Author + information
- Received December 29, 2011
- Revision received July 17, 2012
- Accepted August 2, 2012
- Published online December 1, 2012.
- Robert-Jan van Geuns, MD, PhD⁎,
- Corrado Tamburino, MD, PhD†,
- Jean Fajadet, MD‡,
- Mathias Vrolix, MD§,
- Bernhard Witzenbichler, MD∥,
- Eric Eeckhout, MD, PhD¶,
- Christian Spaulding, MD, PhD#,⁎⁎,
- Krzysztof Reczuch, MD, PhD††,‡‡,
- Alessio La Manna, MD†,
- René Spaargaren, MD§§,
- Héctor M. García-García, MD, PhD∥∥,
- Evelyn Regar, MD, PhD⁎,
- Davide Capodanno, MD†,
- Glenn Van Langenhove, MD, PhD¶¶ and
- Stefan Verheye, MD, PhD¶¶,⁎ ()
- ↵⁎Reprint requests and correspondence
: Dr. S. Verheye, Antwerp Cardiovascular Center, ZNA Middelheim, Lindendreef 1, 2020 Antwerp, Belgium
Objectives This study sought to investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 3 days after implantation in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Background Acute myocardial infarction is associated with vasoconstriction and large thrombus burden. Resolution of vasoconstriction and thrombus load during the first hours to days after primary percutaneous coronary intervention may lead to stent undersizing and malapposition, which may subsequently lead to stent thrombosis or restenosis. In addition, aggressive stent deployment may cause distal embolization.
Methods Eighty patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomized to receive a self-expanding stent (STENTYS, STENTYS SA, Paris, France) (n = 43) or a balloon-expandable stent (VISION, Abbott Vascular, Santa Clara, California; or Driver, Medtronic, Minneapolis, Minnesota) (n = 37) at 9 European centers. The primary endpoint was the proportion of stent strut malapposition at 3 days after implantation measured by optical coherence tomography. Secondary endpoints included major adverse cardiac events (cardiac death, recurrent myocardial infarction, emergent bypass surgery, or clinically driven target lesion revascularization).
Results At 3 days after implantation, on a per-strut basis, a lower rate of malapposed stent struts was observed by optical coherence tomography in the self-expanding stent group than in the balloon-expandable group (0.58% vs. 5.46%, p < 0.001). On a per-patient basis, none of the patients in the self-expanding stent group versus 28% in the balloon-expandable group presented ≥5% malapposed struts (p < 0.001). At 6 months, major adverse cardiac events were 2.3% versus 0% in the self-expanding and balloon-expandable groups, respectively (p = NS).
Conclusions Strut malapposition at 3 days is significantly lower in ST-segment elevation myocardial infarction patients allocated to self-expanding stents when than in those allocated to balloon-expandable stents. The impact of this difference on clinical outcome and the risk of late stent thrombosis need to be evaluated further. (Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction [APPOSITION II]; NCT01008085)
- acute myocardial infarction
- clinical trial information
- optical coherence tomography
- percutaneous coronary intervention
- self-expanding stents
Dr. Witzenbichler received site reimbursement from STENTYS for participation in APPOSITION II Study. Dr. Spaulding is a member of the scientific advisory board and has received honoraria as a member of the speaker board for STENTYS. Dr. Spaargaren is an employee of STENTYS SA. Dr. Capodanno has received speaker's honoraria from AstraZeneca, Boston Scientific, and Eli Lilly. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 29, 2011.
- Revision received July 17, 2012.
- Accepted August 2, 2012.
- American College of Cardiology Foundation