• 1 Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin
  • 2 University Hospital Královské Vinohrady Prague, Czech Republic
  • 3 IKEM Prague, Czech Republic
  • 4 SÚSCCH, a.s. Banská Bystrica, Slovak Republic
  • 5 Hospital General Universitario de Ciudad Real, Ciudad Real
  • 6 Hospital Universitario de Cruces, Bilbao
  • 7 Hospital Universitari Vall d'Hebron
  • 8 Hospital Universitari Germans Trias i Pujol, Badalona, Spain
  • 9 Medical Scientific Affairs, B.Braun France, Saint Cloud, France
  • 10 Pantai Ayer Keroh Hospital, Malaysia
  • 11 Gachon University Gil Medical Center, Incheon
  • 12 Chonnam National University, Gwangju
  • 13 Daegu Fatima Hospital
  • 14 Kangdong Sacred Heart Hospital, South Korea
  • 15 Clinique du Millénaire, Montpellier
  • 16 Clinique Turin Paris
  • 17 Hôpital Albert Schweitzer Colmar
  • 18 Centre Hospitalier d'Avignon, Avignon, France
  • 19 Städtische Kliniken Esslingen, Esslingen, Germany
Medicine (Baltimore), 2020 Feb;99(8):e19119.
PMID: 32080086 DOI: 10.1097/MD.0000000000019119


Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol ( Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.