Comparing the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in type 2 diabetes mellitus patients after coronary stents implantation: a systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Since antiplatelet therapy in type 2 diabetes mellitus (T2DM) patients is very important after intracoronary stenting, and because the most commonly used therapies have been the dual antiplatelet therapy (DAPT) consisting of aspirin and clopidogrel and the triple antiplatelet therapy (TAPT) consisting of aspirin, clopidogrel and cilostazol, we aim to compare the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in T2DM patients.

Methods: Systematic literature search was done from the databases of PubMed, Cochrane, Embase, China National Knowledge Infrastructure (CNKI) and WanFang. Randomized controlled trials (RCTs) comparing the effectiveness and safety between triple therapy and dual therapy in T2DM patients after coronary stents placement were included. Endpoints included major adverse cardiac effects (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), death, stent thrombosis, bleeding and adverse drug reactions during a 9-12 months period, as well as platelet activities.

Results: Four studies including 1005 patients reporting the adverse clinical outcomes and six studies including 519 patients reporting the platelet activities, with a total of 1524 patients have been analyzed in this meta-analysis. The pooling analysis shows that TAPT has significantly decreased the occurrence of MACEs (RR: 0.55; 95 % CI: 0.36-0.86, P = 0.009), TLR (RR 0.41; 95 % CI: 0.21-0.80, P = 0.008), TVR (RR 0.55; 95 % CI: 0.34-0.88, P = 0.01) and the overall incidence of Death/ Myocardial Infarction (MI)/TVR (RR 0.54; 95 % CI: 0.31-0.94, P = 0.03) during this 9 to 12 months follow up period after stents implantation. Stent thrombosis was almost similar in both groups. Bleeding seemed to favor DAPT but the result was not statistically significant. Platelet aggregation, platelet reactivity index (PRI) and platelet reactivity unit (PRU) were also reduced with Weight Mean Difference (WMD) of (-13.80; 95 % CI: -17.03 to -10.56, P < 0.00001), (-22.87; 95 % CI: -23.66 to -22.07, P < 0.00001) and (-44.17; 95 % CI: -58.56 to -29.77, P < 0.00001) respectively.

Conclusion: Since MACEs have been significantly decreased in the triple group, TAPT appears to be more effective than DAPT in T2DM patients after intracoronary stenting. No significant difference in stent thrombosis and bleeding risks between these 2 groups shows TAPT to be almost as safe as DAPT in these diabetic patients.

Fig. 1

Flow diagram for the study selection. One thousand five hundred eighty six articles were identified from PubMed, Embase/Science Direct, CNKI, Wanfang and Cochrane databases. After considering the inclusion and exclusion criteria, finally 8 RCTs were selected and included in this meta-analysis. Showing the detailed flow chart of study selection

Fig. 2

Forest plot comparing the adverse clinical outcomes between TAPT and DAPT in T2DM patients after intracoronary stenting. Adverse clinical outcomes have decreased with the use of this TAPT during a follow up period of 9 to 12 months after coronary stenting

Fig. 3

Forest plot comparing the platelet activities between TAPT and DAPT in T2DM after intracoronary stenting. A lower platelet aggregation, platelet reactivity index and platelet reactivity unit in the TAPT group shows that TAPT seems to be more effective in these T2DM patients

Fig. 4

Forest plot comparing the adverse drug reactions between TAPT and DAPT in T2DM patients after intracoronary stenting. More adverse effects are associated with cilostazol use in this TAPT compared to DAPT in these T2DM patients

Fig. 5

a and b Funnel plots assessing publication bias in the included studies. For all of the above analyses, sensitivity analyses yielded consistent results. Based on a visual inspection of the funnel plots, there has been no evidence of publication bias for the included studies that assessed all clinical end points