 95% CI: 0.23-0.94, P = 0.03 and OR: 0.28, 95% CI: 0.14-0.55; P = 0.0003 respectively at one year. Results for MI, and ST were not statistically significant.
Compared to BMS, DES were associated with a significantly lower rate of repeated revascularization, without any increase in MACEs or mortality in these patients with ITDM during a follow up period of one year. However, due to the very small population size, further studies with a larger number of randomized patients are required to completely solve this issue.
多项研究表明,在2型糖尿病(T2DM)患者中,药物洗脱支架(DES)比裸金属支架(BMS)效果更好。由于此前尚未研究过植入DES和BMS的胰岛素治疗2型糖尿病(ITDM)患者的不良临床结局,我们旨在比较接受DES和BMS治疗的类似心血管疾病患者的临床结局。
从PubMed和EMBASE数据库中检索比较接受DES和BMS治疗患者的随机对照试验(RCT)。仔细提取ITDM患者的结局数据。主要不良心脏事件(MACE)、死亡率、靶血管血运重建(TVR)、靶病变血运重建(TLR)、心肌梗死(MI)和支架血栓形成(ST)被视为该分析的临床终点。计算95%置信区间(CI)的比值比(OR),并使用RevMan 5.3软件进行汇总分析。
本分析纳入了10项RCT,共9141例患者,其中830例ITDM患者(DES组477例,BMS组353例)。在1个月至1年的随访期内,这些ITDM患者使用DES并未增加MACE。在9个月时,DES组的MACE显著较低,OR为0.40,95%CI为0.23 - 0.72;P = 0.002,死亡率未增加。TVR和TLR也有利于DES组,9个月时OR分别为0.44,95%CI为0.22 - 0.88,P = 0.02和OR为0.28,95%CI为0.14 - 0.53;P = 0.0001,1年时OR分别为0.46,95%CI为0.23 - 0.94,P = 0.03和OR为0.28,95%CI为0.14 - 0.55;P = 0.0003。MI和ST的结果无统计学意义。
与BMS相比,DES与重复血运重建率显著降低相关,在这些ITDM患者的1年随访期内,MACE或死亡率没有任何增加。然而,由于样本量非常小,需要更多随机患者的进一步研究来完全解决这个问题。