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

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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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Most cited references 22

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Systematic reviews in health care: Assessing the quality of controlled clinical trials.

P Jüni, D Altman, M. Egger (2001)

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Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study.

Joost Daemen, Peter Wenaweser, Keiichi Tsuchida … (2007)

Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0-30 days) and late (>30 days) stent thrombosis and between SES and PES. Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1.3 per 100 person-years; cumulative incidence at 3 years 2.9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0.6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1.1%) and PES (1.3%), but late stent thrombosis was more frequent with PES (1.8%) than with SES (1.4%; p=0.031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0.0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2.28, 95% CI 1.29-4.03) and diabetes (2.03, 1.07-3.83). Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.

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Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.

Christoph Stettler, Simon Wandel, Sabin Allemann … (2007)

Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a 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. Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021). The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.

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Author and article information

Contributors

: Role: senior research fellow

: Role: research fellow

: Role: professor of cardiology

: Role: professor of medicine

: Role: professor of cardiology

: Role: professor of medicine

: Role: professor of cardiology

: Role: professor of interventional cardiology

: Role: professor of cardiology

: Role: associate professor of cardiology

: Role: head of department

: Role: associate professor of cardiology

: Role: professor of cardiology

: Role: interventional cardiologist

: Role: training fellow in cardiology

: Role: cardiologist

: Role: vice director

: Role: associate professor of cardiology

: Role: interventional cardiologist

: Role: professor of cardiology

: Role: head of division

: Role: professor of cardiology

: Role: head of invasive cardiology

: Role: head of division

Journal

Journal ID (nlm-ta): BMJ

Journal ID (publisher-id): bmj

Title: BMJ : British Medical Journal

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1468-5833

Publication date Collection: 2008

Publication date (Print): 2008

Publication date (Electronic): 29 August 2008

Volume: 337

Electronic Location Identifier: a1331

Affiliations

[1 ]Institute of Social and Preventive Medicine, University of Bern, 3012 Bern, Switzerland

[2 ]Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital, Bern, Switzerland

[3 ]International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College, London

[4 ]Deutsches Herzzentrum, Technische Universität, Munich, Germany

[5 ]Institut Hospitalier Jacques Cartier, Massy, France

[6 ]Division of Cardiology, University Hospital, Basel, Switzerland

[7 ]Columbia University Medical Center, New York, USA

[8 ]Servicio de Cardiología, Hospital Universitario Reina Sofía, Cordoba, Spain

[9 ]Service of Cardiology, Clinique Cecil, Lausanne, Switzerland

[10 ]Department of Medicine, ASAN Medical Center, Seoul, Korea

[11 ]Department of Interventional Cardiology, Hospital de San Pau, Barcelona, Spain

[12 ]Department of Interventional Cardiology, St Antonius Hospital, Nieuwegein, Netherlands

[13 ]Cardiac Catheterisation Laboratory, Rigshospitalet, Copenhagen, Denmark

[14 ]Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris Descartes University, and INSERM U 780, Paris, France

[15 ]San Camillo Hospital, Rome, Italy

[16 ]Antwerp Cardiovascular Institute Middelheim, Antwerp, Belgium

[17 ]Amsterdam Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

[18 ]Division of Cardiology, Masaryk Hospital, Ústí nad Labem, Czech Republic

[19 ]Cardiothoracic and Vascular Department, University of Pisa, Italy

[20 ]University of Latvia, Institute of Cardiology, Riga, Latvia

[21 ]Cardiologia e Cardiologia Invasiva 2–AOU-Careggi, Florence, Italy

[22 ]Institute of Cardiology, S Orsola-Malpighi Hospital, University of Bologna, Italy

[23 ]Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands

[24 ]Department of Cardiology, Bern University Hospital, Bern, Switzerland

[25 ]CTU Bern, Bern University Hospital, 3010 Bern, Switzerland

Author notes

Correspondence to: P Jüni juni@ 123456ispm.unibe.ch

Article

Publisher ID: stec540997

DOI: 10.1136/bmj.a1331

PMC ID: 2527175

PubMed ID: 18757996

SO-VID: 11ffa3fa-19d8-4b12-82ca-78a4a11a4cdb

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This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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

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Most cited references 22

Systematic reviews in health care: Assessing the quality of controlled clinical trials.

Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study.

Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.

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