Drug-eluting Stents for the Treatment of Coronary Artery Disease: Review of Systematic Reviews
July 24, 2009 | Evidence Reports
Our 2006 report compared the safety of DES and bare-metal stent (BMS) implantation and also the relative efficacy and safety of the two DESs then available on the U.S. market (i.e., sirolimus-eluting stents SESs; paclitaxel-eluting stents PESs) when used for nonemergency treatment of CAD. Four research questions were addressed in the report:
Since that report was published, various new studies, including both randomized and non-randomized controlled trials (RCTs), have been published. Some of the studies suggested that there might be a potentially increased risk of late or very late in-stent thrombosis—as well as a subsequent cardiac event (e.g., myocardial infarction MI death)—associated with DES use. The strong safety concerns provoked a wave of efforts to re-examine DES studies in early 2007 and also triggered the U.S. Food and Drug Administration’s (FDA’s) action to rewrite labeling information regarding dual antiplatelet therapy after DES implantation.
The purpose of this report is to update our previous Evidence Report by adding the new evidence that emerged after May 2006. Here we review here published systematic reviews, individual patient data (IPD) meta-analyses of RCTs, and RCTs published after May 2006 that were not included in any of the systematic reviews or IPD meta-analyses. This report does not supersede the 2006 report because the methods of evidence syntheses are different, but the 2006 report is included as one of the systematic reviews or meta-analyses to be reviewed with other published systematic reviews.
Like our previous Evidence Report, we focus only on commercially available DESs in the U.S. market. We compare the efficacy of DESs to BMSs and the relative efficacy of different DESs for labeled indications in the general population. Detailed discussion of on- and off-label use of DESs appears in later sections. Evaluation of DES use for off-label indications or for a subset of the general population (e.g., patients with MI or...