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Harmonizing Optimal Strategy for Treatment of coronary artery diseases--comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial

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Author(s)
Joo Myung LeeJi-Hyun JungKyung Woo ParkEun-Seok ShinSeok Kyu OhJang-Whan BaeJay Young RhewNamho LeeDong-Bin KimUng KimJung-Kyu HanSang Eun LeeHan-Mo YangHyun-Jae KangBon-Kwon KooSanghyun KimYun Kyeong ChoWon-Yong ShinYoung-Hyo LimSeung-Woon RhaSeok-Yeon KimSung Yun LeeYoung-Dae KimIn-Ho ChaeKwang Soo ChaHyo-Soo Kim
Keimyung Author(s)
Cho, Yun Kyeong
Department
Dept. of Internal Medicine (내과학)
Journal Title
Trials
Issued Date
2015
Volume
16
Issue
409
Abstract
Background: Antiplatelet treatment is an important component in optimizing the clinical outcomes after
percutaneous coronary intervention (PCI) especially in patients with acute coronary syndrome (ACS). Prasugrel,
which is a new P2Y12 inhibitor, has been confirmed as efficacious in a large trial in Western countries, and a
similar trial is also to be launched in Asian countries. Although a 60-mg loading dose of prasugrel followed by 10 mg
per day should be acceptable, there have been no data regarding the optimal dose in Asian patients. Furthermore,
serum levels of prasugrel and the rates of platelet inhibition are known to be higher in Asians than Caucasians
with the same dose of the drug.
Polymer, a key component of drug-eluting stents (DES), has been suggested as the cause of inflammation
leading to late complications, and has driven many companies to develop biodegradable-polymer DES. Currently, there
are limited data regarding the head-to-head comparison between BP-BES and the biostable polymer CoCr-EES
or the newest platinum-chromium everolimus-eluting stent (PtCr-EES). Furthermore, the polymer issue may be
more important in ACS where there is ruptured thrombotic plaque where polymer-induced inflammation may
affect the local milieu of the stented artery.
Therefore, the present study dedicated only to ACS patients, will offer important information on the optimal
prasugrel dose in the Asian population by comparing a 10-mg versus a 5-mg maintenance dose beyond
1 month after PCI, as well as giving important insight into the polymer issue by comparing BP-BES versus
biostable-polymer PtCr-EES. Method/Design: Harmonizing Optimal Strategy for Treatment of coronary artery diseases – comparison of
REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS) trial is
a multicenter, randomized and open-label clinical study with a 2 × 2 factorial design, according to the type of
stent (PtCr-EES versus BP-BES) and prasugrel maintenance dose (5 mg versus 10 mg), to demonstrate non-inferiority of
PtCr-EES relative to BP-BES or the reduced prasugrel dose relative to conventional dose in an Asian all-comers PCI
population presenting with ACS. Approximately 3400 patients will undergo prospective, random assignment
separately to either stent or prasugrel arm (1:1 ratio, respectively). When the patients have contraindications
to prasugrel, they are categorized into an antiplatelet observation group after stent-randomization. The primary
endpoint is the patient-oriented composite outcome, which is a composite of all-cause mortality, any myocardial
infarction (MI), any repeat revascularization in the stent arm at 12 months after index PCI. In the prasugrel arm,
primary endpoint is any major adverse cardiovascular event, which is a composite of all-cause mortality, any MI,
any stent thrombosis (Academic Research Consortium (ARC)-defined), any repeat revascularization, stroke, or
bleeding (BARC class ≥ 2).
Discussion: The HOST-REDUCE-POLYTECH-ACS RCT is the first study exploring the optimal maintenance dose of
prasugrel beyond 1 month after PCI for ACS in Asian all-comers. In addition, this is the largest study dedicated
only to ACS patients to evaluate the polymer issue in the situation of ACS by directly comparing biostable-polymer
PtCr-EES versus BP-BES.
Keimyung Author(s)(Kor)
조윤경
Publisher
School of Medicine
Citation
Joo Myung Lee et al. (2015). Harmonizing Optimal Strategy for Treatment of coronary artery diseases--comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial. Trials, 16(409), 1–10. doi: 10.1186/s13063-015-0925-5
Type
Article
ISSN
1745-6215
DOI
10.1186/s13063-015-0925-5
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32972
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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