Comparing the Clinical Outcomes between Drug Eluting Stents and Bare Metal Stents in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of 10 Randomized Controlled Trials.

Pravesh Kumar Bundhun,Mohammad Zafooruddin Sani Soogund,Akash Bhurtu,Man-Yun Long,Umberto Benedetto

doi:10.1371/journal.pone.0154064

Pravesh Kumar Bundhun, Mohammad Zafooruddin Sani Soogund + Show 3 more

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https://doi.org/10.1371/journal.pone.0154064

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Abstract

BackgroundSeveral 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.MethodsRandomized 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.ResultsTen 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.ConclusionCompared 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.

Highlights

Today, an estimated 171 million people suffer from Diabetes Mellitus (DM) all over the world and the prevalence of this chronic disease is expected to double over the two decades [1]
Ten Randomized Controlled Trials (RCTs) consisting of 830 patients with Insulin-Treated Type Diabetes Mellitus (ITDM) (477 patients in the Drug Eluting Stents (DES) group and 353 patients in the Bare Metal Stents (BMS) group) from a total number of 9,141 patients were included in this analysis
At 9 months, Major Adverse Cardiac Events (MACEs) were significantly lower in the DES group with Odds ratios (OR): 0.40, 95% confidence intervals (CIs): 0.23–0.72; P = 0.002 with no increase in mortality

Summary

Introduction

An estimated 171 million people suffer from Diabetes Mellitus (DM) all over the world and the prevalence of this chronic disease is expected to double over the two decades [1]. Even if studies have shown that type 2 Diabetes Mellitus (T2DM) is independently associated with significantly higher adverse clinical outcomes whether with Drug Eluting Stents (DES) or Bare Metal Stents (BMS) [3], compared to non-T2DM, other studies have shown DES to have been associated with better outcomes compared to BMS in patients with T2DM. Since insulin therapy is associated with increased adverse cardiovascular outcomes after PCI [5] and because the adverse clinical outcomes observed with the use of DES and BMS have not been previously studied in patients with ITDM, we aim to solve this issue using data only from RCTs. 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). 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

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