Abstract 10908: Bare Metal Stents, Durable Polymer Drug Eluting Stents or Biodegradable Polymer Stents for Coronary Artery Disease: A Mixed Treatment Comparison Analysis of 254 361 Patient-Years of Follow-up From Randomized Trials
Background: Biodegradable polymer DES preserve the safety of BMS while maintaining the efficacy (restenosis reduction) of DES. However, the efficacy and safety of biodegradable polymer DES when compared with newer generation DES is not known.
Methods: PUBMED, EMBASE, and CENTRAL were searched for RCTs, comparing any of the FDA approved durable polymer DES (SES, PES, CoCr EES, PtCr EES, ZES and ZES-R) or biodegradable polymer stent (BPS), with each other or against BMS. Long-term efficacy [target vessel revascularization (TVR)] and safety [death, myocardial infarction (MI), stent thrombosis] outcomes were evaluated. Landmark analysis at >1-year time point was evaluated to assess the potential late benefit of biodegradable polymer stents.
Findings: From 124 randomized trials and 254 361 patient-years of follow-up, in terms of efficacy (TVR), BPS was superior to PES [Rate ratio (RR) 0.66; 95% credibility interval (CrI) 0.57, 0.78] and ZES (RR 0.69; 95% CrI 0.56, 0.84) but not to newer generation DES (e.g.: vs. CoCr EES Rate ratio RR 1.03; 95% CrI 0.89, 1.21). Similarly, BPS was superior to PES (RR 0.61; 95% CrI 0.37, 0.89) but inferior to CoCr EES (RR 2.04; 95% CrI 1.27, 3.35) for safety (definite stent thrombosis). In the landmark analysis after 1 year, BPS was superior to SES for TVR (RR 0.29; 95% CrI 0.10, 0.82) but was associated with increased mortality compared with CoCr EES (RR 1.52; 95% CrI 1.02, 2.22). Overall, among all stent types, the newer generation DES (ZES-R, CoCr EES and PtCr EES) were the most efficacious (lowest TVR rate) stents, while CoCr EES was the safest with significant reduction in definite stent thrombosis (RR 0.35; 95% CrI 0.21, 0.53), myocardial infarction (RR 0.65; 95% CrI 0.55, 0.75) and death (RR 0.72; 95% CrI 0.58, 0.90) when compared with BMS.
Interpretation: Biodegradable polymer stents, are superior in reducing TVR compared to 1st generation DES, but not to newer generation stents. Newer generation DES and especially CoCr EES have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer DES needs to be proven.
- © 2013 by American Heart Association, Inc.