-
Je něco špatně v tomto záznamu ?
Polymer-free sirolimus-eluting stents in a large-scale all-comers population
F. Krackhardt, V. Kočka, MW. Waliszewski, A. Utech, M. Lustermann, M. Hudec, M. Studenčan, M. Schwefer, J. Yu, MH. Jeong, T. Ahn, WA. Wan Ahmad, M. Boxberger, A. Schneider, M. Leschke,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články
NLK
Directory of Open Access Journals
od 2013
Free Medical Journals
od 2014
Freely Accessible Journals
od 2014
PubMed Central
od 2014
Europe PubMed Central
od 2014
ProQuest Central
od 2014-01-01
Open Access Digital Library
od 2013-01-01
Open Access Digital Library
od 2014-01-01
Health & Medicine (ProQuest)
od 2014-01-01
- Publikační typ
- časopisecké články MeSH
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.
Ambulantes Herzzentrum Kassel Kassel Germany
Cardiocentre of Teaching Hospital of J A Reiman Prešov Slovakia
Department of Cardiology Gil Hospital Gachon University Incheon Republic of Korea
Department of Cardiology SUSCCH a s Banská Bystrica Slovakia
Department of Cardiology University Hospital Královské Vinohrady Prague Czech Republic
Department of Kardiologie Elblandklinikum Riesa Riesa Germany
Department of Kardiologie Helmut G Walther Klinikum Lichtenfels Lichtenfels Germany
Department of Kardiologie Sudharz Klinikum Nordhausen gGmbH Nordhausen Thüringen Germany
Department of Medical Scientific Affairs B Braun Melsungen AG Berlin Germany
Division Cardiology Department of Medicine University Malaya Medical Centre Kuala Lumpur Malaysia
Division of Cardiology Chonnam National University Hospital Gwangju Republic of Korea
Kardiologie Campus Virchow Klinikum Charité Berlin Germany
Klinik für Kardiologie Angiologie Pneumologie Klinikum Esslingen Esslingen Baden Württemberg Germany
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc17032033
- 003
- CZ-PrNML
- 005
- 20171101105804.0
- 007
- ta
- 008
- 171025s2017 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/openhrt-2017-000592 $2 doi
- 035 __
- $a (PubMed)28761678
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Krackhardt, Florian $u Kardiologie, Campus Virchow-Klinikum Charité, Berlin, Germany.
- 245 10
- $a Polymer-free sirolimus-eluting stents in a large-scale all-comers population / $c F. Krackhardt, V. Kočka, MW. Waliszewski, A. Utech, M. Lustermann, M. Hudec, M. Studenčan, M. Schwefer, J. Yu, MH. Jeong, T. Ahn, WA. Wan Ahmad, M. Boxberger, A. Schneider, M. Leschke,
- 520 9_
- $a 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.
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Kočka, Viktor $u Department of Cardiology, University Hospital Královské Vinohrady, Prague, Czech Republic.
- 700 1_
- $a Waliszewski, Matthias W $u Department of Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany.
- 700 1_
- $a Utech, Andreas $u Ambulantes Herzzentrum Kassel, Kassel, Germany.
- 700 1_
- $a Lustermann, Meik $u Department of Kardiologie, Sudharz Klinikum Nordhausen gGmbH, Nordhausen, Thüringen, Germany.
- 700 1_
- $a Hudec, Martin $u Department of Cardiology, SUSCCH a.s., Banská Bystrica, Slovakia.
- 700 1_
- $a Studenčan, Martin $u Cardiocentre of Teaching Hospital of J.A. Reiman, Prešov, Slovakia.
- 700 1_
- $a Schwefer, Markus $u Department of Kardiologie, Elblandklinikum Riesa, Riesa, Germany.
- 700 1_
- $a Yu, Jiangtao $u Department of Kardiologie, Helmut-G.-Walther-Klinikum Lichtenfels, Lichtenfels, Germany.
- 700 1_
- $a Jeong, Myung Ho $u Division of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.
- 700 1_
- $a Ahn, Taehoon $u Department of Cardiology, Gil Hospital, Gachon University, Incheon, Republic of Korea. $7 gn_A_00002515
- 700 1_
- $a Wan Ahmad, Wan Azman $u Division Cardiology, Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia.
- 700 1_
- $a Boxberger, Michael $u Department of Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany.
- 700 1_
- $a Schneider, André $u Klinik für Kardiologie, Angiologie, Pneumologie, Klinikum Esslingen, Esslingen, Baden-Württemberg, Germany.
- 700 1_
- $a Leschke, Matthias $u Klinik für Kardiologie, Angiologie, Pneumologie, Klinikum Esslingen, Esslingen, Baden-Württemberg, Germany.
- 773 0_
- $w MED00186378 $t Open heart $x 2053-3624 $g Roč. 4, č. 2 (2017), s. e000592
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/28761678 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20171025 $b ABA008
- 991 __
- $a 20171101105855 $b ABA008
- 999 __
- $a ind $b bmc $g 1255626 $s 993060
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2017 $b 4 $c 2 $d e000592 $e 20170606 $i 2053-3624 $m Open heart $n Open Heart $x MED00186378
- LZP __
- $a Pubmed-20171025