Background: Coronary artery stents are tiny tubular devices used to 'scaffold' vessels open during percutaneous transluminal coronary angioplasty (PTCA). Restenosis (re-narrowing) of vessels treated with stents is a problem; in order to reduce restenosis, stents that elute drugs over time are now available. However these drug-eluting stents are more expensive and there is a need to assess their clinical benefits prior to recommending their use.
Objectives: To examine evidence from randomised controlled trials (RCTs) to assess the impact of drug eluting stents (DES) compared to bare metal stents (BMS) in the reduction of cardiac events.
Search strategy: The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4), MEDLINE (1990 - April 2009) and EMBASE (1980 - January 2009) were searched. We carried out handsearching (electronic and manual) up to January 2008.
Selection criteria: We included RCTs comparing DES with BMS used in conjunction with PTCA techniques in the review. Participants were adults with stable angina or acute coronary syndrome (ACS). We considered published and unpublished sources and included them if they reported outcome data of interest.
Data collection and analysis: Three review authors independently extracted data, assessed trial quality assessment and checked decisions within the group. Data extraction included composite event rates (major adverse cardiac event, target vessel failure); death; acute myocardial infarction (AMI); target lesion revascularisation (TLR); target vessel revascularisation (TVR) and thrombosis. Data synthesis included meta-analysis of composite event rate, death, AMI and revascularisation rates, presented as odds ratios with 95% confidence intervals (CI) using a fixed-effect model. We assessed heterogeneity between trials.
Main results: We included more than 14,500 patients in 47 RCTs. There were no statistically significant differences in death, AMI or thrombosis between DES and BMS. For composite events, TLR and TVR reductions were evident with use of sirolimus, paclitaxel, everolimus, dexamethasone, zotarolimus and (to a limited extent) tacrolimus-eluting stents. These effects are demonstrated in the longer term follow up. Subgroup analyses (e.g. diabetics) largely mirrored these findings.
Authors' conclusions: Drug-eluting stents releasing sirolimus, paclitaxel, dexamethasone and zotarolimus reduce composite cardiac events. However, this reduction is due largely to reductions in repeat revascularisation rates as there is no evidence of a significant effect on rates of death, MI or thrombosis. The increased cost of drug-eluting stents and lack of evidence of their cost-effectiveness means that various health funding agencies are having to limit or regulate their use in relation to price premium.