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

Joo Myung Lee, Ji Hyun Jung, Kyung Woo Park, Eun Seok Shin, Seok Kyu Oh, Jang Whan Bae, Jay Young Rhew, Namho Lee, Dong Bin Kim, Ung Kim, Jung Kyu Han, Sang Eun Lee, Han Mo Yang, Hyun Jae Kang, Bon Kwon Koo, Sanghyun Kim, Yun Kyeong Cho, Won Yong Shin, Young Hyo Lim, Seung-Woon Rha & 6 others Seok Yeon Kim, Sung Yun Lee, Young Dae Kim, In Ho Chae, Kwang Soo Cha, Hyo Soo Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Article number409
JournalTrials
Volume16
Issue number1
DOIs
Publication statusPublished - 2015 Sep 15

Fingerprint

Acute Coronary Syndrome
Coronary Artery Disease
Stents
Randomized Controlled Trials
Technology
Polymers
Chromium
Percutaneous Coronary Intervention
Platinum
Therapeutics
Drug-Eluting Stents
Prasugrel Hydrochloride
Myocardial Infarction
Inflammation
Mortality
Random Allocation
Population
Thrombosis
Blood Platelets
Arteries

Keywords

  • Acute coronary syndrome
  • Biodegradable implants
  • Drug-eluting stent
  • Everolimus
  • Prasugrel

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / Lee, Joo Myung; Jung, Ji Hyun; Park, Kyung Woo; Shin, Eun Seok; Oh, Seok Kyu; Bae, Jang Whan; Rhew, Jay Young; Lee, Namho; Kim, Dong Bin; Kim, Ung; Han, Jung Kyu; Lee, Sang Eun; Yang, Han Mo; Kang, Hyun Jae; Koo, Bon Kwon; Kim, Sanghyun; Cho, Yun Kyeong; Shin, Won Yong; Lim, Young Hyo; Rha, Seung-Woon; Kim, Seok Yeon; Lee, Sung Yun; Kim, Young Dae; Chae, In Ho; Cha, Kwang Soo; Kim, Hyo Soo.

In: Trials, Vol. 16, No. 1, 409, 15.09.2015.

Research output: Contribution to journalArticle

Lee, JM, Jung, JH, Park, KW, Shin, ES, Oh, SK, Bae, JW, Rhew, JY, Lee, N, Kim, DB, Kim, U, Han, JK, Lee, SE, Yang, HM, Kang, HJ, Koo, BK, Kim, S, Cho, YK, Shin, WY, Lim, YH, Rha, S-W, Kim, SY, Lee, SY, Kim, YD, Chae, IH, Cha, KS & Kim, HS 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, vol. 16, no. 1, 409. https://doi.org/10.1186/s13063-015-0925-5
Lee, Joo Myung ; Jung, Ji Hyun ; Park, Kyung Woo ; Shin, Eun Seok ; Oh, Seok Kyu ; Bae, Jang Whan ; Rhew, Jay Young ; Lee, Namho ; Kim, Dong Bin ; Kim, Ung ; Han, Jung Kyu ; Lee, Sang Eun ; Yang, Han Mo ; Kang, Hyun Jae ; Koo, Bon Kwon ; Kim, Sanghyun ; Cho, Yun Kyeong ; Shin, Won Yong ; Lim, Young Hyo ; Rha, Seung-Woon ; Kim, Seok Yeon ; Lee, Sung Yun ; Kim, Young Dae ; Chae, In Ho ; Cha, Kwang Soo ; Kim, Hyo Soo. / 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. In: Trials. 2015 ; Vol. 16, No. 1.
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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.",
keywords = "Acute coronary syndrome, Biodegradable implants, Drug-eluting stent, Everolimus, Prasugrel",
author = "Lee, {Joo Myung} and Jung, {Ji Hyun} and Park, {Kyung Woo} and Shin, {Eun Seok} and Oh, {Seok Kyu} and Bae, {Jang Whan} and Rhew, {Jay Young} and Namho Lee and Kim, {Dong Bin} and Ung Kim and Han, {Jung Kyu} and Lee, {Sang Eun} and Yang, {Han Mo} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Sanghyun Kim and Cho, {Yun Kyeong} and Shin, {Won Yong} and Lim, {Young Hyo} and Seung-Woon Rha and Kim, {Seok Yeon} and Lee, {Sung Yun} and Kim, {Young Dae} and Chae, {In Ho} and Cha, {Kwang Soo} and Kim, {Hyo Soo}",
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T2 - Study protocol for a randomized controlled trial

AU - Lee, Joo Myung

AU - Jung, Ji Hyun

AU - Park, Kyung Woo

AU - Shin, Eun Seok

AU - Oh, Seok Kyu

AU - Bae, Jang Whan

AU - Rhew, Jay Young

AU - Lee, Namho

AU - Kim, Dong Bin

AU - Kim, Ung

AU - Han, Jung Kyu

AU - Lee, Sang Eun

AU - Yang, Han Mo

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Kim, Sanghyun

AU - Cho, Yun Kyeong

AU - Shin, Won Yong

AU - Lim, Young Hyo

AU - Rha, Seung-Woon

AU - Kim, Seok Yeon

AU - Lee, Sung Yun

AU - Kim, Young Dae

AU - Chae, In Ho

AU - Cha, Kwang Soo

AU - Kim, Hyo Soo

PY - 2015/9/15

Y1 - 2015/9/15

N2 - 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.

AB - 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.

KW - Acute coronary syndrome

KW - Biodegradable implants

KW - Drug-eluting stent

KW - Everolimus

KW - Prasugrel

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