Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysisBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6625 (Published 08 November 2013) Cite this as: BMJ 2013;347:f6625
- Sripal Bangalore, director of research, assistant professor of medicine1,
- Bora Toklu, assistant professor of medicine2,
- Nicholas Amoroso, fellow in cardiovascular medicine1,
- Mario Fusaro, fellow in critical care1,
- Sunil Kumar, fellow in cardiovascular medicine5,
- Edward L Hannan, distinguished professor emeritus of health policy, management and behavior3,
- David P Faxon, professor of medicine4,
- Frederick Feit, professor of medicine1
- 1New York University School of Medicine, The Leon H Charney Division of Cardiology, New York, NY 10016, USA
- 2Virginia Commonwealth University, Richmond, VA, USA
- 3School of Public Health, The University at Albany, Albany, NY, USA
- 4Brigham and Women’s Hospital, Boston, MA, USA
- 5University of Nebraska, Omaha, Nebraska, NE
- Correspondence to: S Bangalore
- Accepted 22 October 2013
Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.
Design Mixed treatment comparison meta-analysis of 258 544 patient years of follow-up from randomized trials.
Data sources and study selection PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.
Outcomes Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.
Results From 126 randomized trials and 258 544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.
Conclusions Biodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, 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 stents needs to be proven.
Contributors: SB was responsible for the study concept and design. SB, BT, SK, MF, and NA were involved in acquisition of data. SB was responsible for analysis and interpretation of data. SM and NT drafted the manuscript. All authors critically revised the manuscript for important intellectual content. SB supervised the study and is the guarantor.
Funding: This research received no specific grant from any funding agency in the public, commercial, or not for profit sectors.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; SB has acted as an advisory board participant/consultant for Boehringer Ingelheim, Daiichi Sankyo, Pfizer, Gilead, Abbott, and Abbott-Vascular; FF is a shareholder in Medtronic, Boston Scientific, and Johnson and Johnson; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Not required.
Data sharing: No additional data available.
Declaration of transparency: The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; no important aspects of the study have been omitted; and any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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