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

Stettler C, Allemann S, Wandel S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, De Carlo M, Erglis A, Chechi T, Ortolani P, Schalij MJ, Diem P, Meier B, Windecker S, Jüni P - BMJ (2008)

Bottom Line: 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.Collaborative network meta-analysis.Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Social and Preventive Medicine, University of Bern, 3012 Bern, Switzerland.

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.

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Related in: MedlinePlus

Fig 1 Identification of trials
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fig1: Fig 1 Identification of trials

Mentions: Forty two trialsw1-w42 met the inclusion criteria (fig 1). Seven trials, totalling about 900 people with diabetes and 3000 without, were excluded because data stratified by diabetes status were not obtainable.w15 w34 w36 w37 w39 w41 w42 The remaining 35 trialsw1-w14 w16-w33 w35 w38 w40 were included. Investigators or manufacturers provided additional data for 32 trials.w1 w4-w14 w16-w19 w21-w33 w35 w38 w40 (The characteristics of the 35 included trials are presented in web extra table A.) Four trialsw1-w3 w29 included only people with diabetes and one trial only people without diabetes.w33 The trials had randomly allocated 3852 people with diabetes mellitus and 10 947 people without diabetes mellitus. Patient recruitment started between August 2000w16 and October 2004w4 and was completed between January 2001w16 and November 2005.w5 Data stratified according to the presence or absence of diabetes were available for all 35 trials on all outcomes, except stent thrombosis (see web extra tables B and C). Twenty nine trials described appropriate methods for allocation concealment,w1 w2 w7 w8 w11-w14 w16-w33 w35 w38 w40 and 28 trials reported blind adjudication for clinical outcomes.w1 w4 w7 w9-w14 w16-w26 w28-w30 w32 w33 w35 w38 w40 For 30 trials all randomised patients could be included in the analyses according to the intention to treat principle.w1 w3-w7 w9 w11 w13 w14 w16-w23 w25-w33 w35 w38 w40 Twenty four trials were considered to be of high quality.w1 w7 w11 w13 w14 w16-w23 w25 w26 w28-w30 w32 w33 w35 w38 w40


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

Stettler C, Allemann S, Wandel S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, De Carlo M, Erglis A, Chechi T, Ortolani P, Schalij MJ, Diem P, Meier B, Windecker S, Jüni P - BMJ (2008)

Fig 1 Identification of trials
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2527175&req=5

fig1: Fig 1 Identification of trials
Mentions: Forty two trialsw1-w42 met the inclusion criteria (fig 1). Seven trials, totalling about 900 people with diabetes and 3000 without, were excluded because data stratified by diabetes status were not obtainable.w15 w34 w36 w37 w39 w41 w42 The remaining 35 trialsw1-w14 w16-w33 w35 w38 w40 were included. Investigators or manufacturers provided additional data for 32 trials.w1 w4-w14 w16-w19 w21-w33 w35 w38 w40 (The characteristics of the 35 included trials are presented in web extra table A.) Four trialsw1-w3 w29 included only people with diabetes and one trial only people without diabetes.w33 The trials had randomly allocated 3852 people with diabetes mellitus and 10 947 people without diabetes mellitus. Patient recruitment started between August 2000w16 and October 2004w4 and was completed between January 2001w16 and November 2005.w5 Data stratified according to the presence or absence of diabetes were available for all 35 trials on all outcomes, except stent thrombosis (see web extra tables B and C). Twenty nine trials described appropriate methods for allocation concealment,w1 w2 w7 w8 w11-w14 w16-w33 w35 w38 w40 and 28 trials reported blind adjudication for clinical outcomes.w1 w4 w7 w9-w14 w16-w26 w28-w30 w32 w33 w35 w38 w40 For 30 trials all randomised patients could be included in the analyses according to the intention to treat principle.w1 w3-w7 w9 w11 w13 w14 w16-w23 w25-w33 w35 w38 w40 Twenty four trials were considered to be of high quality.w1 w7 w11 w13 w14 w16-w23 w25 w26 w28-w30 w32 w33 w35 w38 w40

Bottom Line: 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.Collaborative network meta-analysis.Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Social and Preventive Medicine, University of Bern, 3012 Bern, Switzerland.

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.

Show MeSH
Related in: MedlinePlus