title: One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial.
abstract: There has been no previous prospective study evaluating dual antiplatelet therapy (DAPT) duration shorter than 6 months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration after CoCr-EES implantation. The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding at 1 year. Between September 2012 and October 2013, a total of 1525 patients were enrolled from 58 Japanese centers, with complete 1-year follow-up in 1519 patients (99.6 %). Thienopyridine was discontinued within 4 months in 1444 patients (94.7 %). The event rates beyond 3 months were very low (cardiovascular death: 0.5 %, MI: 0.1 %, ST: 0 %, stroke: 0.7 %, and TIMI major/minor bleeding: 0.8 %). Cumulative 1-year incidence of the primary endpoint was 2.8 % [upper 97.5 % confidence interval (CI) 3.6 %], which was lower than the pre-defined performance goal of 6.6 % (P < 0.0001). Using the CoCr-EES group in the RESET trial as a historical comparison group, where nearly 90 % of patients had continued DAPT at 1 year, cumulative incidence of the primary endpoint tended to be lower in the STOPDAPT than in the RESET (2.8 versus 4.0 %, P = 0.06) and adjusted hazard ratio was 0.64 (95 % CI 0.42-0.95, P = 0.03). The cumulative incidence of definite/probable ST was lower in the STOPDAPT than in the RESET [0 patient (0 %) versus 5 patients (0.3 %), P = 0.03]. In conclusion, stopping DAPT at 3 months in selected patients after CoCr-EES implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.
authors.affiliation: Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Natsuaki
authors.affiliation: Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Erika
authors.initials: E
authors.lastname: Yamamoto
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shiomi
authors.affiliation: Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Furukawa
authors.affiliation: Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Abe
authors.affiliation: Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Nakao
authors.affiliation: Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ishikawa
authors.affiliation: Division of Cardiology, Chikamori Hospital, Kochi, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Kawai
authors.affiliation: Division of Cardiology, Osaka City General Hospital, Osaka, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Yunoki
authors.affiliation: Division of Cardiology, Mashiko Hospital, Kawaguchi, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Shimizu
authors.affiliation: Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Akao
authors.affiliation: Division of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Miki
authors.affiliation: Division of Cardiology, Kimitsu Chuo Hospital, Kimitsu, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan.
authors.forename: Hisayuki
authors.initials: H
authors.lastname: Okada
authors.affiliation: Division of Cardiology, Nagai Hospital, Tsu, Japan.
authors.forename: Kozo
authors.initials: K
authors.lastname: Hoshino
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kadota
authors.affiliation: Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.affiliation: Division of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Igarashi
authors.affiliation: Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.affiliation: Division of Cardiology, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. taketaka@kuhp.kyoto-u.ac.jp.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D000368:Aged; D002858:Chromium Alloys; D003324:Coronary Artery Disease / Q000628:therapy; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D002858:Chromium Alloys; D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus
keywords: Coronary artery disease; Coronary stent; Dual antiplatelet therapy; Everolimus-eluting stent