Short and Long-Term Outcomes with Drug Eluting and Bare Metal Coronary Stents: A Mixed Treatment Comparison Analysis of 117 762 Patient-Years of Follow-up from Randomized Trials
Background—Drug eluting stents (DES) have been in clinical use for nearly a decade. However, the relative short and long-term efficacy and safety of DES when compared with bare metal stents (BMS) and among the DES types are less well defined.
Methods and Results—PUBMED, EMBASE, and CENTRAL were searched for randomized clinical trials (RCTs), until March 2012, comparing any of the FDA approved durable stent and polymer DES [sirolimus Eluting Stent (SES), paclitaxel eluting (PES), everolimus eluting (EES) and zotarolimus eluting stent (ZES) and ZES-Resolute (ZES-R)], with each other or against BMS, for de novo coronary lesions, enrolling at least 100 patients and with follow-up of at least 6-months. Short-term (≤1 year) and long-term efficacy [target vessel revascularization (TVR), target lesion revascularization (TLR)] and safety (death, myocardial infarction (MI), stent thrombosis) outcomes were evaluated and trial level data pooled using both mixed treatment comparison and direct comparison analyses. From 77 RCTs with 117 762 patient-years of follow-up, when compared with BMS, each DES reduced long-term TVR (39% to 61%) but the magnitude varied by DES type (EES~SES~ZES-R >PES~ZES>BMS) with a >42% probability that EES had the lowest TVR rate. There was no increase in the risk of any long-term safety outcomes including stent thrombosis with any DES (vs. BMS). In addition there was reduction in MI (all DES except PES vs. BMS), and stent thrombosis (with EES vs. BMS, RR=0.51, 95% Cr I 0.35-0.73). The safest DES appeared to be EES (>86% probability) with reduction in MI and stent thrombosis when compared with BMS. Short-term outcomes were similar to long-term outcomes with SES, ZES-R and EES being the most efficacious and EES being the safest stent.
Conclusions—DES are highly efficacious at reducing the risk of TVR without increase in any safety outcomes including stent thrombosis. However, within the DES types there were considerable differences, such that EES, SES, and ZES-R were the most efficacious and EES was the safest stent.
- Received February 1, 2012.
- Accepted April 30, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited