RT Journal Article
SR Electronic
T1 Polymer-free sirolimus-eluting stents in a large-scale all-comers population
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e000592
DO 10.1136/openhrt-2017-000592
VO 4
IS 2
A1 Florian Krackhardt
A1 Viktor Kočka
A1 Matthias W. Waliszewski
A1 Andreas Utech
A1 Meik Lustermann
A1 Martin Hudec
A1 Martin Studenčan
A1 Markus Schwefer
A1 Jiangtao Yu
A1 Myung Ho Jeong
A1 Taehoon Ahn
A1 Wan Azman Wan Ahmad
A1 Michael Boxberger
A1 André Schneider
A1 Matthias Leschke
YR 2017
UL http://openheart.bmj.com/content/4/2/e000592.abstract
AB Objective The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied.Methods Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, ‘all comers’ observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated.Results A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001).Conclusions PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).Trial registration number NCT02629575.