Author + information
- Received April 9, 2015
- Revision received May 27, 2015
- Accepted June 1, 2015
- Published online July 1, 2015.
- Yuki Ishibashi, MD, PhD∗,
- Takashi Muramatsu, MD, PhD∗,†,
- Shimpei Nakatani, MD∗,
- Yohei Sotomi, MD‡,
- Pannipa Suwannasom, MD∗,
- Maik J. Grundeken, MD‡,
- Yun-kyeong Cho, MD, PhD∗,
- Hector M. Garcia-Garcia, MD, PhD∗,
- Ad J. van Boven, MD, PhD§,
- Jan J. Piek, MD, PhD‡,
- Manel Sabaté, MD, PhD‖,
- Steffen Helqvist, MD¶,
- Andreas Baumbach, MD, PhD#,
- Dougal McClean, MD∗∗,
- Manuel de Sousa Almeida, MD, PhD††,
- Luc Wasungu, PhD‡‡,
- Karine Miquel-Hebert, PhD‡‡,
- Dariusz Dudek, MD§§,
- Bernard Chevalier, MD‖‖,
- Yoshinobu Onuma, MD, PhD∗ and
- Patrick W. Serruys, MD, PhD¶¶∗ ()
- ∗Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
- †Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan
- ‡The Heart Center, Academic Medical Center, Amsterdam, the Netherlands
- §Medical Center Leeuwarden, Leeuwarden, the Netherlands
- ‖Thorax Institute, Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- ¶Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- #Bristol Heart Institute, Bristol, United Kingdom
- ∗∗Christchurch Hospital, Christchurch, New Zealand
- ††Hospital Santa Cruz, Carnaxide, Portugal
- ‡‡Abbott Vascular, Diegem, Belgium
- §§Jagiellonian University, Krakow, Poland
- ‖‖Institut Jacques Cartier, Massy, France
- ¶¶International Centre for Cardiovascular Health, Imperial College, London, United Kingdom
- ↵∗Reprint requests and correspondence:
Prof. Patrick W. Serruys, International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, South Kensington Campus, London SW7 2AZ, United Kingdom.
Objectives This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation.
Background A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury.
Methods In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise.
Results Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002).
Conclusions There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).
This study was funded by Abbott Cardiovascular Systems, Inc. Dr. Wasungu is a contractor employed by Abbott Vascular. Dr. Miquel-Hebert is an employee of Abbott Vascular. Drs. Onuma and Serruys are members of the advisory board of Abbott Vascular. Drs. Baumbach and Chevalier are consultants with Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 9, 2015.
- Revision received May 27, 2015.
- Accepted June 1, 2015.
- 2015 American College of Cardiology Foundation