Author + information
- Floris Kauer1,
- Marcus Siry2,
- Daniel Weilenmann3,
- Adam Sukiennik4,
- Samer Somi5,
- David Bouchez6 and
- Alexander Ijsselmuiden7
- 1Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands
- 2Klinikum Memmingen, Memmigen, Germany
- 3Dept of Cardiology, Kantonsspital St. Gallen, St. Gallen, Switzerland
- 4Department of Cardiology Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland
- 5HAGA Ziekenhuis, Den Haag, Netherlands
- 6Stentys, Paris, France
- 7Amphia, Breda, Netherlands
While treating a coronary lesion, difficulties are encountered when the vessel presents significant diameter variance or when the diameter is difficult to estimate. Conventional stents are tubular, and often require optimization steps, which may be aggressive for the vessel and abuse the stent structure. Stent apposition is still not guaranteed. Clinical risks may be associated. To date there is a scarcity of data in the use of any coronary stents in these challenging lesions. We investigate the self-apposing sirolimus eluting coronary stent Xposition S (STENTYS,Paris) in these lesions in everyday practice.
The worldwide SIZING registry is designed to provide clinical outcome data on STENTYS stents, from routine clinical practice, in lesion subsets with significant vessel diameter variance: eg. left main coronary, aneurysmatic /ectatic (A/E)vessels, bifurcations, vessels with high thrombus load, significantly tapered vessels, vein grafts,… 3000 patients are expected to be enrolled.The primary endpoint is MACE at 12 months (cardiac death, target vessel related MI, clinically driven TLR).
1650 patients with the different generations of the STENTYS stents were enrolled: this is the largest self-apposing coronary stent registry to date. We report here on an interim analysis of SIZING on all patients with Xposition S. Since March 2015, a total of 588 patients with Xposition S have been enrolled. Median follow-up was 365 days (mean:278 days). Mean age was 65±13year. 66% of patients had ACS, 32% were STEMI patients. Device success rate was 97%. 24.7% of patients received Xposition S for lesions in A/E vessels,16.8% for lesion with thrombus,16.0% in left main or bifurcation,11.2% in significantly tapered vessels,7.5% in saphenous vein grafts. MACE rate is 5.3%. Stent thrombosis rate is low at 1.5%. MACE rate is 5.8% in the A/E vessels group,3.1% in tapered vessels,4.5% in large vessels (≥4,5mm). Events adjudication is ongoing, further subgroup analysis will be presented.
It is the first time large data on Xposition S is reported. The interim analysis of the SIZING registry confirms the interest of the Xposition S in these challenging anatomies where vessel diameter varies.
CORONARY: Stents: Drug-Eluting