title: Prasugrel, a third-generation P2Y12 receptor antagonist, in patients with coronary artery disease undergoing elective percutaneous coronary intervention.
abstract: BACKGROUND
  Prasugrel is being developed in Japan as an antiplatelet therapy for use during percutaneous coronary intervention (PCI). Up to 70% of Japanese patients with coronary artery disease undergo elective PCI. The PRASugrel For Japanese PatIenTs with Coronary Artery Diseases Undergoing Elective PCI (PRASFIT-Elective) study investigated the efficacy and safety of different prasugrel dosing regimens in Japanese patients undergoing elective PCI. METHODS AND RESULTS: A total of 742 patients scheduled for elective coronary artery stenting were enrolled. Patients were randomized to receive either prasugrel (20/3.75 mg, loading/maintenance dose) or clopidogrel (300/75 mg) in a double-blind manner. Endpoints, including cardiovascular events and bleeding, were assessed at weeks 24-48. The incidence rate of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke) up to week 24 was 4.1% (15/370) and 6.7% (25/372) in the prasugrel and clopidogrel groups, respectively. Other incidence rates were: non-coronary artery bypass graft-related major bleeding, 0% and 2.2%; major/minor bleeding, 1.6% and 3.0%; and all bleeding events, 38.1% and 34.4% in the prasugrel and clopidogrel groups, respectively. The incidence rate of bleeding-related adverse events was similar in both groups, being 40.8% and 35.8% in the prasugrel and clopidogrel groups, respectively.
  
  
  CONCLUSIONS
  These results support the risk-benefit profile of an adjusted dosing regimen of prasugrel in Japanese patients undergoing PCI. Larger studies are required to confirm these findings.
authors.affiliation: Division of Cardiology, Teikyo University Hospital.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Isshiki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.forename: Morimasa
authors.initials: M
authors.lastname: Takayama
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kitagawa
authors.forename: Masakatsu
authors.initials: M
authors.lastname: Nishikawa
authors.forename: Shunichi
authors.initials: S
authors.lastname: Miyazaki
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000453:epidemiology; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000188:drug therapy* / Q000601:surgery; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D005500:Follow-Up Studies; D005787:Gene Frequency; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010974:Platelet Aggregation / Q000187:drug effects; D011183:Postoperative Complications / Q000453:epidemiology; D000068799:Prasugrel Hydrochloride; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015607:Stents; D013876:Thiophenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D010879:Piperazines; D058921:Purinergic P2Y Receptor Antagonists; D013876:Thiophenes; D000077144:Clopidogrel; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine