• 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,

. 2017 ; 4 (2) : e000592. [pub] 20170606

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc17032033

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.

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

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...