Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis

Abstract

Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. Design Collaborative network meta-analysis. Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. Conclusion In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes. INTRODUCTIONPeople with diabetes experience a more generalised form of atherosclerosis than people without diabetes. They are at an increased risk for coronary heart disease and have more restenoses after the implantation of coronary stents. On average sirolimus eluting stents and paclitaxel eluting stents are associated with a noticeable reduction in target lesion revascularisation compared with bare metal stents, whereas the rates of overall mortality and cardiac mortality associated with the three stents are similar.1 Differences in the process and dynamics of restenosis along with variations in metabolic profiles may, however, alter safety or effectiveness profiles of the different stent types, particularly in people with diabetes.Randomised trials have reported a reduced revascularisation rate with both sirolimus eluting stents and paclitaxel eluting stents compared with bare metal stents in people with diabetes, 2...

ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD – Summary

“…250 This finding received further support from a meta-analysis of 35 trials comparing DES with BMS, 251 which revealed a similar efficacy of sirolimus-eluting and paclitaxel-eluting stents in this regard (OR 0.29 for sirolimus; 0.38 for paclitaxel) provided dual antiplatelet therapy after DES implantation was continued for >6 months. The risk of death associated with sirolimus-eluting stents was Years since randomization Figure 3.…”

Guidelines on myocardial revascularization

“…SES and PES have been extensively compared in numerous subsets, including diabetes [45,115,230]. While angiographic metrics are superior with SES, no robust clinically relevant differences up to 5-year follow-up were convincingly identified, except for further reduction in reintervention rates with SES vs. PES.…”

“…In selected STEMI patients [234,235], SES and PES were shown to be safe and effective (TYPHOON, HORIZONS-AMI, PASEO, and ZEST-AMI) with follow-up extending from 2 to 4 years. There is no solid evidence that one DES provides superior clinical outcome in patients with diabetes, due to the limited number of smallsized trials or the limitations of subgroup analyses [115]. Studies based on angiographic endpoints favour the use of DES with strong antiproliferative properties (late lumen loss 0.2 mm) [231].…”

“…intervention A large collaborative network meta-analysis has compared DES with BMS in 3852 diabetic patients [115]. Mortality S20…”

Drug-Eluting Stents in Interventional Cardiology

“…Whereas no significant reductions in the risk of death or myocardial infarction could be inferred, both sirolimus-and paclitaxel-eluting stents showed substantial reductions in angiographic end-points such as late lumen loss and binary restenosis [12], as well as clinical end-points such as target lesion revascularization, and major adverse cardiac events [13]. However, the safety of such first-generation drug-eluting stents was questioned repeatedly, given the increased risk of protocol-defined stent thrombosis and the occasionally reported raised risk of death in studies with short-term dual antiplatelet therapy [14].…”