Author + information
- Received September 26, 2016
- Revision received November 22, 2016
- Accepted December 5, 2016
- Published online March 6, 2017.
- Georges El-Hayek, MDa,
- Sripal Bangalore, MD, MHAb,
- Abel Casso Dominguez, MDc,
- Chandan Devireddy, MDa,
- Wissam Jaber, MDa,
- Gautam Kumar, MDa,
- Kreton Mavromatis, MDa,
- Jacqueline Tamis-Holland, MDc and
- Habib Samady, MDa,∗ ()
- aDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia
- bLeon H. Charney Division of Cardiology, New York University School of Medicine, New York, New York
- cDepartment of Cardiovascular Diseases, Mount Sinai St. Luke’s Hospital, New York, New York
- ↵∗Address for correspondence:
Dr. Habib Samady, Emory University School of Medicine, 1364 Clifton Road F622, Atlanta, Georgia 30322.
Objectives The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES).
Background Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial.
Methods The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics.
Results The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (<6 months vs. >6 months), the strut thickness of the BP-DES (thin <100 μm vs. thick >100 μm), or the DAPT duration (≥6 months vs. ≥12 months).
Conclusions BP-DES have similar safety and efficacy profiles to second-generation DP-DES.
Dr. Bangalore has received research grants from Abbott Vascular; and travel grants from Medtronic and Boston Scientific. Dr. Devireddy is a scientific advisory board member with Medtronic and Vascular Dynamics. Dr. Kumar is a consultant for Trireme Medical, CSI Medical, and Abiomed. Dr. Samady has received research funding from Volcano Corporation, St. Jude Medical, Medtronic, Inc., and Abbott Vascular. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.
- Received September 26, 2016.
- Revision received November 22, 2016.
- Accepted December 5, 2016.