Author + information
- Received July 1, 2013
- Accepted July 17, 2013
- Published online January 1, 2014.
- Manel Sabaté, MD, PhD∗,
- Lorenz Räber, MD†,
- Dik Heg, PhD‡,
- Salvatore Brugaletta, MD, PhD∗∗ (, )
- Henning Kelbaek, MD, PhD§,
- Angel Cequier, MD, PhD‖,
- Miodrag Ostojic, MD, PhD¶,
- Andrés Iñiguez, MD, PhD#,
- David Tüller, MD, PhD∗∗,
- Antonio Serra, MD††,
- Andreas Baumbach, MD, PhD‡‡,
- Clemens von Birgelen, MD, PhD§§,
- Rosana Hernandez-Antolin, MD, PhD‖‖,
- Marco Roffi, MD, PhD¶¶,
- Vicente Mainar, MD##,
- Marco Valgimigli, MD, PhD∗∗∗,
- Patrick W. Serruys, MD, PhD†††,
- Peter Jüni, MD‡ and
- Stephan Windecker, MD†
- ∗University Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- †Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland
- ‡Department of Clinical Research, Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
- §Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark
- ‖University Hospital of Bellvitge, Barcelona, Spain
- ¶Clinical Center of Serbia, Belgrade, Serbia
- #Hospital do Meixoeiro, Vigo, Spain
- ∗∗Cardiology Department, Triemlispital, Zurich, Switzerland
- ††University Hospital of Sant Pau, Barcelona, Spain
- ‡‡Bristol Heart Institute, Bristol, United Kingdom
- §§Thoraxcentrum Twente, Twente University, Enschede, the Netherlands
- ‖‖University Hospital San Carlos, Madrid, Spain
- ¶¶Cardiocentro, Lugano, Switzerland
- ##Hospital General of Alicante, Alicante, Spain
- ∗∗∗University Hospital Ferrara, Ferrara, Italy
- †††Erasmus Medical Center, Rotterdam, the Netherlands
- ↵∗Reprint requests and correspondence:
Dr. Salvatore Brugaletta, Department of Cardiology, Hospital Clinic, C/Villaroel 170, 08036 Barcelona, Spain.
Objectives This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI).
Background Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES.
Methods Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year.
Results Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS.
Conclusions Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.
Dr. Sabate is a consultant to Medtronic and Abbott Vascular. Dr. Tüller has received travel grants by Biosensors, Biotronik, Abbott Vascular, and Terumo. Dr. von Birgelen is a consultant to and has received lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic; has received lecture fees from Biotronik and Merck; and his institution has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. Roffi has received research/institutional grants from Abbott Vascular, Boston Scientific, Biosensor, and Medtronic; and is a consultant to Eli Lilly and Daiichi Sankyo. Dr. Juni is an unpaid member of steering group or executive committee of trials funded by Abbott Vascular, Biosensors, Medtronic, and St. Jude Medical. Dr. Windecker is a consultant for Cordis, Medtronic, and St. Jude. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 1, 2013.
- Accepted July 17, 2013.
- American College of Cardiology Foundation