title: 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.
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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (ID: NCT02193971, 13 July 2014).
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. drone80@hanmail.net.
authors.forename: Joo Myung
authors.initials: JM
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. jbjhyun@naver.com.
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Jung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. kwparkmd@snu.ac.kr.
authors.forename: Kyung Woo
authors.initials: KW
authors.lastname: Park
authors.affiliation: Division of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. sesim1989@gmail.com.
authors.forename: Eun-Seok
authors.initials: ES
authors.lastname: Shin
authors.affiliation: Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea. oskcar@wonkwang.ac.kr.
authors.forename: Seok Kyu
authors.initials: SK
authors.lastname: Oh
authors.affiliation: Chungbuk National University, Cheongju, Republic of Korea. drcorazon@hanmail.net.
authors.forename: Jang-Whan
authors.initials: JW
authors.lastname: Bae
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Presbyterian Medical Center, Jeonju, Republic of Korea. jyrhew@nate.com.
authors.forename: Jay Young
authors.initials: JY
authors.lastname: Rhew
authors.affiliation: Cardiology Division, Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea. krheart@hallym.or.kr.
authors.forename: Namho
authors.initials: N
authors.lastname: Lee
authors.affiliation: Cardiovascular Center, St. Paul's Hospital, The Catholic University of Korea, Seoul, Korea. kim-dongbin@hanmail.net.
authors.forename: Dong-Bin
authors.initials: DB
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Yeungnam University Medical Center, Daegu, Korea. woongwa@hanmail.net.
authors.forename: Ung
authors.initials: U
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. hpcrates@medimail.co.kr.
authors.forename: Jung-Kyu
authors.initials: JK
authors.lastname: Han
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. sangeunlee.md@gmail.com.
authors.forename: Sang Eun
authors.initials: SE
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. hanname@hanmail.net.
authors.forename: Han-Mo
authors.initials: HM
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. nowkang@snu.ac.kr.
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. bkkoo@snu.ac.kr.
authors.forename: Bon-Kwon
authors.initials: BK
authors.lastname: Koo
authors.affiliation: Cardiovascular Center, Seoul National University, Boramae Medical Center, Seoul, Korea. shkimmd@snu.ac.kr.
authors.forename: Sanghyun
authors.initials: S
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University College of Medicine, Daegu, Korea. ds010042@gmail.com.
authors.forename: Yun Kyeong
authors.initials: YK
authors.lastname: Cho
authors.affiliation: Department of Cardiology, Soon Chun Hyang University Hospital Cheonan, Cheonan, Korea. shinwy@schmc.ac.kr.
authors.forename: Won-Yong
authors.initials: WY
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Hanyang University Medical Center, Seoul, Korea. mdoim@hanyang.ac.kr.
authors.forename: Young-Hyo
authors.initials: YH
authors.lastname: Lim
authors.affiliation: Korea University Guro Hospital, Seoul, Republic of Korea. swrha617@yahoo.co.kr.
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.affiliation: Department of Cardiology, Seoul Medical Center, Seoul, Korea. ks7688@hanmail.net.
authors.forename: Seok-Yeon
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Inje University Ilsan Paik Hospital, Goyang, Republic of Korea. im2pci@gmail.com.
authors.forename: Sung Yun
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Dong-A University Hospital, Busan, Korea. kimyd@mail.donga.ac.kr.
authors.forename: Young-Dae
authors.initials: YD
authors.lastname: Kim
authors.affiliation: Seoul National University Bundang Hospital, Seongnam, Republic of Korea. ihchae@snubh.org.
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.affiliation: Department of Cardiology, Pusan National University Hospital, Busan, South Korea. chakws1@hanmail.net.
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, Korea. usahyosoo@gmail.com.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D020341:Absorbable Implants; D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000208:ethnology / Q000401:mortality / Q000628:therapy*; D044466:Asian People; D002423:Cause of Death; D002985:Clinical Protocols; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus / Q000008:administration & dosage; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011108:Polymers / Q000009:adverse effects; D000068799:Prasugrel Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea / Q000453:epidemiology; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D000068338:Everolimus; D000068799:Prasugrel Hydrochloride