First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting.

Abstract

AIMS:

A novel balloon delivery system (BDS) for the self-apposing STENTYS sirolimus-eluting stent (SES) has been developed for highly precise longitudinal stent positioning and deployment. The aim of this first-in-man study is to report the quantitative coronary analysis (QCA) angiography and optical coherence tomography (OCT) results as well as the 30-day clinical outcomes of the STENTYS Xposition S SES.

METHODS AND RESULTS:

We included 25 patients (mean age 66.1±10.7 years) with stable coronary artery disease (24%) or acute coronary syndrome (including STEMI in 40%). The device was successfully placed at the intended site in all cases (100%), without procedural complications. Longitudinal geographic miss (entire lesion length [on QCA] not completely covered by the stent) was not observed. Pre-procedural MLD on QCA was 1.30±0.74 mm and post-procedural MLD was 2.74±0.44 mm, p<0.001 (acute gain 1.44±0.70 mm). OCT analyses showed a low percentage of malapposed stent struts directly post stent placement (2.4%), which further decreased after post-dilatation (0.6%, p=0.013), while mean stent area increased (from 9.7 mm2 to 10.5 mm2, p<0.001). At 30-day clinical follow-up, one (4%) major adverse cardiac event (MACE) was observed. One acute stent thrombosis (ST) occurred immediately post procedure in a STEMI patient which was related to inadequate medication therapy.

CONCLUSIONS:

This first-in-man study demonstrated that the use of the novel STENTYS Xposition S balloon delivery system is feasible with a high technical success rate without longitudinal geographical miss. Stent strut malapposition rate directly after STENTYS placement was low and improved further after post-dilatation.

• Authors: Huangling Lu, Alexander J J IJsselmuiden, Maik J Grundeken, Martina Nassif, Arie G de Vries, Auke Weevers, Martijn Scholte, René Spaargaren, Joanna J Wykrzykowska, Jan G P Tijssen, Robbert J de Winter, Karel T Koch
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 11 Issue 12 Pg. 1341-5 (Mar 2016) ISSN: 1969-6213 [Electronic] France
• PMID: 25983027 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Acute Coronary Syndrome (diagnostic imaging, therapy)
• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation)
• Cardiac Catheterization (adverse effects, instrumentation)
• Cardiac Catheters
• Computed Tomography Angiography
• Coronary Angiography (methods)
• Coronary Artery Disease (diagnostic imaging, therapy)
• Coronary Thrombosis (etiology)
• Drug-Eluting Stents
• Equipment Design
• Feasibility Studies
• Female
• Humans
• Male
• Middle Aged
• Netherlands
• Prospective Studies
• ST Elevation Myocardial Infarction (diagnostic imaging, therapy)
• Time Factors
• Treatment Outcome