title: The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.
  
  
  METHODS
  In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.
  
  
  CONCLUSIONS
  The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.
  
  
  BACKGROUND
  ClincalTrials.gov number NCT01267734.
authors.affiliation: Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehang-no, Seoul 110-744, South Korea.
authors.forename: Kyung Woo
authors.initials: KW
authors.lastname: Park
authors.forename: Byoung-Eun
authors.initials: BE
authors.lastname: Park
authors.forename: Si-Hyuck
authors.initials: SH
authors.lastname: Kang
authors.forename: Jin-Joo
authors.initials: JJ
authors.lastname: Park
authors.forename: Seung-Pyo
authors.initials: SP
authors.lastname: Lee
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
authors.forename: Jay Young
authors.initials: JY
authors.lastname: Rhew
authors.forename: Hui-Kyoung
authors.initials: HK
authors.lastname: Jeon
authors.forename: Eun Seok
authors.initials: ES
authors.lastname: Shin
authors.forename: Ju Hyeon
authors.initials: JH
authors.lastname: Oh
authors.forename: Myung-Ho
authors.initials: MH
authors.lastname: Jeong
authors.forename: Sanghyun
authors.initials: S
authors.lastname: Kim
authors.forename: Kyung-Kuk
authors.initials: KK
authors.lastname: Hwang
authors.forename: Jung-Han
authors.initials: JH
authors.lastname: Yoon
authors.forename: Sung Yun
authors.initials: SY
authors.lastname: Lee
authors.forename: Tae-Ho
authors.initials: TH
authors.lastname: Park
authors.forename: Keon Woong
authors.initials: KW
authors.lastname: Moon
authors.forename: Hyuck-Moon
authors.initials: HM
authors.lastname: Kwon
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002857:Chromium; D002858:Chromium Alloys; D023921:Coronary Stenosis / Q000188:drug therapy / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010984:Platinum; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D012107:Research Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D002857:Chromium; D010984:Platinum; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus