title: Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.
abstract: OBJECTIVE
  Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population.
  
  
  METHODS
  The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5.
  
  
  CONCLUSIONS
  The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation.
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Joo Myung
authors.initials: JM
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Myongji Hospital, Gyenggi-Do, South Korea.
authors.forename: Deok-Kyu
authors.initials: DK
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jyhahn@skku.edu.
authors.forename: Joo-Yong
authors.initials: JY
authors.lastname: Hahn
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Young Bin
authors.initials: YB
authors.lastname: Song
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Taek Kyu
authors.initials: TK
authors.lastname: Park
authors.affiliation: Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.
authors.forename: Ju-Hyeon
authors.initials: JH
authors.lastname: Oh
authors.affiliation: Daegu Catholic University Medical Center, Daegu, Republic of Korea.
authors.forename: Jin Bae
authors.initials: JB
authors.lastname: Lee
authors.affiliation: Department of Medicine, Inje University Ilsan Paik Hospital, Goyang, South Korea.
authors.forename: Joon-Hyung
authors.initials: JH
authors.lastname: Doh
authors.affiliation: Cardiovascular Center, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jeong Hoon
authors.initials: JH
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jin-Ho
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Seung-Hyuck
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: hcgwon62@gmail.com.
authors.forename: Hyeon-Cheol
authors.initials: HC
authors.lastname: Gwon
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000628:therapy*; D000328:Adult; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D000077144:Clopidogrel; D016903:Drug Monitoring; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D056910:Republic of Korea; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; D000077144:Clopidogrel; C489443:zotarolimus; D013988:Ticlopidine; D001241:Aspirin; C518022:umirolimus; D020123:Sirolimus