Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

Marco Valgimigli, Manel Sabaté, Christoph Kaiser, Salvatore Brugaletta, Jose Maria de la Torre Hernandez, Soeren Galatius, Angel Cequier, Franz Eberli, Adam de Belder, Patrick W Serruys, Giuseppe Ferrante

Journal: BMJ (Clinical research ed.) 2015;349():g6427

PMID: 25378023

Abstract

OBJECTIVES

To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents.

DESIGN

Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported.

DATA SOURCES AND STUDY SELECTION

Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients.

PRIMARY OUTCOMES

The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death.

RESULTS

The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets.

CONCLUSIONS

This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.

© Valgimigli et al 2014.

Address: Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, Netherlands [email protected].; University Hospital Clinic, IDIBAPS, Cardiology Department, 08036 Barcelona, Spain.; University Hospital 4003 Basel, Switzerland.; Hospital Marqués de Valdecilla, 39008 Santander, Spain.; Gentofte Hospital, 2900 Hellerup, Denmark.; University Hospital of Bellvitge, 08907 Barcelona, Spain.; Stadtspital Triemli, 8063 Zürich, Switzerland.; Brighton and Sussex University Hospitals NHS Trust, Brighton BN1 6AG, UK.; Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, Netherlands.; Interventional Cardiology, Humanitas Clinical and Research Institute IRCCS, 20089 Rozzano, Milan, Italy.
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