Author + information
- Received June 1, 2017
- Revision received July 25, 2017
- Accepted July 26, 2017
- Published online September 18, 2017.
- Satya Shreenivas, MDa,
- Dean J. Kereiakes, MDa,∗ (, )
- Stephen G. Ellis, MDb,
- Runlin Gao, MDc,
- Takeshi Kimura, MDd,
- Yoshinobu Onuma, MD, PhDe,
- Karine Piard-Ruster, MD, PhDf,
- Yunlong Zhang, MDf,
- Kai Koo, PhDf,
- Minh-Thien Vu, MSf,
- Patrick W. Serruys, MD, PhDg and
- Gregg W. Stone, MDh
- aChrist Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio
- bCleveland Clinic, Cleveland, Ohio
- cFu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- dKyoto University Hospital, Kyoto, Japan
- eThoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- fAbbott Vascular, Santa Clara, California
- gInternational Centre for Cardiovascular Health, Imperial College, London, United Kingdom
- hNew York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Dean J. Kereiakes, The Christ Hospital Heart and Vascular Center, The Lindner Research Center, 2123 Auburn Avenue, Suite 424, Cincinnati, Ohio 45219.
Objectives Because females are under-represented in coronary trials, this study sought to assess the relative safety and efficacy of Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) and the Xience everolimus-eluting stent in females compared with males.
Background The Absorb everolimus-eluting BVS provides drug delivery and mechanical support similar to a metallic drug-eluting stent, followed by resorption and restoration of more normal vascular structure with the potential to improve late clinical outcomes.
Methods The ABSORB II, ABSORB III, ABSORB Japan, and ABSORB China trials were pooled. Baseline clinical, angiography, procedural variables, and 2-year outcomes were analyzed by sex and device.
Results Among 3,384 randomized patients, 932 (27.5%) were female. Females were older, more often had diabetes and hypertension, but had less everolimus-eluting stent, 3-vessel disease, and smoking compared with males (all p≤0.001). The 2-year rates of target lesion failure with BVS versus everolimus-eluting stent in females were 8.9% versus 6.2% (study-level adjusted hazard ratio: 1.47; 95% confidence interval [CI]: 0.88 to 2.46) and 8.9% versus 6.4% in males (HR: 1.40; 95% CI: 1.02 to 1.92; pinteraction = 0.85). There were no significant interactions between sex and device type for any of the components of target lesion failure.
Conclusions The relative treatment effects of BVS and everolimus-eluting stent for the 2-year rates of target lesion failure and other cardiovascular outcomes were consistent in females and males.
The ABSORB trials were sponsored by Abbott Vascular, Santa Clara, California. Dr. Kereiakes has served as a consultant to Boston Scientific, Abbott Vascular, Svelte Medical Systems, Inc., Micell Technologies, Inc., and Sino Medical Sciences Technology, Inc.; and received research funding from Boston Scientific and Abbott Vascular. Dr. Ellis has served as a consultant to Boston Scientific, Abbott Vascular, and Medtronic; and has received research funding from Boston Scientific and Abbott Vascular. Dr. Gao has a research grant from Abbott Vascular. Dr. Kimura is an advisory board member for Abbott Vascular; and has received a research grant from Abbott Vascular. Dr. Onuma is an advisory board member for Abbott Vascular. Dr. Stone has served as the global chairman for the Absorb clinical trial program (uncompensated); and as a consultant for Reva. Columbia University, his employer, also receives royalties from Abbott Vascular for sale of the MitraClip. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 1, 2017.
- Revision received July 25, 2017.
- Accepted July 26, 2017.
- 2017 American College of Cardiology Foundation